sirolimus and Coronary-Artery-Disease

Long-term data concerning the efficacy of different polymer-coating strategies of new-generation drug-eluting stents (DES) in patients with coronary artery calcification (CAC) are scant.. We aimed to investigate 10-year outcomes by degree of CAC after new-generation DES implantation with different polymer-coating strategies.. We analysed individual patient and lesion characteristics of patients randomised to treatment with polymer-free sirolimus-eluting, biodegradable-polymer sirolimus-eluting and permanent-polymer zotarolimus- or everolimus-eluting stents. Endpoints of interest at 10 years were all-cause mortality, myocardial infarction (MI), target lesion revascularisation (TLR) and definite or probable stent thrombosis (ST) according to the degree of CAC (no, mild, moderate or severe) and coating strategy (polymer-free vs biodegradable-polymer vs permanent-polymer).. A total of 4,953 patients with 6,924 lesions were included. No, mild, moderate or severe CAC was present in 24.5%, 41.8%, 25.8% and 8.0% of patients, respectively. At 10-year follow-up, overall event rates were high, with an incremental increase according to the degree of CAC (all-cause mortality: no 25.3%, mild 32.1%, moderate 41.7%, severe CAC 46.5%; adjusted [adj.] p=0.004; TLR: no 17.4%, mild 16.5%, moderate 19.8%, severe CAC 28.7%; adj. p=0.001; MI: no 4.9%, mild 5.9%, moderate 6.0%, severe CAC 10.5%; adj. p=0.02; and ST: no 1.3%, mild 1.4%, moderate 1.8%, severe CAC 3.6%; adj. p=0.57). In patients with moderate-severe CAC, event rates were comparable, regardless of the DES polymer-coating strategy.. At 10 years after PCI with new-generation DES, there was an incremental increase in adverse events by degree of coronary calcification. These detrimental effects do not seem to be impacted by different polymer-coating strategies.

Topics: Calcinosis; Coronary Artery Disease; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus; Thrombosis; Treatment Outcome

Improvements in coronary drug-eluting stent technology has focused on reducing the long-term complications associated with the effects of the residual footprint on the vessel wall. Although many of the newer stents have exhibited noninferiority to the durable polymer everolimus-eluting stent (DP-EES), they have yet to exhibit clear superiority. We compared the performance of the latest ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES) to DP-EES.. We searched the electronic databases for randomized controlled trials comparing BP-SES to DP-EES. A random effect meta-analysis was performed using the Poisson regression model. The primary end point was target lesion failure (TLF), a composite of target vessel myocardial infarction (TVMI), cardiac death and target lesion revascularization (TLR).. There was no difference between the stents in stent thrombosis [incidence rate ratio (IRR) = 0.79, 95% confidence interval (CI) 0.58-1.06), TLR (IRR = 0.88, 95% CI 0.57-1.38), TVMI (IRR = 0.79, 95% CI 0.61-1.01), cardiac death (IRR = 0.99, 95% CI 0.76-1.29) and target vessel failure (IRR = 0.82, 95% CI 0.64-1.06). In addition, there was no difference in TLF (IRR = 0.82, 95% CI 0.64-1.06). There was evidence of reduced TLF in small vessels with BP-SES based on definition used (defined as ≤2.75 mm; IRR 0.64, 95% CI 0.46-0.91 versus ≤3 mm; IRR 1.11, 95% CI 0.90-1.36).. In our study, the performance of the latest generation BP-SES was comparable to DP-EES but failed to show superiority. The possible benefit in patients with small vessels should be explored future trials.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus; Treatment Outcome

Percutaneous coronary interventions with drug-eluting stents is currently the preferred revascularization treatment strategy for coronary artery disease. Following the first generation, the second-generation drug-eluting stents was designed with a thinner strut, better biocompatible polymer with/without bioresorbable coating or even polymer-free struts. The SUPRAFLEX stent system has ultra-thin struts (60 μm) across all stent diameters and a biodegradable polymer coating, enabling 70% of the sirolimus elution within 7 days. SUPRAFLEX has been assessed in large scale randomized controlled trials. This review summarizes the design of the SUPRAFLEX stent, the results of the pivotal clinical trials and outlines the ongoing research programs.

Topics: Absorbable Implants; Coronary Artery Disease; Everolimus; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

Drug-eluting stents (DES) have been developed over recent decades and the implantation of DES is the standard of care in contemporary percutaneous coronary intervention for patients with coronary artery disease. The MiStent sirolimus-eluting stent has several unique features; ultra-thin (64 μm) struts, a bioresorbable polymer and a controlled drug release from microcrystalline sirolimus as a reservoir embedded in the vessel wall. Results of recent clinical trials demonstrated the potential performance of this state-of-the-art DES. In the present review, we provide an overview of the development of DES, in particular the design and performance of the novel MiStent sirolimus-eluting stent from technological and clinical points of view and discuss the potentials of this new type of DES.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Stents; Technology; Treatment Outcome

Newest generation drug-eluting stents combine biodegradable polymers with ultrathin stent platforms in order to minimize vessel injury and inflammatory response. Evidence from randomized controlled trials suggested that differences in stent design translate into differences in clinical outcome. The aim of the present study was to evaluate the safety and efficacy of ultrathin strut, biodegradable polymer sirolimus eluting stents (BP SES) compared with thin strut, durable polymer everolimus-eluting stents (DP EES) among patients undergoing percutaneous coronary intervention (PCI).. We pooled individual participant data from 5 randomized trials (NCT01356888, NCT01939249, NCT02389946, NCT01443104, NCT02579031) including a total of 5,780 patients, and performed a one-stage meta-analysis using a mixed effects Cox regression model.. At a median duration of follow-up of 739 days (interquartile range 365-1,806 days), target-lesion failure occurred in 337 (10.3%) and 304 (12.2%) patients treated with BP SES and DP EES (HR 0.86, 95%CI 0.71-1.06, P = .16). There were no significant differences between BP SES and DP EES with regards to cardiac death (111 (3.4%) vs 102 (4.1%); HR 1.05, 95%CI 0.80-1.37, P = .73), target-vessel myocardial infarction (136 (4.1%) vs 126 (5.0%), HR 0.79, 95%CI 0.62-1.01, P = .061), and clinically-driven target-lesion revascularization (163 (5.0%) vs 147 (5.9%); HR 0.94, 95%CI 0.75-1.18, P = .61). The effect was consistent across major subgroups. In a landmark analysis, there was no significant interaction between treatment effect and timing of events.. In this patient-level meta-analysis of 5 randomized controlled trials, BP SES were associated with a similar risk of target-lesion failure compared with DP EES among patients undergoing PCI.. PROSPERO registry (CRD42018109098).

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Factors; Sirolimus; Treatment Outcome

Advances in stent design and the development of bioresorbable polymers have allowed the development of novel stent technologies such as the Orsiro bioresorbable-polymer sirolimus eluting stent (BP-SES). Over several noninferiority trials, the BP-SES has demonstrated itself to be a safe and effective therapy for obstructive coronary artery disease. This article reviews the current evidence of the efficacy of the BP-SES and examines its performance in high-risk populations, such as patients presenting with ST-segment myocardial infarction, chronic total occlusions, diabetes, and small vessel disease.

Topics: Absorbable Implants; Acute Coronary Syndrome; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Percutaneous coronary intervention with a drug-eluting stent is the most common mode of revascularization for coronary artery disease. However, restenosis rates remain high. Non-stent-based local drug delivery by a drug-coated balloon (DCB) has been investigated, as it leaves no metallic mesh. A DCB consists of a semicompliant balloon coated with antiproliferative agents encapsulated in a polymer matrix, which is released into the wall after inflation and contact with the intima. DCB have demonstrated effectiveness in treating in-stent restenosis. Clinical studies using DCB in de novo coronary artery disease have shown mixed results, with a major benefit in small-vessel disease. Differences in study results are not only due to variations in DCB technology but also to disparity in procedural approach, "leave nothing behind" or "combination therapy," and vessel size. This review focuses on the available evidence from randomized trials and proposes a design for future clinical trials.

Topics: Angioplasty, Balloon, Coronary; Antineoplastic Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus

Topics: Clinical Trials as Topic; Coronary Artery Disease; Drug-Eluting Stents; Humans; Prosthesis Design; Sirolimus; Treatment Outcome

Topics: Clinical Trials as Topic; Coronary Artery Disease; Drug-Eluting Stents; Humans; Prosthesis Design; Sirolimus; Treatment Outcome

Percutaneous coronary intervention with the new generation drug eluting stents (DES) is 1 among the revascularization procedures required to treat patients with coronary artery disease (CAD). Since late stent thrombosis and silent myocardial infarction are highly associated with type 2 diabetes mellitus (T2DM), an analysis comparing the newer generation DES in this specific subgroup of patients would be scientifically relevant.In this analysis, we aimed to systematically compare the cardiovascular outcomes observed with the ultrathin bioresorbable polymer sirolimus eluting stents (SES) versus thin, durable polymer everolimus eluting stents (EES) following percutaneous coronary intervention in patients with T2DM.. Through online databases, relevant studies comparing ultrathin bioresorbable polymer SES versus the durable polymer EES were carefully searched. The cardiovascular outcomes were assessed during a follow-up time period of 1 year and more than 1 year (1-5 years) respectively. This meta-analysis was carried out by the latest version of the RevMan software. Following analysis, the results were represented by odds ratios (OR) with 95% confidence intervals (CI).. A total number of 1967 patients with T2DM were included in this analysis. During a 1 year follow-up time period, target lesion failure (TLF) (OR: 0.59, 95% CI: 0.34-1.02; P = .06, target vessel revascularization (TVR) (OR: 0.97, 95% CI: 0.55-1.70; P = .91) and target lesion revascularization (TLR) (OR: 0.91, 95% CI: 0.44-1.87; P = .79) were similarly observed with ultrathin bioresorbable polymer SES versus the thin, durable polymer EES in these patients with T2DM. Other cardiovascular outcomes including myocardial infarction (MI), major adverse cardiac events, all-cause mortality (OR: 0.72, 95% CI: 0.37-1.40; P = .34), cardiac death and stent thrombosis (OR: 0.85, 95% CI: 0.45-1.62; P = .63) were also similarly observed with these 2 types of new stents. During a follow-up time period above 1 year (1-5 years), still no significant difference was observed in TLF, TVR, TLR, major adverse cardiac events, MI, all-cause mortality, cardiac death and stent thrombosis (OR: 0.62, 95% CI: 0.33-1.16; P = .14).. The ultrathin bioresorbable polymer SES were similar to the durable polymer EES in these patients with T2DM. These 2 types of new generation stents were comparable in terms of cardiovascular outcomes. Hence, they might be recommended in patients with T2DM. Upcoming trials should be able to confirm this hypothesis.

Topics: Absorbable Implants; Cardiovascular Diseases; Coronary Artery Disease; Diabetes Mellitus, Type 2; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Outcome Assessment, Health Care; Percutaneous Coronary Intervention; Sirolimus

The aim of this study was to investigate the efficacy and safety of currently used drug-eluting stents (DES).. Head-to-head comparisons among newer DES have shown conflicting results.. For this network meta-analysis, randomized controlled trials comparing different types of currently used DES were searched in PubMed, Scopus, and proceedings of international meetings. The primary endpoint was target lesion failure (TLF) at 1 year and at long-term follow-up.. Seventy-seven trials with 99,039 patients were selected for this network meta-analysis. Among the 10 DES included in the meta-analysis, 4 received the most extensive investigation: Orsiro, XIENCE, Nobori/BioMatrix, and Resolute. At 1 year, the Orsiro stent was associated with lower rates of TLF compared with XIENCE (odds ratio [OR]: 0.84; 95% confidence interval [CI]: 0.71 to 0.98; p = 0.03), Resolute (OR: 0.81; 95% CI: 0.68 to 0.95; p = 0.01), and Nobori/BioMatrix (OR: 0.81; 95% CI: 0.67 to 0.98; p = 0.03). Orsiro had the highest probability to be the best (70.8%), with a surface under the cumulative ranking curve value of 95.9%. However, after a median follow-up period of 50 months (range: 24 to 60 months), no significant difference was apparent in the rates of TLF between any DES, although Orsiro still ranked as the best stent (58.6% probability to be the best). In addition, Orsiro had a lower rate of long-term definite stent thrombosis compared with Nobori/BioMatrix (OR: 0.60; 95% CI: 0.36 to 0.98; p = 0.04) and lower rates of definite and probable stent thrombosis compared with Resolute (OR: 0.66; 95% CI: 0.45 to 0.99; p = 0.04). No differences in cardiac mortality between any DES were observed.. Orsiro is associated with a lower 1-year rate of TLF compared with XIENCE, Resolute, and Nobori/BioMatrix but with an attenuation of the efficacy signal at long-term follow-up.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Humans; Network Meta-Analysis; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Treatment Outcome

The SLENDER Integrated Delivery System (IDS™) is an 'all-in-one' fixed-wire coronary stenting device designed for direct stenting, precluding the need for conventional guidewires and predilatation balloons. It achieves ultra-low profiles (crossing profiles as low as 0.029″/0.737 mm), enabling the downsizing of catheters to facilitate transradial intervention in a large subsets of patients. The IDS represents the first advance in coronary stent delivery since the introduction of rapid-exchange stent delivery systems >20 years ago. SLENDER IDS has demonstrated non-inferiority compared with commercial DES, excellent long-term safety and a potentially more efficient approach to PCI where patient comfort is enhanced, procedures are streamlined, and resource consumption is reduced. This paper will summarize the novel features of this new stent delivery system and the early clinical data demonstrating safety and efficacy.

Topics: Aged; Animals; Cardiac Catheterization; Cardiac Catheters; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Treatment Outcome

Coronary stent neoatherosclerosis, thrombosis, and restenosis remain significant concerns with new-generation drug-eluting stents (DES). The Dual-Therapy CD34 antibody-covered sirolimus-eluting stent [dual therapy stent (DTS)] is a sirolimus-eluting stent with CD34 antibodies immobilized on its luminal surface to capture circulating endothelial progenitor cells and promote early endothelialization. We conducted a meta-analysis to determine whether the DTS was superior to standard DES.. We conducted a comprehensive search for controlled randomized and non-randomized studies. We presented data using risk ratios (95% confidence intervals) and measured heterogeneity using Higgins' I. One-year TLR was significantly higher in the DTS arm compared with second-generation DES. There was no difference in the other 1-year clinical outcomes compared with standard DES.

Topics: Antibodies; Antigens, CD34; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Endothelial Progenitor Cells; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Re-Epithelialization; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Ultrathin bioresorbable polymer sirolimus-eluting stents (BP SES) have been proposed as an alternative to thin durable polymer drug-eluting stents (DP DES). Although BP SES show a significant decrease in target lesion failure rates, clear superiority with respect to efficacy and safety of BP SES in comparison to DP EES has not been consistently proven.. A comprehensive search of several electronic databases identified studies that assessed efficacy and safety of BP SES, compared with DP EES. Relative risks (RRs) were pooled across studies using a fixed-effects model and a random-effect model, respectively, calculating pooled RRs and associated 95% confidence intervals (CIs). The I statistic was used to assess heterogeneity. We retrieved six studies enrolling >7000 patients. BP SES significantly reduced the risk of target vessel myocardial infarction (RR, 0.79; 95% CI, 0.64-0.97; I = 0%; Test for overall effect: z = 2.24, P = 0.03) in comparison with DP EES using a random-effects model. Use of BP SES was associated with a significant reduction in any myocardial infarction (RR, 0.83; 95% CI, 0.70-0.98; I = 12%; Test for overall effect: z = 2.19, P = 0.03), using a fixed-effects model. The subgroup analyses demonstrated, following-up ≥2 years, a statistically significant 27% RR increase in the risk of all-case death for patients randomized to BP SES (RR, 1.27; 95% CI, 1.01-1.60; I = 0%; Test for overall effect: z = 2.08, P = 0.04). No differences in cardiac death, stent thrombosis events (STE), target lesion revascularization (TLR) and target vessel revascularization (TVR) between BP SES and DP EES were observed.. BP SES significantly reduced the risk of any myocardial infarction and target vessel myocardial infarction in comparison with DP EES. There were no differences in cardiac death, STE, TLR, TVR and all-cause death with its follow-up time <2 year between BP SES and DP EES. Following-up ≥2 years, a statistically significant 27% RR increase in the risk of all-case death for patients randomized to BP SES was observed.

Topics: Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Complex coronary artery bifurcation lesions occurred in hard clinical scenarios, such as acute coronary syndromes, may represent a challenge for interventional cardiologists, with not-defined general consensus on treatment. Even if provisional stenting is the most common option used to restore rapidly the coronary branches flow, improvements in industrial technologies and design of new dedicated bifurcation devices might open new modalities of treatment in these complex cases. The Axxess stent (Biosensors Europe SA, Morges, Switzerland) is a self-expanding biolimus-eluting conical V-shape stent, specifically designed to treat "easily" coronary artery bifurcation lesions, with reported favorable long-term clinical results in stable patients compared to a provisional technique. We report for the first time the feasibility to use this device in a case of "true double coronary bifurcation lesion" occurred in the context of acute coronary syndrome. Moreover, we reviewed studies with bifurcation dedicated devices and available cases of "true double bifurcation lesions", underlying advantages/disadvantages of using one device over the others during acute coronary syndrome.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Male; Prosthesis Design; Sirolimus; Treatment Outcome

The study estimated the health economic impact of a latest generation coronary stent with ultrathin struts and bioresorbable polymer coating.. The recent BIOFLOW V trial, an international FDA approval trial (ClinicalTrials.gov: NCT02389946), has shown that an ultrathin, bioresorbable polymer sirolimus-eluting stent had a significantly lower rate of target lesion failure and target vessel-related myocardial infarction than a thin, durable polymer everolimus-eluting stent at 12 months, driven by a lower rate of peri-procedural myocardial infarction (ppMI).. We used a Markov model to project mortality and cost outcomes of that lower ppMI rate from a U.S. health system perspective over a 12-month horizon. Model parameters were derived from BIOFLOW V trial data, a systematic literature review and expert interviews.. Use of the bioresorbable polymer sirolimus-eluting stent compared to durable polymer everolimus-eluting stent is associated with net reductions in medical cost of $124 (Interquartile Range (IQR) $97-154) per patient in 2018 US$, of which $115 (IQR $76-124) accrues to the initial admission and $10 (IQR $7-72) to cost of follow-up. The lower rate of ppMI translates into a gain of 0.000017 (IQR 0.000011-0.000022) quality-adjusted life-years (QALY) per patient.. Lower ppMI rates of bioresorbable polymer sirolimus-eluting stent translate into reductions in direct medical cost, while improving patient outcomes. Most of the cost reduction is attributed to the initial admission with moderate savings up to 12 months post-discharge.

Topics: Absorbable Implants; Cardiovascular Agents; Clinical Trials as Topic; Computer Simulation; Coronary Artery Disease; Cost Savings; Cost-Benefit Analysis; Drug Costs; Drug-Eluting Stents; Everolimus; Health Care Costs; Humans; Markov Chains; Models, Economic; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Several new coronary stents have been, or soon will be, introduced in the United States. These stents incorporate certain characteristics, such as polymer-free drug coatings, ultrathin stent struts, bioresorbable polymers, and composite materials, that address currently unmet clinical needs to enhance acute stent performance, improve longer-term clinical outcomes, and obviate obligatory prolonged dual antiplatelet therapy. This article reviews the key and novel features of these stents.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Prosthesis Design; Sirolimus; Treatment Outcome

Bioresorbable scaffolds (BRS) have been advocated as the 'fourth revolution' in interventional cardiology because they could provide temporary scaffolding and then 'disappear' (resorb) potentially significantly improving coronary artery disease treatment. BRS technology has gradually matured, and there are many devices available worldwide, which are currently undergoing preclinical or clinical testing. Due to the concerns related to polylactide scaffolds, magnesium alloy is now one of the most promising resorbable technologies despite available evidences on its performances

Topics: Absorbable Implants; Clinical Trials as Topic; Coronary Artery Disease; Drug-Eluting Stents; Humans; Magnesium; Sirolimus; Tissue Scaffolds

Patients with diabetes mellitus are prone to increased adverse outcomes after percutaneous coronary intervention, even with contemporary drug-eluting stents. Randomized controlled trials have demonstrated comparable clinical outcomes between an ultrathin bioresorbable-polymer sirolimus-eluting stent (BP-SES) and a thin-strut durable-polymer everolimus-eluting stent (DP-EES) that has specific labeling for patients with diabetes. We aimed to evaluate the safety and efficacy of the BP-SES in patients with diabetes mellitus. To determine the performance of the BP-SES in diabetic patients, patient-level data from the BIOFLOW II, IV, and V randomized controlled trials were pooled. The primary end point was target lesion failure (TLF), defined as the composite of cardiovascular death, target-vessel myocardial infarction, ischemia-driven target lesion revascularization, and definite or probable stent thrombosis, at 1 year. Among 1,553 BP-SES and 791 DP-EES patients, 757 diabetic patients were identified. Of the diabetic patients included in this analysis (494 BP-SES vs 263 DP-EES), the proportion of insulin- and noninsulin-treated patients was similar between groups. The 1-year TLF rate in the diabetic population was 6.3% in the BP-SES group and 8.7% in the DP-EES group (hazard ratio 0.82, 95% confidence interval 0.047 to 1.43, p = 0.493). There were no significant differences, based on stent type or diabetes treatment regimen, in TLF hazards. In a patient-level pooled analysis of the diabetic population from randomized trials, 1-year clinical safety and efficacy outcomes were similar in patients treated with ultrathin BP-SES and thin-strut DP-EES.

Topics: Absorbable Implants; Aged; Coronary Artery Disease; Diabetes Complications; Drug-Eluting Stents; Equipment Design; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Sirolimus; Treatment Outcome

Recent studies suggest the Orsiro sirolimus-eluting stent (O-SES), which has ultrathin struts with a biodegradable sirolimus-eluting polymer coating, performed better than contemporary drug-eluting stents (DES). We performed a meta-analysis to compare clinical outcomes for all randomized controlled trials (RCTs) of O-SES vs contemporary DES.. PubMed, Cochrane CENTRAL, and meeting abstracts were searched for all RCTs comparing O-SES with contemporary DES. Pooled estimates of longest available clinical outcomes at a minimum of one-year follow-up, presented as odds ratios (OR) [95% confidence intervals], were generated with random-effect models.. We included 8 RCTs with a total of 11,176 patients (5444 O-SES and 5732 contemporary DES [3537 EES, 1295 ZES, and 1264 BP-BES) with a mean age of 65±11, 74% were male, 40% underwent PCI for stable angina, and 56% for ACS. We assessed outcomes comparing O-SES vs. everolimus-eluting stents, vs. permanent-polymer DES, and vs. all DES including biodegradable-polymer DES. Orsiro performed comparably in all categories with a trend toward a reduction in myocardial infarction (0.83 [0.68, 1.02], p=0.07) and stent thrombosis (0.75 [0.54, 1.04], p=0.08).. Overall, the Orsiro SES had similar clinical outcomes to contemporary DES with a trend toward reduction in myocardial infarction and stent thrombosis.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The novel dual-therapy COMBO stent aims to promote vessel healing after percutaneous coronary intervention (PCI) in patients with coronary artery disease. The pro-healing technique consists of an anti-CD34+ antibody layer that attracts circulating endothelial progenitor cells (EPCs), which bind to the stent surface and allow rapid endothelialization by differentiation of the EPCs into normal endothelial cells. The COMBO stent combines this pro-healing technique with an abluminal drug elution of sirolimus. The promise of this dual-therapy stent is that it may safely allow a shortened duration of dual-antiplatelet therapy (DAPT) after stent placement. Moreover, with a mature endothelial layer, lower rates of in-stent restenosis may be expected. Clinical outcomes after COMBO stent implantation have been recently evaluated in both randomized trials and large, prospective, multicenter registries, showing low clinical event rates of in-stent restenosis and stent thrombosis. Randomized clinical trials (HARMONEE and RECOVERY) have demonstrated the non-inferiority of COMBO versus "first in class" second generation and newer generation drug-eluting stents. Safety and efficacy of 3 months of DAPT after COMBO stent placement in patients presenting with acute coronary syndrome has been evaluated in the large REDUCE randomized controlled trial, showing non-inferiority to standard duration of 12-month DAPT. In this review we provide an overview of the current pre-clinical and clinical evidence for the performance of the COMBO stent.

Topics: Acute Coronary Syndrome; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Endothelial Progenitor Cells; Humans; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Sirolimus

Drug-eluting stents revolutionized the treatment of coronary artery disease with vastly improved outcomes compared with bare metal stents. As stent technology has evolved, a wide variety of antiproliferative drugs have been developed to prevent stent restenosis and stent thrombosis. The Resolute stent system (Medtronic, CA, USA) elutes zotarolimus from a multipolymer blend to prevent early and late stent-related complications. The Resolute stents have evolved from the initial Resolute stent, to the Resolute Integrity™ and most recently, the Resolute Onyx™. These stents have been studied across a wide range of patients and coronary syndromes. They compare similarly in performance to their contemporary second generation stents. We present a review of the major trials involving these zotarolimus-eluting stents.

Topics: Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Treatment Outcome

The Orsiro biodegradable polymer sirolimus-eluting stent (O-SES) is a new-generation biodegradable polymer drug-eluting stent with the thinnest strut thickness to date developed to improve the percutaneous treatment of patients with coronary artery disease. We perform a meta-analysis of randomized clinical trials (RCTs) comparing the efficacy and safety of an ultra-thin, Orsiro biodegradable polymer sirolimus-eluting stent (O-SES) compared with durable polymer drug-eluting stents (DP-DESs).. Medline, Embase, and CENTRAL databases were searched for randomized controlled trials comparing the safety and efficacy of O-SES versus DP-DES. Paired reviewers independently screened citations, assessed risk of bias of included studies, and extracted data. We used the Mantel-Haenszel method to calculate risk ratio (RR) by means of a random-effects model.. Six RCTs with a total of 6949 patients were selected. All included trials were rated as low risk of bias. The O-SES significantly reduced the risk of myocardial infarction (RR 0.78, 95% confidence interval [CI] 0.62-0.98; I. Among patients undergoing percutaneous coronary intervention, O-SES resulted in significantly lower rates of myocardial infarction than DP-DES and had a trend toward reduction in stent thrombosis.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Treatment Outcome

The present manuscript reviews the mechanism of action of drug-coated balloons (DCBs), offering a brief summary of the main clinical evidence on these devices.. DCBs are regular semi-compliant balloons coated with antiproliferative agents that are rapidly released on contact with the vessel intima, exerting an anti-restenotic effect. This technology may offer some benefits of drug-eluting stents, in particular for the treatment of restenotic lesions, small vessels, and in patients at high-bleeding risk, when the prolonged dual antiplatelet regimen should be avoided. Most recent data have pointed to a possible benefit of these devices in treating bare metal stents (BMS) or drug-eluting stents in-stent restenosis (DES ISR), effectively reducing the recurrence of restenosis and avoiding additional layers of metal in the same coronary segment. In other clinical scenarios such as bifurcations, small vessels, and de novo lesions, data is more scarce and the benefits are still unclear. There are potential benefits related to the use of DCB in selected populations. However, larger clinical trials with longer follow-up are still needed to confirm the enthusiastic initial results.

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Equipment Failure; Foreign-Body Migration; Humans; Neointima; Paclitaxel; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

Treatment of coronary artery disease has made strides over the last decades. Development of drug eluting stents (DES), coated with a polymer layer and an anti-proliferative drug to reduce neointimal hyperplasia, has reduced the incidence of in-stent-restenosis relative to treatment with bare metal stents. Patients treated with first generation DES more likely suffer from (very) late events which can be cause by the permanent presence of a polymer. Therefore second generation DES with more biocompatible coatings, and third generation DES, with very thin struts coated with biodegradable polymers, were developed. Areas covered: The MiStent SES is one of these third generation DES and is designed to limit the duration of polymer exposure, optimize coronary vessel healing and more precisely and consistently control drug elution to improve safety and clinical outcomes. This review provides a detailed description of the technique behind the MiStent SES, and describes the pre-clinical and clinical trials conducted with this device to date. Expert commentary: Recent clinical trials have shown non-inferiority of very thin strut biodegradable polymer coated DES compared to durable polymer coated DES, whilst maintaining an excellent safety profile. Longer follow-up, to see the real potential benefits of these devices, is mandatory however.

Topics: Absorbable Implants; Animals; Clinical Trials as Topic; Coronary Artery Disease; Coronary Restenosis; Drug Implants; Drug Liberation; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Propensity Score; Prosthesis Design; Sirolimus; Swine; Time Factors; Treatment Outcome

The relative long-term efficacy and safety of sirolimus-eluting stents (SES) compared with paclitaxel-eluting stents (PES) in multiple comparative studies remains controversial. This report evaluates 29 randomized trials with 18,379 patients in whom long-term (more than 1 year) outcomes were evaluated. The primary outcomes were target lesion revascularization (TLR) and the secondary end points were death, cardiac death, myocardial infarction (MI), major adverse cardiac events (MACEs), target vessel revascularization (TVR) and stent thrombosis (ST). In comparison with PES, SES significantly reduced the long-term risk of TLR (RR=0.68; 95% CI=0.57 to 0.80, p<0.001), TVR (RR=0.69; 95% CI= 0.60 to 0.79, p<0.001) and MACE (RR=0.82; 95% CI= 0.77 to 0.88, p<0.001), while there were no significant difference with respect to death, cardiac death, MI and STbetween the two groups. SES performance was significantly better for reducing the former three outcomes and comparable for the majority of the secondary end points when compared against PES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cause of Death; Coronary Artery Disease; Drug-Eluting Stents; Humans; Male; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Sirolimus; Treatment Outcome

To compare the efficacy of limus-eluting stent (LES) with paclitaxel-eluting stent (PES) for patients with coronary small vessel disease.. The studies of LES and PES used for patients with coronary small vessel disease were searched in PubMed, Web of Science, ClinicalTrials, SinoMed, CNKI, Wanfang data and CQVIP. The relative risk (RR) estimates with 95% confidence intervals and other statistical variables were calculated with Stata 14.0, and the meta analysis was performed with RevMan 5.2.. Eight studies involving 4738 patients were included in the meta-analysis. Compared with PES, LES implantation was associated with significant reduction in major adverse cardiovascular events (. LES has better efficacy than PES for patients with coronary small vessel disease, which may be the preferred stents for these patients.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Humans; Paclitaxel; Sirolimus; Treatment Outcome

Patients with diabetes and coronary artery disease remain at high risk for adverse cardiovascular events after percutaneous coronary intervention. The efficacy and safety of the various drug-eluting stents (DES) in patients with diabetes is unclear.. Randomized controlled trials comparing first-generation DES [paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES)] with everolimus-eluting stents (EES) and zotarolimus-eluting stents (ZES) in diabetic patients were systematically searched. Efficacy [target vessel revascularization (TVR) and target lesion revascularization (TLR)] and safety [major adverse cardiac events (MACE), all-cause and cardiac mortality, myocardial infarction, stent thrombosis] outcomes were evaluated.. Eighteen randomized controlled trials comprising of 8095 patients (17,000 patient-years of follow-up) were included. Compared to first-generation DES, EES significantly decreased MACE by 18% (relative risk [RR]: 0.82, 95% confidence interval [CI]: 0.70-0.96), myocardial infarction by 43% (RR: 0.57, 95% CI: 0.39-0.84) and stent thrombosis by 46% (RR: 0.54, 95% CI: 0.35-0.82) in patients with diabetes. Moreover EES showed a trend towards reduction in rates of TLR and TVR (p=0.05). ZES was associated with 89% increased risk for TLR (RR: 1.89, 95% CI: 1.10-3.22) compared to first-generation DES. Furthermore, meta-regression analysis showed a greater magnitude of benefit of EES over first-generation DES for MACE (p=0.037) and stent thrombosis (p=0.036) in diabetic patients requiring Insulin.. In patients with diabetes and coronary artery disease undergoing stenting, EES is the most efficacious and safe DES. The outcomes data for ZES in diabetes patients were limited and further trials are needed.

Topics: Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Sirolimus; Treatment Outcome

Two thousand fifteen has been a winning year for Drug Eluting Stents (DES). Increase in the number of patients with cardiovascular diseases treated by Percutaneous Coronary Intervention (PCI) has resulted to a high demand for second generation DES. This current analysis aimed to compare the different types of Stent Thrombosis (ST) associated with Zotarolimus Eluting Stents (ZES) versus Everolimus Eluting Stents (EES) at 1 year follow up.. Electronic databases were searched for studies comparing ZES with EES. Different types of ST reported at 1 year follow up were considered as the primary endpoints in this analysis. Odds Ratios (OR) with 95% Confidence Intervals (CIs) were used as the statistical parameters and the pooled analyses were carried out by the RevMan 5 · 3 software.. A total number of 10,512 patients were included in this analysis. No significant difference in any definite ST, acute definite ST, subacute definite ST, and late definite ST were observed between ZES and EES, at 1 year follow up with OR: 1.70, 95% CI: 0.92 - 3.16; P = 0.09, OR: 3.44, 95% CI: 0.82 - 14.43; P = 0.09, OR: 1.13, 95% CI: 0.43 - 2.95; P = 0.80 and OR: 2.39, 95% CI: 0.83 - 6.85; P = 0.11 respectively. Moreover, any definite or probable ST and definite/probable/possible ST were also not significantly different with OR: 1.39, 95% CI: 0.89 - 2.17; P = 0.15 and OR: 1.19, 95% CI: 0.84 - 1.70; P = 0.33 respectively. In addition, any probable ST, acute probable ST, late probable ST and possible ST were also not significantly different at 1 year follow up with OR: 1.11, 95% CI: 0.60 - 2.05; P = 0.75, OR: 0.53, 95% CI: 0.12 - 2.40; P = 0.41, OR: 1.67, 95% CI: 0.35 - 7.86; P = 0.52 and OR: 1.08, 95% CI: 0.64 - 1.82; P = 0.78 respectively.. At 1 year follow up, ZES were not associated with significantly lower or higher definite and probable ST compared to EES. In addition, no significant difference was observed in acute, subacute and late definite or probable ST. However, further trials are recommended to assess the effects of these second-generation DES during the long-term.

Topics: Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Humans; Odds Ratio; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Newer-generation drug-eluting stents (DES) with enhanced biocompatibility that deliver antiproliferative drugs from a durable polymer have significantly improved safety and efficacy outcomes, compared with both early-generation DES and bare-metal stents, and they represent the current standard of care in all patient and lesion subsets. However, newer durable polymers have been associated with the occurrence of chronic inflammation, delayed vascular healing, incomplete endothelialisation, and neoatherosclerosis, which may result in persistent late adverse cardiovascular events, particularly in patients with high-risk baseline clinical features and angiographic complex coronary artery disease. Newer-generation DES with biodegradable polymer and controlled drug release have been recently introduced to overcome long-term adverse outcomes observed with both early-generation and newer-generation permanent polymer-based DES, and they may be of incremental clinical value in subgroups of patients at higher risk of stent failure. The recent ultrathin-strut cobalt-chromium Orsiro Hybrid DES (BIOTRONIK AG, Bülach, Switzerland) eluting sirolimus from a biodegradable polymer was designed to improve arterial healing and clinical outcomes. The Orsiro Hybrid DES has demonstrated clinical performance comparable to the current state-of-the-art newer-generation thin-strut cobalt-chromium, permanent polymer-based everolimus-eluting stent in a broad patient population. In subgroups of patients at highest-risk of adverse ischemic events, such as patients with diabetes mellitus, small vessels, long lesions, complex coronary lesions, multivessel disease, chronic total occlusion, or ST-segment elevation myocardial infarction, the Orsiro Hybrid DES has shown low rates of adverse clinical outcomes, similar to rates observed in lower-risk patients, and extremely low rates of definite stent thrombosis. This article reviews current evidence on safety and efficacy of the recent ultrathin-strut biodegradable polymer Orsiro Hybrid DES in high-risk subgroups.

Topics: Chromium Alloys; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Factors; Sirolimus

We aim to perform a systematic literature review on all studies reporting the clinical outcomes of the use of bioresorbable scaffolds (BRS) in different settings of coronary artery disease (CAD).. BRS are designed to provide early support of the vessel wall postangioplasty, deliver antiproliferative agents to prevent excessive hyperplastic healing responses and finally "disappear" when no longer required. Emerging data have provided evidence of their use in specific clinical scenarios.. A comprehensive literature search was performed by 2 independent reviewers utilizing MEDLINE, EMBASE, and Cochrane Library databases. The only 2 CE marked BRS: everolimus-eluting Bioresorbable vascular scaffold ABSORB BVS and the myolimus-eluting DESolve Bioresorbable Coronary Scaffold (BCS) System were included.. The studies were categorized into: ST elevation myocardial infarction (STEMI), stable CAD, and "all-comers" group. Thirty-one studies were included; 8 in STEMI patients (all ABSORB), 15 in stable CAD patients. In the STEMI group (n = 606), acute procedural success ranged from 96% to 100%, cardiac mortality 0-9.1%, recurrent MI and stent thrombosis rates were 0-4.3%. In the stable CAD group, the 13 ABSORB studies (n = 3259) demonstrated cardiac mortality rate of 0-0.6%, recurrent MI rate 0-4.5%, and stent thrombosis rate 0-4.3%. Current clinical data suggest the BRS, especially the ABSORB BVS, may represent a reasonable alternative to DES in uncomplicated coronary anatomy.

Topics: Absorbable Implants; Aged; Angioplasty; Antineoplastic Agents; Coronary Artery Disease; Everolimus; Female; Humans; Male; Middle Aged; Sirolimus; Tissue Scaffolds; Treatment Outcome

Topics: Animals; Coronary Artery Disease; Drug-Eluting Stents; Endovascular Procedures; Femoral Artery; Humans; Radiography; Sirolimus

Drug-eluting stents (DES) have dramatically improved the long-term efficacy of percutaneous coronary intervention (PCI). Over the last decade there have been numerous advances in DES platforms, however, all but one currently approved DES in the United States and many of the approved DES worldwide still have 3 common features: a metal stent platform, an anti-proliferative drug, and a permanent polymer. In this context, the polymer is critical to control drug release, but the polymer serves no purpose after the drug is eluted. While designed to be completely biocompatible, synthetic polymers have the potential to illicit an inflammatory response within the vessel including but not limited to delayed healing and hypersensitivity. Adverse vascular reactions to these polymers have been implicated as a cause of very late stent thrombosis, ongoing intimal hyperplasia and late "catch-up" in addition to neoatherosclerosis. To avoid the long-term risks associated with prolonged polymer exposure, DES with bioabsorbable polymers have been developed. The MiStent® Sirolimus-Eluting Absorbable Polymer Coronary Stent System (MiStent SES) (MiCell Technologies, Durham, NC, USA) combines crystalline sirolimus, a rapidly absorbing polylactide-co-glycolic acid (PLGA) coating and a thin-strut cobalt chromium alloy stent platform (Genius MAGIC® Stent System, EuroCor GmbH, Germany). MiCell's supercritical fluid technology allows a rigorously controlled, solvent-free drug and polymer coating to be applied to a bare-metal stent. This solvent-free application of drug uniquely allows a crystalline form of sirolimus to be used on the MiStent SES potentially providing improved clinical benefits. It avoids the uncontrolled burst of drug seen with other DES, provides uniform drug delivery around and between the stent struts, and allows the anti-inflammatory and anti-restenotic drug (sirolimus) to be present in the tissue through the entire polymer absorption period and for months after the polymer has been absorbed. On the MiStent SES, the PLGA/crystalline sirolimus combination is cleared from the stent within 45-60 days and PLGA is fully absorbed within 90 days. The crystalline form of sirolimus uniquely remains in the tissue and continues to expose the surrounding tissue to therapeutic levels of drug for up to 9 months which is long after the polymer is resorbed.

Topics: Absorbable Implants; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus

This study aimed to compare 6 months to 5 years stent thrombosis (ST) and adverse cardiovascular outcomes associated with sirolimus-eluting stents (SES) and other drug-eluting stents (DES) in patients with type 2 diabetes mellitus (T2DM).Electronic databases were searched for studies comparing SES with other DES in patients with T2DM. Total ST, definite ST, probable ST, and other adverse cardiovascular outcomes reported between 6 months and 5 years were considered as the clinical end points in this study. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for categorical variables and the pooled analyses were performed with RevMan 5.3 software.Twenty-nine studies involving a total number of 25,729 patients with diabetes were included in this meta-analysis. SES were not associated with significantly higher total, definite, and probable STs with OR: 0.95, 95% CI: 0.77-1.17, P = 0.62; OR: 0.94, 95% CI: 0.65-1.37, P = 0.76; and OR: 1.05, 95% CI: 0.77-1.45, P = 0.74, respectively. SES were also noninferior to the other non-sirolimus eluting drug eluting stents (non-SE DES) in terms of all-cause mortality, cardiac death, myocardial infarction, and stroke with OR: 0.92, 95% CI: 0.82-1.03, P = 0.16; OR: 1.09, 95% CI: 0.88-1.35, P = 0.44; OR: 0.92, 95% CI: 0.80-1.06, P = 0.26; and OR: 0.79, 95% CI: 0.49-1.28, P = 0.43, respectively. Target vessel revascularization, target lesion revascularization, and major adverse cardiac events were also similarly reported between SES and non-SE DES with OR: 1.04, 95% CI: 0.83-1.31, P = 0.72; OR: 1.25, 95% CI: 0.95-1.64, P = 0.11; and OR: 1.06, 95% CI: 0.90-1.25, P = 0.49, respectively.During this particular follow-up period, SES were not associated with any increase in ST among these patients with T2DM. Mortality and other adverse cardiovascular outcomes were also not significantly different between these 2 groups. Hence, SES should be considered neither superior nor inferior to other DES. They are expected to be equally effective and safe to use in patients with T2DM.

Topics: Cardiovascular Diseases; Coronary Artery Disease; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Drug-Eluting Stents; Humans; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

We aimed to evaluate the safety and effectiveness of the novel abluminal groove-filled biodegradable polymer-coated sirolimus-eluting FIREHAWK stent (MicroPort Medical, Shanghai, China) in a large cohort of patients.. Trials on the FIREHAWK stent allowing targeted sirolimus release were not individually powered to reliably estimate low-frequency safety endpoints such as stent thrombosis (ST) or to examine long-term safety and efficacy. Additionally, the China Food and Drug Administration requires an objective performance criterion (OPC) study for new drug-eluting stents.. The primary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, target vessel myocardial infarction (MI), or clinically indicated target lesion revascularization at 12 months. Patient-level data from 1,007 patients with de novo native coronary lesions exclusively treated with the FIREHAWK stent in the TARGET serial studies (I and II) were prospectively collected, pooled and analyzed throughout a 2-year follow-up.. The 12-month rate of TLF in 1,003 patients (follow-up rate, 99.6%) was 3.9% (upper 95% confidence interval (CI): 5.3%), which was significantly lower than the performance goal of 9.0% (P < 0.0001). The 24-month rates of TLF, PoCE (a composite of all-cause death, all MI, or any revascularization), and ARC definite or probable ST were 4.6%, 7.8% and 0.1%, respectively. In subgroup analysis, long lesion (≥ 30 mm) was an independent predictor of TLF within 2 years (hazard ratio [95%CI]: 2.44 [1.32, 4.53], P < 0.01).. This pooled, patient-level analysis indicates that the FIREHAWK stent exhibits a promising 2-year efficacy and safety profile.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; China; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Compared with the zotarolimus-eluting stent (ZES), the everolimus-eluting stent (EES) has reduced the risk of stent restenosis and thrombosis as found in a number of randomized-controlled trials (RCTs). However, the benefits have been variable.. We evaluate the long-term effect of EES and ZES on the risk of stent thrombosis and target lesion revascularization in patients receiving PCI. We identified RCTs by a systematic search of MEDLINE, EMBASE, and Cochrane Database.. Five RCTs (9853 patients) were included. Overall, EES significantly reduced the risk of target lesion revascularization [odds ratio (OR), 0.77; 95% confidence interval (CI), 0.62-0.95; P=0.01] compared with ZES therapy. However, there was no difference in the risk of target vessel revascularization (OR, 0.93; 95% CI, 0.78-1.10; P=0.38) and definite/probable stent thrombosis (OR, 0.83; 95% CI, 0.56-1.25; P=0.37) between the two groups. Furthermore, the risk of mortality (OR, 1.04; 95% CI, 0.84-1.27; P=0.73), myocardial infarction (OR, 0.95; 95% CI, 0.74-1.23; P=0.70), and major adverse cardiac event (OR, 0.96; 95% CI, 0.84-1.10; P=0.53) was similar between the two groups.. The new-generation Resolute-ZES and EES have a similar long-term safety and efficacy profile.

Topics: Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Percutaneous coronary intervention (PCI) has been a mainstay in the management of coronary artery disease since its introduction in the late 1970s. Bare-metal stent (BMS) and then first- and second-generation drug-eluting stents (DES) have enhanced the results of PCI by improving early results and reducing the risk of restenosis and stent thrombosis (ST). The delay of re-endothelialization and recovery of endothelial function after stenting as well as inhibition of vascular repair after DES implantation, in part related to permanent polymers, are consider important part of ST pathophysiology mechanism. Several progresses have been made to overcome this issue, among them the development of new more biocompatible - first - and completely biodegradable - then - polymer coatings. A third-generation DES using a biodegradable polymer and eluting sirolimus (Ultimaster®, Terumo Corporation, Tokyo, Japan) has been recently introduced to overcome the long-term adverse vascular reactions. Thanks to the polymer coating applied to the outside surface only (abluminal side), the total drug dose applied on the stent platform has been reduced, leaving the luminal side of the stent free from drug and polymer to enhance endothelial coverage. Indeed, 3-4 months after implantation, the Ultimaster® DES has lost most of its coating, acquiring a profile similar to conventional BMS. This article reviews the recent publications investigating the safety and effectiveness of the bioresorbable polymer sirolimus-eluting Ultimaster® stent (BP-SES), for the treatment of coronary artery lesions.

Topics: Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Sirolimus; Thrombosis; Time Factors

The superiority of everolimus-eluting stents (EES) over sirolimus-eluting stents (SES) for long-term clinical outcomes has not been yet firmly established. We conducted a systematic review and a meta-analysis of randomized controlled trials (RCTs) comparing EES directly with SES using the longest available follow-up data. We searched PubMed, the Cochrane database, and ClinicalTrials.gov for RCTs comparing outcomes between EES and SES and identified 13,434 randomly assigned patients from 14 RCTs. EES was associated with significantly lower risks than SES for definite stent thrombosis (ST), definite/probable ST, target-lesion revascularization (TLR), and major adverse cardiac events (MACE). The risks for all-cause death and myocardial infarction were similar between EES and SES. By the stratified analysis according to the timing after stent implantation, the favorable trend of EES relative to SES for ST, TLR, and MACE was consistently observed both within and beyond 1 year. The lower risk of EES relative to SES for MACE beyond 1 year was statistically significant (pooled odds ratio 0.77, 95% confidence interval 0.61 to 0.96, p = 0.02). In conclusion, the current meta-analysis of 14 RCTs directly comparing EES with SES suggested that EES provided improvement in both safety and efficacy; EES compared with SES was associated with significantly lower risk for definite ST, definite/probable ST, TLR, and MACE. The direction and magnitude of the effect beyond 1 year were comparable with those observed within 1 year.

Topics: Antineoplastic Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Follow-Up Studies; Humans; Immunosuppressive Agents; Sirolimus; Time Factors; Treatment Outcome

Coronary atherosclerosis often involves small-caliber coronaries, yet the safety and efficacy of 2.25-mm DES have been poorly defined, with a general lack of separation of 2.25 with 2.5-mm performance. No randomized head-to-head 2.25 mm DES studies have been reported. There are several single-arm prospective studies, and we aim to systematically review all published specific 2.25-mm data to estimate composite DES-specific performance and highlight current knowledge gaps.. We performed a systematic literature search of PubMed, EMBASE, Web of Science and Cochrane database for clinical trials of 2.25-mm DES. Angiographic and composite clinical outcomes were compared with descriptive statistics.. 2.25 mm-Paclitaxel (PES), sirolimus (SES), everolimus (EES) and platinum chromium EES DES-specific outcomes have been reported. Death at 12 months for SES, PES, EES and platinum chromium EES was 1.3%, 3.0%, 1.5%, and 4.4%. Rates of target vessel revascularization at 12 months for SES, PES, EES and platinum chromium EES were 5.7%, 13.3%, 8.8%, and 3.3%. Angiographic outcomes at 9 months to one year were as follows: mean late lumen loss (LLL) for SES, PES, and EES was 0.15 ± 0.11-mm, 0.28 ± 0.11-mm, and 0.16 ± 0.41-mm and mean diameter restenosis for SES, PES, and EES were 29.5 ± 6.2%, 34.7 ± 4.2%, and 20.9 ± 22.5%. Reported stent thrombosis rates for 2.25-mm DES were low ranging from 0% to 2.2% in up to 24-months of follow-up.. This systematic review summarizes and tabulates all available specific data on 2.25-mm DES. Based on our descriptive analysis, 2.25-mm DESs have a favorable safety and efficacy profile for the treatment of very small coronary lesions.

Topics: Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Paclitaxel; Sirolimus

Metallic drug-eluting stents (DES) are the first choice for percutaneous coronary interventional treatment of coronary artery disease at present. Although they have overcome some disadvantages and limitations of plain balloon angioplasty and bare-metal stents, chronic local inflammatory reactions related to permanent polymer existence and poor vascular healing after first generation DES implantation may translate into the increased risk of late and very late stent thrombosis. There have been technological developments in stent design, materials and coatings, including more conformable platform designs, biocompatible or biodegradable polymers and improved kinetics of drug release. The newer generation DES have proven superior to previous DES technology in terms of both safety and efficacy. Accumulating evidence has suggested that DES with cobalt chromium stent platform, modified biodegradable polymer coatings, and rapamycin derivative drugs are associated with improved clinical outcomes. Currently, several new cobalt chromium biodegradable polymer sirolimus-eluting stents have been introduced to clinical practice. This review will describe basic concept and rationale behind the newer cobalt chromium biodegradable polymer sirolimus-eluting stents, systematically present the new clinical experiences with several representative devices.

Topics: Chromium; Cobalt; Coronary Artery Disease; Drug Liberation; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Thrombosis

The purpose of this study was to investigate the differential clinical outcomes after percutaneous coronary intervention (PCI) for coronary bifurcation lesions with 1- or 2-stenting techniques using first- or second-generation drug-eluting stents (DES).. The 2-stenting technique has been regarded to have worse clinical outcomes than the 1-stenting technique after bifurcation PCI with first-generation DES. However, there has been a paucity of data comparing the 1- and 2-stenting techniques with the use of second-generation DES.. Patient-level pooled analysis was performed with 3,162 patients undergoing PCI using first- or second-generation DES for bifurcation lesions from the "Korean Bifurcation Pooled Cohorts" (COBIS [Coronary Bifurcation Stenting] II, EXCELLENT [Registry to Evaluate Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting], and RESOLUTE-Korea [Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent]). The 3-year clinical outcomes were compared between 1- and 2-stenting techniques, stratified by the type of DES.. With first-generation DES, rates of target lesion failure (TLF) or patient-oriented composite outcome (POCO) (a composite of all death, any myocardial infarction, any repeat revascularization, and cerebrovascular accidents) at 3 years were significantly higher after the 2-stenting than the 1-stenting technique (TLF 8.6% vs. 17.5%; p < 0.001; POCO 18.1% vs. 28.5%, p < 0.001). With second-generation DES, however, there was no difference between 1- and 2-stenting techniques (TLF 5.4% vs. 5.8%; p = 0.768; POCO 11.2% vs. 12.9%; p = 0.995). The differential effects of 2-stenting technique on the prognosis according to the type of DES were also corroborated with similar results by the inverse probability weighted model. The 2-stenting technique was a significant independent predictor of TLF in first-generation DES (hazard ratio: 2.046; 95% confidence interval: 1.114 to 3.759; p < 0.001), but not in second-generation DES (hazard ratio: 0.667; 95% confidence interval: 0.247 to 1.802; p = 0.425).. Patient-level pooled analysis of 3,162 patients in Korean Bifurcation Pooled Cohorts demonstrated that the 2-stenting technique showed comparable outcomes to 1-stenting technique with second-generation DES, which is different from the results of first-generation DES favoring the 1-stenting technique.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Circulation; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Registries; Republic of Korea; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The safety and efficacy of everolimus-eluting stent (EES) versus zotarolimus-eluting stent (ZES) are controversial both in randomized controlled clinical trials (RCTs) and observational studies. The aim of this study was to assess the safety and efficacy of EES versus ZES.. Pubmed, Embase, Cochrane database and www.clinicaltrials.gov updated to Mar 2014 with safety [major adverse cardiac events (MACE)], all-cause mortality, non-fatal myocardial infarction (MI), stent thrombosis (ST) and efficacy [target vessel revascularization (TVR), target lesion revascularization (TLR), target vessel failure (TVF), target lesion failure (TLF)] endpoints and follow-up of ≥12 months were identified.. Data from 11,778 patients in 8 RCTs and 34,850 patients in 26 observational studies were included. In RCT studies, no evidence indicating that EES was safer or more efficacious than ZES. In observational studies, EES associated with a significantly lower risk for MACE (RR: 0.56, 95% CI: 0.46-0.69), ST (RR: 0.59, 95% CI: 0.45-0.78), TVR (RR: 0.61, 95% CI: 0.47-0.79), TLR (RR: 0.57, 95% CI: 0.38-0.83) and TLF (RR: 0.69, 95% CI: 0.50-0.93). The pooled data of RCTs and observational studies showed that compared to ZES, EES associated with a significant lower risk for MACE (RR: 0.65, 95% CI: 0.54-0.78), ST (RR: 0.66, 95% CI: 0.52-0.83), TVR (RR: 0.72, 95% CI: 0.58-0.89), TLR (RR: 0.63, 95% CI: 0.49-0.82) and TLF (RR: 078, 95% CI: 0.62-1.00).. In RCTs, EES and ZES showed comparable safety and efficacy, while in observational studies or pooled data, EES was safer and more efficacious than ZES.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Observational Studies as Topic; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus; Treatment Outcome

The advent of fully bioresorbable stent technology and specifically the ABSORB™, a bioresorbable vascular scaffold (BVS) stent, is heralded as breakthrough technology in the current era of percutaneous coronary interventions. This article reviews the current understanding of this technology along with the clinical evidence from trials and registries of ABSORB BVS that included patients with both simple as well as more complex "real-world" coronary lesions. In addition, considering the current limitations of this device-mostly associated with the mechanical properties of the polymeric scaffold structure-a review of guidelines on successful implantation of the ABSORB BVS is presented. Although expert feedback suggests extensive use of this device in routine clinical practice outside the United States despite a paucity of data on long-term safety in this setting, attention to procedural details and implantation technique is obligatory to achieve optimal clinical outcomes.

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Evidence-Based Medicine; Female; Follow-Up Studies; Humans; Male; Prosthesis Design; Risk Assessment; Severity of Illness Index; Sirolimus; Survival Analysis; Time Factors; Tissue Scaffolds; Treatment Outcome

Our aim was to evaluate the five-year clinical impact of side branch (SB) stenting with a drug-eluting stent (DES) following Axxess stent implantation in coronary bifurcation lesions.. Four hundred patients treated with Axxess were pooled from the AXXESS Plus and DIVERGE five-year follow-up studies. We compared unadjusted and propensity-adjusted major adverse clinical events (MACE) between Axxess with no SB stenting ("Axxess provisional") versus Axxess with SB stenting ("Axxess additional"). "Axxess additional" had no impact on the MACE rate, with unadjusted and adjusted HR 1.59 (95% CI: 0.95-2.64) and 1.37 (95% CI: 0.88-2.13), respectively. No differences were seen in the individual components of death, myocardial infarction and ischaemia-driven target lesion revascularisation, respectively, both in unadjusted (HR 0.92 [95% CI: 0.38-2.19]; HR 1.73 [95% CI: 0.78-3.82]; HR 1.65 [95% CI: 0.84-3.26]) and adjusted analysis (HR 0.92 [95% CI: 0.41-2.09]; HR 1.13 [95% CI: 0.59-2.17]; HR 1.31 [95% CI: 0.74-2.31]). No differences in definite stent thrombosis were seen with unadjusted HR 2.1 (95% CI: 0.45-9.88) and adjusted HR 1.0 (95% CI: 0.32-3.1).. Stenting the SB following Axxess implantation does not impact on long-term clinical outcomes compared to MV stenting only. The Axxess stent system offers a safe and tailored alternative for the treatment of coronary bifurcation lesions.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Propensity Score; Proportional Hazards Models; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To establish whether technological improvements in drug-eluting stent (DES) technology introduced in second-generation (G2) DES have contributed to improving patient-focused outcomes.. We performed a systematic review of randomised clinical trials (RCT) comparing first-generation (G1) and G2 DES with a>9-month clinical follow-up. The primary endpoint for efficacy was ischaemia-driven target lesion revascularisation (ID-TLR); safety endpoints were all-cause death, myocardial infarction (MI) and stent thrombosis (ST). Sixteen RCTs involving 25,427 patients met eligibility criteria (17 comparisons). In these trials, paclitaxel (PES) and sirolimus (SES) were compared with everolimus (EES), zotarolimus (ZES) or biolimus A9 (BES) DES. G2 varied in metal alloy, strut thickness and type of drug-eluting matrix. Overall, G2 DES were associated with a 26% relative risk reduction (RRR) of MI (relative risk [RR]=0.74, 95% CI: 0.61-0.90, p=0.003) and ST (RR=0.70, 95% CI: 0.55-0.89, p=0.004), while no significant benefit was observed for ID-TLR and death. Use of 2G DES was associated with a significant reduction in the risk of ID-TLR (RR=0.66, 95% CI: 0.51-0.85, p=0.002), MI (RR=0.60, 95% CI: 0.49-0.72, p<0.001) and ST (RR=0.41, 95% CI: 0.26-0.65, p=0.001) when compared with PES. Strut thickness ≤91 µm in G2 DES was associated with a significantly lower risk of MI (RR=0.54, 95% CI: 0.51-0.86, p=0.002).. The introduction of thinner stent struts and other technological improvements made in G2 DES technology have translated into better patient outcomes. Overall, the net benefit of G2 DES over G1 DES is expressed in terms of ID-TLR and ST risk reduction but it could be masked by heterogeneities in the use of G1 comparators and the use of non-inferiority study designs in RCTs.

Topics: Antineoplastic Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Paclitaxel; Patient Outcome Assessment; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus

The study sought to compare the acute gain and two-year follow-up late lumen loss (LLL) between the Absorb bioresorbable vascular scaffold (BVS) and the analogous everolimus-eluting metallic stent (EES). The current analysis included all the patients recruited in the ABSORB Cohort B and SPIRIT II trials implanted with a single 3.0×18 mm device (Absorb BVS or EES) who underwent serial angiographic examinations at baseline and at two-year follow-up. The acute gain was defined as the difference between post- and preprocedural minimal lumen diameter (MLD). The in-stent/scaffold LLL was calculated as the difference in stent/scaffold segment between the post-procedural MLD and follow-up MLD. Thirty-three patients (33 lesions) implanted with the Absorb BVS, and 26 patients (28 lesions) implanted with the EES were studied. The acute gain was similar in the Absorb BVS group (1.23±0.38 mm) compared to the EES group (1.32±0.26 mm, p=0.29). The in-stent/scaffold LLL at two-year follow-up in the Absorb BVS group (0.26±0.19 mm) was also similar compared to the EES group (0.22±0.22 mm, p=0.29). Although the two groups had similar two-year clinical outcomes (major adverse cardiac events: Absorb BVS: 6.1% vs. EES: 0.0%), patients treated with the Absorb BVS exhibited a significantly lower two-year in-stent/scaffold MLD compared to the EES (2.02±0.26 mm vs. 2.22±0.34 mm, p=0.01). Although BVS and EES demonstrated similar two-year clinical outcomes, patients treated with the Absorb BVS exhibited a significantly lower two-year in-stent/scaffold MLD compared to patients treated with the EES. Appropriately powered randomised trials are necessary to confirm these exploratory results and evaluate their prognostic and clinical significance.

Topics: Absorbable Implants; Clinical Trials as Topic; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Sirolimus; Ultrasonography, Interventional

The meta-analysis was aimed to compare the long time (> 2 year) clinical outcomes of limus-based stents (LBS) and paclitaxel-eluting stents (PES). LBS and PES are two kinds of most common coronary artery stents in clinics.. Electronic data bases of PubMed, Cochrane, and EMBASE were searched. We included randomized controlled clinical trials (RCT) comparing LBS and PES with long time clinical outcomes. Methodological quality of eligible trials was assessed using "risk of bias" tool. The efficacy endpoints included target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis (ST), and the safety endpoints included all cause death, cardiac death, and myocardial infarction (MI). Odds ratios (OR) and 95% confidence intervals (95% CI) were calculated for each endpoint.. A total of 23 RCTs and 19,319 participants were included and analyzed in this meta-analysis. All trials were of an acceptable quality. At 2 years, LBS showed reduced risk of revascularization and ST (TLR: OR = 0.59, 95% CI 0.44-0.78; TVR: OR = 0.63, 95% CI 0.55-0.71; ST: OR = 0.55, 95% CI 0.41-0.73) and a lower rate of MI (OR = 0.67, 95% CI 0.57-0.79). Subgroup analysis showed that both everolimus-eluting stents and sirolimus-eluting stents had better clinical outcomes compared with PES. The comparisons of 3, 4 and 5 year follow-up results revealed that the clinical outcomes of PES were non-inferior to those of LBS but LBS was associated with reduced risk of MI and ST at 3 years.. LBS is associated with better clinical outcomes at 2 years. Both LBS and PES showed similar efficacy and safety at long time period.

Topics: Antineoplastic Agents, Phytogenic; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Follow-Up Studies; Humans; Immunosuppressive Agents; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus; Time Factors; Treatment Outcome

Statins are currently able to stabilize atherosclerotic plaques by lowering plasma cholesterol and pleiotropic effects, but a residual risk for atherosclerotic disease remains. Therefore, effective prevention of atherosclerosis and treatment of its complications is still a major clinical challenge. A large body of evidence indicates that mammalian target of rapamycin (mTOR) inhibitors such as rapamycin or everolimus have pleiotropic anti-atherosclerotic effects so that these drugs can be used as add-on therapy to prevent or delay the pathogenesis of atherosclerosis. Moreover, bioresorbable scaffolds eluting everolimus trigger a healing process in the vessel wall, both in pigs and humans, that results in late lumen enlargement and plaque regression. At present, this phenomenon of atheroregression is poorly understood. However, given that mTOR inhibitors suppress cell proliferation and trigger autophagy, a cellular survival pathway and a process linked to cholesterol efflux, we hypothesize that these compounds can inhibit (or reverse) the basic mechanisms that control plaque growth and destabilization. Unfortunately, adverse effects associated with mTOR inhibitors such as dyslipidemia and hyperglycemia have recently been identified. Dyslipidemia is manageable via statin treatment, while the anti-diabetic drug metformin would prevent hyperglycemia. Because metformin has beneficial macrovascular effects, this drug in combination with an mTOR inhibitor might have significant promise to treat patients with unstable plaques. Moreover, both statins and metformin are known to inhibit mTOR via AMPK activation so that they would fully exploit the beneficial effects of mTOR inhibition in atherosclerosis.

Topics: Absorbable Implants; AMP-Activated Protein Kinases; Animals; Apolipoproteins E; Cholesterol; Clinical Trials as Topic; Coronary Artery Disease; Drug Evaluation, Preclinical; Drug Interactions; Drug Therapy, Combination; Drug-Eluting Stents; Dyslipidemias; Everolimus; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hyperglycemia; Macrophages; Metformin; Mice; Mice, Knockout; Plaque, Atherosclerotic; Rabbits; Receptors, LDL; Rupture, Spontaneous; Sirolimus; Swine; Tissue Scaffolds; TOR Serine-Threonine Kinases; Triglycerides

Everolimus-eluting stent (EES) are considered to have better clinical outcomes than other rapamycin derivative-eluting stents; however, the individual trials may not have sufficient power to prove it. This meta-analysis aimed to compare clinical outcomes of EES against other rapamycin derivative-eluting stents.. We searched Medline, the Cochrane Library, and other internet sources, without language or date restrictions for articles comparing clinical outcomes between EES and other rapamycin derivative-eluting stents. Safety endpoints were stent thrombosis (ST), mortality, cardiac death, and myocardial infarction (MI). Efficacy endpoints were major adverse cardiac events (MACE), target lesion revascularization (TLR), and target vessel revascularization (TVR).. We identified 16 randomized controlled trials with 23,481 patients and a weighted mean follow-up of 18 months. Compared with other rapamycin derivative-eluting stents, EES were associated with a significant reduction in definite ST [relative risk (RR): 0.45; 95% confidence interval (CI): 0.30-0.69; p<0.001] and TLR (RR: 0.87; 95% CI: 0.77-0.99; p=0.03). EES also showed a non-significant trend toward reduction in definite/probable ST (RR: 0.75; 95% CI: 0.56-1.01; p=0.06). However, both groups had similar rates of mortality (RR: 0.95; 95% CI: 0.82-1.09; p=0.45), MI (RR: 0.95; 95% CI: 0.82-1.10; p=0.43), and MACE (RR: 0.94; 95% CI: 0.87-1.02; p=0.35). The stratified analysis of the included trials showed that EES was associated with significantly lower rate of definite ST compared with either zotarolimus-eluting stent (p=0.012) or sirolimus-eluting stent (p=0.006), but not biolimus-eluting stent (p=0.16). In longer follow-up (>1 year) stratification, EES was associated with a significant reduction in risk of definite ST (p<0.001).. EES is associated with a significant reduction in definite ST and TLR for treating patients with coronary artery disease, compared with a pooled group of other rapamycin derivative-eluting stents. Biolimus-eluting stent had similar safety and efficacy for treating patients with coronary artery disease, compared with the EES.

Topics: Aged; Coronary Artery Disease; Databases, Bibliographic; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Revascularization; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Sirolimus; Thrombosis; Treatment Outcome

Drug eluting stents were an important addition to the interventional options available for patients with coronary artery disease, and they effectively reduced the risk of restenosis observed with bare metal stents. However, the drugs and polymers used in the composition of drug eluting stents were found to delay vascular healing and elicit inflammatory responses, which contributed to late and very late stent thrombosis events. Newer generation drug eluting stents have been engineered with polymers that are more biocompatible and have more favorable drug elution profiles. The Resolute(®) zotarolimus eluting stent (R-ZES) is a new-generation drug eluting stent. The Global RESOLUTE clinical program was designed to evaluate the safety and efficacy of the R-ZES. The studies conducted under this program have established that the R-ZES safely and effectively treats coronary artery stenosis, with low rates of target lesion failure, target vessel revascularization, and stent thrombosis during extended follow-up.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Humans; Practice Guidelines as Topic; Product Surveillance, Postmarketing; Sirolimus

Everolimus-eluting stent (EES) reduces the risk of late and very late stent thrombosis (ST) in a number of randomized controlled trials (RCTs). However, the benefits have been variable.. We evaluated the effect of EES and paclitaxel-eluting stent (PES) on the risk of late and very late ST in patients with coronary artery disease.. We identified RCTs by a systematic search of MEDLINE, EMBASE, and Cochrane Database. Seven RCTs (8162 patients) were included. Overall, EES therapy lowered the risk of very late ST significantly [relative risk (RR), 0.40; 95% confidence interval (CI), 0.20-0.80; I(2)=0.0%; P=0.009] compared with PES. Meanwhile, EES was associated with a significantly lower incidence of major adverse cardiac events (RR, 0.76; 95% CI, 0.67-0.86; I(2)=34.2%; P=0.00) driven by a markedly lower rate of myocardial infarction and target-vessel revascularization in the EES group. However, there was no significant difference in the risk of late ST (RR, 0.45; 95% CI, 0.15-1.39; I(2)=30.7%; P=0.166) between the two groups. A subgroup analysis showed that EES might not decrease the risk of very late ST significantly in patients older than 63.5 years or in patients with diabetes, those presenting with acute coronary syndrome, or those with a longer follow-up.. Compared with PES, EES treatment decreased risk of very late ST significantly. However, the risk of late ST was similar between the two groups. More studies are needed to confirm the subgroup findings.

Topics: Age Factors; Cardiovascular Agents; Chi-Square Distribution; Comorbidity; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Humans; Odds Ratio; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The relative short-, long- and overall-term efficacy and safety of sirolimus-eluting stents (SES, Cypher) compared with paclitaxel-eluting stents (PES, Taxus) in large head-to-head comparisons still remain to be defined.. We searched Pubmed, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) for articles comparing outcomes of interest between SES and PES without language restriction. Short- (≤ 1 year), long- (>1 year), and overall-term (the longest follow-up of each study) outcomes were evaluated. The primary endpoint was target lesion revascularization (TLR). Other outcomes of interest were target vessel revascularization (TVR), myocardial infarction, all-cause death, cardiac death, stent thrombosis, major adverse cardiac events (MACEs), restenosis and late lumen loss.. Seventy-six studies including more than 15000 patients in randomized controlled trials and over 70000 patients in adjusted observational studies were included. At overall-term follow-up, SES significantly reduced TLR (relative risk [RR]: 0.61; 95% confidence interval [CI]: 0.49-0.76), TVR (RR: 0.67; 95% CI: 0.54-0.83), MACE (RR: 0.79; 95% CI: 0.72-0.87), myocardial infarction (RR: 0.85; 95% CI: 0.73-0.99), in-segment restenosis (RR: 0.50; 95% CI: 0.38-0.65), and in-segment late lumen loss (weighted mean difference [WMD]: -0.19; 95% CI: -0.24--0.14) in randomized controlled trials compared with PES. In addition, lower rates of death (RR: 0.91; 95% CI: 0.83-1.00), any stent thrombosis (RR: 0.62; 95% CI: 0.45-0.86), definite stent thrombosis (RR: 0.59; 95% CI: 0.45-0.77) were found in patients receiving SES in adjusted observational studies. Largely similar results were found at short- and long-term follow-up, and in patients with diabetes, acute myocardial infarction or long lesions.. SES significantly reduced the short-, long- and overall-term risk of TLR/TVR, MACE, and restenosis, and overall-term risk of myocardial infarction in randomized controlled trials, as compared with PES. Lower rates of death and stent thrombosis were also observed in observational studies in SES-treated patients.

Topics: Cause of Death; Coronary Artery Disease; Drug-Eluting Stents; Humans; Observational Studies as Topic; Odds Ratio; Paclitaxel; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Sirolimus; Treatment Outcome

The Nobori is a new-generation, biodegradable-polymer coated, biolimus-eluting stent (BES) that has recently been investigated in several randomized trials with inconsistent results. The aim of this study was to assess the efficacy and safety of Nobori BES versus other drug-eluting stents (DES) in patients treated with percutaneous coronary intervention (PCI).. We undertook a meta-analysis of randomized trials investigating Nobori BES versus other DES. Primary efficacy and safety outcomes were target lesion revascularization (TLR) and definite/probable stent thrombosis (ST), respectively. Secondary outcomes were the composite of cardiac death/myocardial infarction (MI)/target vessel revascularization (TVR), MI and death.. A total of 9114 PCI-patients randomly received Nobori BES (n=5080) or other DES (n=4034). This latter group comprised patients receiving everolimus- (n=2533), sirolimus- (n=1376) or paclitaxel-eluting stents (n=125). Median follow-up was 11 months [interquartile range 9-12]. The Nobori BES versus other DES showed comparable risk of TLR (odds ratio [95% confidence interval]=0.91 [0.57-1.46], p=0.71). There was significant heterogeneity across trials due to significant lower TLR risk with Nobori BES versus paclitaxel-eluting stent (0.32 [0.10-0.98], p=0.046; p for interaction=0.009). Nobori BES versus other DES showed comparable risk of definite/probable ST (1.40 [0.66-2.97], p=0.39), cardiac death/MI/TVR (1.05 [0.88-1.25], p=0.59), MI (1.13 [0.87-1.48], p=0.37) and death (1.09 [0.81-1.48], p=0.56).. Nobori BES has comparable efficacy with other limus-eluting stents at 1-year follow-up. There is no difference in terms of safety profile between these stent platforms.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Follow-Up Studies; Humans; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Sirolimus; Treatment Outcome

Over the past decades, there has been significant evolution in coronary stents used in percutaneous coronary intervention. The current novel drug-eluting stents available in the United States represent significant advancements compared to angioplasty, bare-metal stents, and the first generation of drug-eluting stents (DES). The Xience everolimus-eluting stents, Promus everolimus-eluting stents, and Resolute zotarolimus-eluting stents currently demonstrate the optimal balance of safety and efficacy. Endeavor zotarolimus-eluting stents have shorter drug-elution courses, and recent evidence suggests that 3 months of dual antiplatelet therapy appears safe, making Endeavor preferred when early discontinuation of dual antiplatelet therapy is warranted. Despite these advances in stent design, the permanent polymer and metallic stent remain in the vessel wall and may precipitate sustained inflammation, persistent vasomotor dysfunction, and in-stent neo-atherosclerosis. Bioresorbable platforms with biodegradable polymers have been developed to overcome the aforementioned limitations, and the outcomes of ongoing clinical trials are eagerly anticipated to determine if these novel stents will further improve clinical outcomes.

Topics: Absorbable Implants; Animals; Cardiovascular Agents; Coronary Artery Disease; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Sirolimus; Treatment Outcome

To examine the safety and effectiveness of cobalt-chromium everolimus eluting stents compared with bare metal stents.. Individual patient data meta-analysis of randomised controlled trials. Cox proportional regression models stratified by trial, containing random effects, were used to assess the impact of stent type on outcomes. Hazard ratios with 95% confidence interval for outcomes were reported.. Medline, Embase, the Cochrane Central Register of Controlled Trials. Randomised controlled trials that compared cobalt-chromium everolimus eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients.. The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite or probable stent thrombosis, target vessel revascularisation, and all cause death.. The search yielded five randomised controlled trials, comprising 4896 participants. Compared with patients receiving bare metal stents, participants receiving cobalt-chromium everolimus eluting stents had a significant reduction of cardiac mortality (hazard ratio 0.67, 95% confidence interval 0.49 to 0.91; P=0.01), myocardial infarction (0.71, 0.55 to 0.92; P=0.01), definite stent thrombosis (0.41, 0.22 to 0.76; P=0.005), definite or probable stent thrombosis (0.48, 0.31 to 0.73; P<0.001), and target vessel revascularisation (0.29, 0.20 to 0.41; P<0.001) at a median follow-up of 720 days. There was no significant difference in all cause death between groups (0.83, 0.65 to 1.06; P=0.14). Findings remained unchanged at multivariable regression after adjustment for the acuity of clinical syndrome (for instance, acute coronary syndrome v stable coronary artery disease), diabetes mellitus, female sex, use of glycoprotein IIb/IIIa inhibitors, and up to one year v longer duration treatment with dual antiplatelets.. This meta-analysis offers evidence that compared with bare metal stents the use of cobalt-chromium everolimus eluting stents improves global cardiovascular outcomes including cardiac survival, myocardial infarction, and overall stent thrombosis.

Topics: Chromium; Cobalt; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Sirolimus; Stents; Thrombosis; Treatment Outcome

The aim of this study was to describe the process to obtain Food and Drug Administration (FDA) approval for the expanded indication for treatment with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Inc., Santa Rosa, California) in patients with coronary artery disease and diabetes.. The R-ZES is the first drug-eluting stent specifically indicated in the United States for percutaneous coronary intervention in patients with diabetes.. We pooled patient-level data for 5,130 patients from the RESOLUTE Global Clinical Program. A performance goal prospectively determined in conjunction with the FDA was established as a rate of target vessel failure at 12 months of 14.5%. In addition to the FDA pre-specified cohort of less complex patients with diabetes (n = 878), we evaluated outcomes of the R-ZES in all 1,535 patients with diabetes compared with all 3,595 patients without diabetes at 2 years.. The 12-month rate of target vessel failure in the pre-specified diabetic cohort was 7.8% (upper 95% confidence interval: 9.51%), significantly lower than the performance goal of 14.5% (p < 0.001). After 2 years, the cumulative incidence of target lesion failure in patients with noninsulin-treated diabetes was comparable to that of patients without diabetes (8.0% vs. 7.1%). The higher risk insulin-treated population demonstrated a significantly higher target lesion failure rate (13.7%). In the whole population, including complex patients, rates of stent thrombosis were not significantly different between patients with and without diabetes (1.2% vs. 0.8%).. The R-ZES is safe and effective in patients with diabetes. Long-term clinical data of patients with noninsulin-treated diabetes are equivalent to patients without diabetes. Patients with insulin-treated diabetes remain a higher risk subset. (The Medtronic RESOLUTE Clinical Trial; NCT00248079; Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; The Medtronic RESOLUTE US Clinical Trial (R-US); NCT00726453; RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population [R-Int]; NCT00752128; RESOLUTE Japan-The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent [RJ]; NCT00927940).

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Device Approval; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Hypoglycemic Agents; Insulin; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; United States; United States Food and Drug Administration

Compared to bare metal stent angioplasty, first-generation drug-eluting stents (DES) have markedly reduced the incidence of in-stent restenosis. However, given the increased concerns over late and very late stent thrombosis, newer-generation DES were developed. To date, these DES have virtually replaced the use of first-generation DES worldwide. In this review article, we carefully consider the pre-clinical and clinical trials that have been performed with currently available, european conformity-marked and Food and Drug Administration-approved new-generation Resolute(®) and Xience V(®) DES.

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Sirolimus; Treatment Outcome

The main approach to obesity and type-II diabetes is to unravel the mechanisms involved in nutrient absorption and fuel allocation. In conditions of over-nutrition, cells must cope with a multitude of extracellular signals generated by changes in nutrient load, hormonal milieu, adverse cytokine/adipokine profile, and apoptosis/anti-apoptosis processes. To date studies have demonstrate that among all nutrients, lipids and carbohydrates play a major regulatory role in the gene transcription of glycolytic and lipogenic enzymes, insulin, and adipokines. These nutrients mainly exert their effects through the gene expression of sterol responsive binding protein 1 and 2 (SREBP) and the mammalian target of rapamycin (mTOR). Excess of adipose tissue is known to confer a significantly higher risk of coronary artery disease. Administration of rapamycin effectively attenuated inflammation, inhibited progression, and enhanced stability of atherosclerotic plaques in animal models. Herein we discuss the mTOR pathway and the molecular mechanisms of mTOR inhibitors, hypothesizing a possible protective role in atherosclerosis, taking into account also previous clinical studies emphasizing their opposite role.

Topics: Adipose Tissue; Animals; Coronary Artery Disease; Diabetes Mellitus, Type 2; Humans; Obesity; Sirolimus; TOR Serine-Threonine Kinases

There is ongoing debate on the optimal drug-eluting stent (DES) in diabetic patients with coronary artery disease. Biodegradable polymer drug-eluting stents (BP-DES) may potentially improve clinical outcomes in these high-risk patients. We sought to compare long-term outcomes in patients with diabetes treated with biodegradable polymer DES vs. durable polymer sirolimus-eluting stents (SES).. We pooled individual patient-level data from 3 randomized clinical trials (ISAR-TEST 3, ISAR-TEST 4 and LEADERS) comparing biodegradable polymer DES with durable polymer SES. Clinical outcomes out to 4 years were assessed. The primary end point was the composite of cardiac death, myocardial infarction and target-lesion revascularization. Secondary end points were target lesion revascularization and definite or probable stent thrombosis.. Of 1094 patients with diabetes included in the present analysis, 657 received biodegradable polymer DES and 437 durable polymer SES. At 4 years, the incidence of the primary end point was similar with BP-DES versus SES (hazard ratio = 0.95, 95% CI = 0.74-1.21, P = 0.67). Target lesion revascularization was also comparable between the groups (hazard ratio = 0.89, 95% CI = 0.65-1.22, P = 0.47). Definite or probable stent thrombosis was significantly reduced among patients treated with BP-DES (hazard ratio = 0.52, 95% CI = 0.28-0.96, P = 0.04), a difference driven by significantly lower stent thrombosis rates with BP-DES between 1 and 4 years (hazard ratio = 0.15, 95% CI = 0.03-0.70, P = 0.02).. In patients with diabetes, biodegradable polymer DES, compared to durable polymer SES, were associated with comparable overall clinical outcomes during follow-up to 4 years. Rates of stent thrombosis were significantly lower with BP-DES.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Diabetes Complications; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Multicenter Studies as Topic; Polymers; Randomized Controlled Trials as Topic; Risk Assessment; Sirolimus; Thrombosis; Treatment Outcome

This study sought to investigate whether the everolimus-eluting stent (EES) is superior to the paclitaxel-eluting stent (PES) with respect to long-term individual clinical outcomes.. Individual studies have indicated a clinical advantage of coronary EES compared with PES with respect to restenosis and the composite endpoint of major adverse cardiac events. However, these trials were not powered for superiority in low-frequency event rates and have reported limited data beyond 1-year follow-up.. We conducted a meta-analysis of the final 3-year results from the international SPIRIT (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) II, III, and IV clinical trials. Individual patient data from 4,989 patients who were prospectively randomized to treatment with EES (n = 3,350) or PES (n = 1,639) were pooled for analysis.. At 3-year follow-up, EES was superior to PES in reducing the following event rates: target lesion failure (8.9% vs. 12.5%, hazard ratio [HR]: 0.71, 95% confidence interval [CI]: 0.59 to 0.85; p = 0.0002), all-cause mortality (3.2% vs 5.1%, HR: 0.65, 95% CI: 0.49 to 0.86; p = 0.003), myocardial infarction (3.2% vs. 5.1%, HR: 0.64, 95% CI: 0.48 to 0.85; p = 0.002), cardiac death or myocardial infarction (4.4% vs. 6.3%, HR: 0.70, 95% CI: 0.54 to 0.90; p = 0.005), ischemia-driven target lesion revascularization (6.0% vs. 8.2%, HR: 0.72, 95% CI: 0.58 to 0.90; p = 0.004), stent thrombosis (0.7% vs. 1.7%, HR: 0.45, 95% CI: 0.26 to 0.78; p = 0.003), and major adverse cardiac events (9.4% vs. 13.0%, HR: 0.71, 95% CI: 0.60 to 0.85; p = 0.0002). No interaction was present between stent type and the 3-year relative rates of target lesion failure across a broad range of subgroups, with the exception of diabetes and vessel (left anterior descending vs. other).. In this large dataset with 3-year follow-up, coronary implantation of EES compared with PES resulted in reduced rates of all-cause mortality, myocardial infarction, ischemia-driven target lesion revascularization, stent thrombosis, and target lesion failure. Further research is warranted to characterize possible interactions between stent type, diabetes, and vessel.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multicenter Studies as Topic; Multivariate Analysis; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To investigate the safety and efficacy of durable polymer drug eluting stents (DES) and biodegradable polymer biolimus eluting stents (biolimus-ES).. Network meta-analysis of randomised controlled trials.. Medline, Google Scholar, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) database search for randomised controlled trials comparing at least two of durable polymer sirolimus eluting stents (sirolimus-ES) and paclitaxel eluting stents (paclitaxel-ES), newer durable polymer everolimus eluting stents (everolimus-ES), Endeavor and Resolute zotarolimus eluting stents (zotarolimus-ES), and biodegradable polymer biolimus-ES.. Safety (death, myocardial infarction, definite or probable stent thrombosis) and efficacy (target lesion and target vessel revascularisation) assessed at up to one year and beyond.. 60 randomised controlled trials were compared involving 63,242 patients with stable coronary artery disease or acute coronary syndrome treated with a DES. At one year, there were no differences in mortality among devices. Resolute and Endeavor zotarolimus-ES, everolimus-ES, and sirolimus-ES, but not biodegradable polymer biolimus-ES, were associated with significantly reduced odds of myocardial infarction (by 29-34%) compared with paclitaxel-ES. Compared with everolimus-ES, biodegradable polymer biolimus-ES were associated with significantly increased odds of myocardial infarction (by 29%), while Endeavor zotarolimus-ES and paclitaxel-ES were associated with significantly increased odds of stent thrombosis. All investigated DES were similar with regards to efficacy endpoints, except for Endeavor zotarolimus-ES and paclitaxel-ES, which were associated with significantly increased the odds of target lesion and target vessel revascularisations compared with other devices. Direction of results beyond one year did not diverge from the findings for up to one year follow-up. Bayesian probability curves showed a gradient in the magnitude of effect, with everolimus-ES and Resolute zotarolimus-ES offering the highest safety profiles.. The newer durable polymer everolimus-ES and Resolute zotarolimus-ES and the biodegradable polymer biolimus-ES maintain the efficacy of sirolimus-ES; however, for safety endpoints, differences become apparent, with everolimus-ES and Resolute zotarolimus-ES emerging as the safest stents to date.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Myocardial Infarction; Polymers; Postoperative Complications; Sirolimus; Thrombosis; Treatment Outcome

To compare the efficacy and safety of biodegradable polymer drug eluting stents with those of bare metal stents and durable polymer drug eluting stents.. Mixed treatment comparison meta-analysis of 258,544 patient years of follow-up from randomized trials.. PubMed, Embase, and Central were searched for randomized trials comparing any of the Food and Drug Administration approved durable polymer drug eluting stents (sirolimus eluting, paclitaxel eluting, cobalt chromium everolimus eluting, platinum chromium everolimus eluting, zotarolimus eluting-Endeavor, and zotarolimus eluting-Resolute) or biodegradable polymer drug eluting stents, with each other or against bare metal stents.. Long term efficacy (target vessel revascularization, target lesion revascularization) and safety (death, myocardial infarction, stent thrombosis). Landmark analysis at more than one year was evaluated to assess the potential late benefit of biodegradable polymer drug eluting stents.. From 126 randomized trials and 258,544 patient years of follow-up, for long term efficacy (target vessel revascularization), biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.66, 95% credibility interval 0.57 to 0.78) and zotarolimus eluting stent-Endeavor (0.69, 0.56 to 0.84) but not to newer generation durable polymer drug eluting stents (for example: 1.03, 0.89 to 1.21 versus cobalt chromium everolimus eluting stents). Similarly, biodegradable polymer drug eluting stents were superior to paclitaxel eluting stents (rate ratio 0.61, 0.37 to 0.89) but inferior to cobalt chromium everolimus eluting stents (2.04, 1.27 to 3.35) for long term safety (definite stent thrombosis). In the landmark analysis after one year, biodegradable polymer drug eluting stents were superior to sirolimus eluting stents for definite stent thrombosis (rate ratio 0.29, 0.10 to 0.82) but were associated with increased mortality compared with cobalt chromium everolimus eluting stents (1.52, 1.02 to 2.22). Overall, among all stent types, the newer generation durable polymer drug eluting stents (zotarolimus eluting stent-Resolute, cobalt chromium everolimus eluting stents, and platinum chromium everolimus eluting stents) were the most efficacious (lowest target vessel revascularization rate) stents, and cobalt chromium everolimus eluting stents were the safest with significant reductions in definite stent thrombosis (rate ratio 0.35, 0.21 to 0.53), myocardial infarction (0.65, 0.55 to 0.75), and death (0.72, 0.58 to 0.90) compared with bare metal stents.. Biodegradable polymer drug eluting stents are superior to first generation durable polymer drug eluting stents but not to newer generation durable polymer stents in reducing target vessel revascularization. Newer generation durable polymer stents, and especially cobalt chromium everolimus eluting stents, have the best combination of efficacy and safety. The utility of biodegradable polymer stents in the context of excellent clinical outcomes with newer generation durable polymer stents needs to be proven.

Topics: Anti-Infective Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Myocardial Infarction; Paclitaxel; Polymers; Randomized Controlled Trials as Topic; Sirolimus; Stents; Treatment Outcome

To compare by meta-analysis the efficacy and safety of sirolimus-eluting and bare-metal stents in coronary artery disease (CAD) patients with diabetes.. PubMed, MEDLINE and EMBASE were searched from 1971 to 2012. Data on the efficacy and safety of sirolimus-eluting and bare-metal stents in patients with diabetes were collected. A meta-analysis was then performed on a total of 1 259 CAD patients with diabetes from six studies. The odds ratio (OR) was used for comparison. Subgroup analysis was performed according to the sample size, year of study, subjects' geographic area and study method.. Compared with those in the bare-metal stent group (BMS), the subjects in the sirolimus-eluting stent (SES) group had a reduced risk for major cardiac events [OR 0.42, 95% confidence interval (CI): 024-0.74, p < 0.01] and target-lesion revascularisation (OR 0.26, 95% CI: 0.11 - 0.59, p < 0.01). There was no difference for myocardial infarction (OR 0.92, 95% CI: 0.61-1.40, p > 0.05) or mortality (OR 1.19, 95% CI: 0.74-1.92, p > 0.05). Subgroup analysis showed a significant difference for overall risk of major cardiac events between SES and BMS when the sample size was ≤ 90 (OR 0.28, 95% CI: 0.16-0.48, p < 0.01), when it was a randomised control trial (RCT) (OR 0.28, 95% CI: 0.19-0.42, p < 0.01), or when it was performed on European subjects (OR 0.45, 95% CI: 0.27-0.77, p < 0.01). The sensitivity was not different when one study was removed at a time.. Our study confirmed that SES are safer and more effective than BMS in CAD patients with diabetes, as far as major cardiac events are concerned.

Topics: Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Diabetic Angiopathies; Drug-Eluting Stents; Humans; Metals; Myocardial Infarction; Odds Ratio; Patient Safety; Patient Selection; Percutaneous Coronary Intervention; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Treatment Outcome

The introduction of metallic drug-eluting stents has reduced the risk of restenosis and widened the indications of percutaneous coronary intervention in treatment of coronary artery disease. However, this medical device can induce hypersensitive reaction that interferes with the endothelialization and healing process resulting in late persistent or acquired malapposition of the permanent metallic implant. Delayed endotheliaization and malapposition may lead to late and very late stent thrombosis. Bioresorbable scaffolds (BRS) have been introduced to potentially overcome these limitations, as they provide temporary scaffolding and then disappear, liberating the treated vessel from its cage. Magnesium is an essential mineral needed for a variety of physiological functions in the human body and its bioresorbable alloy has the strength-to-weight ratio comparable with that of strong aluminum alloys and alloy steels. The aim of this review is to present the new developments in Magnesium BRS technology, to describe its clinical application and to discuss the future prospects of this innovative therapy.

Topics: Alloys; Antibiotics, Antineoplastic; Coronary Artery Disease; Drug-Eluting Stents; Humans; Magnesium; Paclitaxel; Sirolimus

While EES have proven superior to paclitaxel-eluting stents, it remains uncertain whether EES improve clinical outcomes compared to SES, which are the most efficacious among the first-generation drug-eluting stents. We performed a meta-analysis of randomized trials comparing the efficacy and safety of everolimus-eluting stents (EES) versus sirolimus-eluting stents (SES) in patients undergoing percutaneous coronary intervention.. From online and offline search until December 2011, we identified 11 randomized trials (total 12,869 patients). The primary endpoint was major adverse cardiac events.. The risk of major adverse cardiac events did not differ significantly between the patients treated with EES versus SES [OR, 0.90 (95% CI, 0.77-1.04); P = .162]. However, we found a significant reduction in the risk of repeat revascularization in the EES arm [OR, 0.85 (95% CI, 0.71-1.00); P = .047]. There were no significant differences regarding the risk of cardiac death [OR, 0.97 (95% CI, 0.74-1.27); P = .834], or myocardial infarction [OR, 0.95 (95% CI, 0.75-1.20), P = .656]. The risk of definite or probable stent thrombosis tended to be lower [OR, 0.68 (95% CI, 0.45-1.02); P = .065], while definite ST was significantly lower [OR, 0.44 (95% CI, 0.25-0.80); P = .007] with EES.. In a large systematic overview of comparative trials involving percutaneous revascularization with drug-eluting stents, treatment with EES significantly reduced the risk of repeat revascularization and definite ST compared to SES. We found no significant differences in the risk of cardiac death or myocardial infarction.

Topics: Antineoplastic Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Randomized Controlled Trials as Topic; Sirolimus; Treatment Outcome

Relative efficacy and safety of sirolimus-eluting stents (SES) compared with paclitaxel-eluting stents (PES) remains controversial. It is unknown whether there are different effect and safety in coronary bifurcation treatment between SES and PES.. The meta-analysis was performed to compare the clinical outcomes of SES and PES in coronary bifurcation intervention.. Five head-to-head clinical trials of SES versus PES in coronary bifurcation intervention were included. A total of 2,567 patients were involved in the meta-analysis. Mean follow-up period ranged from 6 to 35 months. The primary end points were the need for target lesion revascularization (TLR) and main-branch restenosis. Secondary end points were target vessel revascularization (TVR), cardiac death, major adverse cardiac events (MACE), and stent thrombosis.. Compared with PES, SES significantly reduced the risk of TLR (5.3% vs. 10.6%, odds ratio (OR) 0.52; 95% confidence interval (CI) = 0.38-0.70, P < 0.001), main-branch restenosis (4.59% vs. 12.59%, OR 0.31; 95% CI = 0.18-0.55, P < 0.001) and TVR (7.05% vs. 12.57%, OR 0.58; 95% CI = 0.42-0.81, P = 0.001) in coronary bifurcation intervention. In addition, SES group also had a significantly lower incidence of MACE (8.20% vs. 14.13%, OR 0.58; 95% CI = 0.40-0.84, P = 0.004) than PES group. However, there were no statistical difference with respect to the incidence of cardiac death (1.64% vs. 1.09%, P = 0.19) and stent thrombosis (0.84% vs. 1.08%, P = 0.64) between SES and PES groups.. Compared with PES, SES reduced the incidence of TLR, main-branch restenosis and MACE in coronary bifurcation intervention, while the risk of stent thrombosis was similar between SES and PES groups.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Odds Ratio; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Everolimus-eluting stents (EES; Xience V) are among the most commonly used newer generation drug-eluting stents in clinical practice and have clearly proven superiority over paclitaxel-eluting stents. Nevertheless, the relative merits of EES against the previous gold-standard sirolimus-eluting stent (SES; Cypher) have been less extensively assessed. We aimed to compare the clinical outcomes of EES with SES in patients with coronary artery disease undergoing percutaneous coronary intervention.. We identified eight eligible randomized trials comparing EES with SES including 11,167 patients. The primary endpoint was the incidence of major adverse cardiac events (MACE). Secondary endpoints were target lesion revascularization (TLR) and the composite of definite and probable stent thrombosis. The follow-up ranged from 9 to 36 months. No heterogeneity across the trials was observed regarding the selected endpoints. There was no difference in risk of MACE (HR 0.91 [0.79-1.04]; p = 0.15), TLR (HR 0.86 [0.72-1.04]; p = 0.12) and the composite of definite and probable stent thrombosis (HR 0.84 [0.54-1.29], p = 0.42). The risk of definite stent thrombosis was significantly lower in patients receiving EES (HR 0.49 [0.27 to 0.91]; p = 0.02).. Using the largest available dataset of patients treated in randomized trials, the present meta-analysis demonstrated that the use of EES versus SES was associated with comparable incidence of overall clinical events. However, EES may be associated with a lower risk of definite stent thrombosis.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Randomized Controlled Trials as Topic; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Bare metal stents have a proven safety record, but limited long-term efficacy due to in-stent restenosis. First-generation drug-eluting stents successfully countered the restenosis rate, but were hampered by concerns about their long-term safety. Second generation drug-eluting stents have combined the low restenosis rate of the first generation with improved long-term safety. We review the evolution of drug-eluting stents with a focus on the safety, efficacy, and unique characteristics of everolimus-eluting stents.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Patient Selection; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Treatment Outcome

The aim of this article is to review the current revascularization strategies in patients presenting with unprotected left main coronary artery disease (LMCAD).. Coronary artery bypass grafting (CABG) is the current standard of treatment for patients with LMCAD. The development and refinement of techniques increased the number of percutaneous coronary interventions (PCI) in LMCAD patients.. Although several observational studies show comparable results of CABG and/or PCI in patients with LMCAD, there is currently no convincing randomized evidence that either one of the two is associated with better long-term survival. Recent meta-analyses of four small randomized trials revealed a similar rate of 1-year major adverse cardiovascular and cerebrovascular events, higher rates of target vessel revascularization and lower stroke rates for PCI. Pooling randomized patients studies stratified by lesion complexity strengthened the hypothesis that CABG is better in more complex LMCAD patients. However, the randomized comparisons are affected by methodological limitations and lack power to be conclusive. The ongoing Evaluation of XIENCE V Everolimus Eluting Stent System Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is expected to provide a better answer on the optimal treatment strategy for LMCAD patients. In the meantime, risk models need to be improved and the most appropriate revascularization strategy for the individual LMCAD patient should be chosen using a multidisciplinary heart team that considers not only risk models but also other clinical and economic facets.

Topics: Coronary Artery Bypass; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Netherlands; Percutaneous Coronary Intervention; Risk Assessment; Sirolimus

To evaluate efficacy and safety of two zotarolimus-eluting stent generations versus other limus-eluting stents (LES), and to compare Resolute zotarolimus-eluting stents (R-ZES) with Endeavor zotarolimus-eluting stents (E-ZES).. The performance of zotarolimus-eluting stents versus other LES, and the possible improvements of R-ZES versus E-ZES still remain to be defined.. We undertook a meta-analysis of trials in which patients were randomly assigned to percutaneous coronary interventions (PCI) with R-ZES versus LES, or with E-ZES versus LES, as well as an indirect comparison of R-ZES versus E-ZES, with LES as common comparator. The primary efficacy endpoint was ischaemia-driven target vessel revascularisation (ID-TVR); the primary safety endpoints were myocardial infarction (MI), cardiac death and cumulative definite/probable stent thrombosis (ST).. Overall, 13'709 patients were assigned to PCI with R-ZES versus LES (n=7185) or with E-ZES versus LES (n=6524). The risk of ID-TVR (OR (95% CI)=1.06 (0.90 to 1.25), p=0.47), MI (1.00 (0.81 to 1.25), p=0.97), cardiac death (0.99 (0.69 to 1.42), p=0.96) and ST (1.18 (0.68 to 2.03), p=0.56) did not differ between R-ZES and LES. Patients receiving E-ZES were more likely to undergo ID-TVR as compared with those receiving LES (1.95 (1.40 to 2.73), p<0.0001). The risk of MI (0.91 (0.54 to 1.54), p=0.73), cardiac death (1.02 (0.54 to 1.91), p=0.96) and ST (1.10 (0.50 to 2.44), p=0.81) was similar between E-ZES and LES. At indirect comparison, PCI with R-ZES versus E-ZES reduced the risk of ID-TVR (0.54 (0.37 to 0.78), p=0.001), without increasing MI (1.09 (0.62 to 1.93), p=0.74), cardiac death (0.97 (0.46 to 2.00), p=0.93) and ST (1.07 (0.40 to 2.80), p=0.88).. The antirestenotic efficacy of Resolute zotarolimus-eluting stents is superior to Endeavor zotarolimus-eluting stents and similar to other limus-eluting stents. Endeavor zotarolimus-eluting stents increase the risk of reinterventions as compared with other limus-eluting stents. First and second-generation zotarolimus-eluting stents have similar thrombogenicity compared with other limus-eluting stents.

Topics: Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus; Treatment Outcome

Exaggerated neointimal hyperplasia is considered as the primary mechanism for increased restenosis in patients with diabetes mellitus (DM) treated with bare-metal stent. However, the vessel response in DM and non-DM treated with different drug-eluting stents (DES) has not been systematically evaluated.. We investigated 3D intravascular ultrasound (postprocedure and 6 to 9 months) in 971 patients (267 with DM and 704 without DM) treated with sirolimus- (n=104), paclitaxel- (n=303), zotarolimus- (n=391), or everolimus- (n=173) eluting stents. Volumetric data were standardized by length as volume index (VI). At postprocedure, lumen VI at the stented segment was significantly smaller in DM than in non-DM, whereas vessel VI was similar between the 2 groups. At follow-up, neointimal obstruction and maximum cross-sectional narrowing (neointimal area/stent area) were not significantly different between the 2 groups with no interaction for the DES type. Consequently, lumen VI was smaller in DM than in non-DM at follow-up. In the reference segments, residual plaque burden at postprocedure was significantly greater in DM than in non-DM, although change in lumen VI was similar between the 2 groups. The arterial responses at the reference segments also showed no interaction for the DES type.. DM and non-DM lesions showed similar vessel response in both in-stent and reference segments regardless of the DES type. In the DES era, the follow-up lumen in DM patients seems to be determined primarily by the smaller lumen at postprocedure rather than exaggerated neointima within the stent or plaque proliferation at the reference segments.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Female; Humans; Hyperplasia; Linear Models; Male; Middle Aged; Multicenter Studies as Topic; Multivariate Analysis; Neointima; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Sirolimus; Stents

the everolimus-eluting stent (EES) is a second-generation drug-eluting stent (DES) which is designed to provide better stent deliverability, deployment, safety, and efficacy. We performed a meta-analysis to evaluate the relative safety and efficacy of the EES compared with the paclitaxel-eluting stent (PES).. the published literature was scanned by formal searches of electronic databases from January 2001 to August 2010. All randomized trials comparing EES versus PES and reporting the clinical outcomes were examined for analysis.. a total of four randomized trials were included, involving 6,788 patients. EES were superior to PES with respect to the major adverse cardiac events (cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)) within 1-year follow-up (OR 0.57; P < 0.001). The 1-year rates of MI, ischemia-driven TLR, and definite or probable stent thrombosis (ST) were also lower with EES than with PES (OR 0.57, P < 0.001 for MI; OR 0.48, P < 0.001 for TLR; OR 0.34, P < 0.001 for ST). There was no significant difference between EES and PES with respect to cardiac mortality (OR 0.93; P = 0.81).. the EES is superior to the PES in terms of 1-year safety and efficacy.

Topics: Aged; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Treatment Outcome; Tubulin Modulators

Although it is widely believed that patients with diabetes mellitus obtain the greatest benefit from drug-eluting stents, convincing evidence on long-term efficacy and safety of these stents is lacking.. We performed a meta-analysis of individual patient data from four randomized trials including 583 patients comparing sirolimus eluting with bare metal stents (median follow-up of 4.2 years). These were the only specific trials reporting on drug-eluting stents in diabetic patients. The primary endpoint was the incidence of major cardiac events. The secondary endpoints were all-cause mortality and myocardial infarction as a safety endpoint and target lesion re-intervention as an efficacy endpoint. Stent thrombosis was also evaluated.. There was a significant reduction in the overall hazard of major cardiac events (hazard ratio [HR] 0.48, 95% confidence interval [CI] 0.36-0.63, P < 0.001) with sirolimus-eluting stents. This was mostly due to a significant reduction in the overall hazard of repeat revascularization (HR 0.27, 95% CI 0.18-0.41, P < 0.001) in favor of sirolimus-eluting stents. However, the overall hazard of death (HR 0.91, 95% CI 0.59-1.41, P = 0.68) as well as death or myocardial infarction (HR 0.77, 95% CI 0.54-1.09, P = 0.14) were not significantly different between the groups. No significant differences were observed regarding stent thrombosis (HR 0.50, 95% CI 0.15-1.69, P = 0.26).. Sirolimus-eluting stents are highly effective in reducing the risk for major cardiac events and safe in diabetic patients with coronary artery disease.

Topics: Aged; Coronary Artery Disease; Diabetes Complications; Drug-Eluting Stents; Follow-Up Studies; Humans; Middle Aged; Randomized Controlled Trials as Topic; Sirolimus; Stents; Treatment Outcome

Percutaneous coronary intervention (PCI) is an important treatment approach in the management of symptomatic coronary artery disease (CAD). A significant development in PCI in the mid 1970s was balloon angioplasty, followed by bare-metal stents a decade later, and now, the widespread use of drug-eluting stents (DES). While PCI has conferred remarkable benefit to millions of CAD patients, restenosis, and late stent thrombosis associated with DES remain problematic, and improvements are keenly sought. This article reviews recent developments in DES.

Topics: Angioplasty, Balloon, Coronary; Clinical Trials as Topic; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Paclitaxel; Polymers; Sirolimus; Thrombosis; Treatment Outcome

Stent fracture and subsequent stent thrombosis are known complications after stent implantation, especially in stents with closed cell design like the first generation sirolimus drug eluting stents (DES). Late stent thrombosis is very rarely encountered in our patient population, majority Chinese. We report a case of non-ST elevation myocardial infarction as a result of very late stent thrombosis (three years after implantation) due to stent fracture at the site of overlap of two first generation sirolimus DES. There were initial difficulties in restoring coronary flow by conventional reperfusion therapies but a successful outcome after implantation of an endothelial progenitor cell capture stent, with no further recurrence of ischemic event after 12 months. An attempt was made to analyze all existing factors present and contributing to the stent fracture and stent thrombosis in this case, as reported in the literature.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Humans; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Prosthesis Failure; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The introduction of drug-eluting stents (DES) has improved the efficacy of percutaneous coronary intervention by addressing the issue of neointimal proliferation, a pathology contributing to restenosis. First-generation stents eluting sirolimus or paclitaxel were joined by second-generation stents, such as the everolimus- and the zotarolimus-eluting stents, promising increased safety and efficacy. As a result, there is a plethora of drug-eluting stents available, with differences in the stent platform, the polymer coating and the eluted drug, which translate into differences in biological markers of efficacy, such as late loss. However, it remains controversial whether these discrepancies have an impact on clinical markers of safety and efficacy, or if the improved efficacy of DES is a class effect. This article reviews the differences between DES by looking into the biological differences and into trials and registries of DES.

Topics: Antineoplastic Agents, Phytogenic; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Paclitaxel; Randomized Controlled Trials as Topic; Registries; Sirolimus; Treatment Outcome

The aim of the study was to compare the outcomes after placement of the everolimus-eluting stent (EES; Xience V) and the sirolimus-eluting stent (SES; Cypher) in patients with coronary artery disease. The second-generation EES is currently one of the most commonly used drug-eluting stents in clinical practice. Although it has clearly been shown superior to paclitaxel-eluting stents, its relative merits against SES have been less extensively assessed.. We identified 5 eligible randomized trials comparing EES with SES in 7370 patients. The primary end point was major adverse cardiac events. Secondary end points were cardiac death, myocardial infarction, repeat revascularization, and the composite of definite and probable stent thrombosis. Overall hazard ratios (HR) and 95% confidence intervals (CI) were calculated for EES versus SES for each of the end points. No heterogeneity across the trials was observed regarding the primary and secondary end points. The risk of major adverse cardiac events (HR, 0.91 [95% CI, 0.77 to 1.08]; P=0.28), cardiac death (HR, 1.02 [95% CI, 0.73 to 1.41]; P=0.92), myocardial infarction (HR, 0.97 [95% CI, 0.66 to 1.35]; P=0.76), repeat revascularization (HR, 0.85 [95% CI, 0.68 to 1.07]; P=0.16), and composite of definite and probable stent thrombosis (HR, 0.79 [95% CI, 0.49 to 1.27], P=0.33) were not significantly different between EES and SES.. This meta-analysis did not show significant differences between EES and SES in terms of clinical efficacy and safety. Future studies with longer follow-up are needed to better define the relative merits of these drug-eluting stents.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Prosthesis Implantation; Randomized Controlled Trials as Topic; Recurrence; Risk; Sirolimus; Thrombosis; Treatment Outcome

Some (but not all) prior trials have reported differential outcomes after percutaneous coronary intervention with paclitaxel-eluting stents versus stents eluting rapamycin analogs according to the presence of diabetes mellitus. These studies lacked sufficient power to examine individual safety and efficacy end points.. To determine whether an interaction exists between the presence of diabetes mellitus and treatment with everolimus-eluting stents compared with paclitaxel-eluting stents, we pooled the databases from the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SPIRIT) II, SPIRIT III, SPIRIT IV, and A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice (COMPARE) trials in which percutaneous coronary intervention was performed in 6780 patients, 1869 (27.6%) of whom had diabetes mellitus. Patients without diabetes mellitus treated with everolimus-eluting stents compared with paclitaxel-eluting stents had significantly reduced 2-year rates of mortality (1.9% versus 3.1%; P=0.01), myocardial infarction (2.5% versus 5.8%; P<0.0001), stent thrombosis (0.3% versus 2.4%; P<0.0001), and ischemia-driven target lesion revascularization (3.6% versus 6.9%; P<0.0001). In contrast, among patients with diabetes mellitus, there were no significant differences between the 2 stent types in any measured safety or efficacy parameter. Significant interactions were present between diabetic status and stent type for the 2-year end points of myocardial infarction (P=0.01), stent thrombosis (P=0.0006), and target lesion revascularization (P=0.02).. We have identified a substantial interaction between diabetes mellitus and stent type on clinical outcomes after percutaneous coronary intervention. In patients without diabetes mellitus, everolimus-eluting stents compared with paclitaxel-eluting stents resulted in substantial 2-year reductions in death, myocardial infarction, stent thrombosis, and target lesion revascularization, whereas no significant differences in safety or efficacy outcomes were present in diabetic patients.

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Disease; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Tubulin Modulators

There is an ongoing debate on the optimal drug-eluting stent (DES) in diabetic patients with coronary artery disease. We addressed this issue by making a synthesis of the available evidence on the relative long-term efficacy and safety of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) in these patients.. Individual patient data were analyzed from 6 randomized trials specifically designed to compare SES with PES in diabetic patients. In total, 1183 patients were followed up for a median of 3.9 years (25th, 75th percentiles 3.4-4.5 years). The primary efficacy end point was target lesion revascularization (TLR). The composite of death and myocardial infarction (MI) was the primary safety end point. Stent thrombosis was a secondary end point. Overall hazard ratios (HRs) with 95% CIs were calculated as summary estimates.. No significant heterogeneity was seen across the 6 randomized trials for all analyzed events. Sirolimus-eluting stent was associated with a significant reduction in the risk of TLR (HR 0.65 [0.47-0.91], P = .01). No significant differences were observed regarding the risk of death or MI (HR 1.04 [0.74-1.45], P = .83) and stent thrombosis (HR 1.00 [0.31-3.30], P = .67). Mortality was also not affected by the type of DES (HR 0.95 [0.65-1.39], P = .79).. In diabetic patients with coronary artery disease, SES leads to a sustained reduction in the risk of TLR compared with PES. Both these DES types are, however, comparable with respect to the risk of stent thrombosis, MI, or death over long-term follow-up.

Topics: Coronary Artery Disease; Diabetic Angiopathies; Drug-Eluting Stents; Humans; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus

Spontaneous coronary artery dissection is an unusual condition that mainly happens in fit and healthy women in the peripartum period. Strenuous exercise is a rare cause of dissection in angiographically normal coronary arteries. There is no definitive consensus on the etiology, prognosis and treatment of SCAD. We report a case of successful treatment of a late presentation of a coronary artery dissection secondary to intense physical activity in a 48 year old cyclist who continued to cycle for 3 months post event.

Topics: Angioplasty, Balloon, Coronary; Bicycling; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Exercise; Female; Follow-Up Studies; Humans; Middle Aged; Rupture, Spontaneous; Sirolimus; Treatment Outcome; Ultrasonography, Interventional

Late stent malapposition (LSM) may be acquired (LASM) or persistent. LSM may play a role in patients who develop late stent thrombosis (ST). Our objective was to compare the risk of LASM in bare metal stents (BMS) with drug-eluting stents (DES) and to investigate the possible association of both acquired and persistent LSM with (very) late ST.. We searched PubMed and relevant sources from January 2002 to December 2007. Inclusion criteria were: (a) intra-vascular ultrasonography (IVUS) at both post-stent implantation and follow-up; (b) 6-9-month-follow-up IVUS; (c) implantation of either BMS or the following DES: sirolimus, paclitaxel, everolimus, or zotarolimus; and (d) follow-up for LSM. Of 33 articles retrieved for detailed evaluation, 17 met the inclusion criteria. The risk of LASM in patients with DES was four times higher compared with BMS (OR = 4.36, CI 95% 1.74-10.94) in randomized clinical trials. The risk of (very) late ST in patients with LSM (five studies) was higher compared with those without LSM (OR = 6.51, CI 95% 1.34-34.91).. In our meta-analysis, the risk of LASM is strongly increased after DES implantation compared with BMS. Furthermore, LSM seems to be associated with late and very late ST.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Paclitaxel; Prosthesis Failure; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Stents; Tubulin Modulators

Although originally the practice of using balloon catheters proved successful in the short term, the long-term prognosis was less promising because of restenosis, which occurred in >or=30% of patients. This prompted the development of new techniques and mechanical adjuncts, or stents, to maintain lumen patency after balloon angioplasty. Bare metal stents (BMS), the first type of stent used in percutaneous coronary intervention, were designed to address the issues met by balloon angioplasty. BMS reduced the angiographic and clinical restenosis rates in de novo lesions compared to percutaneous transluminal coronary angioplasty alone and decreased the need for emergency coronary artery bypass graft surgery. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred after 6 months in about 20% of cases, necessitating repeat procedures. Drug-eluting stents (DES) improved on the principle of BMS by also delivering drugs locally to inhibit neointimal hyperplasia. DES greatly reduced the incidence of restenosis and resulted in a better safety profile as compared to radiation or systemic drug administration. These advantages and a lower cost compared to surgical interventions make DES an attractive option to treat coronary artery disease. Currently, five DES are available in the USA: the CYPHER sirolimus-eluting stent from Cordis (approved by FDA on 24 April 2003), the TAXUS Express(2) and Liberté paclitaxel-eluting stents from Boston Scientific (approved by FDA on 4 March 2004 and 10 October 2008, respectively) (hereafter TAXUS Express is referred to as TAXUS), the ENDEAVOR zotarolimus-eluting stent from Medtronic (approved by FDA on 1 February 2008), and the XIENCE V everolimus-eluting stent from Abbott Vascular (approved by FDA on 2 July 2008). Following the approval of CYPHER and TAXUS, the clinical data suggested a potential small increase in the rate of stent thrombosis (ST) in DES compared with BMS after implantation. To determine the differences in ST and other rare events between different stents, some modifications have been made to DES clinical trial design, and postmarket surveillance programs have been included to further evaluate the safety and efficacy of each DES. In this review, we will discuss the key clinical outcomes of DES clinical trials, design and key features of the current coronary stents, and major clinical development programs. Postmarket trials, designed to establish long-term safety around ST and o

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Evidence-Based Medicine; Humans; Metals; Myocardial Infarction; Prosthesis Design; Risk Assessment; Sirolimus; Stents; Thrombosis; Treatment Outcome

Stent fracture has been observed in noncoronary vessels, especially in the superficial femoral and popliteal arteries and with bare metal stents in saphenous vein grafts of coronary arteries. Since the introduction of drug-eluting stents, stent fractures have also been reported in small studies and case reports. We reviewed these publications to assess what is known regarding the incidence, contributing factors, and clinical implications of drug-eluting stent fracture in coronary arteries. The reported rate of drug-eluting stent fracture in coronary arteries ranges from 1 to 8%, although much of the available literature is derived from single-center studies that are heterogeneous in their study methods. A higher risk of stent fracture may be associated with the right coronary artery location, excessive tortuosity or angulation of the vessel, overlapping stents, and longer stents. The closed-cell design of the Cypher stent has been associated with increased rigidity that may increase the risk of stent fracture, although these studies did not assess the overall outcomes between the Cypher and Taxus stents in a head-to-head comparison. Stent fracture has been shown by most studies to be associated with a statistically increased incidence of focal in-stent restenosis, and some have shown an increased risk of target lesion revascularization. Other complications observed with stent fracture include stent thrombosis, coronary aneurysms, myocardial infarction, and sudden death.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Equipment Failure Analysis; Female; Humans; Male; Middle Aged; Paclitaxel; Prosthesis Design; Prosthesis Failure; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The introduction of drug-eluting stents has led to a marked reduction of restenosis, which is a major limitation of percutaneous coronary intervention for coronary artery disease. The next-generation Xience V® (Abbott Vascular, CA, USA) everolimus-eluting stent was designed to address the limitations of first-generation drug-eluting stents. The cobalt-chromium stent platform with an open-cell design offers excellent deliverability. Moreover, the combination of a thin fluoropolymer eluting the antirestenotic drug everolimus provides both an effective suppression of neointimal tissue and rapid re-endothelialization above and between stent struts in preclinical studies. Large randomized clinical trials comparing the everolimus-eluting stent with the Taxus Express® and Liberté® (Boston Scientific, MA, USA) paclitaxel-eluting stents have shown reduced rates of repeat revascularization, myocardial infarction and stent thrombosis at 1-year follow-up with the everolimus-eluting stent. However, we will have to await long-term (5-year) data from these randomized clinical trials with the everolimus-eluting stent to determine whether the observed benefit is robust. Furthermore, data are currently limited the clinical performance of the everolimus-eluting stent relative to drug-eluting stents other than the Taxus Express and Liberté paclitaxel-eluting stents, although a large number of trials are now being conducted to address these questions. In this article, we provide a comprehensive overview of (pre)clinical studies with the everolimus-eluting stent.

Topics: Angioplasty, Balloon, Coronary; Animals; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Randomized Controlled Trials as Topic; Sirolimus; Thrombosis

Small vessel (<3 mm) coronary artery disease is common and has been identified as independent predictor of restenosis after percutaneous coronary intervention. It remains controversial whether bare-metal stent (BMS) implantation in small vessels has an advantage over balloon angioplasty in terms of angiographic and clinical outcomes. Introduction of drug-eluting stent (DES) has resulted in significant reduction in restenosis and the need for repeat revascularization. Several DESs have been introduced resulting in varying reduction in outcomes as compared with BMS. However, their impact on outcomes in small vessels is not clearly known. It is expected that DES could substantially reduce restenosis in smaller vessels. Large, randomized studies are warranted to assess the impact of different DESs on outcomes in patients with small coronary arteries.

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Humans; Paclitaxel; Sirolimus; Stents; Treatment Outcome

Zotarolimus is an anti-proliferative drug used exclusively in the design of coronary drug eluting stent.. To review pathophysiological and clinical data regarding the use of zotarolimus-eluting stent (ZES) for the treatment of coronary artery disease.. Mechanism of action of zotarolimus is reviewed and design of different type of ZES described. Clinical results of the trials by the use of different ZES are discussed.. First and second generations of ZES demonstrated to be safe but less effective in preventing restenosis as the competitive sirolimus eluting stent and paclitaxel eluting stent. Third generation of ZES that show new pharmacokinetic release of the drug may improve clinical results in continuing trials.. Zotarolimus incorporated on stent platform represents a useful tool in treating patients with coronary artery disease. Release kinetic of the drug may play a major role in in-stent neointimal suppression during follow-up.

Topics: Animals; Clinical Trials as Topic; Coronary Artery Disease; Drug-Eluting Stents; Forecasting; Humans; Sirolimus; Treatment Outcome

Drug-eluting stents are widely used for the treatment of coronary artery disease to reduce the risk of restenosis found with bare-metal stents. Nevertheless, there are concerns about device deliverability and safety with the initial generation of drug-eluting stents. The second-generation Xience V everolimus-eluting stent incorporates advanced design features such as a cobalt-chromium stent platform coated with an antirestenotic drug, everolimus, incorporated into a biocompatible polymer with a long history of medical use. The efficacy of the stent has been demonstrated with low rates of angiographic restenosis, whilst randomized trials comparing the Xience V everolimus-eluting stent to the first-generation Taxus paclitaxel-eluting stent have found a reduction in repeat revascularization rates. Further randomized trials, including 'all-comer' patients and registries of unselected patients are currently further evaluating the efficacy and safety of the Xience V stent in high-risk, complex cases.

Topics: Chromium Alloys; Coated Materials, Biocompatible; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Randomized Controlled Trials as Topic; Sirolimus

Coronary angiography, despite its inherent invasiveness and need for contrast media and radiographic exposure, is still routinely employed every year for the diagnostic and therapeutic management of millions of patients with or at risk for coronary artery disease. Whereas approximate visual estimation is the most common way to evaluate coronary angiography findings, since the late 1980s a number of investigators have developed and investigated methods of quantitative coronary angiography (QCA) analysis exploiting automated or semi-automated edge detection. Despite the inherent drawback of QCA due to its focus on the contrast-filled lumen of the vessel, QCA has offered and continues to offer important insights for clinical research and, in selected cases, clinical practice. This review aims thus to provide a comprehensive and updated viewpoint on the actual role of QCA.

Topics: Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Disease Progression; Drug-Eluting Stents; Humans; Image Interpretation, Computer-Assisted; Immunosuppressive Agents; Sirolimus; Tomography, Optical Coherence

Topics: Antineoplastic Agents, Phytogenic; Confidence Intervals; Coronary Artery Disease; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Incidence; Odds Ratio; Paclitaxel; Risk Factors; Sirolimus; Tomography, Optical Coherence; Ultrasonography, Interventional

Recently, a growing body of clinical data has shown that the first generation of drug-eluting stents (1st-gen DES) implantation could elicit coronary conduit artery vasomotor dysfunction at nonstented reference segments as late as 12 months after implantation compared with that seen with bare-metal stents. The mechanism of this phenomenon is still not fully understood. Pathological studies have implicated delayed arterial healing and poor re-endothelialization after the 1st-gen DES implantation. Given the vast use of DES globally, a thorough understanding of the early and long-term safety of these devices is paramount. Therefore, this article systematically reviews the current clinical, pathophysiological, and histopathological available data regarding 1st-gen DES-associated vascular endothelial dysfunction. Meanwhile, we will also review the newer generation of DES and emerging endothelial-friendly technology.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Endothelium, Vascular; Humans; Paclitaxel; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The field of stent based tissue engineering continues to revolutionise modern medicine by designing novel materials to restore vascular tissue function. Accordingly, the following discussion examines a novel, absorbable, polymeric scaffold engineered in combination with dual therapeutic coating, enabling locally administered temporary scaffolding in the coronary arteries for long term vascular patency and repair. This coronary stent platform consists of an absorbable polymeric material stent structure that incorporates a dual partitioned coating, by means of pro-healing EPC (endothelial progenitor cell) capture technology allowing for rapid endothelial coverage, and an absorbable polymer matrix with sustained elution of sirolimus, a drug controlling neointimal proliferation. This paper provides a brief overview of the various innovations developed by OrbusNeich to create this fully absorbable coronary device platform.

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Cell Proliferation; Coated Materials, Biocompatible; Coronary Artery Disease; Drug-Eluting Stents; Endothelial Cells; Humans; Polymers; Prosthesis Design; Sirolimus; Stem Cells; Tissue Scaffolds; Treatment Outcome

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Program Development; Prosthesis Design; Sirolimus; Treatment Outcome

The purpose of this study was to compare estimates for revascularization and major adverse cardiac events (MACE) (death, myocardial infarction, repeat revascularization) in diabetic patients treated with paclitaxel- and sirolimus-eluting stents (PES and SES).. Outcomes in diabetic patients treated with PES and SES have not been adequately evaluated.. We searched MEDLINE/EMBASE from January 2002 to February 2007 and identified abstracts/presentations from this period at major cardiology conferences. Randomized controlled trials (RCTs) and registries were included if data for diabetic patients treated with PES or SES were available. Point estimates with 95% confidence intervals (CIs) were computed as summary statistics.. In RCTs (13 trials; n = 2,422) similar point estimates for target lesion revascularization (TLR) (PES: 8.6%, 95% CI 6.5% to 11.3%; SES: 7.6%, 95% CI 5.8% to 9.9%) and MACE (PES: 15.4%, 95% CI 12.4% to 19.1%; SES: 12.9%, 95% CI 8.5% to 19.2%) were observed. In head-to-head trials (4 RCTs), no difference in the likelihood of TLR (PES vs. SES) was observed (odds ratio [OR] 1.37, 95% CI 0.64 to 2.9, p = 0.42). In registries (16 registries; n = 10,156), point estimates for target vessel revascularization (TVR) (PES: 5.8%, 95% CI 3.9% to 8.5%; SES: 7.2%, 95% CI 4.6% to 11.2%) and MACE (PES: 10.1%, 95% CI 7.3% to 13.8%; SES: 11.9%, 95% CI 8.6% to 16.4%) were also similar. In registries reporting outcomes with both stents (8 registries for TVR and 7 registries for MACE), the likelihood of TVR (PES vs. SES) (OR 0.77, 95% CI 0.54 to 1.10, p = 0.15) and MACE (OR 0.83, 95% CI 0.68 to 1.01, p = 0.056) were nonsignificantly lower with PES.. This analysis of over 11,000 diabetic patients treated with drug-eluting stents demonstrates single-digit revascularization rates. Furthermore, revascularization and MACE estimates are similar with both PES and SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Odds Ratio; Paclitaxel; Randomized Controlled Trials as Topic; Registries; Risk Assessment; Risk Factors; Sirolimus; Treatment Outcome

Drug-coated (i.e., drug-eluting) stents (DES) are frequently used nowadays in the treatment of coronary artery disease given their superior antirestenotic effect and clear benefits in terms of reduction of repeat revascularizations and major adverse cardiac events. However, a number of safety concerns have been raised on DES.. To appraise current data on the safety of DES.. A thorough PubMed search was done for pertinent clinical reports on DES safety with the following string (updated December 2007): (drug(*) OR sirolimus OR paclitaxel) AND eluting(*) AND stent(*) AND (safety OR complication(*) OR thrombos(*) OR infarction) NOT (editorial[pt] OR review[pt]).. A total of 1077 citations were retrieved and appraised. The most relevant threats to DES safety were bleeding, difficulties in balloon deflation and retrieval, endothelial dysfunction and vasospasm, hypersensitivity, infection, late acquired malapposition and aneurysm formation, late restenosis, peri-procedural myocardial infarction, plaque prolapse, stent dislodgement or embolization, stent fracture, and stent thrombosis (with ensuing risk of death, myocardial infarction or arrhythmia). Of these, the most important and debated safety issue is the potentially increased risk in late stent thrombosis, which might offset the antirestenotic benefits of DES especially in patients at higher risk of thrombosis or who cannot comply with the recommended dual antiplatelet regimen. Nonetheless, further clinical studies are warranted to clarify whether these safety threats should be a concern for the large target population of patients with coronary artery disease most likely to benefit from DES implantation.

Topics: Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Humans; Paclitaxel; Patient Compliance; Risk Factors; Sirolimus; Time Factors

First-generation drug-eluting stents (DES) have brought major improvements in results of percutaneous coronary intervention (PCI). However, there is currently debate on the safety of these first-generation DES, given the potential for late stent thrombosis, especially after discontinuation of dual antiplatelet therapy. Second-generation DES, such as zotarolimus- (Endeavor) and everolimus-eluting stents (Xience V), have recently become available in the USA and/or Europe. Indeed, the Xience V stent holds the promise of superior anti-restenotic efficacy as well as long-term safety, yet there is uncertainty on its risk-benefit balance. Authors conducted a systematic review of basic science and clinical evidence on the Xience V, by thoroughly searching PubMed and online databases (updated September 2007). They also compared the clinical results of Xience V vs paclitaxel-eluting stents (Taxus) and sirolimus-eluting stents (Cypher) by means of direct and indirect comparison meta-analysis. A total of three clinical studies has been retrieved focusing on Xience V, however both most recent and important trials were still unpublished. The first trial compared Xience V vs bare-metal stents, whereas the other two randomized trials compared Xience V vs Taxus. Direct meta-analysis of Xience V vs Taxus showed that Xience V was significantly superior to Taxus in preventing binary angiographic restenosis and target lesion revascularization (P<0.05 for both). Indirect comparison between Xience V and Cypher, exploiting a recent 16-trial large meta-analysis, showed that Xience V was at least as effective as Cypher in preventing target lesion revascularization (P=0.12). Everolimus-eluting stents (Xience V) appear as a major breakthrough in coronary interventions, and superior efficacy has already been demonstrated in comparison to paclitaxel-eluting stents (Taxus). Data available to date also suggest that Xience V is at least as effective as sirolimus-eluting stents (Cypher). Whether long-term results and direct comparison to Cypher will also be favorable remains to be established by future clinical trials.

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus; Treatment Outcome

Drug-eluting stents (DES) with antiproliferative drugs attached via polymers on the stent surface have reduced in-stent restenosis and repeat revascularization compared with bare metal stent (BMS) across nearly all lesion and patient subsets. However, the small number of patients with in-stent restenosis after DES treatment still exists. Furthermore, concerns about long-term safety of DES are raised, particularly regarding the higher-than-expected late-event thrombosis. There is no doubt that the DES will continue to play a pivotal role in the treatment of coronary artery disease, yet future designs need to incorporate features that reduce thrombosis and promote endothelialization along with maintaining the efficacy. This review focuses on novel generation of DES, discussing new programs, including new antiproliferative agents, novel polymeric and non polymeric stents.

Topics: Absorbable Implants; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Equipment Design; Everolimus; Evidence-Based Medicine; Humans; Immunosuppressive Agents; Polymers; Prosthesis Design; Sirolimus; Tacrolimus

We assessed the outcomes in diabetic patients undergoing percutaneous coronary intervention (PCI) using sirolimus-eluting stents (SES) as a function of treatment with glycoprotein (GP) IIb/IIIa inhibitors.. Of 551 diabetic patients treated with a SES in nine trials (RAVEL, SIRIUS, E-SIRIUS, C-SIRIUS, REALITY, SVELTE, DIRECT, SIRIUS 2.25, and SIRIUS 4.0), 187 patients (33.9%) were administered GP IIb/IIIa inhibitors during PCI. GP IIb/IIIa blockade was associated with lower rates of myocardial infarction (MI) at 30 days (1.1% vs. 3.3%, P = 0.12) and at 1 year (1.1% vs. 4.7%, P = 0.04), and composite endpoint of cardiac death/MI at 1 year (2.2% vs. 6.2%, P = 0.05). Benefit from GP IIb/IIIa inhibitors was confined to 128 insulin-treated diabetics who had remarkable reduction in MI (0.0% vs. 6.3%, P = 0.04) and cardiac death/MI at 30 days (0.0% vs. 7.6%, P = 0.05) and at 1-year (0.0% vs. 13.4%, P = 0.01 and 0.0% vs. 15.7%, P = 0.0005, respectively). When treated with GP IIb/IIIa inhibitors, insulin-requiring diabetics had similar rates of 1-year death/MI when compared with the nondiabetic patients (0% vs. 4.7%, P = 0.13, respectively). There were no significant differences in outcomes as a function of GP IIb/IIIa blockade in diabetics not treated with insulin.. In this analysis, outcomes of insulin requiring diabetic patients undergoing PCI with SES were considerably improved with adjunctive GP IIb/IIIa inhibitors by decreasing the rates of MI and composite endpoint of cardiac death/MI.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Artery Disease; Diabetes Mellitus, Type 1; Drug-Eluting Stents; Female; Humans; Hypoglycemic Agents; Insulin; Male; Middle Aged; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Proportional Hazards Models; Risk Assessment; Sirolimus; Time Factors; Treatment Outcome

Drug-eluting stents (DES) have been shown to be safe and significantly reduce clinical events and angiographic restenosis in the percutaneous treatment of coronary artery disease. Currently, three DES have been approved in Europe and Northern America: the sirolimus-eluting stent (SES), the paclitaxel-eluting stent (PES) and the zotarolimus-eluting stent (ZES). Everolimus, an analog of sirolimus, is an immunosuppressive and antiproliferative agent. In three studies, the SPIRIT I, FUTURE I and II, the everolimus-eluting stent has proven to be safe, well-tolerated and has shown very favorable clinical and angiographic results. Compared with earlier-generation DES, the XIENCE V everolimus-eluting coronary stent system (Advanced Cardiovascular Systems Inc., an Abbott Vascular Company, CA, USA) may provide enhanced deliverability, radiopacity with thinner strut filaments and, owing to a durable polymer, sustained drug elution and vascular compatibility.

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Everolimus; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus; Stents; Technology Assessment, Biomedical

Standard immunosuppression after cardiac transplantation includes a calcineurin inhibitor in combination with mycophenolate mofetil or azathioprine and corticosteroids. These agents have led to excellent outcomes but have shortcomings in terms of efficacy and toxicity. A new class of immunosuppressants, proliferation signal inhibitors, may meet some of these shortcomings.. The efficacy of the available proliferation signal inhibitors - sirolimus and its derivative everolimus - has been compared with azathioprine in three randomized clinical trials. Sirolimus or everolimus use was associated with lower rates of acute rejection and reduced development of chronic allograft vasculopathy. Sirolimus was not found to be superior to mycophenolate mofetil in a randomized trial. Proliferation signal inhibitors have been reported to be effective in refractory recurrent acute rejection. Nonrandomized studies have demonstrated that proliferation signal inhibitor-based immunosuppression enables recovery from renal dysfunction secondary to calcineurin inhibitor treatment. Proliferation signal inhibitor-based treatment is associated with a lower risk of malignancy than calcineurin inhibitor-based regimens. Proliferation signal inhibitors have significant adverse effects that may limit widespread use.. Proliferation signal inhibitors are important new immunosuppressive agents that have added considerably to the armamentarium allowing further tailored immunosuppression to individualize patient care after heart transplantation.

Topics: Azathioprine; Calcineurin; Calcineurin Inhibitors; Cell Proliferation; Coronary Artery Disease; Dose-Response Relationship, Drug; Everolimus; Graft Rejection; Heart Transplantation; Humans; Immunosuppressive Agents; Mycophenolic Acid; Signal Transduction; Sirolimus

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Stenosis; Humans; Paclitaxel; Quality of Life; Risk; Sirolimus; Stents

Diabetes mellitus is a major risk factor for restenosis in patients undergoing percutaneous coronary intervention. Randomized controlled trials comparing drug-eluting stents (DESs) with bare metal stents (BMSs) showed a marked decrease in in-stent restenosis and target lesion revascularization with DESs in the total patient population enrolled in the studies, including patients with diabetes. However, it remains unclear whether the antirestenotic benefit of DESs is preserved in the high-risk diabetic subgroup. MEDLINE, EMBASE, ISI Web of Knowledge, Current Contents, International Pharmaceutical Abstracts, and recent Scientific Sessions databases were searched to identify relevant clinical trials comparing DESs with BMSs. A randomized controlled trial was included if it provided outcome data for patients with diabetes for > or =1 of the following: late lumen loss, in-stent restenosis, or target lesion revascularization. Data were combined using fixed-effects models, and standard tests for heterogeneity were performed. Eight studies with 1,520 patients with diabetes were identified that reported > or =1 outcome of interest. Mean late lumen losses (7 studies) were 0.93 mm (95% confidence interval [CI] 0.510 to 1.348) with BMSs and 0.18 mm (95% CI -0.088 to +0.446) with DESs. For patients receiving a DES, this translated into a marked decrease in in-stent restenosis (7 studies, RR 0.14, 95% CI 0.10 to 0.22, p <0.001) and target lesion revascularization (8 studies, RR 0.34, 95% CI 0.26 to 0.45, p <0.001). DES use is associated with a marked decrease in in-stent restenosis and target lesion revascularization in patients with diabetes. In conclusion, the analysis supports the current widespread use of DESs in these high-risk patients.

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Databases, Factual; Diabetes Complications; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Follow-Up Studies; Humans; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus; Stents; Treatment Outcome

Drug-eluting stents have radically changed the way we treat coronary artery disease. They offer lower restenotic rates compared with the bare metal stents and this enables more challenging and complex lesions to be treated. However, there are still limitations as restenosis has not been completely abolished and there are concerns about stent thrombosis. The next generation stents offer the technology to address these pertinent issues. This review examines the new analogs of the sirolimus family and their use in novel stent platforms, including the use of biodegradable and bioabsorbable materials employed in both stents and on the polymer. "Reservoir stents" that are specially designed to contain layers of drugs in pockets with different release profiles are discussed and an insight into the emerging field of bioengineered stents is highlighted.

Topics: Biocompatible Materials; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug Delivery Systems; Humans; Immunosuppressive Agents; Polymers; Prosthesis Design; Sirolimus; Stents

The advent of intravascular stenting dramatically reduced the incidence of restenosis among patients undergoing percutaneous transluminal coronary angioplasty. However, a substantial percentage of patients, particularly those with risk factors such as diabetes mellitus or complicated lesions, remain at risk for restenosis. Drug-eluting stents overcome this problem by releasing bioactive agents from a polymeric coating directly into the vessel wall, inhibiting the cellular mechanisms of restenosis while avoiding systemic toxicity. Recent data indicate that local targeting of the proliferative process with drug-eluting stents dramatically reduces the risk for restenosis, even among high-risk patients. A range of bioactive coatings are currently available or in late clinical trials. Both sirolimus- and paclitaxel-eluting stents have demonstrated efficacy in a broad range of patient types; early data from clinical trials of second-generation stent coatings, such as everolimus and ABT-578 (zotarolimus), suggest that these agents are also effective in preventing restenosis. This article reviews the pathophysiology of in-stent restenosis and surveys recent key clinical trials of drug-eluting stents.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Drug Therapy, Combination; Humans; Immunosuppressive Agents; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Stents; Treatment Outcome; Tubulin Modulators

Our purpose was to make a synthesis of the available evidence on the relative efficacy and safety of 2 drug-eluting stents (DES)--sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES)--in patients with coronary artery disease.. It is not known whether there are differences in late outcomes between the 2 most commonly used DES: SES and PES.. Sixteen randomized trials of SES versus PES with a total number of 8,695 patients were included in this meta-analysis. A full set of individual outcome data from 5,562 patients was also available. Mean follow-up period ranged from 9 to 37 months. The primary efficacy end point was the need for reintervention (target lesion revascularization). The primary safety end point was stent thrombosis. Secondary end points were death and recurrent myocardial infarction (MI).. No significant heterogeneity was found across trials. Compared with PES, SES significantly reduced the risk of reintervention (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.63 to 0.87, p < 0.001) and stent thrombosis (HR 0.66; 95% CI 0.46 to 0.94, p = 0.02) without significantly impacting on the risk of death (HR 0.92; 95% CI 0.74 to 1.13, p = 0.43) or MI (HR 0.84; 95% CI 0.69 to 1.03, p = 0.10).. Sirolimus-eluting stents are superior to PES in terms of a significant reduction of the risk of reintervention and stent thrombosis. The risk of death was not significantly different between the 2 DES, but there was a trend toward a higher risk of MI with PES, especially after the first year from the procedure.

Topics: Aged; Blood Vessel Prosthesis; Comorbidity; Coronary Artery Disease; Coronary Thrombosis; Drug Delivery Systems; Global Health; Humans; Immunosuppressive Agents; Middle Aged; Myocardial Infarction; Outcome and Process Assessment, Health Care; Paclitaxel; Randomized Controlled Trials as Topic; Recurrence; Sirolimus; Stents; Survival Analysis; Treatment Outcome; Tubulin Modulators

Coronary stent infection is exceedingly rare despite the widespread use of percutaneous coronary intervention (PCI). The utilization of drug-eluting stents (DES) may have a higher theoretical risk of infection due to their local immunosuppressant effect. Vigilance in suspecting stent infection is important, as the associated mortality rate is approximately 50%. We discuss the case of a patient who presented with an infected DES 2 weeks after implantation which led to spontaneous Type II coronary perforation. The perforation was sealed with prolonged balloon inflation, and the patient was treated with intravenous antibiotics. This is the first reported case of a patient with a stent infection who presented with a spontaneous coronary perforation.

Topics: Aged, 80 and over; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Drug-Eluting Stents; Echocardiography; Fatal Outcome; Female; Humans; Immunosuppressive Agents; Prosthesis-Related Infections; Rupture, Spontaneous; Sirolimus; Staphylococcal Infections

Coronary bifurcations represent a challenging lesions subset and account for up to 15% of all current PCI. Regardless of the stenting technique used, however, restenosis rate after bare metal stent (BMS) is high, especially at the ostium of the side branch (SB). The introduction of drug-eluting stent (DES) has remarkably improved the outcome in bifurcation lesions compared to BMS, resulting in lower adverse events and main branch (MB) restenosis rates. Furthermore, although the "provisional" stenting technique (second stent on the SB placed, after the MB stenting, only in case of suboptimal or inadequate result) remained the prevailing approach, several two-stent techniques emerged (crush) or were re-introduced (V, T, culottes) to allow stenting in both branches when needed. At the present time, only few randomized studies and some observational reports specifically addressed the issue of bifurcation lesion treatment with sirolimus-eluting stents (SES). It is still not clear yet which is the better strategy between the provisional approach and stenting both branches when dealing with a bifurcation lesion which has a stenosis in the SB suitable for stenting. Moreover, no study has so far addressed which is the best strategy to use among the several techniques reported in the literature when both branches are intentionally stented from the outset. Finally, the introduction of dedicated stents for different types of bifurcations, with specific stent designs to provide good deliverability, secured access to the side branch, complete coverage of the lesion site without double/triple layers of stent struts, thus incorporating the benefits of drug elution and ensuring drug availability to all diseased surfaces, may further facilitate the conquest of one of the most challenging areas in interventional cardiology.

Topics: Algorithms; Anti-Bacterial Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Graft Occlusion, Vascular; Humans; Sirolimus

The author presented a review of clinical research works conducted and completed in 2001 - 2005. The review contains data on clinical trials of sirolimus-eluting stents in patients with coronary artery disease. The author analyzed experimental data on the mechanism of action of rapamycin on the cell and also analyzed data of clinical trials of sirolimus-containing stents in the treatment of coronary artery stenosis and chronic occlusion. Results of clinical trials of coated stents in diabetic patients with coronary artery stenosis, as well as data on the use sirolimus-containing stents in the treatment in stent restenosis were also discussed.

Topics: Anti-Bacterial Agents; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Sirolimus; Treatment Outcome

Topics: Coronary Artery Disease; Humans; Myocardial Revascularization; Paclitaxel; Sirolimus; Stents

The superficial femoral artery (SFA) is a frequent target of atherosclerotic disease predominantly in the proximal section near the bifurcation to the deep femoral artery and in the distal section where the adductor muscles tend to compress the artery. In the past, SFA revascularization was the domain of vascular surgery (femoropopliteal and femorodistal bypasses). However, with the development of endovascular treatment and advancing techniques as well as more sophisticated stenting material and balloons, endovascular treatment is nowadays not just a treatment option but, in most cases, preferable at least as initial revascularization procedure in the treatment of peripheral artery vascular disease. In the last years, many efforts have been made to fight restenosis in revascularized artery segments after stenting and/or angioplasty. This article aims to give a review on this topic including the most recent experience with the various latest revascularization techniques such as drug eluting stents, coated stent grafts, brachytherapy, cryoplasty, cutting balloons, and drug coated balloons.

Topics: Angioplasty, Balloon; Arterial Occlusive Diseases; Atherosclerosis; Brachytherapy; Clinical Trials as Topic; Coronary Artery Disease; Femoral Artery; Humans; Leg; Popliteal Artery; Sirolimus; Stents; Vascular Patency

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coronary Artery Disease; Drug Delivery Systems; Humans; Immunosuppressive Agents; Platelet Aggregation Inhibitors; Platelet Glycoprotein GPIIb-IIIa Complex; Sirolimus; Stents

The diabetic patient is at high risk for coronary artery disease. Incidence as well as severity of the disease is highly increased in comparison to non-diabetic patients. The revascularization of the diabetic patient is a great challenge, since the longterm results are disappointing when compared to non-diabetic patients. The success of coronary artery bypass grafting is limited by increased perioperative mortality and a faster occlusion of especially venous bypass grafts. In percutaneous interventions the excessive high restenosis rates worsen longterm results. Several clinical trials investigated the outcome of the two revascularization strategies and could demonstrate at least a tendency towards better results when the operative approach was chosen. Particularly, the BARI trial showed reduced mortality for surgery when compared to percutaneous coronary interventions. However, in this trial, in 87% of patients undergoing bypass surgery all stenoses were successfully treated, whereas in patients undergoing percutaneous coronary intervention only 76% of all stenoses were primarily successfully treated. In addition, no stents were used in this trial.Furthermore, the enrollment of the previous trials dates one decade ago. These trials do therefore not necessarily represent the current standard therapy, especially for percutaneous coronary interventions. The restenosis rate could be decreased in recent years by means of drug-eluting stents and an aggressive antiplatelet therapy from more than 50% to less than 10% leading to considerably improved long-term results. Therefore, percutaneous coronary interventions have developed to be a reasonable alternative to bypass surgery. Different clinical trials are currently underway (BARI 2D, CarDIA, FREEDOM) comparing the outcome of the two approaches.

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Artery Bypass; Coronary Artery Disease; Diabetes Complications; Diabetes Mellitus, Type 2; Humans; Myocardial Revascularization; Paclitaxel; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Sirolimus; Stents

Prospective follow-up at 2 years was obtained for 98.7% of the pooled 1,510 patients enrolled in SIRIUS, E-SIRIUS and C-SIRIUS, 3 randomized controlled trials that compared sirolimus-eluting stents (SESs) with bare metal stents (BMSs) to treat long stenoses in small coronary arteries. By 720 days, clinically driven target lesion revascularizations were performed in 5.7% of patients with SESs versus 22.6% of patients with BMSs (risk ratio 0.25, 95% confidence interval 0.18 to 0.35, p <0.001). Of these, late target lesion revascularization (from 271 to 720 days) was performed in 12 patients who received SESs (1.6%) compared with 37 patients with BMSs (4.9%) (risk ratio 0.32, 0.17 to 0.61, p <0.001). Stent thromboses occurred in 7 of 758 patients with SESs (0.9%, 4 subacute, 3 late) and 5 of 752 patients with BMSs (0.7%, 1 subacute, 4 late) (risk ratio 1.39, 95% confidence interval 0.44 to 4.36, p = 0.774). The Kaplan-Meier estimate of freedom from major cardiac adverse events was 89.3% for patients with SESs versus 73.4% for patients with BMSs (p <0.001). This analysis demonstrates the sustained efficacy and safety of sirolimus-eluting stents at 2 years, characterized by a persistent significant benefit in freedom from repeat revascularization compared with BMSs and a low risk of late stent thrombosis, not different from BMSs.

Topics: Coronary Artery Disease; Equipment Design; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Revascularization; Prospective Studies; Randomized Controlled Trials as Topic; Sirolimus; Stents; Thrombosis; Treatment Outcome

Percutaneous coronary interventions with the use of stents have become the mainstay treatment of patients with various clinical manifestations of coronary artery disease. Despite their remarkable success, restenosis has remained the major drawback and its prevention has absorbed intensive experimental and clinical research work. After the failure of multiple efforts with systemic use of various drugs, local application of antiproliferative and anti-inflammatory agents released by specially designed coated stents led to considerable suppression of neointima and opened new prospects in the prevention of restenosis. An increasing body of evidence is showing the advantages provided by drug-eluting stents (DES) in almost all subsets of patients with coronary artery disease with a drastic decrease in the need for reintervention. To date, the most commonly used and the only US Food and Drug Administration (FDA) approved DES are a sirolimus-eluting stent (Cypher) and a paclitaxel-eluting stent (Taxus), both of which are polymer-based DES and will constitute the focus of this review. Recent data demonstrate that DES are not equal in their safety and efficacy. A less optimistic aspect of DES technology are the reiterated concerns about a more prolonged risk of stent thrombosis. Although all agree on the need of a longer duration of dual antiplatelet therapy in patients treated with DES, its optimal length is still to be defined. Because polymers used for stent coating are often seen at the origin of the compromised long-term safety of DES, new technologies able to avoid permanent polymers may offer a valuable alternative.

Topics: Combined Modality Therapy; Coronary Artery Disease; Drug Delivery Systems; Humans; Immunosuppressive Agents; Paclitaxel; Polymers; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus; Stents; Tubulin Modulators

Patients with type 2 diabetes mellitus represent the 25% of those requiring myocardial revascularization. Choice of treatment in diabetic patients is much more controversial than in non-diabetics: this because coronary artery disease is more often complex and diffuse, left ventricular function is depressed, and concomitant multiple risk factors are present. These subset of patients experience worse outcomes than non diabetic patients undergoing either coronary artery bypass grafting (CABG) or percutaneous coronary interventions (PCI). Large randomized trials performed both in the early era of PCI and in the stent era suggest that CABG is superior to bare metal stent implantation in the treatment of diabetic patients with multivessel coronary artery disease. These findings are reflected in current guidelines, which favor CABG over PCI in most diabetics who require revascularization. However, substantial variability exists in practice patterns among individual hospital, suggesting a lack of clinical consensus. The major advantage of CABG over bare metal stent implantation in diabetic patients is the lower risk of repeat revascularization procedures through the follow-up. Better angiographic results have been demonstrated in the new era of drug-eluting stents (DES). Data from both the sirolimus and paclitaxel-eluting stents trials support the potential advantage of DES implantation both in diabetic and non-diabetic patients. Preliminary data from studies comparing DES versus CABG in diabetic patients with multivessel coronary artery disease suggests that 1) no significant difference exists in the 12-month rate of death, myocardial infarction and cerebrovascular events in patients treated with DES as compared to off-pump bypass surgery, 2) a difference of 7.1% in the rate of repeat revascularization at 12-month exists in favor of bypass surgery and 3) diabetic retinopathy identifies a subgroup with poor outcome after both percutaneous and surgical myocardial revascularization.

Topics: Combined Modality Therapy; Coronary Artery Disease; Diabetic Angiopathies; Drug Delivery Systems; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus; Stents; Tubulin Modulators

To evaluate the effect of drug-eluting vs. bare metal stents for the treatment of coronary artery disease on overall, cardiac, and non-cardiac mortalities.. We conducted a systematic literature search to identify all randomized controlled trials comparing sirolimus or paclitaxel-eluting stents with bare metal stents and reporting mortality data after at least 1 year of follow-up. Trial data were reviewed and extracted independently by two investigators in an unblinded standardized manner. Seventeen trials including a total of 8221 patients were analysed. Peto's odds ratios (ORs) for total mortality after 1 (n=8221), 2 (n=4631), 3 (n=4105), and 4 (n=1293) years of follow-up were 0.94 [95% confidence interval (CI) 0.66-1.34], 1.11 (95% CI 0.76-1.61), 1.25 (95% CI 0.91-1.73), and 1.46 (95% CI 0.92-2.31), respectively. Corresponding ORs for non-cardiac mortality were 1.07 (95% CI 0.64-1.80), 1.72 (95% CI 1.01-2.94), 1.45 (95% CI 0.93-2.25), and 1.65 (95% CI 0.89-3.10). There was no difference in OR for cardiac mortality among all trials. In sensitivity analyses, sirolimus- but not paclitaxel-eluting stents were associated with an increase in non-cardiac mortality at 2 and 3 years of follow-up.. Drug-eluting stents for the treatment of coronary artery disease do not reduce total mortality when compared with bare metal stents. Preliminary evidence suggests that sirolimus- but not paclitaxel-eluting stents may lead to increased non-cardiac mortality. Long-term follow-up and assessment of cause-specific deaths in patients receiving drug-eluting stents is mandatory to determine the long-term safety of these devices.

Topics: Aged; Coronary Artery Disease; Drug Implants; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Middle Aged; Paclitaxel; Randomized Controlled Trials as Topic; Sensitivity and Specificity; Sirolimus; Stents; Tubulin Modulators

Drug-eluting stent technology consisting of a bare metal stent, carrier coating, bioactive drug and delivery system, offers an almost infinite range of possible device configurations. A growing understanding of the mechanisms of restenosis allows for the design of synergistic functions within these components, thus providing a basis for new and improved products. The BioMatrix stent (Biosensors Interventional Technologies Pte Ltd., Singapore) elutes the new sirolimus derivative Biolimus A9 from a biodegradable polylactic acid polymer. Biolimus A9 possesses enhanced anti-inflammatory and antiproliferative activity with an improved pharmacokinetic profile. Permanent polymer-carrier-based platforms may be associated with inflammation, late thrombosis and restenosis. The BioMatrix, with its asymmetric and abluminal coating, releases Biolimus A9 into the vessel wall while the polylactic acid polymer is resorbed by surrounding tissues. Clinical studies have demonstrated the BioMatrix to be well tolerated and effective, and it has now become the subject of an aggressive clinical program.

Topics: Animals; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug Carriers; Drug Delivery Systems; Humans; Lactic Acid; Polyesters; Polymers; Randomized Controlled Trials as Topic; Sirolimus; Stents

The first method of percutaneously treating a diseased vessel was developed by Dotter and Judkins in 1964. Andreas Grüntzig performed the first coronary angioplasty in 1977. In 1985 Palmaz et al. implanted the first balloon-mounted stent in a peripheral artery. Puel and Sigwart implanted the first human coronary stent in March 1986; it was a self-expanding mesh-like device. Schatz et al. applied some small modifications to the original Palmaz stent, which resulted in the first coronary stent available on the market, called Palmaz-Schatz stent. In 1987 Sigwart was the first to suggest the use of coronary stents in acute vessel occlusions during unsuccessful PTCA. Using the device it became possible to cover the intimal flap and to prevent elastic recoil. Because of the high incidence of subacute stent thromboses and the bleeding complications (aggressive anticoagulation regimens) these times the coronary stents were implanted only in order to avoid emergency CABG surgery. In 1993 BENESTENT and STRESS trials have proved that elective stent implantation can significantly reduce the incidence of restenosis. The dual antiplatelet therapy and the high pressure stent implantation technique dramatically reduced the incidence of subacute stent thrombosis. The treatment of coronary artery disease has undergone revolutionary changes in the past decade but remained the leading cause of mortality in the developed world. The most important limitation of PCI has been in-stent restenosis, which occurs in 20-40% of stent implantations. Clinically it results in recurrent ischemic episodes most often requiring repeat revascularisation (rePCI or CABG). With the use of drug-eluting stents the incidence of in-stent restenosis can be reduced dramatically, based on the currently available clinical trials it remains below 10%.

Topics: Cell Cycle; Cell Proliferation; Coronary Artery Disease; Coronary Restenosis; Cost-Benefit Analysis; Delayed-Action Preparations; Humans; Hungary; Muscle, Smooth, Vascular; Paclitaxel; Protein Kinases; Sirolimus; Stents; TOR Serine-Threonine Kinases; Treatment Outcome; Tubulin Modulators; United States

This paper discusses the results of the five-year clinical trials of sirolimus-eluting stents in the treatment of coronary artery disease. Analyzes outcomes of revascularization of the coronary arteries in patients with single focal lesions of the coronal arteries, multi-vessel coronary stenoses, chronic occlusion of the coronary arteries, bifurcation stenoses, and diabetes mellitus. Reviews the results of the use of sirolimus-eluting stents for the treatment of in-stent restenoses. Discusses the mechanism of antiproliferative action of rapamycin.

Topics: Blood Vessel Prosthesis Implantation; Cell Proliferation; Coated Materials, Biocompatible; Coronary Artery Disease; Humans; Immunosuppressive Agents; Myocardial Revascularization; Sirolimus; Stents; Treatment Outcome

For patients with coronary artery disease undergoing percutaneous intervention, drug-eluting stents (DESs) have rapidly become the standard of care. This article reviews the currently available delivery-platform/drug-carrier-vehicle combinations and those expected to become available in the future. It also evaluates and compares current DES platforms in terms of the drug involved, the delivery platform, efficacy, and safety. Currently, 2 DES platforms are available: 1 eluting sirolimus and 1 eluting paclitaxel. Sirolimus is a macrolide antibiotic with a cytostatic mechanism and an anti-inflammatory effect. Paclitaxel is a chemotherapeutic (cytotoxic) agent. The delivery platform is composed of the balloon catheter, the stent, and the drug-carrier vehicle. The carrier vehicle offers controlled drug release and enhances drug distribution. It can be a polymer that serves as a diffusion barrier or a matrix (either durable or degradable) for drug loading. Alternatively, a structural modification on the surface of the stent itself, such as a groove or well in which the drug is placed, can serve as carrier. With respect to efficacy, major trials have shown that the sirolimus platform has a lower late luminal loss rate than does the paclitaxel stent. Moreover, less intimal proliferation and obstruction occurs with the sirolimus platform than with the paclitaxel platform. Also, compared to bare metal stents, the sirolimus platform reduces late luminal loss in challenging subsets of patients. Both stents offer excellent short-term safety. To improve our understanding of these stents, a head-to-head comparison is needed.

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Clinical Trials as Topic; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Humans; Immunosuppressive Agents; Paclitaxel; Prosthesis Design; Sirolimus; Stents; Time Factors

This review characterizes the relative effectiveness and safety of drug-eluting stents (DES) compared to bare metal stents. The data evaluated will include clinical and angiographic outcomes from randomized clinical trials as well as observational databases and registries including RESEARCH, e-Cypher, and DYNAMIC, which typically include a much broader spectrum of patients. In addition, specific patient subsets, including those patients with multivessel coronary disease, will be evaluated.

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Humans; Immunosuppressive Agents; Paclitaxel; Randomized Controlled Trials as Topic; Registries; Safety; Sirolimus; Stents; Treatment Outcome

The two pivotal U.S. trials of drug-eluting stents do not establish the principle that these stents are superior to thin-strut bare-metal stents for preventing repeat revascularization in patients with diabetes. Neither study was adequately powered to make this determination. Moreover, both studies used thick-strut stents known to have high restenosis rates as controls. Low angiographic follow-up underestimates the true target lesion revascularization rate in the Polymer-Based Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease (TAXUS-IV) trial because of the high incidence of silent ischemia in patients with diabetes. Optimal therapy for diabetic coronary disease should include a comprehensive approach directed toward metabolic normalization in addition to local stent-based therapy.

Topics: Clinical Trials as Topic; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Diabetic Angiopathies; Drug Delivery Systems; Humans; Paclitaxel; Sirolimus; Stents

We compared the risk of stent thrombosis (ST) after drug-eluting stents (DES) versus bare-metal stents (BMS), and tested the hypothesis that the risk of DES thrombosis is related to stent length.. Whether DES increase the risk of ST remains unclear. Given the very low restenosis rate after drug-eluting stenting, longer stents are frequently implanted for the same lesion length in comparison to BMS.. We included in a meta-analysis 10 randomized studies comparing DES and BMS. Overall, 5,030 patients were included (2,602 were allocated to DES and 2,428 to BMS). The risk of thrombosis after DES versus BMS was compared, and the relationship between the rate of DES thrombosis and stent length was evaluated.. Incidence of ST was not increased in patients receiving DES (0.58% vs. 0.54% for BMS; odds ratio: 1.05; 95% confidence interval [CI]: 0.51 to 2.15; p = 1.000). The overall rate of ST did not differ significantly between patients receiving sirolimus- or paclitaxel-eluting stents (0.57% vs. 0.58%; p = 1.000). We found a significant relation between the rate of ST and the stented length (Y = -1.455 + 0.121 X; 95% CI for beta: 0.014 to 0.227; R = 0.716; p = 0.031). In patients with DES, mean stented length was longer in those suffering ST (23.4 +/- 8.1 mm vs. 21.3 +/- 4.1 mm, p = 0.025).. Drug-eluting stents do not increase the risk of ST, at least under appropriate anti-platelet therapy. The risk of ST after DES implantation is related to stent length.

Topics: Antibiotics, Antineoplastic; Antineoplastic Agents, Phytogenic; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Thrombosis; Equipment Design; Follow-Up Studies; Humans; Paclitaxel; Postoperative Complications; Risk Factors; Sirolimus; Statistics as Topic; Stents; Treatment Outcome

Topics: Angioplasty; Antineoplastic Agents; Clinical Trials as Topic; Coronary Artery Disease; Coronary Restenosis; Humans; Immunosuppressive Agents; Paclitaxel; Polymers; Sirolimus; Stents; Thrombosis

Topics: Angioplasty, Balloon, Coronary; Anticoagulants; Antineoplastic Agents, Phytogenic; Clinical Trials as Topic; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Humans; Immunosuppressive Agents; Paclitaxel; Polymers; Sirolimus; Stents; Thrombosis; Warfarin

Placement of sirolimus-eluting stents or paclitaxel-eluting stents has emerged as the predominant percutaneous treatment strategy in patients with coronary artery disease (CAD). Whether there are any differences in efficacy and safety between these 2 drug-eluting stents is unclear.. To compare outcomes of sirolimus-eluting and paclitaxel-eluting coronary stents on the basis of data generated by randomized head-to-head clinical trials.. PubMed and the Cochrane Central Register of Controlled Trials, conference proceedings from major cardiology meetings, and Internet-based sources of information on clinical trials in cardiology from January 2003 to April 2005.. Randomized trials comparing the sirolimus-eluting stent with the paclitaxel-eluting stent in patients with CAD reporting the outcomes of interest (target lesion revascularization, angiographic restenosis, stent thrombosis, myocardial infarction [MI], death, and the composite of death or MI) during a follow-up of at least 6 months.. Two reviewers independently identified studies and abstracted data on sample size, baseline characteristics, and outcomes of interest.. Six trials, including 3669 patients, met the selection criteria. No significant heterogeneity was found across trials. Target lesion revascularization, the primary outcome of interest, was less frequently performed in patients who were treated with the sirolimus-eluting stent (5.1%) vs the paclitaxel-eluting stent (7.8%) (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.49-0.84; P = .001). Similarly, angiographic restenosis was less frequently observed among patients assigned to the sirolimus-eluting stent (9.3%) vs the paclitaxel-eluting stent (13.1%) (OR, 0.68; 95% CI, 0.55-0.86; P = .001). Event rates for sirolimus-eluting vs paclitaxel-eluting stents were 0.9% and 1.1%, respectively, for stent thrombosis (P = .62); 1.4% and 1.6%, respectively, for death (P = .56); and 4.9% and 5.8%, respectively, for the composite of death or MI (P = .23).. Patients receiving sirolimus-eluting stents had a significantly lower risk of restenosis and target vessel revascularization compared with those receiving paclitaxel-eluting stents. Rates of death, death or MI, and stent thrombosis were similar.

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Disease; Humans; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus; Stents

Clinical information regarding paclitaxel-eluting coronary artery stents is reviewed.. Restenosis is a significant complication of percutaneous coronary intervention. Coronary artery stenting has reduced restenosis compared with traditional balloon angioplasty, although restenosis still occurs with bare-metal coronary artery stents. The pathogenesis of in-stent restenosis is believed to involve smooth-muscle-cell proliferation and migration in response to vessel injury. A neointimal layer of extracellular matrix and collagen forms, which may impinge on the vessel lumen. Paclitaxel inhibits vascular smooth-muscle-cell proliferation and reduces neointimal mass. Local delivery of paclitaxel through a coronary stent has been shown to reduce restenosis rates and percent diameter stenosis and to produce other angiographic benefits compared with bare-metal stents. Fewer major adverse coronary events are seen with paclitaxel-eluting stents, predominantly because of a reduction in the need for target-vessel revascularization with minimal impact on rates of mortality and myocardial infarction (MI). The Taxus Express(2) stent, the only approved paclitaxel-eluting stent in the United States, costs about three times as much as a bare-metal stent. Cost-effectiveness analyses are needed to determine if the Taxus stent is cost-effective in clinical practice.. Paclitaxel-eluting stents reduce the rates of restenosis and target-vessel revascularization compared with bare-metal stents and have comparable effects on mortality and MI rates.

Topics: Antineoplastic Agents; Clinical Trials as Topic; Coronary Artery Disease; Coronary Restenosis; Humans; Paclitaxel; Sirolimus; Stents

Topics: Anti-Bacterial Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Equipment Design; Humans; Paclitaxel; Sirolimus; Stents

The percutaneous treatment of patients with obstructive atherosclerotic disease in degenerated coronary saphenous vein bypass grafts still remains one of the great challenges in interventional cardiology. In this review, we discuss the actual evidence-based knowledge for the percutaneous management of this lesion subset, focusing in particular on the devices that are actually considered the "gold standard" for this treatment: bare metal stents and distal protection devices. We also comment on the negative results of the randomized trials regarding the promising polytetrafluoroethylene-covered stent-grafts. We finally offer insights into the currently available evidence for the use of drug-eluting stents in saphenous vein grafts. These devices are potentially the principal promise for the long-term successful sealing of vein graft disease; however, clear and definitive data coming from controlled trials are requested.

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coronary Artery Bypass; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Evidence-Based Medicine; Humans; Immunosuppressive Agents; Saphenous Vein; Sirolimus; Stents

The development of stent has been a major advance in the treatment of obstructive coronary artery disease since the introduction of balloon angioplasty. However, neointimal hyperplasia occurring within the stent leading to in-stent restenosis is a main obstacle in the long-term success of percutaneous coronary intervention (PCI). The recent introduction of drug-eluting stents (DES) contributes a major breakthrough to interventional cardiology. Many large randomized clinical trials using DES have shown a remarkable reduction in angiographic restenosis and target vessel revascularization when compared with bare metal stents. The results of these trials also appear to be supported by evidence from everyday practice and non-controlled clinical trials. However, the expanded applications of DES, especially in treating complex lesions such as left main trunk, bifurcation, saphenous vein graft lesions, or in-stent restenosis, are still under evaluation with ongoing studies. With the availability of different types of DES in the market, the issue of cost should not be a deterrent and DES will eventually be an economically viable option for all patients. The adoption of DES in all percutaneous coronary intervention may become a reality in the near future. In this review article, we summarize the recent development and progress of DES as well as compare and update the results of clinical trials.

Topics: Angioplasty, Balloon, Coronary; Anti-Inflammatory Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug Carriers; Growth Inhibitors; Humans; Hyperplasia; Paclitaxel; Prosthesis Design; Sirolimus; Stents; Thrombosis; Treatment Outcome; Tunica Intima

Topics: Angina, Unstable; Atherectomy, Coronary; Catheterization; Coronary Artery Disease; Coronary Thrombosis; Death, Sudden, Cardiac; Humans; Immunosuppressive Agents; Myocardial Infarction; Sirolimus; Stents; Syndrome

The mechanism of action and pharmacokinetics of sirolimus when used as part of a drug-eluting stent (DES) and the efficacy and cost of using DESs versus bare-metal stents are discussed.. The use of balloon angioplasty with or without coronary artery stenting is limited by the phenomenon of in-stent restenosis (ISR). Until very recently, most efforts to overcome ISR had been ineffective. The search to prevent or reduce the frequency of ISR has led to the recent development of novel coronary artery stents designed to deliver a drug that acts locally. The first DES was approved by FDA in April 2003. This stent releases sirolimus, an agent that inhibits vascular smooth-muscle-cell proliferation. To date, four major clinical trials have demonstrated the sirolimus-eluting stent to be safe and effective in preventing restenosis in de novo coronary artery lesions.. The sirolimus-eluting coronary stent is associated with less ISR than non-drug-containing stents, but further investigation is needed to determine its exact place in the treatment of coronary artery occlusion.

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Restenosis; Cost-Benefit Analysis; Drug Delivery Systems; Humans; Immunosuppressive Agents; Patient Selection; Randomized Controlled Trials as Topic; Safety; Sirolimus; Stents

To discuss the current understanding of the pathogenesis, natural history, and diagnosis of cardiac allograft vasculopathy, and to outline new preventive and treatment strategies.. The central event in the development of allograft vasculopathy is the inflammatory response to immune or nonimmune-mediated endothelial damage. This response is characterized by the release of inflammatory cytokines, upregulation of cell-surface adhesion molecules, and the subsequent binding of leukocytes. Once induced, vascular smooth muscle cells proliferate and migrate from the media to form a neointima. Circulating progenitor cells are recruited to sites of arterial injury where they may then differentiate into smooth muscle cells. Because of its diffuse nature, allograft vasculopathy is best detected by intravascular ultrasound. Noninvasive tests, such as dobutamine echocardiography, are gaining in favor. Although the only definitive treatment is retransplantation, the immunosuppressant rapamycin can limit disease progression. Its synthetic derivative, everolimus, effectively prevented intimal hyperplasia in de novo transplant recipients.. These advances have provided hope that allograft vasculopathy may finally be manageable.

Topics: Anticholesteremic Agents; Coronary Artery Disease; Coronary Vessels; Echocardiography; Everolimus; Heart Transplantation; Humans; Immunosuppressive Agents; Reoperation; Risk Factors; Simvastatin; Sirolimus; Transplantation, Homologous; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Anti-Bacterial Agents; Antineoplastic Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Cost-Benefit Analysis; Drug Delivery Systems; Humans; Immunosuppressive Agents; Paclitaxel; Polymers; Randomized Controlled Trials as Topic; Sirolimus; Stainless Steel; Stents

The undisputed superiority of stents over conventional balloon angioplasty has resulted in a plethora of stents in clinical use. Recent data, however, have indicated not all stent models are the same. Nuances in stent design and construction have impacted significantly on the immediate and long-term clinical outcome. Among the stainless steel stents, those with multicellular or tubular designs have proven to be superior to coiled or hybrid stent models, and thin-strut stents perform better than thicker-strut stents. Coating stainless steel stents with gold, carbide, phosphorylcholine or heparin do not appear to confer any additional benefit, compared with bare metal stents. In contrast, randomised trials have demonstrated that drug-eluting stents coated with various anti-proliferative drugs, with or without a carrier polymer, afford unparalleled restenosis rates compared with non-drug-eluting stents. Drug-eluting stents, however, are expensive, and their long-term durability and safety remain undefined. Notwithstanding these unresolved issues, it is likely that the majority of percutaneous coronary interventions will involve the use of drug-eluting stents once a more attractive balance between their cost and clinical effects is reached.

Topics: Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Cost-Benefit Analysis; Drug Delivery Systems; Humans; Paclitaxel; Polymers; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus; Stainless Steel; Stents

Topics: Coronary Artery Disease; Graft Occlusion, Vascular; Heart Transplantation; Humans; Immunosuppressive Agents; Protein Kinase Inhibitors; Protein Kinases; Sirolimus; TOR Serine-Threonine Kinases; Tunica Intima

In this article, the authors intend to provide an update on clinical trials of pharmacologic prevention of restenosis after percutaneous coronary interventions, placed in the perspective of the use of orally administered therapy for the prevention of atherosclerosis progression and clinical events.. AGI-1067, the mono-succinic acid ester of probucol, is a phenolic antioxidant member of a novel class of agents termed v-protectants. It has strong antioxidant properties equipotent to those of probucol and antiinflammatory properties. It inhibits gene expression of VCAM-1 and MCP-1 and has been effective at preventing atherosclerosis in all tested animal models including the non-human primate. In the Canadian Antioxidant Restenosis Trial (CART) 1, AGI-1067 and probucol improved lumen dimensions at the site of percutaneous coronary intervention. AGI-1067 also improved luminal dimensions of non-intervened coronary reference segments in the Canadian Antioxidant Restenosis Trial, which suggests a direct antiatherosclerosis effect. Probucol reduced post-percutaneous coronary intervention restenosis and progression of carotid atherosclerosis in other clinical trials. Although statins reduce atherosclerotic events, they do not appear to have a significant effect on restenosis. The failure of folate therapy to protect against restenosis in the Folate After Coronary Intervention Trial (FACIT) occurred despite significant reductions in homocysteine levels.. Prevention of both post-percutaneous coronary intervention restenosis and atherosclerosis progression with a pharmacologic agent such as AGI-1067 may be an attractive treatment paradigm. Two important trials that test the antioxidant/antiinflammatory hypothesis are ongoing with AGI-1067: the Canadian Atherosclerosis and Restenosis Trial 2, which assesses its value for the reduction of both atherosclerosis progression and post-percutaneous coronary interventions restenosis, and the Aggressive Reduction of Inflammation Stops Events (ARISE) trial which is evaluating its effects on cardiovascular events.

Topics: Anti-Inflammatory Agents; Anticholesteremic Agents; Antioxidants; Clinical Trials as Topic; Coronary Artery Disease; Coronary Restenosis; Folic Acid; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; ortho-Aminobenzoates; Oxidative Stress; Probucol; Sirolimus; Vitamins

Percutaneous treatment of coronary bifurcation lesions, pose a number of technical challenges to the interventional cardiologist. Each lesion has to be approached with its own, targeted solution in the context of the clinical picture, anatomy, and pathology. To achieve acceptable clinical outcomes a number of established techniques are available. The exact anatomy of the lesion determines the technique used. The most common approach is to stent the main vessel across the ostium of the side branch. The side branch can be additionally treated with a second stent or balloon angioplasty depending on the severity of the ostial lesion and/or evidence of active ischemia. Other techniques involve stenting the main branch up to the carina but sparing the side branches, multiple 'kissing stent' approaches ('Y','T', and 'V') or the 'culottes' technique. Follow-up data demonstrates a high (over 90%) technical success rate. Clinical outcome is variable but with conventional stents restenosis rates higher than 30% have been reported in most studies and there is no added advantage in routine stenting of both main vessel and side branch. Recent introduction of drug-eluting stents has resulted in a lower event rate and reduction of main vessel restenosis in comparison with historical controls. Side branch ostial restenosis remains a problem, which may require the development of novel 'bifurcate' stent designs to allow complete coverage with a single stent.

Topics: Angioplasty, Balloon; Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Stenosis; Drug Carriers; Humans; Sirolimus; Stents; Treatment Outcome

The sirolimus-eluting stent (CYPHER( trade mark )) is a metal stent coated with 140 micro g/cm(2) of sirolimus blended with synthetic polymers. After stent implantation, sirolimus is slowly released causing localized cytostatic inhibition of proliferation of vascular smooth muscle cells in the peri-stent arterial wall over a period of about 1 month. Only minimal amounts of sirolimus enter the bloodstream and these appear to be insufficient to be of clinical relevance. In clinical trials that evaluated single de novo lesions and in-stent restenosis in patients with coronary artery disease, the sirolimus-eluting stent was associated with minimal neointimal hyperplasia. In four randomized trials in de novo lesions, sirolimus eluting stents produced a significantly lower incidence of major adverse cardiac events (MACE) than that observed in patients with uncoated stents, during periods of up to 2 years (p < 0.05 for all comparisons). The lower incidence of MACE was mostly due to a reduced requirement for repeat target vessel revascularization. At angiographic follow-up at periods of up to 8 months, late luminal loss was significantly smaller in the sirolimus-eluting stent groups than in the uncoated-stent groups (p < 0.001 in all studies). The sirolimus-eluting stent was well tolerated in clinical trials of up to 3 years' follow-up. Because minimal blood levels of sirolimus are achieved, systemic adverse effects appear to be avoided. To date, there has been no evidence of any potential adverse effects resulting from the polymer coating or local drug toxicity. As yet, there is no evidence of an increased risk of subacute or late thrombosis, or aneurysm formation with the sirolimus-eluting stent compared with the uncoated stent. Long-term follow-up is needed to fully assess these theoretical concerns. Cost-effectiveness analyses over 12 months demonstrated a cost advantage for the sirolimus-eluting stent compared with an uncoated stent because of a reduced requirement for repeat target vessel revascularizations.. Initial clinical trials with the sirolimus-eluting stent in patients with de novo coronary lesions have shown a significantly reduced incidence of MACE and of restenosis compared with a standard stent. Efficacy appears to be maintained throughout follow-up periods of up to 2 years in randomized trials, and to date, systemic or local adverse effects have been avoided. If efficacy and tolerability are consistently demonstrated over the long term, the sirolimus-eluting stent will be a major advance in the control of in-stent restenosis.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Economics, Pharmaceutical; Humans; Sirolimus

Topics: Angioplasty, Balloon, Coronary; Antineoplastic Agents; Atherectomy, Coronary; Brachytherapy; Coronary Artery Disease; Coronary Restenosis; Humans; Paclitaxel; Sirolimus; Stents; Ultrasonography, Interventional

Stent implantation represents the most commonly performed percutaneous coronary intervention nowadays. However, instent restenosis due to exaggerated neointimal hyperplasia remains a problem to overcome. Neointimal hyperplasia is a vascular response to stent injury; it mainly consists of smooth muscle cells proliferation. The underlying molecular mechanisms of restenosis were explained in this review article. Recently, drug-eluting stent has been proposed as a potential method to prevent instent restenosis. Animal studies have confirmed safety and efficacy of sirolimus-eluting stent implantation in vivo. The FIM trial, which was the first clinical study on sirolimus-eluting stent in de novo lesions, has shown an astonishing 0% restenosis rate. The RAVEL trial was the first prospective, double-blind, multi-center trial that randomized 238 patients at 19 institutions with de novo lesions into sirolimus-eluting versus bare Bx velocity stent. Six-month binary restenosis rate in the sirolimus-group was again 0% compared to 26.6% in the control group. Angiographic late loss and major cardiac event were also significantly lower in the sirolimus-group. The SIRIUS trial is an ongoing study conducted in 53 US centers that randomized 1100 patients with de novo lesion into sirolimus-eluting and bare stents. Preliminary results also showed a significant reduction in binary restenosis, late loss and repeat revascularization rates. Apart from de novo lesions, early experience of sirolimus-eluting stent implantation for instent restenosis in non-randomized study was also promising, achieving a single-digit repeat restenosis rate. As compare with standard coronary stent, a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation, restenosis and associated clinical events.

Topics: Angioplasty, Balloon, Coronary; Animals; Anti-Bacterial Agents; Clinical Trials as Topic; Coronary Artery Disease; Coronary Restenosis; Double-Blind Method; Humans; Immunosuppressive Agents; Multicenter Studies as Topic; Prospective Studies; Randomized Controlled Trials as Topic; Registries; Risk Factors; Sirolimus; Stents; Swine

Drug-eluting stents (DES) have entered the arena and are about to changed the landscape of Interventional Cardiology. Today, the number of agents under preclinical and clinical investigation has increased considerably, including drugs such as Paclitaxel, Sirolimus, Tacrolimus, Everolimus, Dexamethasone, etc. Several studies have recently been published or are still ongoing evaluating different stent designs with respect to their safety and efficacy in treatment of coronary lesions. The SCORE trial (Paclitaxel) revealed a significant reduction in restenosis at follow-up (FU) in the drug-eluting stent group (6.4% vs 36.9% control group), attributable to decreased intimal proliferation. However, stentthromboses and myocardial infarctions, due to both stent design and high drug dosages, were observed causing a MACE rate of 10.2% in the DES group. Confirming the beneficial reduction of stent renarrowing using a local drug-eluting device, the rate of restenosis in the TAXUS-I trial (Paclitaxel) was 0% at follow-up in patients with DES vs 10% in patients with bare stents. Differences in MACE were not observed, which underlined the potential impact of an optimal stent design. First clinical experiences with a Sirolimus-coated stent (FIM trial) demonstrated again a profound inhibition of neointimal ingrowth at 4-month follow-up. The RAVEL trial, the first multicenter trial evaluating the Sirolimus stent and the largest DES study published so far, confirmed the FIM findings with a rate of restenosis in the DES group of 0% at 6 month FU. At 12 month FU, the beneficial impact on neointimal growth inhibition was persistent. The pivotal study SIRIUS is addressed to evaluate this stent design more extensively. However, given all the results being available today, local application of anti-proliferative agents delivered by coronary stents is one of the most promising techniques in treatment of coronary lesions. Nevertheless, we need more trials and an agreement of definitions in order to evaluate this treatment concept and eliminate unwanted side-effects.

Topics: Angiogenesis Inhibitors; Angioplasty, Balloon, Coronary; Anti-Bacterial Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Follow-Up Studies; Humans; Immunosuppressive Agents; Multicenter Studies as Topic; Paclitaxel; Pharmaceutical Preparations; Randomized Controlled Trials as Topic; Safety; Sirolimus; Stents; Time Factors

Cardiovascular disease is one of the major causes of morbidity and mortality following solid organ transplantation. Many of the current immunosuppressive drugs are associated with an increase of one or more risk factors for the development of atherosclerosis. This review compares the mechanism by which individual immunosuppressive agents may impact on these risk factors and the differential contribution of cyclosporine, tacrolimus, mycophenolate, azathioprine, and Rapamycin to these individual risk factors. Attention to the potential cardiovascular toxicities of individual immunosuppressive agents may help design strategies for maintenance of immunosuppression tailored to individual patients.

Topics: Adrenal Cortex Hormones; Animals; Cardiovascular System; Coronary Artery Disease; Cyclosporine; Diabetes Mellitus; Humans; Hyperlipidemias; Hypertension; Immunosuppressive Agents; Sirolimus; Tacrolimus

To compare the efficacy and safety of the dual-therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS) and the sirolimus-eluting Orsiro stent (O-SES) in patients with and without acute coronary syndrome (ACS) included in the SORT OUT X study.. The incidence of target lesion failure (TLF) after treatment with modern drug-eluting stents has been reported to be significantly higher in patients with ACS when compared to patients without ACS. Whether the results from the SORT OUT X study apply to patients with and without ACS remains unknown.. In total, 3146 patients were randomized to stent implantation with DTS (n = 1578; ACS: n = 856) or O-SES (n = 1568; ACS: n = 854). The primary end point, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 1 year.. At 1 year, the rate of TLF was higher in the DTS group compared to the O-SES group, both among patients with ACS (6.7% vs. 4.1%; incidence rate ratio: 1.65 [95% confidence interval, CI: 1.08-2.52]) and without ACS (6.0% vs. 3.2%; incidence rate ratio: 1.88 [95% CI: 1.13-3.14]). The differences were mainly explained by higher rates of TLR, whereas rates of cardiac death and target lesion MI did not differ significantly between the two stent groups in patients with or without ACS CONCLUSION: Compared to the O-SES, the DTS was associated with a higher risk of TLF at 12 months in patients with and without ACS. The differences were mainly explained by higher rates of TLR.

Topics: Absorbable Implants; Acute Coronary Syndrome; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The vessel healing process after implantation of biodegradable polymer (BP) and durable polymer (DP) everolimus-eluting stent (EES) in ST-elevation myocardial infarction (STEMI) lesions remains unclear.Methods and Results: We conducted a multicenter prospective randomized controlled trial to compare early (2 weeks) and mid-term (12 months) vascular responses after implantation of BP-EES vs. DP-EES in STEMI patients. In this prespecified subanalysis, serial coronary angioscopy (CAS) analysis was performed in 15 stents in the BP-EES arm (n=10 patients) and 14 stents in the DP-EES arm (n=10 patients). At the 2-week follow-up, there was no significant difference in the estimated marginal means of the neointimal coverage grade (primary endpoint) between the 2 arms (mean [±SE] 0.00±0.00 in both arms; P>0.999). There were no significant differences between the BP-EES and DP-EES groups in the yellow color grade (1.046±0.106 vs. 0.844±0.114, respectively; P=0.201) or the presence of thrombus (77.8% vs. 88.8%, respectively; P=0.205). At 12 months, competent strut coverage, defined as yellow color grade ≤1, no thrombus, and a neointimal coverage grade ≥1 was achieved more frequently in the BP-EES than DP-EES arm (85.2% vs. 53.1%; adjusted odds ratio 2.11 [95% confidence interval 1.26-3.53]; P=0.023).. Neointimal coverage 2 weeks after implantation of BP-EES and DP-EES in STEMI lesions was comparable on CAS evaluation. However, at 1 year, BP-EES was independently associated with competent strut coverage.

Topics: Absorbable Implants; Angioscopy; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Sirolimus; ST Elevation Myocardial Infarction; Treatment Outcome

Comparative studies of ultrathin-strut biodegradable polymer sirolimus-eluting stent (BP-SES) have reported promising results and validated its excellent outcomes in terms of safety and efficacy. However, there are limited studies comparing BP drug-eluting stents with struts of different thicknesses. We compared the long-term clinical outcomes of patients treated with an ultrathin-strut BP-SES or a thick-strut biodegradable polymer biolimus-eluting stent (BP-BES).. The BIODEGRADE trial (Biomatrix and Orsiro Drug-Eluting Stents in Angiographic Result in Patients With Coronary Artery Disease) is a multicenter prospective randomized study comparing coronary revascularization in patients with ultrathin-strut BP-SES and thick-strut BP-BES with the primary end point of target lesion failure at 18 months posttreatment. We performed the prespecified analysis of 3-year clinical outcomes.. In total, 2341 patients were randomized to receive treatment with ultrathin-strut BP-SES (N=1175) or thick-strut BP-BES (N=1166). The 3-year incidence rate of target lesion failure was 3.2% for BP-SES and 5.1% for BP-BES (. In a large, randomized trial, the long-term clinical outcome of target lesion failure at 3 years was significantly better among patients treated with the ultrathin-strut BP-SES. The results indicate the superiority of the ultrathin-strut BP-SES compared with the thick-strut BP-BES.. URL: https://clinicaltrials.gov; Unique identifier: NCT02299011.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Sirolimus; Treatment Outcome

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

Biodegradable polymer drug-eluting stents were developed to improve safety and efficacy outcomes for patients undergoing percutaneous coronary intervention. However, few long-term follow-up efficacy studies are available. The study sought to investigate 5-year results from the SORT OUT VII trial (Scandinavian Organization for Randomized Trials With Clinical Outcome) comparing the biodegradable polymer ultrathin-strut sirolimus-eluting Orsiro stent (O-SES) versus the biodegradable polymer biolimus-eluting Nobori stent (N-BES).. This registry-based, randomized, multicenter, single-blinded, noninferiority trial compared O-SES and N-BES in an all-comer population. The composite primary end point, target lesion failure, consisted of cardiac death, myocardial infarction related to the target lesion, or target lesion revascularization within 1 year. Follow-up was extended to 5 years.. Five-year follow-up was completed for 2521 patients (99.8%). Five-year target lesion failure did not differ between O-SES (12.4%) and N-BES (13.1%; rate ratio [RR], 0.94 [95% CI, 0.75-1.18]). Cardiac death (RR, 0.95 [95% CI, 0.67-1.34]), target myocardial infarction (RR, 1.14 [95% CI, 0.76-1.71]), target lesion revascularization (RR, 0.90 [95% CI, 0.67-1.21]), and definite stent thrombosis rates (RR, 0.73 [95% CI, 0.41-1.33]) did not differ significantly between the 2 stents. Within the first year, definite ST was significantly lower for O-SES (0.4%) compared to N-BES (1.2%; RR, 0.33 [95% CI, 0.12-0.92]), but no difference was from 1 through 5 years: O-SES 1.2% and N-BES 0.9% (RR, 1.28 [95% CI, 0.58-2.82]).. Five years after treatment with biodegradable polymer stents, target lesion failure did not differ among O-SES and N-BES. Definite stent thrombosis was less often seen within the first year in the O-SES but the difference was not maintained after 5 years.. URL: https://clinicaltrials.gov; Unique identifier: NCT01879358.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Factors; Sirolimus; Treatment Outcome

The first-generation polymeric bioresorbable scaffolds resulted in higher than acceptable 3-year rates of device-related adverse outcomes.. We aimed to assess the intermediate-term safety and performance of a novel ultrathin-strut sirolimus-eluting iron bioresorbable scaffold (IBS) in non-complex coronary lesions.. The prospective, single-arm, open-label IBS first-in-human study enrolled 45 patients, each with a single de novo lesion. Enrolled patients were randomly assigned to 2 follow-up cohorts. Angiographic and imaging follow-up with intravascular ultrasound and optical coherence tomography (OCT) were conducted at 6 and 24 months in cohort 1 (n=30) and at 12 and 36 months in cohort 2 (n=15). Clinical follow-up was conducted at 1, 6 and 12 months, and annually thereafter up to 5 years. The coprimary outcomes were target lesion failure (TLF) and angiographic late lumen loss (LLL) at 6 months.. A total of 45 patients were enrolled between April 2018 and January 2019. The mean age was 53.2 years, 77.8% were male, and 26.7% had diabetes. The TLF rates were 2.2% at 6 months and 6.7% at 3 years, which in all cases were due to clinically indicated target lesion revascularisation. No deaths, myocardial infarctions or stent thromboses occurred during 3-year follow-up. In-scaffold LLL was 0.33±0.27 mm at 6 months and 0.37±0.57 mm at 3 years. By OCT, the proportion of covered struts was 99.8% at 6 months and 100% after 1 year. The 3-year strut absorption rate was 95.4%.. In this first-in-human experience, an ultrathin IBS was safe and effective for the treatment of de novo non-complex coronary lesions up to 3-year follow-up.

Topics: Absorbable Implants; Coronary Angiography; Coronary Artery Disease; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Patients with atherothrombotic risk are at high hazard of ischemic events. Preventive medicine plays a major role in modifying their outcomes. Whether the choice of a BP-SES or DP-EES can contribute to the occurrence of events remains unclear. We sought to investigate the outcomes of patients with higher atherothrombotic risk (H-ATR) versus lower atherothrombotic risk (L-ATR) undergoing percutaneous coronary intervention (PCI) with either bioresorbable-polymer sirolimus-eluting stent (BP-SES) or durable-polymer everolimus-eluting stent (DP-EES).. Patients (n = 2361) from BIOFLOW-II, -IV, and -V randomized trials were categorized into H-ATR vs. L-ATR. L-ATR patients had ≤ 1 and H-ATR ≥ 2 of the following criteria: presentation in ACS, diabetes mellitus, previous myocardial infarction, previous PCI/CABG, or previous stroke. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], target lesion revascularization [TLR]) and stent thrombosis (ST) at three years.. H-ATR patients (n = 1023) were more morbid than L-ATR patients (n = 1338). TLF rate was significantly higher in H-ATR patients as compared with L-ATR (11.6% vs. 7.0%; HR 1.67, 95% CI 1.27-2.20, p < 0.0001). With BP-SES TLF rates were numerically lower as compared with DP-EES in H-ATR (10.5% vs. 13.5%; HR 0.78, 95% CI 0.54-1.14, p = 0.20) and significantly lower in L-ATR (5.6% vs. 9.8%; HR 0.57, 95% CI 0.38-0.85, p = 0.006).. In the era of newer-generation DES, patients with H-ATR still are at hazard for ischemic events. Patients with BP-SES had lower TLF rates as compared with DP-EES, most consistent in L-ATR whereas in H-ATR patients most probably secondary preventive strategies are of higher value.. Clinicaltrial.gov. NCT01356888, NCT01939249, NCT02389946. https://clinicaltrials.gov/show/NCT01356888 , https://clinicaltrials.gov/show/NCT01939249 , https://clinicaltrials.gov/show/NCT02389946 .

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Treatment Outcome

Whether ultrathin-strut stents are particularly beneficial for lesions requiring implantation of more than 1 stent is unknown.. In a post-hoc lesion-level analysis of 2 randomized trials comparing ultrathin-strut biodegradable polymer Sirolimus-eluting stents (BP-SES) vs thin-strut durable polymer Everolimus-eluting stents (DP-EES), lesions were stratified into multistent lesions (MSL) vs single-stent lesions (SSL). The primary endpoint was target lesion failure (TLF), a composite of lesion-related unclear/cardiac death, myocardial infarction (MI), or revascularization, at 24 months.. Among 5328 lesions in 3397 patients, 1492 (28%) were MSL (722 with BP-SES, 770 with DP-EES). At 2 years, TLF occurred in 63 lesions (8.9%) treated with BP-SES and 60 lesions (7.9%) treated with DP-EES in the MSL-group (subdistibution hazard ratio [SHR], 1.13; 95% CI, 0.77-1.64; P = .53), and in 121 (6.4%) and 136 (7.4%) lesions treated with BP-SES and DP-EES respectively (SHR, 0.86; 95% CI, 0.62-1.18; P = .35) in the SSL-group (P for interaction = .241). While the rates of lesion-related MI or revascularization were significantly lower in SSL treated with BP-SES as compared to DP-EES (3.5% vs 5.2%; SHR, 0.67; 95% CI 0.46-0.97; P = .036), no significant difference was observed in MSL (7.1% vs 5.4%; SHR, 1.31; 95% CI 0.85-2.03; P = .216) with significant interaction between groups (P for interaction = .014).. Rates of TLF are similar between ultrathin-strut BP-SES and thin-strut DP-EES in MSL and SSL. The use of ultrathin-strut BP-SES vs thin-strut DP-EES did not prove to be particularly beneficial for the treatment of multistent lesions.. Post-hoc analysis from the BIOSCIENCE (NCT01443104) and BIOSTEMI (NCT02579031) trials.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus; Treatment Outcome

There are no randomised trials reporting clinical outcomes of biodegradable polymer biolimus-eluting stents (BP-BES) and durable polymer everolimus-eluting stents (DP-EES) at 10 years.. We aimed to compare the 10-year clinical outcomes between BP-BES and DP-EES.. The randomised NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial (NEXT) was originally designed to evaluate the non-inferiority of BP-BES relative to DP-EES with the primary efficacy endpoint of target lesion revascularisation (TLR) at 1 year and the primary safety endpoint of death or myocardial infarction (MI) at 3 years. In this extended follow-up study, clinical outcomes were compared from 1 year after stent implantation up to 10 years between patients with BP-BES and DP-EES.. From May to October 2011, NEXT enrolled a total of 3,241 patients from 98 centres in Japan. The current study population consisted of 2,417 patients (1,204 patients with BP-BES and 1,213 with DP-EES) from 66 centres that agreed to participate in the extended study. Complete 10-year follow-up was achieved in 87.5% of patients. The cumulative 10-year incidence of death or MI was 34.0% in the BP-BES group and 33.1% in the DP-EES group (hazard ratio [HR] 1.04, 95% confidence interval [CI]: 0.90-1.20; p=0.58). TLR occurred in 15.9% of patients in the BP-BES group and in 14.1% of the DP-EES group (HR 1.12, 95% CI: 0.90-1.40; p=0.32). In a landmark analysis at 1 year, the cumulative incidences of death or MI and TLR were not significantly different between the 2 groups.. The safety and efficacy outcomes for BP-BES were not significantly different from those for DP-EES at 1 year and up to 10 years after stent implantation.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Follow-Up Studies; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Sirolimus; Treatment Outcome

Conventional drug-eluting stents achieve good safety and performance outcomes, but the stents permanently cage the vessel, leading to a non-plateauing rate of clinical events. The DynamX Bioadaptor is designed to reduce these long-term events through unique design features that permit restoring vessel function and physiology through the disengagement of uncaging elements after the resorption of a biodegradable polymer over six months. Promising initial results have been obtained in the DynamX mechanistic study, with excellent safety and effectiveness, positive arterial remodeling, improved vasomotion, compliance, and cyclic pulsatility. We now aim to confirm these findings randomizing the DynamX Bioadaptor against the Resolute Onyx stent.. This multi-center, international, randomized single-blinded study is conducted in 34 sites across Europe, Japan, and New Zealand and is divided into the European/New Zealand cohort and the Japanese cohort (which includes an imaging subset). It is designed to randomly assign 444 patients (222 per region) in a 1:1 ratio to either the DynamX Bioadaptor or the Resolute Onyx stent. Furthermore, a pharmacokinetic substudy is conducted in 9 patients enrolled in Japan to assess the pharmacokinetics of sirolimus after implantation of the DynamX Bioadaptor. Study follow-up is scheduled at one, six, and 12 months, and annually thereafter for five years; imaging follow-up includes angiographic, intravascular ultrasound, and optical coherence tomography assessments at 12 months in a subset of patients. The primary endpoint is 12-month target lesion failure.. This trial will provide valuable insights into the safety and efficacy of this novel bioadaptor when compared to a contemporary drug-eluting stent.. The DynamX Sirolimus-Eluting Bioadaptor has unique design features aiming to reduce long-term events after percutaneous coronary intervention by permitting the restoration of vessel function through the freeing of uncaging elements. Promising initial results have been obtained in the DynamX mechanistic study. This trial aims to confirm these findings in a randomized setting. The European/ New Zealand and Japanese cohorts were designed to randomly assign 444 subjects in a 1:1 ratio to either the DynamX Bioadaptor or the Resolute Onyx stent. Furthermore, a pharmacokinetic substudy is conducted in 9 patients enrolled in Japan to assess the pharmacokinetics of sirolimus.

Topics: Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Treatment Outcome

Limited information is available on the comparative efficacy and safety of different stent platforms in patients at high bleeding risk undergoing an abbreviated dual antiplatelet therapy duration after percutaneous coronary intervention (PCI). The aim of this study was to compare the safety and effectiveness of the biodegradable-polymer sirolimus-eluting stent with the durable-polymer zotarolimus-eluting stent in patients at high bleeding risk receiving 1 month of dual antiplatelet therapy after PCI.. The Bioflow-DAPT Study is an international, randomized, open-label trial conducted at 52 interventional cardiology hospitals in 18 countries from February 24, 2020, through September 20, 2021. Patients with a clinical indication to PCI because of acute or chronic coronary syndrome who fulfilled 1 or more criteria for high bleeding risk were eligible for enrollment. Patients were randomized to receive either biodegradable-polymer sirolimus-eluting stents or durable-polymer, slow-release zotarolimus-eluting stents after successful lesion preparation, followed by 1 month of dual antiplatelet therapy and thereafter single antiplatelet therapy. The primary outcome was the composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year, and was powered for noninferiority, with an absolute margin of 4.1% at 1-sided 5% alpha.. A total of 1948 patients at high bleeding risk were randomly assigned (1:1) to receive biodegradable-polymer sirolimus-eluting stents (969 patients) or durable-polymer zotarolimus-eluting stents (979 patients). At 1 year, the primary outcome was observed in 33 of 969 patients (3.6%) in the biodegradable-polymer sirolimus-eluting stent group and in 32 of 979 patients (3.4%) in the durable-polymer zotarolimus-eluting stent group (risk difference, 0.2 percentage points; upper boundary of the 1-sided 95% CI, 1.8; upper boundary of the 1-sided 97.5% CI, 2.1;. Among patients at high risk for bleeding who received 1 month of dual antiplatelet therapy after PCI, the use of biodegradable-polymer sirolimus-eluting stents was noninferior to the use of durable-polymer zotarolimus-eluting stents with regard to the composite of death from cardiac causes, myocardial infarction, or stent thrombosis.. URL: https://www.. gov; Unique identifier: NCT04137510.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Sirolimus; Stents; Thrombosis; Treatment Outcome

Magnesium-based bioresorbable Magmaris stents are rapidly resorbed. Few randomized studies have evaluated the efficacy of such stents in patients with acute coronary syndrome.. To investigate late lumen loss as assessed via quantitative coronary angiography (QCA) and optical coherence tomography (OCT) in patients with acute coronary syndrome treated with Magmaris stents or permanent, everolimus-eluting metallic Xience stents.. This PRAGUE-22 study was a two-centre, investigator-initiated, randomized study. Fifty patients were randomized based on the inclusion criteria for acute coronary syndrome and the anatomical suitability to receive Magmaris or Xience stents. The patient characteristics did not differ between the Magmaris group (n = 25) and Xience group (n = 25). The mean ages were 57.0 ± 10.5 vs. 55.5 ± 9.2 years (p = 0.541) and the total implanted stent length was 24.6 ± 10.7 mm vs. 27.6 ± 11.1 mm (p = 0.368), respectively. Four clinical events occurred in the Magmaris group and one in the Xience group during 12 months of follow-up. The extent of late lumen loss (assessed via QCA) at 12 months was greater in the Magmaris group than in the Xience group (0.54 ± 0.70 vs. 0.11 ± 0.37 mm; p = 0.029). The late lumen loss diameter (measured via OCT) in the Magmaris group was also significantly larger than that in the Xience group (0.59 ± 0.37 vs. 0.22 ± 0.20 mm; p = 0.01).. Implantation of a magnesium-based bioresorbable stent in patients with acute coronary syndrome is associated with a greater extent of late lumen loss at the 12-month follow-up compared with implantation of a permanent, everolimus-eluting metallic stent.. ISRCTN89434356.

Topics: Absorbable Implants; Acute Coronary Syndrome; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Magnesium; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome

Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes.. We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44-0.96; Pnon-inferiority < 0.001; Psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46-0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups.. In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome.. ClinicalTrials.gov: NCT03321032.

Topics: Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Treatment Outcome

For patients with high bleeding risk, the BioFreedom stent is safer and more effective than a bare metal stent. However, at the one-year follow-up of the SORT OUT IX trial, the BioFreedom stent did not meet the criteria for non-inferiority for target lesion failure (TLF) when compared with the Orsiro stent and had a higher incidence of target lesion revascularisation (TLR).. The aim of the study was to compare the two-year outcomes following coronary implantation of the BioFreedom or the Orsiro stents in all-comer patients.. The Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) IX trial is a prospective, multicentre, randomised clinical trial comparing the BioFreedom and the Orsiro stents. The primary endpoint, TLF, was a composite of cardiac death, myocardial infarction (MI; not related to other lesions) and TLR.. A total of 1,572 patients were randomised to treatment with the BioFreedom stent and 1,579 patients with the Orsiro stent. At two-year follow-up, TLF was 7.8% in the BioFreedom and 6.3% in the Orsiro stent groups (rate ratio [RR] 1.23, 95% confidence interval [CI]: 0.94-1.61). Risks of cardiac death, MI and definite stent thrombosis did not differ significantly between the groups, whereas more patients in the BioFreedom group had TLR (5.1% vs 2.6%; RR 1.98, 95% CI: 1.26-2.89) attributable to a higher risk of TLR within the first year (3.5% vs 1.3%; RR 2.77, 95% CI: 1.66-4.62).. At two years, there were no significant differences between the BioFreedom and Orsiro stents for TLF. TLR was significantly higher with the BioFreedom stent due to higher risk of TLR within the first year.

Topics: Absorbable Implants; Coronary Artery Disease; Death; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Sirolimus; Stents; Treatment Outcome

To compare the efficacy and safety of the dual therapy CD34 antibody-covered sirolimus-eluting Combo stent (DTS) and the sirolimus-eluting Orsiro stent (SES) in patients with and without diabetes mellitus (DM) included in the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) X study.. The incidence of target lesion failure (TLF) after treatment with modern drug-eluting stents has been reported to be significantly higher in patients with DM when compared to patients without DM. Thus, whether the results from the SORT OUT X study apply to patients with and without DM remains unknown.. In total 3146 patients were randomized to stent implantation with DTS (n = 1578; DM: n = 279) or SES (n = 1568; DM: n = 271). The primary end point, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 1 year.. At 1 year, the rate of TLF was increased in the DTS group compared to the SES group, both among patients with DM (9.3% vs. 4.8%; risk difference: 4.5%; incidence rate ratio: 1.99, 95% confidence interval [CI]: 1.02-3.90) and without DM (5.7% vs. 3.5%; incidence rate ratio: 1.67, 95% CI: 1.15-2.42). The differences were mainly explained by higher rates of TLR.. Compared to the SES, the DTS was associated with an increased risk of TLF at 12 months in patients with and without DM. The differences were mainly explained by higher rates of TLR, whereas rates of cardiac death and target lesion MI did not differ significantly between the two stent groups in patients with or without DM.

Topics: Absorbable Implants; Antigens, CD34; Coronary Artery Disease; Death; Diabetes Mellitus; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

Newer generation bioresorbable scaffolds (BRSs) with thinner struts and improved deliverability are expected to enhance safety and efficacy profiles. Bioheart (Bio-Heart, Shanghai, China) BRS is constructed from a PLLA (poly-l-lactic acid) backbone coated with a PDLLA (poly D-l-lactic acid) layer eluting sirolimus. We report 2-year serial intracoronary imaging findings.. In this first-in-human study, 46 patients with single de novo lesions in native coronary vessels (vessel size 3.0-3.75 mm, lesion length ≤ 25 mm) were enrolled at a single institution. Baseline intravascular ultrasound (IVUS) and post-implantation IVUS and optical coherence tomography (OCT) examinations were mandatory. After successful implantations of BRS, the 46 patients were randomized to two different follow-up cohorts in a 2:1 ratio. Thirty patients in cohort 1 had to undergo angiography, IVUS, and OCT follow-ups at 6 and 24 months, respectively. The 16 patients in cohort 2 underwent the same types of imaging follow-ups at 12 and 36 months, respectively. Clinical follow-ups were scheduled uniformly in both cohorts at 1, 6, and 12 months and annually up to 5 years for all patients.. Between August and November 2016, a total of 54 patients were assessed. However, 8 patients could not meet all the inclusion criteria; thus, the remaining 46 patients (age 57.5 ± 8.7 years, 34.8% female, 50.0% with unstable angina, 26.1% diabetics) with 46 target lesions were enrolled in this study. All patients in both cohorts were required to complete clinical follow-up uniformly and regularly. In cohort 1, one patient had definite scaffold thrombosis within 6 months of follow-up; thus, after 6 months, cohort 1 had 96.7% patients . Imaging follow-up was available in 24 patients, and in-scaffold late loss was 0.44 ± 0.47 mm; intracoronary imaging confirmed the late loss was mainly due to to neointimal hyperplasia, but not scaffold recoil.. Serial 2-year clinical and imaging follow-up results confirmed the preliminary safety and efficacy of Bioheart BRS for treatment of simple coronary lesions.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; China; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Previous trials suggested the superiority of ultrathin- over thin-strut drug-eluting stents (DES) concerning target lesion failure (TLF) at 1 year after index percutaneous coronary intervention.. The aim of this randomized comparison study of ultrathin-strut and thin-strut DES (CASTLE [Randomized Comparison All-Comer Study of Ultrathin Strut and Thin Strut Drug-Eluting Stent]; jRCTs032180084) was to examine the impact of differences in strut thickness of DES on clinical outcomes when implanted with angiography and intravascular ultrasound or optical coherence tomographic guidance.. CASTLE was a multicenter, prospective, noninferiority study conducted at 65 institutions in Japan. Percutaneous coronary intervention patients were assigned (1:1) to an ultrathin, biodegradable-polymer sirolimus-eluting stent (BP-SES) or a thin, durable-polymer everolimus-eluting stent (DP-EES). The primary endpoint was TLF, defined as a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target lesion revascularization at 1-year follow-up.. Between May 2019 and March 2020, 1,440 patients were randomly assigned to BP-SES (n = 722) or DP-EES (n = 718). TLF occurred in 6.0% and 5.7% of patients, respectively. Noninferiority (P = 0.040) was met because the upper limit (2.67%) of the 1-sided 95% CI between the groups was lower than the prespecified noninferiority margin (3.3%). No significant interactions were observed in the relative rates of TLF between prespecified subgroups.. The BP-SES was noninferior to the DP-EES regarding 1-year TLF. This demonstrates that strut thickness differences among DES have little impact on clinical outcomes when implanted with intravascular imaging guidance.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Sirolimus; Treatment Outcome

Implantation of drug eluting stents (DES) is the mainstay treatment for patients requiring percutaneous coronary intervention (PCI). The polymer coating of DES has been associated with inflammatory response, increased arterial injury and long-term in-stent restenosis and thrombosis. Polymer-free stents (PFS) were designed to overcome limitations of polymer-coated stents (PCS). Our aim was to compare clinical outcomes of patients undergoing PCI with PFS versus contemporary PCS.. This is a prospective, open-label registry study enrolling consecutive all-comers patients admitted to a single center and undergoing PCI using contemporary DES. Clinical outcomes were compared between patients treated with PFS and PCS. The primary endpoint was target lesion revascularization (TLR) at 12 months. Subgroup analyses were conducted for diabetic and nondiabetic patients.. Overall, 1664 patients were included: 928 (55.8%) of which were treated with PFS and 736 (44.2%) with PCS for 2046 and 1462 lesions, respectively. At 12 months, TLR rates were not significantly different between the groups (1.7% vs. 2.3% for PFS and PCS, respectively, P = 0.48). The use of PFS did not improve clinical outcomes among diabetic patients in comparison with PCS. Target vessel revascularization and major adverse cardiac events rates were also similar between groups, regardless of diabetes status.. Newer generation DES offer excellent results in diabetic and nondiabetic patients without significant differences in outcomes between PCS and PFS.

Topics: Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Sirolimus; Treatment Outcome

Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is a widely adopted strategy for the treatment of de novo coronary artery disease. DES implantation conveys an inherent risk for short- and long-term complications, including in-stent restenosis and stent thrombosis. Drug-coated balloons are emerging as an alternative approach to fulfill the "leaving nothing behind" principle and avoid long-term DES-related complications.. TRANSFORM II is an investigator-initiated, multicenter, noninferiority, randomized clinical trial, testing a sirolimus-coated balloon (SCB) versus the standard of care for native coronary vessels with a 2-3 mm diameter, in terms of 12-month target lesion failure (TLF; primary endpoint) and net adverse cardiovascular events (coprimary endpoint). Patients undergoing PCI will be randomized to be treated with either SCB or new-generation everolimus-eluting stent and will be followed up clinically for up to 60 months. Assuming a TLF rate of 8% at 12 months with DES, a sample size of 1325 patients was chosen to ensure an 80% power to detect a 1.5% lower incidence in the SCB group with a type I error rate of 0.05. The TRANSFORM II trial is registered on clinicaltrials.gov (identification number NCT04893291). Several substudies, including an optical coherence tomography assessment at 9 months (intracoronary imaging substudy), will investigate the study device in different clinical and lesion settings.. The randomized TRANSFORM II trial will determine whether a novel SCB is noninferior to a current everolimus-eluting stent when adopted for the treatment of de novo lesions in coronary vessels with a diameter between 2 and 3 mm.

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

Randomized trials have demonstrated the superiority of ultrathin strut drug-eluting stents compared with alternative stent designs. Whether these differences persist over late-term follow-up is uncertain.. This study sought to compare late-term (5-year) clinical outcomes among patients treated with ultrathin strut (60 µm) bioresorbable polymer sirolimus-eluting stents (BP SES) and thin strut (81 µm) durable polymer everolimus-eluting stents (DP EES).. BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects with Up to Three De Novo or Restenotic Coronary Artery Lesions V) was an international, 2:1 randomized trial comparing percutaneous coronary intervention with ultrathin strut BP SES versus thin strut DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Prespecified outcomes through 5 years were assessed.. Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 5-year rates of TLF were 12.3% for BP SES and 15.3% for DP EES (P = 0.108). Revascularization with BP SES was associated with a significantly lower target vessel-related myocardial infarction (6.6% vs 10.3%, P = 0.015) and late/very late definite/probable stent thrombosis (0.3% vs 1.6%, P = 0.021). Ischemia-driven target lesion revascularization was numerically but not significantly lower with BP SES (5.9% vs 7.7%, P = 0.202). Cardiac death rates were 2.6% versus 1.9% (P = 0.495) for BP SES and DP EES, respectively.. In a large, randomized trial, TLF and the individual outcomes of cardiac death and target lesion revascularization at 5 years were similar among patients treated with BP SES versus DP EES. Both target vessel-related myocardial infarction and late/very late definite/probable stent thrombosis were significantly lower with BP SES. These results confirm the durability of safety and the effectiveness of percutaneous coronary intervention with ultrathin BP SES.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Death; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Sirolimus; Treatment Outcome

Current guidelines recommend dual antiplatelet therapy (DAPT) following percutaneous coronary intervention for 6-12 months in patients with acute coronary syndrome (ACS) and 3-6 months in those with chronic coronary syndromes (CCS). Whether DAPT duration has a differential effect on outcomes following treatment of ischemic coronary disease with durable versus biodegradable drug-eluting stent (DES) is poorly defined.. The TARGET All Comer study was a randomized trial of patients with ischemic coronary artery disease assigned to treatment with either a biodegradable polymer DES (Firehawk) or a durable polymer DES (XIENCE). This pre-specified TARGET AC sub-analysis sought to evaluate the 2-year clinical outcomes before and after DAPT discontinuation. The primary endpoint was target lesion failure (TLF).. A total of 1,296 (78.4%) of 1,653 randomized patients were included in this substudy, of which 1,210 (93.4%) remained on DAPT at 6 months, 863 (66.6%) at 12 months, and 409 (31.6%) at 2 years. There was no difference in TLF between patients treated with Firehawk and XIENCE stents from index procedure to DAPT discontinuation (8.0 and 7.7%, p > .99) or after DAPT discontinuation (2.9 vs. 3.8%, p = .16). After DAPT discontinuation, target vessel myocardial infarction (1.3 vs. 3.3%, p = .07), and ischemia-driven target lesion revascularization (0.5 vs. 1.9%, p = .06) favored treatment with Firehawk.. Although TLF was comparable for both Firehawk and XIENCE stent groups before and after DAPT discontinuation, after DAPT discontinuation, there was a trend for less target vessel myocardial infarction and ischemia-driven revascularization with the biodegradable polymer DES.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Sirolimus; Treatment Outcome

This analysis presents the final five-year results of the I-LOVE-IT 2 trial, a non-inferiority study comparing a biodegradable polymer (BP) sirolimus-eluting stent (SES) with a durable polymer (DP) SES in patients with coronary artery disease.. Overall, 2,737 Chinese patients eligible for coronary stenting were treated with BP-SES or DP-SES in a 2:1 ratio. Patients who were randomised to the BP-SES group were additionally re-randomised to receive either six-month or 12-month dual antiplatelet therapy (DAPT) in a 1:1 ratio. The primary endpoint was 12-month target lesion failure (TLF: cardiac death, target vessel myocardial infarction (MI), or clinically indicated target lesion revascularisation). At five years, the overall follow-up rate was 90.8%, and the cumulative incidence of TLF as the primary endpoint was similar between BP-SES and DP-SES (hazard ratio [HR] 1.01, 95% confidence interval [CI]: 0.79 to 1.28), as was that for the patient-oriented composite endpoint (PoCE: all-cause death, all MI and any revascularisation) (HR 1.03, 95% CI: 0.86 to 1.23), or definite/probable stent thrombosis (ST) (HR 0.91, 95% CI: 0.70 to 1.77). Cumulative events were also similar between the six-month DAPT and 12-month DAPT groups after BP-SES implantation.. I-LOVE-IT 2 showed that the five-year safety and efficacy of BP-SES and DP-SES were similar, as were those between six months and 12 months of DAPT after BP-SES implantation.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Risk Factors; Sirolimus; Treatment Outcome

To compare the outcomes of patients undergoing non-cardiac surgery (NCS) after PCI with either a drug-coated stent (DCS) or a bare-metal stent (BMS), followed by 1-month dual antiplatelet therapy and to explore the impact of the timing of NCS.. This is a subgroup analysis of the LEADERS FREE trial. The primary safety end point was a composite of cardiac death, myocardial infarction, or stent thrombosis, and the primary efficacy end point was clinically driven target lesion revascularization (TLR).. Out of 2432 patients included in the LEADERS FREE trial, 278 (11.4%) underwent NCS within 1 year after PCI. Among NCS patients, the 1-year safety end point was numerically lower with DCS; however, this difference was not significant as compared to BMS (4.7% vs. 10.1%, HR: 0.459 [0.178-1.183], p = 0.099), clinically driven TLR was significantly lower after DCS (2.4% vs. 8.3%, HR: 0.281 [0.079-0.996], p = 0.036), and BARC 3-5 bleeding was similar with DCS vs. BMS (10.2% vs. 7.5%, p = 0.438). In patients treated with BMS, NCS within 3 months after PCI was associated with higher incidence of the safety end point than NCSs performed later: 14.9% vs. 4.4%, HR: 3.586 [1.012-12.709], p = 0.034. The timing of surgery had no impact on patients treated with DCS (4.7% vs. 4.7%, p = 0.947).. Among patients undergoing NCS after PCI, DCS-treated patients had a lower probability of clinically driven TLR compared with BMS. However, there was no significant difference in the occurrence of the primary composite safety end point or bleeding complications. Early NCS after BMS-PCI was associated with impaired safety, while the timing of NCS had no such influence after DCS implantation.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Percutaneous Coronary Intervention; Polymers; Prognosis; Prosthesis Design; Retrospective Studies; Risk Factors; Sirolimus; Surgical Procedures, Operative

Japanese patients have shown improved outcomes after treatment with drug eluting stents compared with Western patients. Outcomes with the ridaforolimus-eluting EluNIR stent in Japanese patients are unknown.. This was a multi-center trial in Japanese patients undergoing PCI with the ridaforolimus eluting EluNIR stent. A propensity-score matched analysis was performed with the EluNIR arm of the BIONICS trial. The matched cohort was compared with the Japanese patients for the primary endpoint of target lesion failure (TLF) in a non-inferiority study. 104 Japanese patients were compared with 410 matched patients from BIONICS. Baseline characteristics were similar except for more frequent multi-vessel disease in the BIONICS cohort. Post dilation was more likely in Japanese patients (90.4% vs. 64.6%, p < 0.001). TLF at 12 months was met by 2 patients (1.9%) in the JNIR study compared with 5.3% in the BIONICS group (Pnoninf = 0.0028). Rates of MI (0% vs. 4.7%, p = 0.03), target vessel MI (0% vs. 3.7%, p = 0.04), MACE (1.0% vs. 6.2%, p = 0.03) and TVF (1.0% vs. 6.9%, p = 0.02) were all significantly lower among Japanese patients.. Treatment of Japanese patients with the EluNIR stent is associated with very low rates of adverse events, significantly fewer than seen in the BIONICS trial.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Japan; Male; Morbidity; Percutaneous Coronary Intervention; Propensity Score; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Compare the degree of acute vascular injury caused by a polymer-free, thin-strut drug-eluting stent (DES) to that caused by a bioresorbable polymer, thick-strut DES using optical coherence tomography (OCT).. Fifty patients requiring nonurgent PCI were randomized to receive either a thin or a thick-strut DES. OCT was performed before and after stent implantation. OCT-based injury score (IS) after implantation was numerically higher within thick-strut stents 0.32 vs. 0.23, but the difference was NS (P = 0.61). Edge dissections were present in 36% of the patients without differences between groups. Tissue prolapse (TP) area was larger with thin-strut stents (2.26 vs. 1.83 mm2, P = 0.04). Stent expansion and symmetry index were similar between the two platforms (85% vs. 94%, P = 0.08; and 0.82 vs. 0.80, P = 0.25). No differences were observed in total malapposition area (1.85 mm2 in thin-strut stents vs. 1.47 mm2, P = 0.48). Regarding the influence of plaque-type, IS tended to be higher (non-significant) with thick strut DES in fibrocalcific plaques. Stent malapposition area was smaller in fibrous plaques, especially with thin strut stents (P = 0.03).. There was no difference in the extent of OCT-based vessel injury associated with thin and thick-strut DES platforms. TP was larger with the thin strut DES, potentially reflecting a deeper stent embedment in the vessel wall.

Topics: Aged; Biodegradable Plastics; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Intraoperative Complications; Male; Outcome Assessment, Health Care; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Sirolimus; Tomography, Optical Coherence; Vascular System Injuries

This analysis of pooled individual patient data (IPD) aimed to evaluate the safety and efficacy of a bioresorbable polymer sirolimus eluting stent system (BP-SES; Orsiro) compared to a durable polymer everolimus eluting stent system (DP-EES; Xience) in the pooled population as well as in subgroups.. IPD with up to 12 months follow-up of the randomized controlled trials BIOFLOW-II (NCT01356888), -IV (NCT01939249), and -V (NCT02389946) as well as the all comers registry BIOFLOW-III (NCT01553526) were pooled. A total of 3,717 subjects (2,923 in BP-SES and 794 in DP-EES) with 5,328 lesions (4,225 lesions in BP-SES and 1,103 in DP-EES) were included in the IPD. The primary endpoint was target lesion failure (TLF) at 12 months follow-up. Subgroups analyzed included diabetes, age (≥65 years), gender, complex lesions (B2/C), small vessels (reference vessel diameter ≤2.75 mm), multivessel treatment, renal disease, and patients with acute coronary syndrome.. Overall, TLF at 12 months was significantly lower with 5.2%in the BP-SES group versus 7.6% in the DP-EES group (p = .0098). Similarly, target vessel myocardial infarction (TV-MI) was 3.1 versus 5.7% (p = .0005). The rate of stent thrombosis was similar in both groups (0.004%). By regression analysis, an independent stent effect in favor of BP-SES was observed for TLF (p = .0043) and TV-MI (p = .0364) in small vessels.. Results of this IPD analysis suggest that the BP-SES with ultrathin struts is as safe as and more efficacious than DP-EES in the overall cohort and especially in small vessels.

Topics: Absorbable Implants; Aged; Coronary Artery Disease; Data Analysis; Drug-Eluting Stents; Everolimus; Humans; Polymers; Prosthesis Design; Sirolimus; Treatment Outcome

The objective of the study is to assess the efficacy and safety of the novel Magic Touch sirolimus coated-balloon (SCB) when compared to the SeQuent Please Neo paclitaxel coated balloon (PCB) for the treatment of de-novo small vessel coronary artery diseases (SVD).. The TRANSFORM I study is a randomized, multicenter, non-inferiority trial with the intent to enroll a total of 114 patients with a de-novo SVD (≤2.5 mm). Vessel size will be pre-screened by on-line QCA. After successful pre-dilatation without major coronary dissections (type C-F) nor Thrombolysis In Myocardial Infarction trial [TIMI] grade flow ≤2, patients will be enrolled in a 1:1 randomization to receive treatment with either the novel SCB balloon or the comparative PCB balloon. The balloon sizing will be selected according to the lumen-based approach derived from optical coherence tomography (OCT). The primary endpoint is 6-month mean net lumen diameter gain (6-month minimum lumen diameter [MLD] minus baseline MLD) assessed by quantitative coronary analysis (QCA) with non-inferiority margin of 0.3 mm in per-protocol analysis. The clinical follow-up will be conducted up to 1 year. The enrollment started in September 2020 and will complete in April 2021.. The TRANSFORM I trial will assess the efficacy of novel SCB in terms of non-inferiority to conventional PCB with a novel OCT measurement approach in patients with a de-novo SVD. Clinical Trial Registration URL: https://clinicaltrials.gov. Unique identifier: NCT03913832.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Humans; Paclitaxel; Prospective Studies; Sirolimus; Treatment Outcome

Treatment of a coronary bifurcation lesion is often required in routine clinical practice, but data on the performance of very thin-strut biodegradable polymer drug-eluting stents are scarce.. Comparison of biodegradable polymer and durable polymer drug-eluting stents in an all comers population (BIO-RESORT) is a prospective, multicenter randomized clinical trial that included 3514 all-comer patients, who were randomized to very thin-strut biodegradable polymer-coated sirolimus- or everolimus-eluting stents, versus thin-strut durable polymer-coated zotarolimus-eluting stents. The approach of bifurcation stenting was left at the operator's discretion, and provisional stenting was generally preferred. This prespecified analysis assessed 3-year clinical outcome of all patients in whom treatment involved at least one bifurcation with a side-branch diameter ≥1.5 mm.. Of all BIO-RESORT trial participants, 1236 patients were treated in bifurcation lesions and analyzed. Single- and two-stent techniques were used in 85.8% and 14.2%, respectively. 'True' bifurcation lesions (main vessel and side-branch obstructed) were treated in 31.1%. Three-year follow-up was available in 1200/1236 (97.1%) patients. The main endpoint target vessel failure (composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization) occurred in sirolimus-eluting stents in 42/412 (10.3%) and in zotarolimus-eluting stents in 49/409 (12.1%) patients (P-logrank = 0.40). In everolimus-eluting stents, target vessel failure occurred in 40/415 (9.8%) patients (vs. zotarolimus-eluting stents: P-logrank = 0.26). There was no between-stent difference in individual components of target vessel failure. Findings were consistent in patients with single-vessel treatment and patients treated with a single-stent technique.. Three years after stenting all-comers with bifurcation lesions, clinical outcome was similar with the sirolimus-eluting and everolimus-eluting stents versus the zotarolimus-eluting stent.

Topics: Biodegradable Plastics; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Equipment Failure Analysis; Everolimus; Female; Humans; Immunosuppressive Agents; Long Term Adverse Effects; Male; Middle Aged; Outcome and Process Assessment, Health Care; Percutaneous Coronary Intervention; Prosthesis Failure; Sirolimus

Topics: Aged; Aspirin; Biodegradable Plastics; Clopidogrel; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Female; Humans; Immunosuppressive Agents; Male; Outcome and Process Assessment, Health Care; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Sirolimus

We evaluated the safety and efficacy of the novel dual-therapy sirolimus-eluting and endothelial progenitor cell (EPC) capture COMBO stent.. (Very) late stent thrombosis (ST) and neo-atherosclerosis limit the performance of drug-eluting stents. The capture of EPCs accelerates stent re-endothelialization, thereby potentially decreasing the risk of restenosis and ST.. In total, 440 patients with de novo lesions in native coronary arteries were randomized (1:1) to either receive the COMBO stent (n = 220) or Nano polymer-free sirolimus-eluting stent (n = 220). The primary endpoint was the 9-month angiographic in-segment late lumen loss (LLL). Secondary endpoints included target lesion failure (TLF), a patient-oriented composite endpoint (PoCE), and ST.. At 9 months, the COMBO in-segment LLL (0.29 ± 0.46 mm) was non-inferior to that of the Nano comparator stent (0.31 ± 0.44 mm; p. The RECOVERY trial has shown the COMBO stent was effective, meeting the primary non-inferiority angiographic endpoint, and safe, with an overall low rate of clinical events in both stent groups, including no ST for up to 2 years.

Topics: Cardiovascular Agents; China; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

This study evaluated the 5-year clinical outcomes of the Genoss DES, the first Korean-made sirolimus-eluting coronary stent with abluminal biodegradable polymer.We previously conducted the first-in-patient prospective, multicenter, randomized trial with a 1:1 ratio of patients using the Genoss DES and Promus Element stents; the angiographic and clinical outcomes of the Genoss DES stent were comparable to those of the Promus Element stent. The primary endpoint was major adverse cardiac events (MACE), which was a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR) at 5 years.We enrolled 38 patients in the Genoss DES group and 39 in the Promus Element group. Thirty-eight patients (100%) from the Genoss DES group and 38 (97.4%) from the Promus Element group were followed up at 5 years. The rates of MACE (5.3% vs 12.8%, P = .431), death (5.3% vs 10.3%, P = .675), TLR (2.6% vs 2.6%, P = 1.000), and target vessel revascularization (TVR) (7.9% vs 2.6%, P = .358) at 5 years did not differ significantly between the groups. No TLR or target vessel revascularization was reported from years 1 to 5 after the index procedure, and no MI or stent thrombosis occurred in either group during 5 years.The biodegradable polymer Genoss DES and durable polymer Promus Element stents showed comparable low rates of MACE at the 5-year clinical follow-up.

Topics: Absorbable Implants; Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Postoperative Complications; Prospective Studies; Republic of Korea; Sirolimus; Treatment Outcome

Very long-term outcomes according to diabetic status of patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) with new-generation drug-eluting stents (DES) are scant. Both, the durable polymer zotarolimus-eluting stent (DP-ZES), the first DES to gain FDA-approval for specific use in patients with diabetes mellitus, and the polymer-free sirolimus- and probucol-eluting stent (PF-SES), with a unique design that enables effective drug release without the need of a polymer offer the potential to enhance clinical long-term outcomes especially in patients with diabetes mellitus.. We investigate 10-year clinical outcomes of the prespecified subgroups of patients with and without diabetes mellitus, randomly assigned to treatment with PF-SES versus DP-ZES in the ISAR-TEST 5 trial. The primary endpoint of interest was major adverse cardiac events (MACE), defined as the composite of all-cause death, any myocardial infarction or any revascularization. Further endpoints of interest were cardiac death, myocardial infarction related to the target vessel and target lesion revascularization as well as the individual components of the primary composite endpoint and the incidence of definite or probable stent thrombosis at 10 years.. This analysis includes a total of 3002 patients randomly assigned to PF-SES (n = 2002) or DP-ZES (n = 1000). Prevalence of diabetes mellitus was high and comparable, 575 Patients (28.7%) in PF-SES group and 295 patients (29.5%) in DP-ZES group (P = 0.66). At 10 years 53.5% of patients with diabetes mellitus and 68.5% of patients without diabetes mellitus were alive. Regarding major adverse cardiac events, PF-SES as compared to DP-ZES showed comparable event rates in patients with diabetes mellitus (74.8% vs. 79.6%; hazard ratio 0.86; 95% CI 0.73-1.02; P = 0.08) and in patients without diabetes (PF-SES 62.5% vs. DP-ZES 62.2%; hazard ratio 0.99; 95% CI 0.88-1.11; P = 0.88).. At 10 years, both new-generation DES show comparable clinical outcome irrespective of diabetic status or polymer strategy. Event rates after PCI in patients with diabetes mellitus are considerable higher than in patients without diabetes mellitus and continue to accrue over time.. ClinicalTrials.gov, NCT00598533, Registered 10 January 2008, https://clinicaltrials.gov/ct2/show/NCT00598533?term=NCT00598533 Kaplan-Meier estimates of endpoints of interest for patients with vs. without diabetes mellitus treated with PF-SES vs. DP-ZES. Bar graphs: Kaplan-Meier estimates as percentages. PF-SES: polymer-free sirolimus-eluting stent; DP-ZES: durable polymer zotarolimus-eluting stent; DM: diabetes mellitus. Comparison of event rates of individual endpoints in patients with and without diabetes mellitus treated with PF-SES vs. DP-ZES all without statistically significant differences. Comparison of event rates of individual endpoints in overall patients with vs. without diabetes mellitus significantly different (P ≤ 0.01 for all comparisons).

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Probucol; Sirolimus; Treatment Outcome

Topics: Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Prognosis; Prospective Studies; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; Survival Rate; Time Factors; Treatment Outcome

Topics: Aged; Coronary Artery Bypass; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Incidence; Male; Middle Aged; Percutaneous Coronary Intervention; Proportional Hazards Models; Republic of Korea; Retrospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The aim of the present study was to evaluate the safety and efficacy of thinner strut Firesorb (100/125 μm) sirolimus-eluting bioresorbable scaffolds (BRS) versus cobalt-chromium everolimus-eluting stents (CoCr-EES) in patients with coronary artery disease.. First-generation thicker strut BRS were associated with unexpected device-related adverse outcomes at long-term follow-up.. Eligible patients with 1 or 2 de novo noncomplex coronary lesions were randomized to the Firesorb BRS group or CoCr-EES group in a 1:1 ratio. The primary endpoint was 1-year angiographic in-segment late loss (LL), powered for noninferiority testing. The key secondary endpoint was the 1-year proportion of covered struts assessed on optical coherence tomography, powered for noninferiority and subsequent superiority testing.. A total of 433 participants from 28 Chinese centers were randomized to the Firesorb BRS group (n = 215) or CoCr-EES group (n = 218). Patient-level 1-year in-segment LL was 0.17 ± 0.27 mm in the Firesorb BRS group and 0.18 ± 0.37 mm in the CoCr-EES group (difference -0.01 mm; 95% confidence interval [CI]: -0.07 to 0.06; p. The thinner strut Firesorb BRS was noninferior to the CoCr-EES for the primary endpoint of 1-year angiographic in-segment LL and the key secondary endpoint of 1-year proportion of covered struts by optical coherence tomography. (A Trial of Firesorb in Patients With Coronary Artery Disease: FUTURE-II [FUTURE-II]; NCT02890160).

Topics: Absorbable Implants; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Treatment Outcome

[Figure: see text].

Topics: Absorbable Implants; Atherosclerosis; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Sirolimus; Stents; Treatment Outcome

To evaluate the long-term safety and efficacy of the novel combined sirolimus-eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL) at 5 years in the REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coated bio-Engineered stEnt) trial.. Drug-eluting stents have limited restenosis and reintervention but are complicated by late and very late thrombosis and accelerated neoatherosclerosis. Alternative or adjunctive technologies are needed to address these limitations.. A total of 183 patients with de novo lesions in native coronary arteries were randomized 2:1 to Combo (n = 124) or Taxus Liberté (n = 59). Primary endpoint was 9 month angiographic in-stent late lumen loss and the secondary endpoint was the occurrence of major adverse events (MACE) through 5-year follow-up.. Compared with Taxus, after 5 years the Combo stent was associated with similar rates of MACE (18.3% vs. 16.9%, p = .89), cardiac death (0.8% vs. 5.1%, p = .07), myocardial infarction (4.1% vs. 3.4%, p = .81), target lesion (9.4% vs. 10.2%, p = .78), and target vessel revascularization (14.4% vs. 11.9%, p = .73). No cases of definite stent thrombosis were reported in the Combo group. The follow-up rate at 5 years was 97.7%.. At 5-year follow-up, the Combo stent remained clinically safe and effective with an overall low rate of MACE comparable to Taxus.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Endothelial Progenitor Cells; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The aim of this study is to demonstrate the non-inferiority of the BiOSS LIM C sirolimus-eluting cobalt-chromium bifurcation dedicated stent against the XIENCE stent regarding the patient-oriented composite endpoint (POCE) at 12 months among patients with left main coronary artery disease (LMCA).. The POLBOS LM study is a single-arm, prospective, multicentre study enrolling 260 patients (SYNTAX score ≤32) with a pre-specified performance goal based on the results of the EXCEL trial with contemporary percutaneous coronary intervention (PCI) for LMCA disease. Patient enrolment will comply with objective inclusion criteria of diameter stenosis ≥50% in the LMCA based on off-line quantitative coronary angiography (QCA) analysed by an independent core laboratory using dedicated bifurcation QCA software. The BiOSS LIM C is used for the treatment of LMCA disease with the same specific technical classification as for the BiOSS LIM (modified MADS classification) and the stent implantation is optimised by using pre-specified intravascular ultrasound criteria. The primary endpoint is POCE (a composite of all-cause death, stroke, any myocardial infarction, and any revascularisation) at 12 months.. The POLBOS LM study will indicate the efficacy of the BiOSS LIM C stent with contemporary PCI for distal left main bifurcation lesions in comparison with the XIENCE stent from the recent EXCEL trial, as a performance index.

Topics: Chromium; Cobalt; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

Long-term data from randomized studies on polymer-free stents are scarce. Long-term data of Cre8 amphilimus eluting stent are still not available. We sought to investigate contribution of a polymer-free design versus a permanent-polymer one on the long-term.. Patients undergoing percutaneous coronary intervention for de novo lesions were randomized 1:1 to Cre8 or Taxus Liberté (323 overall, 126 Cre8). Original primary endpoint (6-month angiographic in-stent late lumen loss) already demonstrated the superiority of Cre8 vs Taxus (0.14 + 0.36 mm vs. 0.34 + 0.40 mm; p < 0.001). Secondary endpoints were the device oriented composite endpoint (DOCE), patient oriented composite endpoint (POCE) up to 5-year. Long-term follow-up data confirmed the superiority shown by Cre8 in the analysis of the angiographic endpoint at 6-month, especially in the diabetic patients, where the device strongly reduced the clinical difference with non-diabetic. Landmark analysis demonstrated that the incidence of DOCE after 1-year and up to 5-year follow up was significantly lower in patients implanted with Cre8 AES (2.1% Cre8 vs. 9.3% Taxus, p = 0.009). While no differences were found in terms of DOCE rate among diabetic and non-diabetic patients treated with the Cre8 AES (HR 1.039; 95%CI 0.320-3.374), this was not true for Taxus (HR 2.64; 95%CI 1.112-6.278).. Cre8 showed favourable safety and efficacy results versus Taxus at 5-years follow-up, with a superior clinical performance for the DOCE endpoint from 1 to 5 years. Cre8, differently from Taxus, has been able to strongly reduce the differences in clinical outcome between diabetic and non-diabetic up to 5 years, suggesting the higher efficacy of Cre8 in the treatment of diabetic patients.

Topics: Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Fatty Acids; Female; Humans; Immunosuppressive Agents; Long Term Adverse Effects; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Treatment Outcome

We compared 10-year clinical outcomes in diabetes and nondiabetes patients treated with Endeavor zotarolimus-eluting (ZES) or Cypher sirolimus-eluting coronary stents (SES). A total of 1,162 patients were randomized to ZES (169 with diabetes) and 1,170 patients were randomized to SES (168 with diabetes). Patients were further stratified by diabetes status at the time of inclusion. A subgroup of patients with diabetes (n = 88) underwent angiographic re-evaluation 10 months after stent implantation. End points included a combined end point of death or myocardial infarction, and the individual end points of death, myocardial infarction, and revascularization. In patients with diabetes, we found no difference in the combined end point (odds ratio [OR] 0.81, 95% confidence interval [CI] 0.53 to 1.24), death (OR 0.80, 95% CI 0.51 to 1.25), or in MI (OR 1.07, 95% CI 0.60 to 1.91). However, diabetics with ZES more frequently underwent coronary revascularization compared with SES patients (OR 1.93, 95% CI 1.05 to 3.66). In patients without diabetes, ZES and SES had similar 10-year rates of all end points (death: OR 1.13, 95% CI 0.93 to 1.39; MI: OR 0.80, 95% CI 0.61 to 1.05; revascularization: OR 0.81, 95% CI 0.61 to 1.09). Landmark analysis from 5 to 10 years showed no difference in outcomes between SES and ZES in either subgroup. In conclusion, at 10 years, SES and ZES performed similarly in patients with and without diabetes. Although coronary revascularization was more prevalent in diabetes patients with ZES, this may, in part, have been related to the angiographic follow-up that was offered to a subgroup of diabetes patients.

Topics: Cause of Death; Coronary Angiography; Coronary Artery Disease; Denmark; Diabetes Mellitus; Drug-Eluting Stents; Follow-Up Studies; Forecasting; Humans; Immunosuppressive Agents; Incidence; Postoperative Complications; Retrospective Studies; Risk Assessment; Sirolimus; Survival Rate

We compared long-term clinical outcomes between patients treated with Orsiro sirolimus-eluting stent (O-SES) and those treated with durable biocompatible polymer Resolute Integrity zotarolimus-eluting stent (R-ZES).. The ORIENT trial was a randomized controlled noninferiority trial to compare angiographic outcomes between O-SES and R-ZES. We performed a post hoc analysis of 3-year clinical outcomes and included 372 patients who were prospectively enrolled and randomly assigned to O-SES (n = 250) and R-ZES (n = 122) groups in a 2:1 ratio. The primary endpoint was target lesion failure defined as a composite of cardiac death, nonfatal myocardial infarction, and target lesion revascularization. At 3 years, target lesion failure occurred in 4.7% and 7.8% of O-SES and R-ZES groups, respectively (hazard ratio, 0.58; 95% confidence intervals, 0.24-1.41; p = .232 by log-rank test). Secondary endpoints including cardiac death, myocardial infarction, and target lesion revascularization showed no significant differences between the groups. Stent thrombosis occurred in two patients in R-ZES group (0.0% vs. 1.6%, p = .040).. This study confirms long-term safety and efficacy of the two stents. We found a trend for lower target lesion failure with O-SES compared to R-ZES, although statistically insignificant.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Republic of Korea; Sirolimus; Time Factors; Treatment Outcome

The FUTURE-I study aimed to assess preliminary safety and effectiveness with the long-term clinical and imaging follow-up for the Firesorb (MicroPort, Shanghai, China), a thinner-strut sirolimus-eluting bioresorbable scaffold (BRS).. First-generation BRS has been associated with unexpected device-related adverse outcomes at long-term follow-up.. In this prospective, open-label, first-in-man study, patients with single de novo lesions in native coronary arteries were randomized 2:1 into two cohorts after successful Firesorb implantation: cohort 1 (n = 30) underwent multimodality imaging assessment at 6 and 24 months; and cohort 2 (n = 15) at 12 and 36 months. All patients underwent clinical follow-up at 1, 6, and 12 months and annually up to 5 years.. Between January and March 2016, 45 patients were enrolled. At 3-year follow-up, one patient had experienced target lesion failure and none scaffold thrombosis. In-scaffold minimal lumen diameter decreased significantly from 6-month to 2-year (2.53 ± 0.24 mm vs. 2.27 ± 0.37 mm, p = .0003), and only numerically from 1-year to 3-year follow-up (2.48 ± 0.28 mm vs. 2.22 ± 0.13 mm, p = .08). By optical coherence tomography, neointimal strut coverage at 3-year follow-up was 99.8%, and very low rate of late scaffold discontinuity was observed, only in one patient on two cross sections with three malapposed struts.. At 3-year follow-up of the FUTURE-I study, implantation of the thinner-strut Firesorb BRS appeared preliminary feasible and effective in the treatment of patients with noncomplex coronary lesions.

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Cardiovascular Agents; China; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Female; Humans; Male; Middle Aged; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited.. In an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority.. A total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority).. Among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.).

Topics: Coronary Artery Disease; Coronary Thrombosis; Drug Therapy, Combination; Drug-Eluting Stents; Heart Diseases; Hemorrhage; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Prosthesis Design; Single-Blind Method; Sirolimus

Stent designs with ultrathin struts may further increase the procedural success of challenging lesion subsets. The objective of this study was to assess the safety and efficacy of ultrathin strut, polymer-free sirolimus eluting stent (PF-SES) implantations in a large scale, unselected patient population.Adult patients underwent percutaneous coronary interventions (PCI) with a thin-strut PF-SES. Data from two all-comers observational studies having the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled. The accumulated target lesion revascularization (TLR) rate at 9-12 months was the primary endpoint. All dual antiplatelet therapy strategies according to the applicable guidelines were permissible.In total, 7243 patients were prospectively enrolled for PCI with PF-SES in stable coronary artery disease or acute coronary syndrome (ACS). Major risk factors in the overall cohort were diabetes (37.3%), ST elevation myocardial infarction (18.1%) and non-ST myocardial infarction (24.6%). The follow-up rate was 88.6% in the overall population. The TLR rate in the overall cohort was 2.2% whereas definite/probable stent thrombosis (ST) occurred in 0.7%. In patients with in-stent restenosis lesions, the major adverse cardiac events rate was 6.4% whereas the corresponding rate for isolated left main coronary artery (LMCA) disease was highest with 6.7% followed by patients with culprit lesions in vein bypasses (VB, 7.1%). The mortality rate in patients treated in VB lesions was highest with 5.4%, followed by the isolated LMCA subgroup (3.4%) and ACS (2.6%).PCI with PF-SES in an unselected patient population, is associated with low clinical event and ST rates. Furthermore, PF-SES angioplasty in niche indications demonstrated favorable safety and efficacy outcomes with high procedural success rates.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Anti-Bacterial Agents; Blood Vessel Prosthesis Implantation; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Graft Occlusion, Vascular; Humans; Middle Aged; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Practice Patterns, Physicians'; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; ST Elevation Myocardial Infarction; Treatment Outcome

The novel sirolimus-eluting ultra-high molecular weight APTITUDE bioreabsorbable vascular scaffold (BRS) displays higher mechanical strength, expansion capabilities and resistance to fracture compared to other BRS technologies. RENASCENT II is a prospective, multicentre first-in-human clinical study evaluating the clinical performance of the APTITUDE BRS in the treatment of single de novo coronary lesions among patients undergoing percutaneous coronary intervention.. The APTITUDE BRS was tested in a prospective study in two countries (Italy and Colombia). Study objectives were angiographic in-scaffold late lumen loss (IS-LLL) measured by quantitative coronary angiography (QCA) and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction (TV-MI) or ischaemia-driven target lesion revascularisation (TLR) at 9 and 24 months. A total of 60 patients were enrolled. All patients underwent lesion predilatation and 46 patients (76.7%) underwent post-dilatation. Clinical device and procedural success were 98.3% (59/60 patients) and 100%, respectively. Angiographic late lumen loss was 0.19±0.26 mm at 9 months and 0.3±0.41 mm at 24 months. At 9 months, TVF occurred in 2/59 patients (3.4%) due to TV-MI but there was no TLR. No further cases of TVF, MACE or stent thrombosis were reported up to 24-month follow-up.. In this multicentre prospective study, the APTITUDE BRS was shown to be safe and effective in the treatment of single coronary lesions at 24-month clinical follow-up.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

The objective was to assess the 2-year clinical performance of three drug-eluting stents in all-comer patients with severely calcified coronary lesions.. Severe lesion calcification increases cardiovascular event risk after coronary stenting, but there is a lack of data on the clinical outcome of all-comers with severely calcified lesions who were treated with more recently introduced drug-eluting stents.. The BIO-RESORT trial (clinicaltrials.gov: NCT01674803) randomly assigned 3,514 all-comer patients to biodegradable polymer Synergy everolimus-eluting stents (EES) or Orsiro sirolimus-eluting stents (SES), versus durable polymer Resolute Integrity zotarolimus-eluting stents (ZES). In a post hoc analysis, we assessed 783 patients (22.3%) with at least one severely calcified target lesion.. At 2-year follow-up (available in 99% of patients), the main composite endpoint target vessel failure occurred in 19/252 (7.6%) of the EES and in 33/265 (12.6%) of the ZES-treated patients (p = .07). Target vessel failure occurred in 24/266 (9.1%) of the SES-treated patients (vs. ZES: p = .21). There was a difference in target vessel revascularization, which was required in EES in 6/252 (2.4%) patients and in ZES in 20/265 (7.7%) patients (p = .01); the target vessel revascularization rate in SES was 9/266 (3.4%, vs. ZES: p = .04). Multivariate analysis showed that implantation of EES, but not SES, was independently associated with lower target vessel revascularization rates than in ZES.. In BIO-RESORT participants with severely calcified target lesions, treatment with EES was associated with a lower 2-year target vessel revascularization rate than treatment with ZES.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Netherlands; Percutaneous Coronary Intervention; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome; Vascular Calcification

The BIOFLOW-VI (Biotronik-Safety and Clinical Performance of the Drug Eluting Orsiro Stent in the Treatment of Subjects With De Novo Coronary Artery Lesions-VI) study evaluates the angiographic efficacy, clinical safety, and effectiveness of the ultrathin strut, biodegradable polymer sirolimus-eluting stent (BP-SES) compared with a durable polymer everolimus-eluting stent (DP-EES). This randomized controlled clinical trial was designed to enable approval of new drug-eluting stents in China.. A total of 440 eligible patients from 11 sites with up to 2 de novo native coronary artery lesions were randomly assigned to receive either BP-SES (n = 220) or DP-EES (n = 220) from July 2014 to September 2016 in this prospective, multicenter, noninferiority trial.. The primary end point of 9-month in-stent late lumen loss (LLL) was 0.05 (0.02) mm in the BP-SES group versus 0.07 (0.02) mm in the DP-EES group, with a mean difference of -0.02 mm (95% CI, -0.06 to 0.03; P = 0.44; P. The randomized BIOFLOW-VI trial showed that BP-SES was noninferior to DP-EES with regard to the primary end point of 9-month in-stent LLL in a Chinese population. ClinicalTrials.gov Identifier: NCT02870985.

Topics: Aged; Asian People; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Sirolimus

Drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy. However, drug-eluting stents with biodegradable polymers may not be a class effect, as stent strut thickness, polymer coating, and drug resorption differ between these groups of stents. Twelve months results of Scandinavian Organization for Randomized Trials With Clinical Outcome VII showed that ultrathin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent. The sirolimus-eluting Orsiro stent was associated with a reduced risk of definite stent thrombosis.. The Scandinavian Organization for Randomized Trials With Clinical Outcome VII trial is a prospective multicenter randomized clinical trial comparing sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent in all-comers patients. The endpoint target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion) and target lesion revascularization.. A total of 1261 patients were randomized to treatment with sirolimus-eluting Orsiro stent and 1264 patients to biolimus-eluting Nobori stent and followed for 3 years. At 3-year the target lesion failure was comparable for sirolimus-eluting Orsiro stent (9.0%) and the biolimus-eluting Nobori stent (9.1%), (rate ratio, 0.99; 95% confidence interval, 0.77-1.29). Cardiac death (sirolimus-eluting Orsiro stent 3.0% vs. biolimus-eluting Nobori stent 2.6% [rate ratio, 1.16; 95% confidence interval, 0.73-1.86]), target lesion revascularization (sirolimus-eluting Orsiro stent 5.2% vs. biolimus-eluting Nobori stent 5.9% [rate ratio, 0.90; 95% confidence interval, 0.64-1.25]), myocardial infarction (sirolimus-eluting Orsiro stent 4.7% vs. biolimus-eluting Nobori stent 4.5% [rate ratio, 1.04; 95% confidence interval, 0.72-1.50]), and definite stent thrombosis (sirolimus-eluting Orsiro stent 1.0% vs. biolimus-eluting Nobori stent 1.7% [rate ratio, 0.59; 95% confidence interval, 0.30-1.18]) did not differ significantly between the two groups.. At 3-year follow-up, target lesion failure did not differ among ultrathin-strut sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent with biodegradable polymers.

Topics: Absorbable Implants; Aged; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Revascularization; Polymers; Prospective Studies; Prosthesis Design; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Treatment of bifurcation lesions is technically challenging and has been associated with an increased risk of adverse events. We sought to evaluate the clinical and angiographic outcomes of patients who underwent bifurcation lesion provisional treatment in the BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis trial. A prospective, multicenter, 1:1 randomized trial was conducted to evaluate the safety and efficacy of ridaforolimus-eluting stents (RES) versus zotarolimus-eluting stents (ZES). Enrollment of bifurcation lesions treated with a provisional 1-stent technique was allowed. Bifurcation lesions were analyzed by an angiographic core laboratory. Outcomes were analyzed according to the presence of a bifurcation lesion treatment. Study population included 686 (35.8%) patients with and 1,228 (64.2%) patients without bifurcation lesion treatment. Procedural success was high and similar between groups. In 2 years, there was no difference in the rate of target lesion failure between the bifurcation and nonbifurcation groups (7.6% vs 7.3%, respectively, p = 0.81) regardless of the presence of side branch stenosis ≥50%. In 159 patients with angiographic follow-up, there was no difference in the rate of binary restenosis between groups (9.0% vs 9.2%, p = 0.96). Rates of target lesion failure at 1-year were similar with ZES and RES, and consistent in patients with and without bifurcation lesions (p

Topics: Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus

The aim of this study was to assess 2-year safety and efficacy of the current-generation thin composite-wire-strut durable-polymer Resolute Onyx zotarolimus-eluting stent (ZES), compared with the ultrathin-strut biodegradable-polymer Orsiro sirolimus-eluting stent (SES) in all-comers and a pre-specified small-vessel subgroup analysis.. The Resolute Onyx ZES is widely used in clinical practice, but no follow-up data beyond 1 year have been published. The randomized BIONYX (Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents) trial (NCT02508714) established the noninferiority of ZES versus SES regarding target vessel failure (TVF) rates.. A total of 2,488 all-comer patients were treated at 7 coronary intervention centers in Belgium, Israel, and the Netherlands. The main endpoint, TVF, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (clinically indicated target vessel revascularization). Two-year follow-up data were analyzed using Kaplan-Meier methods.. Two-year follow-up data were available for 2,460 of 2,488 patients (98.9%). TVF occurred in 93 of 1,243 patients (7.6%) assigned to ZES versus 87 of 1,245 patients (7.1%) assigned to SES (log-rank p = 0.66). There was no significant between-stent difference in individual components of this endpoint. The incidence of definite-or-probable stent thrombosis was low for both treatment arms (0.4% vs. 1.1%; log-rank p = 0.057). In patients stented in small vessels, there was no between-stent difference (TVF 8.2% vs. 8.7% [log-rank p = 0.75], target lesion revascularization 4.0% vs. 4.4% [log-rank p = 0.77]).. At 2-year follow-up, the novel thin composite-wire-strut durable-polymer Resolute Onyx ZES showed in all-comers similar safety and efficacy compared with the ultrathin cobalt-chromium-strut biodegradable-polymer Orsiro SES. The analysis of patients who were treated in small vessels also suggested no advantage for either stent.

Topics: Aged; Belgium; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Israel; Male; Middle Aged; Netherlands; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

In patients with increased bleeding risk, the biolimus A9-coated BioFreedom stent, a stainless steel drug-coated stent free from polymer, has shown superiority compared with a bare-metal stent. The aim of this study was to investigate whether the BioFreedom stent is noninferior to a modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention.. The SORT OUT IX trial (Scandinavian Organization for Randomized Trials With Clinical Outcome IX), was a large-scale, registry-based, randomized, multicenter, single-blind, 2-arm, noninferiority trial. The primary end point, major adverse cardiovascular events, was defined as the composite of cardiac death, myocardial infarction not related to any segment other than the target lesion, or target lesion revascularization within 1 year, analyzed by intention-to-treat. The trial was powered to assess noninferiority for major adverse cardiovascular events of the BioFreedom stent compared with the Orsiro stent with a predetermined noninferiority margin of 0.021.. Between December 14, 2015 and April 21, 2017, 3151 patients were assigned to treatment with the BioFreedom stent (1572 patients, 1966 lesions) or to the Orsiro stent (1579 patients, 1985 lesions). Five patients were lost to follow-up because of emigration (99.9% follow-up rate). Mean age was 66.3±10.9, diabetes mellitus was seen in 19.3% of patients, and 53% of the patients had acute coronary syndromes. At 1 year, intention-to-treat analysis showed that 79 (5.0%) patients, who were assigned the BioFreedom stent, and 59 (3.7%), who were assigned the Orsiro stent, met the primary end point (absolute risk difference 1.29% [upper limit of one-sided 95% CI 2.50%];. The biolimus A9-coated BioFreedom polymer-free stent did not meet criteria for noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02623140.

Topics: Absorbable Implants; Aged; Anti-Inflammatory Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Incidence; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Sirolimus; Treatment Outcome

The aim of this study was to compare late-term clinical outcomes among patients treated with ultrathin-strut (60-μm) bioresorbable-polymer sirolimus-eluting stents (BP SES) and thin-strut (81μm) durable-polymer everolimus-eluting stents (DP EES).. Emerging evidence from comparative studies of drug-eluting stents demonstrates improved safety and efficacy with ultrathin-strut drug-eluting stents, but limited insight exists regarding late-term outcomes.. BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With Up to Three De Novo or Restenotic Coronary Artery Lesions V) is an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure. Analysis of pre-specified 3-year clinical outcomes was performed.. Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 3-year rate of target lesion failure was 8.2% for BP SES and 13.6% for DP EES (p = 0.002), driven by differences in both target vessel myocardial infarction (MI) (5.0% vs. 9.2%; p = 0.003) and clinically driven target lesion revascularization (3.2% vs. 6.7%; p = 0.006). In landmark analysis, significant differences in target vessel MI and target lesion revascularization were observed favoring treatment with BP SES. Definite or probable late or very late stent thrombosis was significantly lower with BP SES (0.1% vs. 1.2%; p = 0.018). Cardiac death or MI rates were 7.7% and 11.7% (p = 0.017) for BP SES and DP EES, respectively.. In a large randomized trial, both target lesion failure and the outcomes of target vessel MI, clinically driven target lesion revascularization, and late or very late stent thrombosis at 3 years were significantly lower among patients treated with BP SES versus DP EES. The results endorse the continued superiority of ultrathin-strut BP SES compared with DP EES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946).

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Outcome data after extended long-term follow-up of patients with coronary artery disease treated with drug-eluting stents (DES) in randomized clinical trials are scant.. Performance differences among devices may be expected to emerge over time depending on whether stenting is done with polymer-free or durable polymer DES. This study assessed the 10-year outcomes of patients enrolled in the ISAR-TEST-5 (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents) trial.. A total of 3,002 patients were randomized to treatment with either polymer-free sirolimus- and probucol-eluting stents (n = 2,002) or durable polymer zotarolimus-eluting stents (n = 1,000). The primary endpoint was the composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization (a device-oriented composite endpoint [DOCE]). Additional endpoints of interest were the patient-oriented composite endpoint (POCE), including all-cause death, any myocardial infarction, or any revascularization; individual components of the composite endpoints; and definite or probable stent thrombosis.. The median age of the patients at randomization was 67.8 years. At 10 years, 63.9% of patients were alive. The rates of DOCE and POCE were high in both groups with no difference in the incidence between polymer-free sirolimus- and probucol-eluting stents and durable polymer zotarolimus-eluting stents (DOCE: 43.8% vs. 43.0%, respectively; hazard ratio: 1.01; 95% confidence interval [CI]: 0.89 to 1.14; p = 0.90; POCE: 66.2% vs. 67.7%, respectively; hazard ratio: 0.94; 95% CI: 0.86 to 1.04; p = 0.22). The rates of the individual components of the composite endpoints were comparable in both groups. The incidence of definite/probable stent thrombosis over 10 years was low and comparable in both groups (1.6% vs. 1.9%; hazard ratio: 0.85; 95% CI: 0.46 to 1.54; p = 0.58).. At 10 years, there were no measurable differences in outcomes between patients treated with polymer-free versus durable polymer DES. The incidence of stent thrombosis was low and comparable in both groups. High overall adverse clinical event rates were observed during extended follow-up. (Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus-Eluting Stents [ISAR-TEST-5]; NCT00598533).

Topics: Absorbable Implants; Aged; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Forecasting; Humans; Male; Polymers; Prosthesis Design; Retrospective Studies; Sirolimus; Treatment Outcome

Patients aged ≥80 years are often treated with new-generation drug-eluting stents (DES), but data from randomized studies are scarce owing to underrepresentation in most trials. We assessed 1-year clinical outcome of octogenarians treated with new-generation DES versus younger patients.. We pooled patient-level data of 9,204 participants in the TWENTE, DUTCH PEERS, BIO-RESORT, and BIONYX (TWENTE I-IV) randomized trials. The main clinical end point was target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or clinically indicated target vessel revascularization.. The 671 octogenarian trial participants had significantly more comorbidities. TVF was higher in octogenarians than in 8,533 patients <80 years (7.3% vs 5.3%, hazard ratio [HR]: 1.36, 95% CI: 1.0-1.83, P = .04). The cardiac death rate was higher in octogenarians (3.9% vs 0.8%, P < .001). There was no significant between-group difference in target vessel MI (2.3% vs 2.3%, P = .88) and repeat target vessel revascularization (1.9% vs 2.8%, P = .16). In multivariate analyses, age ≥ 80 years showed no independent association with TVF (adjusted HR: 1.04, 95% CI: 0.76-1.42), whereas the risk of cardiac death remained higher in octogenarians (adjusted HR: 3.38, 95% CI: 2.07-5.52, P < .001). In 6,002 trial participants, in whom data on major bleeding were recorded, octogenarians (n = 459) showed a higher major bleeding risk (5.9% vs 1.9%; HR: 3.08, 95% CI: 2.01-4.74, P < .001).. Octogenarian participants in 4 large-scale randomized DES trials had more comorbidities and a higher incidence of the main end point TVF. Cardiac mortality was higher in octogenarians, whereas there was no increase in MI or target vessel revascularization rates. Treatment of octogenarian patients with new-generation DES appears to be safe and effective.

Topics: Aged, 80 and over; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Myocardial Infarction; Percutaneous Coronary Intervention; Postoperative Complications; Reoperation; Risk Adjustment; Risk Factors; Sirolimus; Treatment Outcome

To avoid long-term effects associated with permanent implants, bioresorbable vascular scaffolds were developed, as they provide transient vessel support and disappear thereafter. The aim of the BIOSOLVE-II and -III studies was to assess the safety and performance of a magnesium-based sirolimus-eluting scaffold; we report the clinical outcomes at 3 years, 2 years after scaffold resorption.. BIOSOLVE-II and BIOSOLVE-III are international, prospective multi-center studies, including 184 patients with 189 de novo lesions and stable or unstable angina, or documented silent ischemia. Acute myocardial infarction, 3-vessel coronary artery disease, and heavily calcified lesions were excluded. Antiplatelet therapy was recommended for 6 months.. Patients were 65.5 ± 10.8 years old, and lesions were 12.1 ± 4.5 mm long and located in vessels with a diameter of 2.7 ± 0.4 mm. More than half of the lesions (56.5%) were type B2/C lesions. At 2 years, 92.5% (160/173) of patients were symptom-free and 91.5% (151/165) at 3 years; all the other patients had stable angina. At 3 years, target lesion failure occurred in 11 patients (6.3%), consisting of 4 cardiac deaths (2.3%), one target-vessel myocardial infarction (0.6%), and 6 clinically driven target lesion revascularizations (3.4%). There was no definite or probable scaffold thrombosis.. In a low-risk patient population, treatment with a sirolimus-eluting magnesium bioresorbable scaffold can be considered safe, in particular with no definite or probable scaffold thrombosis.. BIOSOLVE-II and -III are prospective, international, multi-center studies including 184 patients with de novo lesions. At 3 years, target lesion failure was 6.3%, consisting of 4 cardiac deaths (2.3%), one target-vessel myocardial infarction (0.6%), and 6 clinically driven target lesion revascularizations (3.4%). There was no definite or probable scaffold thrombosis.

Topics: Absorbable Implants; Aged; Coronary Artery Disease; Drug-Eluting Stents; Humans; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Treatment Outcome

The purpose of the Multivessel TALENT trial is to compare clinical outcomes of the novel Supraflex Cruz stent with those of the SYNERGY stent in patients with three-vessel disease (3VD) undergoing state-of-the-art percutaneous coronary intervention (PCI).. In this prospective, randomised, 1:1 balanced, multicentre, open-label trial, 1,550 patients with de novo 3VD without left main disease will be assigned to the Supraflex Cruz or SYNERGY arm. The following treatment principles of "best practice" PCI will be applied: Heart Team consensus based on SYNTAX score II treatment recommendation, functional lesion evaluation by quantitative flow ratio (QFR), stent optimisation by intravascular imaging, optimal pharmacological treatment and prasugrel monotherapy. The primary endpoint is a non-inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any revascularisation, at 12 months post procedure. The powered secondary endpoint is a superiority comparison of the vessel-oriented composite endpoint (VOCE), defined as vessel-related cardiovascular death, vessel-related myocardial infarction, or clinically and physiologically indicated target vessel revascularisation, at 24 months.. The Multivessel TALENT trial will be evaluating a novel treatment strategy for complex coronary artery disease with state-of-the-art PCI based on angiography-derived QFR with novel ultra-thin Supraflex Cruz stents, compared with SYNERGY stents. Clinical Trial Registration URL: https://www.clinicaltrials.gov/ct2/show/NCT04390672. Unique Identifier: NCT04390672

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Sirolimus; Stents; Treatment Outcome

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Treatment Outcome

Given the characteristic differences between intravascular ultrasound (IVUS) and optical frequency domain imaging (OFDI), their approach to therapeutic guidance during percutaneous coronary interventions (PCIs) and arterial healing response after stenting may also vary.. MISTIC-1 (The Multimodality Imaging Study in Cardiology cohort 1) is a multicenter, randomized-controlled, noninferiority trial that compared imaging end points between OFDI- and IVUS-guided PCI. Patients with stable coronary artery disease were randomly assigned to either OFDI- or IVUS-guided PCI using a Biolimus A9-eluting stent according to a prespecified protocol for imaging guidance. Stent sizing was based on external elastic lamina in IVUS-guided PCI while lumen up-size in OFDI-guided PCI. Postprocedural OFDI was investigated regardless of randomization, while operators in IVUS-guided PCI arm were blinded to the images. The primary end point was in-segment minimum lumen area assessed using OFDI at 8 months, while the secondary end point was a composite of cardiovascular mortality, target-vessel myocardial infarction, or target-lesion revascularization (device-oriented composite end point). Patients were followed up to 3 years after the index procedure.. OFDI-guided PCI was not inferior to IVUS-guided PCI in terms of in-segment minimum lumen area at 8 months. Although a small sample size was acknowledged, OFDI could be an alternative to IVUS when considering intracoronary imaging-guided PCI in selected populations with coronary artery diseases. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03292081.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Japan; Male; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

We aimed to evaluate the safety and performance of a magnesium-based sirolimus-eluting metal scaffold at three-year follow-up to assess vessel response two years beyond scaffold resorption.. BIOSOLVE-II is an international, multicentre first-in-man study, including 123 patients with de novo lesions. Predilatation was mandatory and post-dilatation was left to the discretion of the investigators. Dual antiplatelet therapy was recommended for six months. At three years, 91.1% of patients were angina-free and 8.0% were on dual antiplatelet therapy. The target lesion failure rate was 6.8% (n=8: two cardiac deaths, one target vessel myocardial infarction and five target lesion revascularisations). No probable or definite scaffold thrombosis was observed. Imaging follow-up was voluntary and serial angiographic assessment at 6, 12, and 36 months was available in 25 patients. In these, a slight increase in in-segment and in-scaffold late lumen loss and diameter stenosis was observed between 12 and 36 months (by 0.11±0.28 mm and 0.13±0.30 mm for late lumen loss, and by 3.8±10.1% and 4.1±10.2% for diameter stenosis).. Two years beyond the resorption period of a sirolimus-eluting bioresorbable metal scaffold built from a proprietary magnesium alloy, complication rates remained low. In the patients with serial angiographic assessment, late lumen loss and diameter stenosis did not increase substantially beyond the resorption period.

Topics: Absorbable Implants; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

The aim of the present report was to compare 2-year safety outcomes of two biodegradable polymer (BP) sirolimus-eluting stents (SESs) with different drug eluting and polymer absorption kinetics in a subgroup of complex patients and lesions.. The previously published PANDA III study showed the BuMA BP SES, with faster drug elution and polymer absorption, was non-inferior to the Excel SES in target lesion failure (TLF).. In PANDA III trial, patients who fulfilled one or more of the following criteria were included: Small vessel disease (reference vessel diameter ≤ 2.5 mm); long lesion (lesion length ≥ 20 mm); chronic total occlusion lesion; and diabetic patients.. Among 2,348 patients randomly assigned to treatment with BuMA (n = 1,174) or Excel SES (n = 1,174) in the PANDA III study, 858 in the BuMA group and 855 in the Excel group satisfied the inclusion criteria. At 2-year follow-up, the incidence of definite/probable stent thrombosis (ST) was significantly lower with BuMA SES as compared with Excel SES (0.7% vs. 1.9%, p = 0.03). This difference was mainly caused by decreased subacute stent thrombosis rate (0% vs. 0.6%, p = 0.03). In patients who did not fulfill the complex patient and lesion criteria, there were no between-group difference in ST (0.7% vs. 0%, p = 0.50). Myocardial infarction and TLF rates were similar (5.7% vs. 6.0%, p = 0.79 and 8.8% vs. 7.5%, p = 0.34, respectively), whereas patient-oriented composite endpoint was higher with BuMA SES mainly due to high risk of revascularization (15.6% vs. 11.4%, p = 0.01; 8.4% vs. 4.6%, p < 0.01).. Two-year subgroup analysis of the all-comer PANDA III trial revealed the increased safety benefit of the BuMA SES is more prominently seen in complex patient and lesion population.. ClinicalTrial.gov, Identifier-NCT02017275.

Topics: Absorption, Physicochemical; Acute Coronary Syndrome; Cardiovascular Agents; China; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Humans; Kinetics; Percutaneous Coronary Intervention; Polyesters; Polylactic Acid-Polyglycolic Acid Copolymer; Prospective Studies; Prosthesis Design; Recurrence; Risk Factors; Sirolimus; Treatment Outcome

To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial.. The use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient.. Among 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n = 225) or PP-EES (n = 231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9 months.. In this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p = .29 and 10.2 vs. 13.4%; p = .29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p = .33 and 0.9 vs. 1.7%; p = .43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar.. These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

To evaluate the safety and efficacy outcomes after primary percutaneous coronary intervention (pPCI) with second-generation Resolute™ zotarolimus-eluting stent (R-ZES) in patients enrolled in the DAPT-STEMI Trial (NCT01459627).. R-ZES is one of the most used drug eluting stents worldwide. To date, the safety and efficacy data of this stent in setting of STEMI is limited.. The Resolute-STEMI is a prespecified prospective register that reports the safety and efficacy of R-ZES in setting of ST-Elevation Myocardial Infarction (STEMI) at 6 months for the following endpoints: a composite endpoint of all-cause mortality, any myocardial infarction (MI), any (unscheduled) revascularization, stroke and TIMI major bleeding, as well as target lesion failure and stent thrombosis (ST).. From a total of 1,100 STEMI patients enrolled in the trial, 998 received a R-ZES. At 6 months the PE occurred in 42 (4.2%) patients. All-cause death, MI, revascularization, stroke and TIMI major bleeding was respectively 8 (0.8%), 9 (0.8%), 34 (3.4%), 2 (0.2%), and 4 (0.4%). The rate of target lesion revascularizations involving the culprit lesion was 1.1%. Target lesion failure was 1.5%. The rate of definite ST was 0.5%. The rate of both definite or probable ST was 0.7%.. The present analysis is the largest to date reporting short-term and mid-term clinical outcomes with the R-ZES stent in setting of STEMI. At 30 days and 6-months R-ZES has an outstanding safety and efficacy even in this high-risk category of patients.

Topics: Aged; Cardiovascular Agents; Cause of Death; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Recurrence; Registries; Risk Assessment; Risk Factors; Sirolimus; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome

Coronary stenting without angioplasty pretreatment (direct stenting) may simplify procedures in appropriate lesions. Direct stenting is facilitated by smaller profile coronary stent platforms. The present study was designed for regulatory approval of a novel drug-eluting coronary stent and incorporates both randomized comparison for non-inferiority to an approved predicate device as well as a nested evaluation of subjects eligible for direct stenting. STUDY DESIGN AND OBJECTIVES: Prospective, single-blind, randomized, active-control, multi-center study designed to assess the safety and efficacy of the novel Svelte sirolimus-eluting stent (SES) systems. A total of 1630 subjects with up to 3 target lesions will be randomized 1:1 to the Svelte SES versus either the Xience or Promus everolimus-eluting stents (control). Randomization will be stratified by whether or not a direct stenting strategy is planned by the investigator. The primary endpoint is target lesion failure (TLF) at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a non-inferiority test with a non-inferiority margin of 3.58%. Secondary clinical endpoints include individual components of TLF, stent thrombosis and measures of procedural resource utilization including contrast administration, fluoroscopy exposure and procedural resource utilization as well as costs. CONCLUSION: The OPTMIZE Trial will evaluate the safety, efficacy and clinical value of the novel Svelte SES in subjects with up to 3 lesions, and will provide a comparison of direct stenting between randomized devices.

Topics: Coronary Artery Disease; Dilatation; Drug-Eluting Stents; Equivalence Trials as Topic; Everolimus; Humans; Immunosuppressive Agents; Multicenter Studies as Topic; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Randomized Controlled Trials as Topic; Single-Blind Method; Sirolimus; Treatment Outcome

The aim of this study was to assess the 3-year safety and efficacy of treating all-comer patients with 3 contemporary drug-eluting stents (DES).. The BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) (TWENTE III) randomized trial (NCT01674803) found similar 1-year safety and efficacy for the 2 biodegradable-polymer DES (i.e., ultrathin-strut cobalt-chromium Orsiro sirolimus-eluting stent [SES] and very-thin-strut platinum-chromium Synergy everolimus-eluting stent) compared with the durable-polymer thin-strut cobalt-chromium Resolute Integrity zotarolimus-eluting stent (ZES). Two-year follow-up suggested that the SES might reduce repeat revascularizations beyond 1 year compared with the ZES.. A total of 3,514 all-comer patients were treated at 4 centers for coronary intervention. The main clinical endpoint, target vessel failure, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularization). Secondary endpoints included the individual components of target vessel failure and stent thrombosis.. Three-year follow-up data were available for 3,393 of 3,514 patients (96.6%). Target vessel failure occurred in 8.5% with SES and 10.0% with ZES (p. Despite substantial differences in stent backbone and polymer coating, all 3 DES showed favorable 3-year safety and efficacy in all comers, without significant between-stent differences. Further follow-up is required to definitely answer the question of whether one stent might improve clinical outcomes at a later stage.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Netherlands; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Randomized trials evaluating the Orsiro biodegradable polymer sirolimus-eluting stent (BP-SES; 60 and 80 μm strut thickness for stent diameters ≤3 and >3 mm, respectively) did not stratify according to vessel size and failed to specify the impact of ultrathin-strut thickness on long-term clinical outcomes compared with durable polymer everolimus-eluting stents (DP-EES). We sought to assess the long-term effect of ultrathin-strut (60 μm) BP-SES versus thin-strut (81 μm) DP-EES on long-term outcomes in patients undergoing percutaneous coronary revascularization for small vessel disease.. In a subgroup analysis of the randomized, multicenter, noninferiority BIOSCIENCE trial, patients with stable coronary artery disease or acute coronary syndrome randomly assigned to treatment with BP-SES or DP-EES were stratified according to vessel size (≤3 mm versus >3 mm) as a surrogate to compare patients treated with ultrathin-strut versus thin-strut drug-eluting stent. The primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization, within 5 years.. Among 2109 patients, 1234 (59%) were treated for small vessel disease. At 5 years, target lesion failure occurred in 124 patients (cumulative incidence, 22.3%) treated with ultrathin-strut BP-SES and 109 patients (18.3%) treated with thin-strut DP-EES (rate ratio, 1.22; 95% CI, 0.94-1.58;. We found no significant difference in clinical outcomes throughout 5 years between patients with small vessel disease treated with ultrathin-strut BP-SES versus thin-strut DP-EES.. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104.

Topics: Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Single-Blind Method; Sirolimus; Switzerland; Time Factors; Treatment Outcome

The aim of this study is to compare the SUPRAFLEX sirolimus-eluting stent (SES) with the XIENCE everolimus-eluting stent (EES) with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real-world" patient population.. This is a prospective, randomised, 1:1 balanced, controlled, single-blind, multicentre study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in an "all-comers" patient population, comprising a total of 1,430 enrolled subjects with symptomatic coronary artery disease who qualify for percutaneous coronary interventions at 23 centres in Europe. The primary endpoint is a non-inferiority comparison of the device-oriented composite endpoint target lesion failure (cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation) of the SUPRAFLEX group to the XIENCE group at 12 months post procedure. Secondary endpoints include the patient-oriented composite endpoint, target vessel failure, mortality, myocardial infarction, revascularisation and stent thrombosis rates (ARC classification).. The TALENT trial aims to assess the safety and effectiveness of the thin-strut SUPRAFLEX compared to the current standard of care (XIENCE EES) in patients with atherosclerotic lesions. This will provide valuable information on the impact of this thin-strut device in an all-comers population.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Europe; Everolimus; Humans; Percutaneous Coronary Intervention; Prospective Studies; Single-Blind Method; Sirolimus; Stents; Treatment Outcome

In this substudy of the SORT OUT VII trial, the clinical outcomes among patient with diabetes mellitus treated with Orsiro sirolimus-eluting stent (O-SES; Biotronik, Bülach, Switzerland) or Nobori biolimus-eluting stent (N-BES; Terumo, Tokyo, Japan) were compared.. Diabetes is associated with increased risk of target lesion failure (TLF) after percutaneous coronary intervention.. In total, 2525 patients were randomized to stent implantation with O-SES (n = 1261, diabetes: n = 236) or N-BES (n = 1264, diabetes: n = 235). The primary endpoint, TLF, was a composite of cardiac death, target-lesion myocardial infarction (MI), or target lesion revascularization (TLR) within 2 years.. At 2 year, TLF did not differ between O-SES vs N-BES in diabetic (9.3% vs 9.4%; RR 0.98, 95% CI 0.54-1.78) patients. The individual components of the primary endpoint did not differ among stent type. In diabetics, cardiac death occurred in 3% of O-SES-treated and in 3.8% of N-BES-treated patients (RR 0.77, 95% CI 0.29-2.08), MI occurred in 3.0% of O-SES-treated and in 3.8% of N-BES-treated patients (RR 0.76, 95% CI 0.28-2.06) and TLR occurred in 5,5% of O-SES-treated and in 6.0% of N-BES-treated patients (RR 0.91, 95% CI 0.43-1.95).. TLF did not differ between O-SES- and N-BES-treated diabetic patients.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The impact of coronary artery disease (CAD) extension/complexity on outcomes and on the comparative benefits/risks of zotarolimus-eluting stent (ZES) versus bare-metal stents (BMS) remains unclear in patients at high risk of bleeding or thrombosis or at low restenosis risk.. We performed a post-hoc analysis of the ZEUS trial. The impact of coronary anatomic complexity measured by the SYNTAX score on the differences in outcomes following ZES and BMS was assessed at 1 year.. The mean SYNTAX score was 16.3 ± 13.1 with a median of 12 (IQR: 7 to 22). We stratified patients according to SYNTAX tertiles (0-8: n = 563; >8-19 n = 532; >19: n = 511), and observed that the higher the score, the correspondingly higher was the rate of the primary endpoint of major adverse cardiovascular events (MACE) and other ischemic events, but not bleeding after adjustment. The superior efficacy of ZES versus BMS for MACE was consistent across SYNTAX tertiles (tertile 1: HR 0.71, 95% CI 0.44-1.13; tertile 2: HR 0.71, 95% CI 0.46-1.09; tertile 3: HR 0.83, 95% CI 0.61-1.10) without significant heterogeneity (p for trend = 0.55). This between-groups difference mainly reflected a reduction in MI and TVR without effect on mortality. There was no significant interaction between the SYNTAX score and allocated stent type with respect to ischemic and bleeding endpoints.. The SYNTAX score was predictor of major adverse cardiovascular events but not bleeding and ZES provided superior efficacy and safety than BMS across the whole spectrum of CAD complexity. SYNTAX score may be routinely used for the assessment of the ischemic risk (but not bleeding) after PCI and should not guide the decision-making for DES versus BMS in patients undergoing PCI.

Topics: Aged; Aged, 80 and over; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Hemorrhage; Humans; Internationality; Male; Myocardial Ischemia; Percutaneous Coronary Intervention; Risk Factors; Single-Blind Method; Sirolimus; Stents; Treatment Outcome

Incomplete re-endothelialization of drug eluting stent (DES) segments has been associated with the occurrence of major adverse cardiac events after DES implantation. It is unknown whether on-clopidogrel platelet reactivity (OPR) and/or circulating endothelial progenitor cells (EPC) levels may predict uncovered strut rate in diabetic patients treated by DES implantation.. One-hundred and five diabetic patients undergoing elective DES implantation were included into the study. EPC levels and OPR were assessed at 24 h (baseline) and 3 months. EPC were evaluated by flow cytometric analysis and defined by the co-expression of the markers CD34 and KDR. OPR was assessed using the impedance aggregometer. The degree of DES re-endothelialization was assessed at 3 months by optical coherence tomography.. A direct correlation was observed between the uncovered strut rate and OPR both at baseline (r = 0.47: p < 0.001) and at the 3 months (r = 0.25: p = 0.015). On the contrary, we found no significant correlation between EPC level and uncovered strut rate either at baseline (r = -0.02; p = 0.85) or at 3 months (r = -0.06; p = 0.13). By multivariable regression analysis, independent predictors of uncovered strut rate > 5% were complex lesions (OR = 5.35; 95% confidence interval 1.32-17.57; p = 0.027) and OPR at baseline (OR = 4.73; 95% confidence interval 1.04-8.14; p = 0.039).. In diabetic patients treated with DES implantation OPR at baseline and complex lesions are independent predictors of uncovered strut rate at 3 months.

Topics: Aged; Clopidogrel; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prosthesis Design; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Outcomes for stent-based coronary intervention of lesions with long diseased segments remain relatively unfavorable. This study sought to compare the efficacy of Resolute zotarolimus-eluting stents (R-ZES) and Xience everolimus-eluting stents (EES) for very long coronary lesions.. This randomized, multicenter, prospective trial compared the use of R-ZES with EES for very long (≥50 mm) native coronary lesions. The primary end point was in-segment late luminal loss at 12-month angiographic follow-up. A total of 400 patients were needed to assess the primary end point. However, owing to very slow enrollment of patients, this trial was early terminated (302 patients were enrolled), and thus, this report provides descriptive information on primary and secondary end points. The R-ZES and EES groups had similar baseline characteristics. Lesion length was 49.6±10.2 and 50.6±13.3 mm in the R-ZES and EES groups, respectively (P=0.47). The number of stents used at the target lesion was 2.1±0.3 and 2.2±0.5, respectively. Twelve-month angiographic follow-up was performed in 50% of eligible patients. In-segment late luminal loss did not significantly differ between the R-ZES and EES groups (0.17±0.57 vs. 0.09±0.43 mm, P=0.32). In-segment binary restenosis rates were 8.1 and 5.3% in the R-ZES and EES groups, respectively (P=0.49). There were no significant between-group differences in the rate of adverse events (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes).. For patients with very long native coronary artery disease, R-ZES and EES implantation showed comparable angiographic and clinical outcomes through 1 year of follow-up.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Treatment Outcome

Polymer-free amphilimus-eluting stents (PF-AES) represent a novel elution technology in the current era of drug-eluting stents. The clinical safety and efficacy of PF-AES as compared with latest-generation permanent-polymer zotarolimus-eluting stents (PP-ZES) have not yet been investigated in a large randomized trial.. In this physician-initiated, prospective, multicenter, randomized, noninferiority trial, an all-comers population requiring percutaneous coronary intervention was enrolled across 3 European sites. Randomization (1:1 ratio) to PP-ZES or PF-AES was performed after stratification for troponin status and diabetes mellitus. In both treatment arms, troponin-positive patients were planned for 12-month dual antiplatelet therapy, whereas troponin-negative patients were planned for 1-month dual antiplatelet therapy. Outcome assessors were blinded to the allocated treatment. The device-oriented primary end point of target-lesion failure was defined as cardiac death, target-vessel myocardial infarction, or target-lesion revascularization at 12-months as analyzed by modified intention-to-treat (80% power, and a 3.5% noninferiority margin).. In total, 1502 patients were randomized and 1491 treated with the assigned stent and available for follow-up. The primary end point occurred in 42 (5.6%) of the 744 patients receiving PP-ZES versus 46 (6.2%) of the 747 patients receiving PF-AES. PF-AES were clinically noninferior to PP-ZES (risk difference, 0.5%; upper limit 1-sided 95% confidence interval, 2.6%; P. PF-AES were noninferior to PP-ZES regarding target-lesion failure at 12 months. Findings regarding the secondary end point and prespecified subgroups were generally consistent with that of the primary end point.. URL: https://www.clinicaltrials.gov . Unique identifier: NCT02328898.

Topics: Acute Coronary Syndrome; Aged; Angina, Stable; Angina, Unstable; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

New-generation drug-eluting stents offer the potential for enhanced late outcomes in comparison with early generation drug-eluting stents. However, assessment of extended long-term outcomes for these devices is lacking, especially regarding the comparison between new-generation drug-eluting stents with biodegradable or permanent polymers. The aim of this study is to compare the efficacy and safety of biodegradable polymer-based sirolimus-eluting stents (BP-SES; Yukon Choice PC) versus permanent polymer-based everolimus-eluting stents (PP-EES; Xience) versus early generation permanent polymer-based sirolimus-eluting stents (PP-SES; Cypher) at 10-year follow-up.. Overall, 2603 patients were randomized to treatment with BP-SES (n=1299), PP-EES (n=652), or PP-SES (n=652). The primary end point of this analysis was major adverse cardiac event, the composite of death, myocardial infarction, or target lesion revascularization. The main secondary end point of interest was definite/probable stent thrombosis. Follow-up at 10 years was available in 83% of the study patients.. The 10-year incidence of major adverse cardiac event (BP-SES 47.7% versus PP-EES 46.0% versus PP-SES 54.9%, P=0.003) and mortality (BP-SES 31.8% versus PP-EES 30.3% versus PP-SES 37.2%, P=0.02) was different among the groups. Definite/probable stent thrombosis was not significantly different among the groups (BP-SES 1.8% versus PP-EES 2.5% versus PP-SES 3.7%, P=0.09). Definite stent thrombosis was significantly different among the groups (BP-SES 1.1% versus PP-EES 0.8% versus PP-SES 2.4%, P=0.03). There were no significant differences between BP-SES and PP-EES.. In this unique long-term outcome analysis, BP-SES and PP-EES showed comparable clinical outcomes out to 10 years. PP-SES had higher rates of major adverse cardiac events and definite stent thrombosis.. URL: https://www.clinicaltrials.gov . Unique identifier: NCT00598676.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The optimal duration of antiplatelet therapy in high-bleeding risk (HBR) patients with coronary artery disease treated with newer-generation drug-eluting bioresorbable polymer-coated stents remains unclear.. MASTER DAPT (clinicaltrial.govNCT03023020) is an investigator-initiated, open-label, multicenter, randomized controlled trial comparing an abbreviated versus a standard duration of antiplatelet therapy after bioresorbable polymer-coated Ultimaster (TANSEI) sirolimus-eluting stent implantation in approximately 4,300 HBR patients recruited from ≥100 interventional cardiology centers globally. After a mandatory 30-day dual-antiplatelet therapy (DAPT) run-in phase, patients are randomized to (a) a single antiplatelet regimen until study completion or up to 5 months in patients with clinically indicated oral anticoagulation (experimental 1-month DAPT group) or (b) continue DAPT for at least 5 months in patients without or 2 in patients with concomitant indication to oral anticoagulation, followed by a single antiplatelet regimen (standard antiplatelet regimen). With a final sample size of 4,300 patients, this study is powered to assess the noninferiority of the abbreviated antiplatelet regimen with respect to the net adverse clinical and major adverse cardiac and cerebral events composite end points and if satisfied for the superiority of abbreviated as compared to standard antiplatelet therapy duration in terms of major or clinically relevant nonmajor bleeding. Study end points will be adjudicated by a blinded Clinical Events Committee.. The MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with sirolimus-eluting bioresorbable polymer-coated stent implantation.

Topics: Absorbable Implants; Aged, 80 and over; Coronary Artery Disease; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Female; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Polymers; Postoperative Hemorrhage; Sirolimus

The appropriate stent platform for treating coronary bifurcation lesions (CBLs) remains controversial. Previous bench tests have demonstrated the superiority of a 2-link cell design to 3-link cell design for creating inter-strut dilation at the side branch ostium. This randomized multicenter prospective BEGIN trial compared the biodegradable polymer-based biolimus A9-eluting stent (2-link BES) with the durable polymer-based cobalt chromium everolimus-eluting stent (3-link EES) in 226 patients with de novo CBLs. Patients with true bifurcations, defined as > 50% stenosis in the main vessel and side branch (SB) and an SB diameter > 2.25 mm, were enrolled. Guide wire re-crossing to the distal cell (near the carina) in the jailed SB and final kissing inflation were recommended. The SB angiographic endpoint was < 50% stenosis diameter. Left-main CBLs (13.5% vs. 13.0%) and 2-stent technique (30.6% vs. 22.6%) rates were similar. The primary endpoints (minimum lumen diameter at the SB ostium measured at an independent core laboratory at the 8-month follow-up) were comparable (1.64 ± 0.50 mm vs. 1.63 ± 0.51 mm, p = 0.976). There was no significant difference in composite outcomes of cardiac death, myocardial infarction, or target vascular revascularization at 12 months (7.4% vs. 8.0%, p = 0.894). Two-link BES and 3-link EES showed similar 8-month angiographic and 1-year clinical outcomes for true CBLs.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to compare the thin-strut biodegradable-polymer everolimus-eluting platinum-chromium stent (EES) with the biodegradable-polymer biolimus-eluting stainless-steel stent (BES).. Currently available drug-eluting coronary stents have been refined to reduce the risk for coronary events following implantation.. This randomized, multicenter, all-comers, noninferiority trial was undertaken at 3 sites in western Denmark. Patients with clinical indications for percutaneous coronary intervention were eligible for inclusion. Patients were randomly assigned (1:1) to either EES or BES. The primary endpoint, target lesion failure, was a composite of safety (cardiac death and myocardial infarction not clearly attributable to a nontarget lesion) and efficacy (target lesion revascularization) at 12 months, analyzed using intention-to-treat principles. The trial was powered to assess target lesion failure noninferiority of the EES compared with the BES with a predetermined noninferiority margin of 3%.. A total of 1,385 patients were assigned to treatment with EES and 1,369 patients to treatment with BES. The analysis showed that 55 patients (4.0%) assigned to the EES and 60 (4.4%) assigned to the BES met the primary endpoint (absolute risk difference 0.4%; upper limit of 1-sided 95% confidence interval: 1.7%; p < 0.001).. At 1-year follow-up, the EES was found to be noninferior to the BES with respect to target lesion failure. (Everolimus-eluting SYNERGY Stent Versus Biolimus-Eluting Biomatrix NeoFlex Stent-SORT-OUT VIII; NCT02093845).

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Denmark; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to compare 7-year outcomes between the first-generation sirolimus-eluting stent (SES) and the new-generation everolimus-eluting stent (EES) in a randomized clinical trial.. There is a scarcity of very long-term (beyond 5 years) data from clinical trials investigating whether new-generation drug-eluting stents have clear clinical advantages over first-generation drug-eluting stents.. RESET (Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial) is the largest randomized trial comparing EES with SES (NCT01035450). Among a total of 3,197 patients in the original RESET population from 100 centers, the present extended 7-year follow-up study was conducted in 2,667 patients from 75 centers after excluding those patients enrolled from centers that denied participation. Complete 7-year follow-up was achieved in 91.5% of patients.. The cumulative 7-year incidence of the primary efficacy endpoint of target lesion revascularization was not significantly different between EES and SES (10.2% vs. 11.7%; hazard ratio: 0.87; 95% confidence interval: 0.68 to 1.10; p = 0.24). The risk for the primary safety endpoint of death or myocardial infarction trended lower with EES than with SES (20.6% vs. 23.6%; hazard ratio: 0.85; 95% confidence interval: 0.72 to 1.005; p = 0.06). The cumulative 7-year incidence of definite stent thrombosis was very low and similar between EES and SES (0.9% vs. 1.0%; p = 0.82). The lower risk of EES relative to SES was significant for the composite secondary endpoint of target lesion failure (13.3% vs. 18.1%; hazard ratio: 0.72; 95% confidence interval: 0.59 to 0.88; p = 0.001).. During 7 years of follow-up, the risk for target lesion revascularization was not significantly different between the new-generation EES and the first-generation SES.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove-filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent.. The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial.. The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization.. At 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34).. The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Europe; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The BIOFLOW-IV clinical trial was designed for regulatory submission in Japan. It assessed the safety and efficacy of a new third-generation sirolimus-eluting stent system with bioresorbable polymer (Orsiro, BP-SES) compared with an everolimus-eluting stent system with permanent polymer (XIENCE Prime/Xpedition, PP-EES).. This prospective, international, multicentre, 2:1 randomised, non-inferiority trial enrolled 575 patients (385 BP-SES and 190 PP-EES) with 659 stenotic de novo lesions. Of these, 137 patients (23.8%) were Japanese. Follow-up until five years is ongoing. We herein report outcomes at 12 months. Baseline parameters were well balanced. Device success was 98.9% for BP-SES versus 99.6% for PP-EES, p=0.670. Non-inferiority related to 12-month target vessel failure was met (pnon-inferiority <0.001). Further, there was no significant difference in clinical outcomes between the groups. The target vessel failure rate was 5.5% for BP-SES and 7.5% for PP-EES, the target lesion failure rate was 4.2% versus 5.4%, and the definite or probable stent thrombosis rate was 0.8% versus 0%.. The randomised BIOFLOW-IV trial provides further evidence on the safety and efficacy of the Orsiro BP-SES and its non-inferiority to the current benchmark, an everolimus-eluting permanent polymer stent. ClinicalTrials.gov: NCT01939249.

Topics: Absorbable Implants; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Humans; Japan; Percutaneous Coronary Intervention; Prospective Studies; Safety; Sirolimus; Treatment Outcome

Recent studies showed bioresorbable scaffold (BRS) increased risks of late target lesion failure (TLF) and thrombosis. XINSORB scaffold is a poly-L-lactic acid based BRS.. The study included randomization and registry parts. Eligible patients with one or two de novo lesions were randomly 1:1 assigned to XINSORB scaffold and sirolimus-eluting stent (SES) in randomization part. These patients were clinically and angiographically assessed. In registry part, patients were treated with XINSORB scaffold only and were clinically assessed. The primary endpoint was in-segment late luminal loss (LLL) at 12-month in randomization part. The secondary endpoint was 12-month TLF in all XINSORB-treated patients.. Total 395 and 798 patients were enrolled in randomization and registry part, respectively. Device success was 98.0% (1069/1091) in all XINSORB-treated and 100% (221/221) in SES-treated lesions. The primary endpoint of in-segment LLL at 12-month was 0.19 ± 0.32 mm in XINSORB and 0.31 ± 0.41 mm in SES (P = 0.003), which met the noninferior margin of 0.195 mm (95% CI: -0.20, -0.04, P ≪ 0.0001). No difference was found in TLF between two devices. In all XINSORB-treated patients, 12-month TLF was 0.8% (8/998), which also met the noninferior margin of 9.0% (95% CI: 0.3%, 1.4%, P ≪ 0.0001). Only one device thrombosis was recorded in all XINSORB-treated patients while none in SES.. In the multicenter clinical trial, XINSORB BRS was noninferior to sirolimus-eluting stent for the primary endpoint of in-segment LLL at 12-month in patients with simple and moderate complex de novo coronary lesions. TLF at 12-month was low and comparable.

Topics: Absorbable Implants; Adolescent; Adult; Aged; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Stents; Time Factors; Treatment Outcome; Young Adult

Diabetes mellitus is associated with a higher risk of target lesion revascularization after percutaneous coronary intervention. We compared clinical outcomes in patients with and without diabetes mellitus, treated with everolimus-eluting stents (EES; Synergy; Boston Scientific, Marlborough, Massachusetts) or biolimus-eluting stents (BES; BioMatrix NeoFlex; Biosensors Interventional Technologies Pte Ltd., Singapore). In total, 2,764 patients were randomized to stent implantation with EES (n = 1,385, diabetes: n = 250) or the BES (n = 1,379, diabetes: n = 262), stratified by gender and diabetes. The primary end point, target lesion failure (TLF), was a composite of cardiac death, target-lesion myocardial infarction, or target lesion revascularization at 12 months. Secondary end points included individual components of TLF, all-cause death, and stent thrombosis. TLF was 2.1% lower in the EES versus the BES groups in patients with diabetes (3.6% vs 5.7%; rate ratios 0.61, 95% confidence interval [CI] 0.27 to 1.41) and similar in patients without diabetes (4.1% vs 4.0%; rate ratios 0.99, 95% CI 0.66 to 1.51). In patients with diabetes, the point estimates of the individual components of TLF also favored the EES but CIs were wide. No interaction between stent type and presence of diabetes was found. The current subgroup analysis found that a thin-strut EES as compared with a thicker strut BES had a numerically lower TLF rate in patients with diabetes, but the subgroup analysis was underpowered for definite conclusions.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Confidence Intervals; Coronary Angiography; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Odds Ratio; Percutaneous Coronary Intervention; Reference Values; Risk Assessment; Severity of Illness Index; Sirolimus; Survival Rate; Treatment Outcome

The durable fluoroacrylate polymer-based sirolimus-eluting stent (Angiolite SES) has shown promising preclinical and clinical results regarding inflammatory vascular reaction and neointimal healing. We aimed to compare performance between the Angiolite SES and an everolimus-eluting stent (EES) in patients with coronary artery disease.. The ANGIOLITE trial, a prospective, randomised, multicentre trial, compared the restenosis parameters of both stents in de novo coronary lesions. The primary endpoint was late lumen loss at six-month angiographic follow-up. In-stent healing was assessed by optical coherence tomography (OCT). The main clinical endpoint was target lesion failure (TLF) evaluated up to 24 months. A total of 223 patients were randomised 1:1 to EES or SES. At six months, in-stent late lumen loss was 0.08 mm (±0.38) for EES vs 0.04 mm (±0.39) for SES (difference=-0.04 mm, 95% CI: -0.15, 0.07, p for non-inferiority=0.002). By OCT, the rate of uncovered to total number of struts score >30% was comparable between the groups whereas neointimal thickness was reduced in the SES arm (9.0% [7.6, 10.6] vs 9.9% [8.5, 11.3], p=0.41; and 86.4 [81.6, 91.2] µm vs 72.1 [68.2, 76.0] µm, p<0.01, respectively). At 24 months, TLF occurred in eight patients (7.6% [3.3, 14.5]) in the EES arm and in seven patients (7.1% [2.9, 14.0]) in the SES arm (p=0.88). The definite/probable stent thrombosis rate was comparable between the groups (1.9% [0.2, 6.7] vs 1.0% [0.0, 5.5] EES vs SES, respectively; p=0.59).. This trial demonstrates similar antirestenotic efficacy at midterm follow-up of the Angiolite SES vs an EES. Clinical endpoints were comparable between the groups at two-year follow-up. Visual summary. Main results of the ANGIOLITE trial.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Sirolimus; Treatment Outcome

Amphilimus sirolimus-eluting stents (A-SES) represent a novel elution technology in the current era of drug-eluting stents with promising results in patients with diabetes mellitus. At present no large trial has been designed to evaluate clinical outcomes of A-SES as compared to new-generation drug-eluting stents in unselected patients. Accordingly, we designed this trial to evaluate clinical noninferiority of A-SES as compared with zotarolimus-eluting stents (ZES) in a real-world, all-comers setting.. ReCre8 is a prospective multicenter randomized clinical trial evaluating the clinical outcomes of A-SES as compared with ZES in all-comers requiring percutaneous coronary intervention. Patients are randomized 1:1 to receive either A-SES or ZES. On-site block-randomization is stratified by diabetes mellitus, and troponin status to perform prespecified subanalyses. Patients receive 1-month of dual antiplatelet therapy (DAPT) when troponin-negative, or 12-months of DAPT when troponin-positive. The primary endpoint is target-lesion failure at 1-year follow-up. A total of 1,532 patients will be enrolled to demonstrate clinical noninferiority of A-SES with at least 80% power, a noninferiority margin of 3.5% and a type-I-error of 0.05.. ReCre8 (NCT02328898) is the first randomized multicenter trial with a head-to-head comparison of A-SES as compared with ZES to investigate the clinical safety and efficacy of these new-generation DES in a real-world, all-comers population.

Topics: Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Equivalence Trials as Topic; Humans; Multicenter Studies as Topic; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Absorbable Implants; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

A second iteration of a sirolimus-eluting stent (SES) that has a biodegradable PLGA polymer coating with an electrografting base layer on a thin-strut (80 µm) cobalt-chromium platform (BuMA Supreme; SINOMED, Tianjin, China) has been developed. This first-in-man trial aimed to assess the efficacy and safety of the novel device.. This randomised, multicentre, single-blinded, non-inferiority trial compared the BuMA Supreme SES versus a contemporary durable polymer zotarolimus-eluting stent (ZES) in terms of angiographic in-stent late lumen loss (LLL) at nine-month follow-up as the primary endpoint. A total of 170 patients were randomly allocated to treatment with either SES (n=83) or ZES (n=87). At nine-month angiographic follow-up, in-stent LLL was 0.29±0.33 mm in the SES group and 0.14±0.37 mm in the ZES group (pnon-inferiority=0.45). The in-stent percent diameter stenosis and the binary restenosis rate of the two treatment arms were similar (19.2±12.0% vs. 16.1±12.6%, p=0.09, and 3.3% vs. 4.4%, p=1.00, respectively). At 12-month clinical follow-up, there was no difference between treatment arms with regard to the device-oriented composite clinical endpoint (4.9% vs. 5.7%; p=0.72).. The PIONEER trial did not meet its primary endpoint in terms of in-stent LLL at nine-month follow-up. However, this result did not translate into any increase in restenosis rate or impairment in 12-month clinical outcomes.

Topics: Absorbable Implants; Aged; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Outcome Assessment, Health Care; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus

To assess the safety and efficacy of the novel Resolute (R-) Onyx drug-eluting stent (DES).. The R-Onyx DES consists of a composite wire with an outer shell of cobalt chromium alloy and a platinum-iridium inner core to enhance radiopacity, with thinner, swaged struts and modified stent geometry compared with the predicate Resolute DES, resulting in a slightly lower total drug load in most sizes.. This was a prospective, single-arm non-inferiority trial compared with a historical control. Patients with stable angina/ischemia and up to 2 de novo target lesions ≤35 mm long with reference vessel diameter (RVD) of 2.25-4.2 mm were enrolled. The primary endpoint was late lumen loss at 8-month follow-up. Propensity-score adjusted outcomes from the single-arm RESOLUTE-US trial served as the control.. Seventy-five patients (85 lesions) were enrolled. Mean patient age was 66 ± 9 years, 73% were male, and 32% had diabetes. Mean lesion length was 14.28 ± 6.68 mm, mean RVD was 2.57 ± 0.48 mm, and 86% of lesions were class B2/C. In-stent late lumen loss at 8 months was 0.24 ± 0.39 mm with R-Onyx DES compared with 0.36 ± 0.52 mm with Resolute DES (P < 0.001 for noninferiority, P = 0.029 for superiority). At 8 months, clinically driven target lesion revascularization occurred in 3 patients (4.0%) and target lesion failure occurred in 5 patients (6.7%).. In-stent late lumen loss is non-inferior, and appears to be superior, with the thin-strut novel composite wire R-Onyx DES compared with Resolute DES. Continued evolution of stent design can improve angiographic outcomes in complex lesions, even in the current era of next-generation DES.

Topics: Aged; Angina, Stable; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Iridium; Male; Middle Aged; Percutaneous Coronary Intervention; Platinum; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional; United States

The comparative efficacy of second-generation (G2) vs. first-generation (G1) drug-eluting stents (DES) for calcified coronary lesions is unknown.Methods and Results:We compared the 3-year clinical outcomes of patients with G1- or G2-DES according to the presence or absence of calcified coronary lesions as assessed in an angiographic core laboratory using data from 2 large-scale prospective multicenter randomized trials, RESET and NEXT. G1-DES and G2-DES were implanted in 299 and 1,033 patients, respectively, in the Calc stratum (≥1 lesion with moderate/severe calcification), and 1,208 and 3,550 patients, respectively, in the Non-calc stratum (no/mild calcification). The patients in the Calc stratum had a significantly higher adjusted risk for the primary outcome measure (any target-lesion revascularization (TLR)) than those in the Non-calc stratum (HR: 1.38, 95% CI: 1.11-1.71, P=0.004). The cumulative 3-year incidence of any TLR was not significantly different between the G1-DES and G2-DES groups in both the Calc and Non-calc strata (12.1% vs. 9.7%, P=0.22, and 6.8% vs. 6.1%, P=0.44, respectively). After adjusting for confounders, the effect of G2DES relative to G1-DES for any TLR remained insignificant in both the Calc and Non-calc strata (HR: 0.78, 95% CI: 0.48-1.25, P=0.3, and HR: 0.84, 95% CI: 0.61-1.17, P=0.31, respectively, P interaction=0.55).. The effect of G2-DES relative to G1-DES for TLR was not significantly different regardless of the presence or absence of lesion calcification.

Topics: Aged; Calcinosis; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Revascularization; Sirolimus; Treatment Outcome

There are few randomised studies concerning the optimal duration of dual antiplatelet therapy (DAPT) for patients who receive a second-generation drug-eluting stent (DES). This trial aimed to investigate the safety of six-month compared with 12-month DAPT maintenance after second-generation DES implantation.. A prospective, randomised, multicentre trial was performed at 10 medical centres. The 1,368 patients included in the study received a biolimus-eluting stent (BES) or a zotarolimus-eluting stent (ZES). The primary outcome measured was the composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), or ischaemia-driven target lesion revascularisation at the 12-month follow-up. The secondary outcome was the percentage of uncovered struts at six months in 60 patients (30 ZES, 30 BES) using optical coherence tomography (OCT) assessment. Each patient was randomly assigned to six-month (n=684) or 12-month DAPT (n=684). Major adverse cardiac events at 12 months occurred in eight patients (1.2%) in the six-month DAPT group and in four patients (0.6%) in the 12-month DAPT group (risk difference 0.6%; 95% confidence interval [CI]: -0.4-1.6%; p=0.24). The upper 95% CI limit was lower than the pre-specified limit of 4% non-inferiority (p for non-inferiority <0.05). The percentage of uncovered struts was 3.16±4.30% at six months in 60 stents of 60 patients.. After second-generation DES implantation, six-month DAPT was not inferior to 12-month DAPT in terms of MACE occurrence over the 12-month follow-up period. OCT examination revealed favourable stent strut coverage at six months after stent implantation.

Topics: Aged; Aspirin; Cardiovascular Agents; Clopidogrel; Coronary Angiography; Coronary Artery Disease; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Republic of Korea; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

MiStent is a drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall. It was developed to overcome the limitation of current durable polymer drug-eluting stents eluting amorphous sirolimus. The clinical effect of MiStent sirolimus-eluting stent compared with a durable polymer drug-eluting stents has not been investigated in a large randomised trial in an all-comer population.. We did a randomised, single-blind, multicentre, phase 3 study (DESSOLVE III) at 20 hospitals in Germany, France, Netherlands, and Poland. Eligible participants were any patients aged at least 18 years who underwent percutaneous coronary intervention in a lesion and had a reference vessel diameter of 2·50-3·75 mm. We randomly assigned patients (1:1) to implantation of either a sirolimus-eluting bioresorbable polymer stent (MiStent) or an everolimus-eluting durable polymer stent (Xience). Randomisation was done by local investigators via web-based software with random blocks according to centre. The primary endpoint was a non-inferiority comparison of a device-oriented composite endpoint (DOCE)-cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation-between the groups at 12 months after the procedure assessed by intention-to-treat. A margin of 4·0% was defined for non-inferiority of the MiStent group compared with the Xience group. All participants were included in the safety analyses. This trial is registered with ClinicalTrials.gov, number NCT02385279.. Between March 20, and Dec 3, 2015, we randomly assigned 1398 patients with 2030 lesions; 703 patients with 1037 lesions were assigned to MiStent, of whom 697 received the index procedure, and 695 patients with 993 lesions were asssigned to Xience, of whom 690 received the index procedure. At 12 months, the primary endpoint had occurred in 40 patients (5·8%) in the sirolimus-eluting stent group and in 45 patients (6·5%) in the everolimus-eluting stent group (absolute difference -0·8% [95% CI -3·3 to 1·8], p. The sirolimus-eluting bioabsorbable polymer stent was non-inferior to the everolimus-eluting durable polymer stent for a device-oriented composite clinical endpoint at 12 months in an all-comer population. MiStent seems a reasonable alternative to other stents in clinical practice.. The European Cardiovascular Research Institute, Micell Technologies (Durham, NC, USA), and Stentys (Paris, France).

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Single-Blind Method; Sirolimus; Treatment Outcome

To evaluate long-term clinical outcomes after treatment of complex bifurcation lesions with the AXXESS dedicated self-expanding biolimus A9-eluting bifurcation stent.. Between 2004 and 2013, 123 patients with complex bifurcation lesions were treated in a single-center with the AXXESS stent in the proximal main vessel (MV) and additional drug-eluting stents in branches when required. Median follow-up was 5 years. Primary endpoint was the rate of major adverse cardiac events (MACE). Secondary endpoints included MACE components (cardiac death, non-periprocedural clinical myocardial infarction [MI], target lesion revascularization [TLR] and definite/probable stent thrombosis [ST]) as well as all-cause death, target vessel revascularization (TVR) and non-TVR.. During follow-up, 11 (8.9%) patients experienced a MACE, of whom 2 (1.6%) suffered cardiac death, 2 (1.6%) had a non-periprocedural clinical MI requiring TLR, and 7 (5.7%) underwent elective TLR. No definite/probable ST was observed. All-cause death occurred in 9 (7.3%) patients, TVR in 11 (8.9%) and non-TVR in 11 (8.9%). Patients treated for left main (LM) bifurcation lesions were more likely to experience MACE than non-LM bifurcation lesions (25% vs. 6.5%, p = 0.04).. Percutaneous revascularization of complex bifurcation lesions with the AXXESS stent is safe and provides excellent long-term results, especially in non-LM lesions.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Self Expandable Metallic Stents; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to evaluate the five-year clinical results of a sirolimus-eluting stent (MiStent SES) with a bioabsorbable coating designed for sustained drug delivery during and after rapid polymer dissolution.. The five-year results from the DESSOLVE I and II trials including major adverse cardiac events (MACE), target lesion failure (TLF), target vessel failure (TVF), and stent thrombosis (ST) at five-year follow-up are reported. In DESSOLVE I, 10.3% of patients receiving the MiStent SES (3/29) had a MACE event up to five years without TLF. In DESSOLVE II, 15.1% of patients in the MiStent group (18/119) had a five-year MACE event compared to 22.0% of patients in the Endeavor group (p=0.295). TLF was 9.2% in the MiStent group and 8.5% in the Endeavor group (p=1.00). TVF was 10.1% for MiStent versus 15.3% for Endeavor (p=0.331). Up to five-year follow-up, the MiStent SES has continued to demonstrate low rates of TLR across DESSOLVE I (0.0%) and DESSOLVE II (3.4%). No ST was reported with the MiStent up to five years in the DESSOLVE I trial. In DESSOLVE II, definite or probable ST was 0.0% with MiStent and 1.7% with Endeavor up to five years.. The MiStent SES demonstrated long-term safety and effectiveness with low rates of five-year MACE, TLF, and TVF across these two clinical trials.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Crystallization; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

We aimed to compare the long-term outcomes of the novel biodegradable polymer cobalt-chromium sirolimus-eluting stent (BP-SES) versus the durable polymer sirolimus-eluting stent (DP-SES) in the I-LOVE-IT2 trial.. Comparisons of the long-term safety and efficiency of the BP-DES versus the DP-DES are limited.. A total of 2,737 patients eligible for coronary stenting were randomized to the BP-SES or DP-SES group at a 2:1 ratio. The primary endpoint of target lesion failure (TLF) was defined as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically indicated target lesion revascularization.. A three-year clinical follow-up period was available for 2,663 (97.3%) patients. There were no significant differences in TLF (8.9% vs. 8.6%, P = 0.81), patient-oriented composite endpoint (PoCE) (15.2% vs.14.5%, P = 0.63), or individual components between the BP-SES and DP-SES. Definite/probable stent thrombosis (ST) was low and similar at 3 years (0.8% vs. 1.0%, P = 0.64). Landmark analysis of 1-3 years showed that the TLF (2.7% vs. 2.6%, P = 0.81), PoCE (6.2% vs. 5.1%, P = 0.28), and definite/probable ST (0.4% vs. 0.4%, P = 1.00) were comparable between the 2 arms.. In this prospective randomized trial, the BP-SES showed similar clinical results versus the DP-SES in terms of safety and efficacy outcomes over a 3-year follow-up period.

Topics: Acute Coronary Syndrome; Aged; Cardiovascular Agents; China; Chromium Alloys; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Recurrence; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

In the PANDA III trial, the novel poly-lactide-co-glycolide polymer-based BuMA sirolimus-eluting stent (SES) was non-inferior to the polylactide polymer-based Excel SES for the primary endpoint of one-year target lesion failure (TLF), with a lower incidence of stent thrombosis. We sought to investigate whether the effectiveness profile of BuMA SES, with more rapid drug elution and polymer absorption kinetics, would persist at two years.. A total of 2,348 patients (mean age, 61.2±10.6 years; 24.3% diabetics; 31.2% with acute myocardial infarction within one month) were randomly assigned to receive either BuMA SES (n=1,174) or Excel SES (n=1,174) in the "all-comer" PANDA III trial. Two-year clinical follow-up was available for 2,262 (96.3%) patients. The incidence of TLF and the patient-oriented composite endpoint (PoCE) was low and similar between the BuMA and Excel groups (7.4% vs. 6.9%, p=0.67, and 13.1% vs. 10.9%, p=0.11, respectively). The rate of any revascularisation was significantly higher with the BuMA SES (6.8% vs. 4.6%, p=0.03). Definite and probable thrombosis occurred in 0.7% and 1.4% of patients in the BuMA and Excel groups, respectively (p=0.10).. Two-year rates of TLF and PoCE events were low and similar between the two biodegradable polymer-based SES.

Topics: Absorbable Implants; Aged; Coronary Artery Disease; Drug-Eluting Stents; Humans; Kinetics; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Sirolimus; Treatment Outcome

The authors sought to evaluate the safety and effectiveness of the NeoVas bioresorbable scaffold (BRS) compared with metallic drug-eluting stents.. BRS have the potential to improve very late outcomes compared with metallic drug-eluting stents, but some BRS have been associated with increased rates of device thrombosis before complete bioresorption. NeoVas is a new poly-l-lactic acid BRS that elutes sirolimus from a poly-D, l-lactide coating.. Eligible patients with a single de novo native coronary artery lesion with a reference vessel diameter 2.5 to 3.75 mm and a lesion length ≤20 mm were randomized 1:1 to NeoVas BRS versus cobalt-chromium everolimus-eluting stents (CoCr-EES). Angiographic follow-up was performed in all patients at 1 year. The primary endpoint was angiographic in-segment late loss (LL), and the major secondary endpoint was the rate of angina. Baseline and follow-up optical coherence tomography and fractional flow reserve were performed in a pre-specified subgroup of patients.. The authors randomized 560 patients at 32 centers to treatment with NeoVas (n = 278) versus CoCr-EES (n = 282). One-year in-segment LL with NeoVas and CoCr-EES were 0.14 ± 0.36 mm versus 0.11 ± 0.34 mm (difference 0.03 mm; upper 1-sided 97.5% confidence interval 0.09 mm; p. The NeoVas BRS was noninferior to CoCr-EES for the primary endpoint of 1-year angiographic in-segment LL, and resulted in comparable 1-year clinical outcomes, including recurrent angina. (NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial; NCT02305485).

Topics: Absorbable Implants; Aged; Cardiac Catheterization; Cardiovascular Agents; China; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Fractional Flow Reserve, Myocardial; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polyesters; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Percutaneous Coronary Intervention; Polymers; Sirolimus; Treatment Outcome

This study sought to measure early strut coverage in patients receiving drug-eluting stents (DESs) and to explore the feasibility of short-term dual antiplatelet therapy (DAPT) based on the degree of early strut coverage.. Data for early strut coverage in patients receiving new-generation DESs, and its implications for DAPT continuation were limited.. A randomized, multicenter trial was conducted in 894 patients treated with DESs. Patients were randomly assigned to everolimus-eluting stent (EES) (n = 444) or biolimus-eluting stent (BES) (n = 450) groups and optical coherence tomography (OCT)-guided (n = 445) or angiography-guided (n = 449) implantation groups using a 2-by-2 factorial design. Early strut coverage was measured as the percentage of uncovered struts on 3-month follow-up OCT examination. The primary outcome was the difference in early strut coverage between EES and BES groups and between OCT- and angiography-guided implantation groups. The secondary outcome was a composite of cardiac death, myocardial infarction, stent thrombosis, and major bleeding during the first 12 months post-procedure in patients receiving 3-month DAPT based on the presence of early strut coverage (≤6% uncovered) on 3-month follow-up OCT.. Three-month follow-up OCT data were acquired for 779 patients (87.1%). The median percentage of uncovered struts at 3 months was 8.9% and 8.2% in the EES and BES groups, respectively (p = 0.69) and was lower in the OCT-guided group (7.5%) than in the angiography-guided group (9.9%; p = 0.009). Favorable early strut coverage (≤6% uncovered strut) was observed in 320 of 779 patients (41.1%). At 12 months, the composite event rarely occurred in the 3-month (0.3%) or 12-month (0.2%) DAPT groups (p = 0.80).. OCT-guided DES implantation improved early strut coverage compared with angiography-guided DES implantation, with no difference in strut coverage between EES and BES groups. Short-term DAPT may be feasible in selected patients with favorable early strut coverage (Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents Versus Biolimus A9-eluting Stents [DETECT-OCT]; NCT01752894).

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug Therapy, Combination; Drug-Eluting Stents; Everolimus; Feasibility Studies; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Republic of Korea; Risk Factors; Sirolimus; Stroke; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Dual antiplatelet therapy (DAPT) with thienopyridine and aspirin is the standard care for the prevention of stent thrombosis. However, the optimal duration and effect of the duration of DAPT on intra-stent thrombus (IS-Th) formation are unknown. The NIPPON study (Nobori Dual Antiplatelet Therapy as Appropriate Duration) was an open label, randomized multicenter, assessor-blinded, trial designed to demonstrate the non-inferiority of shorter (6-month) DAPT to prolonged (18-month) DAPT, after biolimus A9 eluting stent implantation in 3773 patients at 130 sites in Japan. Among them, 101 patients were randomly allocated for an optical coherence tomography (OCT) sub-study to assess the difference of local IS-Th formation between the two groups. In addition to standard OCT parameters, the number of IS-Th formed was counted in each target stent at 8 months. Baseline patient characteristics were not different between the 6- and 18-month groups. IS-Th was detected in 9.8% of the cases and the presence of IS-Th was not significantly different between the two groups (10.9% in 6-month vs. 9.1% in 12-month, P = 0.76). Furthermore, the number of IS-Th formed was not significantly different between the two groups. This OCT sub-study was in line with the main NIPPON study which demonstrated the non-inferiority of 6-month DAPT to 18-month DAPT. Shorter DAPT duration did not promote progressive IS-Th formation at the mid-term time point.

Topics: Aged; Aspirin; Coronary Artery Disease; Coronary Vessels; Dose-Response Relationship, Drug; Drug Therapy, Combination; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Pyridines; Retrospective Studies; Single-Blind Method; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular Resistance

The study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts).. The DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices.. In total, 1,811 patients were 1:1 randomized to ZES versus EES. We performed a pre-specified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF, and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated.. Five-year clinical follow-up data was available in 1,798 (99.3%) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2% vs. 14.2%; p. At 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy for treating a broad population of all-comers.

Topics: Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Netherlands; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

We evaluated healing responses with optical coherence tomography, and long-term clinical outcomes after treatment with a dedicated stent versus a conventional culotte technique.. Dedicated bifurcation stents have been proposed as an alternative treatment for coronary bifurcation lesions. The long-term performance of dedicated stents versus conventional dual-stent techniques for the treatment of complex coronary bifurcation lesions is unknown.. Forty patients with true coronary bifurcation lesions were randomized to treatment with a dedicated Axxess bifurcation stent in the proximal main vessel and additional Biomatrix stents in branches versus culotte stenting using Xience stents.. The percentage of uncovered struts in each bifurcation segment at 9 months (primary endpoint) was similar between groups. Five-year clinical follow-up was available for all patients and included major adverse cardiac events [MACE; a composite of cardiac death, myocardial infarction (MI) and ischemia-driven target lesion revascularization (TLR)], target-vessel (TVR) and non-target-vessel revascularization (non-TVR), non-TLR and stent thrombosis. At 5 years, in the culotte group, one patient had undergone TLR and another suffered a clinical MI, resulting in 10% MACE versus none in the Axxess group. TVR (5% vs. 10%, P = 0.54) and non-TVR (5% vs. 20%, P = 0.39) rates were similar between the Axxess and culotte groups, respectively. There was no stent thrombosis.. Compared with culotte stenting with Xience, complex coronary bifurcation stenting using a dedicated strategy combining the Axxess and Biomatrix stents results in similar stent strut coverage at 9 months, and excellent clinical outcomes at 5 years.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The aim of this study was to evaluate the efficacy and safety of the BioNIR stent compared with the Resolute Integrity stent for the treatment of coronary artery disease.. This first-in-human, multicentre, single-blind randomised non-inferiority trial was performed in Europe and Israel. Patients with stable coronary artery disease or acute coronary syndromes were randomly assigned to treatment with BioNIR or Resolute Integrity stents in a 2:1 fashion. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Three hundred and two patients were randomised, of whom 261 (86.0%) underwent six-month angiographic follow-up. The BioNIR stent was non-inferior to the Resolute Integrity stent for the primary endpoint of in-stent LLL at six months (0.04±0.30 mm vs. 0.03±0.31 mm, respectively, pnoninferiority<0.0001). At 12-month follow-up, target lesion failure occurred in 3.4% in the BioNIR group and 5.9% in the Resolute Integrity group (p=0.22). Rates of MACE were similar between the BioNIR and Resolute Integrity groups (4.3% vs. 5.9%, respectively, p=0.45).. The BioNIR stent was non-inferior to the Resolute Integrity stent for the primary endpoint of angiographic in-stent LLL at six months. Clinical outcomes at one year were comparable between the two groups.

Topics: Adult; Aged; Aged, 80 and over; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

Drug-eluting stents with biodegradable polymer coatings have shown promising outcomes in randomised studies.. We compared neointimal healing patterns including strut coverage and assessed neointimal maturity using a novel algorithm in coronary lesions treated with sirolimus-eluting stents with biodegradable polymer coating (BP-SES) or everolimus eluting stents with permanent polymer coating (PP-EES) using optical coherence tomography after 6months.. A total of 39 patients were randomised to BP-SES (n=19) or PP-EES (n=20) for the treatment of coronary lesions. Of those, 29 patients (14 BP-SES and 15 PP-EES) underwent optical coherence tomography (OCT) and angiography at 6-month follow-up. Tissue coverage and apposition were assessed in a total of 6162 struts (BP-SES, n=2889; PP-EES, n=3273). Neointimal maturity was assessed in 3672 neointimal regions above struts using grey scale intensity analysis. OCT analysis showed neointimal coverage of 2433 (BP-SES) vs. 2702 (PP-EES) struts (84.2% vs. 82.6%, p=0.70), whereas the remainder was uncovered after 6months. Mean neointimal thickness did not differ significantly between groups (54.3±7.8μm vs. 80±14.6μm, p=0.12). The rate of malapposed struts was comparable between groups (1.3% vs. 2.2%, p=0.27). Grey scale signal intensity analysis showed mature tissue coverage of struts in 46.2% in BP-SES vs. 31.8% in PP-EES (p=0.31) of neointimal regions.. The present study showed comparable early vascular healing response characterised by neointimal coverage with mainly immature neointima in both BP-SES and PP-EES.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Polymers; Sirolimus; Tomography, Optical Coherence

Durable polymers used in drug-eluting stents are considered a potential cause of hypersensitivity inflammatory response adversely affecting stent healing. Using a sequential follow-up with optical coherence tomography, we compared the differences in healing profiles of 2 drug-eluting stents with a biodegradable or durable polymer.. Sixty patients with multivessel disease were prospectively enrolled to receive both study stents, which were randomly assigned to 2 individual vessels, a Resolute Integrity zotarolimus-eluting stent with a durable BioLinx polymer and a BioMatrix NeoFlex Biolimus A9-eluting stent with a biodegradable polylactic acid polymer. Optical coherence tomography was performed at baseline, then in 5 randomly assigned monthly groups at 2 to 6 months, and at 9 months in all patients. The primary end point was the difference in optical coherence tomography strut coverage at 9 months. Key secondary end points included angiographic late lumen loss and composite major adverse cardiac events (cardiac death, myocardial infarction, target lesion revascularization, and definite or probable stent thrombosis) at 9 months. Resolute Integrity zotarolimus-eluting stent showed significantly better strut coverage than BioMatrix NeoFlex Biolimus A9-eluting stent at 2 to 6 months (. Despite having a durable polymer, Resolute Integrity zotarolimus-eluting stent exhibited better strut coverage than BioMatrix NeoFlex Biolimus A9-eluting stent having a biodegradable polymer; both showed similar antiproliferative efficacy. This novel, longitudinal, sequential optical coherence tomography protocol using each patient as own control could achieve conclusive results in small sample size.. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01742507.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Hong Kong; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The aim of this study was to provide contemporary outcome data for patients with de novo coronary disease and Medina 1,1,1 lesions who were treated with a culotte two-stent technique, and to compare the performance of two modern-generation drug-eluting stent (DES) platforms, the 3-connector XIENCE and the 2-connector SYNERGY.. Patients with Medina 1,1,1 bifurcation lesions who had disease that was amenable to culotte stenting were randomised 1:1 to treatment with XIENCE or SYNERGY DES. A total of 170 patients were included. Technical success and final kissing balloon inflation occurred in >96% of cases. Major adverse cardiovascular or cerebrovascular events (MACCE: a composite of death, myocardial infarction [MI], cerebrovascular accident [CVA] and target vessel revascularisation [TVR]) occurred in 5.9% of patients by nine months. The primary endpoint was a composite of death, MI, CVA, target vessel failure (TVF), stent thrombosis and binary angiographic restenosis. At nine months, the primary endpoint occurred in 19% of XIENCE patients and 16% of SYNERGY patients (p=0.003 for non-inferiority for platform performance).. MACCE rates for culotte stenting using contemporary everolimus-eluting DES are low at nine months. The XIENCE and SYNERGY stents demonstrated comparable performance for the primary endpoint.

Topics: Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Sirolimus; Treatment Outcome

The authors aimed to compare long-term data of an ultrathin cobalt-chromium stent with passive silicon carbide coating and an active biodegradable polymer that releases sirolimus (O-SES) (Orsiro, BIOTRONIK, Bülach, Switzerland) with the durable polymer-based Xience Prime everolimus-eluting stent (X-EES) (Abbott Vascular, Santa Clara, California).. Biodegradable polymer stents have been developed aiming to overcome long-term detrimental effects of durable polymer stents, ultimately leaving a bare-metal stent in the vessel.. This multicenter, assessor-blinded trial randomized 452 patients with 505 lesions to either O-SES or X-EES in a 2:1 fashion. Endpoints at 5 years were target lesion failure (TLF), its components, and stent thrombosis.. TLF occurred in 10.4% (n = 30) of O-SES patients versus 12.7% (n = 19) of X-EES patients (p = 0.473), overall stent thrombosis occurred in 0.7% (n = 2) versus 2.8% (n = 4) (p = 0.088), and definite stent thrombosis in 0% versus 0.7% (n = 1) (p = 0.341). Post hoc analysis was performed in diabetic patients (n = 128) and vessels ≤2.75 mm (n = 259). In diabetic patients, the O-SES group had numerically more target lesion revascularizations (13.5% vs. 4.5%; p = 0.138), but fewer cardiac deaths (1.3% vs. 6.9%; p = 0.089) and stent thrombosis (0% vs. 6.9%; p = 0.039). In small vessels, the O-SES group had a significantly lower 5-year mortality (3.7% vs. 11.3%; p = 0.022).. At 5 years, the biodegradable polymer O-SES demonstrated low TLF rates comparable to the durable polymer X-EES, confirming its long-term safety and performance. Particularly encouraging is the absence of definite stent thrombosis.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polyesters; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The Combo stent (OrbusNeich, Hoevelaken, the Netherlands) combining an abluminal, bioabsorbable polymer eluting sirolimus with a luminal CD34+ antibody to capture endothelial progenitor cells has been developed to further improve safety and efficacy of coronary interventions. We have designed a large-scale registry-based randomized clinical trial to compare the Combo stent to the Orsiro stent (Biotronik, Bülach, Switzerland) in patients undergoing percutaneous coronary intervention.. The SORT OUT X study will randomly assign 3,140 patients to treatment with Combo or Orsiro stents at 3 sites in Western Denmark. Patients are eligible if they are ≥18 years old, have chronic stable coronary artery disease or acute coronary syndromes, and have ≥1 coronary lesion with >50% diameter stenosis requiring treatment with a drug-eluting stent. The primary end point target lesion failure is a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 12 months. Clinically driven event detection will be derived from validated Danish registries. An event rate of 4.2% is assumed in each stent group. With a sample size of 1,570 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level will have 90% power to detect noninferiority of the Combo stent compared with the Orsiro stent with a predetermined noninferiority margin of 2.1%.. The SORT OUT X trial will determine whether the dual-therapy Combo stent is noninferior to the Orsiro stent with respect to clinically driven events (ClinicalTrials.govNCT03216733).

Topics: Acute Coronary Syndrome; Adult; Antibodies; Antigens, CD34; Coated Materials, Biocompatible; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Research Design; Single-Blind Method; Sirolimus

Durable polymer drug-eluting stents (DP-DES) may contribute to persistent inflammation, delayed endothelial healing and subsequent late DES thrombosis. The aim of this optical coherence tomography (OCT) substudy was to compare healing and neointimal coverage of a novel bioabsorbable polymer sirolimus-eluting stent (Firehawk®) (BP-DES) versus the DP-DES (XIENCE) at 90 days in an all-comers patient population.. The TARGET All Comers study is a prospective multicentre randomised post-market trial of 1,656 patients randomised 1:1 to Firehawk or XIENCE at 21 centres in 10 European countries. The TARGET OCT substudy enrolled 36 consecutive patients with 52 lesions at six centres proficient in OCT. Follow-up OCT was performed at three months or prior to revascularisation when occurring before the three-month window. The substudy was designed for non-inferiority of the primary endpoint of neointimal thickness. At follow-up, the mean neointimal thickness by OCT (52 lesions: Firehawk, n=24; XIENCE, n=28), was not significantly different between groups (Firehawk 75.5 μm vs. XIENCE V 82.3 μm) meeting the primary endpoint of non-inferiority (pnoninferiority<0.001). The percentage of stent strut coverage was high in both groups (strut level: 99.9±0.3% vs. 100±0.1%, p=0.26), and the proportion of malapposed struts (1.0±1.6% vs. 1.2±2.0%, p=0.51) was low in both groups.. Based on OCT, the Firehawk BP-DES has a similar healing response three months after implantation compared to the DP-DES, with near complete strut coverage, moderate neointima formation and minimal strut malapposition.

Topics: Atherosclerosis; Chromium; Cobalt; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Europe; Humans; Neointima; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Tomography, Optical Coherence; Treatment Outcome

This study aimed to establish the early healing and neointimal transformation profile of the new polymer-free BioFreedom stent through sequential optical coherence tomography (OCT) within the first nine months following stent implantation.. We randomly assigned 104 BFS recipients to one of five groups with angiography and OCT follow-up at 1, 2, 3, 4, or 5 months, together with another follow-up for all at nine months. The primary endpoint was the degree of OCT-detected strut coverage at nine months. From 1, 2, 3, 4, and 5 months, median neointimal strut coverage increased from 85.8, 87.0, 88.6, 96.8 to 97.1%, respectively, to 99.6% (IQR 98.2-99.9) at nine months. At nine months, median percent neointimal volume was 13.0% and angiographic late lumen loss was 0.21±0.30 mm. Major adverse cardiac events (MACE) were limited to one non-cardiac death, one non-ST-elevation myocardial infarction not related to BFS, and two target lesion revascularisations without stent thrombosis (MACE rate 4.0%).. Neointimal strut coverage of the BFS was rapid and the BFS was shown to be clinically safe and effective.

Topics: Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Drug-eluting stents combining an ultrathin cobalt-chromium stent platform with a biodegradable polymer eluting sirolimus have been shown to be non-inferior or superior to thin-strut, durable-polymer, everolimus-eluting stents in terms of 1 year safety and efficacy outcomes.. In the randomised, single-blind, multicentre, non-inferiority BIOSCIENCE trial, we compared biodegradable-polymer sirolimus-eluting stents with durable-polymer everolimus-eluting stents in patients with chronic stable coronary artery disease or acute coronary syndromes. Here, we assess the final 5-year clinical outcomes of BIOSCIENCE with regards to the primary clinical outcome of target lesion failure, which was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. The primary analysis was done by intention to treat. The BIOSCIENCE trial is registered with ClinicalTrials.gov, number NCT01443104.. 2008 (95%) of 2119 patients recruited between March 1, 2012, and May 31, 2013, completed 5 years of follow-up. Target lesion failure occurred in 198 patients (cumulative incidence 20·2%) treated with biodegradable-polymer sirolimus-eluting stents and in 189 patients (18·8%) treated with durable-polymer everolimus-eluting stents (rate ratio [RR] 1·07, 95% CI 0·88-1·31; p=0·487). All-cause mortality was significantly higher in patients treated with biodegradable-polymer sirolimus-eluting stents than in those treated with durable-polymer everolimus-eluting stents (14·1% vs 10·3%; RR 1·36, 95% CI 1·06-1·75; p=0·017), driven by a difference in non-cardiovascular deaths. We observed no difference between groups in cumulative incidence of definite stent thrombosis at 5 years (1·6% in both groups; 1·02, 0·51-2·05; p=0·950).. 5-year risk of target lesion failure among all-comer patients undergoing percutaneous coronary intervention is similar after implantation of ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents or thin-strut, durable-polymer, everolimus-eluting stents. Higher incidences of all-cause and non-cardiovascular mortality in patients treated with biodegradable-polymer stents eluting sirolimus than in those treated with durable-polymer stents eluting everolimus warrant careful observation in ongoing clinical trials.. Clinical Trials Unit of the University of Bern and Biotronik.

Topics: Absorbable Implants; Acute Coronary Syndrome; Adult; Aged; Aged, 80 and over; Cause of Death; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Intention to Treat Analysis; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Prosthesis Failure; Single-Blind Method; Sirolimus; Thrombosis; Treatment Outcome

FANTOM II is a prospective multicentre trial assessing the safety and efficacy of the Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS). The present substudy focuses on the six- and nine-month IVUS findings.. A total of 240 patients with de novo coronary artery lesions presenting with stable or unstable disease were included in two sequential cohorts (cohort A [n=117] and cohort B [n=123]) in which angiographic follow-up was performed at either six or nine months, respectively. Matched IVUS data were available for 35 paired cases in cohort A and 26 paired cases in cohort B. At six months, mean and minimum scaffold area (SA) decreased from 6.09±1.08 mm2 to 5.88±1.07 mm2, p=0.009, and 5.27±0.99 mm2 to 5.05±0.99 mm2, p=0.01, respectively. At nine months, no significant change in mean scaffold and minimum scaffold area was observed (6.46±1.11 mm2 to 6.38±0.96 mm2; p=0.35, and 5.45±1.00 mm2 to 5.36±0.86 mm2; p=0.32, respectively). Neointimal hyperplasia area was low at both six (0.11±0.12 mm2) and nine months (0.20±0.21 mm2), as was in-scaffold obstruction volume (1.94±2.25% at six months, and 3.40±4.11% at nine months).. The use of the Fantom BRS in stable coronary artery disease was associated with low rates of neointimal hyperplasia volume and in-scaffold volume obstruction at both six and nine months.

Topics: Absorbable Implants; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Humans; Prospective Studies; Sirolimus; Treatment Outcome; Ultrasonography, Interventional

The aim of this study was to evaluate the safety and efficacy of the BioMime sirolimus-eluting coronary stent (SES) compared to the XIENCE family of everolimus-eluting coronary stents (EES) in the treatment of patients with de novo native coronary artery lesions.. The meriT-V is a prospective, multicentre, randomised, open-label, active-controlled, non-inferiority trial. A total of 256 patients with up to two de novo native coronary artery lesions were enrolled and randomly assigned (2:1) to BioMime SES or XIENCE EES. BioMime SES was non-inferior to XIENCE EES for the primary endpoint of in-stent late lumen loss (0.15±0.27 mm vs. 0.15±0.29 mm; difference: -0.006 mm; 95% confidence interval: -0.085 to 0.072; p=0.87; p for non-inferiority <0.0001) at nine-month follow-up. The major adverse cardiac events rate was numerically lower in the BioMime SES group (2.98% vs. 7.14%; p=0.13), driven by a statistically significant lower risk of any myocardial infarction (0.60% vs. 4.76%; p=0.03), when compared with the XIENCE EES group. There was no difference in target vessel myocardial infarction (p=0.62) between the groups. There was no definite or probable stent thrombosis in either group.. In the treatment of de novo native coronary artery lesions, the biodegradable polymer ultra-thin SES (BioMime) was non-inferior to a durable polymer EES (XIENCE) at nine-month follow-up. Further studies powered for clinical endpoints are needed.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Sirolimus; Treatment Outcome

Coronary drug-eluting stent development has introduced new metal alloys, changes in stent architecture, and bioresorbable polymers. Whether these advancements improve long-term clinical safety and efficacy has been inconsistent in prior studies.. The authors sought to compare late-term clinical outcomes among patients treated with an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent (BP SES) and a thin strut (81 μm) durable polymer everolimus-eluting stent (DP EES) in a large randomized trial.. BIOFLOW V (Biotronik Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects with Up to Three De Novo or Restenotic Coronary Artery Lesions V) was an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Analysis of pre-specified 2-year clinical outcomes was performed.. Among 1,334 patients randomized to treatment with BP SES (n = 884) or DP EES (n = 450), the 2-year TLF rate was 7.5% for BP SES and 11.9% for DP EES (-4.33% treatment difference; 95% confidence interval: -8.16% to -0.91%; p = 0.015), driven by differences in target vessel myocardial infarction (MI) (5.3% vs. 9.5%; p = 0.01) and ischemia-driven target lesion revascularization (2.6% vs. 4.9%; p = 0.04). Rates of cardiac death or MI were 7.0% versus 10.4% for BP SES and DP EES, respectively (p = 0.047). Late/very late definite stent thrombosis was statistically lower for BP SES compared with DP EES (0.1% vs. 1.0%; p = 0.045).. In a large randomized trial, significant differences in both TLF and target vessel-related MI persisted through 2 years, favoring treatment with BP SES over DP EES. Significantly lower cumulative target lesion revascularization and late/very late stent thrombosis were also observed with BP SES. (Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions [BIOFLOW-V]; NCT02389946).

Topics: Absorbable Implants; Aged; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Polymers; Prospective Studies; Single-Blind Method; Sirolimus

The aim of this study was to evaluate 1-year clinical safety and efficacy of the dual-therapy COMBO stent in a large, all-comers patient-level pooled cohort.. The COMBO stent (OrbusNeich Medical, Fort Lauderdale, Florida) is a novel stent with abluminal sirolimus elution from a biodegradable polymer and a luminal pro-healing anti-CD34+ antibody layer, which attracts circulating endothelial progenitor cells. These endothelial progenitor cells can quickly mature into normal endothelium, providing rapid endothelialization.. The MASCOT (Multinational Abluminal Sirolimus Coated biO-engineered stenT) (N = 2,614, 61 global sites) and REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt Post Market Registry) (N = 1,000, 9 European sites) registries are 2 prospective, multicenter studies evaluating clinical outcomes after attempted COMBO stent placement in all-comer patients undergoing percutaneous coronary intervention. In this patient-level pooled analysis we analyzed 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Furthermore, we determined predictors of 1-year TLF.. A total of 3,614 patients (63.5 ± 11.2 years of age; 23.8% women) were included in this analysis. The prevalence of diabetes mellitus was 29.3%, and 54.3% patients presented with acute coronary syndrome. The primary endpoint of 1-year TLF occurred in 140 (3.9%) patients, with incidence of cardiac death in 1.6%, target vessel myocardial infarction in 1.2%, clinically driven target lesion revascularization in 2.2%, and definite stent thrombosis in 0.5% patients. Insulin-treated diabetes mellitus, chronic renal failure, and American College of Cardiology/American Heart Association lesion type B2/C were independent predictors of 1-year TLF.. In this large patient-level pooled analysis of patients treated with the dual-therapy COMBO stent excellent results at 1-year were observed. (MASCOT - Post Marketing Registry [MASCOT]; NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the COMBO Stent [REMEDEE Reg]; NCT01874002).

Topics: Absorbable Implants; Aged; Antibodies; Antigens, CD34; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Endothelial Progenitor Cells; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Product Surveillance, Postmarketing; Re-Epithelialization; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Balloon dilatation or debulking seems to be essential to allow successful stent implantation in calcified coronary lesions. Compared with standard balloon predilatation, debulking using high-speed rotational atherectomy (RA) is associated with higher initial procedural success albeit with higher in-stent late lumen loss at intermediate-term follow-up. Whether modified (scoring or cutting) balloons (MB) could achieve similar procedural success compared with RA is not known. In addition, whether new-generation drug-eluting stents could counterbalance the excessive neointimal proliferation triggered by RA remains to be determined.. We randomly assigned patients with documented myocardial ischemia and severely calcified native coronary lesions undergoing percutaneous coronary intervention to a strategy of lesion preparation using MB or RA followed by drug-eluting stent implantation. Stenting was performed using a third-generation sirolimus-eluting stent with a bioabsorbable polymer. The trial had 2 primary end points: strategy success (defined as successful stent delivery and expansion with attainment of <20% in-stent residual stenosis in the presence of TIMI [Thrombolysis in Myocardial Infarction] 3 flow without crossover or stent failure; powered for superiority) and in-stent late lumen loss at 9 months (powered for noninferiority). Two hundred patients were enrolled at 2 centers in Germany (n=100 in each treatment group). The mean age of the study population was 74.9±7.0 years; 76% were men, and 33.5% had diabetes mellitus. Strategy success was significantly more common in the RA group (81% versus 98%; relative risk of failure with an MB- versus RA-based strategy, 9.5; 95% CI, 2.3-39.7; P=0.0001), but mean fluoroscopy time was longer (19.6±13.4 versus 23.9±12.2 minutes; P=0.03). At 9 months, mean in-stent late lumen loss was 0.16±0.39 mm in the MB group and 0.22±0.40 mm in the RA group ( P=0.21, P=0.02 for noninferiority). Target lesion revascularization (7% versus 2%; P=0.17), definite or probable stent thrombosis (0% versus 0%; P=1.00), and target vessel failure (8% versus 6%; P=0.78) were low and not significantly different between the MB and RA groups.. Lesion preparation with upfront RA before drug-eluting stent implantation is feasible in nearly all patients with severely calcified coronary lesions, is more commonly successful as a primary strategy compared with MB, and is not associated with excessive late lumen loss. A strategy of provisional MB remains feasible, safe, and effective as long as bailout RA is readily available and may offer the advantages of compatibility with smaller sized catheters and less irradiation. Both strategies are associated with excellent clinical outcome at 9 months.. URL: https://www.clinicaltrials.gov . Unique identifier: NCT02502851.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Germany; Humans; Male; Neointima; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome; Vascular Calcification

Polymer coatings of drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malapposition (LASM) with the risk of stent thrombosis. This study evaluated, if biodegradable polymer (BP) reduces the incidence of LASM compared to permanent polymer (PP) after treatment with newer generation DES.. Fifty patients with 59 lesions were randomized (2:1) to elective treatment with second generation PP-DES (n = 32, 39 stents), either Everolimus-eluting or Zotarolimus-eluting stents, or with BP-DES (Biolimus-eluting stents [BES]; n = 18, 20 stents) and underwent optical coherence tomography directly after implantation and after 1 year. After implantation acute stent malappositions (ASM) were documented in 30 stents (51%) distributed to 22 stents treated with PP-DES (56%) and 8 with BP-DES (40%; n.s.). After 1 year, late stent malappositions (LSM) were detected in 14 stents (24 %); ASM persisted (APSM) in 9 stents after one year (7 PP-DES-18%, 2 BES-10%), whereas ASM resolved in 21 stents. In addition, LASM was documented in nine stents including five stents without and four stents with additional APSM. All LASM were located in PP-DES (n = 9; 23%), none in BP-DES (P = 0.022). Compared to the reference lumen area, in-stent lumen area of stents without LASM was smaller due to neointimal hyperplasia (P = 0.021), whereas in-stent lumen area at maximum LASM of stents with LASM was larger due to positive remodeling (P = 0.002).. In conclusion the use of BP-DES reduced the occurrence of LASM due to positive remodeling compared to second generation PP-DES.

Topics: Absorbable Implants; Aged; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Incidence; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Polymers; Postoperative Complications; Prospective Studies; Prosthesis Design; Prosthesis Failure; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Using optical coherence tomography, we evaluated early follow-up findings of significant stent malapposition (SSM) in patients treated with second-generation drug-eluting stent.. From the DETECT-OCT randomized trial (Determination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of the Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus- Versus Biolimus-Eluting Stent), a total of 386 patients (390 lesions) who underwent both postintervention and 3-month follow-up optical coherence tomography examinations were included for the present analysis. SSM was defined as a stent that had a strut with a maximal wall-to-strut distance of ≥200 μm. Postintervention, SSM was detected in 175 lesions (44.9%), including 117 lesions with a maximal wall-to-strut distance of ≥200 to <400 μm and 58 lesions with a maximal wall-to-strut distance of ≥400 μm. As the implanted stent diameter-to-reference vessel diameter ratio grew, the risk of postintervention SSM dropped (odds ratio, 0.587; 95% CI, 0.367-0.941; P=0.0398). The optimal value that best separated SSM from non-SSM postintervention was a stent diameter-to-reference vessel diameter ratio of 1.0. At 3 months follow-up, the frequency of SSM decreased from 44.9% to 33.6% (131 lesions; P=0.0001), mainly driven by the decrease in lesions with a maximal wall-to-strut distance of ≥200 to <400 μm. As the maximal wall-to-strut distance on postintervention optical coherence tomography was larger, the risk of 3-month SSM increased (odds ratio, 1.607; 95% CI, 1.131-2.286; P=0.0284). The optimal value that best separated SSM from non-SSM at 3 months follow-up was a maximal wall-to-strut distance postintervention of 230 μm.. A spontaneous decrease in SSM was observed early in this qualified study with a large number of study patients treated with second-generation drug-eluting stent.. URL: https://www.clinicaltrials.gov . Unique identifier: NCT01752894.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Republic of Korea; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The authors sought to investigate the impact of diabetes mellitus (DM) on outcomes following contemporary drug-eluting stent (DES) implantation in the BIONICS (BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis) trial.. Patients with DM are at increased risk for adverse events following percutaneous coronary intervention (PCI).. A prospective, multicenter, 1:1 randomized trial was conducted to evaluate in a noninferiority design the safety and efficacy of ridaforolimus-eluting stents versus zotarolimus-eluting stents among 1,919 patients undergoing PCI. Randomization was stratified to the presence of medically treated DM, and a pre-specified analysis compared outcomes according to the presence or absence of DM up to 2 years.. The overall prevalence of DM was 29.1% (559 of 1,919). DM patients had higher body mass index, greater prevalence of hyperlipidemia and hypertension, and smaller reference vessel diameter. One-year target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) was significantly higher among diabetic patients (7.8% vs. 4.2%; p = 0.002), mainly due to higher target lesion revascularization (4.5% vs. 2.0%; p = 0.002). Rates of cardiac death, myocardial infarction, and stent thrombosis did not statistically vary. Among 158 patients undergoing 13-month angiographic follow-up, restenosis rates were 3 times higher in diabetic patients compared with nondiabetic patients (15.2% vs. 4.7%; p = 0.01). Clinical and angiographic outcomes were similar between ridaforolimus-eluting stent- and zotarolimus-eluting stent-treated patients.. Despite advances in interventional therapies, and the implementation of new-generation DES, diabetic patients still have worse angiographic and clinical outcomes compared with nondiabetic patients undergoing PCI.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prevalence; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

Head to head trials of clinical outcomes of sirolimus eluting polymer free vs. biodegradable polymer stents are lacking.. Single centre prospective open labeled randomised controlled clinical trial. Basis for sample size calculation was the rate of MACE from the ISAR TEST 3 trial in which the absolute difference was 10.25% with a standard deviation of 0.24. Assuming null hypothesis, 80% power and 5% alpha error, to detect a 10% difference, adjusting for 10% loss of follow up, sample size was 204.. Patients with stable coronary artery disease or recent acute coronary syndrome ( >1 week from the date of STEMI), being taken up for elective angioplasty.. Primary end point was MACE at 1 year and secondary end points at the end of 1 year were cardiac death, urgent target lesion revascularization, acute coronary syndrome, stroke and in-stent re-stenosis.. 204 patients were enrolled between January 2013 to July 2014, 91 in the polymer-free group and 113 in the biodegradable polymer group. Baseline characteristics were comparable between both groups. 21 patients (10.29%), were lost to follow up. MACE at 1 year were comparable in both the groups 3 of 85(3.52%) in the polymer-free group and 3 of 98(3.06%) in the biodegradable polymer group, p = 0.859. The secondary end points were also comparable between the two groups- Death- 1 of 85(1.17%) vs. 2 of 98(2.04%), p = 0.646, Stroke 0 of 85 vs. 2 of 98(2.04%), p = 0.185 and acute coronary syndrome - 2 of 85(2.35%) vs. 1 of 98(1.02%), p = 0.204. There were no instances of urgent target lesion re-vascularisation or definite stent thrombosis in either groups. In stent re-stenosis was found in 7 of 85(8.2%) in the polymer-free group vs. 6 of 98(6.12%) in the biodegradable polymer group.. The 1 year MACE rates are comparable in patients who underwent elective coronary revascularization using sirolimus eluting polymer-free and biodegradable polymer stents.

Topics: Absorbable Implants; Adolescent; Adult; Aged; Aged, 80 and over; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Postoperative Complications; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Young Adult

This study sought to compare the clinical outcomes of 6-month versus 12-month dual antiplatelet therapy (DAPT) in patients receiving multiple biodegradable polymer-coated sirolimus-eluting stents (BP-SES) implants.. The clinical outcomes for patients who undergo multiple BP-SES implantation with different DAPT durations are uncertain.. In the I-LOVE-IT 2 trial, 907 patients treated with multiple BP-SES (total stent number ≥2) were assigned to receive 6-month (n = 440) or 12-month (n = 467) DAPT. The primary endpoint was 12-month target lesion failure (TLF), which is a composite of cardiac death, target vessel myocardial infarction (MI) or clinically indicated target lesion revascularization. The major secondary endpoints were 12-month net adverse clinical events, a composite of all causes of death, MI, stroke, any revascularization and bleeding.. The number of stents per patient between the 6-month and 12-month DAPT group was similar (2.4 ± 0.7 vs. 2.4 ± 0.7, P = 0.47). The incidence of 12-month TLF was comparable in the 6-month and 12-month DAPT groups (9.3% vs.7.5%, Log-rank P = 0.33). However, landmark analysis showed that 12-month DAPT, compared to 6-month DAPT, was associated with a significantly lower risk of TLF (4.8% vs. 2.4%, Log-rank P = 0.049) at a cost of a slightly increased risk of all bleeding events (0.5% vs. 1.7%, Log-rank P = 0.07) between 6 and 12 months.. In patients treated with multiple BP-SES, 6- and 12-month DAPT had similar impacts on 12-month clinical outcomes. Additionally, 12-month DAPT might reduce TLF between 6 and 12 months at the cost of a slightly increased risk of all bleeding events. © 2017 Wiley Periodicals, Inc.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; China; Coronary Angiography; Coronary Artery Disease; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Polymers; Prospective Studies; Risk Factors; Sirolimus; Stroke; Time Factors; Treatment Outcome

The aim of this study was to investigate the impact of attenuated-signal plaque (ASP) observed by intravascular ultrasound (IVUS) on vessel response after drug-eluting stent implantation.. Data were derived from the IVUS cohort of the J-DESsERT trial comparing paclitaxel- and sirolimus-eluting stents. Serial IVUS analysis (pre- and post-intervention, and 8-month follow-up) was performed in 136 non-AMI lesions. ASP was defined as hypoechoic plaque with ultrasound attenuation without calcification. Calcified plaque (CP) was defined as brightly echoreflective plaque with acoustic shadowing. ASP and CP scores were calculated by grading their measured angle as 0 to 4 for 0°, <90°, 90-180°, 180-270° and >270°, respectively. The entire stented segment was analyzed at 1-mm intervals.. At pre-intervention, ASP was observed in 40.4% of lesions, and this group had greater % neointimal volume (%NIV) at follow-up than the no-ASP group (p = 0.011). ASP score at pre-intervention positively correlated with %NIV (p = 0.023). During the follow-up, ASP score significantly decreased (p < 0.001), and CP score significantly increased (p < 0.001), with a negative correlation between them (p < 0.001). A decrease in the ASP score was associated with less %NIV in PES (p = 0.031), but not in SES (p = 0.229).. The greater extent of plaque with IVUS-signal attenuation at pre-intervention and its persistence during follow-up were associated with neointimal proliferation, possibly representing sustained inflammatory status, depending on the type of DES used.

Topics: Aged; Cardiovascular Agents; Cell Proliferation; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Japan; Male; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Predictive Value of Tests; Prospective Studies; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Calcification

Limited data is available on the long-term outcome of patients with increased cardiovascular event risk, treated with newer-generation durable polymer drug-eluting stents (DES).. We therefore assessed 3-year follow-up data of high-risk versus low- to intermediate-risk patients of the randomized DUTCH PEERS trial (NCT01331707). In both risk groups we also compared patients treated with Resolute Integrity versus Promus Element DES. Patients were categorized as "high-risk" if they met ≥1 of the following criteria: (1) diabetes (17.9%); (2) previous myocardial infarction (21.9%); (3) previous coronary revascularization (25.8%); (4) chronic renal failure (3.5%); (5) left ventricular ejection fraction ≤30% (1.5%); and (6) age ≥75 years (17.3%).. At the 3-year follow-up, the incidence of the composite endpoint target vessel failure (TVF) (13.2 vs. 7.5%; logrank p < 0.001) and 2 of its components - cardiac death (4.7 vs. 1.5%; logrank p < 0.001) and target vessel revascularization (7.3 vs. 4.7%; logrank p = 0.03) - was higher in high-risk (n = 957) versus low- to intermediate-risk patients (n = 854). Among high-risk patients, treatment with Resolute Integrity (n = 481) and Promus Element stents (n = 476) was similarly safe and efficacious (TVF: 13.3 vs. 13.1%; logrank p = 0.95; definite-or-probable stent thrombosis: 1.7 vs. 1.7%; logrank p = 1.00).. The newer-generation Resolute Integrity and Promus Element stents showed similar results in terms of safety and efficacy for treating high-risk patients, who had significantly higher event rates than patients with low-to-intermediate risk.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Thrombosis; Treatment Outcome

The combined use of a drug-eluting balloon (DEB) and a bare metal stent (BMS) for the treatment of de novo non-small vessel coronary artery diseases (CAD) remains to be evaluated. We investigated the efficacy of a sequential treatment using a DEB together with a BMS implantation in comparison to a zotarolimus-eluting stent (ZES). This study was a prospective, randomized, open-label study. We designed it to demonstrate the non-inferiority of a sequential treatment using a DEB first followed by a BMS (DEB + BMS) compared with the use of a ZES. The primary endpoint was in-segment late loss (LL) at 9 months measured by quantitative coronary angiography (QCA). A total of 180 patients were enrolled in the study. The 9-month follow-up angiography was performed in 72 patients with DEB + BMS and 74 patients with ZES. When comparing the DEB + BMS results with the ZES ones, LL was 0.50 ± 0.46 mm in DEB + BMS patients vs. 0.21 ± 0.44 mm in ZES patients (P < 0.001). The mean difference of the LL was 0.31 mm, which was larger than the prespecified non-inferiority margin of 0.19 mm, and the 2-sided 95% confidence interval was 0.15-0.48. The clinical outcomes were not significantly different. In conclusion, the DEB + BMS strategy is inferior to the ZES one in terms of the LL result at 9 months. The DEB strategy for de novo coronary artery lesions needs to be improved for it to become an alternative treatment option.

Topics: Age Factors; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Diabetes Complications; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Metals; Middle Aged; Prospective Studies; Sirolimus

The PRISON IV trial investigated the next-generation sirolimus-eluting stent (SES) with ultra-thin struts and biodegradable polymer against the second-generation everolimus-eluting stent (EES) with thin struts and durable polymer in patients with successfully recanalised chronic total occlusions (CTO). In this study, we examined the secondary optical coherence tomography endpoints.. The main PRISON IV trial randomised 330 patients to either SES or EES. At nine months, 281 (85%) patients underwent repeat angiography. Of these, 60 consecutive patients received optical coherence tomography divided over both stent groups. The mean number of struts analysed was 750±337 and 633±358 in SES and EES patients, respectively (p=0.07). The minimal lumen area, minimal stent area, maximal neointima area and neointimal thickness were comparable between the groups (4.8±2.1 and 4.4±1.5 mm2; 5.3±1.8 and 5.3±1.4 mm2; 2.5±2.0 and 2.2±1.5 mm2; 0.7±1.7 and 0.4±0.2 mm). The percentage of uncovered struts was higher with EES (6.2±7.5% and 11.9±13.4%, p=0.04), whereas the percentage of malapposed struts and mean number of coronary evaginations were significantly higher with SES (2.9±4.0% and 1.2±2.4%, p=0.02; 18.5±17.7 and 5.3±3.1, p=0.004).. The optical coherence tomography findings of this substudy demonstrated improved strut coverage with ultra-thin strut SES with bioresorbable polymer compared to thin-strut EES with durable polymer in CTO. On the other hand, SES showed a higher rate of stent strut malappositon and coronary evaginations. The clinical relevance of these findings remains to be demonstrated.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Polymers; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

This analysis investigates the 5-year outcomes of the biodegradable polymer biolimus-eluting stent (BP-BES) and durable polymer everolimus-eluting stent (DP-EES) in an all-comers population undergoing percutaneous coronary intervention.. Recent 1- and 3-year results from randomized trials have indicated similar safety and efficacy outcomes of BP-BES and DP-EES. Whether benefits of the biodegradable polymer device arise over longer follow-up is unknown. Moreover, in-depth, prospective, long-term follow-up data on metallic drug-eluting stents with durable or biodegradable polymers are scarce.. The COMPARE II trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent) was a prospective, randomized, multicenter, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BP-BES or DP-EES. The pre-specified endpoint at 5 years was major adverse cardiac events, a composite of cardiac death, nonfatal myocardial infarction, or target vessel revascularization.. Five-year follow-up was available in 2,657 patients (98%). At 5 years, major adverse cardiac events occurred in 310 patients (17.3%) in the BP-BES group and 142 patients (15.6%) in the DP-EES group (p = 0.26). The rate of the combined safety endpoint all-cause death or myocardial infarction was 15.0% in the BP-BES group versus 14.8% in the DP-EES group (p = 0.90), whereas the efficacy measure target vessel revascularization was 10.6% versus 9.0% (p = 0.18), respectively. Interestingly, definite stent thrombosis rates did not differ between groups (1.5% for BP-BES vs. 0.9% for DP-EES; p = 0.17).. The 5-year analysis comparing biodegradable polymer-coated BES and the durable polymer-coated EES confirms the initial early- and mid-term results regarding similar safety and efficacy outcomes in this all-comers percutaneous coronary intervention population.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to explore the safety and efficacy of a dedicated drug-eluting stent for the treatment of coronary lesions with very small reference vessel diameter (RVD).. Smaller RVD is associated with increased risk for restenosis and target lesion failure (TLF) after stent implantation.. This was a prospective, single-arm, multicenter trial of the Resolute Onyx 2.0-mm zotarolimus-eluting stent. The primary endpoint was 12-month TLF, which was compared with a pre-specified performance goal. Subjects with stable or unstable angina or ischemia, target lesions ≤27 mm in length, and RVD ≥2.0 and <2.25 mm were eligible for enrollment. A subset of subjects underwent follow-up angiography at 13 months post-procedure.. A total of 101 subjects with 104 lesions were enrolled. The mean age was 67.3 ± 9.6 years, 47% of subjects had diabetes, the mean lesion length was 12.6 ± 6.3 mm, and the mean RVD was 1.91 ± 0.26 mm. The rate of TLF at 12 months was 5.0%, fulfilling the pre-specified performance goal of 19% (p < 0.001). The rates of target lesion revascularization and target vessel myocardial infarction were 2.0% and 3.0%, respectively. There were no episodes of stent thrombosis. In-stent late lumen loss was 0.26 ± 0.48 mm, and the rate of binary restenosis was 12.0%.. In this first report of a drug-eluting stent with a dedicated size to treat lesions with RVD <2.25 mm, the Resolute Onyx 2.0-mm zotarolimus-eluting stent was associated with a low rate of TLF and late lumen loss, without a signal for stent thrombosis. This novel-sized drug-eluting stent appears to be a feasible option for the treatment of coronary lesions in extremely small vessels. (Medtronic Resolute Onyx 2.0 mm Clinical Study; NCT02412501).

Topics: Aged; Angina, Stable; Angina, Unstable; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; United States

The EVOLVE China randomised study sought to evaluate the clinical safety and effectiveness of the SYNERGY bioabsorbable polymer-coated everolimus-eluting stent (EES) for the treatment of patients with coronary heart disease in China.. Eligible patients with de novo native coronary artery lesions were randomised (1:1) to receive the SYNERGY or PROMUS Element Plus stent. The primary endpoint was in-stent late loss at nine months. Secondary endpoints included death, MI, revascularisation, and stent thrombosis up to 12 months. A total of 412 subjects were randomised (205 SYNERGY; 207 PROMUS Element Plus) at 14 sites in China from October 2013 to July 2014. SYNERGY was non-inferior to PROMUS Element Plus for the primary endpoint of nine-month in-stent late loss: SYNERGY 0.20±0.33 mm vs. PROMUS Element Plus 0.17±0.38 mm with an upper one-sided 97.5% confidence interval of the difference (0.10 mm), significantly less than the non-inferiority margin (0.15 mm; p<0.0008). Clinical adverse event rates were low and not significantly different between groups at nine and 12 months (all p>0.05).. In the EVOLVE China trial, the SYNERGY bioabsorbable polymer-coated EES was noninferior to the PROMUS Element Plus permanent polymer-coated EES for the primary endpoint of late loss at nine months.

Topics: Adolescent; Adult; Aged; China; Chromium; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platinum; Polymers; Sirolimus; Treatment Outcome; Young Adult

The aim of this study was to report whether the superiority of the everolimus-eluting stent (EES) vs. the paclitaxel-eluting stent (PES) at one-year follow-up in the Taxus Element versus Xience Prime in a Diabetic Population (TUXEDO)-India trial was sustained at longer-term follow-up.. One thousand eight hundred and thirty (1,830) patients with diabetes mellitus and coronary artery disease were randomised to EES vs. PES. Follow-up data up to two years were available in 1,701 (92.9%) patients. The primary endpoint was target vessel failure (TVF), defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischaemia-driven target vessel revascularisation (TVR). Treatment with EES had a lower two-year rate of TVF (4.3% vs. 6.6%, p=0.03). Of the secondary endpoints, EES significantly reduced any MI (1.6% vs. 3.5%, p=0.01), TV-MI (0.7% vs. 3.1%, p=0.0001), ST (0.4% vs. 2.2%, p=0.001), cardiac death or target vessel MI (2.9% vs. 4.8%, p=0.04) and TLR (1.9% vs. 3.7%, p=0.02), compared with PES. Between one year and two years, no significant differences in the clinical outcomes were observed (pinteraction >0.05).. In this adequately powered trial, the benefits of EES vs. PES in a diabetic population seen at one year were maintained at two years.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Diabetes Complications; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; India; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome

The aim of this study was to compare the performance of drug-coated stents (DCS) versus bare-metal stents (BMS) in patients who are candidates for long-term oral anticoagulation (OAC) after percutaneous coronary interventions.. The randomized controlled LEADERS FREE (A Randomized Clinical Evaluation of the BioFreedom™ Stent) trial demonstrated the superior safety and efficacy of a polymer-free biolimus A9 DCS compared with a similar BMS used with 1 month of dual antiplatelet therapy in 2,466 patients at high bleeding risk.. The 2 stents were compared in a pre-specified analysis of the 879 LEADERS FREE patients (35.6%) scheduled to remain on OAC after percutaneous coronary intervention. The primary safety endpoint was a composite of cardiac death, myocardial infarction, and stent thrombosis. The primary efficacy endpoint was the incidence of clinically driven target lesion revascularization.. Baseline characteristics of 448 DCS and 431 BMS recipients were similar, 78.8% had histories of atrial fibrillation, and 21% presented with acute coronary syndromes. Four hundred patients in the DCS group and 376 in the BMS group were discharged on OAC after percutaneous coronary intervention. At 2 years, for the DCS and BMS recipients, respectively, the incidence of clinically driven target lesion revascularization was 7.5% versus 11.2% (hazard ratio: 0.63; 95% confidence interval: 0.40 to 1.01; p = 0.0514), the safety endpoint was reached by 14.4% and 15.0% (p = NS), and the rates of major bleeding events (Bleeding Academic Research Consortium 3 to 5) were 10.7% and 12.9% (p = NS).. The efficacy advantage of DCS over BMS up to 2 years appears confirmed in patients on long-term OAC. Despite the very short course of dual antiplatelet therapy, both the DCS and BMS groups experienced similarly high rates of major bleeding. (A Randomized Clinical Evaluation of the BioFreedom™ Stent [Leaders Free]; NCT01623180).

Topics: Acute Coronary Syndrome; Administration, Oral; Aged; Aged, 80 and over; Anticoagulants; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Double-Blind Method; Drug-Eluting Stents; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Male; Metals; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

Our aim was to report the long-term safety and efficacy of the biodegradable polymer-coated biolimus- eluting Nobori stent compared to the durable polymer-coated sirolimus-eluting CYPHER stent.. SORT OUT V randomised 2,468 patients 1:1 to the Nobori (n=1,229) versus the CYPHER stent (n=1,239). Clinically driven event detection based on Danish registries was used. The primary endpoint was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularisation). Individual components of the primary endpoint comprise the secondary endpoints. At five-year follow-up, the composite endpoint rate was found to be similar in patients treated with the two study stents (Nobori 182/1,229 [14.8%] vs. CYPHER 197/1,239 [15.8%]; odds ratio [OR] 0.93, 95% CI: 0.75-1.16; p=0.53). The rates of definite stent thrombosis were also found to be similar in patients treated with the two study stents (Nobori 23/1,229 [1.9%] vs. CYPHER 18/1,239 [1.5%]; OR 1.31, 95% CI: 0.70-2.47; p=0.40), as were the other secondary endpoints.. At five-year follow-up, the Nobori stent with a biodegradable polymer coating provided a similar safety and efficacy profile when compared to the durable polymer first-generation CYPHER stent.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Incidence; Male; Middle Aged; Odds Ratio; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Recurrence; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The development of coronary drug-eluting stents has included use of new metal alloys, changes in stent architecture, and use of bioresorbable polymers. Whether these advancements improve clinical safety and efficacy has not been shown in previous randomised trials. We aimed to examine the clinical outcomes of a bioresorbable polymer sirolimus-eluting stent compared with a durable polymer everolimus-eluting stent in a broad patient population undergoing percutaneous coronary intervention.. BIOFLOW V was an international, randomised trial done in patients undergoing elective and urgent percutaneous coronary intervention in 90 hospitals in 13 countries (Australia, Belgium, Canada, Denmark, Germany, Hungary, Israel, the Netherlands, New Zealand, South Korea, Spain, Switzerland, and the USA). Eligible patients were those aged 18 years or older with ischaemic heart disease undergoing planned stent implantation in de-novo, native coronary lesions. Patients were randomly assigned (2:1) to either an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent or to a durable polymer everolimus-eluting stent. Randomisation was via a central web-based data capture system (mixed blocks of 3 and 6), and stratified by study site. The primary endpoint was 12-month target lesion failure. The primary non-inferiority comparison combined these data from two additional randomised trials of bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent with Bayesian methods. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02389946.. Between May 8, 2015, and March 31, 2016, 4772 patients were recruited into the study. 1334 patients met inclusion criteria and were randomly assigned to treatment with bioresorbable polymer sirolimus-eluting stents (n=884) or durable polymer everolimus-eluting stents (n=450). 52 (6%) of 883 patients in the bioresorbable polymer sirolimus-eluting stent group and 41 (10%) of 427 patients in the durable polymer everolimus-eluting stent group met the 12-month primary endpoint of target lesion failure (95% CI -6·84 to -0·29, p=0·0399), with differences in target vessel myocardial infarction (39 [5%] of 831 patients vs 35 [8%] of 424 patients, p=0·0155). The posterior probability that the bioresorbable polymer sirolimus-eluting stent is non-inferior to the durable polymer everolimus-eluting stent was 100% (Bayesian analysis, difference in target lesion failure frequency -2·6% [95% credible interval -5·5 to 0·1], non-inferiority margin 3·85%, n=2208).. The outperformance of the ultrathin, bioresorbable polymer sirolimus-eluting stent over the durable polymer everolimus-eluting stent in a complex patient population undergoing percutaneous coronary intervention suggests a new direction in improving next generation drug-eluting stent technology.. BIOTRONIK.

Topics: Absorbable Implants; Bayes Theorem; Coronary Artery Disease; Creatine Kinase, MB Form; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Sirolimus

To assess the vessel-healing pattern of Ultimaster drug-eluting stent using optical frequency domain imaging. Our hypothesis is that biodegradable polymer-based drug-eluting technology allows complete very early strut coverage.. The DISCOVERY 1TO3 study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months) is a prospective, single-arm, multicenter study. A total of 60 patients with multivessel disease requiring staged procedure at 1 month were treated with Ultimaster. Optical frequency domain imaging was acquired at baseline, 1, 2, and 3 months. The primary end point is optical frequency domain imaging-assessed strut coverage at 3 months. Mean age of patients was 67.2±9.9 years, and 73.3% were male, and 36.7% presented with acute coronary syndrome. A total of 132 lesions were treated, with average 1.4 lesions per patient treated at baseline and 1.1 lesions treated at 1 month. Strut coverage at 3 months of single implanted stents (n=71, primary end point) was 95.2±5.2% and of combined single and overlapped stents was 95.4±4.9%. Strut coverage of combined single and overlapped stents at 1 (n=49) and 2 months (n=38) was 85.1±12.7% and 87.9±10.8%, respectively. The median neointimal hyperplasia thickness was 0.04, 0.05, and 0.06 mm, whereas mean neointimal hyperplasia obstruction was 4.5±2.4%, 5.2±3.4%, and 6.6±3.3% at 1, 2, and 3 months, respectively.. Nearly complete strut coverage was observed in this complex population very early after implantation of Ultimaster drug-eluting stent.. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01844843.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Europe; Female; Humans; Hyperplasia; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Polyesters; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation has not been established yet. The objectives of this study were to evaluate the optimal duration of DAPT after the DES implantation.. From three randomized controlled trials investigating DAPT duration after coronary stent implantation, we evaluated the clinical outcomes of short-term (6 months or less) DAPT compared with prolonged DAPT (12 months or more) in 1661 DES-treated pairs matched by propensity scores. At follow-up of 1 year, net adverse clinical event (NACE) was defined as cardiac death, myocardial infarction, target vessel revascularization, definite/probable stent thrombosis, or thrombolysis in myocardial infarction major bleeding.. Short-term DAPT as compared with prolonged DAPT was not associated with 1-year NACEs after DES implantation [hazard ratio (HR) 1.068, 95 % confidence interval (CI) 0.787-1.450, p = 0.671]. Predictors for NACEs were old age (>75 years), hypertension, diabetes mellitus, renal dysfunction (serum creatinine ≥2.0 mg/dL), and multi-vessel disease. The DAPT strategy differentially contributed to the occurrence of NACEs according to the risk burden (p for interaction <0.001). In patients with low risk for NACEs, bleeding events were less in short-term DAPT than in prolonged DAPT (HR 0.332, 95 % CI 0.130-0.849, p = 0.021) (p for interaction = 0.098). Meanwhile, short-term DAPT was associated with more ischemic events that included cardiac death, myocardial infarction, target vessel revascularization, or definite/probable stent thrombosis (HR 2.164, 95 % CI 1.340-3.494, p = 0.002) (p for interaction <0.001) in patients with high risk for NACEs.. One-year clinical outcomes of DAPT after DES implantation depended on the burden of cardiovascular risk.

Topics: Aged; Aspirin; Clopidogrel; Coronary Artery Disease; Death, Sudden, Cardiac; Dose-Response Relationship, Drug; Drug Therapy, Combination; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Republic of Korea; Risk Factors; Sirolimus; Ticlopidine; Time Factors

We sought to compare, by means of IVUS and OCT imaging, the performance of a novel sirolimus-eluting drug-eluting stent (DES) with biodegradable polymer (Inspiron™) to the Biomatrix™ DES. From the DESTINY trial, a total of 70 randomized patients (2:1) were enrolled in the IVUS substudy (Inspiron™, n = 46; Biomatrix™: n = 20) while 25 patients were evaluated with OCT (Inspiron™, n = 19; Biomatrix™: n = 06) at 9-month follow-up. The main endpoints were % of neointimal tissue obstruction (IVUS) and neointimal stut coverage (OCT) at 9 months. Patients treated with both DES had very little NIH formation at 9 months either by IVUS (% of NIH obstruction of 4.9 ± 4.1 % with Inspiron™ vs. 2.7 ± 2.9 % with Biomatrix™, p = 0.03) or by OCT (neointimal thickness of 144.2 ± 72.5 µm Inspiron™ vs. 115.0 ± 53.9 µm with Biomatrix™, p = 0.45). Regarding OCT strut-level assessment, again both devices showed excellent 9-month performance, with high rates of strut coverage (99.49 ± 1.01 % with Inspiron™ vs. 97.62 ± 2.21 % with Biomatrix™, p < 0.001) and very rare malapposition (0.29 ± 1.06 % with Inspiron™ vs. 0.53 ± 0.82 % with Biomatrix™, p = 0.44). Patients with any uncovered struts were more frequently identified in the Biomatrix™ group (9.78 ± 7.13 vs. 2.29 ± 3.91 %, p < 0.001). In the present study, midterm IVUS and OCT evaluations showed that both new generation DES with biodegradable polymer were effective in terms of suppressing excessive neointimal response, with very high rates of apposed and covered struts, suggesting a consistent and benign healing pattern.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Humans; Metals; Neointima; Percutaneous Coronary Intervention; Polymers; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

This study sought to investigate the safety and efficacy of a biolimus-eluting stent with biodegradable polymer (BP-BES) (Nobori; Terumo Corp.) compared to an everolimus-eluting stent with durable polymer (DP-EES) (XIENCE V or Prime; Abbott Vascular, or PROMUS; Boston Scientific).. The all-comers NEXT and COMPARE II clinical trials randomly assigned 5,942 patients to BP-BES (N=3,412) or DP-EES (N=2,530). We conducted a patient level pooled analysis at three-year follow-up with specified study endpoints: definite stent thrombosis (ST), the combined safety endpoint cardiac death or target vessel myocardial infarction (TV-MI), and the efficacy endpoint target lesion revascularisation (TLR). At three-year follow-up, all endpoints, namely definite stent thrombosis (BP-BES 0.8% vs. 0.4%, p=0.20), death or TV-MI (BP-BES 7.8% vs. 6.7%, p=0.07), as well as TLR (BP-BES 6.4% vs. 6.4%, p=0.78) were similar between groups. Interestingly, unadjusted (BP-BES 5.6% vs. 4.5%, p=0.02) and adjusted (HR 1.36; 1.01-1.82, p=0.04) TV-MI rates were higher in the BP-BES group than in the DP-EES group.. In this large-scale patient level pooled analysis of the NEXT and COMPARE II randomised trials, the use of BP-BES compared with DP-EES resulted in similar outcomes, but with an observed higher rate of TV-MI in the BP-BES group.

Topics: Adult; Aged; Aged, 80 and over; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome

We aimed to investigate the impact of lesion calcification on angiographic outcomes after Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in comparison with those after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation.. The present post hoc analysis of the ABSORB Japan randomised trial compared post-procedure and 13-month angiographic outcomes between patients implanted with BVS and CoCr-EES based on the presence or absence of calcification, excluding extremely heavily calcified lesions or lesions requiring rotational atherectomy. The study population comprised 384 patients with 384 lesions (including 114 lesions [29.7%] with moderate or severe calcification), classified into two subgroups: calcification, 114 (BVS: n=72 and CoCr-EES: n=42) and non-calcification, 270 (BVS: n=181 and CoCr-EES: n=89). Follow-up angiography was performed in 94.8% of patients. Both post-procedure and follow-up in-device minimal lumen diameters were comparable in both the BVS arm (calcification vs. non-calcification: 2.43±0.32 mm vs. 2.43±0.39 mm, p=0.91 and 2.17±0.49 mm vs. 2.27±0.47 mm, p=0.17) and in the CoCr-EES arm (2.68±0.34 mm vs. 2.65±0.42 mm, p=0.62 and 2.57±0.52 mm vs. 2.47±0.53 mm, p=0.36).. Moderate or severe lesion calcification (excluding patients with extremely heavily calcified lesions or lesions requiring rotational atherectomy) does not negatively affect angiographic outcomes at both post-procedure and 13-month follow-up after BVS implantation.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome; Vascular Calcification

This study sought to assess the safety and effectiveness of the drug-filled stent (DFS) (Medtronic, Santa Rosa, California) in the treatment of patients with coronary artery disease.. Polymer-free drug-eluting stents have the potential to improve clinical outcomes and facilitate shorter durations of dual antiplatelet therapy. The polymer-free DFS is made from a trilayered continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner lumen coated with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution.. The RevElution trial enrolled 100 patients with de novo coronary lesions 2.25 to 3.50 mm in diameter and length ≤27 mm in 2 cohorts of 50 patients for angiographic, intravascular ultrasound, and clinical assessment at 9 or 24 months, with optical coherence tomography performed in a subset of 30 patients at each time period. The primary endpoint was angiographic in-stent late lumen loss at 9 months compared with Resolute zotarolimus-eluting stent (Medtronic) historical control data.. Fifty patients with 56 lesions were treated with DFS in the 9-month cohort. In-stent late lumen loss was 0.26 ± 0.28 mm for DFS and 0.36 ± 0.52 mm for Resolute (p. At 9 months, the polymer-free DFS was safe and effective with high rates of early strut coverage and noninferior late lumen loss compared to Resolute. (Medtronic RevElution Trial [RevElution]; NCT02480348).

Topics: Australia; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Latin America; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prosthesis Design; Risk Factors; Singapore; Sirolimus; Tantalum; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

The authors sought to compare the safety and efficacy of the biocompatible durable-polymer zotarolimus-eluting stent with the biodegradable-polymer biolimus-eluting stent in unselected coronary patients.. Biodegradable-polymer biolimus-eluting stents are superior to first-generation durable-polymer drug-eluting stents in long-term randomized all-comer trials. Long-term data comparing them to second-generation durable-polymer drug-eluting stents are lacking.. The study was a randomized, multicenter, all-comer, noninferiority trial in patients with chronic stable coronary artery disease or acute coronary syndromes and at least 1 coronary artery lesion requiring treatment with a drug-eluting stent. Endpoints included major adverse cardiac events (MACE), a composite of safety (cardiac death and myocardial infarction not clearly attributable to a non-target lesion) and efficacy (target lesion revascularization); the individual endpoints of MACE; all-cause mortality; any myocardial infarction; target vessel revascularization; and definite or probable stent thrombosis at 36 months.. From March 2011 to August 2012, 2,999 patients were randomly assigned (1:1) to receive either the zotarolimus-eluting (1,502 patients) or the biolimus-eluting (1,497 patients) stent. At 3-year follow-up, MACE occurred in 128 (8.6%) patients assigned to the durable-polymer zotarolimus-eluting stent and in 144 (9.6%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0.36). Occurrence of cardiac death (2.7% vs. 3.4%), myocardial infarction not clearly attributable to a non-target lesion (2.7% vs. 2.5%), and target lesion revascularization (5.4% vs. 5.5%) did not differ significantly between the 2 groups. Definite very late stent thrombosis occurred in 6 (0.4%) patients assigned to the durable-polymer zotarolimus-eluting stent and in 10 (0.7%) assigned to the biodegradable-polymer biolimus-eluting stent (p = 0.33).. At 3-year follow-up, the durable-polymer zotarolimus-eluting stent and the biodegradable-polymer biolimus-eluting stent were similar in clinical outcome, with no significant difference in safety and efficacy outcomes, including stent thrombosis.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Denmark; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To evaluate the effects of sex and anthropometry on clinical outcomes in patients who underwent percutaneous coronary intervention (PCI).. From three randomized trials (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation, Impact of intraVascular UltraSound guidance on outcomes of Xience Prime stents in Long lesions, Chronic Total Occlusion InterVention with drUg-eluting Stents), we compared 333 pairs of men and women matched by propensity scores, all of whom underwent intravascular ultrasound (IVUS)-guided PCI for complex lesions.. For 12 months, the incidence of adverse cardiac events, defined as the composite of cardiac death, target lesion-related myocardial infarction, and target lesion revascularization, was not different between women and men (2.4% vs. 2.4%, p=0.939). Using multivariable Cox's regression analysis, post-intervention minimum lumen area [MLA; hazard ratio (HR)=0.620, 95% confidence interval (CI)=0.423-0.909, p=0.014] by IVUS was a predictor of adverse cardiac events. Height on anthropometry and lesions with chronic total occlusion were significantly related to post-intervention MLA. However, female sex was not independently associated with post-intervention MLA. In an age and sex-adjusted model, patients in the low tertile of height exhibited a greater risk for adverse cardiac events than those in the high tertile of height (HR=6.391, 95% CI=1.160-35.206, p=0.033).. Sex does not affect clinical outcomes after PCI for complex lesions. PCI outcomes, however, may be adversely affected by height.

Topics: Aged; Anthropometry; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Propensity Score; Proportional Hazards Models; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

First-generation drug-eluting coronary stents (DES) were introduced in 2003 to 2004, and their use resulted in a considerable reduction in the development of in-stent restenosis at the cost of an increased risk of late stent thromboses.. This study followed clinical outcomes of patients included in a large randomized trial for 10 years to enable detection of late changes in annual event rates that could necessitate medical attention.. A total of 2,098 unselected all-comer patients (50% with acute coronary syndrome) were randomly assigned to have a first-generation DES implanted. This study recorded the occurrence of a major adverse cardiac event (MACE) assessed as the composite of cardiac death, myocardial infarction, and target vessel revascularization. Stent thromboses were also assessed.. Of the 2,098 unselected patients, 73.1% were still alive after 10 years. During the follow-up period, MACE occurred in 346 (32.5%) in the group receiving a sirolimus-eluting stent and in 342 (33.1%) in the group receiving a paclitaxel-eluting stent (hazard ratio: 0.96; 95% confidence interval: 0.83 to 1.11; p = 0.60), with a steady annual rate of 2.6% after the first year. Definite, probable, and possible stent thrombosis appeared in 279 patients (13.3%), with no difference between stent types and with a steady annual rate of 1.3% after the first year.. Among the surviving patients, the long-term annual MACE rate and the stent thrombosis rate appeared constant for both stent types, with no apparent late changes. Although there is no need for extraordinary medical attention for these patients, the absence of declines in annual event rates calls for continuous surveillance. (Danish Organization on Randomized Trials With Clinical Outcome II [SORT OUT II]; NCT00388934).

Topics: Aged; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Time Factors; Treatment Outcome

The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation remains undetermined, especially for those at high risk of cardiac events postprocedure.. This study was aimed to investigate the impact of 6 versus 12 months of DAPT after DES implantation based on risk stratification with the residual SYNTAX score (rSS).. A total of 2737 patients in the I-LOVE-IT 2 trial were grouped according to rSS status (low rSS [rSS = 0, n = 1474] versus high rSS [rSS > 0, n = 1263]) and DAPT duration (6 months vs. 12 months). The primary endpoint was 12-month target lesion failure (TLF), and the major secondary endpoints were 12-month net adverse clinical events (NACE) and major bleeding.. Incidences of TLF (5.2 vs. 7.4%, P = 0.01) and NACE (9.2 vs. 13.4%, P < 0.001) at 12 months were significantly higher in patients with high rSSs compared with patients with low rSSs. Landmark analysis showed that, in patients with high rSS, 12-month DAPT was associated with slightly lower risks of TLF (3.0% vs. 1.6%, P = 0.08) and NACE (7.0 vs. 4.4%, P = 0.054) compared with 6-month DAPT within 6 to 12 months after PCI. Patients with different DAPT durations had similar risks of bleeding both in the low and high rSS groups.. Patients with high rSSs have an increased risk of TLF and NACE at 12 months after DES implantation. Twelve-month DAPT might be superior to 6-month DAPT in patients with high rSS for reducing adverse events within 6 to 12 months after PCI without excessive risk of bleeding. © 2017 Wiley Periodicals, Inc.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; China; Coronary Angiography; Coronary Artery Disease; Decision Support Techniques; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Platelet Aggregation Inhibitors; Predictive Value of Tests; Proportional Hazards Models; Prospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Previous studies have suggested a benefit of cilostazol in addition to standard dual-antiplatelet therapy (DAPT), reducing in-stent late luminal loss and restenosis after percutaneous coronary intervention (PCI) with bare-metal and drug-eluting stent (DES) implantation. However, there is a paucity of intravascular ultrasound (IVUS) assessment of neointimal tissue hyperplasia (NIH) after triple-antiplatelet therapy (TAPT), especially in diabetic patients treated with DES.. This prospective, placebo-controlled trial was conducted in diabetic patients randomized (1:1) to receive either standard DAPT (aspirin and clopidogrel) vs TAPT with cilostazol for a minimum of 12 months after PCI with Endeavor zotarolimus-eluting stent (E-ZES). The primary endpoint was the 9-month comparison of percentage of NIH in both groups. Additionally, we compared in-stent late lumen loss, binary restenosis, major adverse cardiac event (MACE; cardiac death, non-fatal myocardial infarction, and restenosis) rates, and the incidence of vascular/bleeding complications.. In total, 133 diabetic patients were enrolled (cilostazol cohort = 65 patients) with 56.4% male and mean age of 60.8 years. Overall, the two cohorts were comparable in terms of baseline clinical and angiographic characteristics, except for the reference vessel diameter, which was smaller among patients randomized to cilostazol (2.48 ± 0.46 mm vs 2.69 ± 0.48 mm; P=.01). At 9 months, there was a non-significant trend toward less percentage of NIH obstruction in the TAPT cohort (33.2 ± 8.29% vs 35.1 ± 8.45%; P=.07). However, this finding did not impact angiographic late-lumen loss (0.60 ± 0.46 mm cilostazol group vs 0.64 ± 0.48 mm control group; P=.30) and binary restenosis (9.8% vs 6.8%; P=.99). MACE rate also did not significantly differ between the cohorts (13.8% cilostazol group vs 8.8% control group; P=.81). Of note, the addition of a third antiplatelet agent did not increase vascular and bleeding complications.. In diabetic patients treated with E-ZES, TAPT with cilostazol did not add any significant benefit in terms of NIH suppression or MACE reduction.

Topics: Aspirin; Cilostazol; Clopidogrel; Comorbidity; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Diabetes Mellitus; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Sirolimus; Tetrazoles; Ticlopidine; Treatment Outcome

Both biodegradable polymer sirolimus-eluting stents and permanent polymer everolimus-eluting stents offer potential for enhanced late outcomes in comparison with earlier-generation permanent polymer sirolimus-eluting stents. However, long-term comparative efficacy data among these devices remain a scientific gap. We aimed to compare the efficacy and safety of biodegradable polymer sirolimus-eluting stents (Yukon Choice PC) versus permanent polymer everolimus-eluting stents (XIENCE) versus permanent polymer sirolimus-eluting stents (CYPHER) at five-year follow-up.. Overall, 2,603 patients were randomised to treatment with the Yukon Choice PC (n=1,299), XIENCE (n=652) or CYPHER (n=652) stents. The primary endpoint was the device-oriented composite of cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularisation (TLR). The main secondary endpoint was definite/probable stent thrombosis (ST). Follow-up was performed up to five years. Concerning the primary endpoint, there was no significant difference between Yukon Choice PC and XIENCE stents (20.5% vs. 19.5%, HR=1.04, 95% CI: 0.84-1.29; p=0.71) or between CYPHER and XIENCE stents (23.5% vs. 19.5%, HR=1.21, 95% CI: 0.95-1.53; p=0.12). In terms of safety, rates of ST were similar with both Yukon Choice PC and XIENCE (1.2% vs. 1.4%; HR=0.83, 95% CI: 0.37-1.91; p=0.67) but numerically higher with CYPHER as compared to XIENCE (2.4% vs. 1.4%, HR=1.67, 95% CI: 0.73-3.82; p=0.22).. Biodegradable polymer Yukon Choice PC and permanent polymer XIENCE stents showed comparable clinical outcomes at five years. Permanent polymer CYPHER stents showed numerically higher rates of device-related adverse events. Trials registration: ClinicalTrials.gov (identifier: NCT00598676).

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To assess the "real world" clinical outcome of patients with bifurcated lesions undergoing percutaneous coronary intervention with implantation of second and third generations of zotarolimus-eluting stent.. Nine Italian centres participated in a prospective multicentre clinical project evaluating the outcome of patients receiving zotarolimus-eluting Resolute stent and Resolute Integrity stents. Patients with bifurcated lesions entered this evaluation. Clinical characteristics and angiographic and procedural details were prospectively recorded. Clinical outcome was prospectively assessed to evaluate the occurrence of major adverse cardiac events (MACE). A total of 577 patients were enrolled. The target lesion was distal left main in 11.1% and left anterior descending artery in 52.8%, and 30.3% of lesions were Medina 1,1,1. At a mean follow-up time of 27.0 ± 13.5 months, the survival free from MACE was 91.8%. Survival free from MACE was similar in patients grouped according to different bifurcated lesion complexity. On the contrary, patients receiving a single stent had better survival free from MACE as compared with those with double stent (P = 0.005). At multivariable analysis, double stenting (but not bifurcated lesion complexity) was found to be a significant predictor of MACE (hazard ratio, 2.52; 95% confidence interval, 1.28-4.94; P = 0.007). Of note, patients receiving the second stent as a bail-out had worse survival free from MACE compared with those who received it as a planned technique (P = 0.045).. The treatment of patients with bifurcated lesions with second and third generation zotarolimus-eluting stents is associated with good long-term clinical outcomes. Clinical outcome seems to be independent of lesion complexity, but may be influenced by the stenting technique (single or double stenting as well as elective or bail-out double stenting). © 2015 Wiley Periodicals, Inc.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

This study aimed at comparing the mid-term clinical outcome of everolimus-eluting (EES) with sirolimus-eluting (SES) stents in the provisional bifurcation stenting guided by intravascular ultrasound (IVUS). We compared the clinical outcome up to 9-month follow-up results of the prospective J-REVERSE registry of 300 non-left main bifurcation lesions in 298 patients treated with EES (n = 240) and SES (n = 60). The SB dilation with the kissing balloon technique (KBT) was performed in 54 %. The patient and lesion characteristics of the groups were similar. The incidences of SB dissections, occlusions, stenting, and slow flow were similar. A greater luminal volume gain was achieved in the proximal MV after KBT compared in non-KBT treated lesions in the EES group (7.9 ± 2.4 versus 7.0 ± 2.0 mm(3)/mm, p = 0.002), though not in the SES group. The SB diameter stenosis in the non-KBT treatment at 9 months was greater than the KBT in both groups. The incidence of target lesion revascularisation (TLR) was 5.0 % in the EES versus 8.3 % in the SES group (p = 0.35), and the incidence of major adverse cardiac events, including TLR, myocardial infarction, stent thrombosis, and death was 5.4 % in the EES versus 11.7 % in the SES group (p = 0.15). IVUS-guided provisional stenting with EES achieved a greater luminal gain after than without KBT, and similar clinical outcomes as with SES up to 9-month follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Male; Myocardial Infarction; Myocardial Revascularization; Prospective Studies; Registries; Sirolimus; Thrombosis; Ultrasonography, Interventional

To demonstrate the safety and efficacy of a new sirolimus eluting stent with bioresorbable polymer, Ultimaster, (BP-SES) compared with everolimus-eluting, permanent polymer, Xience stent (PP-EES) in bifurcation lesions with respect to the freedom from Target Lesion Failure at 1-year.. Within 1,119 patients enrolled in the CENTURY II randomized controlled multicenter trial, 194 patients were treated for bifurcation lesions and randomized to either BP-SES (n = 95) or PP-EES (n = 99). The primary endpoint was freedom from target lesion failure (TLF) composite endpoint [cardiac death, MI not clearly attributable to a non-target vessel, and clinically driven target lesion revascularization (TLR)] at 1-year.. Baseline patient demographic, angiographic, and stenting characteristics were similar in both study arms. A single stent technique with provisional or "cross over" stenting were the most widely used in both arms (93.2% BP-SES vs. 92.4% PP-EES). Freedom from TLF at 1-year was 94.7% for BP-SES and 91.9% for PP-EES (P for noninferiority 0.031). The rate of clinically driven target lesion revascularization (TLR) at 1-year was 3.2% for BP-SES and 3.0% for PP-EES (P = 0.95). There were no significant differences detected in any of the individual clinical endpoints or other secondary clinical endpoints between the study arms at 1-year follow up.. The new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting in the treatment of patients with bifurcation lesions at 1-year follow up. © 2015 Wiley Periodicals, Inc.

Topics: Absorbable Implants; Aged; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Single-Blind Method; Sirolimus; Time Factors

Percutaneous coronary intervention (PCI) in bifurcated lesions with second-generation drug-eluting stents (DES) was associated with increased myocardial infarction (MI) rates. Flexible stent designs that accommodate well to vessel tapering may be of benefit in challenging anatomies such as bifurcated target lesions, but so far data are scarce.. We analyzed the 2-year follow-up data of the DUTCH PEERS (TWENTE II) trial, which randomized 1811 all-comer patients to PCI with newer generation resolute integrity zotarolimus-eluting (Medtronic) or promus element everolimus-eluting stents (Boston Scientific). In bifurcated lesions, provisional stenting was generally performed. Target vessel failure is a composite endpoint, consisting of cardiac death, target vessel MI, or target vessel revascularization.. Patients with at least one bifurcated lesion (n = 465, 25.7 %) versus patients with non-bifurcated target lesions only (n = 1346, 74.3 %) showed similar rates of clinical endpoints including target vessel failure (9.2 versus 7.9 %, p = 0.36) and definite stent thrombosis (0.4 versus 1.0 %, p = 0.38). Target vessel MI was more common in patients with bifurcated lesions (3.4 versus 1.6 %, p = 0.02); but after multivariate analysis with propensity score adjustment, bifurcation treatment was found not to be an independent predictor of target vessel MI (HR 1.40, 95 % CI 0.71-2.76; p = 0.34). Among patients with bifurcated lesions, DES type and side-branch size did not affect outcome, but periprocedural MI occurred more often after two-stent approaches (9.0 versus 2.1 %; p = 0.002).. All-comer patients treated for bifurcated and non-bifurcated target lesions showed similar and low rates of clinical endpoints, suggesting that the DES used are efficacious and safe for treating bifurcated target lesions.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Netherlands; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The Ultimaster bioresorbable polymer sirolimus-eluting stent (BP-SES) is a newly developed drug-eluting stent (DES) that consists of a thin-strut, cobalt chromium with bioresorbable polymer coated only albuminally. We sought to compare tissue coverage in coronary lesions treated with BP-SES with the XIENCE permanent polymer everolimus-eluting stent (PP-EES) using optical coherence tomography (OCT).. A total of 36 patients participated in the CENTURY II trial in our institution and were randomly assigned to BP-SES (n = 15) and PP-EES (n = 21). Of these, 27 patients (13 BP-SES and 14 PP-EES) underwent OCT at 9-month follow-up. Tissue coverage and apposition were assessed on each strut, and the results in both groups were compared using multilevel logistic or linear regression models with random effects at three levels: patient, lesion, and struts. A total of 6450 struts (BP-SES, n = 2951; PP-EES, n = 3499) were analysed. Thirty and 79 uncovered struts (1.02 and 2.26%, P = 0.35), and 3 and 4 malapposed struts (0.10 and 0.11%, P = 0.94) were found in BP-SES and PP-EES groups, respectively. Mean neointimal thickness did not significantly differ between both groups (110 ± 10 vs. 93 ± 10 µm, P = 0.22). No significant differences in per cent neointimal volume obstruction (13.2 ± 4.6 vs. 10.5 ± 4.9%, P = 0.14) or other areas-volumetric parameters were detected between both groups.. BP-SES shows an excellent vascular healing response at 9-month follow-up, which is similar to PP-EES.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Japan; Male; Neointima; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Single-Blind Method; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

The Absorb bioresorbable vascular scaffold (Absorb BVS) provides similar clinical outcomes compared with a durable polymer-based everolimus-eluting metallic stent (EES) in stable coronary artery disease patients. ST-elevation myocardial infarction (STEMI) lesions have been associated with delayed arterial healing and impaired stent-related outcomes. The purpose of the present study is to compare directly the arterial healing response, angiographic efficacy and clinical outcomes between the Absorb BVS and metallic EES.. A total of 191 patients with acute STEMI were randomly allocated to treatment with the Absorb BVS or a metallic EES 1:1. The primary endpoint is the neointimal healing (NIH) score, which is calculated based on a score taking into consideration the presence of uncovered and malapposed stent struts, intraluminal filling defects and excessive neointimal proliferation, as detected by optical frequency domain imaging (OFDI) six months after the index procedure. The study will provide 90% power to show non-inferiority of the Absorb BVS compared with the EES.. This will be the first randomised study investigating the arterial healing response following implantation of the Absorb BVS compared with the EES. The healing response assessed by a novel NIH score in conjunction with results on angiographic efficacy parameters and device-oriented events will elucidate disease-specific applications of bioresorbable scaffolds.

Topics: Absorbable Implants; Adolescent; Adult; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Sirolimus; Treatment Outcome; Young Adult

This study evaluated coronary endothelial function after the implantation of sirolimus-eluting stents (SESs), everolimus-eluting stents (EESs), and zotarolimus-eluting stents (ZES) by a different methodology, and also analyzed whether optical coherence tomography (OCT) findings represent endothelial healing after stenting.. It is unclear whether OCT assessment of stent strut coverage represents endothelial healing after drug-eluting stent implantation.. Thirty patients with a left anterior descending artery lesion were randomized 1:1:1 to receive an SES, EES, or ZES. The vascular response was evaluated 6 months after stenting by three methods: the functional response by acetylcholine infusion, the morphological response by OCT, and the biological response by measuring vascular endothelial growth factor (VEGF) levels.. The proportion of uncovered struts by OCT at 6 months was significantly higher in both SES and EES than in ZES. However, the vasomotor response was impaired and the VEGF level of the coronary sinus was significantly lower in SES than in EES and ZES. There were no relationships between the OCT findings and vasomotor response to acetylcholine and VEGF levels in all cohorts.. The vascular response at 6 months was more preserved in ZES and EES than in SES. Our results suggest that the morphological assessment with OCT may not always be used as a surrogate for functional and biological healing response after stenting. © 2015 Wiley Periodicals, Inc.

Topics: Acetylcholine; Aged; Aged, 80 and over; Biomarkers; Cardiovascular Agents; Coronary Artery Disease; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Endothelium, Vascular; Everolimus; Female; Humans; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular Endothelial Growth Factor A; Vasodilation; Vasodilator Agents; Wound Healing

The aim of the POLBOS II randomised trial was to compare any regular drug-eluting stents (rDES) with the dedicated bifurcation sirolimus-eluting stent BiOSS LIM for the treatment of coronary bifurcation lesions. The secondary aim was to study the effect of final kissing balloon inflation (FKBI) on clinical outcomes.. Between December 2012 and December 2013, 202 patients with stable coronary artery disease or non-ST-segment elevation acute coronary syndrome were randomly assigned 1:1 to treatment of the coronary bifurcation lesions either with the BiOSS LIM stent (n=102) or with an rDES (n=100). Coronary re-angiography was performed at 12 months. The primary endpoint was the composite of cardiac death, myocardial infarction (MI), and target lesion revascularisation (TLR) at 12 months. The target vessel was located in the left main in one third of the cases (35.3% in BiOSS and 38% in rDES). Side branch treatment was required in 8.8% (rDES) and 7% (BiOSS). At 12 months, the cumulative MACE incidence was similar in both groups (11.8% [BiOSS] vs. 15% [rDES, p=0.08]), as was the TLR rate (9.8% vs. 9% [p=0.8]). The binary restenosis rates were significantly lower in the FKBI subgroup of the BiOSS group (5.9% vs. 11.8%, p<0.05).. MACE rates as well as TLR rates were comparable between the BiOSS LIM and rDES. At 12 months, cumulative MACE incidence was similar in both groups (11.8% vs. 15%), as was the TLR rate (9.8% vs. 9%). Significantly lower rates of restenosis were observed in the FKBI subgroup of the BiOSS group.

Topics: Acute Coronary Syndrome; Adult; Aged; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Sirolimus; Treatment Outcome

Historically, percutaneous coronary intervention (PCI) of bifurcation lesions was associated with worse procedural and clinical outcomes when compared with PCI of non-bifurcation lesions. Newer generation drug-eluting stents (DES) might improve long-term clinical outcomes after bifurcation PCI.. The LEADERS trial was a 10-center, assessor-blind, non-inferiority, all-comers trial, randomizing 1,707 patients to treatment with a biolimus A9(TM) -eluting stent (BES) with an abluminal biodegradable polymer or a sirolimus-eluting stent (SES) with a durable polymer (ClinicalTrials.gov Identifier: NCT00389220). Five-year clinical outcomes were compared between patients with and without bifurcation lesions and between BES and SES in the bifurcation lesion subgroup. There were 497 (29%) patients with at least 1 bifurcation lesion (BES = 258; SES = 239). At 5-year follow-up, the composite endpoint of cardiac death, myocardial infarction (MI) and clinically-indicated (CI) target vessel revascularization (TVR) was observed more frequently in the bifurcation group (26.6% vs. 22.4%, P = 0.049). Within the bifurcation lesion subgroup, no differences were observed in (cardiac) death or MI rates between BES and SES. However, CI target lesion revascularization (TLR) (10.1% vs. 15.9%, P = 0.0495), and CI TVR (12.0% vs. 19.2%, P = 0.023) rates were significantly lower in the BES group. Definite/probable stent thrombosis (ST) rate was numerically lower in the BES group (3.1% vs. 5.9%, P = 0.15). Very late (>1 year) definite/probable ST rates trended to be lower with BES (0.4% vs. 3.1%, P = 0.057).. In the treatment of bifurcation lesions, use of BES led to superior long-term efficacy compared with SES. Safety outcomes were comparable between BES and SES, with an observed trend toward a lower rate of very late definite/probable ST between 1 and 5 years with the BES. © 2015 Wiley Periodicals, Inc.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

In percutaneous coronary intervention (PCI) patients new-generation drug-eluting stent (DES) has reduced adverse events in comparison to early-generation DES. The aim of the current study was to investigate the long-term clinical efficacy and safety of new-generation DES versus early-generation DES for PCI of unprotected left main coronary artery (uLMCA) disease.. The patient-level data from the ISAR-LEFT MAIN and ISAR-LEFT MAIN 2 randomized trials were pooled. The clinical outcomes of PCI patients assigned to new-generation DES (everolimus- or zotarolimus-eluting stent) versus early-generation DES (paclitaxel- or sirolimus-eluting stent) were studied. The primary endpoint was the composite of death, myocardial infarction (MI), target lesion revascularization and stroke (MACCE, major adverse cardiac and cerebrovascular event).. In total, 1257 patients were available. At 3 years, the risk of MACCE was comparable between patients assigned to new-generation DES or early-generation DES (28.2 versus 27.5 %, hazard ratio-HR 1.03, 95 % confidence intervals-CI 0.83-1.26; P = 0.86). Definite/probable stent thrombosis was low and comparable between new-generation DES and early-generation DES (0.8 versus 1.6 %, HR 0.52, 95 % CI 0.18-1.57; P = 0.25); in patients treated with new-generation DES no cases occurred beyond 30 days. Diabetes increased the risk of MACCE in patients treated with new-generation DES but not with early-generation DES (P interaction = 0.004).. At 3-year follow-up, a PCI with new-generation DES for uLMCA disease shows comparable efficacy to early-generation DES. Rates of stent thrombosis were low in both groups. Diabetes significantly impacts the risk of MACCE at 3 years in patients treated with new-generation DES for uLMCA disease. ClinicalTrials.gov Identifiers: NCT00133237; NCT00598637.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Germany; Humans; Italy; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Stroke; Time Factors; Treatment Outcome

The objective of this study is to assess 3-year clinical outcome of patients with true bifurcation lesions (TBLs) versus non-true bifurcation lesions (non-TBLs) following treatment with second-generation drug-eluting stents (DES). TBLs are characterized by the obstruction of both main vessel and side-branch. Limited data are available on long-term clinical outcome following TBL treatment with newer-generation DES. We performed an explorative sub-study of the randomized TWENTE trial among 287 patients who had bifurcated target lesions with side-branches ≥2.0 mm. Patients were categorized into TBL (Medina classes: 1.1.1; 1.0.1; 0.1.1) versus non-TBL to compare long-term clinical outcome. A total of 116 (40.4 %) patients had TBL, while 171 (59.6 %) had non-TBL only. Target-lesion revascularization rates were similar (3.5 vs. 3.5 %; p = 1.0), and definite-or-probable stent thrombosis rates were low (both <1.0 %). The target-vessel myocardial infarction (MI) rate was 11.3 versus 5.3 % (p = 0.06), mostly driven by (periprocedural) MI ≤48 h from PCI. All-cause mortality and cardiac death rates were 8.7 versus 3.5 % (p = 0.06) and 3.5 versus 1.2 % (p = 0.22), respectively. The 3-year major adverse cardiac event rate for patients with TBL versus non-TBL was 20.0 versus 11.7 % (p = 0.05). At 1-, 2-, and 3-year follow-up, 6.5, 13.0, and 11.0 % of patients reported chest pain at less than or equal moderate physical effort, respectively, without any between-group difference. Patients treated with second-generation DES for TBL had somewhat higher adverse event rates than patients with non-TBL, but dissimilarities did not reach statistical significance. Up to 3-year follow-up, the vast majority of patients of both groups remained free from chest pain.

Topics: Aged; Angina Pectoris; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

We compared the outcomes of a novel, thin-strut, cobalt-chromium, absorbable, polymer sirolimus-eluting stent (APSES; MiStent) to the durable polymer cobalt-chromium everolimus-eluting stent (EES; Xience). A propensity-matched analysis was performed comparing data from the DES With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in the Native Coronary Arteries (DESSOLVE) I and II studies, evaluating the APSES to the EES arm of the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents-4 study. Target lesion failure (TLF) and its components were evaluated at 12 months and annually to 3 years; 805 patients (APSES = 153; EES = 652) were included with propensity matching in 204 patients (APSES = 102; EES = 102). APSES compared with EES had lower TLF at 1 year (3.0% vs 8.0%, p = 0.12) driven by a difference in target lesion revascularization (TLR; 1% vs 6%, p = 0.05), with no difference in target vessel myocardial infarction (p = 0.56) or stent thrombosis (p = 0.31). At 3 years, TLF (5.0% vs 12.5%, p = 0.07) and TLR (2.0% vs 8.4%, p = 0.04) remained lower with APSES. By landmark analysis, there was no significant difference in TLF between 1 and 3 years (p = 0.36). In conclusion, in a propensity-matched analysis, the APSES demonstrated reduced clinically indicated TLR rates at 1 and 3 years compared with the durable polymer EES, with minimal accrual of events between 1 and 3 years.

Topics: Absorbable Implants; Aged; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Propensity Score; Prosthesis Design; Sirolimus; Treatment Outcome

The aim of this study was to compare the efficacy of amphilimus-eluting stents (AES) with that of everolimus-eluting stents (EES) in patients with diabetes mellitus (DM).. The AES is a polymer-free drug-eluting stent that elutes sirolimus formulated with an amphiphilic carrier from laser-dug wells. This technology could be associated with a high efficacy in patients with DM.. This was a multicenter, randomized, noninferiority trial. Patients with DM medically treated with oral glucose-lowering agents or insulin and de novo coronary lesions were randomized in a 1:1 fashion to AES or EES. The primary endpoint was the neointimal (NI) volume obstruction assessed by optical coherence tomography at 9-month follow-up.. A total of 116 lesions in 112 patients were randomized. Overall, 40% were insulin-treated patients, with a median HbA1c of 7.3% (interquartile range: 6.7% to 8.0%). The primary endpoint, NI volume obstruction, was 11.97 ± 5.94% for AES versus 16.11 ± 18.18% for EES, meeting the noninferiority criteria (p = 0.0003). Pre-specified subgroup analyses showed a significant interaction between stent type and glycemic control (p = 0.02), with a significant reduction in NI hyperplasia in the AES group in patients with the higher HbA1c (p = 0.03). By quantitative coronary angiography, in-stent late loss was 0.14 ± 0.24 for AES versus 0.24 ± 0.57 mm for EES (p = 0.27), with a larger minimal lumen diameter at follow-up for AES (p = 0.02), mainly driven by 2 cases of occlusive restenosis in the EES group.. AES are noninferior to EES for the coronary revascularization of patients with DM. These results suggest a high efficacy of the AES and may support the potential benefit of this stent in patients with DM. (A Randomized Comparison of Reservoir-Based Polymer-Free Amphilimus-Eluting Stents Versus Everolimus-Eluting Stents With Durable Polymer in Patients With Diabetes Mellitus [RESERVOIR]; NCT01710748).

Topics: Aged; Biomarkers; Blood Glucose; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Female; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Spain; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The purpose of this study was to evaluate the efficacy and long-term outcomes of a novel polymer/carrier-free drug-coated stent (DCS) in patients with de novo coronary lesions.. The BioFreedom (BFD) DCS incorporates a low-profile, stainless-steel platform, with a surface that has been modified to create a selectively microstructured abluminal surface that allows adhesion and further release of Biolimus A9 (Biosensors Europe SA, Morges, Switzerland).. A total of 182 patients (183 lesions) were randomized into a 1:1:1 ratio for treatment with BFD "standard dose" (BFD) or BFD "low dose" (BFD-LD) versus first-generation paclitaxel-eluting stents (PES) at 4 sites in Germany.. Baseline and procedural characteristics were well matched. At 4-month angiographic follow-up (Cohort 1, n = 75), in-stent late lumen loss (LLL) was significantly lower with BFD and BFD-LD versus PES (0.08 and 0.12 mm vs. 0.37 mm, respectively; p < 0.0001 for BFD vs. PES, and p = 0.002 for BFD-LD vs. PES). At 12 months (Cohort 2, n = 107), in-stent LLL (primary endpoint) was 0.17 mm in BFD versus 0.35 mm in PES (p = 0.001 for noninferiority; p = 0.11 for superiority); however, the BFD-LD (0.22 mm) did not reach noninferiority (p = 0.21). At 5 years (175 of 182), there were no significant differences in major adverse cardiac events (23.8%, 26.4%, and 20.3%) and clinically indicated target lesion revascularization (10.8%, 13.4%, and 10.2%) for BFD, BFD-LD, and PES, respectively; also, there was no definite/probable stent thrombosis reported.. The BFD, but not the BFD-LD, demonstrated noninferiority versus PES in terms of in-stent LLL, a surrogate of neointimal hyperplasia, at 12-month follow-up. At 5 years, clinical event rates were similar, without occurrence of stent thrombosis in all groups. (BioFreedom FIM Clinical Trial; NCT01172119).

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Stainless Steel; Surface Properties; Time Factors; Treatment Outcome

Head-to-head optical coherence tomography (OCT) data comparing metallic stents with bioresorbable vascular scaffolds (BVS) are lacking. This study assessed vascular healing at 9-month follow-up after implantation of everolimus- and biolimus-eluting stents (EES; BES) and everolimus-eluting BVS.. OCT was performed in 74 patients enrolled in the EVERBIO II (NCT01711931) trial (23 with EES: 26 lesions, 7 625 struts; 23 with BES: 26 lesions, 6 140 struts; 28 with BVS: 33 lesions, 10 891 struts). OCT images were acquired using the pullback and nonocclusive flushing technique and analysed offline.. BVS demonstrated fewer uncovered struts per patient (12 ± 27 [3.8 ± 8.4%] vs 59 ± 55 [21.8 ± 13.7%] in the EES&BES group, p <0.001), and thicker neointimal hyperplasia (BVS 102 ± 44 µm vs EES&BES 66 ± 36 µm, p <0.01). There was no significant difference with regard to malapposed struts (2.1 ± 2.7% in the BVS vs 4.4 ± 8.8% in the EES&BES group, p = 0.41). In a predefined signal intensity scale, quantitative analysis of the "key component" (black) revealed lower intensity in BVS than EES&BES (14 ± 23% vs 13 ± 12%, p = 0.007). Intensity was lower in polylactide-containing stents (BVS&BES) than in EES (15 ± 19% vs 10 ± 10%, p <0.001).. BVS has fewer uncovered struts and presents with a thicker neointimal coverage compared with EES&BES. It is not known whether this improved capping correlates with superior vascular healing. Polylactide-containing stents (BVS and BES) demonstrate lower peristrut intensity compared with EES.

Topics: Absorbable Implants; Aged; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Single-Blind Method; Sirolimus; Tissue Scaffolds; Tomography, Optical Coherence; Treatment Outcome

Long-term safety and efficacy for everolimus-eluting stents (EES) versus those of sirolimus-eluting stents (SES) are unknown.. This study compared 5-year outcomes for EES with those for SES from the SORT OUT IV (Scandinavian Organization for Randomized Trials with Clinical Outcome) trial.. Five-year follow-up was completed for 2,771 patients (99.9%). Primary endpoint was a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and definite stent thrombosis.. At 5-years, MACE occurred in 14.0% and 17.4% in the EES and SES groups, respectively (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.66 to 0.97; p = 0.02). The MACE rate did not differ significantly within the first year (HR: 0.96, 95% CI: 0.71 to 1.19; p = 0.79), but from years 1 through 5, the MACE rate was lower with EES (HR: 0.71, 95% CI: 0.55 to 0.90; p = 0.006; p interaction = 0.12). Definite stent thrombosis was lower with EES (0.4%) than with SES (2.0%; HR: 0.18, 95% CI: 0.07 to 0.46), with a lower risk of very late definite stent thrombosis in the EES group (0.2% vs. 1.4%, respectively; HR: 0.16, 95% CI: 0.05 to 0.53). When censoring the patients at the time of stent thrombosis, we found no significant differences between the 2 stent groups for MACE rates (HR: 0.89, 95% CI: 0.73 to 1.08; p = 0.23), target lesion revascularization (HR: 0.90, 95% CI: 0.64 to 1.27; p = 0.55), and MI (HR: 0.93, 95% CI: 0.64 to 1.36; p = 0.72).. At 5-year follow-up, MACE rate was significantly lower with EES- than with SES-treated patients, due largely due to a lower risk of very late definite stent thrombosis. (Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease [SORT OUT IV]; NCT00552877).

Topics: Coronary Artery Disease; Denmark; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Postoperative Complications; Prosthesis Design; Retrospective Studies; Single-Blind Method; Sirolimus; Survival Rate; Time Factors; Treatment Outcome

This study sought to investigate the ischemic and bleeding outcomes of patients fulfilling high bleeding risk (HBR) criteria who were randomized to zotarolimus-eluting Endeavor Sprint stent (E-ZES) or bare-metal stent (BMS) implantation followed by an abbreviated dual antiplatelet therapy (DAPT) duration for stable or unstable coronary artery disease.. DES instead of BMS use remains controversial in HBR patients, in whom long-term DAPT poses safety concerns.. The ZEUS (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates) is a multinational, randomized single-blinded trial that randomized among others, in a stratified manner, 828 patients fulfilling pre-defined clinical or biochemical HBR criteria-including advanced age, indication to oral anticoagulants or other pro-hemorrhagic medications, history of bleeding and known anemia-to receive E-ZES or BMS followed by a protocol-mandated 30-day DAPT regimen. The primary endpoint of the study was the 12-month major adverse cardiovascular event rate, consisting of death, myocardial infarction, or target vessel revascularization.. Compared with patients without, those with 1 or more HBR criteria had worse outcomes, owing to higher ischemic and bleeding risks. Among HBR patients, major adverse cardiovascular events occurred in 22.6% of the E-ZES and 29% of the BMS patients (hazard ratio: 0.75; 95% confidence interval: 0.57 to 0.98; p = 0.033), driven by lower myocardial infarction (3.5% vs. 10.4%; p < 0.001) and target vessel revascularization (5.9% vs. 11.4%; p = 0.005) rates in the E-ZES arm. The composite of definite or probable stent thrombosis was significantly reduced in E-ZES recipients, whereas bleeding events did not differ between stent groups.. Among HBR patients with stable or unstable coronary artery disease, E-ZES implantation provides superior efficacy and safety as compared with conventional BMS. (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS]; NCT01385319).

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Male; Metals; Myocardial Infarction; Patient Selection; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Stents; Time Factors; Treatment Outcome

No data are available on the long-term performance of ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES). We reported 2-year clinical outcomes of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularisation) trial, which compared BP-SES with durable-polymer everolimus-eluting stents (DP-EES) in patients undergoing percutaneous coronary intervention.. A total of 2119 patients with minimal exclusion criteria were assigned to treatment with BP-SES (n=1063) or DP-EES (n=1056). Follow-up at 2 years was available for 2048 patients (97%). The primary end point was target-lesion failure, a composite of cardiac death, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. At 2 years, target-lesion failure occurred in 107 patients (10.5%) in the BP-SES arm and 107 patients (10.4%) in the DP-EES arm (risk ratio [RR] 1.00, 95% CI 0.77-1.31, P=0.979). There were no significant differences between BP-SES and DP-EES with respect to cardiac death (RR 1.01, 95% CI 0.62-1.63, P=0.984), target-vessel myocardial infarction (RR 0.91, 95% CI 0.60-1.39, P=0.669), target-lesion revascularization (RR 1.17, 95% CI 0.81-1.71, P=0.403), and definite stent thrombosis (RR 1.38, 95% CI 0.56-3.44, P=0.485). There were 2 cases (0.2%) of definite very late stent thrombosis in the BP-SES arm and 4 cases (0.4%) in the DP-EES arm (P=0.423). In the prespecified subgroup of patients with ST-segment elevation myocardial infarction, BP-SES was associated with a lower risk of target-lesion failure compared with DP-EES (RR 0.48, 95% CI 0.23-0.99, P=0.043, Pinteraction=0.026).. Comparable safety and efficacy profiles of BP-SES and DP-EES were maintained throughout 2 years of follow-up.. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Linear Models; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Switzerland; Time Factors; Treatment Outcome

The aim of this study was to evaluate the late clinical performance of a polymer-free sirolimus- and probucol-eluting stent compared with a new-generation durable polymer-based zotarolimus-eluting stent.. It was previously shown that polymer-free sirolimus- and probucol-eluting stents were noninferior to zotarolimus-eluting stents at 12 months. However, long-term follow-up of these devices is critical to evaluate late comparative efficacy.. In a clinical trial with minimal exclusion criteria, 3,002 patients were randomly assigned to treatment with polymer-free sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents. The primary endpoint was the combined incidence of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization.. At 5 years, there was no difference in the incidence of the primary endpoint between sirolimus- and probucol-eluting stents and zotarolimus-eluting stents (23.8% vs. 24.2%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.84 to 1.15; p = 0.80). The rates of the individual components of the primary endpoint were also comparable in both groups. The incidence of definite or probable stent thrombosis was low in both groups (1.3% vs. 1.6%, respectively; hazard ratio: 0.86; 95% confidence interval: 0.46 to 1.62; p = 0.64). The rates of any death, myocardial infarction, and revascularization were similar in both groups. Results were consistent across pre-specified subgroups of age, sex, diabetes, and vessel size.. Long-term outcomes of patients treated with polymer-free sirolimus- and probucol-eluting stents compared with a new-generation durable polymer-based zotarolimus-eluting stent were similar. Rates of stent thrombosis were low and comparable in both treatment groups, with few events beyond 12 months. (Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis [ISAR-TEST-5]; NCT00598533).

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Probucol; Proportional Hazards Models; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Whether the rate of drug elution and polymer absorption affects clinical outcomes of biodegradable polymer-based drug-eluting stents (DES) is unknown. The widely used polylactide polymer-based Excel stent (JW Medical, Weihai, China) elutes sirolimus within 180 days, and the polylactide polymer is completely absorbed within 6 to 9 months. In contrast, the poly-lactide-co-glycolide polymer-based BuMA stent (Sino Medical, Tianjin, China) elutes sirolimus within 30 days, and the poly-lactide-co-glycolide polymer is completely absorbed within 3 months. Thus, both metallic DES elute sirolimus, isolating major differences to the polymer and elution kinetics.. The goal of this study was to compare the safety and effectiveness between the BuMA sirolimus-eluting stent (SES) and Excel SES in an "all-comers" population.. PANDA III was a multicenter trial with few exclusion criteria, powered for sequential noninferiority and superiority testing. The primary endpoint was 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization.. Between December 2013 and August 2014, 2,348 patients were randomly assigned to treatment with BuMA (n = 1,174) or Excel SES (n = 1,174). The 1-year primary endpoint of TLF occurred in 6.4% of patients in each group (difference: 0.06%; 95% confidence interval: 1.93% to 2.04%; pnoninferiority = 0.0003; psuperiority = 0.95). There were no significant between-group differences in any of the secondary endpoints other than the incidence of definite/probable stent thrombosis, which occurred less frequently with the BuMA stent (0.5% vs. 1.3%; log-rank p = 0.048).. The BuMA SES was demonstrated to be noninferior to the Excel SES for 1-year TLF, with a lower incidence of stent thrombosis. (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice [PANDA-III]; NCT02017275).

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Percutaneous Coronary Intervention; Polyesters; Polymers; Prospective Studies; Prosthesis Design; Sirolimus; Thrombosis

Our aim is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.. The EBC MAIN study is a prospective, multinational, randomised clinical study of left main stem true bifurcation lesions (type 1,1,1 or 0,1,1: both left anterior descending and circumflex artery >2.75 mm diameter). The study hypothesis is that left main coronary bifurcation lesions are best treated with a planned single-stent strategy rather than a planned dual-stent strategy, with respect to death, target lesion revascularisation and myocardial infarction at one year. A total of 450 patients will be enrolled and treated either with a planned single or a planned dual zotarolimus-eluting stent strategy according to randomisation. The primary study endpoint is a composite of death, myocardial infarction and target lesion revascularisation at 12 months. Secondary endpoints are: death, myocardial infarctions, and target lesion revascularisation, each at 12 months; angina status, stent thrombosis, death, myocardial infarction, target lesion revascularisation at three- and five-year clinical follow-up.. EBC MAIN will be the first randomised clinical trial to compare single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.

Topics: Aged; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

There is an ongoing controversy regarding the efficacy and safety of different percutaneous stenting techniques for coronary bifurcation lesions needing >1 stent. The promise of safe vessel restoration with bioresorbable scaffolds (BRS) may not be transferable to complex double BRS bifurcation techniques, and permanent metallic scaffolding of the bifurcation core may be needed. We identified modified-T stenting as the most promising fully bioresorbable 2-stent strategy in a preclinical setting. The objective of this study is to assess acute performance and compare long-term vessel healing with this strategy, versus an approach combining BRS with a dedicated metallic drug-eluting bifurcation stent.. In a single center, 60 consecutive patients with true and complex coronary bifurcation lesions will be randomly assigned to treatment with the dedicated self-expanding Axxess. To date the use of Absorb

Topics: Absorbable Implants; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Middle Aged; Prosthesis Design; Sirolimus; Tissue Scaffolds; Tomography, Optical Coherence; Treatment Outcome

Metal absorbable scaffolds constitute a conceptually attractive alternative to polymeric scaffolds. Promising 6-month outcomes of a second-generation drug-eluting absorbable metal scaffold (DREAMS 2G), consisting of an absorbable magnesium scaffold backbone, have been reported. We assessed the 12-month safety and performance of this novel device.. The prospective, international, multi-centre, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to two de novo lesions with a reference diameter between 2.2 and 3.7 mm. All patients were scheduled for angiographic follow-up at 6 months, and-if subjects consented-at 12 months. Dual antiplatelet therapy was recommended for 6 months. Quantitative coronary angiography (QCA) parameters remained stable from 6 to 12 months [paired data of 42 patients: in-segment late lumen loss 0.20 ± 0.21 mm vs. 0.25 ± 0.22 mm, P = 0.117, Δ 0.05 ± 0.21 mm (95% CI: -0.01;0.12); in-scaffold late lumen loss 0.37 ± 0.25 mm vs. 0.39 ± 0.27 mm, P = 0.446, Δ 0.03 ± 0.22 (95% CI: -0.04;0.10), respectively]. Intravascular ultrasound and optical coherence tomography findings corroborated the QCA results. Target lesion failure occurred in four patients (3.4%), consisting of one death of unknown cause, one target-vessel myocardial infarction, and two clinically driven target lesion revascularization. No additional event occurred beyond the 6-month follow-up. During the entire follow-up of 12 months, none of the patients experienced a definite or probable scaffold thrombosis.. The novel drug-eluting metal absorbable scaffold DREAMS 2G showed a continuous favourable safety profile up to 12 months and stable angiographic parameters between 6 and 12 months.. NCT01960504.

Topics: Absorbable Implants; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Humans; Metals; Prospective Studies; Sirolimus; Treatment Outcome

This registry evaluated the safety and clinical outcomes of the Combo stent in an all-comers population in routine clinical practice. We report 1-year results.. Limitations of current generation drug-eluting stents (DES) are 3-fold: stent thrombosis, neoatherosclerosis related to impaired healing, and repeat revascularization due to (late-) in-stent restenosis. The Combo stent combines an abluminal biodegradable coating eluting sirolimus and a luminal anti-CD34(+) antibody layer to attract endothelial progenitor cells in order to promote vessel healing, thus preventing neointima formation and restenosis.. The REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) post-market registry was an international, multicenter, prospective trial that evaluated clinical outcomes after deployment of the Combo stent, in an all-comers population of patients treated with a Combo stent in the setting of routine clinical care. Clinical endpoints were target lesion failure (TLF), defined as a composite of cardiac death, nonfatal myocardial infarction (MI), or target lesion revascularization (TLR).. Between June 2013 and March 2014, a total of 1,000 patients were included in the registry, 49.9% of whom presented with acute coronary syndrome. Mean age was 65 ± 11 years old (range: 34 to 94 years of age), and 74% of patients were male; 58.9% of 1,255 lesions were American Heart Association type B2 or C lesions. The primary endpoints were 5.7% TLF, 1.7% cardiac death, 0.7% target vessel MI, and 4.4% TLR. Definite stent thrombosis occurred in 0.5% of subjects; no thrombosis occurred after 9 days post-stenting.. This registry showed excellent 1-year results of novel Combo bioengineered stent technology in an all-comers patient population. (Prospective Registry to Assess the Long-term Safety and Performance of the Combo Stent [REMEDEE]; NCT01874002).

Topics: Acute Coronary Syndrome; Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Neointima; Percutaneous Coronary Intervention; Product Surveillance, Postmarketing; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Wound Healing

Treatment of lesions in small vessels was associated with worse clinical outcome, and various definitions of "small vessels" have been used. Data with novel drug-eluting stents are scarce.. To compare the outcome of patients with vs without small-vessel treatment, we assessed 2-year follow-up data of the DUTCH PEERS randomized trial (ClinicalTrials.gov: NCT01331707), in which 1,811 all-comers were treated with contemporary zotarolimus-eluting (Resolute Integrity) or everolimus-eluting (Promus Element) stents. Primary end point was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization.. The rates of TLF (9.5% vs 5.4%; P log rank = .001) and 2 individual components thereof-target vessel myocardial infarction (3.1% vs 1.3%; P log rank = .006) and target lesion revascularization (4.8% vs 2.8%; P log rank = .02)-were higher among 798 (44.1%) patients treated in at least one small vessel (<2.50 mm by quantitative coronary angiography). Multivariate analysis with propensity score adjustment demonstrated that treatment of small-vessel lesions independently predicted TLF at 2-year follow-up (hazard ratio 1.60, 95% CI 1.09-2.34). Patients with the smallest target vessel being <2.25 mm had TLF rates similar to patients with smallest target vessels of 2.25 to <2.50 mm; however, patients treated in vessels no smaller than 2.50 to <3.00 mm and patients treated in vessels ≥3.00 mm had lower TLF rates (9.3%, 9.8%, 5.0%, and 5.8%, respectively; P log rank = .009).. Patients treated with novel drug-eluting stents in small-vessel lesions had higher adverse event rates than did patients who had no small-vessel treatment. Our data suggest that with current stents, a vessel diameter <2.50 mm is a suitable threshold to identify small target vessels.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Organ Size; Outcome and Process Assessment, Health Care; Percutaneous Coronary Intervention; Sirolimus

CENTURY II is a prospective, multicentre, randomised, single-blind trial comparing the bioresorbable polymer sirolimus-eluting Ultimaster® stent (BP-SES) with the permanent polymer everolimus-eluting XIENCE stent (PP-EES). Here we present a pre-specified analysis of safety and efficacy outcomes in a subgroup of patients with small vessel coronary artery disease.. CENTURY II included 525 patients with lesions of reference diameter ≤2.5 mm. Treatment was randomly assigned: 277 patients received BP-SES (399 lesions) and 248 patients received PP-EES (377 lesions). The primary outcome was target lesion failure (TLF), which is a composite of cardiac death, target vessel-related myocardial infarction (MI) and target lesion revascularisation (TLR). There was no significant difference between treatment groups in baseline or procedural data. Mean pre-procedural reference diameter was similar (BP-SES 2.30±0.40 mm, PP-EES 2.31±0.42 mm, p=0.59). Stented length was 24.0±11.7 mm for BP-SES and 23.5±11.5 mm for PP-EES (p=0.45). At 12 months, there was no significant difference between the BP-SES and PP-EES groups in TLF (6.9% vs. 7.7%; p=0.72), cardiac death (1.1% vs. 1.2%; p=0.90), target vessel MI (1.8% vs. 3.2%; p=0.30), TLR (4.0% vs. 5.7%; p=0.37), or definite or probable stent thrombosis (0.7% vs. 1.2%; p=0.57).. In the large-scale, randomised CENTURY II trial, use of BP-SES and PP-EES for the treatment of small vessel coronary artery disease resulted in similar outcomes at 12 months.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Sirolimus

The aim of this study was to analyze the difference in neointima pattern assessed by intravascular ultrasound (IVUS) between two dedicated bifurcation stents, BiOSS® Expert and BiOSS® LIM at 12-month follow-up. This manuscript reports IVUS findings obtained from the analysis of patients enrolled into first-in-man registries initially assessing the BiOSS Expert® (paclitaxel) and BiOSS LIM® (sirolimus) stents. Quantitative angiographic analysis was performed pre, post-stenting, and at follow-up. IVUS examination was performed at 12 months. There were analyzed 34 cases (BiOSS Expert® 11 patients, BiOSS LIM® 23 patients). Procedural characteristics in the two groups were similar, except for rates of main vessel predilatation and FKB/POT, which were higher in BiOSS® LIM group, 54.5 % vs 73.9 % (P < 0.05) and 0 % vs 39.1 % (P < 0.05), respectively. When comparing late lumen loss (LLL) for both stents there were significantly bigger values for main vessel and main branch in the BiOSS® Expert group, but not in side branch. Intravascular ultrasound examination showed that in the BiOSS LIM® group comparing with the BiOSS Expert® group there was lower neointima burden in the whole stent (24.7 ± 7.5 % vs 19.4 ± 8.6 %, P < 0.05) as well as in main vessel (22.8 ± 5.6 % vs 16.9 ± 6.1 %, P < 0.05) and main branch (36.1 ± 6.5 % vs 27.6 ± 8.7 %, P < 0.05), but not at the level of bifurcation (15.1 ± 3.8 % vs 13.6 ± 5.4 %, P = NS). In addition, we found that final kissing balloon/proximal optimization technique (FKB/POT) was associated with significantly smaller value of LLL in main vessel (0.24 ± 0.09 mm vs 0.32 ± 0.14 mm, P < 0.05), which in IVUS analysis resulted in smaller neointima burden in main vessel (13.7 ± 3.9 % vs 18.9 ± 4.45 %, P < 0.05) as well as at the bifurcation site (12.6 ± 4.1 % vs 14.1 ± 2.4 %, P < 0.05). The obtained results suggest that neointima proliferation was the largest in main branches of both stents assessed in quantitative angiography (LLL) as well as in IVUS (neointima burden) and the neointima increase was smaller in BiOSS LIM® stents than in BiOSS Expert® stents. Moreover, the middle part of the stent seems to not to be associated with excessive neointima proliferation and more aggressive protocol of implantation with the use FKB/POT seems to decrease this process.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Non-ST Elevated Myocardial Infarction; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Registries; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Coronary drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy.. The Scandinavian Organization for Randomized Trials With Clinical Outcome (SORT OUT) VII trial-a large-scale registry-based randomized, multicenter, single-blind, 2-arm, noninferiority trial-compared 2 biodegradable polymer drug-eluting stents: the thin-strut cobalt-chromium sirolimus-eluting Orsiro stent and the stainless steel biolimus-eluting Nobori stent in an all-comer patient population. The primary end point target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 1 year, analyzed by intention to treat (noninferiority margin of 3.0%). Clinically driven event detection based on Danish registries was used. A total of 1261 patients were assigned to receive the sirolimus-eluting stent (1590 lesions) and 1264 patients to the biolimus-eluting stent (1588 lesions). At 1 year, the composite end point target lesion failure occurred in 48 patients (3.8%) in the sirolimus-eluting group and in 58 patients (4.6%) in the biolimus-eluting group (absolute risk difference, -0.78% [upper limit of 1-sided 95% confidence interval, 0.61%]; P<0.0001). Rates of definite stent thrombosis occurred in 5 (0.4%) of the sirolimus-eluting group compared with 15 (1.2%) biolimus-eluting stent-treated patients (rate ratio, 0.33; 95% confidence interval, 0.12-0.92; P=0.034), which largely was attributable to a lower risk of subacute definite stent thrombosis: 0.1% versus 0.6% (rate ratio, 0.12; 95% confidence interval, 0.02-1.00; P=0.05).. The thin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent in unselected patients for target lesion failure at 1 year.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01879358.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Chromium Alloys; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Intention to Treat Analysis; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Registries; Risk Factors; Scandinavian and Nordic Countries; Single-Blind Method; Sirolimus; Stainless Steel; Time Factors; Treatment Outcome

Current monotherapy drug-eluting stents are associated with impaired healing, neoatherosclerosis, and late stent thrombosis. The healing profile and neointimal transformation of the first dual-therapy endothelial progenitor cell-capturing sirolimus-eluting stent are unknown.. In this prospective, single-center study, 61 patients treated with the Combo stent had optical coherence tomography at baseline, early follow-up (4 monthly groups in a 1:2:2:1 ratio from 2 to 5 months), 9 months, and 24 months. Optical coherence tomography early strut coverage increased from 77.1% to 92.5% to 92.7% to 94.9% between 2 and 5 months. At 9 months, the major adverse cardiac event rate was 1.64%, and angiographic in-stent late loss was 0.24 mm (0.08-0.40). The 36-month major adverse cardiac event rate was 3.3%. From 9 to 24 months, neointimal regression was confirmed by optical coherence tomography: neointimal thickness (median [first quartile and third quartile]), 0.14 mm (0.08 and 0.21) versus 0.12 mm (0.07 and 0.19), P<0.001; neointimal volume, 29.9 mm(3) (22.1 and 43.2) versus 26.2 mm(3) (19.6 and 35.8), P=0.003; and percent neointimal volume, 17.8% (12.2 and 21.2) versus 15.7% (11.2 and 19.4), P=0.01. No definite or probable late stent thrombosis was recorded.. With additional endothelial progenitor cell-capturing technology, the Combo stent exhibits a unique late neointimal regression (from 9 to 24 months) that has not been reported in any drug-eluting stents, translating into good 36-month clinical results with minimal restenosis and no late stent thrombosis. This is the first study testing the concept of using a longitudinal sequential optical coherence tomography protocol to continuously document early healing profile and late neointimal transformation, predicting long-term outcomes of a new novel stent platform.. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01274234, NCT01756807, and NCT02263313.

Topics: Aged; Cardiovascular Agents; Combined Modality Therapy; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Endothelial Progenitor Cells; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

This study presents the two-year clinical outcomes of the Amsterdam ABSORB registry stratified by lesion and patient characteristics complexity (SYNTAX score and ABSORB II study enrolment criteria).. Patients treated with BVS were included in this prospective registry and stratified according to the ABSORB II trial inclusion and exclusion criteria and the SYNTAX score. The registry comprises 135 patients (59±11 years, 73% male, 18% diabetic) with 159 lesions. Median follow-up duration was 774 days (742-829). Median SYNTAX score was 11.5 (Q1-Q3: 6-17.5). Two-year event rates were cardiac death 0.7%, MI 5.3%, TVR 13.6%, TLR 11.4%, definite ST 3.0% and TVF 14.4%, respectively. Stratified analyses showed a significantly higher revascularisation rate in patients not meeting ABSORB II criteria (TVR: 2.3% vs. 19.2%, p=0.010, and TLR: 2.3% vs. 15.8%, p=0.025) and patients with SYNTAX score ≥11.5 (TVR: 4.8% vs. 21.8%, p=0.006, and TLR: 3.2% vs. 17.4%, p=0.007).. The use of Absorb BVS in patients meeting the ABSORB II trial inclusion criteria or those with low SYNTAX scores is associated with acceptable clinical outcomes at two-year follow-up. Patients with more complex characteristics have significantly higher revascularisation rates.

Topics: Absorbable Implants; Adult; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Sirolimus; Treatment Outcome

A randomised clinical trial of bioresorbable vascular scaffold (BVS) vs. metal drug-eluting stent (DES) was initiated, using positron emission tomography (PET) perfusion imaging to assess the effects of both treatments on (hyperaemic) myocardial blood flow (MBF) and coronary flow reserve (CFR) over a three-year period (VANISH trial). In the present study, early, i.e., after one month, MBF and CFR are reported.. Sixty patients (45 men [75%], 55±7 years) with a documented single-vessel type A or B1 lesion were included in this single-blind randomised clinical trial. Patients were randomised to implantation of a BVS or DES in a one-to-one fashion. Approximately one month after percutaneous coronary intervention, patients underwent [15O]H2O PET to assess (hyperaemic) MBF, cold pressor test MBF, and CFR. One patient refused PET perfusion at one-month follow-up (in the DES arm). MBF of the treated myocardial territory during rest, CPT, and hyperaemia were not different in BVS-treated patients as compared to DES-treated patients (1.02±0.28 vs. 0.96±0.24 mL·min-1·g-1, p=0.38, 1.20±0.38 vs. 1.08±0.23 mL·min-1·g-1, p=0.16, and 3.04±0.80 vs. 3.33±0.77 mL·min-1·g-1, p=0.16, respectively). CFR of the treated myocardial territory was significantly lower in the BVS-treated patients (3.09±0.94 vs. 3.57±0.85, p<0.05).. No differences in PET-derived absolute myocardial perfusion were observed between BVS-treated patients as compared to DES-treated patients at one-month follow-up. CFR was attenuated in BVS-treated patients, although still within the normal range.

Topics: Absorbable Implants; Adult; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome

We sought to assess the performance of drug-eluting stents combining an ultrathin cobalt-chromium platform with a biodegradable polymer across categories of increasing SYNTAX score (SS).. Patients included in the BIOSCIENCE trial and randomly allocated to treatment with biodegradable polymer sirolimus-eluting stents (BP-SES) or durable polymer everolimus-eluting stents (DP-EES) were categorised according to SS tertiles (low <8, medium 8-15, high >15). The primary endpoint, target lesion failure (TLF), was defined as a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation. The patient-oriented endpoint (POCE) included death, myocardial infarction, or any repeat revascularisation. The SS was available in 2,041 out of 2,119 patients (96.3%). At two-year follow-up, patients with an SS >15 experienced higher rates of both TLF and POCE as compared to patients with medium and low SS (14.5% vs. 8.1% and vs. 5.9%, p<0.001; 22.7% vs. 14.9% and vs. 12.4%; p<0.001), respectively. Comparable rates of the composite endpoints were documented for both stent types in each category of SS.. Increasing lesion complexity as assessed by SS was associated with higher rates of TLF and POCE in a contemporary PCI population with minimal exclusion criteria. BP-SES and DP-EES showed comparable performance across the entire spectrum of CAD severity.

Topics: Absorbable Implants; Adult; Aged; Aged, 80 and over; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome

Our aim was to demonstrate the safety and efficacy of the Svelte sirolimus-eluting coronary stent-on-a-wire Integrated Delivery System (IDS) with bioresorbable drug coating compared to the Resolute Integrity zotarolimus-eluting stent with durable polymer in patients with de novo coronary artery lesions.. Direct stenting, particularly in conjunction with transradial intervention (TRI), has been associated with reduced bleeding complications, procedure time, radiation exposure and contrast administration compared to conventional stenting with wiring and predilatation. The low-profile Svelte IDS is designed to facilitate TRI and direct stenting, reducing the number of procedural steps, time and cost associated with coronary stenting. DIRECT II was a prospective, multicentre trial which enrolled 159 patients to establish non-inferiority of the Svelte IDS versus Resolute Integrity using a 2:1 randomisation. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Target vessel failure (TVF), as well as secondary clinical endpoints, will be assessed annually up to five years. At six months, in-stent LLL was 0.09±0.31 mm in the Svelte IDS group compared to 0.13±0.27 mm in the Resolute Integrity group (p<0.001 for non-inferiority). TVF at one year was similar across the Svelte IDS and Resolute Integrity groups (6.5% vs. 9.8%, respectively).. DIRECT II demonstrated the non-inferiority of the Svelte IDS to Resolute Integrity with respect to in-stent LLL at six months. Clinical outcomes at one year were comparable between the two groups.

Topics: Absorbable Implants; Adult; Aged; Aged, 80 and over; Coronary Angiography; Coronary Artery Disease; Drug Carriers; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

The prevalence of factors that are associated with an increased risk of stent thrombosis (ST), including smoking, diabetes mellitus, and small stent size, is different in women and men who underwent percutaneous coronary intervention. Thus, gender may potentially modify the relation between stent type and the incidence of ST during long-term follow-up. We explored the data of Patient Related Outcomes With Endeavor Versus Cypher stenting Trial (PROTECT) to evaluate this hypothesis. PROTECT randomized 2,061 women and 6,648 men who underwent percutaneous coronary intervention for various indications to Endeavor zotarolimus-eluting stenting (E-ZES) or Cypher sirolimus-eluting stenting (C-SES). Dual antiplatelet therapy was prescribed for at least 3 months. Data on study end points were collected until 5 years after randomization, including ST, death, and cardiovascular events. We analyzed end points and treatment effect (E-ZES vs C-SES) in relation to gender. Women were on average 4.7 years older (65.8 vs 61.1), had a higher prevalence of insulin-dependent diabetes mellitus, were less often smokers, and had a shorter total stent length than men. At discharge and throughout follow-up, a slightly lower fraction of women were using dual antiplatelet therapy. During 5-year follow-up, definite or probable ST was observed in 36 women (1.8%) and 152 men (2.4%; log-rank p = 0.15). E-ZES reduced the incidence of ST compared with C-SES in women (hazard ratio 0.58) and men (hazard ratio 0.61), with no evidence of heterogeneity (p = 0.89). In conclusion, in PROTECT, women and men had similar cumulative incidence of ST at 5 years after stent placement. The favorable effect of the study stent E-ZES over C-SES was not modified by gender.

Topics: Aged; Antibiotics, Antineoplastic; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Hypoglycemic Agents; Insulin; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Proportional Hazards Models; Sex Factors; Sirolimus; Thrombosis; Treatment Outcome

Limited data are available on the long-term effects of contemporary drug-eluting stents versus contemporary bare-metal stents on rates of death, myocardial infarction, repeat revascularization, and stent thrombosis and on quality of life.. We randomly assigned 9013 patients who had stable or unstable coronary artery disease to undergo percutaneous coronary intervention (PCI) with the implantation of either contemporary drug-eluting stents or bare-metal stents. In the group receiving drug-eluting stents, 96% of the patients received either everolimus- or zotarolimus-eluting stents. The primary outcome was a composite of death from any cause and nonfatal spontaneous myocardial infarction after a median of 5 years of follow-up. Secondary outcomes included repeat revascularization, stent thrombosis, and quality of life.. At 6 years, the rates of the primary outcome were 16.6% in the group receiving drug-eluting stents and 17.1% in the group receiving bare-metal stents (hazard ratio, 0.98; 95% confidence interval [CI], 0.88 to 1.09; P=0.66). There were no significant between-group differences in the components of the primary outcome. The 6-year rates of any repeat revascularization were 16.5% in the group receiving drug-eluting stents and 19.8% in the group receiving bare-metal stents (hazard ratio, 0.76; 95% CI, 0.69 to 0.85; P<0.001); the rates of definite stent thrombosis were 0.8% and 1.2%, respectively (P=0.0498). Quality-of-life measures did not differ significantly between the two groups.. In patients undergoing PCI, there were no significant differences between those receiving drug-eluting stents and those receiving bare-metal stents in the composite outcome of death from any cause and nonfatal spontaneous myocardial infarction. Rates of repeat revascularization were lower in the group receiving drug-eluting stents. (Funded by the Norwegian Research Council and others; NORSTENT ClinicalTrials.gov number, NCT00811772 .).

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Retreatment; Sirolimus; Stents

In percutaneous coronary intervention for de-novo coronary bifurcation lesions, the optimal technique for provisional side-branch stenting is still a matter of debate. We tested whether in this setting culotte stenting reduces the incidence of restenosis as compared with T-and-protrusion (TAP) stenting.. This trial included 300 patients with a coronary bifurcation lesion requiring a side-branch stent. Patients were randomly assigned to culotte stenting or TAP stenting using drug-eluting stents in a 1:1 fashion. Primary endpoint was maximal per cent diameter stenosis of the bifurcation lesion at 9-month angiographic follow-up. As clinical endpoints we assessed target lesion re-intervention (TLR) and target lesion failure (composite of cardiac death, target vessel myocardial infarction, and TLR).Angiographic follow-up was available in 91% of the patients. After culotte stenting, the maximum per cent diameter stenosis in the treated bifurcation lesion was 21 ± 20% as compared with 27 ± 25% after TAP stenting (P = 0.038). The respective corresponding binary restenosis rates were 6.5 and 17% (P = 0.006). The 1-year incidence of TLR was 6.0% after culotte stenting vs. 12.0% after T-stenting (P = 0.069). Target lesion failure occurred in 6.7% of the culotte group and in 12.0% of the TAP group (P = 0.11). Only one patient of the culotte group incurred a definite stent thrombosis during 1-year follow-up.. Compared with the TAP stenting, culotte stenting was associated with a significantly lower incidence of angiographic restenosis.

Topics: Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Sirolimus; Treatment Outcome

The biodegradable polymer drug-eluting stents (DES) were developed to improve vascular healing. However, further data and longer-term follow-up are needed to confirm safety and efficacy of these stents. This randomized clinical trial aimed to compare safety and efficacy of 2 sirolimus-eluting stents (SES): Cordimax-a novel abluminal biodegradable polymer SES and Cypher Select-a durable polymer SES, at 9 months angiographic and 5-year clinical follow-up.. We randomized 402 patients with coronary artery disease to percutaneous coronary intervention with Cordimax (n = 202) or Cypher select (n = 200). Angiographic follow-up was performed at 9 months after the index procedure and clinical follow-up annually up to 5 years. The primary endpoint was angiographic in-stent late luminal loss (LLL). Secondary endpoints included angiographic restenosis rate, target vessel revascularization (TVR), and major adverse cardiac events (MACEs; defined as cardiac death, myocardial infarction, or TVR) at 5-year follow-up.. Cordimax was noninferior to Cypher select for in-stent LLL (0.25 ± 0.47 vs 0.18 ± 0.49 mm; P = 0.587) and in-stent mean diameter stenosis (22.19 ± 12.21% vs 19.89 ± 10.79%; P = 0.064) at 9 months angiographic follow-up. The MACE rates were not different at 1 year (5.9% vs 4.0%, P = 0.376); however, MACE rates from 2 to 5 years were lower in the Cordimax group (6.8% vs 13.1%; P = 0.039).. Abluminal biodegradable polymer SES is noninferior to durable polymer SES at 9-month angiographic and 1-year clinical follow-up. However, MACE rates from 2 to 5 years were less in the abluminal biodegradable polymer group.

Topics: Absorbable Implants; Aged; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Durable Medical Equipment; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Postoperative Complications; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

We examined long-term outcomes after implantation of the Resolute zotarolimus-eluting stent (R-ZES) in ST-segment elevation acute myocardial infarction (STEMI) patients.. We compared long-term outcomes of STEMI patients undergoing primary angioplasty <12 hours from symptom onset who were randomised to the R-ZES (n=122) or the everolimus-eluting stent (EES, n=158) in the RESOLUTE All Comers Trial after propensity score adjustment. The five-year cumulative incidence of target lesion failure (TLF) was 7.6% versus 10.4% among patients treated with R-ZES versus EES, respectively, (adjusted p=0.304), and comprised clinically driven target lesion revascularisation (TLR, 2.5% versus 2.0%, adjusted p=0.766) and cardiac death/target vessel MI (5.1% versus 9.1%, adjusted p=0.123). The five-year cumulative incidence of stent thrombosis was 0.8% for R-ZES patients versus 1.3% for EES patients (adjusted p=0.868). In the RESOLUTE Global Clinical Trial Program, excluding RESOLUTE All Comers, the three-year cumulative incidence of TLF with R-ZES was 9.8% and comprised 7.0% clinically driven TLR and 4.5% cardiac death/target vessel MI.. Patients with STEMI who received R-ZES had excellent long-term clinical outcomes which were similar to those of patients who received EES.

Topics: Adult; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Sirolimus; ST Elevation Myocardial Infarction; Time; Treatment Outcome

The study sought to investigate clinical and multimodality imaging assessment of a bioresorbable sirolimus-eluting scaffold (NeoVas, Lepu Medical, Beijing, China) for patients with single de novo coronary artery lesions.. The NeoVas first-in-man study was a prospective, open-label study which enrolled 31 patients with single de novo lesions treated with a bioresorbable sirolimus-eluting scaffold. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation (TLR). Angiography, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging were performed at baseline and six months. Procedural success and device success were 100% (31/31 patients). At six months, the rate of TLF was 3.2%, with only one patient having clinically indicated TLR. No scaffold thrombosis was observed. The angiographic six-month in-scaffold late loss was 0.26±0.32 mm. The minimal scaffold area decreased from 7.11±1.56 mm2 post procedure to 6.74±1.38 mm2 at six months, as measured by IVUS. The OCT results showed that the neointimal hyperplasia area was low (1.56±0.46 mm2), with a high proportion of scaffold strut coverage (95.7%).. This first-in-man study shows feasibility, promising clinical and multimodality imaging results up to six months for the NeoVas bioresorbable sirolimus-eluting scaffold in the treatment of patients with simple de novo lesions, with an acceptable in-scaffold late loss, low neointimal hyperplasia, and a high percentage of scaffold strut coverage.

Topics: Absorbable Implants; Adult; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Multimodal Imaging; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

To report 1- and 2-year clinical outcomes of patients receiving platinum chromium everolimus-eluting stents (PtCr-EES) in the prospective, single-arm PLATINUM small vessel (SV) and long lesion (LL) studies.. Small vessel diameter and long lesion length are independently associated with increased risk of adverse cardiac events after drug-eluting stent implantation.. The PLATINUM SV study enrolled 94 patients with coronary artery lesions in vessels ≥2.25 mm to <2.50 mm in diameter and ≤28 mm in length. The PLATINUM LL study enrolled 102 patients with lesions >24 to ≤34 mm long in vessels ≥2.50 to ≤4.25 mm in diameter. The primary endpoint for both studies was target lesion failure (TLF) at 1 year compared to a prespecified performance goal based on outcomes with the TAXUS Express paclitaxel-eluting stent in small vessels and long lesions.. One-year TLF rates with the PtCr-EES were significantly (P < 0.001) lower than the predetermined performance goals: 2.4% versus 21.1% in the SV cohort and 3.2% versus 19.4% in the LL cohort. Cumulative rates of TLF to 2 years were 4.7% in the SV cohort and 8.8% in the LL cohort. No myocardial infarction or ARC definite/probable stent thromboses occurred in either cohort through 2-year follow-up.. The clinical efficacy and safety outcomes observed in these small vessel and long lesion cohorts support the use of the PtCr-EES in the treatment of small diameter vessels and long lesions.

Topics: Aged; Cardiovascular Agents; Chromium; Coronary Artery Disease; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Japan; Male; Middle Aged; New Zealand; Percutaneous Coronary Intervention; Platinum; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; United States

The Japan drug-eluting stents evaluation: a randomized trial (J-DESsERT) was conducted to compare the effectiveness of 2 different drug-eluting stents (DES). It remains uncertain which is more efficacious in diabetic patients, sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES). In this trial, the largest of its kind, 3,533 patients including 1,724 diabetes mellitus (DM) patients were randomized to either SES or PES. Stratification was based on the presence or absence of DM. PES target vessel failure (TVF) non-inferiority at 8 months (primary endpoint) was not demonstrated when compared to SES (SES 4.5 % vs. PES 6.4 %, p = 0.23). In addition, PES TVF superiority at 8 months in the DM subset (secondary endpoint) was not shown (SES 5.6 % vs. PES 7.6 %, p = 0.10). Insulin treatment was associated with increased TVF rates, however, this was less pronounced in the PES group. At 8 months, the similar TVF rates for SES and PES up to that point diverged significantly, favoring SES out to 12 months. Patients undergoing routine angiographic follow-up demonstrated lower TVF prior to the 8-month point, and higher TVF after 8 months, as compared to those followed clinically. In conclusion, the current study failed to demonstrate the proposed superiority of PES for DM patients. In addition, the diversion of TVF at 8 months may reflect an "oculo-stenotic reflex" bias (the tendency to treat lesions found during routine, rather than clinically driven, angiographic follow-up), which could constitute an obstacle for evaluating the true clinical effect of new devices.

Topics: Aged; Anti-Bacterial Agents; Coronary Artery Disease; Coronary Restenosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Japan; Male; Middle Aged; Paclitaxel; Sirolimus; Treatment Outcome; Tubulin Modulators

We studied coronary vasomotion in patients treated with the Mistent(®) absorbable polymer sirolimus-eluting stent (APSES) and in patients implanted with the Endeavor(®) zotarolimus-eluting stent (ZES).. First generation (1st-gen) drug-eluting stents (DES) induce persistent vasomotor dysfunction in the treated coronary artery. It is unknown whether and to what extent the implantation of an absorbable polymer DES impairs coronary vasomotion.. This sub-study of the DESSOLVE II trial included 19 APSES Mistent(®) and 10 ZES Endeavor(®) patients. Incremental atrial pacing and quantitative coronary angiography were used to assess vasomotion proximal and distal to the stent and in a reference segment at 9 months after implantation. Percent changes in vessel diameter with pacing versus baseline were calculated and compared. Vasomotor response of the APSES group was also compared with changes observed in a historical group of 17 patients implanted with a 1st-gen sirolimus-eluting stent (SES).. Normal vasomotion (vasodilatation) was preserved and of comparable magnitude in the APSES and in the ZES group both proximally (P = 0.34) and distally (P = 0.38) to the stent. This finding was not observed in the 1st-gen SES group showing marked pacing-induced vasoconstriction at both stent edges (P < 0.05 vs. APSES). The results were practically unchanged after excluding patients with absolute changes in vessel diameter <3% between baseline and maximal pacing.. The implantation of an absorbable polymer sirolimus-eluting stent is associated with preserved coronary vasomotion, comparable to that observed after implantation of the Endeavor(®) ZES, and distinct from 1st-gen SES which induce coronary vasomotor dysfunction.

Topics: Absorbable Implants; Aged; Cardiac Pacing, Artificial; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Europe; Female; Historically Controlled Study; Humans; Male; Middle Aged; New Zealand; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; Vasoconstriction; Vasodilation

Biodegradable-polymer drug-eluting stents (BP-DES) were developed to be as effective as second-generation durable-polymer drug-eluting stents (DP-DES) and as safe >1 year as bare-metal stents (BMS). Thus, very late stent thrombosis (VLST) attributable to durable polymers should no longer appear.. To address these early and late aspects, 2291 patients presenting with acute or stable coronary disease needing stents ≥3.0 mm in diameter between April 2010 and May 2012 were randomly assigned to biolimus-A9-eluting BP-DES, second-generation everolimus-eluting DP-DES, or thin-strut silicon-carbide-coated BMS in 8 European centers. All patients were treated with aspirin and risk-adjusted doses of prasugrel. The primary end point was combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years. The combined secondary safety end point was a composite of VLST, myocardial infarction, and cardiac death. The cumulative incidence of the primary end point was 7.6% with BP-DES, 6.8% with DP-DES, and 12.7% with BMS. By intention-to-treat BP-DES were noninferior (predefined margin, 3.80%) compared with DP-DES (absolute risk difference, 0.78%; -1.93% to 3.50%; P for noninferiority 0.042; per protocol P=0.09) and superior to BMS (absolute risk difference, -5.16; -8.32 to -2.01; P=0.0011). The 3 stent groups did not differ in the combined safety end point, with no decrease in events >1 year, particularly VLST with BP-DES.. In large vessel stenting, BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS, but without evidence for better safety nor lower VLST rates >1 year. Findings challenge the concept that durable polymers are key in VLST formation.. http://www.clinicaltrials.gov. Unique identifier: NCT01166685.

Topics: Absorbable Implants; Aged; Anti-Inflammatory Agents; Aspirin; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Longitudinal Studies; Male; Metals; Middle Aged; Piperazines; Platelet Aggregation Inhibitors; Polymers; Prasugrel Hydrochloride; Purinergic P2Y Receptor Antagonists; Single-Blind Method; Sirolimus; Stents; Switzerland; Thiophenes; Treatment Outcome

Although the use of drug-eluting stents (DESs) in patients with coronary artery disease has contributed to a significant reduction in in-stent restenosis and repeat revascularization, treating diffuse long lesions using DESs remains challenging due to the high rates of in-stent restenosis and stent thrombosis. Intravascular ultrasound (IVUS) provides tomographic images of coronary vascular structure and is useful for evaluating lesion morphology and stent optimization during percutaneous coronary intervention. However, it remains controversial whether IVUS guidance in DES implantation for long coronary lesions could reduce adverse clinical outcomes.. We hypothesize that the long-term clinical outcomes of IVUS-guided DES implantation would be superior to those of angiography-guided DES implantation in a subset of patients with long coronary lesions.. This study is a randomized, prospective, multi-center trial comparing the long-term clinical outcomes of IVUS-guided and angiography-guided everolimus-eluting stent implantation in patients with long coronary lesions (implanted stent ≥28 mm in length). The primary end point is a composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or target lesion revascularization at 1 year following intervention. A total of 1,400 patients will be required to be enrolled according to sample size calculations.. This study will test the hypothesis that IVUS guidance improves long-term clinical outcomes in patients treated with everolimus-eluting stents for long coronary lesions compared with angiographic guidance.

Topics: Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Prospective Studies; Republic of Korea; Research Design; Risk Factors; Sirolimus; Ultrasonography, Interventional

The currently recommended duration of dual antiplatelet therapy (DAPT) in drug-eluting stent (DES) recipients is 12 months to reduce the risk of late stent thrombosis, particularly in those with acute coronary syndrome (ACS).. This study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients.. A multicenter, randomized study assigned patients undergoing implantation of everolimus-eluting stents with confirmed nonresistance to aspirin to receive 6- or 24-month DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-stenting.. A total of 2,031 patients were enrolled in 70 European and Middle Eastern centers. The trial was prematurely terminated due to recruitment problems, leaving 941 patients randomized to 24-month DAPT and 953 to 6-month DAPT. The 2 treatment groups had similar baseline and procedural characteristics. There was no significant difference in the primary endpoint (24-month: 1.5% vs. 6-month: 1.6%; p = 0.85). Noninferiority was demonstrated for 6- versus 24-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p for noninferiority = 0.0002). There were no significant differences in stent thrombosis or bleeding complications. In the 792 (44%) high-risk patients with ACS, primary and secondary endpoints did not significantly differ (hazard ratio: 1.7 [95% confidence interval: 0.519 to 6.057; p = 0.361]).. Rates of bleeding and thrombotic events were not significantly different according to 6- versus 24-month DAPT after PCI with new-generation DES in good aspirin responders. (Is There A LIfe for DES After Discontinuation of Clopidogrel [ITALICplus]; NCT01476020).

Topics: Aged; Aspirin; Clopidogrel; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Early Termination of Clinical Trials; Europe; Everolimus; Female; Hemorrhage; Humans; Immunosuppressive Agents; Male; Middle Aged; Middle East; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Postoperative Complications; Sirolimus; Ticlopidine; Time Factors; Treatment Outcome

The clinical benefits of optical coherence tomography-guided percutaneous coronary intervention are unclear. Therefore, in this study we sought to evaluate the impact of optical coherence tomography guidance on stent strut coverage following drug-eluting stent implantation.. A total of 101 patients in 105 lesions were randomly assigned to receive percutaneous coronary intervention under either optical coherence tomography guidance (n = 51 lesions of 50 patients) or angiography guidance (n = 54 lesions of 51 patients), and underwent a follow-up optical coherence tomography examination 6 months after zotarolimus-eluting stent implantation. The primary and secondary end points were the percentage of uncovered and malapposed struts, respectively, on 6-month follow-up optical coherence tomography.. The percentage of uncovered struts was significantly lower in the optical coherence tomography-guided arm (1.60% [1.84]%, [median, 1.06%] vs 4.51% [5.43]% [median, 2.38%]; P = .0004) at 6-month follow-up. The incidence of stents with ≥ 5.9% uncovered struts was also significantly lower in the optical coherence tomography-guided arm (2 patients [3.9%] vs 14 patients [25.9%]; P = .002). In addition, the percentage of malapposed struts was significantly lower in the optical coherence tomography-guided arm (0.19% [0.51]% [median, 0.0%] vs 0.98% [2.53]% [median, 0.0%]; P = .027).. Optical coherence tomography-guided percutaneous coronary intervention significantly reduced the incidence of uncovered stent struts at 6 months compared to angiography-guided percutaneous coronary intervention. These findings suggest that optical coherence tomography-guided percutaneous coronary intervention has a beneficial effect on drug-eluting stent strut coverage.

Topics: Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Surgery, Computer-Assisted; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Only limited data from large randomized clinical trials have been published on the long-term performance of second-generation drug-eluting stents in bifurcation lesions.. We investigated in patients in the randomized TWENTE trial the long-term safety and efficacy of treating bifurcation lesions with 2 widely applied second-generation drug-eluting stents, the zotarolimus-eluting Resolute stent (Medtronic Inc, Santa Rosa, CA) and the everolimus-eluting Xience V stent (Abbott Vascular, Santa Clara, CA). Three-year follow-up was available in 99.3%. Patients were categorized into treatment for ≥1 bifurcation lesion versus treatment for nonbifurcation lesions only.. Among the 1,391 patients of the TWENTE trial, 362 (26%) were treated for bifurcation lesions. At 3-year follow-up, target-vessel failure did not differ between patients treated for bifurcation versus nonbifurcation lesions (13.1% vs 12.6%; P = .84), whereas the periprocedural myocardial infarction rate was higher in patients with bifurcation lesions (6.9% vs 3.1%; P < .01). Of the 362 patients with bifurcation lesion treatment, 179 (49.4%) were treated with Resolute and 183 (50.6%) with Xience V. There was no significant difference in target-vessel failure between the Resolute and Xience V groups with bifurcation treatment (13.6% vs 12.6%; P = .78), and their incidence of definite-or-probable stent thrombosis was low and similar (1.1% vs 0.5%, respectively; P = .62).. Despite a significant difference in periprocedural myocardial infarction, 3-year clinical outcome after implantation of second-generation stents was favorable and similar for patients with and without bifurcation lesions. In addition, we observed no difference in long-term clinical outcome after bifurcation lesion treatment with Resolute and Xience V stents.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Revascularization; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus

We compared 5-year clinical outcomes in diabetic and nondiabetic patients treated with Endeavor zotarolimus-eluting stents (ZESs; Endeavor Sprint, Medtronic, Santa Rosa, California) or Cypher sirolimus-eluting stents (SESs; Cordis, Johnson & Johnson, Warren, New Jersey) coronary implantation. We randomized 2,332 patients to either ZESs (n = 1,162, n = 169 diabetic patients) or SESs (n = 1,170, n = 168 diabetic patients) stratified according to presence or absence of diabetes mellitus. End points included major adverse cardiac event (MACE), a composite of cardiac death, myocardial infarction, target vessel revascularization (TVR), and definite stent thrombosis. Among diabetic patients, MACE occurred more frequently in patients treated with ZESs than SESs (48 [28.4%] vs 31 [18.5%]; odds ratio [OR] 1.75, 95% confidence interval [CI] 1.05 to 2.93, p = 0.032) because of a higher rate of TVR (32 [18.9%] vs 14 [8.3%]; OR 2.57, 95% CI 1.32 to 5.02, p = 0.006). Among nondiabetic patients, ZES and SES had similar MACE rates at 5-year follow-up but SES was associated with a significantly higher risk of definite stent thrombosis (10 [1.0%] vs 23 [2.3%]; OR 0.43, 95% CI 0.20 to 0.91, p = 0.028). Moreover, during the last 4 years, ZES had fewer MACE, TVR, and stent thrombosis events among nondiabetic patients. In conclusion, SES remains superior to ZES in patients with diabetes throughout the 5-year follow-up, however, among nondiabetic patients, SES demonstrated a highly dynamic performance with favorable initial results followed by a late catch-up that included an overall higher risk of stent thrombosis.

Topics: Blood Vessel Prosthesis Implantation; Case-Control Studies; Coronary Artery Disease; Coronary Restenosis; Diabetes Complications; Diabetes Mellitus; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Male; Myocardial Infarction; Prosthesis Failure; Reoperation; Sirolimus; Thrombosis; Treatment Outcome

To assess the safety and performance of the Nobori drug-eluting stent with biodegradable polymer versus the TAXUS drug-eluting stent with permanent polymer, in the treatment of patients with de novo coronary artery lesions.. NOBORI 1 was a multicentre, randomised (2:1), prospective, controlled, clinical trial which enrolled 363 patients (238 Nobori and 125 TAXUS) with up to two de novo lesions in two epicardial vessels. The primary endpoint was in-stent late loss at nine months, while secondary endpoints included safety and efficacy up to five years. At five years, clinical data were available for 350 patients (96%). There were no differences in the composite of death and myocardial infarction (10.9% vs. 11.2%) and target lesion failure (9.2% and 10.4%), while ischaemia- and non-ischaemia-driven target lesion revascularisations were less frequent in the Nobori (6.3%) than in the TAXUS arm (16.0%). The rates of stent thrombosis (definite and probable according to the ARC definitions) were 0.0% and 3.2%, in the Nobori and TAXUS stents, respectively (p=0.014).. Five years after implantation, the Nobori DES resulted in durable treatment effects with very low TLR and no stent thrombosis. The study was not powered to assess the differences in clinical endpoints. These data are hypothesis-generating.

Topics: Absorbable Implants; Aged; Coronary Artery Bypass; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Mortality; Myocardial Infarction; Myocardial Revascularization; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Treatment Outcome

To evaluate the preliminary safety and efficacy of the EXCEL II stent system.. Although the first biodegradable polymer drug-eluting stent (BP-DES), EXCEL, was launched nearly a decade ago, in-stent restenosis and stent thrombosis remain pertinent clinical problems in practice. A new cobalt-chromium BP-DES EXCEL II has been developed with the aim of improving stent safety and efficacy.. Forty-five patients with single de novo native coronary lesions were enrolled and randomized to two groups in a 2:1 ratio, the 4-month follow-up group (n = 30) and the 12-month follow-up group (n = 15). All patients underwent percutaneous coronary intervention (PCI) with the EXCEL II stent system. Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) were used to assess coronary vasculature at the designated 4- or 12-month follow-up. The primary outcome was major adverse cardiac events (MACE) at 30 days post-PCI.. No MACE, thrombotic events, or target lesion failure was found in the 45 patients during the 12-month follow-up. There was no significant difference (P > 0.05) between the two groups in terms of in-stent and in-segment late lumen loss (LLL). No in-stent and in-segment restenosis was found in either group. At follow-up, the ratio of >10% uncovered struts per lesion was 26.67% in the 4-month group and 0% in the 12-month group (P < 0.05). Neointimal coverage in the 12-month group was significantly better than in the 4-month group (98.58% vs. 93.51%, P < 0.01).. This first-in-man study demonstrates promising feasibility, safety, and efficacy of EXCEL II stents. These stents were found to have rapid endothelialization and low LLL rates at 4 and 12 months after implantation.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; China; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Polymers; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Biodegradable polymers for release of antiproliferative drugs from drug-eluting stents aim to improve vascular healing. We assessed noninferiority of a novel ultrathin strut drug-eluting stent releasing sirolimus from a biodegradable polymer (Orsiro, O-SES) compared with the durable polymer Xience Prime everolimus-eluting stent (X-EES) in terms of the primary end point in-stent late lumen loss at 9 months.. A total of 452 patients were randomly assigned 2:1 to treatment with O-SES (298 patients, 332 lesions) or X-EES (154 patients, 173 lesions) in a multicenter, noninferiority trial. The primary end point was in-stent late loss at 9 months. O-SES was noninferior to X-EES for the primary end point (0.10±0.32 versus 0.11±0.29 mm; difference=0.00063 mm; 95% confidence interval, -0.06 to 0.07; Pnoninferiority<0.0001). Clinical outcome showed similar rates of target-lesion failure at 1 year (O-SES 6.5% versus X-EES 8.0%; hazard ratio=0.82; 95% confidence interval, 0.40-1.68; log-rank test: P=0.58) without cases of stent thrombosis. A subgroup of patients (n=55) underwent serial optical coherence tomography at 9 months, which demonstrated similar neointimal thickness among lesions allocated to O-SES and X-EES (0.10±0.04 mm versus 0.11±0.04 mm; -0.01 [-0.04, -0.01]; P=0.37). Another subgroup of patients (n=56) underwent serial intravascular ultrasound at baseline and 9 months indicating a potential difference in neointimal area at follow-up (O-SES, 0.16±0.33 mm(2) versus X-EES, 0.43±0.56 mm(2); P=0.04).. Compared with durable polymer X-EES, novel biodegradable polymer-based O-SES was found noninferior for the primary end point in-stent late lumen loss at 9 months. Clinical event rates were comparable without cases of stent thrombosis throughout 1 year of follow-up.. http://www.clinicaltrials.gov. Unique identifier: NCT01356888.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Neointima; Polymers; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes.. There are limited data on long-term outcome after EES vs SES implantation in diabetic patients.. We randomized 213 patients with diabetes and coronary artery disease to EES (n = 108) or SES (n = 105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up.. At 10-month angiographic follow-up, in-stent late lumen loss was 0.20 ± 0.53 mm and 0.11 ± 0.49 mm (P = 0.28), and angiographic restenosis rate was 3.8% and 5.2% (P = 0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4%) patients in the EES group and 25 (23.8%) patients in SES group (HR 0.84, 95% CI 0.47-1.49; P = 0.55), with TLR performed in 6 (5.6%) and 10 (9.5%) patients in the two groups (HR 0.57, 95% CI 0.21-1-58; P = 0.28).. EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Denmark; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The first CE-approved bioresorbable vascular scaffold (BVS) is effective at treating simple lesions and stable coronary artery disease, but it has yet to be assessed versus the best-in-class drug-eluting stents (DES).. This study sought to compare the performance of a BVS with that of everolimus-eluting stents (EES) and biolimus-eluting stents (BES) in all-comer patients.. The EVERBIO II (Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents II) trial was a single-center, assessor-blinded study of 240 patients randomly assigned in a 1:1:1 ratio to EES, BES, or BVS. The only exclusion criterion was a reference vessel diameter >4.0 mm, which precluded treatment with BVS. The primary endpoint was angiographic late lumen loss (LLL) at 9 months. Secondary endpoints included patient-oriented major acute coronary events (MACE) (death, myocardial infarction [MI], and any revascularization), device-oriented MACE (cardiac death, MI, and target lesion revascularization), and stent thrombosis at the 9-month clinical follow-up.. Follow-up angiography was performed in 216 patients (90.7%) at 9 months. In-stent LLL was similar between patients treated with BVS (0.28 ± 0.39 mm) and those treated with EES/BES (0.25 ± 0.36 mm; p = 0.30). Clinical outcomes were similar at 9 months: the patient-oriented MACE rate was 27% in BVS and 26% in the EES/BES group (p = 0.83) and the device-oriented MACE rate was 12% in BVS and 9% in the EES/BES group (p = 0.6).. New-generation metallic DES (EES/BES) were not superior to BVS in terms of angiographic LLL and clinical outcomes. (Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents [EVERBIO II]; NCT01711931).

Topics: Absorbable Implants; Aged; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Materials Testing; Middle Aged; Percutaneous Coronary Intervention; Postoperative Complications; Sirolimus; Tissue Scaffolds; Treatment Outcome

The use of drug-eluting stents (DES) in patients at high risk of bleeding or thrombosis has not been prospectively studied; limited data are available in patients who have a low restenosis risk.. This study sought to compare a hydrophilic polymer-based, second-generation zotarolimus-eluting stent (ZES) with a unique drug fast-release profile versus bare-metal stents (BMS) under similar durations of dual-antiplatelet therapy (DAPT).. We randomly assigned 1,606 patients with stable or unstable symptoms, and who on the basis of thrombotic bleeding or restenosis risk criteria, qualified as uncertain candidates for DES, to receive ZES or BMS. DAPT duration was on the basis of patient characteristics, rather than stent characteristics, and allowed for a personalized 1-month dual antiplatelet regimen. The primary endpoint was the risk of 1-year major adverse cardiovascular events (MACE), which included death, myocardial infarction (MI), or target vessel revascularization (TVR).. Median DAPT duration was 32 days (interquartile range [IQR]: 30 to 180 days) and did not differ between the groups. In the ZES group, 140 patients (17.5%) reached the primary endpoint, compared with 178 patients (22.1%) in the BMS group (hazard ratio: 0.76; 95% confidence interval: 0.61 to 0.95; p = 0.011) as a result of lower MI (2.9% vs. 8.1%; p < 0.001) and TVR rates (5.9% vs.10.7%; p = 0.001) in the ZES group. Definite or probable stent thrombosis was also significantly reduced in ZES recipients (2.0% vs. 4.1%; p = 0.019).. Compared with BMS, DES implantation using a stent with a biocompatible polymer and fast drug-eluting characteristics, combined with an abbreviated, tailored DAPT regimen, resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantation. (Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS] Study; NCT01385319).

Topics: Aged; Aged, 80 and over; Aspirin; Biocompatible Materials; Clopidogrel; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Hemorrhage; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Postoperative Complications; Risk Assessment; Risk Factors; Sirolimus; Ticlopidine; Treatment Outcome

Despite great reduction of in-stent restenosis, first-generation drug-eluting stents (DESs) have increased the risk of late stent thrombosis due to delayed endothelialization. Arsenic trioxide, a natural substance that could inhibit cell proliferation and induce cell apoptosis, seems to be a promising surrogate of sirolimus to improve DES performance. This randomized controlled trial was to evaluate the efficacy and safety of a novel arsenic trioxide-eluting stent (AES), compared with traditional sirolimus-eluting stent (SES).. Patients with symptoms of angina pectoris were enrolled and randomized to AES or SES group. The primary endpoint was target vessel failure (TVF), and the second endpoint includes rates of all-cause death, cardiac death or myocardial infarction, target lesion revascularization (TLR) by telephone visit and late luminal loss (LLL) at 9-month by angiographic follow-up.. From July 2007 to 2009, 212 patients were enrolled and randomized 1:1 to receive either AES or SES. At 2 years of follow-up, TVF rate was similar between AES and SES group (6.67% vs. 5.83%, P = 0.980). Frequency of all-cause death was significantly lower in AES group (0 vs. 4.85%, P = 0.028). There was no significant difference between AES and SES in frequency of TLR and in-stent restenosis, but greater in-stent LLL was observed for AES group (0.29 ± 0.52 mm vs. 0.10 ± 0.25 mm, P = 0.008).. After 2 years of follow-up, AES demonstrated comparable efficacy and safety to SES for the treatment of de novo coronary artery lesions.

Topics: Aged; Arsenic Trioxide; Arsenicals; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Oxides; Percutaneous Coronary Intervention; Polymers; Sirolimus

Most trials comparing percutaneous coronary intervention (PCI) with coronary-artery bypass grafting (CABG) have not made use of second-generation drug-eluting stents.. We conducted a randomized noninferiority trial at 27 centers in East Asia. We planned to randomly assign 1776 patients with multivessel coronary artery disease to PCI with everolimus-eluting stents or to CABG. The primary end point was a composite of death, myocardial infarction, or target-vessel revascularization at 2 years after randomization. Event rates during longer-term follow-up were also compared between groups.. After the enrollment of 880 patients (438 patients randomly assigned to the PCI group and 442 randomly assigned to the CABG group), the study was terminated early owing to slow enrollment. At 2 years, the primary end point had occurred in 11.0% of the patients in the PCI group and in 7.9% of those in the CABG group (absolute risk difference, 3.1 percentage points; 95% confidence interval [CI], -0.8 to 6.9; P=0.32 for noninferiority). At longer-term follow-up (median, 4.6 years), the primary end point had occurred in 15.3% of the patients in the PCI group and in 10.6% of those in the CABG group (hazard ratio, 1.47; 95% CI, 1.01 to 2.13; P=0.04). No significant differences were seen between the two groups in the occurrence of a composite safety end point of death, myocardial infarction, or stroke. However, the rates of any repeat revascularization and spontaneous myocardial infarction were significantly higher after PCI than after CABG.. Among patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG. (Funded by CardioVascular Research Foundation and others; BEST ClinicalTrials.gov number, NCT00997828.).

Topics: Aged; Coronary Artery Bypass; Coronary Artery Disease; Coronary Restenosis; Diabetes Complications; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Postoperative Complications; Prospective Studies; Sirolimus; Stroke

In a previous randomized trial, we found that percutaneous coronary intervention (PCI) was not inferior to coronary artery bypass grafting (CABG) for the treatment of unprotected left main coronary artery stenosis at 1 year.. This study sought to determine the 5-year outcomes of PCI compared with CABG for the treatment of unprotected left main coronary artery stenosis.. We randomly assigned 600 patients with unprotected left main coronary artery stenosis to undergo PCI with a sirolimus-eluting stent (n = 300) or CABG (n = 300). The primary endpoint was a major adverse cardiac or cerebrovascular event (MACCE: a composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target vessel revascularization) and compared on an intention-to-treat basis.. At 5 years, MACCE occurred in 52 patients in the PCI group and 42 patients in the CABG group (cumulative event rates of 17.5% and 14.3%, respectively; hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 0.84 to 1.90; p = 0.26). The 2 groups did not differ significantly in terms of death from any cause, myocardial infarction, or stroke as well as their composite (8.4% and 9.6%; HR, 0.89; 95% CI, 0.52 to 1.52; p = 0.66). Ischemia-driven target vessel revascularization occurred more frequently in the PCI group than in the CABG group (11.4% and 5.5%, respectively; HR: 2.11; 95% CI: 1.16 to 3.84; p = 0.012).. During 5 years of follow-up, our study did not show significant difference regarding the rate of MACCE between patients who underwent PCI with a sirolimus-eluting stent and those who underwent CABG. However, considering the limited power of our study, our results should be interpreted with caution. (Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [PRECOMBAT]; NCT00422968).

Topics: Aged; Coronary Artery Bypass; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Time Factors; Treatment Outcome

This study assessed clinical events and patient-reported chest pain 2 years after treatment of all-comers with Resolute Integrity zotarolimus-eluting stents (Medtronic Vascular, Santa Rosa, California) and Promus Element everolimus-eluting stents (Boston Scientific, Natick, Massachusetts).. For both drug-eluting stents (DES), no all-comer outcome data from >12 months of follow-up have been published. Although there is increasing interest in patient-reported chest pain following stenting, data with novel DES are scarce.. The DUTCH PEERS multicenter trial (TWENTE II) (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial [TWENTE II]) randomized 1,811 all-comer patients to treatment with 1 type of DES. Monitoring and event adjudication were performed by independent contract research organizations.. The 2-year follow-up of 1,810 patients (99.9%) was available. The primary composite endpoint target vessel failure occurred in 8.6% and 7.8% of patients treated with zotarolimus- and everolimus-eluting stents, respectively (p = 0.55). Rates of components of target vessel failure were: cardiac death (2.4% vs. 1.9%, p = 0.42); target vessel-related myocardial infarction (2.4% vs. 1.8%, p = 0.33); clinically-indicated target vessel revascularization (4.6% vs. 4.9%, p = 0.83). At 1- and 2-year follow-up, >80% of patients were free from chest pain (no between-stent difference). In addition, >87% of patients were either free from chest pain or experienced pain only at maximal physical exertion, but not during normal daily activities. Patients with chest pain after 12 months at no more than moderate physical effort had a higher risk of target vessel revascularization during the following year (hazard ratio: 1.89 [95% confidence interval: 1.05 to 3.39], p = 0.03).. During the second year of follow-up, the incidence of adverse clinical endpoints remained similar and low for both DES. The vast majority of patients were free from chest pain.

Topics: Aged; Angina Pectoris; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

Although trials comparing antiplatelet strategies after percutaneous coronary intervention report average risks of bleeding and ischemia in a population, there is limited information to guide choices based on individual patient risks, particularly beyond 1 year after treatment. Patient-level data from Patient Related Outcomes With Endeavor vs Cypher Stenting Trial (PROTECT), a broadly inclusive trial enrolling 8,709 subjects treated with drug-eluting stents (sirolimus vs zotarolimus-eluting stent), and PROTECT US, a single-arm study including 1,018 subjects treated with a zotarolimus-eluting stent, were combined. The risk of ischemic events, cardiovascular death/non-periprocedural myocardial infarction (MI)/definite or probable stent thrombosis, and bleeding events, Global Use of Strategies to Open Occluded Arteries moderate or severe bleed, were predicted using logistic regression. At median follow-up of 4.1 years, major bleeding occurred in 260 subjects (2.8%) and ischemic events in 595 (6.3%). Multivariate predictors of bleeding were older age, smoking, diabetes mellitus, congestive heart failure, and chronic kidney disease (all p <0.05). Ischemic events shared all the same predictors with bleeding events and gender, body mass index, previous MI, previous coronary artery bypass graft surgery, ST-segment elevation MI on presentation, stent length, and sirolimus-eluting stent use (all p <0.05). Within individual subjects, bleeding and ischemic risks were strongly correlated; 97% of subjects had a greater risk of ischemic events than bleeding. In conclusion, individual patient risks of ischemia and bleeding are related to many common risk factors, yet the predicted risks of ischemic events are greater than those of major bleeding in the large majority of patients in long-term follow-up.

Topics: Aged; Blood Transfusion; Coronary Artery Disease; Dose-Response Relationship, Drug; Drug-Eluting Stents; Europe; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Postoperative Hemorrhage; Prognosis; Retrospective Studies; Sirolimus; Survival Rate; Time Factors

The study sought to compare long-term optical coherence tomography (OCT)-based in-stent vascular response between the abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) and the durable polymer everolimus-eluting stent (EES) in the TARGET I trial. The TARGET I trial was a prospective, multicenter, randomized clinical trial which enrolled 458 patients with single de novo lesions treated by abluminal groove-filled biodegradable polymer SES and EES. A subset of 43 patients underwent angiography and OCT examinations at 3 years. All OCT images were analyzed at 0.4 mm intervals. A similar increase in angiographic late lumen loss was observed in SES and EES (from 0.05 ± 0.05 vs. 0.05 ± 0.05 mm [p = 0.84] at 9 months to 0.25 ± 0.37 vs. 0.26 ± 0.19 mm [p = 0.99] at 3 years, respectively), without significant differences at 3 years in mean neointimal thickness of stent struts (SES: 0.13 ± 0.02 mm vs. EES: 0.13 ± 0.02 mm, p = 0.80); mean percentage of covered struts (SES: 99.2 % vs. EES: 99.3 %, p = 0.53), or malapposed strut rates (SES: 0.08 % vs. EES: 0.06 %, p = 0.15). The OCT-based in-stent vascular response evaluation found similar vascular healing for the two studied devices, indicating that the luminal loss in EES from 9 months to 3 years cannot be imputed on its coated biocompatible polymer.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; China; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular Remodeling; Wound Healing

Third-generation coronary drug-eluting stents (DES) with biodegradable polymers have been designed to improve safety and efficacy. We designed a large scale registry-based randomized clinical trial to compare 2 third-generation DES: a thin strut, cobalt-chromium DES with silicon carbide-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the stainless steel biodegradable polymer biolimus-eluting Nobori stents (N-BES, Nobori; Terumo, Tokyo, Japan) in an all-comer patient population.. The multicenter SORT OUT VII trial (NCT01879358) randomly assigned 2,530 patients to treatment with biodegradable polymer O-SES or biodegradable polymer N-BES at 3 sites in Western Denmark. Patients were eligible, if they were ≥18 years old; had chronic stable coronary artery disease or acute coronary syndromes; and ≥1 coronary lesion with >50% diameter stenosis, requiring treatment with a DES. The primary end point target lesion failure is a composite of cardiac death, myocardial infarction (not related to other than index lesion), or target lesion revascularization within 12 months. Clinically, driven event detection based on Danish registries will be used. An event rate of 6.5% is assumed in each stent group. With a sample size of 1,157 patients in each treatment arm, a 2-group large-sample normal approximation test of proportions with a 1-sided 5% significance level will have 90% power to detect noninferiority of the O-SES compared with the N-BES with a predetermined noninferiority margin of 3.0%.. The SORT OUT VII trial will determine whether the biodegradable polymers O-SES is noninferior to the N-BES with respect to driven event.

Topics: Coronary Artery Disease; Denmark; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Single-Blind Method; Sirolimus; Societies, Medical; Treatment Outcome

To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating.. This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year.. After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups.. The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent.

Topics: Absorbable Implants; Aged; Brazil; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

Drug-eluting stents (DES) improve outcomes in elderly patients with small coronary artery disease compared with bare-metal stents (BMS), but randomized data in elderly patients in need of large coronary stents are not available.. Planned secondary analysis of patients ≥75 years recruited to the "BASKET-PROVE" trial, in which 2,314 patients undergoing percutaneous coronary intervention for large (≥3.0 mm) native vessel disease were randomized 2:1 to DES (everolimus- vs sirolimus-eluting stents 1:1) versus BMS. All patients received 12 months of dual antiplatelet therapy. The primary end point was a composite of cardiac death or nonfatal myocardial infarction at 2 years.. Comparison of DES versus BMS among 405 patients ≥75 years showed significantly lower rates of the primary end point for DES (5.0% vs 11.6%; hazard ration (HR) 0.64 [0.44-0.91]; P = .014). Rates of nonfatal myocardial infarction (1.2% vs 5.5%, hazard ration (HR) 0.44 [0.21-0.83]; P = .009), all-cause death (7.4% vs 14.4%; HR 0.7 [0.51-0.95]; P = .02), and target vessel revascularization (TVR) (2.3% vs 6.2%; HR 0.59 [0.34-0.99]; P = .046) were also lower, whereas stent thrombosis and bleeding rates were similar. In contrast, among patients <75 years (n = 1,909), the only significant benefit of DES was a reduced rate of TVR (4.0% vs 8.7%, HR 0.66 [0.55-0.80]; P < .0001).. In patients ≥75 years requiring large (≥3.0 mm) coronary stents, use of DES was beneficial compared with BMS and reduced the rate of ischemic events, mortality, and TVR. These data suggest that DES should be preferred over BMS in elderly patients.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Europe; Everolimus; Follow-Up Studies; Humans; Immunosuppressive Agents; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Survival Rate; Treatment Outcome

The aim of the present study was to compare vascular healing response between the first-generation sirolimus-eluting stent (SES) and the second-generation everolimus-eluting stent (EES) by using optical coherence tomography (OCT).. The RESET was a prospective, multicentre, randomised, open-label trial comparing EES and SES. Of the 3,197 patients enrolled in the RESET, nine-month follow-up OCT after stent implantation was performed in 100 patients (48 EES-treated lesions in 44 patients and 62 SES-treated lesions in 56 patients), thus constituting the OCT substudy population. The percentage of uncovered struts per lesion (8±15% vs. 14±19%, p=0.031) and cross-sections with >30% uncovered struts per lesion (6±14% vs. 18±29%, p=0.009) was significantly lower in EES compared with SES. The frequency of DES-treated lesions with incomplete stent apposition (8 [17%] vs. 29 [47%], p<0.001) was significantly lower in EES compared with SES. Intra-stent thrombus was comparably observed between EES and SES (1 [2%] vs. 5 [8%], p=0.229).. Compared with SES, EES was associated with a favourable vascular response at nine months after stent implantation.

Topics: Aged; Angina, Unstable; Antineoplastic Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Neointima; Percutaneous Coronary Intervention; Sirolimus; Tomography, Optical Coherence

Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month.. In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who underwent PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization.. We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated-stent group and in 154 patients (12.9%) in the bare-metal-stent group (risk difference, -3.6 percentage points; 95% confidence interval [CI], -6.1 to -1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P=0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated-stent group and in 113 patients (9.8%) in the bare-metal-stent group (risk difference, -4.8 percentage points; 95% CI, -6.9 to -2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001).. Among patients at high risk for bleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet therapy. (Funded by Biosensors Europe; LEADERS FREE ClinicalTrials.gov number, NCT01623180.).

Topics: Aged; Combined Modality Therapy; Coronary Artery Disease; Double-Blind Method; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Prosthesis Design; Sirolimus; Stents

The choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention (PCI) has been debated. Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) have produced contradictory results, ranging from equivalence between stent types to superiority of everolimus-eluting stents.. We randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95% confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up.. At 1 year, paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point (rate of target-vessel failure, 5.6% vs. 2.9%; risk difference, 2.7 percentage points [95% confidence interval, 0.8 to 4.5]; relative risk, 1.89 [95% confidence interval, 1.20 to 2.99]; P=0.38 for noninferiority). There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure (P=0.005), spontaneous myocardial infarction (3.2% vs. 1.2%, P=0.004), stent thrombosis (2.1% vs. 0.4%, P=0.002), target-vessel revascularization (3.4% vs. 1.2%, P=0.002), and target-lesion revascularization (3.4% vs. 1.2%, P=0.002).. In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. (Funded by Boston Scientific; TUXEDO-India Clinical Trials Registry-India number, CTRI/2011/06/001830).

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Diabetes Complications; Drug-Eluting Stents; Everolimus; Female; Humans; Intention to Treat Analysis; Logistic Models; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Retreatment; Sirolimus; Treatment Outcome

Frequency-domain optical coherence tomography (FD-OCT) is a high-resolution imaging tool (~10-15 μm), which enables near-histological in-vivo images of the coronary vessel wall. The use of the technique is increasing, both for research- and clinical purposes. This study sought to investigate the intra- and interobserver reliability, as well as the intra-catheter reproducibility of quantitative FD-OCT-assessment of morphometric stent parameters and qualitative FD-OCT-evaluation of strut coverage in 10 randomly selected 6-month follow-up Nobori® biolimus-eluting stents (N-BESs).. Ten N-BESs (213 cross sectional areas (CSAs) and 1897 struts) imaged with OCT 6 months post-implantation were randomly selected and analyzed by 2 experienced analysts, and the same 10 N-BESs were analyzed by one of the analysts 3 months later. Further, 2 consecutive pullbacks randomly performed in another 10 N-BESs (219 CSAs and 1860 struts) were independently assessed by one of the analysts.. The intraobserver variability with regard to relative difference of mean luminal area and mean stent area at the CSA-level was very low: 0.1%±1.4% and 0.5%±3.2%. Interobserver variability also proved to be low: -2.1%±3.3% and 2.1%±4.6%, and moreover, very restricted intra-catheter variation was observed: 0.02%±6.8% and -0.18%±5.2%. The intraobserver-, interobserver- and intra-catheter reliability for the qualitative evaluation of strut coverage was found to be: kappa (κ)=0.91 (95% confidence interval (CI): 0.88-0.93, p<0.01), κ=0.88 (95% CI: 0.85-0.91, p<0.01), and κ=0.73 (95% CI: 0.68-0.78, p<0.01), respectively.. FD-OCT is a reproducible and reliable imaging tool for quantitative evaluation of stented coronary segments, and for qualitative assessment of strut coverage.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Denmark; Drug-Eluting Stents; Evaluation Studies as Topic; Female; Follow-Up Studies; Humans; Male; Middle Aged; Observer Variation; Prosthesis Design; Prosthesis Failure; Prosthesis Implantation; Reproducibility of Results; Risk Assessment; Severity of Illness Index; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular Patency

The aim of this study was to assess the safety and the efficacy of the novel sirolimus-eluting Prolim® stent with a biodegradable polymer in the all-comers population.. We prospectively enrolled all patients with stable coronary artery disease or acute coronary syndrome treated with Prolim® stent between January and December 2013 in two interventional cardiology centers in Poland. Angiographic control was planned at 12 months, in which 15 % of patients (randomly chosen) underwent optical coherence tomography imaging. The primary end-point was the cumulative rate of cardiac death, myocardial infarction, and target lesion revascularization at 12 months.. There were 204 patients enrolled, in whom 238 Prolim® stents were deployed (1.17 stent per patient). The mean age was 68 ± 10 years and 32.8 % were females. The examined stent was implanted in 5.9 % in STEMI patients, in 21.6 % - in NSTE-ACS and in 72.5 % - in patients with stable coronary artery disease. The Prolim® stent was most frequently implanted in right coronary artery (38.2 %) followed by left anterior descending artery (34.0 %). The cumulative major adverse cardiovascular events rate at 12 months was 6.9 %, and the clinically-driven target lesion revascularization rate - 5.4 %. At 12 months in quantitative coronary angiography the late lumen loss was 0.21 ± 0.18 mm, and in optical coherence tomography the mean neointima burden was 24.6 ± 8.6 %.. Sirolimus-eluting Prolim® stent with a biodegradable polymer is a feasible device with a very good safety profile and long-term clinical effectiveness.. ClinicalTrials.gov NCT02545985 .

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Neointima; Percutaneous Coronary Intervention; Poland; Polymers; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Previously, we reported that the nine-month angiographic result after treatment of coronary bifurcation lesions with provisional T-stenting was not significantly different from that with routine T-stenting. To compare long-term clinical outcomes of the two stenting strategies, we extended the follow-up of our study on bifurcation stenting.. One hundred and one patients with coronary bifurcation lesions had been randomly assigned to provisional T-stenting and 101 to routine T-stenting, using sirolimus-eluting stents. We performed complete five-year follow-up. The primary efficacy endpoint was the incidence of target lesion revascularisation (TLR), and the primary safety endpoint was the incidence of definite/probable stent thrombosis (ST). We also monitored death, myocardial infarction (MI) and MACE (composite of death, MI and TLR). The cumulative five-year incidence of TLR in the provisional T-stenting arm was not significantly different from that in the routine T-stenting arm (16.2% vs. 16.3%, p=0.97). The same was true for MACE (22.8% vs. 22.9%, p=0.91), the composite of death and MI (9.9% vs. 13.9%, p=0.40), and ST (2.0% vs. 5.1%; p=0.25).. During five-year follow-up, routine T-stenting offered no advantage over provisional T-stenting with respect to TLR or MACE. ClinicalTrials.gov Identifier: NCT00288535

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to evaluate the Sparrow sirolimus-eluting stent (Sparrow-SES) against the Sparrow bare-metal stent (Sparrow-BMS) and conventional balloon-expandable bare-metal stent (BMS: Driver/Micro-Driver stent, Medtronic Vascular, Santa Rosa, CA).. The Sparrow stent (Biosensors International, Singapore) consists of a guide wire-based, self-expandable, ultra-thin nitinol stent. The performance of this device with sirolimus in a fully biodegradable polymer has not been determined.. A total of 74 patients were included in this intravascular ultrasound (IVUS) sub-study of the CARE II trial, which was a prospective, randomized, multicenter trial in the treatment of single de novo native coronary artery lesions in vessels ranging from 2.0 mm to 2.75 mm in diameter (Sparrow-SES: n = 31, Sparrow-BMS: n = 22, BMS: n = 21).. Stent volume index (VI) was significantly increased 8-month later in Sparrow-SES and Sparrow-BMS, but not in BMS (4.0 ± 1.0 to 4.6 ± 1.0 mm(3) /mm, p<0.0001, 4.0 ± 0.6 to 4.4 ± 0.8 mm(3) /mm, p<0.05, and 5.2 ± 1.0 to 5.1 ± 0.9 mm(3) /mm, p=0.421, respectively). % neointimal obstruction in Sparrow-SES was significantly smaller than those in Sparrow-BMS and BMS at follow-up (17.6 ± 9.4 vs. 36.2 ± 13.8 and 39.9 ± 11.1%, p<0.001). Sparrow-SES showed a mean 15% stent expansion and good suppression of neointimal proliferation, resulting in a significantly lower percentage of change in lumen VI during follow-up period (Sparrow-SES: -6.2 ± 16.2%, Sparrow-BMS: -30.4 ± 11.6%, BMS: -40.4 ± 10.0%, p<0.001).. The self-expanding Sparrow-SES demonstrated chronic stent expansion, good suppression of neointimal proliferation and resulted in a more preserved lumen in stented small vessels compared with the Sparrow-BMS and conventional balloon expandable BMS.

Topics: Aged; Alloys; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional

To assess the predictive value of C-reactive protein (CRP) on periprocedural myocardial injury (PMI), evaluated by creatine kinase-myocardial band isoform (CK-MB) elevation in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation for the treatment of coronary bifurcation lesions is actually unknown.. Systemic inflammation as assessed by CRP has been associated with averse events after DES implantation. After PCI, the occurrence of PMI is common and has also been associated with worse outcomes. Finally, bifurcations are frequently encountered anatomically complex lesions which the treatment is associated with higher complication rate compared with simple lesions.. A total of 96 patients (66 ± 10 years, 70 men) from the Coronary bifurcations: Application of the Crushing Technique Using Sirolimus-eluting stents (CACTUS) trial who had baseline CRP dosage and both baseline and postprocedural CK-MB measurement were included.. A complex bifurcation strategy was implemented in 53 (55%) patients, and angiographic success was achieved in all but two (2%) patients. Periprocedural myocardial necrosis (increase of CK-MB between one and three times the upper limit of normal [ULN]) was observed in 12 (13%) patients, and four (4%) patients had PCI-related myocardial infarction (increase of CK-MB more than three times ULN). Notably, progressively higher CRP levels were observed in patients with different increase in CK-MB (P = 0.041). Moreover, CRP >1 mg/L significantly predicted CK-MB rise (odds ratio 5.6, 95% confidence interval 1.5-4.3, P = 0.011).. In the setting of true coronary bifurcations treated by DES, baseline CRP levels were significantly associated with both the incidence and the extent of PMI.

Topics: Aged; Biomarkers; C-Reactive Protein; Cardiovascular Agents; Coronary Artery Disease; Creatine Kinase, MB Form; Drug-Eluting Stents; Female; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Myocardium; Necrosis; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome; Up-Regulation

The long-term performance of polymer-free stent systems in patients with diabetes mellitus has not been investigated extensively. This study reports long-term results of the LIPSIA Yukon trial which compared the polymer-free sirolimus-eluting Yukon Choice stent with the polymer-based paclitaxel-eluting Taxus Liberté stent in this subpopulation. At 9 months, the Yukon Choice stent failed to show non-inferiority in terms of the primary end point late lumen loss, while no significant difference in clinical outcome was detected.. The LIPSIA Yukon trial randomized 240 patients with diabetes mellitus to a polymer-free sirolimus eluting stent (Yukon Choice, Translumina) versus a polymer-based paclitaxel-eluting stent (Taxus Liberté, Boston Scientific). Clinical follow-up was conducted with a standardized telephone follow-up and all events were centrally adjudicated. Follow-up was available for 98.3% of patients after a median of 5.0 years. The incidence of all-cause death (16.9% versus 14.0%, P = 0.67), respectively definite or presumed cardiovascular death (7.6% versus 8.8%, P = 0.94) were similar in the Yukon Choice and the Taxus Liberté group. There were no significant differences in the rates of myocardial infarction (9.3% versus 7.9%, P = 0.88), definite stent thrombosis (0.8% versus 0.9%, P = 1.0), target lesion revascularization (15.3% versus 15.8%, P = 1.0), target vessel revascularization (18.6% versus 23.7%, P = 0.44), non-target vessel revascularization (18.6% versus 26.3%, P = 0.21), and stroke (3.4% versus 4.4%, P = 0.96) between patients assigned to the Yukon Choice and the Taxus Liberté stent.. At 5 years of follow-up, clinical outcome was similar between the polymer-free sirolimus-eluting Yukon Choice stent and the polymer-based paclitaxel-eluting Taxus Liberté stent.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Diabetic Angiopathies; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To evaluate the effects of the everolimus-eluting Xience™/Promus™ stent (EES) and the sirolimus-eluting Cypher™ stent (SES) on intimal hyperplasia (IH) in diabetic patients.. Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to intimal hyperplasia (IH).. In a sub study of the Randomized Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents in Patients Treated with Percutaneous Coronary Intervention (SORT OUT IV trial), serial intravascular ultrasound (IVUS) 10-month follow-up data were available in 88 patients, including 48 EES and 40 SES treated patients. IVUS endpoints included IH volume, in-stent % volume obstruction and changes in external elastic membrane (EEM) volume.. Compared with the SES group, IH volume was increased in the EES group [median (interquartile range): 2.8 mm(3) (0.0-12.6) vs. 0.0 mm(3) (0.0-1.1), P = 0.001]. In-stent % volume obstruction was increased in EES compared to SES [median (interquartile range): 1.6% (0.0-8.2) vs. 0.0% (0.0-1.0), P = 0.001]. Peri-stent external elastic membrane (EEM) volume: (post procedure vs. follow-up EES [300 mm(3) (219-491) vs. 307 mm(3) (223-482), P = 0.73] and SES [316 mm(3) (235-399) vs. 323 mm(3) (246-404), P = 0.05]) and peri-stent plaque volume: EES [163 mm(3) (103-273) vs. 184 mm(3) (115-291), P = 0.18] and SES [186 mm(3) (139-248) vs. 175 mm(3) (153-243), P = 0.26]) were unchanged in both groups. In the proximal reference segment a significant increase in plaque area was seen in the EES group only, without vascular remodeling.. In diabetic patients, EES stent implantation was associated with increased IH volume obstruction without involvement of vascular remodeling.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Female; Humans; Hyperplasia; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Remodeling

Drug-eluting stents (DES) constitute a major achievement in preventing re-stenosis, concerns remain regarding the increased inflammatory responses associated with the polymers used. This analysis focuses on outcomes in patients receiving the polymer-free sirolimus-eluting stent system YUKON-Choice (Yukon-DES, Translumina, Germany).. From 01/2006-09/2008 all patients receiving Yukon-DES (≥2.5 mm diameter) were prospectively enrolled in our registry. The primary endpoint was long-term major adverse cardiac events (MACE).. 701 patients were included in our registry. Mean age was 65.7 ± 10 years (73% male gender, 35.5% diabetes, and 32.2% acute coronary syndrome). 76% of the lesions were of Type B2/C. Lesion length was 24.6 ± 5.2 mm and mean stent diameter was 2.8 ± 0.4 mm. A total of 511 pts (72%) underwent 6-months angiographic follow-up, target vessel revascularization was noted in 23.5%. At 5 years clinical outcomes were: cardiac death 5.8%; myocardial infarction 3.4%; and TVR 24.6%. The incidence of MACE differed significantly between "on-label" and "off-label" indications (14.8% vs. 40.8% MACE; P < 0.001). Incidence of definitive/probable stent thrombosis (ST) was 1.14% (8/701); very late (>1 year) ST occurred in 0.29%.. Our data suggests that the implantation of the sirolimus-coated polymer-free YUKON-DES is safe and feasible with a very low incidence of ST in this real world patient cohort with high percentage of diabetes and small vessels.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Germany; Humans; Incidence; Male; Polymers; Prospective Studies; Registries; Sirolimus; Survival Rate; Time Factors

The purpose of this study was to evaluate the 1-year clinical outcomes of more complex XIENCE V USA real-world patients with small versus nonsmall vessel lesions.. Patients with small vessel lesions undergoing coronary stent placement are at higher risk of major adverse cardiac events. Improved safety and efficacy of XIENCE V everolimus eluting stents (EES) have been previously demonstrated in selected low-risk small vessel populations in randomized clinical trials.. The XIENCE V USA study was a condition of approval, single-arm study in unselected real-world patients. Baseline and 1-year clinical outcomes were compared between XIENCE V USA patients who received a single 2.5 mm stent (small vessel group, N = 838) and patients implanted with a single >2.5 mm stent (non-small vessel group, N = 2,015). Mean reference vessel diameter was 2.55 ± 0.36 and 3.25 ± 0.46 mm in the small and non-small vessel groups, respectively (P < 0.001).. Small vessel group had more females, presented with a higher rate of diabetes, and had more complex lesion characteristics. The definite or probable ST rates analyzed using Kaplan-Meier method were low and not significantly different between the groups at 0.37 and 0.40% for the small and nonsmall vessel group (P = 0.88), respectively. The composite rate of cardiac death or MI was comparable at 4.5% for the small and 5.1% for the non-small vessel 1 groups (P = 0.57). The 1-year target lesion revascularization rate was also comparable in the small vessel group (3.8% vs. 3.0%, P = 0.35).. Despite gender difference, higher prevalence of diabetes and more complex lesions in the small vessel groups, the 1-year clinical outcomes were similar in both small and nonsmall vessel groups. These results demonstrate the therapeutic benefit of XIENCE V EES in a real-world all inclusive patient population with small vessel disease.

Topics: Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Revascularization; Product Surveillance, Postmarketing; Prospective Studies; Prosthesis Design; Sirolimus; Treatment Outcome

This study sought to evaluate the impact of anatomic and procedural variables on the outcome of the unprotected left main coronary artery (uLMCA) itself after drug-eluting stent (DES) implantation.. There is a controversial debate regarding when and how to perform percutaneous coronary intervention (PCI) for an uLMCA stenosis.. This analysis is based on a randomized study of 607 patients undergoing PCI for uLMCA, randomized 1:1 to receive paclitaxel- or sirolimus-eluting stents. We evaluated the impact of the SYNTAX score, uLMCA anatomy, and stenting technique on in-stent restenosis (ISR), target lesion revascularization (TLR), and the 3-year outcomes.. The 3-year cardiac mortality rate was 5.8%; 235 (39%) patients had a true bifurcation lesion (TBL), and the median SYNTAX score was 27. TBL was associated with a higher need for multiple stents (72% vs. 37%, p < 0.001). TBL was a significant predictor of ISR (23% vs. 14%, p = 0.008) and for TLR (18% vs. 9%, p < 0.001). The need for multiple stents was a predictor of ISR (22% vs. 13%, p = 0.005) and for TLR (16% vs. 9%, p = 0.005). Culotte stenting showed better results compared with T-stenting for ISR (21% vs. 56%, p = 0.02) and for TLR (15% vs. 56%, p < 0.001). We observed a significant association between uLMCA-TLR and SYNTAX scores (9.2% for scores ≤ 22, 14.9% for scores 23 to 32, and 13.0% for scores ≥ 33, p = 0.008).. PCI of uLMCA lesions with DES is safe and effective out to 3 years. TBL and multiple stents were independent predictors for ISR. In the multivariate analysis, independent predictors for TLR were TBL, age, and EuroSCORE (European System for Cardiac Operative Risk Evaluation). (Drug-Eluting-Stents for Unprotected Left Main Stem Disease [ISAR-LEFT-MAIN]; NCT00133237).

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Proportional Hazards Models; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Percutaneous coronary interventions in patients with chronic kidney disease have shown suboptimal results. Drug-eluting stents (DES) might reduce the rate of target vessel revascularization in comparison with bare-metal stents (BMS) in patients with chronic kidney disease. However, given the multiple concomitant individual variables present in such patients, the comparison of neointimal growth after percutaneous coronary intervention is complex and difficult to assess.. Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient with Chronic Kidney Disease (RENAL-DES) was a prospective, randomized, multicenter study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent (Xience V) and BMS with an identical design (Multi-Link Vision), both implanted in the same patient with multivessel coronary artery disease and chronic kidney disease (estimated glomerular filtration rate <60 mL/min). The primary end point of the study was the ischemia-driven target vessel revascularization as detected with myocardial scintigraphy at 12 months. In 215 patients, 512 coronary vessels were successfully treated with the randomly assigned DES (n=257) or BMS (n=255). At 1 year, the rate of ischemia-driven target vessel revascularization for DES and BMS groups was 2.7% (95% confidence interval, 1.1%-5.6%) and 11.4% (95% confidence interval, 7.8% to 16%), respectively, P<0.001. For the multivariate analysis, independent predictors of the ischemia-driven target vessel revascularization were BMS implantation (odds ratio, 4.95; 95% confidence interval, 2.1-11.6; P<0.001) and vessel size (odds ratio, 0.32; 95% confidence interval, 0.1-0.7; P=0.006).. This is the first randomized trial showing a reduction of clinical restenosis with a new-generation DES in comparison with a BMS of equal design, in patients who have chronic kidney disease with multivessel coronary artery disease.. http://clinicaltrials.gov. Unique identifier: NCT00818792.

Topics: Aged; Aged, 80 and over; Comorbidity; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Endpoint Determination; Everolimus; Female; Glomerular Filtration Rate; Humans; Male; Middle Aged; Multivariate Analysis; Percutaneous Coronary Intervention; Prospective Studies; Renal Insufficiency, Chronic; Risk Factors; Sirolimus; Stents; Treatment Outcome

In patients with coronary artery disease (CAD), there is an increasing therapeutic need among interventional cardiologists to conduct dual antiplatelet therapy (DAPT) whose duration is shorter than current guideline-recommended 6-12 months after the implantation of drug-eluting stents. However, no clinical grounds sufficient to rationalize the need are available.. To define the optimal duration of DAPT and to examine the safety and efficacy of the Endeavor zotarolimus-eluting stent (E-ZES) in real-world Japanese patients with CAD.. The present prospective, nonrandomized, multicenter, controlled study is uniquely designed to examine the analysis set to be formulated after integrating two different databases consisting of the following two study arms: the 3-month DAPT arm, in which 1,210 patients were consecutively enrolled at 106 medical institutions; and the 12-month DAPT arm, in which 1,210 patients will be consecutively extracted from the Endeavor Japan post-marketing surveillance at 60 medical institutions. The primary endpoint is "net adverse cardiac and cerebrovascular events-death, myocardial infarction, cerebrovascular accident, and major bleeding)" at 12 months after implantation. The secondary endpoints are as follows: major adverse cardiac events at 1, 3, 6, 9, and 12 months after implantation; target vessel revascularization and target lesion revascularization at 9 and 12 months after implantation; and stent thrombosis, DAPT compliance, and bleeding events at 12 months after implantation. Noninferiority in the E-ZES's profiles between the study arms will be investigated.. The present study will provide insight into the optimal duration of DAPT after the E-ZES implantation in individual, real-world patients with CAD.

Topics: Aged; Coronary Artery Disease; Drug Therapy, Combination; Drug-Eluting Stents; Follow-Up Studies; Humans; Incidence; Japan; Male; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Prospective Studies; Prosthesis Design; Sirolimus; Treatment Outcome

Second-generation everolimus-eluting stents (EES) and third generation biolimus-eluting stents (BES) have been shown to be superior to first-generation paclitaxel-eluting stents (PES) and second-generation sirolimus-eluting stents (SES). However, neointimal proliferation and very late stent thrombosis is still an unresolved issue of drug-eluting stent (DES) implantation overall. The Absorb™ (Abbott Vascular, Abbott Park, IL, USA) is the first CE approved DES with a bioresorbable vascular scaffold (BVS) thought to reduce long-term complication rates. The EVERBIO II trial was set up to compare the BVS safety and efficacy with both EES and BES in all patients viable for inclusion.. The EVERBIO II trial is a single-center, assessor-blinded, randomized trial. The study population consists of all patients aged≥18 years old undergoing percutaneous coronary intervention. Exclusion criterion is where the lesion cannot be treated with BVS (reference vessel diameter>4.0 mm). A total of 240 patients will be enrolled and randomly assigned into 3 groups of 80 with either BVS, EES or BES implantation. All patients will undergo a follow-up angiography study at 9 months. Clinical follow-up for up to 5 years will be conducted by telephone. The primary endpoint is in-segment late lumen loss at 9 months measured by quantitative coronary angiography. Secondary endpoints are patient-oriented major adverse cardiac event (MACE) (death, myocardial infarction and target-vessel revascularization), device-oriented MACE (cardiac death, myocardial infarction and target-lesion revascularization), stent thrombosis according to ARC and binary restenosis at follow-up 12 months angiography.. EVERBIO II is an independent, randomized study, aiming to compare the clinical efficacy, angiographic outcomes and safety of BVS, EES and BES in all comer patients.. The trial listed in clinicaltrials.gov as NCT01711931.

Topics: Absorbable Implants; Cardiovascular Agents; Clinical Protocols; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Research Design; Sirolimus; Switzerland; Time Factors; Tissue Scaffolds; Treatment Outcome

The Absorb everolimus-eluting bioresorbable vascular scaffold (AbsorbBVS) is a completely resorbable device engineered to overcome the limitations of permanent metallic stents, providing temporary scaffolding and antiproliferative drug delivery for the treatment of obstructive coronary artery disease.. The objective of the AIDA trial is to evaluate the efficacy and performance in an contemporary all-comer population of the AbsorbBVS strategy vs the XIENCE family everolimus-eluting metallic coronary stent system in the treatment of coronary lesions. The AIDA trial is a prospective, randomized (1:1), active-control, single-blinded, all-comer, noninferiority trial. A total of 2,690 subjects will be enrolled with broad inclusion and limited exclusion criteria according to the "Instructions for Use" of the AbsorbBVS strategy. The study population includes both simple and complex lesions, in patients with stable and acute coronary syndrome. The follow-up continues for 5years. The primary end point of the trial is target vessel failure, defined as the composite of cardiac death, myocardial infarction, and target vessel revascularization, at 2years. This study is registered on ClinicalTrials.gov with number NCT01858077.. The AIDA trial will provide the first randomized direct comparison between the everolimus-eluting bioresorbable vascular scaffold and the everolimus-eluting metallic stent in contemporary percutaneous coronary intervention practice.

Topics: Aged; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Single-Blind Method; Sirolimus; Treatment Outcome

There are conflicting data on the use of cilostazol as triple antiplatelet therapy (TAPT) for improving clinical outcomes after drug-eluting stent implantation. We aimed to evaluate whether 3-month use of cilostazol in addition to dual antiplatelet therapy (DAPT) improved clinical outcomes in patients with long or multivessel coronary artery disease (CAD) after biolimus-eluting stent (BES) implantation.. Patients (n = 630) who had been successfully treated with BES implantation for lesions with ≥28 mm in stent length or ≥2 stents for different coronary arteries were enrolled in this prospective randomized multicenter trial. All patients were randomly assigned to receive either DAPT (aspirin and clopidogrel for 12 months, n = 314) or TAPT (DAPT plus 3-month cilostazol use, n = 316). The primary end point was a device-oriented composite consisting of cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel), and ischemia-driven target lesion revascularization at 1-year follow-up.. A total of 314 patients in DAPT and 308 patients in TAPT were analyzed. Multivessel CAD was present in 65.7% of patients. Stents ≥28 mm in length were implanted in 58.1% of lesions. There were no significant differences in baseline and angiographic characteristics between the 2 groups. The primary end point was similar between the 2 groups (2.3% in DAPT vs 1.9% in TAPT, log-rank P = .799).. In patients treated with BES implantation for long or multivessel CAD, 3 months of cilostazol use in addition to DAPT did not improve clinical outcome at 1-year follow-up.

Topics: Aged; Cilostazol; Clopidogrel; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Dose-Response Relationship, Drug; Drug Therapy, Combination; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Platelet Aggregation Inhibitors; Prospective Studies; Sirolimus; Tetrazoles; Ticlopidine; Time Factors; Treatment Outcome

The PLATINUM randomized trial enrolled 1530 patients treated with either the platinum chromium PROMUS Element everolimus-eluting stent (PtCr-EES; Boston Scientific, Natick, MA, USA) or the predicate cobalt chromium PROMUS/XIENCE V EES (CoCr-EES; manufactured as XIENCE V by Abbott Vascular, Santa Clara, CA, USA also distributed as PROMUS by Boston Scientific), including 124 patients from Japanese sites. This substudy examines 2-year outcomes in the Japanese and non-Japanese cohorts.. Patients with 1 or 2 de novo native coronary artery lesions (baseline vessel diameter ≥2.50mm to ≤4.25mm and length ≤24mm) were randomized 1:1 to PtCr-EES (N=63 patients in Japan) versus CoCr-EES (N=61 patients in Japan).. Several significant differences were noted in baseline demographics, lesion characteristics, and procedural technique between Japanese and non-Japanese patients, including longer fluoroscopy time, less use of contrast, and greater post-dilatation usage and maximum pressure in Japan. Dual antiplatelet usage at 2 years was also higher in Japan. Despite these differences, the 2-year rates of target lesion failure were comparable in patients treated with PtCr-EES and CoCr-EES both in Japan (3.2% vs 5.0% respectively, p=0.68) and outside Japan (4.7% vs 5.9% respectively, p=0.33; p for interaction=0.82).. This PLATINUM study subanalysis suggests that the PtCr-EES and CoCr-EES provide comparable safety and efficacy in both Japanese and non-Japanese patients.

Topics: Aged; Asian People; Chromium Alloys; Cohort Studies; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Fluoroscopy; Follow-Up Studies; Humans; Male; Middle Aged; Platelet Aggregation Inhibitors; Platinum Compounds; Racial Groups; Sirolimus; Treatment Outcome

Percutaneous treatment of complex coronary bifurcation lesions remains challenging, even in the drug-eluting stent era. We sought to evaluate the baseline and 9 months intravascular ultrasound (IVUS) analysis of the Axxess™ stent, a self-expanding, Biolimus A9™-eluting, and dedicated bifurcation stent.. We enrolled the first 76 patients from selected sites of the 302 patients large DIVERGE trial (a prospective, single-arm, multicenter trial evaluating the safety and efficacy of the Axxess stent). Both baseline and 9 months IVUS images were collected for serial two-dimensional (2D) and 3D analysis. A minimal amount and a low percentage of neointimal volume index were seen in the Axxess stent at 9 months (0.4 ± 0.6 mm(3) /mm and 4.3 ± 5.2%, respectively). Vessel, lumen, and stent volume indices increased significantly (respectively, 17.0 ± 3.6 to 18.9 ± 3.7 mm(3) /mm, P < 0.0001; 7.3 ± 2.0 to 9.2 ± 2.5 mm(3) /mm, P < 0.0001; and 7.4 ± 2.0 to 9.6 ± 2.6 mm(3) /mm, P < 0.0001). This resulted in minimum lumen area (MLA) enlargement (6.1 ± 1.9 to 7.2 ± 2.3 mm(2) , P < 0.0001), whereas peristent plaque area decreased (8.7 ± 2.5 to 8.5 ± 2.1 mm(3) /mm, P = 0.016). At 9 months, 16 (26%) incomplete stent apposition (ISA) persisted from baseline, while six resolved (9.7%). Only one (2%) ISA was late acquired. In the additional distal sirolimus-eluting stents, MLA decreased from 4.3 ± 1.1 to 4.1 ± 1.2 mm(2) (P = 0.04) at 9 months for the main branch, and from 3.4 ± 1.2 to 3.2 ± 1.2 mm(2) (P = 0.09) for the side branch.. The dedicated bifurcation Axxess stent system demonstrates significant stent volume increase with minimal neointimal formation and a low incidence of late-acquired ISA at 9 months.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Prosthesis Design; Reproducibility of Results; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Young Adult

The aim of this study was to compare 5-year cost-effectiveness and clinical outcomes of patients with oral rapamycin (OR) plus bare-metal stent versus the drug-eluting stent (DES) strategy. During 2006 to 2007, a total of 200 patients were randomized to OR (n = 100) and DES (n = 100). Primary end point was to compare costs of initial procedure and cost-effectiveness of both revascularization strategies. Safety was evaluated by the composite of death, myocardial infarction, and cerebrovascular accident. Efficacy was assessed by target vessel and target lesion revascularizations. The 2 groups had similar baseline demographic, clinical, and angiographic characteristics. In the DES group, paclitaxel-, zotarolimus-, and sirolimus-eluting stents were used. Five-year clinical follow-up was accomplished in 99% patients. The DES group had significantly higher procedural (p <0.001), discharge to first-year (p = 0.02), and 1- to 5-year costs (p <0.001) compared with the OR group. At 5 years, the composite end point of death, myocardial infarction, and cerebrovascular accident (12% in the OR group vs 25% in the DES group, p = 0.01) was significantly less in the OR group. Target vessel revascularization (14.5% in the OR group vs 21% in the DES group, p = 0.16) and target lesion revascularization (10% in the OR group vs 17.6% in the DES group, p = 0.05) were not significantly different. In conclusion, a strategy of OR plus bare-metal stent was cost saving than a first-generation DES.

Topics: Administration, Oral; Aged; Coronary Artery Disease; Cost-Benefit Analysis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Sirolimus; Stents; Treatment Outcome

Unexpected requests for non-cardiac surgery requiring discontinuation of dual antiplatelet therapy (DAPT) frequently occur in daily clinical practice. The objectives of this study were to evaluate prevalence, timing and clinical outcomes of such unexpected requests for non-cardiac surgery or other invasive procedures during the first year after drug-eluting stents (DESs) implantation.. We prospectively investigated the prevalence, timing and clinical outcomes of unexpected requests for non-cardiac surgery or other procedures during the first year after DESs implantation in 2117 patients.. The prevalence of requested non-cardiac surgery or invasive procedures was 14.6% in 310 requests and 12.3% in 261 patients. Among 310 requests, those were proposed in 11.3%<1 month, 30.0% between 1 and 3 months, 36.8% between 4 and 6 months and 21.9% between 7 and 12 months post-DES implantation. The rates of actual discontinuation of DAPT and non-cardiac surgery or procedure finally performed were 35.8% (111 of 310 requests) and 53.2% (165 of 310 requests), respectively. On multivariate regression analysis, the most significant determinants for actual discontinuation of DAPT were Endeavor zotarolimus-eluting stent implantation with 3-month DAPT (OR=5.54, 95% CI 2.95-10.44, p<0.001) and timing of request (OR=2.84, 95% CI 1.97-4.11, p<0.001). There were no patients with any death, myocardial infarction, or stent thrombosis related with actual discontinuation of DAPT.. Those unexpected requests with premature discontinuation of DAPT were relatively common and continuously proposed during the first year following DES implantation. No death, myocardial infarction or stent thrombosis occurred in patients with actual discontinuation of DAPT.

Topics: Aged; Attitude to Health; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Health Behavior; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Regression Analysis; Sirolimus; Surgical Procedures, Operative; Treatment Outcome; Treatment Refusal

In head-to-head comparisons of coronary drug-eluting stents, the primary endpoint is traditionally assessed after 9-12 months. However, the optimum timepoint for this assessment remains unclear. In this study, we assessed clinical outcomes at up to 5 years' follow-up in patients who received two different types of drug-eluting stents.. We undertook this multicentre, open-label, randomised superiority trial at five percutaneous coronary intervention centres in Denmark. We randomly allocated 2332 eligible adult patients (≥18 years of age) with an indication for drug-eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson, Warren, NJ, USA). Randomisation of participants was achieved by computer-generated block randomisation and a telephone allocation service. The primary endpoint of the SORT OUT III study was a composite of major adverse cardiac events-cardiac death, myocardial infarction, and target vessel revascularisation-at 9 months' follow-up. In this study, endpoints included the occurrence of major adverse cardiac events and definite stent thrombosis at follow-up times of up to 5 years. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00660478.. We randomly allocated 1162 patients to receive the zotarolimus-eluting stent and 1170 to the sirolimus-eluting stent. At 5-year follow-up, rates of major adverse cardiac events were similar in patients treated with both types of stents (zotarolimus-eluting stents 197/1162 [17.0%] vs sirolimus-eluting stents 182/1170 [15.6%]; odds ratio [OR] 1.10, 95% CI 0.88-1.37; p=0.40). This finding was indicative of the directly contrasting results for rates of major adverse cardiac events at 1-year follow up (zotarolimus 93/1162 [8.0%] vs sirolimus 46/1170 [3.9%]; OR 2.13, 95% CI 1.48-3.07; p<0.0001) compared with those at follow-up between 1 and 5 years (104 [9.0%] vs 136 [11.6%]; OR 0.78, 95% CI 0.59-1.02; p=0.071). At 1-year follow-up, definite stent thrombosis was more frequent after implantation of the zotarolimus-eluting stent (13/1162 [1.1%]) than the sirolimus-eluting stent (4/1170 [0.3%]; OR 3.34, 95% CI 1.08-10.3; p=0.036), whereas the opposite finding was recorded for between 1 and 5 years' follow-up (zotarolimus-eluting stent 1/1162 [0.1%] vs sirolimus-eluting stent 21/1170 [1.8%], OR 0.05, 95% CI 0.01-0.36; p=0.003). 26 of 88 (30%) target lesion revascularisations in the zotarolimus-eluting stent group occurred between 1 and 5 years' follow-up, whereas 54 of 70 (77%) of those in the sirolimus-eluting stent group occurred during this follow-up period.. The superiority of sirolimus-eluting stents compared with zotarolimus-eluting stents at 1-year follow-up was lost after 5 years. The traditional 1-year primary endpoint assessment therefore might be insufficient to predict 5-year clinical outcomes in patients treated with coronary drug-eluting stent implantation.. Cordis and Medtronic.

Topics: Aged; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Cytostatic Agents; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Research Design; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

Drug eluting stents for the treatment of small vessel coronary artery disease have traditionally yielded inferior clinical outcomes compared to the use of DES in large vessels. The benefit of the second-generation Resolute zotarolimus-eluting stent (R-ZES) in small vessels was examined.. Two-year clinical outcomes from five combined R-ZES studies were compared between patients with small (reference vessel diameter [RVD] ≤2.5 mm; n = 1,956) and large (RVD >2.5 mm; n = 3174) vessels.. Despite a higher incidence of comorbidities in the small vessel group, there was no significant difference in target lesion failure (TLF) (10.1% vs. 8.7%; P = 0.54) at 2 years. When the subgroup of patients with diabetes was examined (n = 1,553) there was no significant difference in 2-year TLF in small compared to large vessels (11.2% vs. 11.1%; P = 0.17). Similarly, within the small vessel cohort, no significant difference was seen regarding TLF at 2 years between people with and without diabetes (11.2% vs 9.6%; P = 0.28).. When used for the treatment of small vessels, the R-ZES appears to provide acceptable clinical results at 2 years when compared to its performance in large vessels.

Topics: Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Time Factors; Treatment Outcome

The INSPIRON-I trial is a first-in-man evaluation of the safety and efficacy of the Inspiron drug-eluting stent, a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromium alloy.. This is a randomised, multicentre comparison between Inspiron and a stent with the same metallic structure but without polymer coating or drug elution (Cronus). The primary objective was to evaluate the in-segment late loss (LLL) at six months. Secondary endpoints included percent in-stent obstruction as measured by intravascular ultrasound (IVUS) at six months and major adverse cardiac events (MACE). Fifty-eight patients were enrolled (60 lesions), 39 for Inspiron and 19 for Cronus. Baseline clinical and angiographic characteristics of both groups were similar. At six months, the in-segment LLL was reduced in the Inspiron group compared to the control group (0.19±0.16 mm vs. 0.58±0.4 mm, respectively; p<0.001), as well as the percent neointimal obstruction (7.8±7.1% vs. 26.5±11.4%; p<0.001). At two-year follow-up, incidence of MACE was similar between groups (7.9 vs. 21.1%, respectively; p=0.20), with lower target lesion revascularisation for Inspiron (0 vs. 21.1%, respectively; p=0.01) and no stent thrombosis.. Sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloy proved effective in reducing restenosis at six months.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Brazil; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Prospective Studies; Prosthesis Design; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Procedural and clinical outcomes still remain unfavorable for patients with long coronary lesions who undergo percutaneous coronary intervention. The current study, therefore, evaluated 2 innovative drug-eluting stents for the management of long-lesion coronary artery disease.. This randomized, multicenter, prospective trial, called the Long Drug-Eluting Stent (LONG-DES) V trial, compared the biodegradable polymer-based biolimus A9-eluting stent (BES) and the durable polymer-based platinum chromium everolimus-eluting stent (PtCr-EES) in 500 patients with long (≥ 25 mm) coronary lesions. The primary end point of the trial was in-segment late luminal loss at the 9-month angiographic follow-up. The BES and PtCr-EES groups had similar baseline characteristics, with a slightly shorter lesion length in the BES group versus the PtCr-EES group (29.24 ± 12.17 versus 32.27 ± 13.84 mm; P = 0.016). In-segment late luminal loss was comparable between the 2 groups at the 9-month angiographic follow-up (BES, 0.14 ± 0.38 versus PtCr-EES, 0.11 ± 0.37 mm; difference, 0.031; 95% confidence interval, -0.053 to 0.091; P = 0.03 for a noninferiority margin of 0.11, P = 0.45 for superiority), as was in-stent late luminal loss (0.20 ± 0.41 versus 0.24 ± 0.38 mm; P = 0.29). The incidence of in-segment (6.1% versus 4.9%; P = 0.63) and in-stent (3.7% versus 4.9%; P = 0.59) binary restenosis was also similar between the groups. There was no significant between-group difference in the rate of composite outcome of death, myocardial infarction, and target vessel revascularization (41, 16.7% in BES versus 42, 16.5% in PtCr-EES; P=0.94).. BES and PtCr-EES implantation showed analogous angiographic and clinical outcomes for patients with de novo long coronary lesions.. http://www.clinicaltrials.gov. Unique identifier: NCT01186120.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Single-Blind Method; Sirolimus; Survival Rate; Thrombosis; Treatment Outcome

Aim of the study was to report on the feasibility and early safety and efficacy of Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) for coronary artery bifurcations (CABs) treatment at a single high-volume center.. All patients treated with Absorb implantation at our institution from March 2013 to March 2014 were enrolled in the prospective, single-center, ongoing, all-comers registry, which has the main purpose of evaluating the safety and efficacy of Absorb implantation in unselected patients treated in daily practice. In-hospital and at follow-up clinical outcomes of 46 patients undergoing treatment with Absorb in 46 CAB lesions were reported in the present study.. Treated CAB lesions involved the left main in 13.0% of cases, the left anterior descending artery in 65.0%, the left circumflex in 19.6%, and the right coronary artery in 2.2%. Bifurcations were classified as true (47.8%) and non-true (52.2%) according to the Medina classification. The provisional and the two-BVS techniques were used in 78.3% and 21.7%, respectively. Two-BVS techniques included: mini-crush 13.0%; reverse culotte 2.2%; T-stenting 2.2%; and V-stenting 4.3%. No in-hospital adverse events occurred. At 6 months no adverse events occurred. Only one case of target lesion revascularization was observed at day 227. No stent thrombosis occurred during follow-up.. Our preliminary experience suggested that CABs treatment with Absorb is feasible and associated with promising immediate and short-term clinical outcomes. However, larger studies with long-term follow-up are needed to adequately address the safety and efficacy of BVS use in CABs.

Topics: Absorbable Implants; Aged; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Feasibility Studies; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Sirolimus; Time Factors; Tissue Scaffolds; Treatment Outcome

First generation drug-eluting stents (DES) were associated with a high incidence of late stent thrombosis (ST), mainly due to delayed healing and re-endothelization by the durable polymer coating. This study sought to assess the safety and efficacy of the Nano polymer-free sirolimus-eluting stent (SES) in the treatment of patients with de novo coronary artery lesions.. The Nano trial is the first randomized trial designed to compare the safety and efficacy of the Nano polymer-free SES and Partner durable-polymer SES (Lepu Medical Technology, Beijing, China) in the treatment of patients with de novo native coronary lesions. The primary endpoint was in-stent late lumen loss (LLL) at 9-month follow-up. The secondary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction or target lesion revascularization.. A total of 291 patients (Nano group: n = 143, Partner group: n = 148) were enrolled in this trial from 19 Chinese centers. The Nano polymer-free SES was non-inferior to the Partner durable-polymer DES at the primary endpoint of 9 months (P < 0.001). The 9-month in-segment LLL of the polymer-free Nano SES was comparable to the Partner SES (0.34 ± 0.42) mm vs. (0.30 ± 0.48) mm, P = 0.21). The incidence of MACE in the Nano group were 7.6% compared to the Partner group of 5.9% (P = 0.75) at 2 years follow-up. The frequency of cardiac death and stent thrombosis was low for both Nano and Partner SES (0.8% vs. 0.7%, 0.8% vs. 1.5%, both P = 1.00).. In this multicenter randomized Nano trial, the Nano polymer-free SES showed similar safety and efficacy compared with the Partner SES in the treatment of patients with de novo coronary artery lesions. Trials in patients with complex lesions and longer term follow-up are necessary to confirm the clinical performance of this novel Nano polymer-free SES.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Sirolimus

Previous reports have shown potential disadvantages of limus-derivative drugs for the stenting treatment of patients with diabetes mellitus (DM). METHODS AND RESULTS: We studied 159 coronary artery lesions (DM: n=72, non-DM: n=87) in 123 patients treated with everolimus-eluting stent (EES) and who underwent scheduled 9-month follow-up angiography with optical coherence tomography (OCT) regardless of symptoms. In addition to standard OCT variables, neointimal unevenness score (maximum/average neointimal thickness) and stent eccentricity index (minimum/maximum stent diameter) were calculated for each cross-section. To investigate a potential baseline difference between DM and non-DM lesions, pre- and post-interventional intravascular ultrasound (IVUS) images were also evaluated as an IVUS subgroup analysis. The average neointimal thickness and neointimal coverage did not differ between DM and non-DM patients. DM patients had, however, greater asymmetric stent expansion and variability of neointimal thickness than non-DM patients. There was a weak, but significant association between average stent eccentricity index and neointimal unevenness score. The IVUS substudy showed that the culprit plaque volume and plaque eccentricity in DM patients were significantly greater than in non-DM patients.. Although EES provided a similar level of average neointimal thickness and coverage both in the presence and absence of DM, uneven neointimal suppression occurred in DM patients. A larger plaque volume of the culprit lesion may hamper symmetric stent expansion, possibly explaining the non-uniform neointimal suppression in DM patients.

Topics: Aged; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Middle Aged; Neointima; Sirolimus; Tomography, Optical Coherence

Drug-eluting stents (DES) with durable polymer have significantly reduced restenosis and target vessel revascularization compared with bare metal stents. Durable polymer has been linked with persistent inflammation of vessel wall and delayed endothelial healing that may increase the risk of late and very late stent thrombosis. This study sought to evaluate the efficacy and safety of HELIOS completed biodegradable polymer sirolimus-eluting stent (SES) in de novo coronary lesions.. Totally, 287 patients with one or two de novo coronary lesions (lesion length ≤ 38 mm and reference vessel diameter 2.5-4.0 mm) were enrolled in the HOPE study, a prospective, multicenter, randomized, non-inferiority trial. Patients were randomized to treatment either with HELIOS completed biodegradable polymer SES (n = 142) or PARTNER durable polymer SES (n = 145). The primary endpoint was angiographic in-stent late lumen loss (LLL) at 9-month follow-up. The secondary endpoint included stent thrombosis and major adverse cardiac events including cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR).. The 9-month in-stent LLL in the HELIOS group was similar to the PARTNER group, (0.16 ± 0.22) mm vs. (0.19 ± 0.30) mm (P = 0.28). The difference and 95% confidence interval were -0.03 (-0.09, 0.04), and the P value for non-inferiority <0.01. Major adverse cardiovascular event (MACE) occurred in 7.9% vs. 8.2%, MI in 2.4% vs. 3.0%, TLR in 5.5% vs. 3.0%, and stent thrombosis in 0 vs. 1.5%; and events were comparable between the HELIOS group and PARTNER group at three-year follow-up (all P > 0.05). The three-year cardiac death was lower in the HELIOS group, but with no significant difference, 0 vs. 3.0% (P = 0.12).. In the HOPE trial, the novel completed biodegradable polymer SES HELIOS was non-inferior to the durable polymer SES PARTNER with respect to nine-month in-stent LLL in de novo coronary lesions. The incidence of other clinical endpoints was low for both of the stents in three-year follow-up.

Topics: Adult; Aged; Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Middle Aged; Percutaneous Coronary Intervention; Polymers; Sirolimus; Titanium; Treatment Outcome; Young Adult

This study sought to assess in vivo sex differences in the pathophysiology of ST-segment elevation myocardial infarction (STEMI) and vascular response to primary percutaneous coronary intervention (PCI).. There is no consensus on whether differences in the pathophysiology of STEMI and response to primary PCI between women and men reflect biological factors as opposed to differences in age.. In this prospective, multicenter study, 140 age-matched men and women with STEMI undergoing primary PCI with everolimus-eluting stent were investigated with intravascular optical coherence tomography, histopathology-immunohistochemistry of thrombus aspirates, and serum biomarkers. Primary endpoints were the percentages of culprit plaque rupture at baseline and everolimus-eluting stent strut coverage at 9-month follow-up as determined by optical coherence tomography.. Men and women had similar rates of plaque rupture (50.0% vs. 48.4%; risk ratio [RR]: 1.03; 95% confidence interval [CI]: 0.73 to 1.47; p = 0.56). Nonruptured/eroded plaques comprised 25% of all cases (p = 0.86 in men vs. women). There were no sex differences in composition of aspirated thrombus and immune and inflammatory serum biomarkers. At 9 months, women had similar strut coverage (90.9% vs. 92.5%; difference in medians: RR: 0.2%; 95% CI: -0.4% to 1.3%; p = 0.89) and amount of in-stent neointimal obstruction (10.3% vs. 10.6%; p = 0.76) as men did. There were no sex differences in clinical outcome either at 30-day or 1-year follow-up.. In patients presenting with STEMI undergoing primary PCI, no differences in culprit plaque morphology and factors associated with coronary thrombosis were observed between age-matched men and women. Women also showed similar vascular healing response to everolimus-eluting stents as men did. (Optical Coherence Tomography Assessment of Gender Diversity In Primary Angioplasty: The OCTAVIA Trial [OCTAVIA]; NCT01377207).

Topics: Aged; Aged, 80 and over; Biomarkers; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Health Status Disparities; Humans; Male; Middle Aged; Myocardial Infarction; Neointima; Odds Ratio; Percutaneous Coronary Intervention; Prospective Studies; Risk Factors; Rupture, Spontaneous; Sex Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

Biodegradable polymers for release of antiproliferative drugs from metallic drug-eluting stents aim to improve long-term vascular healing and efficacy. We designed a large scale clinical trial to compare a novel thin strut, cobalt-chromium drug-eluting stent with silicon carbide-coating releasing sirolimus from a biodegradable polymer (O-SES, Orsiro; Biotronik, Bülach, Switzerland) with the durable polymer-based Xience Prime/Xpedition everolimus-eluting stent (EES) (Xience Prime/Xpedition stent, Abbott Vascular, IL) in an all-comers patient population.. The multicenter BIOSCIENCE trial (NCT01443104) randomly assigned 2,119 patients to treatment with biodegradable polymer sirolimus-eluting stents (SES) or durable polymer EES at 9 sites in Switzerland. Patients with chronic stable coronary artery disease or acute coronary syndromes, including non-ST-elevation and ST-elevation myocardial infarction, were eligible for the trial if they had at least 1 lesion with a diameter stenosis >50% appropriate for coronary stent implantation. The primary end point target lesion failure (TLF) is a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization within 12 months. Assuming a TLF rate of 8% at 12 months in both treatment arms and accepting 3.5% as a margin for noninferiority, inclusion of 2,060 patients would provide more than 80% power to detect noninferiority of the biodegradable polymer SES compared with the durable polymer EES at a 1-sided type I error of 0.05. Clinical follow-up will be continued through 5 years.. The BIOSCIENCE trial will determine whether the biodegradable polymer SES is noninferior to the durable polymer EES with respect to TLF.

Topics: Absorbable Implants; Acute Coronary Syndrome; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Research Design; Sirolimus

Long-term outcomes are imperative to confirm safety of drug-eluting stents. There have been 2 randomized controlled trials comparing everolimus-eluting stents (EESs) and Resolute zotarolimus-eluting stents (ZES-Rs). To date, long-term clinical outcomes of these stents were limited to only 1 report, which has recently reported 4-year comparisons of these stents. Therefore, more evidence is needed regarding long-term clinical outcomes of the second-generation stents. This study compared the long-term clinical outcomes of EES with ZES-R in "all-comer" cohorts up to 3-year follow-up. The EXCELLENT and RESOLUTE-Korea registries prospectively enrolled 3,056 patients treated with EES and 1,998 with ZES-R, respectively, without exclusions. Stent-related composite outcomes (target lesion failure) and patient-related composite events up to 3-year follow-up were compared in crude and propensity score-matched analyses. Of 5,054 patients, 3,830 patients (75.8%) had off-label indication (2,217 treated with EES and 1,613 treated with ZES-R). The stent-related outcome (189 [6.2%] vs 127 [6.4%], p = 0.812) and the patient-related outcome (420 [13.7%] vs 250 [12.5%], p = 0.581) did not differ between EES and ZES-R, respectively, at 3 years, which was corroborated by similar results from the propensity score-matched cohort (hazard ratio [HR] 0.92, 95% confidence interval [CI] 0.70 to 1.20, p = 0.523 and 0.85, 95% CI 0.70 to 1.02, p = 0.081, for stent- and patient-related outcomes, respectively). The rate of definite or probable stent thrombosis up to 3 years (22 [0.7%] vs 10 [0.5%], p = 0.370) was also similar. The rate of very late definite or probable stent thrombosis was very low and comparable between the 2 stents (3 [0.1%] vs 1 [0.1%], p = 0.657). In multivariate analysis, chronic renal failure (adjusted HR 3.615, 95% CI 2.440 to 5.354, p <0.001) and off-label indication (adjusted HR 1.782, 95% CI 1.169 to 2.718, p = 0.007) were the strongest predictors of target lesion failure at 3 years. In conclusion, both stents showed comparable safety and efficacy at 3-year follow-up in this robust real-world registry with unrestricted use of EES and ZES-R. Overall incidences of target lesion failure and definite stent thrombosis, including very late stent thrombosis, were low, even in the patients with off-label indications, suggesting excellent long-term safety and sustained efficacy of both types of second-generation drug-eluting stents.

Topics: Antineoplastic Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Electrocardiography; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Registries; Republic of Korea; Sirolimus; Survival Rate; Time Factors; Treatment Outcome

In this randomized trial, strut coverage and neointimal proliferation of a therapy of bare metal stents (BMSs) postdilated with the paclitaxel drug-eluting balloon (DEB) was compared with everolimus drug-eluting stents (DESs) at 6-month follow-up using optical coherence tomography. We hypothesized sufficient stent coverage at follow-up.. A total of 105 lesions in 90 patients were treated with either XIENCE V DES (n=51) or BMS postdilated with the SeQuent Please DEB (n=54). At follow-up, comparable results on the primary optical coherence tomography end point (percentage uncovered struts 5.64±9.65% in BMS+DEB versus 4.93±9.29% in DES; P=0.366) were found. Thus, BMS+DEB achieved the prespecified noninferiority margin of 5% uncovered struts versus DES (difference between treatment means, 0.71%; one-sided upper 95% confidence interval, 4.14%; noninferiority P=0.04). Optical coherence tomography analysis showed significantly more global neointimal proliferation in the BMS+DEB group (15.7±7.8 versus 11.0±5.2 mm(3) proliferation volume/cm stent length; P=0.002). No significant focal in-stent stenosis analyzed with angiography (percentage diameter stenosis at follow-up, 22.8±11.9 versus 16.9±10.4; P=0.014) and optical coherence tomography (peak local area stenosis, 39.5±13.8% versus 36.8±15.6%; P=0.409) was found.. Good stent strut coverage of >94% was found in both therapy groups. Despite greater suppression of global neointimal growth in DES, both DES and BMS+DEB effectively prevented clinically relevant focal restenosis at 6-month follow-up.. http://www.clinicaltrials.gov. Unique identifier: NCT01056744.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Germany; Humans; Male; Metals; Middle Aged; Neointima; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Single-Blind Method; Sirolimus; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular Access Devices

The aim of this study was to investigate the hypothesis that a novel biodegradable polymer-coated, cobalt-chromium (CoCr), sirolimus-eluting stent (BP-SES) is noninferior in safety and efficacy outcomes compared with a durable polymer (DP)-SES.. No randomized trials have the compared safety and efficacy of BP-SES versus DP-SES on similar CoCr platforms, thereby isolating the effect of the polymer type.. In this prospective, single-blind, randomized trial conducted at 32 Chinese sites, 2,737 patients eligible for coronary stenting were treated with BP- or DP-SES in a 2:1 ratio. The primary endpoint was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. Secondary endpoints included TLF components, and definite/probable stent thrombosis.. At 12 months, the difference in the primary endpoint of TLF between BP-SES (6.3%) and DP-SES (6.1%) groups was 0.25% (95% confidence interval: -1.67% to 2.17%, p for noninferiority = 0.0002), demonstrating noninferiority of BP-SES to DP-SES. Individual TLF components of cardiac death (0.7% vs. 0.6%, p = 0.62), target vessel myocardial infarction (3.6% vs. 4.3%, p = 0.39), and clinically indicated target lesion revascularization (2.6% vs. 2.2%, p = 0.50) were similar, as were low definite/probable stent thrombosis rates (0.4% vs. 0.6%, p = 0.55).. In this large-scale real-world trial, BP-SES was noninferior to DP-SES for 1-year TLF. (Evaluate Safety and Effectiveness of the Tivoli ® DES and the Firebird ® DES for Treatment of Coronary Revascularization; NCT01681381).

Topics: Aged; Cardiovascular Agents; China; Chromium Alloys; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Recurrence; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

This study sought to investigate the in-scaffold vascular response (SVR) and edge vascular response (EVR) after implantation of an everolimus-eluting bioresorbable scaffold (BRS) using serial optical coherence tomography (OCT) imaging.. Although studies using intravascular ultrasound have evaluated the EVR in metal stents and BRSs, there is a lack of OCT-based SVR and EVR assessment after BRS implantation.. In the ABSORB Cohort B (ABSORB Clinical Investigation, Cohort B) study, 23 patients (23 lesions) in Cohort B1 and 17 patients (18 lesions) in Cohort B2 underwent truly serial OCT examinations at 3 different time points (Cohort B1: post-procedure, 6 months, and 2 years; B2: post-procedure, 1 year, and 3 years) after implantation of an 18-mm scaffold. A frame-by-frame OCT analysis was performed at the 5-mm proximal, 5-mm distal edge, and 2-mm in-scaffold margins, whereas the middle 14-mm in-scaffold segment was analyzed at 1-mm intervals.. The in-scaffold mean luminal area significantly decreased from baseline to 6 months or 1 year (7.22 ± 1.24 mm(2) vs. 6.05 ± 1.38 mm(2) and 7.64 ± 1.19 mm(2) vs. 5.72 ± 0.89 mm(2), respectively; both p < 0.01), but remained unchanged from then onward. In Cohort B1, a significant increase in mean luminal area of the distal edge was observed (5.42 ± 1.81 mm(2) vs. 5.58 ± 1.53 mm(2); p < 0.01), whereas the mean luminal area of the proximal edge remained unchanged at 6 months. In Cohort B2, the mean luminal areas of the proximal and distal edges were significantly smaller than post-procedure measurements at 3 years. The mean luminal area loss at both edges was significantly less than the mean luminal area loss of the in-scaffold segment at both 6-month and 2-year follow-up in Cohort B1 or at 1 year and 3 years in Cohort B2.. This OCT-based serial EVR and SVR evaluation of the Absorb Bioresorbable Vascular Scaffold (Abbott Vascular, Santa Clara, California) showed less luminal loss at the edges than luminal loss within the scaffold. The luminal reduction of both edges is not a nosologic entity, but an EVR in continuity with the SVR, extending from the in-scaffold margin to both edges. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Everolimus; Female; Humans; Male; Middle Aged; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

This study sought to describe the frequency and clinical impact of acute scaffold disruption and late strut discontinuity of the second-generation Absorb bioresorbable polymeric vascular scaffolds (Absorb BVS, Abbott Vascular, Santa Clara, California) in the ABSORB (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) cohort B study by optical coherence tomography (OCT) post-procedure and at 6, 12, 24, and 36 months.. Fully bioresorbable scaffolds are a novel approach to treatment for coronary narrowing that provides transient vessel support with drug delivery capability without the long-term limitations of metallic drug-eluting stents. However, a potential drawback of the bioresorbable scaffold is the potential for disruption of the strut network when overexpanded. Conversely, the structural discontinuity of the polymeric struts at a late stage is a biologically programmed fate of the scaffold during the course of bioresorption.. The ABSORB cohort B trial is a multicenter single-arm trial assessing the safety and performance of the Absorb BVS in the treatment of 101 patients with de novo native coronary artery lesions. The current analysis included 51 patients with 143 OCT pullbacks who underwent OCT at baseline and follow-up. The presence of acute disruption or late discontinuities was diagnosed by the presence on OCT of stacked, overhung struts or isolated intraluminal struts disconnected from the expected circularity of the device.. Of 51 patients with OCT imaging post-procedure, acute scaffold disruption was observed in 2 patients (3.9%), which could be related to overexpansion of the scaffold at the time of implantation. One patient had a target lesion revascularization that was presumably related to the disruption. Of 49 patients without acute disruption, late discontinuities were observed in 21 patients. There were no major adverse cardiac events associated with this finding except for 1 patient who had a non-ischemia-driven target lesion revascularization.. Acute scaffold disruption is a rare iatrogenic phenomenon that has been anecdotally associated with anginal symptoms, whereas late strut discontinuity is observed in approximately 40% of patients and could be viewed as a serendipitous OCT finding of a normal bioresorption process without clinical implications. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).

Topics: Absorbable Implants; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Patients with coronary total occlusions are at especially high risk for restenosis and new revascularizations. Sirolimus-eluting stents dramatically improved the clinical outcome of this subset of patients in randomized trials, but other drug-eluting stents, mainly the everolimus-eluting stent (currently the most frequently used stent), have not yet been evaluated in patients with coronary total occlusions. The objective was to compare the second-generation everolimus-eluting stent with the first-generation sirolimus-eluting stent in patients with coronary total occlusions.. A total of 207 patients with coronary total occlusions and estimated time since occlusion >2 weeks were randomized to everolimus- or sirolimus-eluting stent. The primary end point was in-stent late loss at 9-month angiographic follow-up (noninferiority trial). Clinical follow-up was performed at 1 and 12 months. In-stent late loss at 9 months was 0.29±0.60 versus 0.13±0.69 mm in patients allocated to sirolimus- and everolimus-eluting stent, respectively. The observed difference in in-stent late loss between both groups was -0.16 mm (95% confidence interval, 0.04 to -0.36 mm; P for noninferiority <0.01). The rate of binary angiographic restenosis was 10.8% and 9.1% in patients allocated to sirolimus- and everolimus-eluting stent, respectively (P=0.709), whereas the rate of vessel reocclusion was 3.2% and 1.1%, respectively (P=0.339). At 12 months, the rate of major adverse events was 15.9% versus 11.1% with sirolimus- and everolimus-eluting stent, respectively (P=0.335), and probable or definitive stent thrombosis occurred in 3.0% and 0.0% of patients, respectively (P=0.075).. In patients with coronary total occlusions, everolimus-eluting stent is as effective as sirolimus-eluting stent.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00793221.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Postoperative Complications; Risk; Sirolimus; Survival Analysis; Treatment Outcome

to compare the vascular healing process between the sirolimus-eluting NEVO and the everolimus-eluting Xience stent by optical coherence tomography (OCT) at 1-year follow-up.. Presence of durable polymer on a drug-eluting metallic stent may be the basis of an inflammatory reaction with abnormal healing response. The NEVO stent, having a bioresorbable polymer eluted by reservoir technology, may overcome this problem.. All consecutive patients, who received NEVO or Xience stent implantation between September 2010 and October 2010 in our institution, were included. Vascular healing was assessed at 1-year as percentage of uncovered struts, neointimal thickness (NIT), in-stent/stent area obstruction and pattern of neointima.. A total 47 patients (2:1 randomization, n = 32 NEVO, n = 15 Xience) were included. Eighteen patients underwent angiographic follow-up (eight patients with nine lesions for NEVO vs. 10 patients with 11 lesions for Xience). The angiographic late loss was numerically higher but not statistically different in NEVO compared with Xience treated lesions (0.38 ± 0.47 mm vs. 0.18 ± 0.27 mm; P = 0.171). OCT analysis of 4,912 struts demonstrated similar rates of uncovered struts (0.5 vs. 0.7%, P = 0.462), higher mean NIT (177.76 ± 87.76 µm vs. 132.22 ± 30.91 µm; P = 0.170) and in stent/stent area obstruction (23.02 ± 14.74% vs. 14.17 ± 5.94%, P = 0.120) in the NEVO as compared with Xience.. The NEVO stent with a reservoir technology seems to exhibit more neointimal proliferation as compared to Xience stent. The findings of our study, which currently represent the unique data existing on this reservoir technology, would need to be confirmed in a large population.

Topics: Aged; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

This study was designed to compare neointimal hyperplasia and peri-stent arterial remodeling after implantation of everolimus-eluting stent (EES) versus sirolimus-eluting stent (SES) using intravascular ultrasound (IVUS). The study population was a subgroup of 278 patients from the EXCELLENT trial, a randomized study comparing EES to SES in de novo coronary artery lesions (total n = 1,443, 3:1 randomization) who underwent post-PCI and 9-month follow-up IVUS evaluation. There were 209 patients in the EES group and 69 in the SES group. Baseline clinical and angiographic characteristics were similar between the two groups except for age and target lesion locations. At 9 months, percent neointimal volume obstruction did not differ between EES and SES (2.6 ± 4.0 % vs. 2.5 ± 4.8 %, p = 0.814). However, the relative change in the vessel (4.3 ± 13.7 % vs. 8.8 ± 18.6 %, p = 0.030) and plaque volume index (4.2 ± 17.4 % vs. 10.5 ± 22.3 %, p = 0.016) of the stented segment from post-intervention to follow-up was significantly less with EES than with SES. In addition, positive peri-stent vascular remodeling defined as an increase in vessel volume index >10 % (27.8 vs. 42.0 %, p = 0.027) and late acquired stent malapposition (LASM, 1.9 vs. 15.9 %, p < 0.001) were observed less frequently with EES than SES. EES and SES were similarly effective in reducing neointimal hyperplasia. However, positive peri-stent vascular remodeling and LASM occurred less frequently with EES than SES.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Hyperplasia; Logistic Models; Male; Middle Aged; Multivariate Analysis; Neointima; Odds Ratio; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Republic of Korea; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

This study sought to compare clinical outcomes and angiographic findings using the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Santa Rosa, California) versus the Taxus Liberte paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in an all-comer Chinese population.. Concerns regarding restenosis risk led to new-generation drug-eluting stents (DES) designed for use in patients with complex clinical or lesion characteristics. In-stent late lumen loss (LLL) is a measure of restenosis risk.. Patients with an indication for treatment with a DES were randomized in a 1:1 ratio to placement of at least 1 R-ZES or PES with minimal exclusions. The primary endpoint was angiographic in-stent LLL at 9 months post-procedure. Clinical endpoints at 12 months are compared between the 2 stents.. A total of 198 patients received a R-ZES, and 202 patients received a PES. Most patients were male; 25.8% and 29.2% of R-ZES and PES patients, respectively, had diabetes. Over 70% of lesions in both cohorts were American College of Cardiology/American Heart Association lesion classification Type B2 and C (B2/C). In-stent LLL was 0.16 ± 0.38 mm for R-ZES and 0.33 ± 0.52 mm for PES at 9 months (p < 0.001; 95% confidence interval [CI]: -0.26 to -0.08). The rates of clinically driven target lesion revascularization were 1.5% for R-ZES and 7.0% for PES (p = 0.011). The rate of target lesion failure was 5.6% for R-ZES and 11% for PES (p = 0.068).. In an all-comers Chinese population, 9-month in-stent LLL was significantly less with R-ZES compared with PES, which was reflected in lower revascularization rates at 12 months for the R-ZES patients. Results are consistent with previous clinical trials of the R-ZES in all-comer populations. (Resolute Zotarolimus-Eluting Stent Versus the Taxus Liberte Paclitaxel-Eluting Stent for Percutaneous Coronary Intervention in China [R-China RCT]; NCT01334268).

Topics: Aged; Cardiovascular Agents; China; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

This study sought to report the final 5-year outcomes of the ENDEAVOR IV (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) trial comparing the Endeavor zotarolimus-eluting stent (E-ZES) (Medtronic, Santa Rosa, California) with the Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in patients with single de novo coronary lesions.. Primary results of the ENDEAVOR IV trial demonstrated similar clinical outcomes with E-ZES and PES. Concerns with regard to late adverse clinical events with drug-eluting stents highlight the need for long-term follow-up with these devices.. Late outcomes after the use of E-ZES and PES were examined in the multicenter randomized ENDEAVOR IV trial in cumulative and landmark analyses. Assessed outcomes were related to device efficacy and patient safety.. At 5 years, clinical data were available for 722 (93.4%) E-ZES patients and 718 (92.6%) PES patients. Overall rates of target lesion revascularization (7.7% vs. 8.6%, p = 0.70) and target vessel failure were similar (17.2% vs. 21.1%, p = 0.061) with E-ZES compared with PES. The incidence of cardiac death or myocardial infarction (MI) was lower with E-ZES (6.4% vs. 9.1%, p = 0.048), primarily driven by a lower rate of target vessel MI with E-ZES (2.6% vs. 6.0%, p = 0.002). Although overall definite/probable stent thrombosis rates were similar between stents (1.3% vs. 2%, p = 0.42), rates of very late stent thrombosis (0.4% vs. 1.8%, p = 0.012) and late MI events (1.3% vs. 3.5%, p = 0.008) were significantly lower with E-ZES compared with PES.. These data demonstrate the durable efficacy and safety of E-ZES compared with PES for the treatment of de novo coronary lesions. Significant improvements in late safety outcomes were observed with E-ZES but should be considered hypothesis-generating, given the limited statistical power of the trial. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; United States

Randomized trials showed that mTOR inhibitors prevent early development of cardiac allograft vasculopathy (CAV). However, the action of these drugs on CAV late after transplant is controversial, and their effectiveness for CAV prevention in clinical practice is poorly explored. In this observational study we included 143 consecutive heart transplant recipients who underwent serial intravascular ultrasound (IVUS), receiving either everolimus or mycophenolate as adjunctive therapy to cyclosporine. Ninety-one recipients comprised the early cohort, receiving IVUS at weeks 3-6 and year 1 after transplant, and 52 the late cohort, receiving IVUS at years 1 and 5 after transplant. Everolimus independently reduced the odds for early CAV (0.14 [0.01-0.77]; p = 0.02) but it did not appear to influence late CAV progression. High-dose statins were found to be associated with reduced CAV progression both early and late after transplant (p ≤ 0.05). Metabolic abnormalities, such as high triglycerides, were associated with late, but not with early CAV progression. By highlighting a differential effect of everolimus and metabolic abnormalities on early and late changes of graft coronary morphology, this observational study supports the hypothesis that everolimus may be effective for CAV prevention but not for CAV treatment, and that risk factors intervene in a time-dependent sequence during CAV development.

Topics: Adolescent; Adult; Antineoplastic Agents; Biopsy; Coronary Artery Disease; Coronary Vessels; Disease Progression; Dose-Response Relationship, Drug; Everolimus; Female; Follow-Up Studies; Graft Rejection; Heart Transplantation; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardium; Retrospective Studies; Sirolimus; Time Factors; Transplantation, Homologous; Treatment Outcome; Ultrasonography, Interventional; Young Adult

Paclitaxel-eluting stents (PESs) have been shown to inhibit neointimal hyperplasia after percutaneous coronary intervention. Coroflex Please (B Braun, Melsungen, Germany) is a newly developed PES. We compared the clinical and angiographic efficacy of Coroflex Please with Taxus Liberte (Boston Scientific, Natick, MA) in a real-world practice.. We performed a prospective, open-label, randomized, controlled study that enrolled 945 patients undergoing percutaneous coronary interventions in 18 centers in Korea. The primary end point was clinically driven target vessel revascularization at 9 months. The baseline characteristics were mostly similar and comparable between 2 groups. At 9 months, the incidence of clinically driven target vessel revascularization was 14.6% for Coroflex and 6.4% for Taxus, which was significantly different (hazard ratio 2.43, 95% CI 1.50-3.94, noninferiority P value = 1.000). This is well corroborated by the difference of in-stent late loss between 2 stents (0.71 ± 0.64 mm vs 0.52 ± 0.50 mm, P < .001) by 9-month follow-up angiography (n = 415 vs 215). Among secondary clinical end points, stent thrombosis (definite and probable) for 1 year was 2.2% in Coroflex and 1.3% in Taxus (P = .317). Also, myocardial infarction for 9 months was higher in Coroflex group than that in Taxus (4.9% vs 1.6%, P = .012), which was partly contributed by the higher incidence of periprocedural myocardial infarction in Coroflex arm (2.2% vs 0.3%, P = .028).. Coroflex Please was inferior to Taxus Liberte with regard to clinical and angiographic efficacy.

Topics: Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

NEXT (NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial) was designed for evaluating the noninferiority of a biolimus-eluting stent (BES) relative to an everolimus-eluting stent (EES) in terms of target lesion revascularization (TLR) at 1 year.. Efficacy and safety data comparing biodegradable polymer BES with durable polymer cobalt-chromium EES are currently limited.. The NEXT trial is a prospective, multicenter, randomized, open-label, noninferiority trial comparing BES with EES. Between May and October 2011, 3,235 patients were randomly assigned to receive either BES (n = 1,617) or EES (n = 1,618).. At 1 year, the primary efficacy endpoint of TLR occurred in 67 patients (4.2%) in the BES group, and in 66 patients (4.2%) in the EES group, demonstrating noninferiority of BES relative to EES (p for noninferiority <0.0001, and p for superiority = 0.93). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.25% vs. 0.06%, p = 0.18). An angiographic substudy enrolling 528 patients (BES: n = 263, and EES: n = 265) demonstrated noninferiority of BES relative to EES regarding the primary angiographic endpoint of in-segment late loss (0.03 ± 0.39 mm vs. 0.06 ± 0.45 mm, p for noninferiority <0.0001, and p for superiority = 0.52) at 266 ± 43 days after stent implantation.. One-year clinical and angiographic outcome after BES implantation was noninferior to and not different from that after EES implantation in a mostly stable coronary artery disease population. One-year clinical outcome after both BES and EES use was excellent, with a low rate of TLR and extremely low rate of stent thrombosis.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Polymers; Prospective Studies; Radiography; Single-Blind Method; Sirolimus; Treatment Outcome

The DIRECT study is a first-in-human evaluation of the safety and efficacy of the Svelte sirolimus-eluting coronary stent mounted on a fixed-wire, "all-in-one" integrated delivery system (IDS) in patients with de novo coronary artery lesions. The system permits easy delivery, deployment and post-dilatation of a cobalt-chromium stent eluting sirolimus from a fully bioabsorbable amino acid coating. The stent on its IDS has a very low profile, and is designed specifically to facilitate direct stenting.. Patients with symptomatic ischaemic heart disease and a single de novo native coronary lesion suitable for percutaneous coronary intervention were prospectively enrolled at four New Zealand sites. The lesion length had to be <23 mm and the vessel reference diameter 2.5-3.5 mm. The primary safety and efficacy endpoints were target vessel failure (TVF) and angiographic in-stent late lumen loss (LLL) at six months, respectively. Twenty-nine of 30 enrolled patients completed six-month follow-up. TVF occurred in two patients (7%). The in-stent LLL was 0.22 ± 0.27 mm. No patient had clinically-driven target lesion revascularisation. Intravascular ultrasound neointimal volume was 3.3 ± 4.4 mm3 and volume obstruction was 2.7 ± 4.5% at six months. Optical coherence tomography showed 98 ± 4% strut coverage at a depth of 0.12 ± 0.06 mm. No patient developed stent thrombosis.. Percutaneous coronary intervention using the Svelte sirolimus-eluting coronary stent mounted on an IDS appears safe and effective in de novo coronary artery lesions, with minimal in-stent proliferation and excellent stent strut coverage at six months.

Topics: Aged; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; New Zealand; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The study sought to evaluate the safety and efficacy of FIREHAWK, a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent (SES) for treating patients with single de novo coronary lesions compared with the durable polymer everolimus-eluting stent (EES) XIENCE V.. A total of 458 patients with single de novo native coronary lesions ≤24 mm in length and a coronary artery ≥2.25 to ≤4.0 mm in diameter were enrolled in the TARGET I study, a prospective, randomised, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) at nine-month follow-up. The secondary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, target vessel myocardial infarction (TVMI), or ischaemia-driven target lesion revascularisation (iTLR). Patients were centrally randomised to treatment with either biodegradable polymer SES (n=227) or durable polymer EES (n=231). The nine-month in-stent LLL of the biodegradable polymer SES was comparable to the EES group (0.13 ± 0.24 mm vs. 0.13 ± 0.18 mm, p=0.94; difference and 95% confidence interval 0.00 [-0.04, 0.04] mm; p for non-inferiority <0.0001). Cardiac death (0.4% vs. 0.0%), TVMI (1.3% vs. 1.7%), iTLR (0.4% vs. 0.4%) and TLF (2.2% vs. 2.2%) were similar between the biodegradable polymer SES and durable polymer EES groups at 12-month follow-up (all p>0.05). No definite/probable stent thrombosis was observed in both of these groups.. In the multicentre TARGET I trial, the novel abluminal groove-filled biodegradable polymer SES FIREHAWK was non-inferior to the durable polymer EES XIENCE V with respect to the primary endpoint of in-stent LLL at nine months for treating patients with single de novo coronary lesions. The incidences of clinical endpoints were low in both of the stents at 12-month follow-up. (ClinicalTrials.gov identifier: NCT01196819).

Topics: Absorbable Implants; Aged; Analysis of Variance; Antineoplastic Agents; Chi-Square Distribution; China; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Least-Squares Analysis; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

Intravascular ultrasound (IVUS) offers tomographic images of the coronary artery, helping physicians to refine drug-eluting stent (DES) implantation in angiographically complex lesions. However, controversy exists regarding whether the routine use of IVUS in short-length lesions leads to improved clinical outcomes after DES implantation. Therefore, we evaluated the usefulness of IVUS in predicting major adverse cardiac events (MACE), including cardiovascular death, myocardial infarction, or target vessel revascularization, at 1 year after DES implantation in short-length lesions. The present study was a subanalysis of the REal Safety and Efficacy of a 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation (RESET) study with different clinical outcome parameters. The study population consisted of 662 patients with IVUS guidance and 912 patients with angiography guidance who underwent DES implantation (stent length ≤24 mm). In the IVUS-guided group, adjuvant postdilation was more frequently performed (43.0% vs 34.6%, p <0.001), and the postintervention minimal lumen diameters were greater (2.88 ± 0.44 mm vs 2.72 ± 0.43 mm, p <0.001). MACE occurred in 15 IVUS-guided (2.3%) and 19 angiographically guided (2.1%) patients (p = 0.872). In a subset of patients with diabetes mellitus (n = 292), the MACE rate was 3.4% (n = 4) and 1.7% (n = 3) in the IVUS- and angiographically guided patients, respectively (p = 0.384). The MACE rate in the IVUS- and angiographically guided patients with acute coronary syndrome (n = 601) was 1.1% (n = 3) and 2.7% (n = 9), respectively (p = 0.194). The clinical benefits of IVUS-guided DES implantation compared with angiographically guided DES implantation in short-length lesions could not be confirmed even in patients with clinically high-risk presentations (acute coronary syndrome and diabetes mellitus). In conclusion, routine IVUS guidance does not provide clinical benefits when performing short-length DES implantation.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prognosis; Sirolimus; Treatment Outcome; Ultrasonography, Interventional

Everolimus-eluting stents (EES) have shown favorable clinical outcomes. However, there have been no studies evaluating early vascular response after EES implantation. We designed a prospective study to compare the neointimal response between zotarolimus-eluting stents (ZES) and EES at 3 and 12 months using serial optical coherence tomography examinations.. Sixty patients who underwent 3-month and 12-month follow-up optical coherence tomography (36 EES, 24 ZES) were included. Neointimal coverage and malapposition were evaluated using a strut-based analysis at both 3 and 12 months. Neointimal hyperplasia area and thrombus were assessed. ZES showed a higher incidence of covered struts (81.5 vs. 77.1%, P<0.0001) and lower incidence of malapposed struts (1.4 vs. 2.3%, P=0.001) than EES at 3 months. However, at 12 months, EES showed a slightly higher incidence of covered struts (96.4 vs. 93.6%, P<0.0001) and a lower incidence of malapposed struts (0.9 vs. 1.1%, P=0.03) than ZES. Neointimal hyperplasia area was greater in the ZES group than in the EES group at both 3 and 12 months (0.77 vs. 0.49 mm, P=0.03 and 1.50 vs. 0.97 mm, P=0.01, respectively). No significant difference in the incidence of thrombus was observed at both 3 and 12 months.. ZES showed rapid neointimal healing compared with EES at 3 months. However, at 12 months, EES had a slightly better vascular healing profile than ZES.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Hyperplasia; Male; Middle Aged; Neointima; Observer Variation; Odds Ratio; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Reproducibility of Results; Republic of Korea; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

To assess long-term outcomes of Endeavor Zotarolimus-eluting stent (E-ZES) implantation in patients with diabetes mellitus (DM).. Patients with DM and coronary artery disease have lower restenosis with drug-eluting stent (DES) compared with bare-metal stents. Recent data suggest that the E-ZES is inferior to other DES in this population.. Patient-level data for 601 patients with DM from the ENDEAVOR III and ENDEAVOR IV trials were pooled, of which 337 were treated with E-ZES and 264 were treated with other DES. The primary outcome was target vessel failure (TVF) in the course of 5 years. Outcomes are reported as rates using Kaplan-Meier (KM) survival method and differences between E-ZES and other stent types (sirolimus-eluting stent or paclitaxel-eluting stent) were compared using the log-rank statistic. The independent effect of stent type on TVF was assessed using Cox proportional hazards regression.. Baseline characteristics were similar between the groups. Five-year TVF KM rate estimate was numerically lower for E-ZES, but the difference did not reach statistical significance (20.2 vs. 26.9%, P = 0.065). The 5-year KM rate estimates of major adverse cardiac events (17.7 vs. 26.6%, P = 0.012), death (7.6 vs. 15.0%, P = 0.004), and myocardial infarction (1.3 vs. 5.1%, P = 0.011) were also lower for E-ZES versus other DES.. Patients with DM implanted with E-ZES have favorable long-term outcomes compared to first-generation DES. Long-term performance of DES should be assessed routinely and may differ from initial performance.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Diabetic Angiopathies; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To evaluate the atherosclerotic evolution in coronary bifurcations located proximally and distally to a bioresorbable scaffold.. Thirty bifurcations located >5 mm beyond the scaffolded segment, being investigated with serial intravascular ultrasound virtual histology (IVUS-VH) examinations, at baseline and 2-years, in patients enrolled in the ABSORB cohort B1 study were included in this analysis. In each bifurcation, the frames portraying the proximal rim, in-bifurcation, and distal rim of the ostium of the side branch were analyzed. The geometric parameters and plaque types were evaluated at baseline and 2-years follow-up.. There were no significant differences in the geometrical parameters such as lumen, vessel and plaque areas as well as in the composition of the atheroma between baseline and 2-years follow-up.When we separately examined the bifurcations located proximally and distally to the scaffolded segment, no changes were found at the distal bifurcations, while at the proximal bifurcations there was a statistical significant decrease in the plaque burden (36.67 ± 13.33% at baseline vs. 35.06 ± 13.20% at 2 years follow-up, p = 0.04).Ten necrotic core rich plaques were found at baseline, of which 2 regressed to either fibrotic plaque or to intimal thickening at 2 years follow-up. The other 8 did not change. Disease progression was noted in 3 plaques (1 adaptive intimal thickening, 1 fibrotic and 1 fibrocalcific plaque) that evolved to necrotic rich plaques.. Plaque regression was noted at the bifurcations located proximally to the bioresorbable scaffold but not at these located distally. Additional studies are required to confirm this finding and examine further the effect of drug elution on atherosclerotic evolution.

Topics: Aged; Coronary Artery Disease; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Echocardiography; Everolimus; Female; Humans; Image Enhancement; Image Interpretation, Computer-Assisted; Immunosuppressive Agents; Male; Reproducibility of Results; Sensitivity and Specificity; Sirolimus; Subtraction Technique; Treatment Outcome; Ultrasonography, Interventional; User-Computer Interface

The EVOLVE FHU trial demonstrated non-inferiority of six-month late loss with two dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) compared with the durable polymer PROMUS Element (PE) EES. The current analysis describes the six-month IVUS and clinical results through two years from the EVOLVE FHU trial.. EVOLVE recruited 291 patients from 29 centres. At six months, IVUS-assessed in-stent net volume obstruction was 3.40 ± 5.06% for PROMUS Element (PE) vs. 2.68 ± 4.60% for SYNERGY (p=0.34) and 3.09 ± 4.29% for SYNERGY ½ dose (p=0.68 vs. PE). There were no significant differences between groups for any other measured IVUS parameter including resolved, persistent, and late-acquired incomplete stent apposition (ISA). At two years, target lesion failure (TLF) was 6.1% for PE vs. 5.5% for SYNERGY (p=0.87) and 5.2% for SYNERGY ½ dose (p=0.81). There were no significant differences between groups for cardiac death, repeat revascularisation, MI or stent thrombosis through two years.. At six months, everolimus delivered from an ultrathin bioabsorbable abluminal polymer resulted in equivalent net volume obstruction and ISA compared with a permanent polymer EES. There were no significant differences between PE and either SYNERGY stent for any major cardiac endpoint through two years. Clinical trials number: NCT01135225.

Topics: Australia; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Europe; Everolimus; Humans; Kaplan-Meier Estimate; Myocardial Infarction; New Zealand; Percutaneous Coronary Intervention; Polymers; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

No randomized studies have been conducted to investigate serial changes in optical coherence tomography (OCT) analyses following implantation of biolimus-A9-eluting stents (BES) and sirolimus-eluting stents (SES).. A total of 60 patients fulfilling the study criteria were randomly assigned into BES (n=30) and SES (n=30) implantation groups. Serial OCT evaluation at post-procedure, 3- and 12-month follow-up was performed in 46 patients [BES (n=22) and SES (n=24)]. OCT analyses were compared according to the type of stents and the follow-up time intervals. The percentage of uncovered struts was defined as the ratio of uncovered struts to total struts in all cross-sections. The primary endpoint was the percentage change (Δ) of uncovered struts in the 3- and 12-month follow-up samples.. The percentage of uncovered struts at the 3-month time period was not significantly different in the BES and SES groups; the median value (interquartile range) was 14.7% (0.0-23.4) versus 8.6% (0.7-21.5) (p=0.98), respectively. However, OCT at the 12-month follow-up showed a significantly lower percentage of uncovered struts [2.6% (0.8-5.6) versus 6.2% (1.7-14.7), (p=0.028), respectively] without significant difference of neointimal thickness. BES showed a greater reduction of percentage Δ of uncovered struts from 3-12 months than that of SES [-17.2±14.5% versus -7.7±16.3%, respectively (p=0.043)].. Both drug-eluting stents showed a high percentage of incomplete strut coverage at 3 months. However, BES showed a significantly lower percentage of uncovered struts at 12 months compared to that of SES. This was achieved by superior strut coverage from 3 to 12 months.

Topics: Antineoplastic Agents, Phytogenic; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Reproducibility of Results; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima

We report the initial human evaluation of the novel BioMimeTM sirolimus-eluting stent (SES) (Meril Life Sciences Pvt. Ltd., Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymer for the treatment of de novo coronary lesions.. The meriT-1 trial was a prospective, non-randomised, single-arm, single-centre, first-in-human evaluation of the safety, feasibility and performance of the BioMime SES. Lesion criteria included non-occlusive stenosis ≤ 19 mm in length located in native coronary vessels. Clinical follow-up (FU) was performed at 1, 8 and 12 months; all patients were assigned for angiographic FU at eight months. A total of 30 patients (30 lesions) were enrolled between March 2009 and February 2010. Mean age was 49.9 years, 30% were diabetics, and 36.7% had previous myocardial infarction (MI). Baseline median [25%, 75% interquartile range] lesion length, reference diameter and % diameter stenosis were 15.51 mm [12.74, 20.27], 2.94 mm [2.71, 3.34], and 80.5% [67.0%, 90.7%], respectively. Overall, there was one stent implanted per lesion and procedural success was 100%. At eight-month angiographic FU (26/30), median in-stent late lumen loss was 0.15 mm [0.09, 0.33]; also, there were no cases of binary restenosis within the treated segment. Clinical FU at 12 months (100%) demonstrated absence of MACE (cardiac death, MI and target lesion revascularisation) and stent thrombosis (ST).. The novel BioMime SES demonstrated excellent performance in single coronary lesions including high procedural success and efficacy, as demonstrated by the relatively low late lumen loss (a surrogate of neointimal hyperplasia) at eight-month angiographic FU. Overall, there were no safety concerns in this preliminary evaluation including absence of MACE or ST up to 12 months.

Topics: Adult; Aged; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Polymers; Prospective Studies; Sirolimus; Treatment Outcome

This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial.. The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES.. The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The primary endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary endpoints included extending the primary endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat.. At 5 years, the BES was noninferior to SES for the primary endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority <0.0001, p for superiority = 0.069). The BES was associated with a significant reduction in the more comprehensive patient-orientated composite endpoint of all-cause death, any MI, and all-cause revascularization (297 [35.1%] vs. 339 [40.4%], RR: 0.84 [95% CI: 0.71 to 0.98], p for superiority = 0.023). A significant reduction in very late definite ST from 1 to 5 years was evident with the BES (n = 5 [0.7%] vs. n = 19 [2.5%], RR: 0.26 [95% CI: 0.10 to 0.68], p = 0.003), corresponding to a significant reduction in ST-associated clinical events (primary endpoint) over the same time period (n = 3 of 749 vs. n = 14 of 738, RR: 0.20 [95% CI: 0.06 to 0.71], p = 0.005).. The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220).

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Europe; Female; Humans; Intention to Treat Analysis; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

This study sought to compare the safety and efficacy of the zotarolimus-eluting stent (ZES) and the everolimus-eluting stent (EES) for treatment of unprotected left main coronary artery (uLMCA) disease.. The second-generation ZES and EES have reduced the risk of restenosis in large patient cohorts. However, their comparative performance in uLMCA lesions is not known.. In this study, patients with symptomatic coronary artery disease undergoing percutaneous coronary intervention for uLMCA lesions were randomly assigned to receive either a ZES (n = 324) or an EES (n = 326). The primary endpoint was the combined incidence of death, myocardial infarction, and target lesion revascularization at 1 year. Secondary endpoints were definite or probable stent thrombosis at 1 year and angiographic restenosis based on analysis of the left main coronary artery area at follow-up angiography.. At 1 year, the cumulative incidence of the primary endpoint was 17.5% in the ZES group and 14.3% in the EES group (relative risk: 1.26; 95% confidence interval [CI]: 0.85 to 1.85; p = 0.25). Three patients in the ZES group (0.9%) and 2 patients in the EES group (0.6%) experienced definite or probable stent thrombosis (p > 0.99). All-cause mortality at 1 year was equal in the 2 groups (5.6%; relative risk: 1.00; 95% CI: 0.52 to 1.93; p = 0.98). Angiographic restenosis occurred in 21.5% of patients in the ZES group and 16.8% in the EES group (relative risk: 1.28; 95% CI: 0.86 to 1.92; p = 0.24).. Within the statistical limitations of the present study, treatment of uLMCA lesions with a ZES or an EES provided comparable clinical and angiographic outcomes at 1-year follow-up.

Topics: Aged; Aged, 80 and over; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Middle Aged; Myocardial Infarction; Sirolimus

Clinical outcomes of new-generation drug-eluting stents (DES), Everolimus-eluting stent (EES) or Resolute zotarolimus-eluting stent (R-ZES), have been reported. However, angiographic follow-up data of new-generation DES are limited, especially in Asians. We investigated the angiographic and clinical outcomes of EES and R-ZES in a real-world setting of Korean patients.. Angiographic and clinical outcomes of 679 patients (866 lesions) who had been treated with EES or R-ZES from Jun 2008 to May 2010 were evaluated. The primary analysis was to compare in-segment late loss at 9 months and the secondary analyses were to compare the clinical outcomes.. In-segment late loss at 9-month follow-up angiography was 0.23 ± 0.52 mm for EES and 0.29 ± 0.64 mm for R-ZES (p = 0.248). In addition, the rate of binary restenosis did not show between-group differences (5.8% vs. 6.8% for EES and R-ZES, respectively, p = 0.716). During a median follow-up of 33 months, there were no significant differences in Kaplan-Meier estimates of target lesion failure (TLF) (7.5% vs. 7.9% for EES and R-ZES, respectively, p = 0.578) and patient-oriented composite outcomes (POCO including all-cause death, any myocardial infarction, and any revascularization, 22.8% vs. 20.1%, p = 0.888). The adjusted hazard ratios for TLF and POCO were 0.875 (95% CI 0.427 - 1.793; p = 0.715) and 1.029 (95% CI 0.642 - 1.650; p = 0.904), respectively, for EES over R-ZES in the propensity score matched group analysis.. In Korean patients undergoing new-generation DES implantation for coronary artery disease, EES and R-ZES showed similar angiographic outcomes at 9 months and comparable clinical outcomes during 2.8 years of median follow-up.

Topics: Aged; Cohort Studies; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Registries; Republic of Korea; Sirolimus; Treatment Outcome

This first-in-human multicenter study sought to examine prospectively the safety and efficacy of a new, cobalt chromium thin-strut, coronary absorbable polymer-coated, sirolimus-eluting stent.. Bioabsorbable polymers on drug-eluting stents may lower the long-term risks of inflammation, delayed healing, and adverse events.. We enrolled patients with symptomatic coronary artery disease with stable or unstable angina pectoris and >50% diameter stenosis, amenable to coverage with a ≤23-mm long stent in a vessel 2.5 to 3.5 mm in diameter. All patients received dual antiplatelet therapy after implantation. Patients, in groups of 10, underwent repeat angiography, intravascular ultrasound, and optical coherence tomography at 4, 6, or 8 months, and all patients were seen or contacted at 18 months of follow-up.. The median (range) in-stent late lumen loss (LLL) was 0.03 mm (-0.22 to 0.21 mm), 0.10 mm (-0.03 to 1.2 mm), and 0.08 mm (-0.01 to 0.28 mm), at 4, 6, and 8 months, respectively. At 18 months, the median in-stent LLL was 0.08 mm (-0.30 to 0.46 mm). On optical coherence tomography, the proportion of uncovered stent struts decreased from a median of 7.3% (range 0.4% to 46.3%) at 4 months to 0% (range: 0% to 3.4%) at 18 months. The percentage of neointimal volume obstruction by intravascular ultrasound increased from a median of 5.3% to 9.1% between 4 and 6 months and remained nearly unchanged thereafter through 18 months of follow-up. The only recorded major adverse cardiac event was a myocardial infarction.. At 18 months of follow-up, this absorbable polymer-coated, cobalt chromium sirolimus-eluting stent was associated with a low and stable in-stent LLL, complete strut coverage, and no stent thrombosis. (First-In-Human Trial of the MiStent Drug-Eluting Stent [DES] in Coronary Artery Disease [DESSOLVE-I]; NCT01247428).

Topics: Absorbable Implants; Adult; Aged; Aged, 80 and over; Angina, Stable; Angina, Unstable; Australia; Belgium; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Neointima; New Zealand; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Prospective Studies; Prosthesis Design; Severity of Illness Index; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

This study sought to investigate the efficacy and performance of the XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in the treatment of de novo coronary lesions in patients with 2- to 3-vessel multivessel coronary artery disease (MV-CAD).. Drug-eluting stents (DES) have emerged as an alternative to conventional coronary artery bypass surgery in patients with MV-CAD although first-generation DES yielded inferior efficacy and safety compared with surgery.. Prospective, randomized (1:1), multicenter feasibility trial was designed to assess angiographic efficacy of EES compared with the TAXUS paclitaxel-eluting stent (PES) in 200 patients, and a prospective, open-label, single-arm, controlled registry was designed to analyze the clinical outcome of EES at 1-year follow-up in 400 MV-CAD patients. For the randomized trial, the primary endpoint was in-stent late loss at 9 months. For the registry, the primary endpoint was a composite of all-cause death, myocardial infarction, and ischemia-driven target vessel revascularization at 12 months.. The primary endpoint per single lesion was significantly lower in the EES group compared with the PES group (-0.03 ± 0.49 mm vs. 0.23 ± 0.51 mm, p = 0.001). Similar results were observed when analyzing all lesions (0.05 ± 0.51 mm vs. 0.24 ± 0.50 mm, p < 0.001). Clinical outcome at 1 year yielded a composite of major adverse cardiac events of 9.2% in the single-arm registry, and 11.1% and 16.5% in the EES and PES randomized groups, respectively (p = 0.30).. The EXECUTIVE trial was a randomized pilot trial dedicated to the comparison of the efficacy of 2 different DES among patients with 2- to 3-vessel MV-CAD. The study shows lower in-stent late loss at 9 months with the EES XIENCE V compared with the PES TAXUS Libertè, and a low major adverse cardiac event rate at 1 year in patients with 2-to 3-vessel MV-CAD. (EXECUTIVE [EXecutive RCT: Evaluating XIENCE V in a Multi Vessel Disease]; NCT00531011).

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Feasibility Studies; Female; Humans; Italy; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Time Factors; Treatment Outcome

To report the three-year clinical outcome of the Axxess™ stent, a nitinol self-expanding Biolimus A9™ eluting stent for treatment of de novo coronary bifurcation lesions. The Axxess stent is a new-generation drug-eluting stent that might offer advantages in terms of improved clinical outcomes and safety profile in bifurcation lesion stenting.. The DIVERGE study was a multicentre, prospective, single-arm trial. The primary endpoint was the cumulative rate of major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and ischaemia-driven target lesion revascularisation (TLR) at one, two and three years. Secondary safety endpoints were cumulative stent thrombosis (ST). A total of 302 patients were included across 14 sites: 77.4% had a true bifurcation lesion, with the left anterior descending/diagonal as target vessel in 80.8%. The Axxess stent was placed in 299 patients (99.0%) and scored as optimal in 93.0%. Two hundred and ninety-eight patients (98.7%) returned for the three-year follow-up. The MACE rate was 9.3% at one year, 14.0% at two years and 16.1% at three years. Individual components at three years were 10.1% for ischaemia-driven TLR, 3.0% for death (2.0% cardiac death), and 7.4% for MI. In the secondary safety endpoint at three years, a total of seven patients (2.3%) had ST with six (2.0%) definite and two (0.7%) probable ST events.. The present large study of the Axxess stent reports a good cumulative MACE rate during three years of long-term follow-up. The Axxess stent offers a promising treatment strategy for bifurcation lesions.

Topics: Aged; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Sirolimus; Time Factors; Treatment Outcome

Angiographic and clinical outcomes remain relatively unfavorable for diabetic patients even after the use of drug-eluting stent. This prospective, multicenter, randomized study compared the relative efficacy and safety of resolute zotarolimus-eluting stent (R-ZES) and sirolimus-eluting stent (SES) implantation in diabetic patients with coronary artery disease. The primary end point was noninferiority of angiographic in-segment late loss at 9 months. Clinical events were also monitored for at least 12 months. Patient recruitment was prematurely stopped after enrollment of 256 patients (127 in R-ZES group and 129 in SES) because of discontinuing production of SES. The R-ZES was noninferior to the SES for 9-month in-segment late loss (0.34 ± 0.30 vs 0.39 ± 0.43 mm; difference -0.048; 95% confidence interval -0.157 to 0.061; upper 1-sided 95% confidence interval 0.044; p <0.001 for noninferiority). In addition, in-stent late loss (0.22 ± 0.29 vs 0.21 ± 0.40 mm, p = 0.849) and the rates of in-segment (1.2% vs 6.7%, p = 0.119) and in-stent (1.2% vs 3.3%, p = 0.621) binary restenoses were similar between the 2 groups. At 12 months, there were no statistical differences between the 2 groups in the incidence of any clinical outcomes (death, myocardial infarction, stent thrombosis, ischemia-driven target lesion revascularization, ischemia-driven target vessel revascularization, and composite outcomes). In conclusion, despite having reduced power because of early study termination, our study suggests that the R-ZES has noninferior angiographic outcomes at 9 months to the SES in diabetic patients with coronary artery disease.

Topics: Coronary Angiography; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Electrocardiography; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Prosthesis Design; Sirolimus; Treatment Outcome

This study sought to demonstrate the 5-year clinical and functional multislice computed tomography angiographic results after implantation of the fully resorbable everolimus-eluting scaffold (Absorb BVS, Abbott Vascular, Santa Clara, California).. Multimodality imaging of the first-in-humans trial using a ABSORB BVS scaffold demonstrated at 2 years the bioresorption of the device while preventing restenosis. However, the long-term safety and efficacy of this therapy remain to be documented.. In the ABSORB cohort A trial (ABSORB Clinical Investigation, Cohort A [ABSORB A] Everolimus-Eluting Coronary Stent System Clinical Investigation), 30 patients with a single de novo coronary artery lesion were treated with the fully resorbable everolimus-eluting Absorb scaffold at 4 centers. As an optional investigation in 3 of the 4 centers, the patients underwent multislice computed tomography (MSCT) angiography at 18 months and 5 years. Acquired MSCT data were analyzed at an independent core laboratory (Cardialysis, Rotterdam, the Netherlands) for quantitative analysis of lumen dimensions and was further processed for calculation of fractional flow reserve (FFR) at another independent core laboratory (Heart Flow, Redwood City, California).. Five-year clinical follow-up is available for 29 patients. One patient withdrew consent after 6 months, but the vital status of this patient remains available. At 46 days, 1 patient experienced a single episode of chest pain and underwent a target lesion revascularization with a slight troponin increase after the procedure. At 5 years, the ischemia-driven major adverse cardiac event rate of 3.4% remained unchanged. Clopidogrel was discontinued in all but 1 patient. Scaffold thrombosis was not observed in any patient. Two noncardiac deaths were reported, 1 caused by duodenal perforation and the other from Hodgkin's disease. At 5 years, 18 patients underwent MSCT angiography. All scaffolds were patent, with a median minimal lumen area of 3.25 mm(2) (interquartile range: 2.20 to 4.30). Noninvasive FFR analysis was feasible in 13 of 18 scans, which yielded a median distal FFR of 0.86 (interquartile range: 0.82 to 0.94).. The low event rate at 5 years suggests sustained safety after the implantation of a fully bioresorbable Absorb everolimus-eluting scaffold. Noninvasive assessment of the coronary artery with an option of functional assessment could be an alternative to invasive imaging after treatment of coronary narrowing with such a polymeric bioresorbable scaffold. (ABSORB Clinical Investigation, Cohort A [ABSORB A] Everolimus-Eluting Coronary Stent System Clinical Investigation [ABSORB]; NCT00300131).

Topics: Aged; Biocompatible Materials; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Europe; Everolimus; Female; Fractional Flow Reserve, Myocardial; Humans; Male; Middle Aged; Multidetector Computed Tomography; New Zealand; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

The current recommendation is for at least 12 months of dual antiplatelet therapy after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet therapy with specific types of drug-eluting stents remains unknown.. To assess the clinical noninferiority of 3 months (short-term) vs 12 months (long-term) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI) with zotarolimus-eluting stents.. The OPTIMIZE trial was an open-label, active-controlled, 1:1 randomized noninferiority study including 3119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1, 3, 6, and 12 months. Eligible patients were those with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing PCI with zotarolimus-eluting stents.. After PCI with zotarolimus-eluting stents, patients were prescribed aspirin (100-200 mg daily) and clopidogrel (75 mg daily) for 3 months (n = 1563) or 12 months (n = 1556), unless contraindicated because of occurrence of an end point.. The primary end point was net adverse clinical and cerebral events (NACCE; a composite of all-cause death, myocardial infarction [MI], stroke, or major bleeding); the expected event rate at 1 year was 9%, with a noninferiority margin of 2.7%. Secondary end points were major adverse cardiac events (MACE; a composite of all-cause death, MI, emergent coronary artery bypass graft surgery, or target lesion revascularization) and Academic Research Consortium definite or probable stent thrombosis.. NACCE occurred in 93 patients receiving short-term and 90 patients receiving long-term therapy (6.0% vs 5.8%, respectively; risk difference, 0.17 [95% CI, -1.52 to 1.86]; P = .002 for noninferiority). Kaplan-Meier estimates demonstrated MACE rates at 1 year of 8.3% (128) in the short-term group and 7.4% (114) in the long-term group (HR, 1.12 [95% CI, 0.87-1.45]). Between 91 and 360 days, no statistically significant association was observed for NACCE (39 [2.6%] vs 38 [2.6%] for the short- and long-term groups, respectively; HR, 1.03 [95% CI, 0.66-1.60]), MACE (78 [5.3%] vs 64 [4.3%]; HR, 1.22 [95% CI, 0.88-1.70]), or stent thrombosis (4 [0.3%] vs 1 [0.1%]; HR, 3.97 [95% CI, 0.44-35.49]).. In patients with stable coronary artery disease or low-risk ACS treated with zotarolimus-eluting stents, 3 months of dual antiplatelet therapy was noninferior to 12 months for NACCE, without significantly increasing the risk of stent thrombosis.. clinicaltrials.gov Identifier: NCT01113372.

Topics: Acute Coronary Syndrome; Aged; Aspirin; Clopidogrel; Coronary Artery Disease; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Risk; Sirolimus; Stroke; Thrombosis; Ticlopidine

This study sought to evaluate the long-term safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in patients with obstructive coronary artery disease.. The use of EES compared to PES has been shown to result in improved clinical outcomes in patients undergoing PCI. However, there have been concerns regarding the durability of these benefits over longer-term follow-up.. SPIRIT III was a prospective, multicenter trial in which 1,002 patients were randomized 2:1 to EES versus PES. Endpoints included ischemia-driven target vessel failure (TVF) (death, myocardial infarction (MI), or ischemia-driven target vessel revascularization [TVR]), the pre-specified primary endpoint), target lesion failure (TLF) (cardiac death, target-vessel MI, or ischemia-driven target lesion revascularization [TLR]), major adverse cardiac events (MACE) (cardiac death, MI, or ischemia-driven TLR), their individual components and stent thrombosis.. Five-year follow-up was available in 91.9% of patients. Treatment with EES versus PES resulted in lower 5-year Kaplan-Meier rates of TVF (19.3% vs. 24.5%, p = 0.05), TLF (12.7% vs. 19.0%, p = 0.008), and MACE (13.2% vs. 20.7%, p = 0.007). EES also resulted in reduced rates of all-cause death (5.9% vs. 10.1%, p = 0.02), with nonsignificantly different rates of MI, stent thrombosis, and TLR, and no evidence of late catch-up of TLR over time.. At 5 years after treatment, EES compared to PES resulted in durable benefits in composite safety and efficacy measures as well as all-cause mortality. Additionally, the absolute difference in TLR between devices remained stable over time without deterioration of effect during late follow-up.

Topics: Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Humans; Kaplan-Meier Estimate; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; United States

The drug-eluting absorbable metal scaffold has demonstrated feasibility, safety, and promising clinical and angiographic outcomes at 12 months in human coronary arteries. This study aimed to evaluate the degradation rate and long-term vascular responses to drug-eluting absorbable metal scaffold.. BIOSOLVE-I was a multicenter, single-arm, first-in-man trial assessing the safety and performance of drug-eluting absorbable metal scaffold in 46 patients with coronary artery disease. Patients who underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography, at 6 and 12 months were included in this study. From postimplantation to follow-up, arterial curvature and angulation were significantly increased by the degradation process. The greatest increase was seen from postimplantation to 6 months. The systolic-diastolic changes of the curvature and angulation gradually improved throughout the follow-up period. At the site of implantation, vasoconstriction (-10% mean reduction) was observed during the acetylcholine test at 6 months. The average percent hyperechogenicity of the scaffolded segments showed a continuous decrease over time, with the most pronounced changes within the first 6 months (from 22.1±7.0% to 15.8±3.7%; P<0.001). Struts discernible on optical coherence tomography at 6 and 12 months showed full neointimal coverage, with stabilization of the mean scaffold area from 6 to 12 months. Furthermore, the mean neointimal area (1.55±0.51 versus 1.58±0.34 mm(2); P=0.794) remained unchanged from 6 to 12 months.. This serial analysis of drug-eluting absorbable metal scaffold confirmed the safety and efficacy of this new device, with vasomotion restoration and continued degradation over time demonstrated by multi-invasive imaging modalities.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01168830.

Topics: Absorbable Implants; Angioplasty; Coronary Angiography; Coronary Artery Disease; Everolimus; Follow-Up Studies; Humans; Incidence; Magnesium; Neointima; Sirolimus; Tissue Scaffolds; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

The Orsiro Hybrid sirolimus-eluting stent is a newly developed third-generation drug-eluting stent, featuring a unique dual-polymer mix. An active bioabsorbable polymer delivers the anti-proliferative drug, sirolimus, via controlled release, while a passive biocompatible polymeric coating shields the metallic strut from surrounding tissue, preventing interaction. To date, the Orsiro Hybrid sirolimus-eluting stent has excelled in terms of late lumen loss at 9 months in a first-in-man single-arm trial. However, the efficacy and safety data for Orsiro Hybrid sirolimus-eluting stents in a broader population of all-comers are limited. The present study offers an angiographic and clinical comparison of the Orsiro Hybrid sirolimus-eluting stent and the Resolute Integrity zotarolimus-eluting stent in the treatment of patients with coronary artery disease.. The ORIENT trial is a multicenter, randomized, open-label, parallel-arm study designed to demonstrate the non-inferiority of the Orsiro Hybrid sirolimus-eluting stent relative to the Resolute Integrity zotarolimus-eluting stent. A total of 375 patients with a spectrum of coronary artery disease will undergo prospective, random assignment to a Orsiro Hybrid sirolimus-eluting stent or Resolute Integrity zotarolimus-eluting stent (2:1 ratio), for a primary endpoint of in-stent late lumen loss at 9 months by quantitative coronary angiography. Secondary 12-month clinical endpoints are death, target lesion revascularization, target vessel revascularization, myocardial infarction, stent thrombosis and target lesion failure (a composite of cardiac death, target lesion revascularization and target vessel-related myocardial infarction).. The ORIENT trial is the first study to date comparing the Orsiro Hybrid sirolimus-eluting stent with the Resolute Integrity zotarolimus-eluting stent for efficacy and safety in a population of all-comers with coronary artery disease.. Clinicaltrials.gov NCT01826552.

Topics: Cardiovascular Agents; Clinical Protocols; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Republic of Korea; Research Design; Sirolimus; Time Factors; Treatment Outcome

The aim of the study was to compare long-term follow-up results of crush versus culotte stent techniques in coronary bifurcation lesions.. The randomized Nordic Stent Technique Study showed similar 6-month clinical and 8-month angiographic results with the crush and culotte stent techniques of de novo coronary artery bifurcation lesions using sirolimus-eluting stents. Here, we report the 36-month efficacy and safety of the Nordic Stent Technique Study.. A total of 424 patients with a bifurcation lesion were randomized to stenting of both main vessel and side branch with the crush or the culotte technique and followed for 36 months. Major adverse cardiac events-the composite of cardiac death, myocardial infarction, stent thrombosis, or target vessel revascularization-were the primary endpoint.. Follow-up was complete for all patients. At 36 months, the rates of the primary endpoint were 20.6% versus 16.7% (p = 0.32), index lesion restenosis 11.5% versus 6.5% (p = 0.09), and definite stent thrombosis 1.4% versus 4.7% (p = 0.09) in the crush and the culotte groups, respectively.. At 36-month follow-up, the clinical outcomes were similar for patients with coronary bifurcation lesions treated with the culotte or the crush stent technique. (Nordic Bifurcation Study. How to Use Drug Eluting Stents [DES] in Bifurcation Lesions? NCT00376571).

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Finland; Humans; Latvia; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Scandinavian and Nordic Countries; Sirolimus; Time Factors; Treatment Outcome

We aimed comparing two-year clinical outcomes of the Everolimus-Eluting Promus and Paclitaxel-Eluting TAXUS Liberte stents used in routine clinical practice. Patients with objective evidence of ischemia and coronary artery disease eligible for PCI were prospectively randomized to everolimus-eluting stent (EES) or paclitaxel-eluting stent (PES) groups. The primary end-point was ischemia-driven target vessel revascularization (TVR) at 2 yr after intervention, and the secondary end-point was a major adverse cardiac event (MACE), such as death, myocardial infarction (MI), target lesion revascularization (TLR), TVR or stent thrombosis. A total of 850 patients with 1,039 lesions was randomized to the EES (n=425) and PES (n=425) groups. Ischemic-driven TVR at 2 yr was 3.8% in the PES and 1.2% in the EES group (P for non-inferiority=0.021). MACE rates were significantly different; 5.6% in PES and 2.5% in EES (P = 0.027). Rates of MI (0.8% in PES vs 0.2% in EES, P = 0.308), all deaths (1.5% in PES vs 1.2% in EES, P = 0.739) and stent thrombosis (0.3% in PES vs 0.7% in EES, P = 0.325) were similar. The clinical outcomes of EES are superior to PES, mainly due to a reduction in the rate of ischemia-driven TVR.

Topics: Antineoplastic Agents, Phytogenic; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Thrombosis; Treatment Outcome

We compared the outcomes of patients treated with everolimus-eluting stents (EES) versus paclitaxel-eluting stents (PES) at 3 years from the large-scale randomized SPIRIT IV trial.. SPIRIT IV is the largest randomized trial comparing the outcomes of EES and PES. The present report represents the final long-term follow-up analysis from this study.. A total of 3,687 patients were randomized 2:1 to EES or PES, stratified by presence of diabetes mellitus and lesion characteristics. Prespecified subgroups were compared for interaction with stent allocation. The primary end point was target lesion failure (TLF) (the composite of cardiac death, target vessel-related myocardial infarction [MI], or ischemia-driven target lesion revascularization).. At 3 years, TLF occurred in 9.2% versus 11.7% of EES- and PES-treated patients (hazard ratio [HR] 0.78 [0.63-0.97], P = .02). The incidence of death or MI was 5.9% versus 9.1%, respectively (HR 0.67 [0.52-0.85], P = .001), and there was a 64% reduction in stent thrombosis (Academic Research Consortium definite or probable definition) with EES (0.59% vs 1.60%, HR 0.36 [0.18-0.72], P = .003). The difference in target lesion revascularization at 3 years did not reach statistical significance (6.2% vs 7.8%, respectively, HR 0.78 [0.60-1.01], P = .06). There was no significant interaction between treatment allocation and any of the subgroups, including diabetes.. When compared with PES, EES provides durable and significant reduction in TLF, especially due to its enhanced safety profile, with lower rates of death or MI and stent thrombosis up to 3 years.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Failure; Single-Blind Method; Sirolimus; Treatment Outcome; Tubulin Modulators

A pre-planned substudy of a larger multicenter randomized trial was undertaken to compare the efficacy of everolimus with reduced-dose cyclosporine in the prevention of cardiac allograft vasculopathy (CAV) after heart transplantation to that of mycophenolate mofetil (MMF) with standard-dose cyclosporine.. CAV is a major cause of long-term mortality following heart transplantation. Everolimus has been shown to reduce the severity and incidence of CAV as measured by first year intravascular ultrasound (IVUS). MMF, in combination with cyclosporine, has also been shown to have a beneficial effect in slowing the progression of CAV.. Study patients were a pre-specified subgroup of the 553-patient Everolimus versus mycophenolate mofetil in heart transplantation: a randomized, multicenter trial who underwent heart transplantation and were randomized to everolimus 1.5 mg or MMF 3 g/day. IVUS was performed at baseline and at 12 months. Evaluable IVUS data were available in 189 patients (34.6%).. Increase in average maximal intimal thickness (MIT) from baseline to month 12 was significantly smaller in the everolimus 1.5 mg group compared with the MMF group (0.03 mm vs. 0.07 mm, p < 0.001). The incidence of CAV, defined as an increase in MIT from baseline to month 12 of greater than 0.5 mm, was 12.5% with everolimus versus 26.7% with MMF (p = 0.018). These findings remained irrespective of sex, age, diabetic status, donor disease, and across lipid categories.. Everolimus was significantly more efficacious than MMF in preventing CAV as measured by IVUS among heart-transplant recipients after 1 year, a finding, which was maintained in a range of patient subpopulations. CV surgery: transplantation, ventricular assistance, cardiomyopathy.

Topics: Coronary Artery Disease; Everolimus; Female; Heart Transplantation; Humans; Immunosuppressive Agents; Male; Middle Aged; Mycophenolic Acid; Postoperative Complications; Sirolimus; Ultrasonography, Interventional

Coronary bifurcation lesions can be approached using a simple or a complex strategy. In clinical trials with first-generation drug-eluting stents, the complex strategy was not superior to the simple approach. However, to date, the best strategy when using second-generation drug-eluting stents has not been defined.. We performed a prospective randomized study comparing a simple vs a complex strategy involving T-stenting for the percutaneous revascularization of bifurcation lesions using the everolimus-eluting stent. Angiographic and clinical follow-up were performed at 9 months.. We included 70 lesions in 69 patients, who were randomized to the simple (34 lesions, 33 patients) or complex strategy (36 lesions and patients). In all, 85.6% of the lesions included were true bifurcations. The crossover rate was 17.1%. The binary restenosis rate was 12.1%, with no differences between the groups. Side branch restenosis tended to be higher with the simple strategy in the intention to treat analysis (10.7% vs 0%) but not in the per protocol analysis (5.9% vs 4.2%). The incidence of major adverse cardiac events (cardiac death, myocardial infarction, and target vessel revascularization) was 9.2%, with no differences between groups. There were no cases of stent thrombosis.. According to the clinical and angiographic findings, the complex strategy was not significantly superior to the simple approach in the revascularization of bifurcation lesions with second-generation everolimus-drug eluting stents.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus

Patients on maintenance hemodialysis (HD) are at high risk for restenosis after percutaneous coronary intervention (PCI) even if treated with a sirolimus-eluting stent (SES). The aim of this study was to compare the effects of SES and paclitaxel-eluting stent (PES) in preventing restenosis in HD patients with coronary artery disease.. A total of 100 consecutive patients on HD who underwent PCI were enrolled into the study. They were randomly assigned to receive either SES or PES. We compared follow-up angiographic outcomes between the SES and PES groups at 8-month follow-up.. The angiographical restenosis rate, defined as % diameter stenosis>50% at 8-month follow-up, was 19.7% in the SES group and 20.0% in the PES group (p=0.97). Late loss was also similar between the two groups (0.49±0.70 mm vs. 0.48±0.91 mm, P=0.94). There were no significant differences in the rates of all-cause death, non-fatal myocardial infarction, or TLR due to stent restenosis-induced ischemia between the two groups (2.0% vs. 4.0%, p=0.56, 2.0% vs. 4.0%, p=0.56, and 16.0% vs. 12.0%, p=0.57, respectively).. There was no significant difference in angiographical outcome at 8-month follow-up between HD patients treated with SES and PES. Even if treated with DES including SES and PES, patients on HD are at high risk of restenosis after PCI.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Radiography; Renal Dialysis; Sirolimus; Treatment Outcome

New generation drug-eluting stents (DES) incorporate thinner struts and novel alloys to improve clinical performance. Nevertheless, the impact of novel stent materials and designs on human vascular response to DES remains elusive. We sought to evaluate the in-vivo coronary artery response to platinum-chromium (PtCr) versus cobalt-chromium (CoCr) stents featuring the same durable polymer and antiproliferative drug by optical coherence tomography (OCT).. A total of 42 patients with de novo lesions in native coronary vessels was treated with PtCr-everolimus eluting stent (EES; n = 21) or CoCr-EES (n = 21). Angiography, intravascular ultrasound, and OCT were performed at the index procedure and 6-month follow-up. PtCr-EES and CoCr-EES had similar concentric expansion (stent eccentricity index; median 0.91 vs. 0.90, respectively, P = 0.47) and very low rate of strut malapposition (median 1.15 vs. 1.80%, P = 0.92) at post implantation. Proportion of struts embedded in tissue was lower in PtCr-EES compared to CoCr-EES (median 2.67 vs. 15.23%, P < 0.001). The primary prespecified end point, the percentage of uncovered struts per patient at 6 months follow-up, was 8.46% [interquartile range (IQR) = 3.05-17.26] in PtCr-EES and 5.88% (IQR = 1.35-13.27) in CoCr-EES (P = 0.36), whereas malapposed struts were observed in 0.00% (IQR = 0.00-0.25) versus 0.48% (IQR = 0.00-1.44), respectively, (P = 0.10). Strut-level neointimal thickness did not differ between the two platforms (median 0.09 vs. 0.08 mm, P = 0.49).. Acute and mid-term responses to EES using PtCr or CoCr platforms were similar, with concentric stent expansion, low malapposition, similar strut coverage and limited amount of neointima. Conversely, at postprocedure, PtCr-EES had fewer embedded struts compared with CoCr-EES.

Topics: Aged; Antineoplastic Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Revascularization; Prospective Studies; Sirolimus; Tomography, Optical Coherence; Ultrasonography, Interventional

To evaluate the differential treatment effects of zotarolimus-eluting stents (ZES), sirolimus-eluting stents (SES), and paclitaxel-eluting stents (PES) according to diabetic status.. Diabetic patients have a higher risk of ischemic complications after stenting than nondiabetic patients.. Using data from the ZEST randomized trial, comparing ZES with SES and PES, we evaluated relative outcomes among stents in diabetic and nondiabetic patients. The primary outcome was a major adverse cardiac event (MACE), defined as a composite of death, myocardial infarction, or ischemia-driven target-vessel revascularization.. Of the 2,645 patients enrolled in the ZEST trial, 760 (29%) had diabetes mellitus. Baseline clinical and angiographic characteristics were similar in the three stent groups, regardless of diabetic status. In diabetic patients, ZES showed similar rates of MACE as compared to PES (13.8% vs. 15.3%, P = 0.58), but higher rates of MACE than SES (13.8% vs. 7.7%, P = 0.05). In nondiabetic patients, ZES showed similar rates of MACE as compared to SES (10.3% vs. 10.8%, P = 0.72), whereas significantly lower rates of MACE compared to PES (10.3% vs. 15.3%, P = 0.01). In comparing the ZES and SES groups, there was a substantial interaction between diabetic status and stent types on MACE occurrence (Interaction P = 0.07). However, in comparison of ZES and PES, there were no significant interactions between diabetes and stent type on MACE (Interaction P = 0.25).. In diabetic patients, SES showed the lowest rate of MACE compared with ZES and PES. But, in nondiabetic patients, SES and ZES showed significantly lower rates of MACE than PES. ZES shows a diabetes-related interaction on MACE compared with SES, but not with PES.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Polymer-free sirolimus- and probucol-eluting stents (Real Dual drug-eluting stents [DES]) is as effective as first-generation DES in treating coronary artery stenosis. It is unknown whether sirolimus-eluting stents containing biodegradable polymer (Excel) would be superior to real Dual DES. This study aimed to investigate the difference in target vessel revascularization (TVR) at 12 months in patients with coronary artery disease treated by the implantation of Dual DES or Excel stents.. Three hundred and forty-six patients with de novo coronary artery disease were recruited from six centers in China and randomly assigned to either the Dual DES or the Excel group. The primary endpoint was the occurrence of TVR at 12 months. The secondary endpoint was angiographic in-stent restenosis and late lumen loss at 13 months. Stent thrombosis (ST) served as the safety endpoint. Dual anti-platelet therapy (DAPT) was prescribed for 6 months.. Clinical follow-up for 12 months and repeat angiography at 13 months were available in 100% and >90% of patients, respectively. The ISR and in-stent late loss were significantly different between the Excel (3.1%, 0.09 ± 0.11 mm) and the Dual DES (19.5%, 0.36 ± 0.32 mm, P < 0.001, P < 0.001, respectively) groups. The TVR (3.5%) in the Excel group was significantly less than in the Dual DES group (13.9%, P = 0.001). The ST rate beyond 12 months in the Dual DES group was 0%, and this was 1.2% in the Excel group (P = 0.499).. The Excel stent was statistically superior to the Dual DES in terms of restenosis, late loss, and TVR for long lesions.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Chi-Square Distribution; China; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Disease-Free Survival; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Probucol; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

Out-stent plaque characteristics and eosinophilic inflammatory response, which correlates with positive remodeling after first-generation drug-eluting stent implantation, may be associated with late restenosis and very late stent thrombosis. The differences of out-stent plaque characteristics were compared between paclitaxel-eluting stents (PES) and zotarolimus-eluting stents (ZES), using integrated backscatter-intravascular ultrasound (IB-IVUS).. Of 78 patients enrolled, 25 receiving PES and 25 receiving ZES had adequate IVUS assessment. Volumetric IVUS analysis was performed after stenting and at 8-month follow-up. Out-stent plaque change in the stented segment was compared on IB-IVUS. The relationship between systemic inflammatory response and out-stent plaque change was evaluated. In PES, vessel volume significantly increased (365-389 mm(3), P<0.0001), whereas it did not change in ZES (315-314 mm(3), P=0.81). In culprit lesions at baseline in PES, fibrous plaque tended to increase (3.1-3.6mm(2), P=0.051) and lipid plaque significantly increased (4.3-5.1mm(2), P=0.02), whereas in ZES the fibrous plaque significantly increased (2.9-4.0mm(2), P<0.0001) but lipid plaque significantly decreased (5.1-3.6mm(2), P<0.0001). Systemic eosinophil increase was significantly correlated with positive remodeling and out-stent lipid plaque increase.. Chronic out-stent plaque change in ZES consisted of less positive remodeling and more favorable effects on out-stent plaque characteristics than PES. Systemic eosinophil change might be a marker of out-stent lipid plaque change.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Eosinophils; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Risk Factors; Sirolimus; Treatment Outcome; Tubulin Modulators; Ultrasonography, Interventional; Vasculitis; Ventricular Remodeling

The long-term results after second generation everolimus eluting bioresorbable vascular scaffold (Absorb BVS) placement in small vessels are unknown. Therefore, we investigated the impact of vessel size on long-term outcomes, after Absorb BVS implantation.. In ABSORB Cohort B Trial, out of the total study population (101 patients), 45 patients were assigned to undergo 6-month and 2-year angiographic follow-up (Cohort B1) and 56 patients to have angiographic follow-up at 1-year (Cohort B2). The pre-reference vessel diameter (RVD) was <2.5 mm (small-vessel group) in 41 patients (41 lesions) and ≥2.5 mm (large-vessel group) in 60 patients (61 lesions). Outcomes were compared according to pre-RVD.. At 2-year angiographic follow-up no differences in late lumen loss (0.29±0.16 mm vs 0.25±0.22 mm, p=0.4391), and in-segment binary restenosis (5.3% vs 5.3% p=1.0000) were demonstrated between groups. In the small-vessel group, intravascular ultrasound analysis showed a significant increase in vessel area (12.25±3.47 mm(2) vs 13.09±3.38 mm(2) p=0.0015), scaffold area (5.76±0.96 mm(2) vs 6.41±1.30 mm(2) p=0.0008) and lumen area (5.71±0.98 mm(2) vs 6.20±1.27 mm(2) p=0.0155) between 6-months and 2-year follow-up. No differences in plaque composition were reported between groups at either time point. At 2-year clinical follow-up, no differences in ischaemia-driven major adverse cardiac events (7.3% vs 10.2%, p=0.7335), myocardial infarction (4.9% vs 1.7%, p=0.5662) or ischaemia-driven target lesion revascularisation (2.4% vs 8.5%, p=0.3962) were reported between small and large vessels. No deaths or scaffold thrombosis were observed.. Similar clinical and angiographic outcomes at 2-year follow-up were reported in small and large vessel groups. A significant late lumen enlargement and positive vessel remodelling were observed in small vessels.

Topics: Absorbable Implants; Adolescent; Adult; Aged; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tissue Scaffolds; Treatment Outcome; Ultrasonography, Interventional; Young Adult

The optimal duration of dual-antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is an important, unanswered question. This study was designed to evaluate the association of varying durations of DAPT on clinical outcomes after DES implantation for the treatment of coronary artery disease. Using the National Heart, Lung, and Blood Institute Dynamic Registry, patients enrolled in the last 2 waves after index percutaneous coronary intervention with DES and who were event free at the time of landmark analysis were included. Landmark analysis was performed 12 and 24 months after percutaneous coronary intervention, and patients were stratified according to continued use of DAPT or not. Subjects were evaluated for rates of death, myocardial infarction, and stent thrombosis at 4 years from their index procedures. The numbers of evaluable patients were 2,157 and 1,918 for the 12- and 24-month landmarks, respectively. In both landmark analyses, there was a significantly lower 4-year rate of death or myocardial infarction in the group that continued DAPT compared to the group that did not (12 months: 10.5% vs 14.5%, p = 0.01; 24 months: 5.7% vs 8.6%, p = 0.02). Beneficial differences in the group that continued on DAPT were preserved after multivariate and propensity adjustment. There were no significant differences in definite stent thrombosis in either landmark analysis. In conclusion, at 12 and 24 months after DES implantation, continued use of DAPT was associated with lower 4-year risk for death and myocardial infarction.

Topics: Antineoplastic Agents, Phytogenic; Aspirin; Clopidogrel; Coronary Artery Disease; Dose-Response Relationship, Drug; Drug Therapy, Combination; Drug-Eluting Stents; Follow-Up Studies; Humans; Immunosuppressive Agents; Paclitaxel; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Recurrence; Registries; Retrospective Studies; Sirolimus; Survival Rate; Ticlopidine; Time Factors; Treatment Outcome; United States

The Resolute zotarolimus-eluting stent (R-ZES) utilizes the same metallic platform and anti-restenotic drug as the Endeavor zotarolimus-eluting stent (E-ZES) but is coated with a more biocompatible polymer with enhanced drug-release kinetics. The aim of this study was to compare the long-term clinical outcomes of 2 zotarolimus-eluting stent generations.. In two randomized trials with broad inclusion criteria (ISAR-TEST 2 and ISAR-TEST 5), 1,000 patients were treated with R-ZES and 339 patients treated with E-ZES. In both trials follow-up angiography was scheduled at 6 to 8 months. The efficacy endpoint of interest was target lesion revascularization and the safety endpoints were the combined incidence of cardiac death or myocardial infarction related to target vessel as well as the incidence of definite stent thrombosis at 2-year follow-up.. The incidence of target lesion revascularization at 2 years was 12.0% in the R-ZES group and 16.0% in the E-ZES (HR 0.72 [95% CI: 0.52-1.00], P = .052). The incidence of cardiac death or myocardial infarction was 5.5% vs. 4.8% (HR 1.15, [95% CI: 0.66-2.02], P = .62) and of definite stent thrombosis was 0.4% vs. 0.6% (HR 0.68, [95% CI: 0.12-3.72], P = .66), respectively. All measures of angiographic restenosis were in favor of the R-ZES; in-stent late lumen loss was 0.29 ± 0.56 with the R-ZES versus 0.58 ± 0.55 with the E-ZES (P < .0001).. Comparison of the 2 Food and Drug Administration-approved zotarolimus-eluting stents suggested that the R-ZES as compared to the E-ZES displayed overall superior antirestenotic efficacy. Both devices were associated with a similar low risk of adverse safety events through 2 years.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Death; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Myocardial Infarction; Prosthesis Design; Risk Assessment; Sirolimus; Thrombosis; Treatment Outcome

Evidence regarding therapy with drug-eluting stents in the left main coronary artery (LM) is based mostly on trials performed with first-generation drug-eluting stents. The aim of this study was to evaluate long-term clinical outcomes after treatment for unprotected LM disease with paclitaxel-eluting stents (PES) and everolimus-eluting stents (EES). The ESTROFA-LM is a multicenter retrospective registry including consecutive patients with unprotected LM disease treated with PES or EES. A total of 770 patients have been included at 21 centers, 415 with treated PES and 355 with EES. Treatment with 2 stents was more frequent with PES (17% vs 10.4%, p = 0.007), whereas intravascular ultrasound was more frequently used with EES (35.2% vs 26%, p = 0.006). The 3-year death and infarction survival rates were 86.1% for PES and 87.3% for EES (p = 0.50) and for death, infarction, and target lesion revascularization were 83.6% versus 82% (p = 0.60), respectively. Definite or probable thrombosis was 1.6% for PES and 1.4% for EES (p = 0.80). The use of 2 stents, age, diabetes, and acute coronary syndromes were independent predictors of mortality. In the subgroup of distal lesions, the use of intravascular ultrasound was an independent predictor of better outcome. Comparison of propensity score-matched groups did not yield differences between the 2 stents. In conclusion, the results of this multicenter registry show comparable safety and efficacy at 3 years for PES and EES in the treatment of LM disease. The use of bifurcation stenting techniques in distal lesions was a relevant independent predictor for events. The use of intravascular ultrasound appears to have a positive impact on patients treated for LM distal disease.

Topics: Aged; Antineoplastic Agents, Phytogenic; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Paclitaxel; Registries; Retrospective Studies; Sirolimus; Spain; Time Factors; Treatment Outcome

To assess the safety and performance of the XIENCE V everolimus-eluting stent (EES) versus the TAXUS paclitaxel-eluting stent (PES) in the treatment of patients with de novo coronary artery lesions after a five-year follow-up period. Second-generation drug-eluting stents (DES) were developed with the aim of improving the safety profile of DES, after reports of stent thrombosis (ST) with first-generation devices. However, long-term follow-up data are scarce.. SPIRIT II was a multicentre, prospective, single-blind, clinical trial, randomising 300 patients with up to two de novo coronary artery lesions in a ratio of 3:1 to either a EES or a PES. The five-year clinical follow-up was completed in 244 patients (81%). At five-year follow-up, 19.5% of patients were on thienopyridine in the EES arm, while 30.5% were on the same therapy in the PES arm. Cardiac mortality was significantly lower in EES than in PES (1.5% vs. 7.3%, p=0.015). There was a trend towards lower cardiac death and MI (4.8% vs. 11.4%) and lower ID-TLR (4.7% vs. 9.4%) in EES than in PES. As a result, there was a consistent reduction in ID-MACE for EES vs. PES (ID-MACE 8.0% vs. 18.1%, p=0.018). In addition, the ARC-defined stent thrombosis rate was numerically lower in EES compared to PES (0.9% vs. 2.8%). No definite stent thrombosis events were observed after two years in the EES arm.. Five-year clinical follow-up of the SPIRIT II trial demonstrated the continuing long-term safety and efficacy of EES.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Incidence; Kaplan-Meier Estimate; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Myocardial Ischemia; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Single-Blind Method; Sirolimus; Treatment Outcome

To assess the endothelial dysfunction (ED) after bare metal stents (BMS) and sirolimus eluting stents (SES) implantation in the same patient, overcoming the confounding role of individual variables.. SES reduce restenosis rate compared to BMS but causes more ED. ED is a potentially unsafe phenomenon, since it is the first step in the cascade of atherosclerosis. Studies showing more pronounced ED with drug eluting stents than BMS involved different series of patients, making the comparison difficult because endothelial function (EF) is responsive to many risk factors.. we designed a prospective comparison of 6 months post-deployment EF of SES versus BMS implanted in the same patient, but in different coronary segments. Forty-eight lesions were randomly assigned on a 1:1 allocation using block sizing of 4 according to a computer-generated sequence (SAS System, Version 9.1) basis to treatment with SES or BMS. The EF was evaluated by measuring vessel diameter variation in the stented segment, before and after selective intracoronary infusion of acetylcholine (iiAch).. In eligible patients, the relative magnitudes of major vasoconstriction were 2.6, 2.9, 4.6, and 3.1 at 5 mm proximal and 5, 10 and 20 mm distal to the stent edge. Overall, a 3.5-fold major distal vasoconstriction after iiAch of SES vs. BMS was calculated.. in the same patients, but treating different coronary segments, SES implantation induces a higher rate of vasoconstriction compared to BMS. The increased vasoconstriction after iiAch is an indicator of ED.

Topics: Acetylcholine; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Endothelium, Vascular; Female; Humans; Infusions, Intra-Arterial; Male; Metals; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Rome; Sirolimus; Stents; Time Factors; Treatment Outcome; Vasoconstriction; Vasoconstrictor Agents

Women are underrepresented in clinical research, and few data are available from randomized head-to-head comparisons of second-generation drug-eluting stents (DES) in female patients. Aim of this study was to assess safety and efficacy of two second-generation DES in women. In TWENTE-a prospective, randomized, comparative DES trial-"real-world" patients were stratified for gender before randomization for Resolute or Xience V stents.. Target vessel failure (TVF; cardiac death, target vessel-related myocardial infarction, and clinically indicated target vessel revascularization) after 1 year was the predefined endpoint.. Among 1,391 patients, 382 (27.5%) women were randomized to Resolute (n = 192) and Xience V (n = 190). Baseline and procedural characteristics were similar for females in both study arms, except for smaller vessel and stent diameters in Resolute-treated lesions. After 1 year, TVF (8.9 vs. 8.4%; adjusted odds ratio [OR]: 0.95, 95% confidence interval [CI]: 0.41-2.20, P = 0.91) and a patient-oriented composite endpoint (13.0 vs. 12.1%, P = 0.79) did not differ significantly between women in both arms. Women were older than men (P < 0.01) and had more often diabetes mellitus (26.4 vs. 19.8%, P = 0.01) and hypertension (63.6 vs. 52.5%, P < 0.01), but there was no significant gender difference in TVF (adjusted OR: 1.18, 95% CI: 0.73-1.92, P = 0.50).. This gender-stratified TWENTE trial analysis resulted in no significant difference in safety and efficacy outcomes between Resolute- and Xience V-treated females.

Topics: Age Factors; Aged; Cardiovascular Agents; Chi-Square Distribution; Comorbidity; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Netherlands; Odds Ratio; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Sex Factors; Sirolimus; Time Factors; Treatment Outcome

Third-generation biodegradable polymer drug-eluting stents might reduce the risk of stent thrombosis compared with first-generation permanent polymer drug-eluting stents. We aimed to further investigate the effects of a biodegradable polymer biolimus-eluting stent compared with a durable polymer-coated sirolimus-eluting stent in a population-based setting.. This randomised, multicentre, all-comer, non-inferiority trial was undertaken at three sites across western Denmark. Eligible patients were aged 18 years or older with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion (>50% diameter stenosis). We randomly assigned patients (1:1) using an independently managed computer-generated allocation sequence to receive either a biolimus-eluting biodegradable polymer stent (Nobori, Terumo, Tokyo, Japan) or a sirolimus-eluting permanent polymer stent (Cypher Select Plus, Cordis, Johnson & Johnson, Warren, NJ, USA). The primary endpoint was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularisation) at 9 months, analysed by intention to treat (non-inferiority margin of 0·02). This trial is registered with ClinicalTrials.gov, number NCT01254981.. From July, 2009, to January, 2011, we assigned 1229 patients (1532 lesions) to receive the biolimus-eluting stent and 1239 (1555 lesions) to receive the sirolimus-eluting stent. One patient was lost to follow-up because of emigration. Intention-to-treat analysis showed that 50 (4·1%) patients who were assigned the biolimus-eluting stent and 39 (3·1%) who were assigned the sirolimus-eluting stent met the primary endpoint (risk difference 0·9% [upper limit of one-sided 95% CI 2·1%]; p(non-inferiority)=0·06). Significantly more patients in the biolimus-eluting stent group had definite stent thrombosis at 12 months than did those in the sirolimus-eluting stent group (9 [0·7%] vs 2 [0·2%], risk difference 0·6% [95% CI 0·0-1·1]; p=0·034). Per-protocol analysis showed that 45 (3·8%) of 1193 patients who received a biolimus-eluting stent and 39 (3·2%) of 1208 who received a sirolimus-eluting stent met the primary endpoint (risk difference 0·5% [upper limit of one-sided 95% CI 1·8%]; p(non-inferiority)=0·03).. At 1 year follow-up, the biodegradable polymer biolimus-eluting Nobori stent did not improve clinical results compared with a first-generation sirolimus-eluting stent. We will need to obtain long-term data before we can make recommendations for the role of this biolimus-eluting stent in routine clinical practice.. Terumo and Cordis (Johnson & Johnson).

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Aspirin; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Retreatment; Sirolimus

Drug-eluting stents with durable biocompatible or biodegradable polymers have been developed to address the risk of thrombosis associated with first-generation drug-eluting stents. We aimed to compare the safety and efficacy of a biodegradable polymer-coated biolimus-eluting stent with a thin-strut everolimus-eluting stent coated with a durable biocompatible polymer.. This open-label, prospective, randomised, controlled, non-inferiority trial was undertaken at 12 sites across Europe. We used limited exclusion criteria (age >18 years, life expectancy >5 years, reference vessel diameter 2·0-4·0 mm) to enrol patients eligible for percutaneous coronary intervention. Patients were randomly allocated (2:1) by computer-generated random numbers to receive either a biodegradable polymer biolimus-eluting stent (Nobori, Terumo, Tokyo, Japan) or a durable fluoropolymer-based everolimus-eluting stent (Xience V or Prime, Abbott Vascular, Santa Clara, CA, USA, or Promus, Boston Scientific, Natick, MA, USA). The primary endpoint was a composite of safety (cardiac death and non-fatal myocardial infarction) and efficacy (clinically indicated target vessel revascularisation) at 12 months, analysed by intention to treat. Patients received dual antiplatelet therapy for 12 months after discharge. The trial is registered with ClinicalTrials.gov, number NCT01233453.. From Jan 12, 2009, to Feb 7, 2011, we enrolled 2707 patients (4025 lesions), 1795 of whom were assigned to receive the biolimus-eluting stent (2638 lesions) and 912 to an everolimus-eluting stent (1387 lesions). 2688 (99·3%) patients completed 12 months' follow-up. Significantly more patients in the biolimus-eluting stent group received a non-assigned stent than did those in the everolimus-eluting stent group (105 [5·9%] vs 19 [2·1%]; p<0·0001). The primary endpoint occurred in 93 (5·2%) patients in the biolimus-eluting stent group and 44 (4·8%) patients in the everolimus-eluting stent group at 12 months (relative risk 1·07 [95% CI 0·75-1·52]; p(non-inferiority)<0·0001). Analysis per protocol did not change the outcome of this trial (p(non-inferiority)<0·0001).. Biodegradable polymer biolimus-eluting stents are as safe and efficacious as the current standard of a thin-strut everolimus-eluting stent with a durable biocompatible polymer. We need to follow-up patients for longer to show whether the biolimus-eluting stent reduces the risk of stent thrombosis after 1 year when compared with the everolimus-eluting stent.. Terumo Europe (Leuven, Belgium) and the Research Foundation of the Cardiology Department, Maasstad Hospital (Rotterdam, Netherlands).

Topics: Absorbable Implants; Aspirin; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Materials Testing; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Prospective Studies; Sirolimus

The CREATE is a post-marketing surveillance multicenter registry that demonstrated satisfactory angiographic and clinical (at 18 months) outcomes of a biodegradable polymer based sirolimus-eluting stent (EXCEL, JW Medical System, Weihai, China) for the treatment of patients in routine clinical practice.. To evaluate the three-year clinical safety and efficacy outcomes in patients enrolled in the CREATE study.. A total of 2077 all comers have been enrolled in the CREATE study at 59 centers from four countries. Recommended antiplatelet regimen was clopidogrel and aspirin for six months followed by chronic aspirin therapy. The prespecified primary outcome was the rate of major adverse cardiac events (MACE) at 12, 18, and 36 months.. Clinical follow-up was completed in 2025 (97.5%) patients at three years. The average duration of clopidogrel treatment was 199.8 ± 52.7 days and 80.5% of discharged patients discontinued clopidogrel at six months. The cumulative rate of MACE was 4.5% and the rate of stent thrombosis was 1.53% at three years. At six months to three years, prolonged clopidogrel therapy (>6 months) was not beneficial in reducing cumulative hazards of MACE (3.4% vs. 3.1%, log rank P = 0.725) or stent thrombosis (1.5% vs. 0.6%, log rank P = 0.053).. This study demonstrates sustained three-year clinical safety and efficacy of biodegradable polymer-based sirolimus-eluting stents when used with six months of dual antiplatelet therapy in a "real-world" setting.

Topics: Absorbable Implants; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Follow-Up Studies; Humans; Immunosuppressive Agents; Platelet Aggregation Inhibitors; Polymers; Prospective Studies; Sirolimus; Time Factors; Treatment Outcome

Scattering centers (SC) are often observed with optical coherence tomography (OCT) in some struts of bioresorbable vascular scaffolds (BVS). These SC might be caused by crazes in the polymer during crimp-deployment (more frequent at inflection points) or by other processes, such as physiological loading or hydrolysis (eventually increasing with time). The spatial distribution and temporal evolution of SC in BVS might help to understand their meaning.. Three patients were randomly selected from 12 imaged with Fourier-domain OCT at both baseline and 6 months in the ABSORB cohort B study (NCT00856856). Frame-by-frame analysis of the SC distribution was performed using spread-out vessel charts, and the results from baseline and 6 months were compared. A total of 4,328 struts were analyzed. At baseline and follow-up all SC appeared at inflection points. No significant difference was observed between baseline and 6 months in the number of SC struts (14.9 vs. 14.5%, P=0.754) or in the distribution of SC. The proportion and distribution of SC did not vary substantially among the patients analyzed.. The SC observed in OCT imaging of the BVS are located exclusively at inflection points and do not increase with time. These findings strongly suggest that SC are caused by crazes in the polymer during crimp-deployment, ruling out any major role of hydrolysis or other time-dependent processes.

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Cardiac Imaging Techniques; Cohort Studies; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Follow-Up Studies; Humans; Hydrolysis; Immunosuppressive Agents; Polyesters; Prosthesis Design; Registries; Sirolimus; Tomography, Optical Coherence

Serial intravascular ultrasound virtual histology (IVUS-VH) after implantation of metallic stents has been unable to show any changes in the composition of the scaffolded plaque overtime. The everolimus-eluting ABSORB scaffold potentially allows for the formation of new fibrotic tissue on the scaffolded coronary plaque during bioresorption. We examined the 12 month IVUS-VH changes in composition of the plaque behind the struts (PBS) following the implantation of the ABSORB scaffold. Using IVUS-VH and dedicated software, the composition of the PBS was analyzed in all patients from the ABSORB Cohort B2 trial, who were imaged with a commercially available IVUS-VH console (s5i system, Volcano Corporation, Rancho Cordova, CA, USA), immediately post-ABSORB implantation and at 12 month follow-up. Paired IVUS-VH data, recorded with s5i system, were available in 17 patients (18 lesions). The analysis demonstrated an increase in mean PBS area (2.39 ± 1.85 mm(2) vs. 2.76 ± 1.79 mm(2), P = 0.078) and a reduction in the mean lumen area (6.37 ± 0.90 mm(2) vs. 5.98 ± 0.97 mm(2), P = 0.006). Conversely, a significant decrease of 16 and 30% in necrotic core (NC) and dense calcium (DC) content, respectively, were evident (median % NC from 43.24 to 36.06%, P = 0.016; median % DC from 20.28 to 11.36%, P = 0.002). Serial IVUS-VH analyses of plaque located behind the ABSORB struts at 12-month demonstrated an increase in plaque area with a decrease in its NC and DC content. Larger studies are required to investigate the clinical impact of these findings.

Topics: Absorbable Implants; Aged; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Europe; Everolimus; Female; Fibrosis; Humans; Male; Middle Aged; Necrosis; New Zealand; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Tissue Scaffolds; Treatment Outcome; Ultrasonography, Interventional

The Oral Rapamycin in ARgentina (ORAR) III trial is a randomized study comparing a strategy of oral rapamycin (OR) plus bare-metal stent (BMS) versus a strategy of drug-eluting stents (DES) in patients with de novo coronary lesions. The purpose of this study was to assess the 3 years cost-effectiveness outcome of each strategy.. OR after BMS has been associated with reduction of target vessel revascularization (TVR) although its value in long-term efficacy in comparison with DES is unknown.. In three hospitals in Buenos Aires, Argentina, 200 patients were randomized to OR plus BMS (n = 100) or DES (n = 100). Primary objectives were costs and effectiveness. Cost analysis included in-hospital and follow-up costs. Safety was defined as the composite of death, myocardial infarction (MI), and stroke. Efficacy was defined as TVR.. Baseline characteristics between groups were similar. The 3-year follow-up rate was 99%. Cardiac mortality was 2% and 5% in OR group and DES group, respectively (P = 0.44). The composite of death, MI and stroke rate was 11% in OR group and 20% in DES group (P = 0.078). TVR rate was 14.5% in OR group and 17.6% in DES group (P = 0.50), respectively. Three year cumulative costs were significantly lower in the OR arm as compared to the DES arm (P = 0.0001) and DES strategy did not result cost-effective according to the non-inferiority test.. At 3 years follow-up, there were no differences in effectiveness between the two strategies, and DES strategy was not more cost-effective as compared to OR plus BMS.

Topics: Administration, Oral; Aged; Argentina; Cardiovascular Agents; Chi-Square Distribution; Combined Modality Therapy; Coronary Artery Disease; Coronary Restenosis; Cost Savings; Cost-Benefit Analysis; Drug Costs; Drug-Eluting Stents; Female; Health Care Costs; Hospital Costs; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Stroke; Time Factors; Treatment Outcome

The SPIRIT Small Vessel (SV) was designed to evaluate the safety and effectiveness of the 2.25-mm XIENCE V everolimus eluting coronary stent system (EECSS), known as the XIENCE nano EECSS, in subjects with SVs and ischemic heart disease.. The core sizes of XIENCE V EECSS are associated with low rates of restenosis and thrombosis in the general population, but the XIENCE nano EECSS has not been tested in the United States.. This prospective, single-arm, open-label study was conducted at 33 centers and in 150 patients in the United States. The primary endpoint was the target lesion failure (TLF) rate at 1 year, required to meet the prespecified performance goal (PG) of 20.4%, derived from historical data.. The mean patient age was 63 years, 38% were women, 39.2% were diabetic, 49.3% had multivessel disease, and the reference vessel diameter was 2.13 ± 0.23 mm. The 1-year TLF rate was 8.1% in with an upper limit of the one-sided 95% confidence interval of 13.0%, which met the PG of 20.4% (P < 0.0001). At 1 year, the rate of cardiac death was 1.5%, the target vessel myocardial infarction rate was 1.5%, and clinically indicated target lesion revascularization rate was 5.1%. The 8-month angiographic in-stent late loss was 0.2 ± 0.4 mm, respectively. The 1-year academic research consortium defined definite/probable stent thrombosis rate was 1.5%.. Based on the 1-year clinical and 8-month angiographic SPIRIT SV data, the XIENCE nano EECSS is considered safe and effective in the treatment of SVs.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Nanomedicine; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; United States

We retrospectively analyzed the potential of sirolimus as a primary immunosuppressant in the long-term attenuation of cardiac allograft vasculopathy progression and the effects on cardiac-related morbidity and mortality.. Forty-five cardiac transplant recipients were converted to sirolimus 1.2 years (0.2, 4.0) after transplantation with complete calcineurin inhibitor withdrawal. Fifty-eight control subjects 2.0 years (0.2, 6.5 years) from transplantation were maintained on calcineurin inhibitors. Age, sex, ejection fraction, and time from transplantation to baseline intravascular ultrasound study were not different (P>0.2 for all) between the groups; neither were secondary immunosuppressants and use of steroids. Three-dimensional intravascular ultrasound studies were performed at baseline and 3.1 years (1.3, 4.6 years) later. Plaque index progression (plaque volume/vessel volume) was attenuated in the sirolimus group (0.7±10.5% versus 9.3±10.8%; P=0.0003) owing to reduced plaque volume in patients converted to sirolimus early (<2 years) after transplantation (P=0.05) and improved positive vascular remodeling (P=0.01) in patients analyzed late (>2 years) after transplantation. Outcome analysis in 160 consecutive patients maintained on 1 therapy was performed regardless of performance of intravascular ultrasound examinations. Five-year survival was improved with sirolimus (97.4±1.8% versus 81.8±4.9%; P=0.006), as was freedom from cardiac-related events (93.6±3.2% versus 76.9±5.5%; P=0.002).. Substituting calcineurin inhibitor with sirolimus as primary immunosuppressant attenuates long-term cardiac allograft vasculopathy progression and may improve long-term allograft survival owing to favorable coronary remodeling. Because of the lack of randomization and retrospective nature of our analysis, the differences in outcome should be interpreted cautiously, and prospective clinical trials are required.

Topics: Adult; Calcineurin; Coronary Angiography; Coronary Artery Disease; Enzyme Inhibitors; Female; Heart Transplantation; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Myocardial Infarction; Retrospective Studies; Sirolimus; Survival Rate; Transplantation, Homologous; Treatment Outcome; Ultrasonography, Interventional; Vascular Diseases

To quantify the circumferential healing process at 6 and 12 months following scaffold implantation.. The healing process following stent implantation consists of tissue growing on the top of and in the space between each strut. With the ABSORB bioresorbable vascular scaffold (BVS), the outer circumference of the scaffold is detectable by optical coherence tomography (OCT), allowing a more accurate and complete evaluation of the intra-scaffold neointima.. A total of 58 patients (59 lesions), who received an ABSORB BVS 1.1 implantation and a subsequent OCT investigation at 6 (n=28 patients/lesions) or 12 (n=30 patients with 31 lesions) months follow-up were included in the analysis. The thickness of the neointima was calculated circumferentially in the area between the abluminal side of the scaffold and the lumen by means of an automated detection algorithm. The symmetry of the neointima thickness in each cross section was evaluated as the ratio between minimum and maximum thickness.. The neointima area was not different between 6 and 12 months follow-up (1.57±0.42 mm(2) vs. 1.64±0.77 mm(2); p=0.691). No difference was also found in the mean thickness of the neointima (median [IQR]) between the two follow-up time points (210 μm [180-260]) vs. 220 μm [150-260]; p=0.904). However, the symmetry of the neointima thickness was higher at 12 than at 6 months follow-up (0.23 [0.13-0.28] vs. 0.16 [0.08-0.21], p=0.019).. A circumferential evaluation of the healing process following ABSORB implantation is feasible, showing the formation of a neointima layer, that resembles a thick fibrous cap, known for its contribution to plaque stability.

Topics: Absorbable Implants; Algorithms; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Delayed-Action Preparations; Endovascular Procedures; Everolimus; Fibrosis; Humans; Image Processing, Computer-Assisted; Neointima; Polyesters; Predictive Value of Tests; Sirolimus; Time Factors; Tissue Scaffolds; Tomography, Optical Coherence; Treatment Outcome

Among drug-eluting stents released to date, the sirolimus-eluting stent has demonstrated the least amount of late lumen loss, but its efficacy and safety have not been compared head-to-head with the next-generation everolimus-eluting stent.. The Scandinavian Organization for Randomized Trials with Clinical Outcome IV (SORT OUT IV) trial was a randomized multicenter, single-blind, all-comer, 2-arm, noninferiority trial comparing the everolimus-eluting stent with the sirolimus-eluting stent in patients with coronary artery disease. The primary end point was a composite of safety (cardiac death, myocardial infarction, definite stent thrombosis) and efficacy (target vessel revascularization) parameters. The noninferiority criterion was a risk difference of 0.015. Intention-to-treat analyses were done at 9- and 18-month follow-ups. A total of 1390 patients were assigned to receive the everolimus-eluting stent and 1384 patients to the sirolimus-eluting stent. At the 9-month follow-up, 68 patients (4.9%) treated with the everolimus-eluting stent compared with 72 patients (5.2%) treated with the sirolimus-eluting stent experienced the primary end point (hazard ratio, 0.94; 95% confidence interval, 0.67-1.31; P for noninferiority=0.01). At the 18-month follow-up, this differential remained: 99 patients (7.2%) treated with the everolimus-eluting stent versus 105 (7.6%) treated with the sirolimus-eluting stent (hazard ratio, 0.94; 95% confidence interval, 0.71-1.23). At the 9-month follow-up, the rate of definite stent thrombosis was higher in the sirolimus-eluting group (2 patients [0.1%] versus 9 patients [0.7%]; hazard ratio, 0.22; 95% confidence interval, 0.05-1.02). At the 18-month follow-up, this difference was sustained (3 patients [0.2%] versus 12 patients [0.9%]; hazard ratio, 0.25; 95% confidence interval, 0.07-0.88).. The everolimus-eluting stent was found to be noninferior to the sirolimus-eluting stent.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00552877.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Risk Factors; Sirolimus; Treatment Outcome

The substudy was performed to evaluate the acute and eight-month follow-up effect of final kissing balloon dilatation (FKBD) on fractional flow reserve (FFR) in the side branch (SB) after main vessel (MV) stenting.. We included 75 patients in the Nordic-Baltic Bifurcation Study III FFR substudy: 42 in the FKBD group and 33 in the no-FKBD group. Complete angiographic and FFR eight-month follow-up was obtained in 25 (60%) patients in the FKBD group and 21 (63%) patients in the no-FKBD group. In the FKBD group the post-PCI mean SB FFR was significantly higher compared to the no-FKBD group (0.92 vs. 0.85, respectively; p=0.011). No significant difference in FFR value between treatments was detected at eight-month follow-up (0.91 vs. 0.87; p=0.19). There were no significant changes in mean SB FFR during the follow-up period (0.92 vs. 0.91; p=0.80) in the FKBD group and (0.87 vs. 0.87; p=0.91) in the no-FKBD group.. FKBD in simple stenting of bifurcation lesions improved acute functional outcome in SB compared to leaving the SB jailed. No significant difference was detected at follow-up. In both groups there was no significant functional late loss during follow-up. Thus, both strategies were equally effective in ensuring that side branch jailing would not cause ischaemia in the long term.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Vessel Anomalies; Coronary Vessels; Denmark; Drug-Eluting Stents; Female; Finland; Follow-Up Studies; Humans; Latvia; Male; Middle Aged; Norway; Regional Blood Flow; Retrospective Studies; Sirolimus; Treatment Outcome

This study sought to compare the safety and efficacy of 2 dose formulations of SYNERGY, a novel bioabsorbable polymer everolimus-eluting stent (EES) (Boston Scientific Corp., Natick, Massachusetts) compared with the durable polymer PROMUS Element EES (Boston Scientific Corp.).. Durable polymer coatings on drug-eluting stents have been associated with chronic inflammation and impaired healing. Bioabsorbable polymer-coated drug-delivery systems may reduce the risk of late adverse events, including stent thrombosis, and thus the need for prolonged dual-antiplatelet therapy.. A total of 291 patients with a de novo lesion ≤28 mm in length, in a coronary artery of ≥2.25 to ≤3.5 mm diameter, were enrolled in the EVOLVE study, a prospective, randomized, single-blind, noninferiority trial. Patients were randomly assigned in a 1:1:1 ratio to PROMUS Element, SYNERGY, or SYNERGY half dose. The primary clinical endpoint was the 30-day rate of target lesion failure, defined as cardiac death or myocardial infarction related to the target vessel, or target lesion revascularization. The primary angiographic endpoint was 6-month in-stent late loss measured by quantitative coronary angiography.. The 30-day primary clinical endpoint of target lesion failure occurred in 0%, 1.1%, and 3.1% of patients in the PROMUS Element, SYNERGY, and SYNERGY half dose groups, respectively. The 6-month in-stent late loss was 0.15 ± 0.34 mm for PROMUS Element, 0.10 ± 0.25 mm for SYNERGY, and 0.13 ± 0.26 mm for SYNERGY half dose (SYNERGY, difference -0.06, upper 95.2% confidence limit: 0.02, p for noninferiority <0.001; SYNERGY half dose, difference -0.03, upper 95.2% confidence limit: 0.05, p for noninferiority <0.001). Clinical event rates remained low and comparable between groups, with no stent thromboses in any group at 6 months.. The EVOLVE trial confirms the effective delivery of everolimus by a unique directional bioabsorbable polymer system utilizing the SYNERGY stent. (A Prospective Randomized Multicenter Single-Blind Noninferiority Trial to Assess the Safety and Performance of the Evolution Everolimus-Eluting Monorail Coronary Stent System [Evolution Stent System] for the Treatment of a De Novo Atherosclerotic Lesion [EVOLVE]; NCT01135225).

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Electrocardiography; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Polymers; Prospective Studies; Prosthesis Design; Single-Blind Method; Sirolimus; Treatment Outcome

The aim of this study was to compare the safety and efficacy of Resolute zotarolimus-eluting stents (ZES) (Medtronic Cardiovascular, Santa Rosa, California) with Xience V everolimus-eluting stents (EES) (Abbott Vascular Devices, Santa Clara, California) at 1-year follow-up.. Only 1 randomized trial previously compared these stents.. This investigator-initiated, patient-blinded, randomized noninferiority study had limited exclusion criteria (acute ST-segment elevation myocardial infarctions not eligible). Patients (n = 1,391; 81.4% of eligible population) were randomly assigned to ZES (n = 697) or EES (n = 694). Liberal use of stent post-dilation was encouraged. Cardiac biomarkers were systematically assessed. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, myocardial infarction not clearly attributable to non-target vessels, and clinically indicated target-vessel revascularization. An external independent research organization performed clinical event adjudication (100% follow-up data available). Analysis was by intention-to-treat.. Acute coronary syndromes were present in 52% and "off-label" feature in 77% of patients. Of the lesions, 70% were type B2/C; the post-dilation rate was very high (82%). In ZES and EES, TVF occurred in 8.2% and 8.1%, respectively (absolute risk-difference 0.1%; 95% confidence interval: -2.8% to 3.0%, p(noninferiority) = 0.001). There was no significant between-group difference in TVF components. The definite-or-probable stent thrombosis rates were relatively low and similar for ZES and EES (0.9% and 1.2%, respectively, p = 0.59). Definite stent thrombosis rates were also low (0.58% and 0%, respectively, p = 0.12). In EES, probable stent thrombosis beyond day 8 was observed only in patients not adhering to dual antiplatelet therapy.. Resolute ZES were noninferior to Xience V EES in treating "real-world" patients with a vast majority of complex lesions and "off-label" indications for drug-eluting stents, which were implanted with liberal use of post-dilation. (The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario; NCT01066650).

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Electrocardiography; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Prosthesis Design; Retrospective Studies; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

Data from randomized clinical trials have shown the safety and efficacy of the XIENCE V in selected populations. However, limited data are available comparing the XIENCE V to the first-generation CYPHER sirolimus-eluting stent. This study aimed to assess the long-term safety and clinical efficacy of the XIENCE V everolimus-eluting stent compared to first-generation stents in an unselected patient population. This retrospective analysis included 6,069 patients treated with CYPHER, TAXUS, and XIENCE stents from 2003 to 2009 at our institution. The patients were followed up for ≥1 year after the index procedure. The baseline characteristics were generally comparable among the 3 groups, with the exception of a significantly greater prevalence of diabetes mellitus, systemic hypertension, and a history of angioplasty and coronary bypass surgery among the XIENCE patients. The XIENCE patients also had a twofold greater rate of type C lesions. One-year follow-up data were available for 82% of the patients. The 1-year major adverse cardiovascular events rate was 9.3% for the XIENCE stent versus 9.8% for the CYPHER stent and 11.5% for the TAXUS stent (p = 0.11). Mortality was lower in the XIENCE group than in the CYPHER and TAXUS groups (3.6% vs 4.9% vs 7.2%, respectively, p <0.001), and target lesion revascularization was similar (5.9% vs 5.2% vs 5.6%, respectively; p = 0.34). Stent thrombosis was lower in the XIENCE patients (0.2% vs 1.2% vs 0.7%, p = 0.007). In conclusion, in a contemporary United States clinical practice with an unselected patient population, use of the XIENCE V stent was associated with an improved safety profile and reduction of all-cause mortality and stent thrombosis compared to first-generation drug-eluting stents. The XIENCE V failed to demonstrate superiority for overall major adverse cardiovascular events, Q-wave myocardial infarction, and revascularization rates.

Topics: Aged; Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Prosthesis Design; Retrospective Studies; Sirolimus; Treatment Outcome

 More widespread use of drug-eluting stents (DES) to treat coronary heart disease (CHD) has recently generated more attention to thrombosis, which was relative to the polymer. Polymer-free and biodegradable polymer-based stents are more frequently studied, but their efficacy on preventing detrimental clinical events is unclear.. To assess whether polymer-free paclitaxel-eluting stent (YINYI stent) was noninferior or equivalent to biodegradable polymer-based rapamycin-eluting stents (EXCEL stent) in preventing detrimental clinical cardiovascular events, a total of 167 consecutive CHD patients requiring DES implantation were randomly divided into the YINYI group (n = 82) and the EXCEL group (n = 85). The primary end-point was major adverse cardiac events (MACE). The secondary end-points included stent thrombosis events, all-cause mortality, and rehospitalization. The study was designed to test the noninferiority or equivalence of the YINYI stent compared with the EXCEL stent with respect to one-year MACE according to a noninferiority or equivalence margin of 0.1. One-year MACE was 6.10% in the YINYI group versus 5.88% in the EXCEL group. The lower limit of the one-sided 95% confidence interval was -0.0582 (P = 0.002 from the test for noninferiority). The 95% confidence interval for the equivalence test was [-0.0698, 0.0742] (P1 =0.004 and P2 =0.007 from 2 times the 1-sided test for equivalence). There was no statistically significant difference in thrombosis events, all-cause death, and rehospitalization (all P > 0.05).. In this small randomized trial, polymer-free paclitaxel-eluting stents appear to be noninferior or equivalent to biodegradable polymer-based rapamycin-eluting stents.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Patient Readmission; Polymers; Sirolimus; Thrombosis

Controversy exists about the impact of treating bifurcations on overall outcome of coronary interventions using drug-eluting stents (DES). We sought to investigate 1-year outcome of the treatment of bifurcation lesions using DES in a large "real-world" cohort.. Among 5,126 patients enrolled in phase I of the multicenter German Drug-Eluting Stent Registry, 814 (16%) were treated for a bifurcation lesion. Patients with bifurcations were compared to those without bifurcations in terms of baseline characteristics, major adverse cardiac and cerebrovascular events (MACCE) and target vessel revascularization (TVR) at 1 year. Usage of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) was also evaluated. In total, 1,021 and 5,189 stents were implanted in the bifurcation (1.25 stents/patient) and nonbifurcation (1.2 stents/patient) group, respectively, but 64.5% of bifurcation lesions were treated with a single stent. More complex lesion and procedural characteristics were observed in the bifurcation group. However, there was no difference in 1-year MACCE rates (a composite of death, myocardial infarction, and stroke) between the bifurcation group and nonbifurcation group (8.1% vs. 8.3%, P = 0.85). Rates of TVR (11.2% vs. 10.8%, P = 0.75) and Academic Research Consoritum-defined definite stent thrombosis (0.9% vs. 0.8%, P = 0.67) were also comparable. MACCE and TVR rates remained similar after adjustment for differences in baseline characteristics. MACCE and TVR in SES patients were 7.2% and 12.6% versus 8.7% and 10.2% in PES patients (P = 0.46 and P = 0.30, respectively).. In this large multicenter registry, treatment of bifurcation lesions with DES appears effective and safe. The presence of bifurcations did not affect 1-year outcomes after DES implantation. The outcomes for SES and PES were similar.

Topics: Aged; Antineoplastic Agents, Phytogenic; Cohort Studies; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Germany; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Registries; Sirolimus; Treatment Outcome

Routine angiographic follow-up after bare-metal stent implantation has been associated with an increase in coronary revascularization. The impact of angiographic follow-up after drug-eluting stent placement remains poorly characterized. The prospective, randomized, single-blinded SPIRIT III trial assigned patients to the everolimus-eluting stent or the paclitaxel-eluting stent (PES). Major adverse cardiovascular events (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization [ID-TLR]) at 3 years were assessed by angiographic versus clinical-only follow-up at 8 months ± 28 days and a landmark survival analysis from 9 months to 3 years. Of 1,002 patients, 564 patients were assigned to angiographic follow-up at 8 months ± 28 days and 438 patients underwent clinical follow-up alone. Three-year major adverse cardiovascular event rates were 10.6% in the angiographic group and 12.0% in the clinical follow-up group (p = 0.64). Ischemia-driven revascularization increased twofold at 9 months, but no difference was noted in ID-TLR for either device. Non-ID-TLR was significantly higher in patients in the angiographic group (4.5% vs 1.0%, p = 0.002), a difference resulting from PES (9.1% vs 0.7%, p = 0.0007) rather than everolimus-eluting stent (2.2% vs 1.1%, p = 0.36) treatment. The landmark analysis showed no significant differences between the angiographic and clinical follow-up groups from 9 months to 3 years of major clinical outcomes. In conclusion, routine angiographic follow-up in SPIRIT III did not increase rates of ID-TLR compared to clinical follow-up alone. Despite higher nonischemia-driven revascularization rates with angiographic follow-up of patients with PESs, none of the safety end points were adversely affected.

Topics: Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coronary Angiography; Coronary Artery Disease; Everolimus; Follow-Up Studies; Humans; Immunosuppressive Agents; Paclitaxel; Prospective Studies; Prosthesis Design; Reproducibility of Results; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

To compare the efficacy of sirolimus- and everolimus-eluting stents in patients with bifurcation lesions treated with provisional side-branch stenting.. The efficacy of everolimus-eluting stents in bifurcation lesions has been poorly tested.. Patients with all types of Medina bifurcation lesions were randomly assigned to treatment with either a sirolimus- (n = 145) or everolimus-eluting stent (n = 148). We included patients with main vessel diameter over 2.5 mm and side branches over 2.25 mm. Patients with diffuse side-branch stenosis were excluded.. There were no significant differences between patients from the sirolimus and everolimus groups in terms of age, risk factors, clinical status, location of the bifurcation lesions or angiographic variables. Immediate results and in-hospital outcome were also similar in both groups of patients. In-hospital death occurred in two patients, one from each group. Target lesion revascularization was required in nine patients: four patients (2.7%) from the sirolimus group and five patients (3.4%) from the everolimus group. Late cardiac mortality occurred in two patients from the sirolimus group and in one patient from the everolimus group. Major cardiac event rates at 1 year were similar in both groups: nine patients (6.2%) in the sirolimus group and nine patients (6.1%) from the everolimus group (p: ns).. In patients with bifurcation lesions, no significant differences in clinical outcome at 1-year follow-up were observed between sirolimus- and everolimus-eluting stent groups.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Spain; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Implantation of a metallic prosthesis creates local stiffness with a subsequent mismatch in the compliance of the vessel wall, disturbances in flow and heterogeneous distribution of wall shear stress. Polymeric bioresorbable ABSORB scaffolds have less stiffness than metallic platform stents. We sought to analyze the mismatch in vascular compliance after ABSORB implantation and its long-term resolution with bioresorption.. A total of 83 patients from the ABSORB trials underwent palpography investigations (30 and 53 patients from ABSORB Cohorts A and B, respectively) to measure the compliance of the scaffolded and adjacent segments at various time points (from pre-implantation up to 24 months). The mean of the maximum strain values was calculated per segment by utilizing the Rotterdam Classification (ROC) score and expressed as ROC/mm. Scaffold implantation lead to a significant decrease in vascular compliance (median [IQR]) at the scaffolded segment (from 0.37 [0.24-0.45] to 0.14 [0.09-0.23], P<0.001) with mismatch in compliance in a paired analysis between the scaffolded and adjacent segments (proximal: 0.23 [0.12-0.34], scaffold: 0.12 [0.07-0.19], distal: 0.15 [0.05-0.26], P=0.042). This reported compliance mismatch disappears at short- and mid-term follow-up.. The ABSORB scaffold decreases vascular compliance at the site of scaffold implantation. A compliance mismatch is evident immediately post-implantation and in contrast to metallic stents disappears in the mid-term, likely leading to a normalization of the rheological behavior of the scaffolded segment.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Biomechanical Phenomena; Cardiovascular Agents; Compliance; Coronary Angiography; Coronary Artery Disease; Coronary Circulation; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Hemodynamics; Humans; Male; Middle Aged; Polyesters; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The long-term clinical performance of drug-eluting stents (DES) coated with biodegradable polymers is poorly known.. A total of 274 coronary patients were randomly allocated to paclitaxel-eluting stents, sirolimus-eluting stents, or bare metal stents (2:2:1 ratio). The two DES used the same biodegradable polymers and were identical except for the drug. At three years, the pooled DES population had similar rates of cardiac death or myocardial infarction (9.0% vs. 7.1; p=0.6), but lower risk of repeat interventions (10.0% vs. 29.9%; p<0.01) than controls with bare stents. The cumulative 3-year incidence of definite or probable stent thrombosis in the pooled DES group was 2.3% (first year: 1.8%; second year: 0.4%; third year: zero). There were no significant differences in outcomes between paclitaxel- and sirolimus-eluting stents.. The biodegradable-polymer coated DES releasing either paclitaxel or sirolimus were effective in reducing the 3-year rate of re-interventions.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The TWENTE trial recently enrolled more than 80% of all eligible patients, who were randomised to zotarolimus-eluting Resolute or everolimus-eluting XIENCE V stents. In the present study, we investigated whether eligible, non-enrolled patients differed from the randomised TWENTE trial population in baseline characteristics and one-year outcome.. Characteristics of 1,709 eligible patients were analysed. Independent external adjudication of clinical events was likewise performed for non-enrolled (n=318) and randomised patients (n=1,391). Non-enrolled and randomised patients did not differ in gender distribution, diabetes mellitus, and clinical presentation, but differed significantly in age and cardiovascular history. Nevertheless, clinical outcome after one year did not differ in the primary composite endpoint target-vessel failure (TVF; 9.8% vs. 8.1%; p=0.34), and its components cardiac death (1.6% vs. 1.2%; p=0.61), target vessel-related myocardial infarction (4.7% vs. 4.6%; p=0.92), and target-vessel revascularisation (3.8% vs. 3.0%; p=0.48). Previous bypass surgery predicted TVF in non-enrolled patients (p=0.001); removal of these patients resulted in identical TVF rates for non-enrolled and randomised patients (7.3% vs. 7.3%; p=0.99).. Despite some differences in baseline characteristics, non-enrolled and randomised patients did not differ in one-year outcome, which was favourable for both populations and may be related to the drug-eluting stents used.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Drug-Eluting Stents; Eligibility Determination; Everolimus; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Netherlands; Odds Ratio; Patient Selection; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Diabetic patients respond less favorably to revascularization and have poorer long-term outcomes. Our main aim was to evaluate the angiographic efficacy of XIENCE V (everolimus-eluting stent, or EES) in diabetic patients compared with TAXUS Liberté (paclitaxel-eluting stent, or PES).. The SPIRIT V Diabetic Study was a prospective, single-blind, randomized study that enrolled 324 diabetic (insulin and non-insulin dependent) patients at 28 sites in Europe and Asia Pacific. Randomization was 2:1 between EES (n = 218) and PES (n = 106). The primary end point was sequential noninferiority and superiority of EES for in-stent late loss at 9 months. Secondary clinical end points included stent thrombosis, death, myocardial infarction, and revascularization rates up to 1 year.. Everolimus-eluting stent was superior to PES for in-stent late loss at 9 months (0.19 mm vs 0.39 mm, respectively; P(superiority) = .0001). The composite rate of death, myocardial infarction, and target vessel revascularization was the same in the 2 groups at 1 year (16.3% vs 16.4%). No stent thromboses (Academic Research Consortium definite and probable) were seen through 1 year with EES compared with 2 of 104 (2%) with PES (P = .11).. In this prospective, randomized trial in a high-risk group of diabetic patients, implantation of EES compared with PES resulted in significantly better inhibition of intimal hyperplasia with a comparable safety outcome.

Topics: Aged; Angioplasty, Balloon, Coronary; Asia; Coronary Angiography; Coronary Artery Disease; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Drug-Eluting Stents; Europe; Evaluation Studies as Topic; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Prognosis; Prospective Studies; Risk Assessment; Single-Blind Method; Sirolimus; Statistics, Nonparametric; Survival Analysis; Taxus; Treatment Outcome

Durable polymers used for first-generation drug-eluting stents (DES) potentially contribute to persistent inflammation and late DES thrombosis. We report the first in human experience with the rapamycin-eluting biodegradable polymer coated cobalt-chromium FIREHAWK stent with abluminal groove.. A total of 21 patients with stable or unstable angina, or prior myocardial infarction, with single de novo native coronary stenoses < 30 mm in length in vessel sizes ranging from 2.25 to 4.0 mm were enrolled. The primary endpoint was major adverse cardiac events (MACE) at 30 days defined as the composite of cardiac death, myocardial infarction (Q and non-Q), or ischemia-driven target lesion revascularization. Secondary endpoints include device, lesion, and clinical success rates, 4-month in-stent late lumen loss by quantitative coronary angiography (QCA), proportion of uncovered or malapposed stent struts by optical coherence tomograpphy (OCT) at 4 months, and MACE at 4, 12, 24 and 36-month follow-up.. Device success was 95.7%, lesion and clinical success was 100.0%. There were no MACE events at 30 days. One patient died of non-cardiac hemorrhagic stroke 5 days after index procedure. At 4 months, in-stent late loss was (0.13 ± 0.18) mm, and complete strut coverage was 96.2% by OCT with 0.1% strut malapposition. At 4-month follow-up there was no additional MACE events, and a single target vessel (non-target lesion) revascularization.. The FIREHAWK abluminal groove biodegradable polymer rapamycin-eluting stent demonstrated feasibility, safety and efficacy in this first in human experience. OCT findings indicated excellent stent strut coverage 4 months after implantation. Larger studies are required to confirm whether the early FIREHAWK stent results translate into longer term restenosis and thrombosis benefits.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Polymers; Sirolimus; Tomography, Optical Coherence

Although several drug-eluting stents (DESs) have been shown to be economically attractive compared to bare-metal stents in patients at moderate to high risk of restenosis, little is known about the cost-effectiveness of alternative DES designs, especially second-generation DESs. We therefore performed an economic substudy alongside the SPIRIT-IV trial, in which 3,687 patients undergoing single or multivessel percutaneous coronary intervention were randomized to receive second-generation everolimus-eluting stents (EESs; n = 2,458) or first-generation paclitaxel-eluting stents (PESs; n = 1,229). Costs through 2 years of follow-up were assessed from the perspective of the United States health care system. The primary cost-effectiveness end point was the incremental cost-effectiveness ratio assessed as cost per quality-adjusted life year gained. Over a 2-year period, use of EESs versus PESs led to a trend toward decreased overall repeat revascularization procedures (14.2 vs 16.2 per 100 subjects, p = 0.20) driven by a significant decrease in the number of target vessel revascularization procedures (8.2 vs 11.0 per 100 subjects, p = 0.02) but also a slight increase in the number of nontarget vessel revascularization procedures (6.0 vs 5.1 per 100 subjects, p = 0.37). Follow-up cardiovascular costs were decreased by $273/patient in the EES group (95% confidence interval for difference 1,048 less to 502 more, p = 0.49). Formal cost-effectiveness analysis based on these results demonstrated that the probability that EES was an economically attractive strategy (incremental cost-effectiveness ratio <$50,000/quality-adjusted life year gained) was 85.7%. These findings demonstrate that in patients undergoing percutaneous coronary intervention with DESs, use of EESs is economically attractive compared to PESs with improved clinical outcomes and lower overall medical care costs at 2 years.

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Disease; Cost-Benefit Analysis; Drug-Eluting Stents; Everolimus; Female; Health Care Costs; Hospitalization; Humans; Male; Myocardial Revascularization; Paclitaxel; Prospective Studies; Single-Blind Method; Sirolimus; United States

This study sought to investigate in vivo the vascular response at the proximal and distal edges of the second-generation ABSORB everolimus-eluting bioresorbable vascular scaffold (BVS).. The edge vascular response after implantation of the BVS has not been previously investigated.. The ABSORB Cohort B trial enrolled 101 patients and was divided into B(1) (n = 45) and B(2) (n = 56) subgroups. The adjacent (5-mm) proximal and distal vessel segments to the implanted ABSORB BVS were investigated at either 6 months (B(1)) or 1 year (B(2)) with virtual histology intravascular ultrasound (VH-IVUS) imaging.. At the 5-mm proximal edge, the only significant change was modest constrictive remodeling at 6 months (Δ vessel cross-sectional area: -1.80% [-3.18; 1.30], p < 0.05), with a tendency to regress at 1 year (Δ vessel cross-sectional area: -1.53% [-7.74; 2.48], p = 0.06). The relative change of the fibrotic and fibrofatty (FF) tissue areas at this segment were not statistically significant at either time point. At the 5-mm distal edge, a significant increase in the FF tissue of 43.32% [-19.90; 244.28], (p < 0.05) 1-year post-implantation was evident. The changes in dense calcium need to be interpreted with caution since the polymeric struts are detected as "pseudo" dense calcium structures with the VH-IVUS imaging modality.. The vascular response up to 1 year after implantation of the ABSORB BVS demonstrated some degree of proximal edge constrictive remodeling and distal edge increase in FF tissue resulting in nonsignificant plaque progression with adaptive expansive remodeling. This morphological and tissue composition behavior appears to not significantly differ from the behavior of metallic drug-eluting stents at the same observational time points.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Fibrosis; Humans; Male; Middle Aged; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tissue Scaffolds; Treatment Outcome; Ultrasonography, Interventional; Vascular Calcification

Several recent randomized trials comparing everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) reported similar outcomes. However, only 1 trial was powered for a clinical end point, and no trial was powered for evaluating target-lesion revascularization.. Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized open-label trial comparing EES with SES in Japan. The trial was powered for evaluating noninferiority of EES relative to SES in terms of target-lesion revascularization. From February and July 2010, 3197 patients were randomly assigned to receive either EES (1597 patients) or SES (1600 patients). At 1 year, the primary efficacy end point of target-lesion revascularization occurred in 65 patients (4.3%) in the EES group and in 76 patients (5.0%) in the SES group, demonstrating noninferiority of EES to SES (P(noninferiority)<0.0001, and P(superiority)=0.34). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%, P=0.77). An angiographic substudy enrolling 571 patients (EES, 285 patients and SES, 286 patients) demonstrated noninferiority of EES relative to SES regarding the primary angiographic end point of in-segment late loss (0.06±0.37 mm versus 0.02±0.46 mm, P(noninferiority)<0.0001, and P(superiority)=0.24) at 278±63 days after index stent implantation.. One-year clinical and angiographic outcome after EES implantation was noninferior to and not different from that after SES implantation in a stable coronary artery disease population with relatively less complex coronary anatomy. One-year clinical outcome after both EES and SES use was excellent with a low rate of target-lesion revascularization and a very low rate of stent thrombosis.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035450.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Japan; Male; Middle Aged; Prospective Studies; Sirolimus; Treatment Outcome

Topics: Absorbable Implants; Adult; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Polymers; Sirolimus; Treatment Outcome

This study sought to examine the 3-year clinical outcomes in patients treated with the Endeavor (Medtronic, Santa Rosa, California) zotarolimus-eluting stent (ZES) or the Cypher (Cordis, Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) in routine clinical practice.. The long-term clinical outcome in patients treated with ZES in comparison with SES is unclear.. The authors randomized 2,332 patients to ZES (n = 1,162) or SES (n = 1,170) implantation. Endpoints included major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction, or target vessel revascularization; the individual endpoints of MACE; and definite stent thrombosis.. At 3-year follow-up, the MACE rate was higher in patients treated with ZES than in patients treated with SES (148 [12.9%] vs. 116 [10.1%]; hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 1.04 to 1.69; p = 0.022). Target vessel revascularization was more frequent in the ZES group compared with the SES group (103 [9.1%] vs. 76 [6.7%]; HR: 1.40, 95% CI: 1.04 to 1.89; p = 0.025), whereas the occurrence of myocardial infarction (3.8% vs. 3.3%) and cardiac death (2.8% vs. 2.8%) did not differ significantly. Although the rate of definite stent thrombosis was similar at 3-year follow-up (1.1% vs. 1.4%), very late (12 to 36 months) definite stent thrombosis occurred in 0 (0%) patients in the ZES group versus 12 (1.1%) patients in the SES group (p = 0.0005).. Although the 3-year MACE rate is higher in patients treated with ZES versus SES, our data highlight a late safety problem concerning definite stent thrombosis with the use of SES. This finding underscores the importance of long-term follow-up in head-to-head comparisons of drug-eluting stents. (Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients [SORT OUT III]; NCT00660478).

Topics: Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Sirolimus; Time Factors; Treatment Outcome

We sought to compare the long-term safety of two devices with different antiproliferative properties: the Endeavor zotarolimus-eluting stent (E-ZES; Medtronic, Inc) and the Cypher sirolimus-eluting stent (C-SES; Cordis, Johnson & Johnson) in a broad group of patients and lesions.. Between May 21, 2007 and Dec 22, 2008, we recruited 8791 patients from 36 recruiting countries to participate in this open-label, multicentre, randomised, superiority trial. Eligible patients were those aged 18 years or older undergoing elective, unplanned, or emergency procedures in native coronary arteries. Patients were randomly assigned to either receive E-ZES and C-SES (ratio 1:1). Randomisation was stratified per centre with varying block sizes of four, six, or eight patients, and concealed with a central telephone-based or web-based allocation service. The primary outcome was definite or probable stent thrombosis at 3 years and was analysed by intention to treat. Patients and investigators were aware of treatment assignment. This trial is registered with ClinicalTrials.gov, number NCT00476957.. PROTECT randomised 8791 patients, of whom 8709 provided consent to participate and were eligible: 4357 were allocated to the E-ZES group and 4352 patients to the C-SES group. At 3 years, rates of definite or probable stent thrombosis did not differ between groups (1·4% for E-ZES [predicted: 1·5%] vs 1·8% [predicted: 2·5%] for C-SES; hazard ratio [HR] 0·81, 95% CI 0·58-1·14, p=0·22). Dual antiplatelet therapy was used in 8402 (96%) patients at discharge, 7456 (88%) at 1 year, 3041 (37%) at 2 years, and 2364 (30%) at 3 years.. No evidence of superiority of E-ZES compared with C-SES in definite or probable stent thrombosis rates was noted at 3 years. Time analysis suggests a difference in definite or probable stent thrombosis between groups is emerging over time, and a longer follow-up is therefore needed given the clinical relevance of stent thrombosis.. Medtronic, Inc.

Topics: Aged; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Sirolimus; Thrombosis

To address safety concerns with first-generation drug-eluting stents (DESs), the everolimus-eluting stent (EES) has been developed as a second-generation DES. The study aim was to: (1) demonstrate that use of the EES in Japanese patients is non-inferior to use of the paclitaxel-eluting stent (PES) in US patients; and (2) compare vessel response to the EES in Japanese vs US patients.. The SPIRIT III Japan Registry, a prospective single-arm multicenter study was a part of the SPIRIT III global clinical program using harmonization by doing. The primary endpoint was in-segment late loss at 8 months, compared to US PES.. A total of 88 subjects were enrolled in the Japan EES group. Angiographic in-segment late loss was significantly less in Japan EES vs US PES (0.15 ± 0.34 mm vs 0.28 ± 0.48 mm, respectively; P=.0185; Pnon-inferio r<.0001), while target vessel failure (TVF; 8.0% vs 9.9%) and major adverse cardiac events (MACE) at 9 months (5.7% vs 8.8%) were not significantly different between the 2 groups. No differences were observed between Japan and US EES populations in terms of late loss, TVF, or MACE. Neointimal volume and postprocedural incomplete stent apposition rate were lower in Japan EES vs US EES/PES.. The SPIRIT III Japan Registry met the primary endpoint of lower late loss in the Japan EES group vs the US PES group, with comparable results for EES between the Japanese and US patients.

Topics: Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Male; Paclitaxel; Platelet Aggregation Inhibitors; Prospective Studies; Registries; Sirolimus; Survival Analysis; Treatment Outcome; United States

There are limited head-to-head randomized data on patient-related versus stent-related outcomes for everolimus-eluting stents (EES) and sirolimus-eluting stents (SES).. In the SORT OUT IV (Scandinavian Organization for Randomized Trials With Clinical Outcome IV) trial, comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months.. The primary endpoint was a composite: cardiac death, myocardial infarction (MI), definite stent thrombosis, or target vessel revascularization. Safety and efficacy outcomes at 2 years were further assessed with specific focus on patient-related composite (all death, all MI, or any revascularization) and stent-related composite outcomes (cardiac death, target vessel MI, or symptom-driven target lesion revascularization). A total of 1,390 patients were assigned to receive the EES, and 1,384 patients were assigned to receive the SES.. At 2 years, the composite primary endpoint occurred in 8.3% in the EES group and in 8.7% in the SES group (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.73 to 1.22). The patient-related outcome: 15.0% in the EES group versus 15.6% in the SES group, (HR: 0.95, 95% CI: 0.78 to 1.15), and the stent-related outcome: 5.2% in the EES group versus 5.3% in the SES group (HR: 0.97, 95% CI: 0.70 to 1.35) did not differ between groups. Rate of definite stent thrombosis was lower in the EES group (0.2% vs. 0.9%, (HR: 0.23, 95% CI: 0.07 to 0.80).. At 2-year follow-up, the EES was found to be noninferior to the SES with regard to both patient-related and stent-related clinical outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Death; Denmark; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Single-Blind Method; Sirolimus; Thrombosis; Treatment Outcome

Diabetes is associated with increased risk of major adverse cardiac events (MACEs) after percutaneous coronary intervention. The purpose of this substudy of the SORT OUT IV trial was to compare clinical outcomes in patients with and without diabetes mellitus treated with everolimus-eluting stents (EESs) or sirolimus-eluting stents (SESs). In total 2,774 patients (390 with diabetes, 14.1%) were randomized to stent implantation with EESs (n = 1,390, diabetes in 14.0%) or SESs (n = 1,384, diabetes in 14.2%). Randomization was stratified by presence/absence of diabetes. The primary end point was MACEs, a composite of cardiac death, myocardial infarction, definite stent thrombosis, or target vessel revascularization within 18 months. MACEs were higher in diabetic than in nondiabetic patients (13.1% vs 6.4%, hazard ratio [HR] 2.08, 95% confidence interval [CI] 1.51 to 2.86). In diabetic patients, MACEs were seen in 10.3% of those treated with EESs and in 15.8% of those treated with SESs (HR 0.63, 95% CI 0.36 to 1.11). In nondiabetic patients, MACEs occurred in 6.6% of EES-treated and in 6.3% SES-treated patients (HR 1.06, 95% CI 0.77 to 1.46). In diabetics, cardiac death occurred in 3.1% of EES-treated and in 4.6% of SES-treated patients (HR 0.67, 95% CI 0.24 to 1.89), myocardial infarction occurred in 0.5% of EES-treated and in 3.6% of SES-treated patients (HR 0.14, 95% CI 0.02 to 1.16), and clinically driven target lesion revascularization was needed in 3.1% of EES-treated and in 7.7% of SES-treated patients (HR 0.40, 95% CI 0.15 to 1.02). No interaction between diabetes status and type of drug-eluting stent was found for the end points. In conclusion, patients with diabetes have higher MACE rates than nondiabetics. No significant differences in safety or efficacy outcomes after EES or SES implantation were present in nondiabetic or diabetic patients.

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Disease; Denmark; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Retrospective Studies; Sirolimus; Survival Rate; Treatment Outcome

This study sought to assess stent strut coverage, malapposition, protrusion, and coronary evaginations as markers of healing 5 years after implantation of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), by optical coherence tomography (OCT).. Early-generation drug-eluting stents have been shown to delay vascular healing.. A total of 88 event-free patients with 1 randomly selected lesion were suitable for final OCT analysis 5 years after drug-eluting stent implantation. The analytical approach was based on a hierarchical Bayesian random-effects model.. OCT analysis was performed at 5 years in 41 SES lesions with 6,380 struts, and in 47 PES lesions with 6,782 struts. A total of 196 struts were uncovered in SES (1.5%) compared with 185 struts in PES lesions (1.0%, 95% credibility interval [CrI]: 0.5 to 1.6; p = 0.32). Malapposed struts were present in 1.2% of SES compared with 0.7% of PES struts (0.7%, 95% CrI: 0.03 to 1.6; p = 0.23). Protruding struts were more frequent among SES (n = 114; 0.8%) than PES lesions (n = 24; 0.1%, 95% CrI: 0.3 to 1.3; p < 0.01). Coronary evaginations were more common among SES- than PES-treated lesions (17 vs. 7 per 100 cross sections, p = 0.003). During extended clinical follow-up, 2 patients suffered from very late stent thrombosis showing a high degree of malapposition, protrusion, and coronary evaginations at the time of OCT investigation.. Early-generation drug-eluting stents show a similar degree of strut coverage and malapposition at 5 years of follow-up. Despite an overall low degree of uncovered and malapposed struts in event-free patients, some lesions show a clustering of these characteristics, indicating a heterogeneous healing response, which may be the source for very late adverse events.

Topics: Angioplasty, Balloon, Coronary; Bayes Theorem; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

This 2-year follow-up of the XIENCE V USA study examines both the long-term safety and effectiveness of the everolimus-eluting coronary stent system (EECSS) in real-world patients.. The safety and effectiveness of EECSS at 1 year in real-world clinical settings have been demonstrated in XIENCE V USA trial with low rates of target lesion revascularization (TLR), cardiac death, myocardial infarction (MI), and stent thrombosis (ST). Data on whether efficacy is maintained after 1 year and the event rate of very late stent thrombosis (VLST) between 1 and 2 years have not yet been reported.. XIENCE V USA is a prospective, multicenter, single-arm, FDA required condition of approval study designed to examine the safety and effectiveness of EECSS in an all-inclusive, consecutively enrolled population from real-world clinical settings. Clinical end-point events, including ST, cardiac death, MI, and revascularization were adjudicated by an independent Clinical Events Committee..  Four thousand eight hundred and seventy-three (96.4%) out of 5,054 participants (1,875 standard-risk; 3,059 extended-risk) reached 2-year follow-up. The 2-year rate of Academic Research Consortium (ARC)-defined definite and probable ST was 0.96% (95% CI 0.70-1.28) in the overall population and 0.34% (95% CI 0.12-0.74) and 1.33% (95% CI 0.95-1.81) in the standard-risk and extended-risk cohorts, respectively. The rate of VLST was 0.06% in the overall population, 0.0% in the standard-risk, and 0.10% in the extended-risk cohorts. The 2-year composite rate of cardiac death and ARC-defined MI was 8.9% (95% CI 8.08-9.70) in the overall population and 5.6% (95% CI 4.61-6.78) and 10.8% (95% CI 9.71-11.94) in the standard-risk and extended-risk cohorts, respectively.. Low event rates observed at 1 year were maintained through 2 years. Despite the increased number of patients who discontinued dual antiplatelet therapy by 2 years, the ST rate remained consistently low, and <1% at 2 years due to low VLST occurrence. These results demonstrate continued safety and effectiveness of the XIENCE V everolimus-eluting stent in a highly complex, real-world patient population through 2 years.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Sirolimus; Thrombosis; United States

Procedural and clinical outcomes still remain unfavorable for patients with long coronary lesions who undergo stent-based coronary interventions. Therefore, we compared the relative efficacy and safety of resolute zotarolimus-eluting stents (R-ZES) and sirolimus-eluting stents (SES) for patients with de novo long coronary lesions.. This randomized, multicenter, prospective trial, called the Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV (LONG-DES IV) trial, compared long R-ZES and SES in 500 patients with long (≥25 mm) native coronary lesions. The primary end point of the trial was in-segment late luminal loss at 9-month angiographic follow-up. The baseline characteristics were not different between R-ZES and SES groups, including lesion lengths (32.4±13.5 mm versus 31.0±13.5 mm, P=0.27). At 9-month angiographic follow-up, the R-ZES was noninferior to the SES with respect to in-segment late luminal loss, the primary study end point (0.14±0.38 mm versus 0.12±0.43 mm, P for noninferiority=0.03, P for superiority=0.68). In addition, in-stent late luminal loss (0.26±0.36 mm versus 0.24±0.42 mm, P=0.78) and the rates of in-segment (5.2% versus 7.2%, P=0.44) and in-stent (4.0% versus 6.0%, P=0.41) binary restenosis were not significantly different between the 2 groups. There were no significant between-group differences in the rate of adverse clinical events (death, myocardial infarction, stent thrombosis, target-lesion revascularization, and composite outcomes).. For patients with de novo long coronary artery disease, R-ZES implantation showed noninferior angiographic outcomes as compared with SES implantation.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186094.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Nonserial observations have shown this bioresorbable scaffold to have no signs of area reduction at 6 months and recovery of vasomotion at 1 year. Serial observations at 6 months and 2 years have to confirm the absence of late restenosis or unfavorable imaging outcomes.. The ABSORB trial is a multicenter single-arm trial assessing the safety and performance of an everolimus-eluting bioresorbable vascular scaffold. Forty-five patients underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography at 6 and 24 months of follow-up. From 6 to 24 months, late luminal loss increased from 0.16±0.18 to 0.27±0.20 mm on quantitative coronary angiography, with an increase in neointima of 0.68±0.43 mm(2) on optical coherence tomography and 0.17±0.26 mm(2) on intravascular ultrasound. Struts still recognizable on optical coherence tomography at 2 years showed 99% of neointimal coverage with optical and ultrasonic signs of bioresorption accompanied by increase in mean scaffold area compared with baseline (0.54±1.09 mm(2) on intravascular ultrasound, P=0.003 and 0.77±1.33 m(2) on optical coherence tomography, P=0.016). Two-year major adverse cardiac event rate was 6.8% without any scaffold thrombosis.. This serial analysis of the second generation of the everolimus-eluting bioresorbable vascular scaffold confirmed, at medium term, the safety and efficacy of the new device.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Diagnostic Imaging; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Male; Middle Aged; Neointima; New Zealand; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Tissue Scaffolds; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

The purpose of this study was to investigate the vascular response of the everolimus-eluting stent (EES) compared with the paclitaxel-eluting stent (PES) using serial intravascular ultrasound (IVUS).. Data were obtained from the SPIRIT III trial, a multicentre, 2:1 randomised, controlled study comparing EES and PES in de novo native coronary artery lesions. IVUS images were eligible for volumetric analysis at eight-month follow-up in 158 lesions (EES: 113, PES: 45). At eight months, EES had a smaller neointimal volume index (VI: mm3/mm) (EES: 0.4±0.4 vs. PES: 0.8±0.8 mm3/mm, p=0.002) and also a smaller % neointimal obstruction (EES: 7.1±6.7% vs. PES: 11.1±10.5%, p=0.005) compared with PES. While there was no significant change in vessel VI with EES, there was a significant increase in vessel VI in PES during eight-month follow-up (EES: 0.1±1.2 vs. PES: 1.2±0.8 mm3/mm, p=0.001). There were no statistical differences in the frequency of edge dissection or incomplete stent apposition between the two groups.. Detailed IVUS analysis confirmed significantly less neointimal hyperplasia with EES compared with PES. While there was no increase in vessel volume with EES during the eight-month follow-up period, vessel enlargement was seen at the stented segment in PES.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Hyperplasia; Japan; Male; Middle Aged; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional; United States

Currently, no data are available on the direct comparison between the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) and conventional metallic drug-eluting stents.. The ABSORB II study is a randomized, active-controlled, single-blinded, multicenter clinical trial aiming to compare the second-generation Absorb BVS with the XIENCE everolimus-eluting metallic stent. Approximately 501 subjects will be enrolled on a 2:1 randomization basis (Absorb BVS/XIENCE stent) in approximately 40 investigational sites across Europe and New Zealand. Treated lesions will be up to 2 de novo native coronary artery lesions, each located in different major epicardial vessels, all with an angiographic maximal luminal diameter between 2.25 and 3.8 mm as estimated by online quantitative coronary angiography (QCA) and a lesion length of ≤48 mm. Clinical follow-up is planned at 30 and 180 days and at 1, 2, and 3 years. All subjects will undergo coronary angiography, intravascular ultrasound (IVUS) and IVUS-virtual histology at baseline (pre-device and post-device implantation) and at 2-year angiographic follow-up. The primary end point is superiority of the Absorb BVS vs XIENCE stent in terms of vasomotor reactivity of the treated segment at 2 years, defined as the QCA quantified change in the mean lumen diameter prenitrate and postnitrate administration. The coprimary end point is the noninferiority (reflex to superiority) of the QCA-derived minimum lumen diameter at 2 years postnitrate minus minimum lumen diameter postprocedure postnitrate by QCA. In addition, all subjects allocated to the Absorb BVS group will undergo multislice computed tomography imaging at 3 years.. The ABSORB II randomized controlled trial (ClinicalTrials.gov NCT01425281) is designed to compare the safety, efficacy, and performance of Absorb BVS against the XIENCE everolimus-eluting stent in the treatment of de novo native coronary artery lesions.

Topics: Absorbable Implants; Adult; Aged; Aspirin; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Europe; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Ischemia; New Zealand; Piperazines; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Research Design; Sample Size; Single-Blind Method; Sirolimus; Spectroscopy, Near-Infrared; Thiophenes; Tissue Scaffolds; Tomography, X-Ray Computed; Ultrasonography, Interventional

This study sought to evaluate the safety and efficacy of the NOYA stent which is a cobalt chromium-based sirolimus-eluting stent (SES) with DL-polylactide biodegradable polymer (Medfavour Medical, Beijing, China) in treating de novo coronary artery lesions.. The NOYA I trial was designed to compare the NOYA stent with the FIREBIRD2™ stent, a durable polymer SES widely used in China (MicroPort Medical, Shanghai, China); the trial was a non-inferiority trial with a primary angiographic endpoint of the in-stent late lumen loss (LLL) at nine-month follow-up. The secondary endpoints were binary restenosis rates within nine months, major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction (MI) or target lesion revascularisation (TLR), and definite/probable stent thrombosis (ST) at 24-month follow-up. A total of 300 patients (n=150 in each group) were enrolled in the study from 16 Chinese centres. The LLL in the NOYA group at nine-month follow-up was similar to the FIREBIRD2 group (0.11±0.18 mm vs. 0.14±0.23 mm, p=0.16; non-inferiority p<0.001). The rates of MACE, death, MI and TLR at 24-month follow-up were comparable between these two devices (p>0.05, respectively).. The biodegradable polymer NOYA stent was non-inferior to the FIREBIRD2 durable polymer stent with respect to the primary non-inferiority endpoint of in-stent LLL at nine-month follow-up. Clinical outcomes at 24-month follow-up were comparable between the two stents. (ClinicalTrials.gov number, NCT01226355).

Topics: Absorbable Implants; Aged; Analysis of Variance; Cardiovascular Agents; Chi-Square Distribution; China; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polyesters; Predictive Value of Tests; Prosthesis Design; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

Current recommendations for antithrombotic therapy after drug-eluting stent (DES) implantation include prolonged dual antiplatelet therapy (DAPT) with aspirin and clopidogrel ≥12 months. However, the impact of such a regimen for all patients receiving any DES system remains unclear based on scientific evidence available to date. Also, several other shortcomings have been identified with prolonged DAPT, including bleeding complications, compliance, and cost. The second-generation Endeavor zotarolimus-eluting stent (E-ZES) has demonstrated efficacy and safety, despite short duration DAPT (3 months) in the majority of studies. Still, the safety and clinical impact of short-term DAPT with E-ZES in the real world is yet to be determined.. The OPTIMIZE trial is a large, prospective, multicenter, randomized (1:1) non-inferiority clinical evaluation of short-term (3 months) vs long-term (12-months) DAPT in patients undergoing E-ZES implantation in daily clinical practice. Overall, 3,120 patients were enrolled at 33 clinical sites in Brazil. The primary composite endpoint is death (any cause), myocardial infarction, cerebral vascular accident, and major bleeding at 12-month clinical follow-up post-index procedure.. The OPTIMIZE clinical trial will determine the clinical implications of DAPT duration with the second generation E-ZES in real-world patients undergoing percutaneous coronary intervention.

Topics: Adult; Aspirin; Brazil; Clopidogrel; Coronary Angiography; Coronary Artery Disease; Drug Therapy, Combination; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Postoperative Period; Prospective Studies; Research Design; Sirolimus; Ticlopidine; Time Factors; Treatment Outcome; Young Adult

The FOCUS registry is a prospective, multicentre, web-based programme designed to collect clinical outcome data from real-world patients receiving the second-generation cobalt-chromium sirolimus-eluting stent (CoCr-SES).. From March 2009 to February 2010, a total of 5,084 patients from 83 centres who were eligible to receive CoCr-SES were enrolled in the FOCUS registry. The primary endpoint was 12-month major adverse cardiac events (MACE, defined as the composite of cardiac death, myocardial infarction [MI], and target vessel revascularisation [TVR]). One-year data were available for 5,013 (98.6%) of the 5,084 patients enrolled. The primary endpoint occurred in 174 (3.47%) of 5,013 patients, consisting of 43 (0.86%) cardiac deaths, 132 (2.63%) MI, and 46 (0.92%) TVR. According to the Academic Research Consortium definition, definite and probable stent thrombosis (ST) occurred in 0.52% (26/5,013) of patients, including 19 cases of early ST and 7 of late ST. The 12-month MACE rates were 3.73% and 2.60% for extended-use and standard-use patients, respectively (p=0.065).. The second-generation CoCr-SES was associated with low rates of 12-month MACE and ST in a broad spectrum of patients, thereby confirming the clinical safety and efficacy of this stent in a real-world setting.

Topics: Aged; Antibiotics, Antineoplastic; China; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Equipment Failure; Female; Humans; Indonesia; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Registries; Retreatment; Sirolimus; Thailand; Treatment Outcome

This report describes the 4-year clinical outcomes of the SPIRIT II study, which randomized 300 patients to treatment with the XIENCE V everolimus-eluting stent (EES), or the TAXUS paclitaxel-eluting stent. At 4-year clinical follow-up, which was available in 256 (85.3%) patients, treatment with EES lead to a trend for lower rates of ischemia-driven major adverse cardiovascular events, a composite of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization (EES 7.7% vs. paclitaxel-eluting stent 16.4%, P = 0.056). Treatment with EES also resulted in a trend toward lower rates of cardiac death and numerically lower rates of myocardial infarction, ischemia-driven target lesion revascularization, and stent thrombosis. Overall, this study reports numerically fewer clinical events in patients treated with EES at 4-year follow-up, which is consistent with results from earlier follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The aims of this study were to identify the efficacy of optimal stent expansion (OSE) according to the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study) criteria in drug-eluting stent (DES) and compare paclitaxel-eluting stent (PES) to sirolimus-eluting stent (SES).. Although poststent high-pressure balloon dilatation is proposed after bare metal stent implantation according to OSE, defined by the criteria of the MUSIC Study, very little data are available in DES.. Two hundred fifty patients (M:F = 149:101; age, 61.5 ± 9.2 years) who underwent 9-month follow-up angiography in the Poststent Optimal Stent Expansion Trial (POET) were included in this study. We assessed angiographic in-stent restenosis (ISR) and neointima volume (NV) using IVUS at 9 months.. At 9-month follow up, there were no significant differences in ISR and NV index (NV/stent length, mm(2) ) between patients with and without OSE. However, the rate of ISR and NV index were higher in PES [ISR: 18 (13.7%) and 4 (3.4%), P = 0.004; NV index: 1.02 ± 0.99 mm(2) and 0.21 ± 0.37, P < 0.001 in PES and SES].. OSE according to the MUSIC Study criteria was not related to ISR and NV in the DES era but PES had a significantly higher ISR rate and NV than SES after poststent high-pressure balloon dilatation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Odds Ratio; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Implantation of a coronary stent results in a mechanical enlargement of the coronary lumen with stretching of the surrounding atherosclerotic plaque. Using intravascular ultrasound virtual-histology (IVUS-VH) we examined the temporal changes in composition of the plaque behind the struts (PBS) following the implantation of the everolimus eluting bioresorbable vascular scaffold (BVS). Using IVUS-VH and dedicated software, the composition of plaque was analyzed in all patients from the ABSORB B trial who were imaged with a commercially available IVUS-VH console (s5i system, Volcano Corporation, Rancho Cordova, CA, USA) post-treatment and at 6-month follow-up. This dedicated software enabled analysis of the PBS after subtraction of the VH signal generated by the struts. The presence of necrotic core (NC) in contact with the lumen was also evaluated at baseline and follow-up. IVUS-VH data, recorded with s5i system, were available at baseline and 6-month follow-up in 15 patients and demonstrated an increase in both the area of PBS (2.45 ± 1.93 mm(2) vs. 3.19 ± 2.48 mm(2), P = 0.005) and the external elastic membrane area (13.76 ± 4.07 mm(2) vs. 14.76 ± 4.56 mm(2), P = 0.006). Compared to baseline there was a significant progression in the NC (0.85 ± 0.70 mm(2) vs. 1.21 ± 0.92 mm(2), P = 0.010) and fibrous tissue area (0.88 ± 0.79 mm(2) vs. 1.15 ± 1.05 mm(2), P = 0.027) of the PBS. The NC in contact with the lumen in the treated segment did not increase with follow-up (7.33 vs. 6.36%, P = 0.2). Serial IVUS-VH analysis of BVS-treated lesions at 6-month demonstrated a progression in the NC and fibrous tissue content of PBS.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Europe; Everolimus; Female; Fibrosis; Humans; Image Interpretation, Computer-Assisted; Male; Middle Aged; Necrosis; New Zealand; Predictive Value of Tests; Prosthesis Design; Sirolimus; Software; Time Factors; Treatment Outcome; Ultrasonography, Interventional

This prospective, open-label multicenter study was conducted to assess the pharmacokinetics of Biolimus A9 after elution from BioMatrix II coronary stents. Recent clinical trials have demonstrated the efficacy and safety of Biolimus A9 eluted from different stent platforms. To date, the pharmacokinetics of Biolimus A9 in patients following the deployment of BioMatrix II stents has not yet been studied. BioMatrix II stents were implanted into 27 patients with coronary artery disease. The primary endpoints of the study were the systemic concentrations of Biolimus A9 after 28 days and 6 months as measured using a sensitive validated liquid chromatography-tandem mass spectrometry assay.. The highest measured blood concentration at any time point was 394 pg/mL. At 28 days and 6 months following stent placement, 51.8 and 100% of patients, respectively, had Biolimus A9 concentrations <10 pg/mL. After 9 months, 100% of the patients were free of major cardiac adverse events (MACE). There was no Biolimus A9 toxicity, no cardiac or non-cardiac deaths, no myocardial infarctions, nor target vessel or target lesion revascularizations during the 9 months of follow-up. No case of acute, subacute, or late stent thrombosis was detected.. Compared to other drug-eluting stents, such as Cypher, BioMatrix II results in relatively low systemic exposure, which may be explained by the ablominal coating of the Biomatrix II stent in combination with Biolimus A9's high lipophilicity.

Topics: Aged; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Sirolimus; Treatment Outcome

Uncertainty exists about the long-term safety and efficacy outcomes of sirolimus-eluting stents (SESs) in unselected patients. The present study was performed to evaluate the safety and efficacy of the SES in treatment of patients with coronary artery disease in an unselected population. Over a 2-year period, 1,504 consecutive patients undergoing percutaneous coronary intervention with ≥1 SES were enrolled. The primary end point was the occurrence of target vessel failure (TVF; a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization). An independent clinical event committee adjudicated all adverse events up to 2-year follow-up. Dual antiplatelet therapy was recommended for ≥1 year throughout the study period. Mean age was 65 ± 11 years; 75% were men, and 34% were diabetics. SESs were implanted for off-label indications in 86% of cases. TVF rates were 3.3%, 6.9%, 11.5%, and 15.5% at 30-day, 6-month, 1-year, and 2-year follow-ups, respectively. The 2-year cumulative rate of definite/probable stent thrombosis was 0.9%; 0.2% was very late thrombosis, occurring from 1 year to 2 years. Patients off dual antiplatelet therapy at 6 months had a significantly increased rate of subsequent death from noncardiac causes. Patients off dual antiplatelet therapy at 1 year had a significantly decreased rate of subsequent clinically driven target lesion revascularization. In conclusion, use of SESs in unselected patients with coronary artery disease was associated with a low TVF rate at 2 years with an acceptable incidence of stent thrombosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Diabetes Complications; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Platelet Aggregation Inhibitors; Prospective Studies; Registries; Risk Factors; Sirolimus; Treatment Outcome

The safety and efficacy of the XIENCE V everolimus-eluting stent (EES) compared to the Taxus Express(2) paclitaxel-eluting stent (PES) has been demonstrated through 2 years in the SPIRIT II and III randomized clinical trials, but limited longer-term data have been reported. In the SPIRIT III trial, 1,002 patients with up to 2 lesions in 2 coronary arteries were randomized 2:1 to EESs versus PESs at 65 United States sites. At completion of 3-year follow-up, treatment with EES compared to PES resulted in a significant 30% decrease in the primary clinical end point of target vessel failure (cardiac death, myocardial infarction, or ischemic-driven target vessel revascularization, 13.5% vs 19.2%, hazard ratio 0.70, 95% confidence interval 0.50 to 0.96, p = 0.03) and a 43% decrease in major adverse cardiovascular events, cardiac death, myocardial infarction, or ischemic-driven target lesion revascularization (9.1% vs 15.7%, hazard ratio 0.57, 95% confidence interval 0.39 to 0.83, p = 0.003). In a landmark analysis, major adverse cardiovascular events were decreased to a similar extent with EES compared to PES 0 through 1 year and 1 year through 3 years (hazard ratio 0.56, 95% confidence interval 0.35 to 0.90; hazard ratio 0.59, 95% confidence interval 0.31 to 1.11, respectively). In conclusion, patients treated with EES rather than PES in the SPIRIT III trial had significantly improved event-free survival at 3 years. From 1 year to 3 years hazard curves continued to diverge in favor of EES, consistent with an improving long-term safety and efficacy profile of EES compared to PES, with no evidence of late catchup.

Topics: Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Logistic Models; Male; Middle Aged; Paclitaxel; Prospective Studies; Single-Blind Method; Sirolimus; Survival Rate; Treatment Outcome; Tubulin Modulators; United States

We sought to evaluate the prognostic impact of age on the procedural results and subsequent clinical outcomes in patients with multivessel disease (MVD) treated either by coronary artery bypass surgery (CABG) or by percutaneous coronary intervention (PCI) with or without drug eluting stents, based on data of the Arterial Revascularisation Therapies Study (ARTS) part I and part II. The potential influence of age in determining the most appropriate revascularisation strategy for patients with MVD is largely unknown.. Three year clinical outcome of ARTS I patients randomised to PCI with bare metal stent (BMS) (n= 600) or CABG (n= 605), and matched patients treated by PCI with sirolimus-eluting stents (SES) in ARTS II (n= 607) were reviewed according to four age quartiles. Endpoints were measured in terms of major adverse cardiac and cerebrovascular events MACCE) during hospital stay and up to three years. The frequency of female, diabetes, hypertension, peripheral vascular disease, pulmonary disease, as well as lesion complexity increased with age. At three years, MACCE free survival was comparable between patients treated by CABG or SES PCI, regardless of age quartile. The incidence of MACCE was higher among ARTS I BMS treated patients in all but the second age quartile. This was primarily related to a higher need for repeat revascularisation among BMS treated patients. However, age, which emerged as a strong independent predictor of MACCE following CABG (p<0.005), was not predictive of adverse events following PCI. Conversely, diabetes was the strongest independent predictor of MACCE among PCI treated patients (p<0.02), but didn't affect three-year outcomes following CABG.. Age seems to influence the CABG outcome in-hospital but not PCI. PCI-SES could offer lower immediate risk in patients with MVD and comparable long-term outcome as CABG especially in older patients. The worst outcome of PCI-BMS group is primarily related to the need for repeat revascularisation. Diabetes is the most important predictor of MACCE following PCI.

Topics: Age Factors; Aged; Aged, 80 and over; Coronary Artery Bypass; Coronary Artery Disease; Disease-Free Survival; Drug-Eluting Stents; Female; Hospital Mortality; Humans; Male; Middle Aged; Sirolimus; Stents; Survival Rate; Treatment Outcome

This study investigated the differences in clinical outcomes between patients with bifurcation lesions (BL) treated with a biolimus-eluting stent (BES) with a biodegradable polymer, and a sirolimus-eluting stent (SES) with a durable polymer.. The clinical outcomes were assessed in the 497 patients (BES 258, SES 239) enrolled in the multicentre, randomised LEADERS trial who underwent treatment of ≥1 BL (total=534 BL). At 12-months follow-up there was no significant difference in the primary endpoint of MACE, a composite of cardiac death, myocardial infarction and clinically indicated target vessel revascularisation (BES 12.8% vs. SES 16.3%, p=0.31). Patients treated with BES had comparable rates of cardiac death (BES 2.7% vs. SES 2.9%, p=1.00), numerically higher rates of myocardial infarction (BES 8.9% vs. SES 5.4%, p=0.17), and significantly lower rates of clinically indicated target vessel revascularisation (4.3% vs. 11.3%, p=0.004) when compared to those treated with SES. The rate of stent thrombosis at 12-months was 4.3% and 3.8% for BES and SES, respectively (p=0.82).. In the treatment of BL the use of BES lead to superior efficacy and comparable safety compared to SES.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Polymers; Sirolimus; Treatment Outcome

Experimental and clinical studies have shown that paclitaxel-eluting stent (PES) attenuates the effect of diabetes on re-stenosis after percutaneous coronary intervention. Although impaired glucose tolerance (IGT) is a pre-diabetic phase characterized as post-prandial hyperglycemia and hyperinsulinemia, the efficacy of PES in these pre-diabetic patients remains unknown. The purpose of the present study was therefore to compare the efficacy of PES in IGT patients with that of sirolimus-eluting stent (SES).. A total of 370 IGT patients with coronary artery disease were examined (SES, n=229; PES, n=141). The incidence of major adverse cardiovascular events (MACE; all-cause death, non-fatal myocardial infarction or repeat revascularization) was compared between the 2 groups. The PES group had lower body mass index, total cholesterol and low-density lipoprotein cholesterol levels and higher prevalence of previous myocardial infarction than the SES group. The incidence of repeat revascularization in the PES group was similar to that in the SES group (22% vs. 19%, P=0.71). The incidence of hard cardiac events such as all-cause death and non-fatal myocardial infarction were also similar between the 2 groups. Finally, there were no significant differences in MACE between the SES and PES groups (23% vs. 21%, P=0.76).. In patients with IGT, the efficacy of PES was similar to that of SES, and any advantage of PES over SES was not observed in these pre-diabetic patients.

Topics: Aged; Aged, 80 and over; Antineoplastic Agents, Phytogenic; Body Mass Index; Cholesterol, LDL; Coronary Artery Disease; Drug-Eluting Stents; Female; Glucose Tolerance Test; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Prospective Studies; Sirolimus

The NEVO sirolimus-eluting stent (NEVO SES) is a novel cobalt-chromium stent combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure. The aim of this study was to assess the arterial response to the NEVO SES in a randomized, blinded comparison versus the surface-coated TAXUS Liberte paclitaxel-eluting stent (TAXUS Liberté PES) in human native coronary lesions using intravascular ultrasound (IVUS).. The NEVO ResElution-I IVUS substudy enrolled 100 patients (1:1 randomization). In addition to standard IVUS variables, uniformity of neointimal distribution within stents was evaluated in 3 dimensions by computing mean neointimal thickness within 12 equally spaced radial sectors on every 1-mm cross section along the stented segment. The NEVO SES showed significantly less neointimal proliferation (neointimal obstruction: 5.5±11.0% versus 11.5±9.7%, P=0.02), resulting in less late lumen area loss and smaller maximum cross-sectional narrowing at 6 months. The absolute variability of neointima distribution, assessed by the standard deviation of neointimal thickness within each stent, was significantly reduced with the NEVO SES compared with the TAXUS Liberté PES(0.04±0.04 mm versus 0.10±0.07 mm, P<0.0001). TAXUS Liberté PES showed significantly greater positive vessel remodeling than the NEVO SES (Δvessel volume index: 1.30±1.36 mm(3)/mm versus 0.36±0.63 mm(3)/mm, respectively, P=0.003).. The NEVO SES with focal release of sirolimus from reservoirs achieved significantly greater and more consistent suppression of neointimal hyperplasia than the surface-coated TAXUS Liberté PES. This was associated with less positive remodeling and no increased morphological or morphometric abnormalities surrounding the stent or at the stent margins.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00714883.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Hyperplasia; Male; Middle Aged; Neointima; Paclitaxel; Prospective Studies; Single-Blind Method; Sirolimus; Ultrasonography, Interventional

In the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) trial, we demonstrated the noninferiority of biodegradable polymer (BP) sirolimus-eluting stent to permanent polymer (PP) sirolimus/everolimus-eluting stent (Cypher/Xience-V) on the basis of clinical outcomes. In this study, we compare the antirestenotic efficacy of these stents in ISAR-TEST-4 patients with paired angiographic studies.. Patients with de novo coronary lesions in native vessels (excluding left main lesions) were randomly assigned to receive a BP stent or a PP stent. Endpoints of interest of this study were in-stent late lumen loss, in-segment binary restenosis, and restenosis morphology at 6-8-month follow-up angiogram.. Of the 2,603 patients (3,372 lesions) enrolled in ISAR TEST-4 trial, 2,016 patients (2,637 lesions) underwent repeat angiographic examination 6-8 months after randomization: 1,006 patients (1,323 lesions) treated with BP stents and 1,010 patients (1,314 lesions) treated with PP stents. No difference was observed between BP and PP stents in in-stent late lumen loss (0.24 ± 0.6 vs. 0.26 ± 0.5 mm, respectively, P = 0.49) or in in-segment binary restenosis (11.6% [153 lesions] vs. 11.8% [155 lesions], P = 0.85). Focal pattern of restenosis was observed in the majority of patients receiving either BP or PP stents. The diffuse pattern of restenosis was observed in 26.8% of patients treated with BP stent and 26.5% of patients treated with PP stent (P = 0.79).. Angiographic characteristics of restenosis after BP-based limus-eluting stents are similar to those of PP-based limus-eluting stents.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Polymers; Predictive Value of Tests; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

This study sought to compare the procedural performance and the acute angiographic result on side-branch ostium obtained using 2 different drug-eluting stents (DES) to treat patients with bifurcated coronary lesions.. Drug-eluting stents are routinely used in percutaneous coronary interventions (PCI) of bifurcated coronary lesions. Different DES types have major technical differences that may influence the procedural and clinical performance in bifurcation PCI.. Consecutive patients with bifurcated lesions undergoing DES implantation using a systematic provisional-stenting strategy were randomized to sirolimus-eluting stent (SES) or everolimus-eluting stent (EES) before intervention. The procedural details for PCI were prospectively recorded to assess the occurrence of any trouble in the side-branch (SB) management (primary end point). Post-PCI angiographic result (primary end point: minimal lumen diameter at SB ostium) was evaluated offline by 3-dimensional reconstruction and quantitative coronary analysis. Clinical outcome was prospectively recorded up to 18 months to assess the occurrence of target bifurcation failure.. A total of 150 patients were enrolled in the study (29% diabetics, 17% unprotected left main). The stent was successfully implanted according to randomization in all cases. Procedural performance was not significantly different between the 2 kinds of DES. Three-dimensional reconstruction and quantitative coronary analysis showed similar post-PCI results in the main vessel and better results in the SB with EES than with SES (minimal lumen diameter at SB ostium: 1.94 ± 0.72 mm vs. 1.64 ± 0.62 mm; p = 0.013). At 18 months, target bifurcation failure occurred in 7 (9.0%) of SES-treated patients versus 8 (10.7%) of EES patients (p = 0.57).. In patients with bifurcated lesions treated by provisional stenting technique, EES compared with SES is associated with similar procedural performance and better 3-dimensional reconstruction and quantitative coronary analysis result in the SB. Both DES are associated with low rates of major adverse events and angiographic failure. (Sirolimus Versus Everolimus-Eluting Stent Randomized Assessment in Bifurcated Lesions and Clinical Significance of Residual Side-Branch Stenosis [SEA-SIDE]; NCT00697372).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Prospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Failure

In the RESOLUTE All Comers trial, the Resolute zotarolimus-eluting stent was non-inferior to the Xience V everolimus-eluting stent for the primary stent-related endpoint of target lesion failure (cardiac death, target vessel myocardial infarction, and ischaemia-driven target lesion revascularisation) at 1 year. However, data for long-term safety and efficacy from randomised studies of new generation drug-eluting coronary stents in patients treated in routine clinical practice are scarce. We report the prespecified 2-year clinical outcomes from the RESOLUTE All Comers trial.. In 2008, patients with at least one coronary lesion 2.25-4.0 mm in diameter, with greater than 50% stenosis, were randomly assigned to a Resolute zotarolimus-eluting stent or a Xience V everolimus-eluting stent at 17 centres in Europe and Israel. Randomisation was by an interactive voice response system stratified by centre. Study investigators were not masked to treatment allocation; but those who did data management and analysis, and patients were masked. There were no restrictions as to the number of vessels or lesions treated, or the number of stents implanted. We assessed prespecified safety and efficacy outcomes at 2 years with specific focus on patient-related composite (all death, all myocardial infarction, all revascularisation) and stent-related composite outcomes. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00617084.. 1140 patients were assigned to the zotarolimus-eluting stent and 1152 to the everolimus-eluting stent; 1121 and 1128 patients, respectively, completed 2-year follow-up. The patient-related outcome (231 [20.6%] zotarolimus vs 231 [20.5%] everolimus; difference 0.1%, 95% CI-3.2 to 3.5; p=0.958) and stent-related outcome (126 [11.2%] vs 121 [10.7%]; difference 0.5%, -2.1 to 3.1; p=0.736) did not differ between groups, although rates of the stent-related outcome were substantially lower than were those for the patient-related outcome. Three patients in each group (0.3%) had very late (after 1 year) stent thrombosis.. Similar safety and efficacy outcomes were sustained between two new generation drug-eluting stents at 2-year follow-up. The greater number of patient-related than stent-related events in patients with complex clinical and lesion characteristics emphasises that during long-term follow-up, the optimisation of secondary prevention is at least as important as the selection of which new generation drug-eluting stent to implant in a specific lesion.. Medtronic (USA).

Topics: Adult; Aged; Confounding Factors, Epidemiologic; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Death, Sudden, Cardiac; Drug-Eluting Stents; Europe; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Israel; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Prospective Studies; Secondary Prevention; Sirolimus; Treatment Outcome

The RESOLUTE US (R-US) trial is a prospective, observational study designed to evaluate the clinical effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in a U.S. population.. The R-ZES releases zotarolimus over a 6-month period in order to achieve optimal clinical effectiveness and safety.. The R-US trial recruited patients with de novo native coronary lesions suitable for 1- or 2-vessel treatment with stents from 2.25 to 4.0 mm in diameter. In the main analysis cohort (2.5- to 3.5-mm stents and single-lesion treatment), the primary endpoint was 12-month target lesion failure (TLF) defined as the composite of cardiac death, myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR), compared with data from Endeavor zotarolimus-eluting stent (E-ZES) trials, adjusting for baseline covariates through propensity scores.. Overall, 1,402 patients were enrolled with a mean reference vessel diameter of 2.59 ± 0.47 mm and diabetes prevalence of 34.4%. In the main analysis cohort, TLF was 3.7% at 12 months compared with historical E-ZES results (TLF = 6.5%). The R-ZES met the 3.3% margin of noninferiority (rate difference = -2.8%, upper 1-sided 95% confidence interval: -1.3%, p < 0.001). The overall TLF rate was 4.7%, and rates of cardiac death, MI, and TLR were 0.7%, 1.4%, and 2.8%, respectively. The 12-month rate of stent thrombosis was 0.1%.. The R-ZES achieved a very low rate of clinical restenosis while maintaining low rates of important clinical safety events such as death, MI, and stent thrombosis at 1-year follow-up. (The Medtronic RESOLUTE US Clinical Trial [R-US]; NCT00726453).

Topics: Aged; Cohort Studies; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Diabetes Mellitus; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prevalence; Prospective Studies; Sirolimus; Treatment Outcome; United States

We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI).. Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance.. A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received ≥1 assigned study stent), powered for noninferiority.. The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, p(noninferiority) = 0.001, p(superiority) = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00).. In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Single-Blind Method; Sirolimus; Treatment Outcome

This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents.. The SXscore can identify patients treated with PCI who are at highest risk of adverse events.. The SXscore was calculated prospectively in 2,033 of the 2,292 patients enrolled in the RESOLUTE All Comers study (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention). Clinical outcomes in terms of a patient-oriented composite endpoint (POCE) of all-cause death, myocardial infarction (MI), and repeat revascularization; the individual components of POCE; target lesion failure (TLF) (a composite of cardiac death, target-vessel MI, and clinically driven target lesion revascularization); and stent thrombosis were subsequently stratified according to SXscore tertiles: SXscore(LOW) ≤ 9 (n = 698), 9 17 (n = 659).. At 12-month follow-up, rates of POCE, MI, repeat revascularization, TLF, and the composite of death/MI were all significantly higher in patients in the highest SXscore tercile. Rates of stent thrombosis were all highest in the SXscore(HIGH) tertile (p > 0.05). After multivariate adjustment, the SXscore was identified as an independent predictor of POCE, MI, repeat revascularization, and TLF (p < 0.05 for all). At 12-month follow-up, the SXscore, ACEF score, and Clinical SXscore had C-statistics of 0.57, 0.78, and 0.67, respectively, for mortality and of 0.62, 0.56, 0.63, respectively, for POCE. No significant between-stent differences were observed for TLF or POCE in any of the SXscore tertiles.. The SYNTAX score is able to stratify risk amongst an all-comers population treated with PCI with second-generation drug-eluting stents (DES); however, improvements can be made with the inclusion of clinical variables. (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Health Status Indicators; Humans; Israel; Kaplan-Meier Estimate; Linear Models; Male; Middle Aged; Myocardial Infarction; Predictive Value of Tests; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Survival Rate; Time Factors; Treatment Outcome

Available drug-eluting stents (DES) have achieved great success in reducing restenosis rates. Recently, investigators have demonstrated that the durable polymer carrier plays a significant role in DES-related hypersensitive reaction and delays vessel healing. TIVOLI stent is a novel sirolimus-eluting coronary stent with biodegradable coating containing sirolimus and polylactic-co-glycolic acid (PLGA) polymer. The present study sought to evaluate the effectiveness and safety of the TIVOLI biodegradable-polymer-based sirolimus-eluting stent in treating patients with coronary artery disease.. A prospective, multicenter clinical trial comparing TIVOLI biodegradable coated sirolimus-eluting stent with ENDEAVOR zotarolimus-eluting stent was conducted in 324 patients (TIVOLI group: 168 patients; ENDEAVOR group: 156 patients) at 12 centers in China to demonstrate the non-inferiority of in-stent late loss with TIVOLI stent compared to ENDEAVOR stent in subjects with a maximum of two de novo native coronary artery lesions (lesion length ≤ 40 mm, reference vessel diameter 2.25-4.00 mm). The primary end point was angiographic in-stent late loss at 8-month. The secondary end points were clinical outcomes at 2 years, including major adverse cardiac events (cardiac death, myocardial infarction, or target-lesion revascularization) and stent thrombosis.. Angiographic late lumen loss at 8 months in the TIVOLI group was superior to the ENDEAVOR group (in-stent (0.25 ± 0.33) mm vs. (0.57 ± 0.55) mm, diff (95%CI) -0.23 (-0.32, -0.14), P < 0.0001; in-segment (0.25 ± 0.33) mm vs. (0.42 ± 0.55) mm, diff (95%CI) -0.13 (-0.23, -0.02), P = 0.0083). The rate of in-stent binary restenosis at 8 months was reduced from 8.6% in the ENDEAVOR group to 2.9% in the TIVOLI group (P = 0.0229). Compared to ENDEAVOR stent, TIVOLI stent resulted in a significant reduction in target-lesion revascularization (4.2% vs. 9.6%, P = 0.0495) at 2 years. The two-year major adverse cardiac events (MACE) rate was lower for the TIVOLI group, but not significantly different (6.6% vs. 10.9%, P = 0.1630).. TIVOLI was superior to ENDEAVOR stent with respect to late lumen loss at 8 months, and it yielded both lower rates of angiographic binary restenosis at 8 months and target lesion revascularization (TLR) at 2 years. The MACE rate at 2 years was comparable in both groups.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Polymers; Sirolimus; Treatment Outcome

The aim of this study was to compare the 5-year outcomes of patients with multivessel disease (MVD) involving the proximal left anterior descending (LAD) artery who were treated with sirolimus drug-eluting stents (SES), bare metal stents (BMS) and coronary artery bypass surgery (CABG).. Clinical outcomes were compared between the 682 patients enrolled in the ARTS-I and ARTS-II study who had MVD involving the proximal LAD, and were treated with BMS (27.4%), CABG (30.2%), and SES (42.4%). At 5-year follow-up the primary endpoint of major adverse cardiovascular and cerebrovascular events (MACCE) occurred in 33.7%, 18.0% and 24.9% of patients treated with BMS, CABG and SES, respectively (BMS vs. SES p=0.04, CABG vs. SES p=0.07). Unadjusted and adjusted rates of mortality and death/stroke/myocardial infarction (safety) were comparable between all three treatments. Repeat revascularisation was significantly lower following CABG irrespective of adjustment. The absolute difference in MACCE between patients with a logistic EuroSCORE above and below the mean (i.e., 2.09%) was 18.8% (p=0.001), and 1.9% (p=0.28) for CABG and SES, respectively. In patients with a high EuroSCORE, SES was a significantly safer treatment (p=0.04) whilst repeat revascularisation remained lower with CABG irrespective of the EuroSCORE.. At 5-year follow-up CABG has comparable safety, and superior efficacy in terms of reducing repeat revascularisation compared to BMS and SES in the treatment of patients with MVD involving the proximal LAD however, appropriate patient selection remains imperative.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Metals; Middle Aged; Myocardial Infarction; Netherlands; Patient Selection; Proportional Hazards Models; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Stents; Stroke; Thrombosis; Time Factors; Treatment Outcome

Drug-eluting stents (DES) are commonly used to treat obstructive coronary disease and avoid restenosis. Newer DES have been developed to improve effectiveness and safety. We describe a clinical trial to evaluate a DES with a novel polymer that may improve the antirestenosis effectiveness while maintaining the safety standards of currently Food and Drug Administration-approved DES.. The RESOLUTE US Trial is a multicenter, nonrandomized trial prospectively designed to compare the Resolute zotarolimus-eluting stent (R-ZES) to the Food and Drug Administration-approved Endeavor ZES using patient-level historical control data, adjusting for baseline covariates through propensity score. The stents differ primarily in the polymer, which, in the R-ZES, is designed to elute zotarolimus over a longer period. The study will enroll up to 1,574 patients with ischemic heart disease due to de novo native coronary lesions suitable for 1- or 2-vessel treatment with stents from 2.25 to 4.0 mm in diameter. The primary end point is target lesion failure at 12 months postprocedure, defined as the composite of cardiac death, target-vessel myocardial infarction (MI), and clinically driven target lesion revascularization by percutaneous or surgical methods. Secondary end points include device, lesion and procedural success, death, MI, cardiac death and MI, composites of these clinical events, and stent thrombosis at each follow-up assessment up to 5 years postprocedure.. The RESOLUTE US Trial (ClinicalTrials.gov #NCT00726453) is a prospective, multicenter, observational study with a patient-level historical control designed to assess the safety and efficacy of the R-ZES for the treatment of de novo lesions in native coronary arteries.

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Follow-Up Studies; Humans; Prospective Studies; Prosthesis Design; Sirolimus; Treatment Outcome

This study sought to compare late safety and efficacy outcomes following percutaneous coronary revascularization with zotarolimus-eluting stents (ZES) and sirolimus-eluting stents (SES).. Despite higher late lumen loss and binary restenosis with ZES compared with SES, it is uncertain whether differences in early angiographic measures translate into more disparate late clinical events.. Clinical outcomes were prospectively evaluated through 5 years in the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) that randomized 436 patients of relatively low anatomic and clinical risk to treatment with ZES (n = 323) or SES (n = 113) and evaluated a primary endpoint of 8-month angiographic late lumen loss.. At 5 years (completeness of follow-up: 95.2%), pre-specified endpoints of all-cause mortality (5.2% vs. 13.0%, p = 0.02), myocardial infarction (1.0% vs. 4.6%, p = 0.03), and the composite event rates of cardiac death/myocardial infarction (1.3% vs. 6.5%, p = 0.009) and major adverse cardiac events (14.0% vs. 22.2%, p = 0.05) were significantly lower among patients treated with ZES. Rates of target lesion (8.1% ZES vs. 6.5% SES, p = 0.68) and target vessel revascularization were similar between treatment groups. Stent thrombosis was infrequent and similar in both groups (0.7% ZES vs. 0.9% SES, p = 1.0). Between 9 months and 5 years, progression of major adverse cardiac events was significantly more common with SES than with ZES (16.7% vs. 7.8%, p = 0.015).. Despite initially higher angiographic late lumen loss, rates of clinical restenosis beyond the protocol-specified angiographic follow-up period remain stable with ZES compared with the rates for SES, resulting in similar late-term efficacy. Over 5 years, significant differences in death, myocardial infarction, and composite endpoints favored treatment with ZES. (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to investigate the impact of patient and lesion complexity on outcomes with newer-generation zotarolimus-eluting stents (ZES) and everolimus-eluting stents (EES).. Clinical and angiographic outcomes of newer-generation stents have not been described among complex patients.. Patients enrolled in the RESOLUTE All Comers trial (A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention) were stratified into "complex" and "simple.". Of 2,292 patients, 1,520 (66.3%) were complex and treated with ZES (n = 764) or EES (n = 756). Event rates were higher among complex patients, and results did not differ between ZES and EES, regardless of complexity. At 1 year, target lesion failure was 8.9% in ZES- and 9.7% in EES-treated complex patients (p = 0.66) and 6.8% in ZES- and 5.7% in EES-treated simple patients (p = 0.55). Rates of cardiac death (1.3% vs. 2.2%, p = 0.24), target-vessel myocardial infarction (4.3% vs. 4.4%, p = 0.90), and clinically indicated target lesion revascularization (4.4% vs. 4.0%, p = 0.80) were similar for both stent types among complex patients. Definite or probable stent thrombosis occurred in 20 (1.3%) complex patients with no difference between ZES (1.7%) and EES (0.9%, p = 0.26). Angiographic follow-up showed similar results for ZES and EES in terms of in-stent percentage diameter stenosis (22.2 ± 15.4% vs. 21.4 ± 15.8%, p = 0.67) and in-segment binary restenosis (6.6% vs. 8.0%, p = 0.82) in the complex group.. In this all-comers randomized trial, major adverse cardiovascular events were more frequent among complex than simple patients. The newer-generation ZES and EES proved to be safe and effective, regardless of complexity, with similar clinical and angiographic outcomes for both stent types through 1 year. (RESOLUTE-III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084).

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Myocardial Ischemia; Sirolimus; Treatment Outcome

First-generation drug-eluting stents have been proved to be very effective for the treatment of bare metal stent in-stent restenosis (BMS ISR). The efficacy of second-generation drug-eluting stents in this setting remains less well defined. The present study compared the long-term clinical outcome after treatment of BMS ISR using the second-generation everolimus-eluting stent (EES) to that after treatment using the paclitaxel-eluting stent (PES). A total of 174 patients with BMS ISR underwent percutaneous coronary intervention using a PES (95 patients) or an EES (79 patients) from 2003 to 2010. The patients in the PES and EES groups were followed up for 42.2 ± 22.2 and 18.3 ± 8.2 months, respectively. The primary end point of the study was survival free of major adverse cardiac events at 1 year. The secondary end points were survival free of the need for revascularization of the target lesion and definite stent thrombosis. The baseline clinical and angiographic parameters were comparable between the 2 groups. The freedom from major adverse cardiac event rate at 1 year of follow-up was 4.5% and 13.6% (p = 0.0663) for the EES and PES groups, respectively. The target lesion revascularization (TLR) rates were greater in the PES group at 1 year of follow-up compared to the EES group (1% vs 11.5%, p = 0.0193). The rate of myocardial infarction, death, and definite stent thrombosis for the EES and PES groups at 1 year of follow-up was 0% versus 4.2% (p = 0.0984), 3% versus 2.1% (p = 0.6855), and 0% versus 2.1% (p = 0.2382), respectively. The use of a PES for treatment of ISR was the only independent predictor of recurrent TLR at 1 year of follow-up (odds ratios 1.11, 95% confidence interval 1.05 to 1.18; p = 0.0193). During the complete follow-up period, the rates of TLR, myocardial infarction, death, major adverse cardiac events, and definite stent thrombosis were not different between the 2 treatment groups. In conclusion, EES resulted in reduced rates of TLR at 1 year of follow-up compared to PES when used for treatment of BMS ISR. However, at long-term follow-up, the event rates between EES and PES were comparable after treatment of BMS ISR.

Topics: Aged; Angioplasty; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Treatment Outcome

Long-term comparative data of first-generation drug-eluting stents are scarce. We investigated clinical and angiographic outcomes of sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) at 5 years as part of the Sirolimus-Eluting Versus Paclitaxel-Eluting Stents for Coronary Revascularization (SIRTAX) LATE study.. A total of 1012 patients were randomly assigned to SES or PES. Repeat angiography was completed in 444 of 1012 patients (43.8%) at 5 years. Major adverse cardiac events occurred in 19.7% of SES- and 21.4% of PES-treated patients (hazard ratio, 0.89; 95% confidence interval, 0.68 to 1.17; P=0.39) at 5 years. There were no differences between SES and PES in terms of cardiac death (5.8% versus 5.7%; P=0.35), myocardial infarction (6.6% versus 6.9%; P=0.51), and target lesion revascularization (13.1% versus 15.1%; P=0.29). Between 1 and 5 years, the annual rate of target lesion revascularization was 2.0% (95% confidence interval, 1.4% to 2.6%) for SES and 1.4% (95% confidence interval, 0.9% to 2.0%) for PES. Among patients undergoing paired angiography at 8 months and 5 years, delayed lumen loss amounted to 0.37 ± 0.73 mm for SES and 0.29 ± 0.59 mm for PES (P=0.32). The overall rate of definite stent thrombosis was 4.6% for SES and 4.1% for PES (P=0.74), and very late definite stent thrombosis occurred at an annual rate of 0.65% (95% confidence interval, 0.40% to 0.90%).. Long-term follow-up of first-generation drug-eluting stents shows no significant differences in clinical and angiographic outcomes between SES and PES. The continuous increase in late lumen loss in conjunction with the ongoing risk of very late stent thrombosis suggests that vascular healing remains incomplete up to 5 years after implantation of first-generation drug-eluting stents.

Topics: Aged; Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Treatment Outcome

This study sought to compare the efficacy of passive stent coating with titanium-nitride-oxide (TiNO) with drug-eluting stents releasing zotarolimus (ZES) (Endeavor, Medtronic, Minneapolis, Minnesota).. Stent coating with TiNO has been shown to reduce restenosis compared with bare-metal stents in experimental and clinical studies.. In an assessor-blind noninferiority study, 302 patients undergoing percutaneous coronary intervention were randomized to treatment with TiNO or ZES. The primary endpoint was in-stent late loss at 6 to 8 months, and analysis was by intention to treat.. Both groups were well balanced with respect to baseline clinical and angiographic characteristics. The TiNO group failed to reach the pre-specified noninferiority margin for the primary endpoint (in-stent late loss: 0.64 ± 0.61 mm vs. 0.47 ± 0.48 mm, difference: 0.16, upper 1-sided 95% confidence interval [CI]: 0.26; p(noninferiority) = 0.54), and subsequent superiority testing was in favor of ZES (p(superiority) = 0.02). In-segment binary restenosis was lower with ZES (11.1%) than with TiNO (20.5%; p(superiority) = 0.04). A stratified analysis of the primary endpoint found particularly pronounced differences between stents among diabetic versus nondiabetic patients (0.90 ± 0.69 mm vs. 0.39 ± 0.38 mm; p(interaction) = 0.04). Clinical outcomes showed a similar rate of death (0.7% vs. 0.7%; p = 1.00), myocardial infarction (5.3% vs. 6.7%; p = 0.60), and major adverse cardiac events (21.1% vs. 18.0%, hazard ratio: 1.19, 95% CI: 0.71 to 2.00; p = 0.50) at 1 year. There were no differences in rates of definite or probable stent thrombosis (0.7% vs. 0%; p = 0.51) at 1 year.. Compared with TiNO, ZES was superior with regard to late loss and binary restenosis. The concept of passive stent coating with TiNO remains inferior to drug-eluting stent technology in reducing restenosis. ([TIDE] Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent: NCT00492908).

Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Confidence Intervals; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Myocardial Reperfusion; Platelet Aggregation Inhibitors; Risk Factors; Sirolimus; Statistics as Topic; Statistics, Nonparametric; Switzerland; Ticlopidine; Titanium

Patients with diabetes mellitus have increased risk of in-stent restenosis after coronary stent implantation due to neointimal hyperplasia (NIH). The aim of this study was to use quantitative coronary angiography (QCA) and volumetric intravascular ultrasound (IVUS) to evaluate the effects of the sirolimus-eluting Cypher® stent (SES) and the zotarolimus-eluting Endeavor® stent (ZES) on angiographic late lumen loss and intima hyperplasia in diabetic patients.. In the DiabeDES III trial, 127 patients were randomised to SES or ZES stent implantation. Angiographic 10-month follow-up data were available in 105 patients, including 48 SES and 57 ZES treated patients. Angiographic endpoints were in-stent late lumen loss and minimal lumen diameter. IVUS endpoints included NIH volume and in-stent percent volume obstruction. Baseline clinical characteristics and lesion parameters were similar in the two groups. At 10-month follow-up, angiographic in-stent late lumen loss (0.14±0.37 mm vs. 0.74±0.45 mm, p<0.001) was reduced and minimum lumen diameter was higher (2.36±0.53 mm vs. 1.96±0.65, p<0.001) in the SES group as compared to the ZES group. As compared to the ZES group, NIH volume was significantly reduced in the SES group (median [interquartile range]: 0.0 mm3 [0.0 to 1.2] vs. 16.5 mm3 [6.2 to 31.1], p<0.001). In-stent% volume obstruction was significantly reduced in SES as compared to ZES (median [interquartile range]: 0.0% [0.0-0.7] vs. 13.0% [6.7-20.8], p<0.001).. In diabetic patients, the SES reduced angiographic late lumen loss and inhibited NIH more effectively than ZES.

Topics: Aged; Angioplasty, Balloon, Laser-Assisted; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Diabetes Complications; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Hyperplasia; Male; Middle Aged; Neointima; Risk Factors; Single-Blind Method; Sirolimus; Treatment Outcome; Ultrasonography, Interventional

Durable polymer coatings have been implicated in mid- and long-term adverse events after drug-eluting stent implantation. A polymer-free dual-drug sirolimus- and probucol-eluting stent and a new generation permanent polymer zotarolimus-eluting stent are recently developed technologies demonstrating encouraging results.. In a clinical trial with minimal exclusion criteria, we randomly assigned 3002 patients to treatment with sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents. The trial was designed to demonstrate noninferiority of the sirolimus- and probucol-eluting stents. The primary end point was the combined incidence of cardiac death, target-vessel-related myocardial infarction, or target-lesion revascularization at 1-year follow-up. Follow-up angiography was scheduled at 6 to 8 months. The sirolimus- and probucol-eluting stent was noninferior to the zotarolimus-eluting stent in terms of occurrence of the primary end point (13.1% versus 13.5%, respectively, P(noninferiority)=0.006; hazard ratio=0.97, 95% confidence interval, 0.78 to 1.19; P(superiority)=0.74). The incidence of definite/probable stent thrombosis was low in both groups (1.1% versus 1.2%, respectively; hazard ratio=0.91 [95% confidence interval, 0.45 to 1.84], P=0.80). With regard to angiographic efficacy, there were no differences between the sirolimus- and probucol-eluting stent and the zotarolimus-eluting stent in terms of either in-segment binary angiographic restenosis (13.3% versus 13.4% respectively; P=0.95) or in-stent late luminal loss (0.31±0.58 mm versus 0.29±0.56 mm, respectively; P=0.46).. In this large-scale study powered for clinical end points, a polymer-free sirolimus- and probucol-eluting stent was noninferior to a new generation durable polymer-based zotarolimus-eluting stent out to 12 months.. http://www.clinicaltrials.gov. Unique identifier NCT 00598533.

Topics: Aged; Angioplasty, Balloon, Coronary; Anticholesteremic Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Polymers; Probucol; Prosthesis Design; Sirolimus; Treatment Outcome

Drug-eluting stents significantly improved angiographic and clinical outcomes compared with bare metal stents in diabetic patients. However, a comparison of everolimus-eluting stents and sirolimus-eluting stents in diabetic patients has not been evaluated. Therefore we compared effectiveness of everolimus-eluting stents and sirolimus-eluting stents in patients with diabetes mellitus.. This prospective, multicenter, randomized study compared everolimus-eluting stent (n=149) and sirolimus-eluting stent (n=151) implantation in diabetic patients. The primary end point was noninferiority of angiographic in-segment late loss at 8 months. Clinical events were also monitored for at least 12 months. Everolimus-eluting stents were noninferior to sirolimus-eluting stents for 8-month in-segment late loss (0.23 ± 0.27 versus 0.37 ± 0.52 mm; difference, -0.13 mm; 95% confidence interval, -0.25 to -0.02; upper 1-sided 95% confidence interval, -0.04; P<0.001 for noninferiority), with reductions in in-stent restenosis (0% versus 4.7%; P=0.029) and in-segment restenosis (0.9% versus 6.5%; P=0.035). However, in-stent late loss (0.11 ± 0.26 versus 0.20 ± 0.49 mm; P=0.114) was not statistically different between the 2 groups. At 12 months, ischemia-driven target lesion revascularization (0.7% versus 2.6%; P=0.317), death (1.3% versus 3.3%; P=0.448), and myocardial infarction (0% versus 1.3%; P=0.498) were not statistically different between the 2 groups. Major adverse cardiac events, including death, myocardial infarction, and ischemia-driven target lesion revascularization (2.0% versus 5.3%; P=0.218), were also not statistically different between the 2 groups.. Everolimus-eluting stents were noninferior to sirolimus-eluting stents in reducing in-segment late loss and reduced angiographic restenosis at 8 months in patients with diabetes mellitus and coronary artery disease.

Topics: Adolescent; Adult; Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Restenosis; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Sirolimus; Treatment Outcome; Young Adult

This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with biodegradable polymer as compared with sirolimus-eluting stents (SES) with durable polymer through 2 years of follow-up.. BES with a biodegradable polymer provide similar efficacy and safety as SES with a durable polymer at 9 months. Clinical outcomes beyond the period of biodegradation of the polymer used for drug release and after discontinuation of dual antiplatelet therapy are of particular interest.. A total of 1,707 patients were randomized to unrestricted use of BES (n = 857) or SES (n = 850) in an all-comers patient population.. At 2 years, BES remained noninferior compared with SES for the primary endpoint, which was a composite of cardiac death, myocardial infarction, or clinically indicated target vessel revascularization (BES 12.8% vs. SES 15.2%, hazard ratio [HR]: 0.84, 95% confidence interval [CI]: 0.65 to 1.08, p(noninferiority) < 0.0001, p(superiority) = 0.18). Rates of cardiac death (3.2% vs. 3.9%, HR: 0.81, 95% CI: 0.49 to 1.35, p = 0.42), myocardial infarction (6.3% vs. 5.6%, HR: 1.12, 95% CI: 0.76 to 1.65, p = 0.56), and clinically indicated target vessel revascularization (7.5% vs. 8.6%, HR: 0.86, 95% CI: 0.62 to 1.20, p = 0.38) were similar for BES and SES. The rate of definite stent thrombosis through 2 years was 2.2% for BES and 2.5% for SES (p = 0.73). For the period between 1 and 2 years, event rates for definite stent thrombosis were 0.2% for BES and 0.5% for SES (p = 0.42). After discontinuation of dual antiplatelet therapy, no very late definite stent thrombosis occurred in the BES group.. At 2 years of follow-up, the unrestricted use of BES with a biodegradable polymer maintained a similar safety and efficacy profile as SES with a durable polymer. (Limus Eluted From a Durable Versus Erodable Stent Coating [LEADERS]; NCT00389220).

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Drug Therapy, Combination; Drug-Eluting Stents; Europe; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Survival Rate; Thrombosis; Time Factors; Treatment Outcome

Diabetes is associated with an increased risk of major adverse cardiac events after percutaneous coronary intervention. We compared clinical outcomes in patients with and without diabetes mellitus treated with the second-generation Endeavor zotarolimus-eluting stent (ZES) or the first-generation Cypher Select+ sirolimus-eluting stent (SES). We randomized 2,332 patients to treatment with ZESs (n = 1,162, n = 169 diabetics) or SESs (n = 1,170, n = 168 diabetics) and followed them for 18 months. Randomization was stratified by presence/absence of diabetes. The primary end point was major adverse cardiac events defined as a composite of cardiac death, myocardial infarction, or target vessel revascularization. Secondary end points included these individual end points plus all-cause mortality and target lesion revascularization. In diabetic patients, use of ZES compared to SES was associated with an increased risk of major adverse cardiac events (18.3% vs 4.8%, hazard ratio 4.05, 95% confidence interval 1.86 to 8.82), myocardial infarction (4.7% vs 0.6%, hazard ratio 8.09, 95% confidence interval 1.01 to 64.7), target vessel revascularization (14.2% vs 3.0%, hazard ratio 4.99, 95% confidence interval 1.90 to 13.1), and target lesion revascularization (12.4% vs 1.2%, hazard ratio 11.0, 95% confidence interval 2.59 to 47.1). In patients without diabetes differences in absolute risk decrease were smaller but similarly favored SES. In conclusion, implantation of ZESs compared to SESs is associated with a considerable increased risk of adverse events in patients with diabetes at 18-month follow-up.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Retreatment; Risk Assessment; Sirolimus

The aim of this study was to compare the 3-year efficacy and safety of biodegradable polymer with permanent polymer stents and of everolimus-eluting stents (EES) with sirolimus-eluting stents (SES).. Biodegradable polymer drug-eluting stents (DES) offer potential for enhanced late outcomes in comparison with permanent polymer stents. In addition, there is increasing interest in the comparison of EES (Xience, Abbott Vascular, Abbott Park, Illinois) versus SES (Cypher, Cordis Corporation, Miami Lakes, Florida).. The ISAR-TEST 4 (Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents-4) was a randomized clinical trial with broad inclusion criteria, enrolling 2,603 patients at 2 clinics in Munich, Germany. Patients were randomized to either biodegradable polymer (n = 1,299) or permanent polymer stents (n = 1,304); patients treated with permanent polymer stents were randomly allocated to EES (n = 652) or SES (n = 652). The primary endpoint was the composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization.. Clinical events continued to accrue at a low rate out to 3 years in all groups. Overall, there was no significant difference between biodegradable polymer and permanent polymer DES with regard to the primary endpoint (20.1% vs. 20.9%, hazard ratio [HR]: 0.95, 95% confidence interval [CI]: 0.80 to 1.13; p = 0.59). Rates of definite/probable stent thrombosis were also similar in both groups (1.2% vs. 1.7%, respectively; HR: 0.71, 95% CI: 0.37 to 1.39; p = 0.32). In patients treated with permanent polymer stents, EES were comparable to SES with regard to the primary endpoint (19.6% vs. 22.2%, respectively; HR: 0.87, 95% CI: 0.68 to 1.11; p = 0.26) as well as definite/probable stent thrombosis (1.4% vs. 1.9%, HR: 0.75, 95% CI: 0.32 to 1.78; p = 0.51).. Biodegradable polymer and permanent polymer DES are associated with similar clinical outcomes at 3 years. In addition, EES are comparable to SES in terms of overall clinical efficacy and safety. (Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting STents [ISAR-TEST 4]: Prospective, Randomized Trial of 3-limus Agent-eluting Stents With Different Polymer Coatings; NCT00598676).

Topics: Absorbable Implants; Aged; Cause of Death; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Germany; Humans; Immunosuppressive Agents; Male; Polymers; Sirolimus; Survival Rate; Time Factors; Treatment Outcome

The SYNTAX score (SXscore) has been shown to be an effective predictor of clinical outcomes in patients undergoing percutaneous coronary intervention (PCI).. The SXscore was prospectively collected in 1,397 of the 1,707 patients enrolled in the "all-comers" LEADERS trial (patients post-surgical revascularisation were excluded). Post hoc analysis was performed by stratifying clinical outcomes at two-year follow-up, according to one of three SXscore tertiles: SXlow ≤8 (n=464), 816 (n=461). At two-year follow-up the rate of major adverse cardiovascular events was 18.4%, 12.0% and 9.4% in the SXhigh, SXmid, and SXlow tertile, respectively (HR 1.45; CI 1.21-1.74; p<0.01). There was a significantly higher rate of cardiac death in patients in the highest SXscore tertile (7% SXhigh versus 2.4% SXmid versus 1.8% SXlow; HR 2.22; CI 1.5-3.27; p<0.001). Within the SXhigh tertile the rate of cardiac death was significantly lower in patients treated with the biolimus-eluting stent compared with the sirolimus-eluting stent (4.7% versus 9.6%, HR 0.48; CI 0.23-0.99; p=0.046).. The SXscore when applied to an "all-comers" patient population allows for prospective risk stratification of patients undergoing PCI up to two years follow-up. In addition, the SXscore appears to separate the performance of devices in high risk patient groups.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Heart Diseases; Humans; Male; Middle Aged; Polymers; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The current study reports clinical outcomes at three year follow-up of the LEADERS clinical trial which was the first all-comers trial comparing a new generation biodegradable polymer biolimus drug-eluting stent (BES) with the first generation permanent polymer sirolimus-eluting stent (SES).. One thousand seven hundred and seven patients were randomised to unrestricted use of BES (n=857) or SES (n=850) in an all-comers population. Three year follow-up was available in 95% of the patients, 812 treated with BES and 809 treated with SES. At three years, BES remains non-inferior to SES for the primary endpoint of major adverse cardiac events (composite of cardiac death, myocardial infarction (MI), or clinically-indicated target vessel revascularisation (CI-TVR) (BES 15.7% versus SES 19%; HR 0.82 CI 0.65-1.03; p=0.09). The MACE Kaplan Meier event curves increasingly diverge with the difference in events increasing from 1.4% to 2.4% and 3.3% at 1, 2 and 3 years, respectively in favour of BES. The rate of cardiac death was non-significantly lower 4.2% versus 5.2% (HR=0.81 CI 0.52-1.26; p=0.34) and the rate of myocardial infarction was equivalent 7.2% versus 7.1% (HR 1.01 CI 0.70-1.44; p=0.97) for BES versus SES, respectively. Thus BES was non-inferior to SES in all the safety endpoints. Clinically-indicated TVR occurred in 9.4% of BES treated patients versus 11.1% of SES treated patients (HR 0.84 CI 0.62-1.13; p=0.25). Rates of definite stent thrombosis were 2.2% for BES and 2.9% for SES (HR 0.78 CI 0.43-1.43; p=0.43), with the event rate increase of 0.2% from one to three years for BES and 0.9% for SES. For patients presenting with ST-elevation myocardial infarction BES was superior to SES in reducing MACE.. The findings of the three year follow-up support the claim that the biodegradable polymer biolimus-eluting stent has equivalent safety and efficacy to permanent polymer sirolimus-eluting stent in an all-comers patient population. Its performance is superior in some subpopulations such as in ST-elevation MI patients and event rates for BES are overall lower than for SES with a trend toward increasing divergence of outcomes over three years.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Drug Therapy, Combination; Drug-Eluting Stents; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Safety concerns regarding use of drug-eluting stent systems (DES) are related mostly to late stent thrombosis, which is facilitated by incomplete stent endothelial coverage. Specific information about time course and amount of endothelial strut coverage of different DES is required, in order to further refine the concept of antiplatelet therapy after DES implantation. Optical coherence tomography (OCT) is emerging as a new gold standard for endovascular imaging of stents, atherosclerosis progression, vulnerable plaque, and neointimal proliferation. The aim of this study is a comparative evaluation using OCT of the XIENCE V everolimus-eluting stent (Abbot Vascular, Santa Clara, CA, USA) on one hand, and the bare metal stent Coroflex Blue postdilated with the paclitaxel-eluting balloon Sequent Please (both from B Braun Melsungen AG, Melsungen, Germany) on the other hand, with respect to endothelial coverage and neointimal proliferation.. Eighty patients scheduled for elective percutaneous coronary intervention (PCI) of a native coronary stenosis suitable for DES implantation and OCT imaging are scheduled to be openly randomised 1:1 to either XIENCE or Coroflex Blue/Sequent Please. The study is conducted prospectively at a university high-volume PCI centre with OCT expertise. Angiographic follow-up and time-domain OCT imaging with motorised pull-back at 1 mm/s are planned six months after study stent implantation in all patients. OCT endpoints are: (1) endothelial coverage, expressed as % of struts without coverage and % of stent length containing non-covered struts, and respectively (2) neointimal proliferation, given as % neointimal volumetric proliferation within the whole stent and also as peak focal % neointimal area proliferation. The study is not powered for clinical endpoints, which are: subacute or late stent thrombosis and need for revascularisation of the stent segment. Given the high number of measurements (15 cross-section images / 1 mm stent length), OCT endpoints are likely to reach significance at the level p <0.05, if the drop-out rate in follow-up does not exceed 20%.. The study is currently on-going and its termination is scheduled for February 2010. (ClinicalTrials.gov identifier: NCT01056744).

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Drug-Eluting Stents; Endothelial Cells; Everolimus; Germany; Humans; Metals; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Research Design; Sirolimus; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima

The effectiveness of durable polymer drug-eluting stents comes at the expense of delayed arterial healing and subsequent late adverse events such as stent thrombosis (ST). We report the 4 year follow-up of an assessment of biodegradable polymer-based drug-eluting stents, which aim to improve safety by avoiding the persistent inflammatory stimulus of durable polymers.. We did a multicentre, assessor-masked, non-inferiority trial. Between Nov 27, 2006, and May 18, 2007, patients aged 18 years or older with coronary artery disease were randomly allocated with a computer-generated sequence to receive either biodegradable polymer biolimus-eluting stents (BES) or durable polymer sirolimus-eluting stents (SES; 1:1 ratio). The primary endpoint was a composite of cardiac death, myocardial infarction, or clinically-indicated target vessel revascularisation (TVR); patients were followed-up for 4 years. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00389220.. 1707 patients with 2472 lesions were randomly allocated to receive either biodegradable polymer BES (857 patients, 1257 lesions) or durable polymer SES (850 patients, 1215 lesions). At 4 years, biodegradable polymer BES were non-inferior to durable polymer SES for the primary endpoint: 160 (18·7%) patients versus 192 (22·6%) patients (rate ratios [RR] 0·81, 95% CI 0·66-1·00, p for non-inferiority <0·0001, p for superiority=0·050). The RR of definite ST was 0·62 (0·35-1·08, p=0·09), which was largely attributable to a lower risk of very late definite ST between years 1 and 4 in the BES group than in the SES group (RR 0·20, 95% CI 0·06-0·67, p=0·004). Conversely, the RR of definite ST during the first year was 0·99 (0·51-1·95; p=0·98) and the test for interaction between RR of definite ST and time was positive (p(interaction)=0·017). We recorded an interaction with time for events associated with ST but not for other events. For primary endpoint events associated with ST, the RR was 0·86 (0·41-1·80) during the first year and 0·17 (0·04-0·78) during subsequent years (p(interaction)=0·049).. Biodegradable polymer BES are non-inferior to durable polymer SES and, by reducing the risk of cardiac events associated with very late ST, might improve long-term clinical outcomes for up to 4 years compared with durable polymer SES.. Biosensors Europe SA, Switzerland.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Follow-Up Studies; Humans; Polymers; Sirolimus; Thrombosis

Vessel angulation and large changes in vessel geometry after stent implantation have been associated with an increased risk of target lesion failure (TLF) using bare-metal stents. Second-generation drug-eluting stents (DES)offer superior conformability and inhibition of neointima. The aim of the study is to investigate the relationship between pre and post-implant vessel geometry and the occurrence of TLF at 1 year after treatment with second-generation DES; and to compare the conformability of Resolute and Xience stents.. The RESOLUTE All-Comers trial randomized 2292 patients (3366 lesions) to Resolute zotarolimus-DES (Medtronic CardioVascular) or Xience everolimus-DES (Abbott Vascular). At 1 year, 176 lesions (121 patients)presented with TLF; a composite of cardiac death, acute myocardial infarction (AMI) and target lesion revascularization (TLR). Lesions with TLF were matched with 176 lesions (168 patients) without TLF adjusting for clinical and procedural characteristics. The number of bends, vessel curvature and angulation were assessed with quantitative coronary angiography pre and post-implantation. The absolute difference post minus pre-implantation was used as a surrogate of stent conformability.. At pre-implantation, lesions without and with TLF had similar numbers of bends/lesion (1.81 vs 1.74; P = .35), vessel curvature (0.295 cm(-1) vs 0.363 cm(-1); P = .13) and vessel angulation (46.3° vs 43.5°; P = .80), respectively. Lesions without and with TLR also had similar numbers of bends/lesion (1.39 vs 1.39; P = .83), vessel curvature (0.368 cm(-1) vs 0.325 cm(-1); P = .33) and angulation (40.2° vs 37.2°; P = .19). Lesions without and with in-hospital AMI also presented with similar number of bends/lesion (1.69 vs 1.81; P = .48), vessel curvature (0.349 cm(-1) vs 0.345 cm(-1); P = .91) and vessel angulation (43.53° vs 48.45°; P = .38). The absolute difference post- - pre-implantation was similar in lesions without and with TLF, TLR and In-hospital AMI. The absolute difference post- - pre-implantation was similar with both Resolute and Xience in vessel curvature (-0.046 cm(-1) vs -0.047 cm(-1); P = .66) and was smaller in number of bends/lesion (-0.08 vs -0.16; P = .13) and in vessel angulation (-6.0° vs -10.1°; P = .03) with the Resolute.. Bended, curved, and angulated lesions and changes in the number of bends/lesion, vessel curvature, and angulation from pre to post-implantation have no relation with TLF and TLR at 1 year and have no relation with In-hospital AMI using second-generation of DES. Resolute appears to be more conformable than Xience.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Prosthesis Implantation; Sirolimus; Treatment Failure

This study sought to compare the neointimal response of metallic everolimus drug-eluting stents (DES) and polymeric everolimus bioresorbable vascular scaffolds (BVS) by optical coherence tomography at 1 year.. DES decrease the risk of restenosis by reducing the neointimal response. However, DES may impair strut coverage, and this has been associated with late stent/scaffold thrombosis. BVS may overcome the risk of stent/scaffold thrombosis when completely resorbed. It is unknown if, during the bioresorption process, the neointimal response of the everolimus BVS (Absorb, Abbott Vascular, Santa Clara, California) differs from that of the metallic everolimus DES (Xience, Abbott Vascular).. A total of 19 lesions were treated with a single everolimus DES, and 31 lesions were treated with everolimus BVS and imaged with optical coherence tomography at 1 year. Neointimal response was assessed as percentage of uncovered struts, neointimal thickness, in-stent/scaffold area obstruction, and pattern of neointima.. At 1 year, no significant differences in the angiographic lumen loss were seen for the everolimus DES and everolimus BVS (0.18 ± 0.20 mm vs. 0.29 ± 0.36 mm; p = 0.42). optical coherence tomography analysis of 951 cross sections and 8,385 struts demonstrated similar rates of uncovered struts (5.3% everolimus DES vs. 4.5% everolimus BVS; p = 0.11), mean neointimal thickness (120.6 ± 46.0 μm vs. 136.1 ± 71.4 μm; p = 0.82) and in-stent/scaffold area obstruction (12.5 ± 7.1% vs. 13.6 ± 9.7%; p = 0.91), respectively. There was a trend of higher heterogenic tissue pattern of neointima (21.1% vs. 6.5%; p = 0.12) and less intraluminal masses (0% vs. 12.9%; p = 0.10) with everolimus DES than with everolimus BVS.. The everolimus BVS (Absorb) demonstrated a similar neointimal response as the everolimus DES (Xience). However, the presence of intraluminal masses at 12 months in a small proportion of patients warranted watchful follow-up of these cases.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Metals; Middle Aged; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima

This study sought to investigate quantitative and homogeneity differential echogenicity changes of the ABSORB scaffold (1.1) during the first year after implantation.. The imaging of the ABSORB bioresorbable vascular scaffold degradation by intravascular ultrasound (IVUS) has previously demonstrated diminishing gray-level intensity of the struts over time that can be evaluated by IVUS-based differential echogenicity. The first generation of ABSORB (1.0) showed a 50% reduction in hyperechogenicity at 6 months and restoration of the pre-ABSORB implantation values at 2 years. The second generation of ABSORB (1.1), investigated in the ABSORB B trial, was modified to prolong the duration of luminal scaffolding.. A total of 63 patients were examined by IVUS immediately post-implantation and at 6-month (Cohort B1, n = 28) or 12-month (Cohort B2, n = 35) follow-up. IVUS-based tissue composition analysis software was used to quantify changes in hyperechogenicity over time in the scaffolded regions. Relative changes in hyperechogenicity were calculated as: 100 × (% hyperechogenicity at follow-up - % hyperechogenicity at baseline)/% hyperechogenicity at baseline.. At 6- and 12-month follow-up, there was a 15% (from 22.58 ± 9.77% to 17.42 ± 6.69%, p = 0.001) and 20% (from 23.51 ± 8.57% to 18.25 ± 7.19%, p < 0.001) reduction in hyperechogenicity, respectively, compared with post-implantation values. No difference in hyperechogenicity changes were observed between the proximal, medial, or distal part of the scaffolded segment.. Quantitative differential echogenicity changes of the ABSORB scaffold (1.1) during the first 12 months after implantation are lower compared with those previously observed with its first generation (1.0), confirming the value of the manufacturing changes and suggesting a slower degradation rate of the scaffold.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Metals; Middle Aged; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

To assess the efficacy of the sirolimus-eluting stent when implanted in smaller caliber vessels using three-dimensional intravascular ultrasound (IVUS) analysis.. One hundred and twenty-three patients (69 sirolimus-coated Bx Velocity and 54 control) who underwent successful three-dimensional IVUS at follow up comprised this IVUS substudy from the SIRIUS (SIRolImUS-coated Bx Velocity stent in the treatment of patients with de novo coronary artery lesions) population. To evaluate the impact of vessel size, 2 groups were created using QCA reference vessel diameter (RVD; large vessel group: RVD>/=2.75 mm and small vessel group: RVD<2.75 mm).. Sirolimus-eluting stents significantly reduced neointimal hyperplasia by the same relative magnitude within the stent in small vessels as well as in large vessels. Although sirolimus-eluting stents had favorable effects on lumen area at stent edges in larger vessels, the effect was less in smaller vessels, especially at the proximal edge. IVUS-detected adverse vessel response, such as late-acquired incomplete apposition, did not increase in smaller vessels even with relatively higher dose exposure.. Sirolimus-eluting stents showed inhibition of neointimal hyperplasia in small vessels compared to bare metal stents with no increase of vascular complications.

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Hyperplasia; Imaging, Three-Dimensional; Immunosuppressive Agents; Sirolimus; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

Myocardial revascularization with drug-eluting stents (DESs) is emerging as an alternative to conventional coronary artery bypass surgery in patients with multivessel coronary artery disease (MV-CAD). First-generation DESs have yielded equivalent safety results at mid-term compared with surgery, but inferior efficacy in preventing the recurrence of ischemic symptoms. The outcome of percutaneous coronary intervention with a second-generation everolimus DES as compared with a paclitaxel DES in patients with MV-CAD has not been established.. The aim of the study is the assessment of the efficacy and performance of the XIENCE V everolimus-eluting stent in the treatment of de-novo coronary artery lesions in patients with MV-CAD.. The study is composed of two parts: a prospective, double arm, randomized multicenter trial to assess the angiographic efficacy of the XIENCE V everolimus-eluting coronary stent system (EECSS) compared with the Taxus Liberté Paclitaxel Eluting Coronary Stent System (Taxus Liberté Stent) and a prospective, open-label, single arm, controlled registry to analyze the clinical efficacy and safety of XIENCE V EECSS at mid-term and long-term follow-up in patients treated for MV-CAD.. For the EXECUTIVE randomized trial, the primary endpoint is in-stent late lumen loss at 9 months. For the EXECUTIVE registry, the primary endpoint is a composite of all death, myocardial infarction (Q-wave and non-Q-wave), and ischemia-driven target vessel revascularization at 12 months. The study will be conducted at 30 study centers in Italy and 600 patients will be enrolled in total: 200 patients will be enrolled (1: 1) in the randomized trial and 400 patients will enter the registry.. It was calculated that, assuming a mean in-stent late lumen loss of 0.20 +/- 0.41 mm in the XIENCE V EECSS arm and 0.30 +/- 0.53 mm in the Taxus Liberté stent arm, and a noninferiority margin delta of 0.12 (according to the SPIRIT III results), the analysis of 81 lesions per arm would provide over 90% power. Therefore, 200 patients will be enrolled to account for dropouts.. The present study is expected to provide as yet unavailable information about the performance of second-generation stents in the specific setting of patients with MV-CAD.

Topics: Angiography; Blood Vessel Prosthesis Implantation; Clinical Protocols; Coronary Artery Disease; Cost-Benefit Analysis; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Myocardial Revascularization; Prospective Studies; Research Design; Sirolimus

The ENDEAVOR IV (Randomized Comparison of Zotarolimus-Eluting and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial evaluated the safety and efficacy of the zotarolimus-eluting stent (ZES) compared with the paclitaxel-eluting stent (PES).. First-generation drug-eluting stents have reduced angiographic and clinical restenosis, but long-term safety remains controversial. A second-generation drug-eluting stent, which delivers zotarolimus, a potent antiproliferative agent, via a biocompatible phosphorylcholine polymer on a cobalt alloy thin-strut stent has shown promising experimental and early clinical results.. This is a prospective, randomized (1:1), single-blind, controlled trial comparing outcomes of patients with single de novo coronary lesions treated with ZES or PES. The primary end point was noninferiority of 9-month target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization.. Among a total of 1,548 patients assigned to ZES (n = 773) or PES (n = 775), at 9 months, ZES was noninferior to PES with rates of target vessel failure 6.6% versus 7.1%, respectively (p(noninferiority) < or = 0.001). There were fewer periprocedural myocardial infarctions with ZES (0.5% vs. 2.2%; p = 0.007), whereas at 12 months, there were no significant differences between groups in rates of cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis. Although incidence of 8-month binary angiographic in-segment restenosis was higher in patients treated with ZES versus PES (15.3% vs. 10.4%; p = 0.284), rates of 12-month target lesion revascularization were similar (4.5% vs. 3.2%; p = 0.228), especially in patients without planned angiographic follow-up (3.6% vs. 3.2%; p = 0.756).. These findings demonstrate that ZES has similar clinical safety and efficacy compared with PES in simple and medium complexity single de novo coronary lesions. (ENDEAVOR IV Clinical Trial; NCT00217269).

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Single-Blind Method; Sirolimus; Treatment Outcome

The purpose of this study is to compare the 5-year clinical outcomes, safety, and efficacy of sirolimus-eluting stents (SES) in the ARTS II (Arterial Revascularization Therapies Study II) with the outcomes of coronary artery bypass graft (CABG) and bare-metal stenting (BMS) from the ARTS I.. The long-term outcomes after SES implantation in patients with multivessel disease remains to be established.. The ARTS I was a randomized trial of 1,205 patients with multivessel disease comparing CABG and BMS. The ARTS II study was a nonrandomized trial with the Cypher sirolimus-eluting stent (Cordis, a Johnson & Johnson Company, Warren, New Jersey), applying the same inclusion and exclusion criteria, end points, and protocol definitions. The ARTS II trial enrolled 607 patients, with an attempt to enroll at least one-third of patients with 3-vessel disease.. At 5-year, the death/stroke/myocardial infarction event-free survival rate was 87.1% in ARTS II SES, versus 86.0% (p = 0.1) and 81.9% (p = 0.007) in ARTS I CABG and BMS cohorts, respectively. The 5-year major adverse cardiac and cerebrovascular event (MACCE) rate in ARTS II (27.5%) was significantly higher than ARTS I CABG (21.1%, p = 0.02), and lower than in ARTS I BMS (41.5%, p < 0.001). The cumulative incidence of definite stent thrombosis was 3.8%. Thirty-two percent (56 of 176) of major adverse cardiac events (MACE) at 5 years were related to possible, probable, or definite stent thrombosis.. At 5 years, SES had a safety record comparable to CABG and superior to BMS, and a MACCE rate that was higher than in patients treated with CABG, and lower than in those treated with BMS. Approximately one-third of the events seen with SES could be prevented through the elimination of early, late, and very late stent thrombosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Bypass; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Sirolimus; Time Factors; Treatment Outcome

We aimed to compare the long-term clinical outcomes of patients treated with sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) for coronary bifurcation lesions.. There are limited data regarding comparisons of SES and PES for the treatment of bifurcation lesions.. Patients who received percutaneous coronary intervention for non-left main bifurcation lesions were enrolled from 16 centers in Korea between January 2004 and June 2006. We compared major adverse cardiac events (MACE [cardiac death, myocardial infarction, or target lesion revascularization]) between the SES and PES groups in patients overall and in 407 patient pairs generated by propensity-score matching.. We evaluated 1,033 patients with bifurcation lesions treated with SES and 562 patients treated with PES. The median follow-up duration was 22 months. Treatment with SES was associated with a lower incidence of MACE (hazard ratio [HR]: 0.53, 95% confidence interval [CI]: 0.32 to 0.89, p < 0.01) and target lesion revascularization (HR: 0.55, 95% CI: 0.31 to 0.97, p = 0.02), but not of cardiac death (HR: 2.77, 95% CI: 0.40 to 18.99, p = 0.62) and cardiac death or myocardial infarction (HR: 0.97, 95% CI: 0.38 to 2.49, p = 0.94). After propensity-score matching, patients with SES still had fewer MACE and target lesion revascularization incidences than did patients with PES (HR: 0.52, 95% CI: 0.30 to 0.91, p = 0.02, and HR: 0.48, 95% CI: 0.25 to 0.91, p = 0.02, respectively). There was no significant difference in the occurrences of stent thrombosis between the groups (0.7% vs. 0.7%, p = 0.94).. In patients with bifurcation lesions, the use of SES resulted in better long-term outcomes than did the use of PES, primarily by decreasing the rate of repeat revascularization. (Coronary Bifurcation Stenting Registry in South Korea [COBIS]; NCT00851526).

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Death, Sudden, Cardiac; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Korea; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Registries; Retrospective Studies; Sirolimus; Survival Rate; Treatment Outcome

The aim of this study was to investigate the feasibility of using quantitative differential echogenicity to monitor the in vivo absorption process of a drug-eluting poly-l-lactic-acid (PLLA) bioabsorbable stent (BVS, Abbott Vascular, Santa Clara, California).. A new bioabsorbable, balloon-expanded coronary stent was recently evaluated in a first-in-man study. Little is known about the absorption process in vivo in diseased human coronary arteries.. In the ABSORB (Clinical Evaluation of the BVS everolimus eluting stent system) study, 30 patients underwent treatment with the BVS coronary stent system and were examined with intracoronary ultrasound (ICUS) after implantation, at 6 months and at 2-year follow-up. Quantitative ICUS was used to measure dimensional changes, and automated ICUS-based tissue composition software (differential echogenicity) was used to quantify plaque compositional changes over time in the treated regions.. The BVS struts appeared as bright hyperechogenic structures and showed a continuous decrease of their echogenicity over time, most likely due to the polymer degradation process. In 12 patients in whom pre-implantation ICUS was available, at 2 years the percentage-hyperechogenic tissue was close to pre-implantation values, indicating that the absorption process was either completed or the remaining material was no longer differentially echogenic from surrounding tissues.. Quantitative differential echogenicity is a useful plaque compositional measurement tool. Furthermore, it seems to be valuable for monitoring the absorption process of bioabsorbable coronary stents made of semi-crystalline polymers.

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Europe; Everolimus; Feasibility Studies; Humans; Image Interpretation, Computer-Assisted; Lactic Acid; New Zealand; Polyesters; Polymers; Predictive Value of Tests; Prosthesis Design; Sirolimus; Solubility; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Previous studies have established the superiority of coronary everolimus-eluting stents over paclitaxel-eluting stents with respect to angiographic findings. However, these trials were not powered for superiority in clinical end points.. We randomly assigned 3687 patients at 66 U.S. sites to receive everolimus-eluting stents or paclitaxel-eluting stents without routine follow-up angiography. The primary end point was the 1-year composite rate of target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization).. Everolimus-eluting stents were superior to paclitaxel-eluting stents with respect to the primary end point of target-lesion failure (4.2% vs. 6.8%; relative risk, 0.62; 95% confidence interval, 0.46 to 0.82; P=0.001). Everolimus-eluting stents were also superior with respect to the major secondary end point of the 1-year rate of ischemia-driven target-lesion revascularization (P=0.001) and were noninferior with respect to the major secondary end point of the 1-year composite rate of cardiac death or target-vessel myocardial infarction (P<0.001 for noninferiority; P=0.09 for superiority). The 1-year rates of myocardial infarction and stent thrombosis were also lower with everolimus-eluting stents than with paclitaxel-eluting stents (1.9% vs. 3.1%, P=0.02 for myocardial infarction; 0.17% vs. 0.85%, P=0.004 for stent thrombosis). Target-lesion failure was consistently reduced with everolimus-eluting stents as compared with paclitaxel-eluting stents in 12 prespecified subgroups, except in the subgroup of patients with diabetes (6.4% vs. 6.9%, P=0.80).. Everolimus-eluting stents, as compared with paclitaxel-eluting stents, resulted in reduced rates of target-lesion failure at 1 year, results that were consistent in all patients except those with diabetes, in whom the results were nonsignificantly different. (ClinicalTrials.gov number, NCT00307047.)

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Glycoprotein GPIIb-IIIa Complex; Retreatment; Single-Blind Method; Sirolimus; Thrombosis; Treatment Failure

To evaluate whether an everolimus-eluting stent (EES) with thinner stent struts and polymer results in less periprocedural myonecrosis and adverse outcomes.. Higher periprocedural myocardial infarction (MI) rates have been reported with the TAXUS® EXPRESS(2) paclitaxel-eluting stent (PES) compared to the bare metal EXPRESS(2)® stent due to more frequent side branch compromise, presumably attributable to the thickness of the stent/polymer on the PES.. In the SPIRIT III trial, we identified 113 patients in the XIENCE V® EES group and 63 patients in the TAXUS EXPRESS(2) PES group who met the criteria of having a lesion with a jailed side branch (<2 mm diameter, and <50% stenosis). Two-year clinical outcomes were evaluated.. A periprocedural increase in Creatine Kinase-MB >1× upper normal level occurred in 9.0% of EES compared to 29.7% of PES patients with jailed side branches, P = 0.01. Through 2 years, major adverse cardiac events (MACE; cardiac death, MI, or target lesion revascularization [TLR]) occurred in 6.8% of EES and 19.0% of PES jailed side branch patients (P = 0.03), with numerically lower rates of MI (2.9% vs. 10.3%, P = 0.07) and TLR (3.9% vs. 10.3%, P = 0.17) in the EES group, with comparable rates of cardiac death (1.9% vs. 1.7%, P = 1.00).. In this post-hoc analysis of the SPIRIT III RCT, patients undergoing stenting of target lesions with jailed side branches with the thin strut and polymer XIENCE V EES compared to the thicker strut TAXUS PES had lower rates of MACE through 2 years due to fewer MIs and TLRs. © 2010 Wiley-Liss, Inc.

Topics: Aged; Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Creatine Kinase, MB Form; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Myocardium; Necrosis; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; United States

The ABSORB Cohort A clinical study has shown the feasibility and safety of the fully bioabsorbable everolimus-eluting structure (BVS, revision 1.0). However, the study also demonstrated somewhat higher acute and late recoil with the BVS structure compared to metallic drug eluting stents. Based on these clinical observations, modifications to the stent design (BVS, revision 1.1) were introduced for the ABSORB Cohort B study in order to decrease recoil. The aim was to compare in vivo the strut distribution between the BVS revision 1.0 (Cohort A), and BVS revision 1.1 (Cohort B) designs.. OCT analysis was performed by two independent analysts in four patients from each cohort of the ABSORB study. Strut distribution was assessed in cross-section, and longitudinally in a frameby-frame analysis. Variables recorded included inter-strut angle, maximum inter-strut angle and number of frames with < or =3 struts. The inter-observer correlation coefficient was also assessed. For both designs, on a patient level there was no significant difference in the number of analysed struts corrected for the length of the scaffold (p=0.78). Likewise, on a frame by frame analysis mean stent area, number of struts per frame, mean maximum inter-strut angle, and mean inter-strut angle were similar for both groups. However, in both structures there was a cyclical variation in the maximum number of struts per frame. The frequency of this variation was significantly higher in Cohort B. The inter-observer correlation coefficient for strut counts, inter-strut angle and maximum inter-strut angle was 0.91, 0.87 and 0.74 respectively.. This ad hoc analysis confirms that the revision 1.1 BVS design has a different longitudinal strut distribution to the revision 1.0 BVS design, indicating that the new design has a reduced maximum circular unsupported cross sectional area.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Observer Variation; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Reproducibility of Results; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Assessment of health related quality-of-life (HRQL) has become increasingly important as not only the clinician's view of the technical success, but also the patient's perception is being measured. We evaluated the HRQL following sirolimus-eluting coronary stent (SES) (CYPHER(R); Cordis, Johnson & Johnson, Warren, NJ, USA) implantation in patients with multivessel disease, comparing the outcomes with the historical surgical and bare metal stent (BMS) arms of the ARTS-I study.. The HRQL outcomes were compared to the outcome of the historical cohorts of the randomised ARTS-I trial using the same inclusion and exclusion criteria. HRQL was evaluated at baseline, at one month and at 6, 12 and 36 months after revascularisation using the SF-36 in patients treated with SES (n=585), BMS (n=483) or coronary artery bypass graft (CABG) (n=492). The HRQL compliance rates varied from 100% at baseline to 92% at 36 months. Both stenting and CABG resulted in significant improvement of HRQL and anginal status. There was a trend towards better HRQL after CABG than BMS beyond six months. Already from the first month up to three years, SES patients had, on average, 10% significantly better HRQL than BMS patients on the HRQL subscales physical functioning, role physical functioning, role emotional functioning and mental health (p<0.01) and a trend towards better HRQL in the other subscales. Up to 12 months, the HRQL was better after SES than CABG and was identical thereafter. At all time points, angina was more prevalent in the BMS group than in both the SES and CABG groups, in which the incidence of angina was similar. At three years, 10% of the SES patients suffered from angina, 13% of the CABG patients and 20% of the BMS patients.. Both stenting and CABG resulted in a significant improvement in HRQL and angina. Along with a substantial reduction of restenosis, HRQL after SES was significantly improved as compared with BMS, and was similar to CABG.

Topics: Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Bypass; Coronary Artery Disease; Drug-Eluting Stents; Emotions; Female; Humans; Male; Mental Health; Metals; Middle Aged; Prosthesis Design; Quality of Life; Recovery of Function; Registries; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome

Novolimus, a macrocyclic lactone with anti-proliferative properties, has a similar efficacy to currently available agents; however it requires a lower dose, and less polymer, and is therefore conceivably safer.. The EXCELLA II study was a prospective, multicentre, single-blind, non-inferiority clinical trial which randomised 210 patients with a maximum of two de novo coronary artery lesions in two different epicardial vessels in a ratio of 2:1 to treatment with either the Elixir DESyne Novolimus Eluting Coronary Stent System (NES n=139, Elixir Medical, Sunnyvale, CA, USA) or the Endeavor zotarolimus eluting stent (ZES n=71, Medtronic, Santa Rosa, CA, USA). The primary endpoint was in-stent mean late lumen loss (LLL) at 9-months follow-up. In-stent percent volume obstruction (%VO) was measured in a?sub-group of 65 patients having 9-month intravascular ultrasound (IVUS) follow-up. Clinical secondary endpoints included a device orientated composite of cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularisation (CI-TLR) assessed at 9-months follow-up. At 9-months, the in-stent LLL was 0.11+/-0.32 mm in the NES arm, as compared to 0.63+/-0.42 mm in the ZES (p<0.0001 non-inferiority, p<0.0001 superiority). In-stent%VO was 4.5+/-5.1% and 20.9+/-11.3% for NES and ZES, respectively (p<0.001). There was no significant difference between stent groups in the device orientated composite endpoint (NES 2.9% vs. ZES 5.6%, -2.8% [-8.8%, 3.3%], p=0.45) or its individual components of cardiac death, target vessel MI and CI-TLR.. This non-inferiority randomised study not only met its primary endpoint, but also demonstrated superiority of NES compared to the ZES in terms of in-stent LLL.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Macrolides; Male; Middle Aged; Prospective Studies; Single-Blind Method; Sirolimus; Time Factors

The optimal stenting strategy in true coronary artery bifurcation lesions has not been determined. In this study, a strategy of always stenting both the main vessel and the side branch (MV plus SB) was compared with a strategy of stenting the MV only with optional stenting of the SB. Stents used were sirolimus-eluting stents and paclitaxel-eluting stents.. A total of 108 patients with true coronary bifurcation lesions were randomly assigned to either routine stenting with drug-eluting stents (DES) in both the branches (group MV plus SB) or provisional stenting with DES placement in the main branch and DES placement in the SB only if MV stenting alone provided inadequate results (group MV). The primary end points were major adverse cardiac events (MACE) at 8 months, including myocardial infarction, cardiac death, and stent thrombosis or target vessel revascularization by either percutaneous coronary intervention or coronary artery bypass grafting.. Angiographic follow-up revealed 28.91+/-20.43% stenosis of the SB after provisional stenting and 18.93+/-15.34% (P<0.01) after routine stenting. The corresponding binary restenosis rates were 35.2 and 14.8% (P=0.015). SB stents were implanted in 16.7% of patients in the provisional stenting group and 94.4% of patients in the routine stenting group. In the main branch, binary restenosis rates prebifurcation were 11.1% after provisional and 7.4% after routine stenting (P=0.51), whereas binary restenosis rates postbifurcation were 14.8 and 9.3% (P=0.38), respectively. The overall 8-month incidence of target lesion reintervention was 31.5% after provisional and 7.4% after routine stenting (P<0.01), and cumulative MACE were 38.9 and 11.1% (P<0.01), respectively.. Routine stenting significantly improved the MACE outcome of percutaneous coronary intervention in true coronary bifurcation and bifurcation angle of 60 or less lesions as compared with provisional stenting.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; China; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Little is known about the impact of treatment with drug-eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) in patients with calcified or noncalcified culprit lesions.. The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six-month and 2-year angiographic follow-up and clinical follow-up up to 3 years were completed.. The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6-month in-stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia-driven target lesion revascularization (ID-TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in-stent ABR (7.4% vs. 0%, P = 0.08) and ID-TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID-TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12).. The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. © 2010 Wiley-Liss, Inc.

Topics: Aged; Angioplasty, Balloon, Coronary; Calcinosis; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; India; Kaplan-Meier Estimate; Male; Middle Aged; New Zealand; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

There remains significant concern about the long-term safety of drug-eluting stents (DES). However, bare metal stents (BMS) have been used safely for over two decades. There is therefore a pressing need to explore alternative strategies for reducing restenosis with BMS. This study was designed to examine whether IVUS-guided cutting balloon angioplasty (CBA) with BMS could convey similar restenosis rates to DES.. In the randomised REstenosis reDUction by Cutting balloon angioplasty Evaluation (REDUCE III) study, 521 patients were divided into four groups based on device and IVUS use before BMS (IVUS-CBA-BMS: 137 patients; Angio-CBA-BMS: 123; IVUS-BA-BMS: 142; and Angio-BA-BMS: 119). At follow-up, the IVUS-CBA-BMS group had a significantly lower restenosis rate (6.6%) than the other groups (p=0.016). We performed a quantitative coronary angiography (QCA) based matched comparison between an IVUS-guided CBA-BMS strategy (REDUCE III) and a DES strategy (Rapamycin-Eluting-Stent Evaluation At Rotterdam Cardiology Hospital, the RESEARCH study). We matched the presence of diabetes, vessel size, and lesion severity by QCA. Restenosis (>50% diameter stenosis at follow-up) and target vessel revascularisation (TVR) were examined. QCA-matched comparison resulted in 120-paired lesions. While acute gain was significantly greater in IVUS-CBA-BMS than DES (1.65±0.41 mm vs. 1.28±0.57 mm, p=0.001), late loss was significantly less with DES than with IVUS-CBA-BMS (0.03±0.42 mm vs. 0.80±0.47 mm, p=0.001). However, no difference was found in restenosis rates (IVUS-CBA-BMS: 6.6% vs. DES: 5.0%, p=0.582) and TVR (6.6% and 6.6%, respectively).. An IVUS-guided CBA-BMS strategy yielded restenosis rates similar to those achieved by DES and provided an effective alternative to the use of DES.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Evaluation Studies as Topic; Follow-Up Studies; Humans; Immunosuppressive Agents; Middle Aged; Prospective Studies; Sirolimus

To examine the two year clinical outcomes in dual-vessel disease from the SPIRIT III trial comparing the XIENCE V(r) everolimus-eluting stent (EES) to the TAXUS Express2(tm) paclitaxel-eluting stent (PES).. From a total of 1,002 randomised subjects, 103 and 51 patients in the EES and PES groups respectively underwent stenting of two lesions in two vessels (one lesion per epicardial vessel). Two-year event rates were lower in one compared to two-vessel treated patients regardless of stent type. For EES vs. PES, major adverse cardiac events (MACE=cardiac death, MI or TLR) was clinically reduced 35.0% in the single vessel patients (6.5% vs. 9.6%, p=0.09) and was significantly reduced 64% in dual vessel patients (11.9% vs. 30.1%, p=0.006). There was no significant interaction between stent type (EES vs. PES) and the number of stented vessels (two vs. single) for either 2-year TVF and MACE (interaction p values were 0.69 and 0.16, respectively).. In the SPIRIT III randomised trial, patients with both single and dual vessel treatment with EES showed improved clinical outcomes at two years compared to those treated with PES. Follow-up to five years is ongoing.

Topics: Aged; Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus

Multimodality imaging of the first-in-man trial using a fully resorbable everolimus-eluting scaffold (BVS, Abbott Vascular, Santa Clara, CA, USA) demonstrated at two years the bioresorption of the device while preventing restenosis. Nevertheless, the long-term safety and efficacy of this novel therapy remain to be documented.. The ABSORB trial completed in July 2006 at four clinical sites in Europe and New Zealand the enrolment of 30 patients with a single de novo native coronary artery lesion. The major clinical endpoint was ischaemia-driven major adverse cardiac events (ID-MACE) defined as a composite of cardiac death, myocardial infarction, or ischaemia-driven target lesion revascularisation. Clinical follow-up was available in 29 patients since one patient withdrew consent. At 46 days, one patient experienced a single episode of chest pain and underwent a diagnostic optical coherence tomography and subsequently a target lesion revascularisation with slight troponin rise after the procedure. At 3-year the hierarchical ID-MACE of 3.4% remained unchanged. Clopidogrel therapy was discontinued in all but one patient. There has been no stent thrombosis reported. Two non-cardiac deaths were reported; one from duodenal perforation, the other from Hodgkin disease. Two patients underwent non-ischaemia driven target vessel revascularisation.. Three-year clinical results have demonstrated a sustained low MACE rate (3.4%) without any late complication such as stent thrombosis.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus

To investigate the mechanistic basis underlying antirestenosis and the antiatherogenic effect of pioglitazone in patients with type 2 diabetes mellitus who were undergoing zotarolimus-eluting stent implantation.. Recent studies highlight the beneficial effect of pioglitazone in attenuating neointimal growth after stent implantation. Patients with coronary artery diseases were randomly assigned to pioglitazone (n=47) or placebo (n=47) after stent implantation. Pioglitazone significantly reduced neointimal hyperplasia within the stented lesion and attenuated total plaque burden in the in-segment regions of the stent, as assessed by intravascular ultrasonography at the 8-month follow-up. These changes were preceded by reduced circulating natural killer (NK) cells, diminished interleukin 6 and monocyte chemoattractant protein-1 levels, and downregulation of chemokine receptor 2 at 2 days after stent implantation; and an elevated interleukin 10 level at 10 days after implantation. Furthermore, the proliferation and migration of vascular smooth muscle cells were inhibited in the presence of pioglitazone-treated patient serum, demonstrating that the antiproliferative effects of pioglitazone occurred concurrently with its antiinflammatory action.. Our data present early cellular and immunologic changes by pioglitazone that might have been associated with antirestenotic and antiatherogenic effects in diabetic patients. Inhibiting proinflammatory responses while promoting antiinflammatory circuits, together with an antiproliferative action, may, in part, account for the antirestenotic effect of pioglitazone by altering vascular remodeling processes in the early phase.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Biomarkers; Blood Glucose; Cardiovascular Agents; Cell Movement; Cell Proliferation; Cells, Cultured; Chemokine CCL2; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Drug-Eluting Stents; Female; Glycated Hemoglobin; Humans; Hyperplasia; Hypoglycemic Agents; Inflammation Mediators; Insulin; Interleukin-6; Killer Cells, Natural; Lipids; Male; Middle Aged; Myocytes, Smooth Muscle; Pioglitazone; Prospective Studies; Prosthesis Design; Receptors, CCR2; Republic of Korea; Single-Blind Method; Sirolimus; Thiazolidinediones; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

Although octogenarians are increasingly referred for percutaneous coronary intervention (PCI), data are lacking on long-term safety and efficacy of drug-eluting stents in this high-risk subpopulation. The aim of this study was to evaluate 5-year clinical outcome of octogenarians who underwent PCI using sirolimus-eluting stents (SESs) or paclitaxel-eluting stents (PESs) compared to bare-metal stents (BMSs). From January 2000 to December 2005, 319 consecutive octogenarian patients who underwent PCI with BMSs (n = 93, January 2000 to April 2002), SESs (n = 52, April 2002 to February 2003), or PESs (n = 174, February 2003 to December 2005) were included prospectively. Primary study end points were all-cause mortality and major adverse cardiac events (MACEs), defined as all-cause death, any myocardial infarction, or any revascularization. Mean age of the study population was 83 ± 2 years and 51% of patients were men. Median follow-up duration was 5.4 years (range 3 to 9). Five-year mortality rates in the BMS, SES, and PES cohorts were similar (41%, 42%, and 41%, respectively). Cumulative 5-year MACE-free survival in the BMS, SES, and PES cohorts were 44%, 52%, and 48%, respectively. Compared to the BMS cohort, adjusted hazard ratios for MACEs in the SES and PES cohorts were 0.5 (95% confidence interval [CI] 0.3 to 0.9, p <0.05) and 0.5 (95% CI 0.2 to 1.4, p = 0.2), respectively. Overall, use of drug-eluting stents was associated with fewer MACEs (adjusted hazard ratio 0.5, 95% CI 0.3 to 0.9, p <0.05) and a trend toward less target vessel revascularization (adjusted hazard ratio 0.5, 95% CI 0.2 to 1.2, p = 0.1). In conclusion, PCI with drug-eluting stents in octogenarians was found to be safe and more effective compared to PCI with BMSs.

Topics: Aged, 80 and over; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Paclitaxel; Prospective Studies; Registries; Sirolimus; Stents; Survival Rate; Time Factors; Treatment Outcome

Drug-eluting stents reduce restenosis and reintervention rates but are complicated by stent thrombosis, which may be related to polymer coating. The NEVO sirolimus-eluting coronary stent (NEVO SES) is designed to improve long-term percutaneous coronary intervention safety by combining sirolimus release from reservoirs with bioabsorbable polymer to reduce spatial and temporal polymer exposure.. NEVO ResElution-I was a prospective randomized study in 394 patients with coronary artery disease comparing the NEVO SES with the TAXUS Liberté paclitaxel-eluting coronary stent (TAXUS Liberté PES) stent. The primary end point was in-stent angiographic late loss at 6 months. Six months after percutaneous coronary intervention (PCI), the primary end point favored NEVO SES (0.13±0.31 mm versus 0.36±0.48 mm, P<0.001 for noninferiority and superiority). The study was not powered for clinical end points and showed no significant difference for NEVO SES versus TAXUS Liberté PES: death: 0.5 versus 1.6%, P=0.36; myocardial infarction: 2.0 versus 2.6%, P=0.75; target lesion revascularization: 1.5 versus 3.2%, P=0.33; major adverse cardiac events: 4.0 versus 7.4%, P=0.19. No stent thrombosis was observed with NEVO SES, whereas 2 cases occurred in TAXUS Liberté PES. Intravascular ultrasound showed lower percent volume obstruction for NEVO SES (5.5±11% versus 11.5±9.7%, P=0.016).. This trial proved the superiority of NEVO SES over TAXUS Liberté PES for the primary angiographic end point of in-stent late loss. No stent thrombosis occurred in the NEVO SES group.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00606333.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Prospective Studies; Single-Blind Method; Sirolimus; Ultrasonography, Interventional

We compared the safety and efficacy of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) with the TAXUS Express (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) among the large cohort of randomized diabetic patients enrolled in the SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) trial.. Diabetes mellitus remains a significant predictor of adverse clinical outcomes after percutaneous coronary intervention with drug-eluting stents, and the comparative outcomes of different drug-eluting stents in diabetic patients remains ill-defined.. In the SPIRIT IV trial, 3,687 patients with up to 3 de novo native coronary artery lesions were prospectively randomized 2:1 to receive EES or PES. Randomization was stratified by the presence of diabetes and lesion complexity. The primary end point was the occurrence of target lesion failure (TLF) (cardiac death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Clinical outcomes were evaluated in randomized diabetic (n = 1,185 [786 EES; 399 PES]) and nondiabetic patients (n = 2,498 [1,669 EES; 829 PES]).. The EES compared with PES reduced TLF in nondiabetic patients (3.1% vs. 6.7%, p < 0.0001), with significant reductions in myocardial infarction, stent thrombosis, and target lesion revascularization. In contrast, no difference in TLF (6.4% vs. 6.9%, respectively, p = 0.80) or any of its components was present among diabetic patients, regardless of insulin use. A significant interaction between the presence of diabetes and stent type on TLF (p(interaction) = 0.02) was observed.. In the SPIRIT IV randomized trial, EES compared with PES provided similar clinical outcomes in diabetic patients and superior clinical outcomes in nondiabetic patients at 1 year. (SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00307047).

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Prospective Studies; Sirolimus; Treatment Failure

The rates of side branch occlusion and subsequent periprocedural MI during everolimus-eluting stent (EES) and paclitaxel-eluting stent (PES) placement were examined in the randomised SPIRIT III trial. Periprocedural myocardial infarction (MI) following drug-eluting stent placement is associated with long-term adverse outcomes. Occlusion of side branches may be an important factor contributing to periprocedural MIs. Consecutive procedural angiograms of patients randomly assigned to EES (n=669) or PES (n=333) were analysed by an independent angiographic core laboratory. Side branch occlusion was defined as Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 or 1. Clinical outcomes through three years were compared by stent type and presence of side branch occlusion.. A total of 2,048 side branches were evaluated (EES N=1,345 side branches in 688 stented lesions, PES N=703 side branches in 346 stented lesions). Patients with compared to those without transient or final side branch occlusion had significantly higher non-Q-wave MI (NQMI) rates in-hospital (9.0% vs. 0.5%, p<0.0001). By multivariable analysis side branch occlusion was an independent predictor of NQMI (OR 4.45; 95% CI [1.82, 10.85]). Transient or final side branch occlusion occurred less frequently in patients receiving EES compared to PES (2.8% vs. 5.2%, p=0.009), contributing to the numerically lower rates of in-hospital NQMI with EES arm compared to PES (0.7% vs. 2.3%, p=0.05). Patients treated with EES rather than PES were less likely to develop side branch occlusion during stent placement, contributing to lower rates of periprocedural MI with EES compared to PES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; United States

Sirolimus-eluting stents (SES) have been shown to reduce intimal hyperplasia (IH) within the stent. Although angiographic studies have suggested focal distribution of IH, these data are limited by its spatial resolution and the minimal amount of IH. Therefore, the exact distribution pattern of SES IH remains unclear. Ninety-six SIRIUS trial patients who underwent SES (51) or bare metal stent (45) implantation and three-dimensional IVUS at 8 months follow-up were enrolled. Neointimal area (stent-lumen area) was obtained at every 0.5-mm interval throughout the stented segment. The length of each stent with IVUS-detectable neointima was determined and divided by the stented length in each case to normalize the data. Even with IVUS, IH was detectable in very limited SES stented segments (median 8% of total stented length) compared to the diffuse nature of IH within BMS with only 5 stented lesions having segments free from IH. In 25% (13 of 51) of patients, no IH was detectable within whole SES stented segments. In conclusion, SES has reduced not only the total amount of IH, but also limited the distribution. These data suggest that local conditions (heterogeneity of biological responses of particular plaques, pharmacokinetics, or their combination) may play a role in IH following SES implantation.

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Disease; Drug-Eluting Stents; Humans; Hyperplasia; Immunosuppressive Agents; Sirolimus; Tunica Intima; Ultrasonography, Interventional

The RIFT study aimed to observe the impact of renal insufficiency (RI) on the incidence of stent thrombosis (ST) after percutaneous coronary intervention.. The RIFT study enrolled 1,174 patients undergoing revascularization exclusively with sirolimus-eluting stents. The occurrence of ST and major adverse cardiac events were compared between patients with (n = 309) and without (n = 865) RI, and independent predictors of ST were also identified.. During follow-up (mean 18.9 +/- 9.2 months), the rate of ST was significantly higher in patients with than without RI [5.5% (n = 17) vs. 1.7% (n = 15), p < 0.001], and the presence of severe RI (estimated glomerular filtration rate <30 ml/min.1.73 m(2)) was an independent predictor of ST (odds ratio = 4.5, 95% confidence interval 1.4-15, p = 0.011). In patients with RI and diabetes or left ventricular ejection fraction (LVEF) <50%, the incidence of ST was significantly increased [13.0% (n = 10) vs. 3.6% (n = 7), p = 0.010; 11.6% (n = 8) vs. 1.9% (n = 3), p = 0.004, respectively] compared to those with diabetes or LVEF <50% alone. The influence of RI on ST was not significant in patients with multivessel disease, calcified or bifurcation lesions, and target lesion revascularization.. These findings substantiate the importance of long-term antiplatelet therapy for patients with RI after drug-eluting stent implantation.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Disease-Free Survival; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prospective Studies; Renal Insufficiency; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis

Systemic inflammation after coronary intervention identifies patients at increased risk of subsequent cardiac events. Cardiac events, especially in-stent restenosis, are less frequent after use of sirolimus-eluting stent (SES) compared with paclitaxel-eluting stent (PES). However, the underlying mechanism for this disparity is not well investigated. We hypothesize that an attenuated inflammatory response after SES implantation may be a contributor.. In the present study, we sought to determine the early inflammatory response after SES implantation in patients with single-vessel disease compared with PES implantation, and evaluate the relationship between inflammatory response and late clinical outcomes in a randomized design.. Thirty-two patients with stable angina were randomly enrolled into the two groups, SES or PSE group (n = 16 respectively). Peripheral blood samples were taken before PCI, 24 and 72 h after stenting. The plasma concentrations of C-reactive protein (CRP) and interleukin-6 (IL-6) were determined by enzyme-linked immunosorbent assay (ELISA). The clinical and angiographic follow-up was performed at 8 months after stenting.. The data showed that there was no significant difference in clinical and angiographic baseline characteristics between the two groups. The plasma CRP and IL-6 levels at 24 h after stenting were significant higher in both groups compared with baseline (p < 0.01 respectively). Likewise, the CRP levels at 72 h after stenting were also significant higher compared with baseline in both groups (p < 0.01 respectively). However, the plasma levels of IL-6 at 24 h and CRP at 72 h after stenting were higher in PES group compared with SES group (p < 0.05). At 8 months follow-up, the rates of major adverse cardiac events, target lesion revascularization, in-stent and in-segment restenosis were similar in both groups. However, the late loss in both in-stent and in-segment was significantly higher in the PES group than in SES group (p < 0.001 respectively).. Our findings suggest that a drug-eluting stent implantation could trigger a systemic inflammatory response as previously demonstrated. However, SES implantation results in a lower inflammatory response compared with PES implantation, which seems to be associated with greater late of in-stent and in-segment loss at 8-month follow-up with PES.

Topics: Adult; Angina Pectoris; Angioplasty, Balloon, Coronary; C-Reactive Protein; Coronary Artery Disease; Drug-Eluting Stents; Enzyme-Linked Immunosorbent Assay; Female; Follow-Up Studies; Humans; Interleukin-6; Male; Middle Aged; Paclitaxel; Prospective Studies; Sirolimus; Time Factors; Treatment Outcome

Systemic inflammation after percutaneous coronary intervention (PCI) identifies patients at increased risk of subsequent major adverse cardiac event. During PCI, the technique of stent implantation including direct stenting (DS) and complementary stenting (CS) is guided using both clinical and angiographic features. DS was practiced with increased frequency during PCI in an attempt to reduce both restenosis and major adverse cardiac event in the drug-eluting stent (DES) era. Impact of DS on the early inflammatory response has, however, not been investigated. We hypothesized that a direct DES implantation may attenuate the early inflammatory response compared with CS.. In this study, therefore, we prospectively select the sirolimus-eluting stent (SES) as a model of DESs, and sought to determine the early systemic inflammatory response in patients with single-vessel disease after PCI using either DS or CS techniques.. Thirty-nine patients who had single-vessel disease implanted with SES were randomly enrolled into the two groups: DS group (n=20) or CS group (n=19). The blood samples were taken before PCI, 24 and 72 h after stenting. The plasma concentrations of C-reactive protein and interleukin-6 (IL-6) were determined by enzyme-linked immunosorbent assay.. No significant difference in baseline clinical, angiographic, and inflammatory parameters between the two groups is observed. The plasma IL-6 levels at 24 h after stent implantation were significantly higher than that at baseline in both groups (P<0.05, respectively). Plasma IL-6 level was, however, higher in CS group than in DS group (P<0.01) and was returned to baseline levels in both groups at 72 h after stenting. Meanwhile, the plasma levels of C-reactive protein were also significant higher in CS group compared with DS group at both 24 and 72 h after stenting (P<0.05, respectively).. Taken together, our findings demonstrated that a direct SES implantation significantly attenuated the early systemic inflammatory response in patients with single-vessel disease compared with CS technique.

Topics: Adult; Angioplasty, Balloon, Coronary; Biomarkers; C-Reactive Protein; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Inflammation Mediators; Interleukin-6; Male; Middle Aged; Prospective Studies; Prosthesis Design; Sirolimus; Systemic Inflammatory Response Syndrome; Time Factors; Treatment Outcome; Troponin I; Up-Regulation

Sirolimus-eluting stents have been reported to be effective in the treatment of coronary bifurcations. Still, it has not been fully clarified which strategy would provide the best results with true bifurcation lesions.. The CACTUS trial (Coronary bifurcations: Application of the Crushing Technique Using Sirolimus-eluting stents) is a prospective, randomized, multicenter study comparing 2 different techniques of stenting, with mandatory final kissing-balloon inflation, in true bifurcations: (1) elective "crush" stenting and (2) stenting of only the main branch, with provisional side-branch T-stenting. From August 2004 to June 2007, 350 patients were enrolled in 12 European centers. The primary angiographic end point was the in-segment restenosis rate, and the primary clinical end point was the occurrence of major adverse cardiac events (cardiac death, myocardial infarction, or target-vessel revascularization) at 6 months. At 6 months, angiographic restenosis rates were not different between the crush group (4.6% and 13.2% in the main branch and side branch, respectively) and the provisional stenting group (6.7% and 14.7% in the main branch and side branch, respectively; P=NS). Additional stenting on the side branch in the provisional stenting group was required in 31% of lesions. Rates of major adverse cardiac events were also similar in the 2 groups (15.8% in the crush group versus 15% in the provisional stenting group, P=NS).. In most bifurcations with a significant stenosis in both branches, a provisional strategy of stenting the main branch only is effective, with the need to implant a second stent on the side branch occurring in approximately one third of cases. The implantation of 2 stents does not appear to be associated with a higher incidence of adverse events at 6 months.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Treatment Outcome

In the prospective randomized Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial, an everolimus-eluting stent (EES) compared with a widely used paclitaxel-eluting stent (PES) resulted in a statistically significant reduction in angiographic in-segment late loss at 8 months and noninferior rates of target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) at 1 year. The safety and efficacy of EES after 1 year have not been reported.. A total of 1002 patients with up to 2 de novo native coronary artery lesions (reference vessel diameter, 2.5 to 3.75 mm; lesion length < or =28 mm) were randomized 2:1 to EES versus PES. Antiplatelet therapy consisted of aspirin indefinitely and a thienopyridine for > or =6 months. Between 1 and 2 years, patients treated with EES compared with PES tended to have fewer episodes of protocol-defined stent thrombosis (0.2% versus 1.0%; P=0.10) and myocardial infarctions (0.5% versus 1.7%; P=0.12), with similar rates of cardiac death (0.3% versus 0.3%; P=1.0) and target vessel revascularization (2.9% versus 3.0%; P=1.0). As a result, at the completion of the 2-year follow-up, treatment with EES compared with PES resulted in a significant 32% reduction in target vessel failure (10.7% versus 15.4%; hazard ratio, 0.68; 95% confidence interval, 0.48 to 0.98; P=0.04) and a 45% reduction in major adverse cardiac events (cardiac death, myocardial infarction, or target lesion revascularization; 7.3% versus 12.8%; hazard ratio, 0.55; 95% confidence interval, 0.36 to 0.83; P=0.004). Among the 360 patients who discontinued clopidogrel or ticlopidine after 6 months, stent thrombosis subsequently developed in 0.4% of EES patients versus 2.6% of PES patients (P=0.10).. Patients treated with EES rather than PES experienced significantly improved event-free survival at a 2-year follow-up in the SPIRIT III trial, with continued divergence of the hazard curves for target vessel failure and major adverse cardiac events between 1 and 2 years evident. The encouraging trends toward fewer stent thrombosis episodes after 6 months in EES-treated patients who discontinued a thienopyridine and after 1 year in all patients treated with EES rather than PES deserve further study.

Topics: Aged; Angioplasty; Antineoplastic Agents, Phytogenic; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Paclitaxel; Platelet Aggregation Inhibitors; Prospective Studies; Sirolimus; Treatment Outcome

The main objective was to use IVUS-backscatter radiofrequency (IVUS-RF) to assess the degradation of a bioabsorbable stent by measuring serial changes in dense calcium (DC) and necrotic core (NC) as assessed by intravascular ultrasound-Virtual Histology (IVUS-VH) and in the strain as assessed by palpography.. In the ABSORB trial, 27 patients treated with a single bioabsorbable everolimus-eluting stent (BVS, Abbott Vascular, Santa Clara, CA, USA) were all imaged with IVUS-RF post-stenting and at 6-month follow-up, and 13 and 12 patients were also investigated pre-stenting with IVUS-VH and palpography respectively. From pre- to post-stenting, with VH (n = 13), there was an increase in mean "DC" (9.8 vs. 25.4%, p = 0.0002) and "NC" (15.5 vs. 30.5%, p = 0.0002). In palpography (n = 12), the mean number of frames with Rotterdam Classification (ROC) III/IV per cm decreased from 1.22 +/- 1.91 to 0.12 +/- 0.31 (p = 0.0781) and the mean cumulative strain values (all frames with ROC I-IV scores) changed from 0.50 +/- 0.27 to 0.20 +/- 0.10% (p = 0.0034). Comparing post-stenting with follow-up (n = 27), VH showed a decrease in "DC" (29.7% vs. 21.1%, p = 0.0001). "NC" also decreased (26.9 vs. 21.5%, p = 0.0027). For palpography (n = 25 patients), an increase in the mean number of frames with ROC III/IV per cm was observed from 0.09 +/- 0.26 to 0.22 +/- 0.36 (p = -0.1563) while the mean cumulative strain values (all frames with ROC I-IV scores) changed from 0.15 +/- 0.10 to 0.26 +/- 0.12% (p < 0.0001).. IVUS-VH changes at 6 months suggest alteration of the BVS with reduction of RF backscattering by polymeric struts. Strained plaques on the palpograms were almost abolished following stent implantation. However, strain values reappeared within 6 months suggesting an increase in endoluminal deformability of the stented vessel.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Calcinosis; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Male; Middle Aged; Necrosis; New Zealand; Prospective Studies; Prosthesis Design; Sirolimus; Stress, Mechanical; Time Factors; Treatment Outcome; Ultrasonography, Interventional; User-Computer Interface

The aim of the current study was to compare the short and mid-term outcome between males and females treated with percutaneous coronary intervention (PCI) with bare metal stent implantation or coronary artery bypass graft (CABG) surgery and drug-eluting stent implantation in the Arterial Revascularisation Therapies Study I and II (ARTS I and II).. The patients included in ARTS I were randomised to PCI with bare metal stents or to CABG. The patients enrolled in ARTS II were treated with Cypher stent implantation. All patients were scheduled for clinical follow-up at one, six and twelve months, and after three and five years. Major adverse cardiac and cerebrovascular events (MACCE) included death, cerebrovascular accident (CVA), myocardial infarction (MI), repeat target vessel PCI (RPCI) and CABG. At one and three-year follow-up in ARTS II, both the female and male patients had an incidence of MACCE similar to ARTS I-CABG. When comparing the female and male population of ARTS II, there were no differences between the two genders in terms of in-hospital outcome. At one year and three years there were no gender specific differences in the incidence of MACCE.. Female and male patients in ARTS II had significantly lower MACCE rates compared with ARTS I-PCI, but similar to that of ARTS I-CABG. In ARTS II, MACCE free survival was similar for the two genders at three years follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Artery Bypass; Coronary Artery Disease; Drug-Eluting Stents; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Prosthesis Design; Reoperation; Risk Assessment; Sex Factors; Sirolimus; Stents; Time Factors; Treatment Outcome; Women's Health

The The Arterial Revascularization Therapies Study (ARTS)-II trial found no differences in survival or overall adverse events between sirolimus-eluting stents (SES) and the surgical arm of ARTS-I. Nevertheless, existing data suggest that patients with disease of the proximal left anterior descending artery (LAD) may derive particular benefit from coronary artery bypass grafting (CABG). We therefore analysed the clinical outcome of patients in ARTS-I and ARTS-II with proximal LAD involvement.. Multicentre observational study.. Forty-five European academic hospitals.. Patients with multivessel coronary artery disease.. Patients in ARTS-II with proximal LAD disease treated with SES (289/607, 48%) were compared with 187/600 (31%) bare metal stent patients (ARTS-I BMS) and 206/605 (34%) surgical patients (ARTS-I CABG) with proximal LAD involvement from ARTS-I.. Major adverse cardiac and cerebrovascular events after 3 years.. The Arterial Revascularization Therapies study part 2 (ARTS-II) subgroup had better survival than both ARTS-I groups (ARTS-II 98.6% vs ARTS-I BMS 95.7%, p = 0.05 and vs ARTS-I CABG 94.7%, p = 0.01) and lower rates of the hard clinical composite endpoint of death or non-fatal myocardial infarction (ARTS-II 3.1% vs ARTS-I BMS 9.6%, p = 0.002 and vs ARTS-I CABG 9.7%, p = 0.002). Although the ARTS-I CABG patients had a lower need for repeat revascularisation than ARTS-II (5.3% vs 13.1%, p = 0.002), the overall composite adverse event rates (death, myocardial infarction, stroke or any repeat revascularisation) were not significantly different between the ARTS-I CABG and ARTS-II patients (15.0% vs 18.0%, p = 0.4).. SES are not inferior to CABG or bare metal stents for the treatment of patients with multivessel coronary disease including involvement of the proximal LAD.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Bypass; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Radiography; Sirolimus; Stents; Stroke; Survival Analysis; Treatment Outcome

The aim of this trial was to compare the safety and efficacy of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) for treatment of unprotected left main coronary artery (uLMCA) disease.. Both PES and SES have reduced the risk of restenosis, particularly in high-risk patient and lesion subsets. However, their comparative performance in uLMCA lesions is not known.. In this randomized study, 607 patients with symptomatic coronary artery disease undergoing percutaneous coronary intervention for uLMCA were enrolled: 302 were assigned to receive a PES (Taxus, Boston Scientific, Natick, Massachusetts) and 305 assigned to receive a SES (Cypher, Cordis, Johnson & Johnson, New Brunswick, New Jersey). The primary end point was the combined incidence of death, myocardial infarction, and target lesion revascularization (TLR) at 1 year. The secondary end point was angiographic restenosis on the basis of the LMCA area analysis at follow-up angiography.. At 1 year the cumulative incidence of death, myocardial infarction, or TLR was 13.6% in the PES and 15.8% in the SES group (relative risk [RR]: 0.85, 95% confidence interval [CI]: 0.56 to 1.29, p = 0.44). One patient in the PES group (0.3%) and 2 patients in the SES group (0.7%) experienced definite stent thrombosis (p = 0.57). Mortality at 2 years was 10.7% in the PES and 8.7% in the SES group (RR: 1.14, 95% CI: 0.66 to 1.95, p = 0.64). Angiographic restenosis was 16.0% with PES and 19.4% with SES (RR: 0.82, 95% CI: 0.57 to 1.19, p = 0.30).. Implantation of either PES or SES in uLMCA lesions is safe and effective; both of these drug-eluting stents provide comparable clinical and angiographic outcomes. (Drug-Eluting-Stents for Unprotected Left Main Stem Disease [ISAR-LEFT-MAIN]; NCT00133237).

Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Confidence Intervals; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Incidence; Male; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Risk; Sirolimus; Ticlopidine; Tubulin Modulators

Our goal is to report the first large multicenter data for percutaneous coronary intervention (PCI) of bifurcation disease with drug-eluting stents (DES) in the United States.. Bifurcation PCI remains a challenge to this date. There are limited data on outcomes of patients treated with bifurcation DES implantation, particularly in the United States.. There were 161 patients with bifurcation disease [side branch (SB) >or=2-mm] treated with >or=1 sirolimus-eluting stents at 41 centers participating in the Stent deployment Techniques on cLinicaL outcomes of patients treated with the cypheRstent (STLLR) trial. There was no protocol mandated strategy for bifurcation PCI. One-year outcome data were collected. Angiographic and clinical data were adjudicated independently.. There were 147 patients (91.3%) treated with single stent strategy. Only 14 (8.7%) patients received sirolimus-eluting stents implantation in both branches. Among patients with single stent strategy, double wire strategy (DW) was selected in 27 (18.4%) patients whereas single wire strategy (SW) was selected in 120 (81.6%) patients. There were 48 (32.7%) Medina 1,1,1 bifurcations treated with SW (n = 34; 70.8%) and DW (n = 14; 29.2%). There were 26 procedures started with SW which had SB dilatation during the procedure, one as a bailout (TIMI-1 grade flow in the SB). Overall 1-year death, myocardial infarction, and target lesion revascularization occurred in 2.4, 4.0, and 5.6%, respectively. There was no significant difference in clinical outcomes between SW and DW. SB dilatation was associated with a high rate of stent thrombosis (8.6%).. Main branch stenting without SB protection is the most common approach utilized in the STLLR study, which may reflect contemporary DES bifurcation strategies in the Unite States. This strategy was associated with an acceptable low incidence of adverse outcomes at 1-year.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

This study sought to evaluate the safety and efficacy of a biodegradable polymer-coated sirolimus-eluting stent (Excel, JW Medical System, Weihai, China) with 6-month dual antiplatelet therapy in daily practice.. It has been hypothesized that persistent presence of polymer may compromise the safety of drug-eluting stents, and that therefore biodegradable polymer coatings might reduce late adverse events.. Between June and November 2006, 2,077 patients, exclusively treated with Excel stents at 59 centers from 4 countries, were enrolled in this prospective, multicenter registry. Recommended antiplatelet regimen included clopidogrel and aspirin for 6 months followed by chronic aspirin therapy.. The average duration of clopidogrel treatment was 199.8 +/- 52.7 days and 80.5% of discharged patients discontinued clopidogrel at 6 months. The cumulative rates of major adverse cardiac events were 0.9% at 30 days, 2.7% at 1 year, and 3.1% at 18 months. Overall rate of stent thrombosis was 0.87% at 18 months. The rates of acute, subacute, late, and very late stent thrombosis were 0.1%, 0.38%, 0.34%, and 0.05%, respectively. Angiographic follow-up, performed in 974 (31.6%) lesions from 653 patients (31.7%), revealed a mean in-stent late lumen loss of 0.21 +/- 0.39 mm. Binary restenosis rates were 3.8% in-stent and 6.7% in-segment.. This multicenter registry documents satisfactory safety and efficacy profiles, as evidenced by low rates of major adverse cardiac events and stent thrombosis up to 18 months, for the Excel biodegradable polymer-based sirolimus-eluting stent when used with 6 months of dual antiplatelet therapy in a "real-world" setting. (Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent [CREATE]; NCT00331578).

Topics: Aged; Angioplasty, Balloon, Coronary; Asia; Aspirin; Cardiovascular Agents; Clopidogrel; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Platelet Aggregation Inhibitors; Polymers; Product Surveillance, Postmarketing; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Sirolimus; Thrombosis; Ticlopidine; Time Factors; Treatment Outcome

We used optical coherence tomography, which has a resolution of <20 microm, to analyze thin layers of neointima in rapamycin-eluting coronary stents.. Lack of neointimal coverage has been implicated in the pathogenesis of drug-eluting coronary stent thrombosis. Angiography and intracoronary ultrasound lack the resolution to examine this.. We conducted a randomized trial in patients receiving polymer-coated rapamycin-eluting stents (Cypher, Cordis, Johnson & Johnson, Miami, Florida) and nonpolymer rapamycin-eluting stents (Yukon, Translumina, Hechingen, Germany) to examine neointimal thickness, stent strut coverage, and protrusion at 90 days. Twenty-four patients (n = 12 for each group) underwent stent deployment and invasive follow-up at 90 days with optical coherence tomography. The primary end point was binary stent strut coverage. Coprimary end points were neointimal thickness and stent strut luminal protrusion.. No patient had angiographic restenosis. For polymer-coated and nonpolymer rapamycin-eluting stents, respectively, mean (SD), neointimal thickness was 77.2 (25.6) microm versus 191.2 (86.7) mum (p < 0.001). Binary stent strut coverage was 88.3% (11.8) versus 97.2% (6.1) (p = 0.030). Binary stent strut protrusion was 26.5% (17.5) versus 4.8% (8.6) (p = 0.001).. Mean neointimal thickness for the polymer-coated rapamycin-eluting stent was significantly less than the nonpolymer rapamycin-eluting stent but as a result coverage was not homogenous, with >10% of struts being uncovered. High-resolution imaging allowed development of the concept of the protrusion index, and >25% of struts protruded into the vessel lumen with the polymer-coated rapamycin-eluting stent compared with <5% with the nonpolymer rapamycin-eluting stent. These findings may have important implications for the risk of stent thrombosis and, therefore, future stent design. (An optical coherence tomography study to determine stent coverage in polymer coated versus bare metal rapamycin eluting stents. ORCA 1, from the Optimal Revascularization of the Coronary Arteries group; ISRCTN42475919).

Topics: Confidence Intervals; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Endothelium, Vascular; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Polymers; Sirolimus; Tomography, Optical Coherence

We evaluated the role of gender on clinical and angiographic results of the everolimus-eluting stent in the SPIRIT III trial.. The SPIRIT III trial demonstrated superior efficacy of the XIENCE V everolimus-eluting stent compared with the TAXUS paclitaxel-eluting stent. Whether these results are applicable to women is unknown.. A total of 1,002 patients with coronary artery lesions of 28 mm or less long in 2.5-3.75 mm diameter vessels were prospectively randomized to receive percutaneous coronary intervention with either XIENCE V stent or TAXUS stent placement. Post hoc gender subset analysis was performed.. A total of 669 patients (200 women) received the XIENCE V stent, and 332 patients (114 women) were assigned to the TAXUS stent. Women were older and had more hypertension and diabetes than men. At 1 year, rates of MACE (11.1% vs. 5.7%, P = 0.004), TVF (13.7% vs. 7.5%, P = 0.003), TVR (10.8% vs. 4.6%, P = 0.0007), and TLR (7.2% vs. 2.7%, P = 0.002) were higher in women compared with men. The difference in 1 year MACE and TVF rates between men and women remained after adjusting for baseline covariates. Although the angiographic characteristics at baseline were similar among the female cohort, women assigned to XIENCE V had lower in-stent late loss (0.19 vs. 0.42 mm, P = 0.01) compared with women treated with the TAXUS stent. Although 30-day clinical outcomes were similar for women treated with XIENCE V and TAXUS stents, at 1 year, women with XIENCE V stents had significantly lower MACE (8.2% vs. 16.1 %, P = 0.04) and TVR (3.1% vs. 8.9%, P = 0.03) compared with those treated with TAXUS stents. Stent thrombosis rates were similar between women receiving either XIENCE V or TAXUS stents.. Women in the SPIRIT III trial had inherently higher MACE and TVF rates than men. However, the angiographic and clinical benefits of using XIENCE V stents are generalizable to women.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Linear Models; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sex Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Women's Health

We sought to compare patient-oriented outcomes related to target vessel or nontarget vessel events for sirolimus-eluting stents (SES) versus bare-metal stents.. SES significantly reduce restenosis but the influence of reduced restenosis on overall patient-oriented outcome has not been reported.. The study population included 1,057 patients randomized in the SIRIUS (Sirolimus-Eluting Stent in De Novo Native Coronary Lesions) study and followed clinically for 5 years. The primary end point was a composite of all-cause mortality, any myocardial infarction, or any repeat revascularization. In secondary analyses, myocardial infarction and repeat revascularization events attributed to the target vessel or a nontarget vessel were compared by stent type.. Patients with an SES were more likely to be free from the primary composite end point at 5 years (60.4% vs. 47.8%, p < 0.001) chiefly due to a sustained reduction in target lesion revascularization for SES (cumulative incidence: 12.5% vs. 28.8%, p < 0.001). There was no difference in the cumulative incidence of myocardial infarction or revascularization attributed to remote segments of the target vessel. Events attributed to the nontarget vessel were frequent and not different for SES versus bare-metal stents (25.7% vs. 25.8%).. The benefit of SES over bare-metal stents for reduced target lesion revascularization is maintained for 5 years. Remote coronary segments of the target vessel and nontarget vessel remain an important cause of future adverse events despite sustained restenosis benefit.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Disease Progression; Double-Blind Method; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

Several invasive studies have reported delayed reendothelialization and endothelial dysfunction following sirolimus-eluting stent (SES) implantation. We evaluated the changes in coronary endothelial function following SES implantation by using a noninvasive method that involved positron emission tomography and cold pressor testing (CPT).. The study was conducted on 14 lesions on which percutaneous coronary intervention (PCI) was successively performed. The lesions were classified into 2 groups depending on the PCI performed: the conventional PCI group, in which 7 conventional PCIs (plain old balloon angioplasty or bare-metal stents) were performed, and the SES group, in which 7 SESs were implanted. Coronary endothelial function was defined as the percent increase in the myocardial blood flow (MBF) during CPT.. The resting MBF in the segments distal to the PCI sites did not differ between the conventional PCI and SES groups; however, the MBF significantly decreased in the SES group during CPT.. These data suggest that SES implantation induces coronary endothelial dysfunction in the segments distal to the PCI sites.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Antibiotics, Antineoplastic; Blood Vessel Prosthesis Implantation; Cold Temperature; Coronary Artery Disease; Coronary Circulation; Coronary Vessels; Drug-Eluting Stents; Endothelium, Vascular; Female; Hemodynamics; Humans; Male; Middle Aged; Positron-Emission Tomography; Sirolimus; Treatment Outcome

The aim of this study was to evaluate long-term clinical outcomes after implantation of sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) among patients with unprotected left main coronary artery (LMCA) disease.. There have been few comparisons of long-term outcomes among currently available drug-eluting stents (DES) for the treatment of LMCA disease.. A total of 858 consecutive patients with unprotected LMCA stenosis were treated with SES (n = 669) or PES (n = 189) between May 2003 and June 2006. Primary outcome was the composite of death, myocardial infarction (MI), or target vessel revascularization (TVR).. Baseline clinical and angiographic characteristics were similar in the 2 groups. During 3 years of follow-up, the adjusted risk of primary composite outcome was similar among the groups (SES vs. PES: 25.8% vs. 25.7%, hazard ratio [HR]: 0.95, 95% confidence interval [CI]: 0.64 to 1.41, p = 0.79). The 2 groups also showed a comparable adjusted rate of each component of outcome: death (9.1% vs. 11.0%, HR: 0.92, 95% CI: 0.47 to 1.80, p = 0.82), MI (8.1% vs. 8.0%, HR: 0.80, 95% CI: 0.43 to 1.48, p = 0.47), and TVR (12.1% vs. 10.6%, HR: 1.10, 95% CI: 0.53 to 2.29, p = 0.81). The 3-year rates of definite or probable stent thrombosis were 0.6% in the SES group and 1.6% in the PES group (adjusted p = 0.18).. In consecutive patients with unprotected LMCA disease undergoing DES implantation, SES and PES showed similar long-term clinical outcomes in terms of death, MI, repeat revascularization, and stent thrombosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Treatment Outcome; Tubulin Modulators

The aim of this study was to compare the vessel response between zotarolimus-eluting stents (ZES) and paclitaxel-eluting stents (PES) using intravascular ultrasound.. The ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease) trial was a randomized controlled study of zotarolimus-eluting, phosphorylcholine-coated, cobalt-alloy stents for the treatment of de novo coronary lesions compared with using PES for the same treatment.. Data were obtained from patients with serial (baseline and 8-months follow-up) intravascular ultrasound analysis available (n = 198). Volumetric analysis was performed for vessel, lumen, plaque, stent, and neointima. Cross-sectional narrowing (given as percentage) was defined as neointimal area divided by stent area. Neointima-free frame ratio was calculated as the number of frames without intravascular ultrasound-detectable neointima divided by the total number of frames within the stent. Subsegment analysis was performed at every matched 1-mm subsegment throughout the stent.. At follow-up, the ZES group showed significantly greater percentage of neointimal obstruction (16.6 +/- 12.0% vs. 9.9 +/- 8.9%, p < 0.01) and maximum cross-sectional narrowing (31.8 +/- 16.1% vs. 25.2 +/- 14.9%, p < 0.01) with smaller minimum lumen area than the PES group did. However, the incidence of maximum cross-sectional narrowing >50% was similar in the 2 groups. Neointima-free frame ratio was significantly lower in the ZES group. In overall analysis, whereas the PES group showed positive remodeling during follow-up (13.7 +/- 4.2 mm(3)/mm to 14.3 +/- 4.3 mm(3)/mm), the ZES group showed no significant difference (12.7 +/- 3.6 mm(3)/mm to 12.9 +/- 3.5 mm(3)/mm). In subsegment analysis, significant focal positive vessel remodeling was observed in 5% of ZES and 25% of PES cases (p < 0.05).. There were different global and focal vessel responses for ZES and PES. Both drug-eluting stents showed a similar incidence of lesions with severe narrowing despite ZES having a moderate increase in neointimal hyperplasia compared with neointimal hyperplasia in PES. There was a relatively lower neointima-free frame ratio in ZES, suggesting a greater extent of neointimal coverage. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

Topics: Aged; Alloys; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Cobalt; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Hyperplasia; Male; Middle Aged; Paclitaxel; Phosphorylcholine; Prosthesis Design; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional; United States

In the 300-patient SPIRIT II and 1002-patient SPIRIT III randomized trials, the everolimus-eluting stent (EES) compared to the paclitaxel-eluting stent (PES) resulted in reduced angiographic late loss (a primary end point in both trials), noninferior rates of 9-month target vessel failure (a primary end point in SPIRIT III), and reduced rates of target lesion revascularization and major adverse cardiac events (secondary end points). However, neither trial was powered for superiority for clinical end points, and the routine performance of angiographic follow-up may have artificially exaggerated the absolute benefits of EES. The relative efficacy of these 2 stents in patients with diabetes mellitus also remains controversial. We therefore designed a large-scale randomized trial without angiographic follow-up to further assess the differences between these 2 stent platforms.. SPIRIT IV is an ongoing prospective, active-controlled, single-blinded, multicenter clinical trial in which 3690 patients with native coronary artery disease have been randomized 2:1 to EES versus PES. Patients with up to 3 de novo native coronary artery lesions (maximum 2 lesions per epicardial vessel) with length or=2.5 to

Topics: Antineoplastic Agents, Phytogenic; Coronary Artery Disease; Drug-Eluting Stents; Electrocardiography; Everolimus; Follow-Up Studies; Humans; Immunosuppressive Agents; Myocardial Revascularization; Paclitaxel; Prospective Studies; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

There is little information about the relationship between balloon inflation time and sirolimus-eluting stent (SES) expansion. In this randomized intravascular ultrasound (IVUS) study, 92 de novo lesions in native coronary arteries that underwent SES implantation were enrolled. Sirolimus-eluting stent was implanted using an inflation pressure of 14 atm. Stent balloon was gradually inflated until 14 atm in 10 s. In the short inflation group, it was deflated immediately after an image of the balloon inflated at 14 atm was taken. Stent balloon inflation lasted 60 s in the long inflation group. Intravascular ultrasound was then performed. The long balloon inflation resulted in a larger stent cross-sectional area (4.9 +/- 1.6 mm(2) vs 4.3 +/- 1.4 mm(2), P < 0.05) and expansion (71% +/- 13% vs 60% +/- 13%, P < 0.001) compared to the short balloon inflation, although stent expansion was relatively low in both groups. The relatively longer balloon inflation time using an inflation pressure of 14 atm results in better SES expansion. However, in the majority of lesions, adequate stent expansion is not achieved even using long balloon inflation, if it is inflated at 14 atm.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Pressure; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Drug-eluting stents with low late loss may be particularly beneficial in small coronary arteries. We therefore examined whether the everolimus-eluting stent is superior to the paclitaxel-eluting stent in patients treated with 2.5-mm stents in the SPIRIT III trial.. The SPIRIT III trial was a prospective, multicenter, randomized (2:1; XIENCE V: TAXUS Express) trial in which 1002 patients were enrolled. One or more 2.5-mm stents were implanted in 160 patients in the XIENCE V arm, and 59 patients, in the TAXUS arm. Mean vessel diameter was 2.36 +/- 0.30 and 2.34 +/- 0.33 mm in the XIENCE V and TAXUS groups, respectively (P = .69).. At 9 months, XIENCE V compared to TAXUS reduced the rates of major adverse cardiac events (cardiac death, myocardial infarction, or ischemic target lesion revascularization) from 12.5% to 3.2% (P = .02) and target vessel failure (cardiac death, reinfarction, or ischemic target vessel revascularization) from 16.1% to 5.2% (P = .02), the differences being driven primarily by reductions in target lesion revascularization (12.5% vs 1.3%; P = .002). In-stent late loss was significantly reduced by XIENCE V when compared to TAXUS (0.54 +/- 0.74 vs 0.11 +/- 0.43 mm, P = .01), as was In-segment binary angiographic restenosis (20.8% vs 4.1%, P = .02).. In this post hoc analysis from the SPIRIT III trial, the XIENCE V 2.5-mm stent significantly reduced clinical and angiographic restenosis compared to the TAXUS 2.5-mm stent, further supporting the hypothesis that lower late loss is beneficial in small vessel disease.

Topics: Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Prospective Studies; Sirolimus

In a number of coronary bifurcation lesions, both the main vessel and the side branch need stent coverage. Using sirolimus eluting stents, we compared 2 dedicated bifurcation stent techniques, the crush and the culotte techniques in a randomized trial with separate clinical and angiographic end-points.. A total of 424 patients with a bifurcation lesion were randomized to crush (n=209) and culotte (n=215) stenting. The primary end point was major adverse cardiac events; cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis after 6 months. At 6 months there were no significant differences in major adverse cardiac event rates between the groups; crush 4.3%, culotte 3.7% (P=0.87). Procedure and fluoroscopy times and contrast volumes were similar in the 2 groups. The rates of procedure-related increase in biomarkers of myocardial injury were 15.5% in crush versus 8.8% in culotte group (P=0.08). A total of 324 patients had a quantitative coronary assessment at the index procedure and after 8 months. The angiographic end-points of in-segment and in-stent restenosis of main vessel and/or side branch after 8 months were found in 12.1% versus 6.6% (P=0.10) and in 10.5% versus 4.5% (P=0.046) in the crush and culotte groups, respectively.. Both the crush and the culotte bifurcation stenting techniques were associated with similar and excellent clinical and angiographic results. Angiographically, there was a trend toward less in-segment restenosis and significantly reduced in-stent restenosis following culotte stenting.

Topics: Aged; Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Denmark; Drug-Eluting Stents; Female; Finland; Humans; Kaplan-Meier Estimate; Latvia; Male; Middle Aged; Myocardial Infarction; Norway; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

This article reports the 2-year clinical, angiographic, and intravascular ultrasound outcomes of the everolimus-eluting stent (EES) compared with the paclitaxel-eluting stent (PES) in the randomized SPIRIT II trial.. This was a prospective, single-blind clinical trial in which a total of 300 patients with de novo native coronary artery lesions were randomized to either EES or PES in a 3:1 fashion. Clinical follow-up was planned at 2 years in all patients. A subset of 152 patients underwent serial angiographic and intravascular ultrasound analyses at 6 months and 2 years. After 2 years, target lesion failure (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization) rates were 6.6% and 11% in EES and PES, respectively (P=0.31). At 6 months, a significant reduction in angiographic in-stent late loss and percentage volume obstruction measured by intravascular ultrasound was observed in the EES group. However, at 2-year follow-up, a late increased intimal hyperplasia growth after implantation of an EES was observed. There were no significant differences between EES and PES for in-stent late loss (EES, 0.33+/-0.37 mm versus PES, 0.34+/-0.34 mm; P=0.84) and percentage volume obstruction (EES, 5.18+/-6.22% versus PES, 5.80+/-6.31%; P=0.65) at 2 years. The incidence of stent thrombosis was low and comparable in both groups (EES, 0.9%; PES, 1.4%).. Although the previously reported angiographic and clinical superiority of the EES has vanished over time, this report confirms and extends the previously demonstrated noninferiority in terms of in-stent late loss of the EES when compared with the PES up to 2-year follow-up. There were no significant differences between EES and PES in clinical, angiographic and intravascular ultrasound outcomes at 2 years.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; India; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Myocardial Ischemia; New Zealand; Paclitaxel; Prospective Studies; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

This paper reports the 3-year clinical outcomes of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) compared with the TAXUS (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) in the randomized SPIRIT II (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions) study.. The Xience V EES is a new-generation drug-eluting stent (DES) that might offer advantages over the first-generation DES in terms of improved clinical outcomes and a better safety profile.. The SPIRIT II trial was a multicenter, prospective, randomized, single-blind, clinical trial, randomizing 300 patients with de novo coronary artery lesions in a ratio of 3:1 to either EES or PES. The primary end point was in-stent late loss at 180 days.. At 3-year clinical follow-up cardiac death was numerically lower with EES than PES (0.5% vs. 4.3%, p = 0.056). The observed rate of myocardial infarction was 3.6% for EES and 7.2% for PES (p = 0.31). The rate of ischemia-driven target lesion revascularization was 4.6% and 10.1% for EES and PES, respectively (p = 0.14). Overall, there was a trend for lower major adverse cardiovascular events in the EES group compared with PES (7.2% vs. 15.9%, p = 0.053). The rate of stent thrombosis was low and comparable in both groups (EES 1.0% vs. PES 2.9%).. The present study reports the favorable 3-year clinical outcomes of the EES, which are consistent with the results from other studies of the EES with shorter follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

The aim of this study was to evaluate clinical and economic outcomes for subjects receiving zotarolimus-eluting (ZES) (n = 323) versus sirolimus-eluting stents (SES) (n = 113) in the ENDEAVOR III (Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) clinical trial.. Although previous clinical trials have evaluated long-term clinical outcome for drug-eluting stents, none considered their economic implications.. We analyzed case report form information with quality-of-life adjustment and Medicare cost weights applied from secondary sources; compared differences in clinical outcomes, quality-adjusted survival, medical resource use, and medical costs; and evaluated cost-effectiveness through 3-year follow-up.. The use of ZES versus SES reduced the 3-year rates/100 subjects of death or myocardial infarction (3.9 vs. 10.8; difference, -6.9; 95% confidence interval [CI]: -13.0 to 0.8; p = 0.028), with no difference in target vessel revascularization rates (17.9 vs. 12.2; difference, 5.7; 95% CI: -3.7 to 15.1; p = 0.23) but greater use of coronary artery bypass graft (CABG) surgery (3.5 vs. 0.0; difference 3.5; 95% CI: 1.3 to 5.7; p = 0.002). After discounting at 3% per annum, total medical costs for ZES versus SES were similar ($23,353 vs. $21,657; difference, $1,696; 95% CI: -$1,089 to $4,482, p = 0.23), and the 3-year cost-effectiveness ratio was $57,002/quality-adjusted life year.. Despite a reduction in death or myocardial infarction and no difference in total revascularizations, medical costs were not decreased due to increased CABG repeat revascularization procedures for subjects receiving ZES versus SES. If future trials observe similar differences, improved safety with no difference in medical costs, the use of ZES versus SES will be a clinically and economically attractive treatment strategy. (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Coronary Artery Disease; Cost-Benefit Analysis; Drug-Eluting Stents; Female; Health Care Costs; Humans; Male; Medicare; Middle Aged; Models, Economic; Myocardial Infarction; Prosthesis Design; Quality of Life; Quality-Adjusted Life Years; Risk Assessment; Sirolimus; Time Factors; Treatment Outcome; United States

The aim of this study was to assess, after 2 years of follow-up, the safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent (ZES) compared with a paclitaxel-eluting stent (PES) in patients with native coronary lesions.. Early drug-eluting stents were associated with a small but significant incidence of very late stent thrombosis (VLST), occurring >1 year after the index procedure. The ZES has shown encouraging results in clinical trials.. The ENDEAVOR IV trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions), a randomized (1:1), single-blind, controlled trial (n = 1,548) compared ZES versus PES in patients with single de novo coronary lesions. Two-year follow-up was obtained in 96.0% of ZES and 95.4% of PES patients. The primary end point was target vessel failure (TVF), and safety end points included Academic Research Consortium-defined stent thrombosis. Economic end points analyzed included quality-adjusted survival, medical costs, and relative cost-effectiveness of ZES and PES.. The TVF at 2 years was similar in ZES and PES patients (11.1% vs. 13.1%, p = 0.232). There were fewer myocardial infarctions (MIs) in ZES patients (p = 0.022), due to fewer periprocedural non-Q-wave MIs and fewer late MIs between 1 and 2 years. Late MIs were associated with increased VLST (PES: 6 vs. ZES: 1; p = 0.069). Target lesion revascularization was similar comparing ZES with PES (5.9% vs. 4.6%; p = 0.295), especially in patients without planned angiographic follow-up (5.2% vs. 4.9%; p = 0.896). The cost-effectiveness of ZES and PES was similar.. After 2 years of follow-up, ZES demonstrated efficacy and cost-effectiveness comparable to PES, with fewer MIs and a trend toward less VLST. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Constriction, Pathologic; Coronary Angiography; Coronary Artery Disease; Cost-Benefit Analysis; Drug-Eluting Stents; Female; Health Care Costs; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Models, Economic; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Quality of Life; Quality-Adjusted Life Years; Risk Assessment; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; United States

We performed this study to investigate the vascular response in early period after zotarolimus-eluting stent (ZES) (Endeavor Sprint, Medtronic CardioVascular, Minneapolis, Minnesota) implantation.. The ZES has different characteristics, with biocompatible polymer and rapid drug-elution, compared with the first-generation drug-eluting stents (DES).. The ENDEAVOR OCT (Evaluation in 3 Months Duration of Neointimal Coverage after Zotarolimus-Eluting Stent Implantation by Optical Coherence Tomography) trial is a prospective, single-center study evaluating vascular healing patterns with optical coherence tomography (OCT) at 3 months after stent implantation. A total of 31 ZES in 30 patients underwent serial OCT at immediate post-intervention and 3 months. Neointimal growth and malapposition were analyzed at each stent strut of cross-sectional OCT images with 0.5-mm intervals.. The incidence of malapposition at post-intervention and 3 months was 6.0% and 0.2%, respectively. However, late acquired malapposition was not detected at 3 months. Of 31 stents, 27 stents (87.1%) were covered completely with neointima, but the remaining 4 stents had 2 (0.8%), 4 (0.9%), 4 (1.2%), and 6 (1.4%) uncovered struts. Overall mean percentage of covered stent struts was 99.9 +/- 0.4%. This finding was consistent among groups with acute coronary syndrome and stable angina pectoris (99.9 +/- 0.3% vs. 99.9 +/- 0.4%, p = 0.92). Intracoronary thrombus was documented in 1 stent (3.2%) among 31 stents.. Most of the stent struts were covered with neointima, and late acquired malapposition was not found at 3 months after ZES implantation. Therefore, the current study demonstrated that ZES might have a favorable in vivo vascular response at 3 months after stent implantation. (Evaluation of Zotarolimus Eluting Stent at 3 Months Using Optical Coherence Tomography [ENDEAVOR OCT]; NCT00815139).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

To evaluate effects of sirolimus-eluting stents (SES) compared to bare-metal stents (BMS) at stent edges in patients with acute myocardial infarction (AMI).. Clinical, angiographic, intravascular ultrasound (lVUS) and virtual histology (VH)-IVUS results were obtained and analysed in 20 SES and 20 BMS AMI patients at the index procedure and at nine months follow-up. Quantitative angiography and IVUS showed a trend toward decreases in mean lumen diameter, vessel volume, minimum lumen area and mean lumen area at both stent edges of BMS, and at the proximal edge of SES. At the distal stent edge, a significant difference between BMS and SES treated patients in mean lumen area was found (D-0.8+/-1.6 mm2 versus D0.2+/-0.8 mm2 respectively, p=0.04). Furthermore, in-stent SES had a larger lumen volume (SES: 167.7+/-59.2 mm3 versus BMS: 125.1+/-43.8 mm3; p=0.02) and less neointima volume (7.3+/-9.1 mm3 versus 53.2+/-35.1 mm3; p<0.001). Neither SES nor BMS demonstrated a significant effect on plaque composition at follow-up VH-IVUS analysis.. A significant difference between SES and BMS treated patients was observed with respect to mean lumen diameter distal to the stented segment which suggests a downstream effect of sirolimus elution.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Hyperplasia; Male; Metals; Middle Aged; Myocardial Infarction; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Previous randomised studies have shown a significant reduction in restenosis when oral rapamycin (OR) is administered to patients undergoing bare metal stent (BMS) implantation. How this regimen compares to drug eluting stents (DES) is unknown.. Two-hundred patients with de novo coronary lesions were randomised to treatment with OR plus BMS (100 pts) or with DES (100 pts). OR was given as a bolus of 10 mg per day before PCI followed by daily doses of 3 mg during following 13 days. Primary endpoints were to compare hospital, follow-up and overall cost at one, two, three and five years of follow-up. The secondary endpoints included death, myocardial infarction (MI) and stroke and were analysed as major adverse cardiovascular events (MACCE). Target vessel (TVR) and target lesion revascularisation (TLR) were independently analysed. Costs included procedural resources, hospitalisation, medications, repeat revascularisation procedures and professional fees. Baseline demographic, clinical and angiographic characteristics were similar. At 18.3 +/- 7 months of follow-up, the initial strategy of OR plus BMS resulted in significant cost saving when compared to DES (p=0.0001). TLR rate was 8.2% with DES and 7.0% with OR plus BMS (p=0.84), similarly no differences in TVR rate in both groups was seen (10.6% and 10.5% in OR and DES group respectively, p=0.86). Non-inferiority testing, determined that DES therapy failed to be cost saving compared to OR in all possible cost scenarios.. A strategy of OR plus BMS is cost saving compared to DES in patients undergoing PCI for de novo coronary lesions.

Topics: Administration, Oral; Aged; Angioplasty, Balloon, Coronary; Argentina; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Cost Savings; Drug-Eluting Stents; Female; Health Care Costs; Hospital Mortality; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Metals; Middle Aged; Myocardial Infarction; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Sirolimus; Stents; Stroke; Time Factors; Treatment Outcome

The aim of this study was to assess the pharmacokinetics and tolerability of Biolimus A9 eluted from Nobori coronary stents.. : The release kinetics and pharmacokinetics of drugs delivered via coronary stents have been shown to play an essential role in the efficacy and safety of drug eluting stents.. Twenty patients with coronary artery disease were treated with single 14-mm (10 patients) or 28-mm long stent (10 patients). Blood samples were drawn at 16 time points to determine the pharmacokinetics of Biolimus A9. At seven time points, complete laboratory and toxicology panels were assessed to screen for potential Biolimus A9 toxicity. The primary endpoint of the study was the systemic blood concentrations of Biolimus A9 after 28 days and 6 months as measured using highly specific and sensitive liquid chromatography- tandem mass spectrometry assay.. At 28 days, 6 patients (30%) had quantifiable Biolimus A9 concentrations in blood. The highest Biolimus A9 blood concentration measured in any sample was 32.2 pg/mL. The median time to maximum concentration was 2 hr, ranging from 0.05 hr to 3 months. Six months after stent implantation, only 1 of 20 patients had measurable Biolimus A9 concentrations at the lowest level of quantification, while at 9 months no sample had quantifiable Biolimus A9 concentrations. Laboratory and toxicology assessments did not indicate any impact of Biolimus A9 on the evaluated parameters.. Results of this study suggest that systemic exposure to Biolimus A9 was very low and that Biolimus A9 was well tolerated.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chromatography, Liquid; Colorado; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prospective Studies; Prosthesis Design; Serbia; Sirolimus; Tandem Mass Spectrometry; Treatment Outcome

The purpose of this study was to assess the 3-year outcome of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) using sirolimus-eluting stents (SES) in patients who had multivessel coronary artery disease with and without diabetes mellitus.. The optimal method of revascularization in diabetic patients remains in dispute.. The ARTS-II (Arterial Revascularization Therapies Study-Part II) trial is a single-arm study (n = 607) that included 159 diabetic patients treated with SES whose 3-year clinical outcome was compared with that of the historical diabetic and nondiabetic arms of the randomized ARTS-I trial (n = 1,205, including 96 diabetic patients in the CABG arm and 112 in the PCI arm).. At 3 years, among nondiabetic patients, the incidence of the primary composite of death, CVA, myocardial infarction (MI), and repeat revascularization (major adverse cardiac and cerebrovascular events [MACCE]), was significantly lower in ARTS-II than in ARTS-I PCI (adjusted odds ratio [OR]: 0.41; 95% confidence interval [CI]: 0.26 to 0.64) and similar to ARTS-I CABG. The ARTS-II patients were at significantly lower risk for death, CVA, and MI as compared with both the ARTS-I PCI (adjusted OR: 0.55; 95% CI: 0.34 to 0.91) and ARTS-I CABG patients (adjusted OR: 0.56; 95% CI: 0.35 to 0.92). Among diabetic patients, the incidence of MACCE in ARTS-II was similar to that of both PCI and CABG in ARTS-I. Conversely, the incidence of death, CVA, and MI was significantly lower in ARTS-II than in ARTS-I PCI (adjusted OR: 0.67; 95% CI: 0.27 to 1.65) and was similar to that of ARTS-I CABG.. At 3 years, PCI using SES for patients with multivessel coronary artery disease seems to be safer and more efficacious than PCI using bare-metal stents, irrespective of the diabetic status of the patient. Hence, PCI using SES appears to be a valuable alternative to CABG for both diabetic and nondiabetic patients.

Topics: Angioplasty, Balloon, Coronary; Case-Control Studies; Confidence Intervals; Coronary Artery Bypass; Coronary Artery Disease; Death, Sudden, Cardiac; Diabetes Complications; Diabetes Mellitus; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Odds Ratio; Prospective Studies; Risk Factors; Sirolimus; Stroke; Time Factors; Treatment Outcome

The risk of stent thrombosis has been reported to increase with percutaneous coronary intervention (PCI) complexity. The present study reports the pre-specified secondary endpoint of a 14-month stent thrombosis and major adverse cardiac events in patients stented with a simple versus a complex bifurcation technique using sirolimus eluting stents (SES).. A total of 413 patients with a coronary bifurcation lesion were randomised to a simple treatment strategy; stenting of main vessel and optional stenting of side branch (MV group), or to a complex stenting strategy; stenting of both main vessel and side branch (MV+SB group). Mortality data were available in all patients and 14-month clinical follow-up data in 395 (96%) of the patients. After 14 months, the rates of definite, probable and possible stent thrombosis (ARC criteria) were 1.0% vs. 0.5%, 1.0% vs. 0% and 0.5% vs. 0% (ns) in the MV and in the MV+SB groups, respectively. Rates of MACE were 9.5% in the MV group and 8.2% in the MV+SB group (ns). Total death was seen in 2.4% vs. 1.0% and non-PCI related myocardial infarction in 2.0% vs. 1.0% in the MV and the MV+SB groups, respectively.. After 14 months, two months after recommended cessation of dual antiplatelet therapy, the rates of stent thrombosis and major adverse cardiac events were low and independent of treatment complexity in patients treated with SES for coronary artery bifurcation lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Platelet Aggregation Inhibitors; Sirolimus; Thrombosis; Treatment Outcome

First generation DES have markedly reduced restenosis. However, there is a major interest in developing new DES with greater flexibility, radiopacity and safety profile. The Elixir Medical drug eluting stent is a novel DES that combines a chromium-cobalt platform with novolimus (an antiproliferative sirolimus-analogue drug) and a polymer from the methacrylate family. As potential advantages, it provides a lower drug dose as compared to Cypher (85 microg of novolimus vs. 140 microg of sirolimus) and therefore has a lower polymer load. We sought to evaluate the safety and efficacy of this novel device in reducing neointimal hyperplasia as assessed by QCA and IVUS.. In April 2007 a consecutive cohort of patients with de novo lesions < or = 14 mm in length, located in native coronaries of diameter from 3.0 to 3.5 mm were consecutively enrolled in this First-in-Man study (FIM). By protocol, angiography and IVUS would be done at baseline and repeated at four and eight months. Dual anti-platelet therapy was maintained for a minimum of 12 months. The primary endpoint was QCA lumen loss at 4-month follow-up. Secondary endpoints included MACE, in-stent neointimal obstruction by IVUS and device success. A total of 15 patients were included with 67% female patients and diabetes was detected in 47% of the cohort. Angiographic and procedural success was achieved in all patients. At 4-month angiographic follow-up there was in-stent late lumen loss (0.15 +/- 0.29 mm) by QCA and % volume obstruction (2.6 +/- 2.6) by IVUS. The angiographic in-stent late lumen loss results at eight months were 0.31 +/- 0.25 mm and % volume obstruction by IVUS was 6.0 +/- 4.4%. Late incomplete stent apposition (ISA) were not observed among these patients and no MACE was evidenced through nine month clinical follow-up.. In this FIM study, implantation of the novolimus-eluting stent was proven to be feasible, safe and elicited minimum neointimal proliferation. Additional large clinical trials should be considered to confirm these promising results.

Topics: Aged; Angioplasty, Balloon, Coronary; Antibiotics, Antineoplastic; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Feasibility Studies; Female; Follow-Up Studies; Humans; Macrolides; Male; Middle Aged; Sirolimus; Treatment Outcome; Ultrasonography, Interventional

The Custom NX 36 Drug Eluting Stent (DES) System is designed to treat coronary lesions via in situ stent length customisation. The stent evaluated in this study consists of nine interdigitated stent segments, each 4 mm in length, coated with a biodegradable formulation of Biolimus A9 and Poly-Lactic-Acid, a biodegradable drug carrier, and loaded into a unique sheath protected, integrated balloon delivery system.. The objective of this non-randomised prospective multicentre CUSTOM I Trial was to demonstrate the safety of in situ stent length customisation in 30 consecutive patients. Angiographic (QCA) and intravascular ultrasound (IVUS) follow-up was performed at two cohort time intervals: four (n=10) or eight (n=20) months. Mean lesion length and reference vessel diameters were 17.7 +/- 9.6 mm and 2.6 +/- 0.3 mm, respectively. Procedural success was 93%. There were three MACEs in the study population from enrollment through to twenty-four month follow-up. The in-hospital MACE rate was 2/30, with non-Q-wave myocardial infarctions events in two patients who recovered without further sequelae. At five months, one patient who had crossed over initially to PTCA required CABG surgery. Results from QCA and IVUS assessments at four and eight months showed no binary restenosis, mean in-stent late luminal loss of 0.25 +/- 0.23 mm and 0.26 +/- 0.23 mm.. This first evaluation of the new customisable Biolimus A9-eluting Custom NX stent suggests safety and efficacy through twenty-four month follow-up. Further evaluations are warranted to confirm the overall favourable outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Artery Disease; Drug Delivery Systems; Drug-Eluting Stents; Feasibility Studies; Female; Follow-Up Studies; Humans; Lactic Acid; Male; Middle Aged; Polyesters; Polymers; Prospective Studies; Sirolimus; Treatment Outcome

The effects of stem cell therapy on the coronary vasculature were investigated in patients with acute myocardial infarction who underwent peripheral blood stem cell (PBSC) therapy in the MAGIC Cell-3-DES study.. Among 50 patients with acute myocardial infarction who underwent either sirolimus-eluting stent or paclitaxel-eluting stent implantation for the culprit lesion, intravascular ultrasound was analysed in 36 patients (cell infusion: n = 19 and control: n = 17). In the cell infusion group, PBSCs mobilised by granulocyte-colony stimulating factor were delivered via intracoronary infusion into infarcted myocardium. Proximal and distal reference segments, and stented segments, were evaluated with intravascular ultrasound at immediate post-intervention and 6-month follow-up, respectively.. In the proximal and distal reference segments, the serial changes of lumen area, vessel area, and plaque plus media area were not significantly different between the cell infusion and the control groups. Within stented segments, mean neointimal area was similar in the two groups (cell infusion: 0.2 (SD 0.5) mm(2) vs control: 0.3 (SD 0.4) mm(2), p>0.05). However, there was a significant increase in mean peri-stent area of stented segment in the cell infusion group compared with the control group (0.7 (SD 1.4) mm(2) vs -0.1 (SD 1.2) mm(2), p<0.05). This difference mainly came from paclitaxel-eluting stent-implanted patients.. Intracoronary infusion of PBSCs mobilised with G-CSF does not aggravate de novo atherosclerotic lesion and neointimal hyperplasia with DES implantation. However, it may induce peri-stent tissue growth at the stented segment, especially in patients receiving PES. Its clinical significance needs to be evaluated with long-term follow-up.

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Granulocyte Colony-Stimulating Factor; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Peripheral Blood Stem Cell Transplantation; Sirolimus; Treatment Outcome; Tubulin Modulators; Ultrasonography, Interventional

Inflammatory markers are elevated in acute coronary syndromes, and are also known to play a crucial role in the pathogenesis of neointimal proliferation and stent restenosis. Drug-eluting stents (DESs) have been shown to decrease stent restenosis in different studies. In this study, we aimed to investigate the effect of treatment with DESs on systemic inflammatory response in patients with unstable angina pectoris who underwent percutaneous coronary intervention (PCI). We compared plasma high-sensitivity C-reactive protein (hsCRP), human tumor necrosis factor alpha (Hu TNF-alpha), and interleukin 6 (IL-6) levels after DES (dexamethasone-eluting stent [DEXES], and sirolimuseluting stent [SES]) implantation with levels after bare metal stent (BMS) implantation. We performed PCI with a single stent in 90 patients (62 men; 59 +/- 9 years of age; n = 30 in the BMS group, n = 30 in the DEXES group, n = 30 in the SES group) who had acute coronary syndrome. Plasma hsCRP, Hu TNF-alpha, and IL-6 levels were determined before intervention and at 24 h, 48 h, and 1 week after PCI. The results were as follows. Plasma hsCRP levels at 48 h (11.19 +/- 4.54, 6.43 +/- 1.63 vs 6.23 +/- 2.69 mg/l, P = 0.001) after stent implantation were significantly higher in the BMS group than in the DES group; this effect persisted for 7 days (P = 0.001). Plasma Hu TNF-alpha levels at each time point were higher in the SES group than in the BMS and DEXES groups (P < 0.05). The time course of Hu TNF-alpha values was similar in all groups. Although IL-6 levels at baseline and at 24 and 48 h showed no statistically significant difference between the study groups, postprocedural values at 7 days were slightly statistically significant in the SES group (P = 0.045). Drug-eluting stents showed significantly lower plasma hsCRP levels after PCI compared with BMSs. This may reflect the potent effects of DESs on acute inflammatory reactions induced by PCI.

Topics: Angina, Unstable; Angioplasty, Balloon, Coronary; Anti-Inflammatory Agents; C-Reactive Protein; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Dexamethasone; Drug-Eluting Stents; Female; Humans; Inflammation Mediators; Interleukin-6; Male; Metals; Middle Aged; Prospective Studies; Prosthesis Design; Sirolimus; Systemic Inflammatory Response Syndrome; Time Factors; Treatment Outcome; Tumor Necrosis Factor-alpha

A thin, cobalt-chromium stent eluting the antiproliferative agent everolimus from a nonadhesive, durable fluoropolymer has shown promise in preliminary studies in improving clinical and angiographic outcomes in patients with coronary artery disease.. To evaluate the safety and efficacy of an everolimus-eluting stent compared with a widely used paclitaxel-eluting stent.. The SPIRIT III trial, a prospective, randomized, single-blind, controlled trial enrolling patients at 65 academic and community-based US institutions between June 22, 2005, and March 15, 2006. Patients were 1002 men and women undergoing percutaneous coronary intervention in lesions 28 mm or less in length and with reference vessel diameter between 2.5 and 3.75 mm. Angiographic follow-up was prespecified at 8 months in 564 patients and completed in 436 patients. Clinical follow-up was performed at 1, 6, 9, and 12 months.. Patients were randomized 2:1 to receive the everolimus-eluting stent (n = 669) or the paclitaxel-eluting stent (n = 333).. The primary end point was noninferiority or superiority of angiographic in-segment late loss. The major secondary end point was noninferiority assessment of target vessel failure events (cardiac death, myocardial infarction, or target vessel revascularization) at 9 months. An additional secondary end point was evaluation of major adverse cardiac events (cardiac death, myocardial infarction, or target lesion revascularization) at 9 and 12 months.. Angiographic in-segment late loss was significantly less in the everolimus-eluting stent group compared with the paclitaxel group (mean, 0.14 [SD, 0.41] mm vs 0.28 [SD, 0.48] mm; difference, -0.14 [95% CI, -0.23 to -0.05]; P < or = .004). The everolimus stent was noninferior to the paclitaxel stent for target vessel failure at 9 months (7.2% vs 9.0%, respectively; difference, -1.9% [95% CI, -5.6% to 1.8%]; relative risk, 0.79 [95% CI, 0.51 to 1.23]; P < .001). The everolimus stent compared with the paclitaxel stent resulted in significant reductions in composite major adverse cardiac events both at 9 months (4.6% vs 8.1%; relative risk, 0.56 [95% CI, 0.34 to 0.94]; P = .03) and at 1 year (6.0% vs 10.3%; relative risk, 0.58 [95% CI, 0.37 to 0.90]; P = .02), due to fewer myocardial infarctions and target lesion revascularization procedures.. In this large-scale, prospective randomized trial, an everolimus-eluting stent compared with a paclitaxel-eluting stent resulted in reduced angiographic late loss, noninferior rates of target vessel failure, and fewer major adverse cardiac events during 1 year of follow-up.. clinicaltrials.gov Identifier: NCT00180479.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Single-Blind Method; Sirolimus; Ultrasonography, Interventional

Drug eluting stents (DES) have been shown to reduce restenosis compared with bare metal stents in bifurcated lesions. The aim of this study was to evaluate the long-term clinical outcomes of patients with bifurcated lesions treated by 3 different DES.. Consecutive patients with symptomatic coronary artery disease on one bifurcated lesion with SB>2.25 mm (on visual estimation) undergoing at the Department of Cardiology of the Catholic University of Rome, Italy were screened. Patients treated with Sirolimus-eluting stent (Cypher Select; SES Group), Tacrolimus-eluting stent (Taxus-Libertè; TA Group) and Zotarolimus-eluting stent (Endeavor Driver; ZOT Group) were enrolled in the study. Clinical and angiographic characteristics of all patients were prospectively recorded. Major adverse clinical events (MACE), including death, acute myocardial infarction (MI) or target lesion revascularization (TVR) by either percutaneous coronary intervention (PCI) or coronary surgery were recorded during the follow-up. Incidence of definite or probable stent thrombosis was calculated according to the ARC criteria.. Two hundred and forty-one consecutive patients were enrolled (89 Group CY, 98 Group TA and 54 Group EN). Length of follow-up was 235+/-60 days. Baseline clinical and angiographic characteristic were similar across the groups. The adopted technique for stent implantation was provisional stenting (73.4%), T-stenting technique (7%), crush (7%) and V-stenting (2.6%). The rate of patients finally treated with two stents was similar among groups. The cumulative rate of MACE (9% SES, 12% TA, 11% ZOT: P=0.7) and of TVR (2% SES, 9% TA, 7% ZOT) was similar among groups. No definite stent thrombosis was observed during follow-up, while 1 probable stent thrombosis was observed in TA group.. The clinical outcome of bifurcated lesions using DES and mainly a technique of single stent implantation is good. In the present observational study, clinical adverse events did not differ in patients with bifurcated lesions treated by Cypher, Taxus or Endeavor stent implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Proportional Hazards Models; Prospective Studies; Risk Factors; Rome; Sirolimus; Tacrolimus; Treatment Outcome

Rapamycin has been shown to reduce anatomical evidence of cardiac allograft vasculopathy, but its effect on coronary artery physiology is unknown.. Twenty-seven patients without angiographic evidence of coronary artery disease underwent measurement of fractional flow reserve (FFR), coronary flow reserve (CFR), and the index of microcirculatory resistance (IMR) within 8 weeks and then 1 year after transplantation using a pressure sensor/thermistor-tipped guidewire. Measurements were compared between consecutive patients who were on rapamycin for at least 3 months during the first year after transplantation (rapamycin group, n = 9) and a comparable group on mycophenolate mofetil (MMF) instead (MMF group, n = 18).. At baseline, there was no significant difference in FFR, CFR, or IMR between the 2 groups. At 1 year, FFR declined significantly in the MMF group (0.87 +/- 0.06 to 0.82 +/- 0.06, P = .009) but did not change in the rapamycin group (0.91 +/- 0.05 to 0.89 +/- 0.04, P = .33). Coronary flow reserve and IMR did not change significantly in the MMF group (3.1 +/- 1.7 to 3.2 +/- 1.0, P = .76; and 27.5 +/- 18.1 to 19.1 +/- 7.6, P = .10, respectively) but improved significantly in the rapamycin group (2.3 +/- 0.8 to 3.8 +/- 1.4, P < .03; and 27.0 +/- 11.5 to 17.6 +/- 7.5, P < .03, respectively). Multivariate regression analysis revealed that rapamycin therapy was an independent predictor of CFR and FFR at 1 year after transplantation.. Early after cardiac transplantation, rapamycin therapy is associated with improved coronary artery physiology involving both the epicardial vessel and the microvasculature.

Topics: Coronary Artery Disease; Coronary Vessels; Female; Heart Transplantation; Humans; Immunosuppressive Agents; Male; Middle Aged; Mycophenolic Acid; Sirolimus; Transplantation, Homologous; Treatment Outcome

Metallic allergy is associated with restenosis following bare metal stent implantation, but the impact of metallic allergy on the outcome after implantation of drug-eluting stents (DES) has not been investigated.. The present study group consisted of 88 consecutive patients (109 lesions) who underwent percutaneous coronary intervention with sirolimus-eluting stents (SES). Follow-up angiography was obtained at 8 months in all patients. At that time, the patients underwent epicutaneous patch tests for nickel, chromate, molybdenum, manganese, and titanium, which were evaluated after 48 h of contact. The patch test was positive in 14 patients (16%) (5 for manganese, 3 for nickel, 1 for chromate, 1 for Nickel and manganese, and 4 for manganese and chromate). The binary restenosis rate in the patients with a positive patch test was similar to those with negative patch test (6.3% vs 6.5%, p=0.98). Serial quantitative coronary angiography analyses identified no significant differences in late lumen loss of in-stent segments between patients with positive patch test and those with negative patch test (0.19+/-0.49 mm vs 0.12+/-0.48 mm, p=0.55).. SES prevent restenosis irrespective of metallic allergy. The classic relationship between metallic allergy and in-stent restenosis, seen with bare metal stents, does not appear to arise with DES, possibly because of the immunosuppressive effect of sirolimus.

Topics: Aged; Angioplasty, Balloon, Coronary; Chromates; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Hypersensitivity; Immunosuppressive Agents; Male; Manganese; Metals; Middle Aged; Molybdenum; Nickel; Patch Tests; Sirolimus; Titanium; Treatment Outcome; Tunica Intima

Stent implantation causes significant injury to the vascular wall, resulting in inflammatory activation. Although sirolimus-eluting stents (SES) have anti-inflammatory properties, their effect on periprocedural systemic inflammatory response has not been sufficiently investigated. Eighty-one patients with stable coronary artery disease involving severe stenosis of one major epicardial coronary artery underwent coronary angioplasty with stent implantation and randomly received either SES or bare metal stents (BMS). Blood samples were taken 24h before, at 24h, 48 h and 1 month after the angioplasty and levels of high sensitive C-reactive protein (hsCRP), interleukin-6 (IL-6), interleukin-1 beta (IL-1 beta), and monocyte chemoattractant protein-1 (MCP-1) were determined. HsCRP after BMS implantation increased over 24h (p<0.001) and then remained steady, as did IL-6 and IL-1 beta similarly. In contrast, their levels in SES patients decreased to below baseline by the end of the month. MCP-1 levels increased by the end of 1 month (p<0.001) in the BMS group, whereas in SES they steadily decreased, becoming significantly lower than baseline from 48 h (p=0.015). In conclusion, patients with SES exhibit an attenuation of the postprocedural systemic inflammatory activation during a 1-month follow-up after stent implantation. This might partially explain the reduced restenosis rate associated with SES.

Topics: Aged; C-Reactive Protein; Chemokine CCL2; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Inflammation; Interleukin-1beta; Interleukin-6; Male; Middle Aged; Sirolimus

Although long-term follow-up after sirolimus-eluting stent implantation shows a sustained clinical benefit in several randomized and registered trials, little is known about the pattern of neointimal growth beyond the first 6 to 9 months. In this study, we therefore evaluated the possible delayed restenosis in patients with coronary artery disease treated with sirolimus-eluting stent.. A total of consecutive 333 patients with 453 lesions were enrolled in this study (among 782 consecutive patients with 1023 lesions). Lesions were subjected to follow-up by quantitative coronary angiography, and patients were divided into two groups according to the time of follow-up by quantitative coronary angiography: early group (< or =270 days, n=270 with 369 lesions) and late group (>270 days, n=63 with 84 lesions). Binary restenosis was defined as stenosis of more than 50% of the lumen diameter in the target lesion.. Baseline clinical, demographic or angiographic characteristics were well balanced between the two groups. The in-stent restenosis rate was not significant between the early group and the late group (3.5 vs. 6.0%; P>0.05). The late loss and target lesion revascularization appeared higher in late group but there were no significant differences (0.15+/-0.38 mm vs. 0.24+/-0.44 mm; and 4.9 vs. 9.5%, P>0.05, respectively). Similarly, overall thrombosis rate was also same in both groups. In-segment restenosis was, however, higher in late group compared with that in early group (7.9 vs. 16.7%, P=0.013).. In this unrestricted population, the beneficial effects of sirolimus-eluting stent implantation extend out more than 1 year in real world practice, that has been confirmed by the results of the large randomized clinical trials. The late in-segment restenosis could, however, be found, suggesting that a prolonged clinical and angiographic surveillance in this subset of patients seems to be warranted.

Topics: Aged; Aged, 80 and over; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Delayed-Action Preparations; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Retrospective Studies; Sirolimus; Stents; Treatment Outcome

To describe a novel modification of the T-stenting technique and to report the bench test as well as the first clinical results obtained.. The best technique to treat bifurcated coronary lesions has not been defined.. This novel modification of the T-stenting technique is based, after stenting of the main vessel (MV) and kissing balloon, on the intentional minimal protrusion of the side-branch (SB) stent within the MV. Final kissing balloon is performed using the balloon kept uninflated into the MV before SB stenting. The technique was tested in vitro and applied in two independent series of patients undergoing elective drug-eluting stent implantation on one bifurcated lesion. Bifurcated lesions were classified according to the Medina classification. Patients' outcome up to 9 month was prospectively assessed.. The bench test showed perfect coverage of the bifurcation with minimal stent's struts overlap at the proximal part of SB ostium and a small, single layer stent struts, neo-carina not affecting the MV patency. Seventy-three complex patients (67% of Medina 1,1,1 lesions; 44% of unprotected distal left main lesions) were treated with sirolimus-, paclitaxel-, or zotarolimus-eluting stents using the TAP technique. Procedural success was achieved in all cases and the clinical outcome up to 9 month was characterized by a low rate of clinically-driven target vessel revascularization (6.8%).. The TAP-stenting is a modification of the T-stenting technique which allows full coverage of bifurcated lesions and facilitates final kissing balloon. The first clinical experience suggests that this technique may be practical, thus calling for further evaluations of the technique.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Disease; Female; Humans; Italy; Korea; Male; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Radiography, Interventional; Severity of Illness Index; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

The randomized Reduction of Restenosis In Saphenous Vein Grafts with Cypher Sirolimus-Eluting Stent trial compared angiographic outcomes of sirolimus-eluting stents (SESs) versus bare metal stents (BMSs) in saphenous vein grafts (SVG). Using intravascular ultrasound (IVUS) performed during 6-month follow-up angiography, we compared the vascular effects of the 2 types of stent on SVGs. Of 75 patients (96 lesions) included, 59 patients underwent IVUS in 61 SVGs; 29 patients received 40 SESs for 34 lesions, and 30 patients received 42 BMSs for 39 lesions. IVUS parameters (diameters, areas, and volumes) were compared in the 2 groups. A specific analysis was performed for overlapping SESs. Median neointimal volume was 1.3 mm(3) (interquartile range 0 to 13.1) in SESs versus 24.5 (7.8 to 39.5) in BMSs (p <0.001). Minimal incomplete stent apposition was detected at only 3 stent edges (2 BMSs, 1 SES) next to ectatic regions of the SVG. Compared with single SESs, overlapping SESs showed significant increases in neointimal reaction, with a neointimal volume of 0.6 mm(3)/mm of stent (0.1 to 1.8) versus 0 (0 to 0.4) in single SESs (p = 0.03), and this phenomenon was mainly localized in overlapping SES segments, where neointimal volume per millimeter of stent was 1.1 mm(3)/mm (0.6 to 4.4) versus 0 (0 to 1.3) in nonoverlapping segments (p = 0.05). In conclusion, SESs effectively inhibit neointimal hyperplasia volume compared with BMSs in diseased vein grafts, without evidence of increased incomplete apposition risk. The neointimal response to overlapping SES layers seems higher than to a single SES layer.

Topics: Aged; Aged, 80 and over; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Double-Blind Method; Drug Delivery Systems; Female; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Saphenous Vein; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional

Using serial intravascular ultrasound (IVUS), the efficacy of reduced-dose sirolimus-eluting stents (SESs) in the prevention of neointimal hyperplasia (NH) and maintenance of luminal patency in human coronary arteries was evaluated.. In the animal model, a broad therapeutic window regarding sirolimus doses in suppressing NH has been reported.. Serial cross-sectional and volumetric IVUS analyses were performed in 44 patients treated with SES that contained lower sirolimus doses (either 45% or 70%) than standard SES. For cross-sectional analysis, minimum lumen area (MLA) was measured. Percent (%) NH volumetric obstruction was calculated as 100 x NH volume/stent volume.. IVUS measurements were similar between the two drug-dose groups. At 12 months follow-up, only one case developed late incomplete stent apposition. Between 4 and 12 months, a slight increase of in-stent % area loss and % NH obstruction was noted (3.5% +/- 10.4% to 6.7% +/- 10.7% and 1.9% +/- 5.0% to 4.4% +/- 8.0%, respectively). The majority of studied cases, however, sustained less than a 10% volumetric (93% of studied cases) and area loss (75% of studied cases) in the stented segment up to 12 months. At 12 months, % area loss within the stented segments and 5-mm reference segments were comparable (7.0% +/- 19.6% versus 6.7% +/- 10.7%).. Although slight increases of NH were noted, SESs, delivering two reduced drug doses, appeared to be effective for maintaining luminal patency during 12 months follow-up.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Dose-Response Relationship, Drug; Drug-Eluting Stents; Humans; Hyperplasia; Sirolimus; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional; Vascular Patency

Long-term results of recent landmark trials document both benefits and risks of drug-eluting stents (DES) for coronary revascularization. Interestingly, the conclusions drawn from these data vary widely since significant differences in DES penetration rates become obvious when the utilization of this technology is compared between hospitals or even countries. Based on the recommendations of the European Society of Cardiology, the FDA as well as data derived from the BASKET-LATE study, we propose that a maximum penetration rate of 50% for DES seems appropriate at present. Analysis of the length/diameter distribution combined with the use of validated restenosis reference charts allows identification of high-risk patients regarding restenosis risk and modeling the use of DES depending on financial resources and clinical indication. Such algorithm provides the rational for preprocedural risk stratification and efficient use of resources.

Topics: Coronary Artery Disease; Coronary Restenosis; Cost-Benefit Analysis; Drug Administration Routes; Female; Humans; Immunosuppressive Agents; Male; Paclitaxel; Sirolimus; Stents

The time course of neointimal formation after stent implantation has not been studied extensively by angioscopy in the drug-eluting stent era.. Serial angioscopic findings at first follow-up (3.6+/-1.1 months), second follow-up (10.5+/-1.6 months), and third follow-up (21.2+/-2.2 months) after stent implantation were compared between sirolimus-eluting stents (SES, n=17) and bare-metal stents (BMS, n=11). Neointimal coverage, thrombus, and presence of yellow plaques underneath the stents were assessed. Neointimal coverage was graded as follows: grade 0, stent struts were fully visible; grade 1, struts bulged into the lumen, although they were covered; grade 2, struts were embedded by the neointima but were seen translucently; or grade 3, struts were fully embedded and invisible. Neointimal coverage was remarkably different between SES and BMS at each follow-up point. Neointimal coverage grade was 1.1+/-0.5 in SES versus 2.9+/-0.3 in BMS at the first follow-up (P<0.0001), 1.1+/-0.5 in SES versus 3.0+/-0.0 in BMS (P<0.0001) at the second follow-up, and 1.3+/-0.5 in SES versus 3.0+/-0.0 in BMS at the third follow-up (P=0.0009). No significant serial changes in coverage grade were noted in the BMS group, whereas coverage grade slightly but significantly increased at the third follow-up in the SES group (P<0.05). Thrombi were detected in 4 SES: a red thrombus was seen from the first to the third follow-up in 2; another was detected only at the third follow-up; and the fourth was seen at the first follow-up but disappeared at the second follow-up, associated with a new white thrombus despite dual antiplatelet therapy. Yellow plaques had disappeared by the time of the second follow-up in BMS. In contrast, yellow plaques were exposed in 71% of SES at the first follow-up and remained exposed until the third follow-up. Neointimal coverage grades correlated with thrombi (P=0.002) and with yellow plaques (P<0.0001).. Serial angioscopic findings up to 2 years after SES implantation were markedly different from those after BMS. Neointimal coverage was completed by 3 to 6 months in BMS. In contrast, SES demonstrated the presence of thrombi and yellow plaques even as much as 2 years after implantation.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Metals; Middle Aged; Platelet Aggregation Inhibitors; Sirolimus; Stents; Tunica Intima

Zotarolimus-eluting phosphorylcholine-coated cobalt-chromium alloy Driver stents (ZES) demonstrated significant reductions in target lesion revascularization rate with few apparent adverse events compared with bare metal stents (BMS; uncoated Driver stents) in a prospective, multicenter, double-blind, randomized controlled trial in de novo coronary lesions. The aim of this study was to examine detailed vascular responses to ZES compared with BMS using serial intravascular ultrasound analysis. A total of 343 patients (ZES n = 178, BMS n = 165) were enrolled in this formal, prespecified intravascular ultrasound substudy of the Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE Zotarolimus-Eluting Driver Coronary Stent in de Novo Native Coronary Artery Lesions (ENDEAVOR II), a prospective, multicenter, double-blind, randomized controlled trial to compare ZES and BMS in de novo native coronary artery lesions. Quantitative and qualitative intravascular ultrasound analyses were performed postprocedurally and at 8-month follow-up in stented and reference segments. ZES showed significantly less neointima, with a larger lumen than BMS at 8 months (percentage neointimal volume 17.6 +/- 10.1% vs 29.4 +/- 17.2%, p <0.0001; maximum percentage neointimal area 32.9 +/- 13.0% vs 47.6 +/- 18.6%, p <0.0001; minimum luminal area 4.9 +/- 1.6 vs 4.0 +/- 1.7 mm(2), p <0.0001) and no unfavorable edge effect. In the 18-mm single stents, ZES showed evenly inhibited neointima compared with BMS. Neither persistent stent-edge dissection nor late-acquired incomplete stent apposition was observed in either group. In conclusion, ZES showed evenly inhibited neointima with no apparent adverse vascular response in stented and reference segments at 8 months compared with BMS.

Topics: Chromium Alloys; Coated Materials, Biocompatible; Cohort Studies; Coronary Artery Disease; Coronary Restenosis; Double-Blind Method; Endosonography; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Phosphorylcholine; Prospective Studies; Sirolimus; Stents; Tunica Intima

Percutaneous coronary intervention (PCI) has been increasingly employed to treat unprotected left main coronary artery (LMCA) stenosis, with variable success. This strategy has been applied to patients undergoing drug-eluting stent (DES) implantation for unprotected LMCA stenosis.. From April 2003 to June 2006, 114 consecutive patients with de novo unprotected LMCA stenosis underwent PCI with DES, and were followed over a mean period of 17.1 +/- 9.1 months. The primary endpoint of the study was the occurrence of major adverse cardiovascular events (MACE) (cardiac death, myocardial infarction [MI] or target lesion revascularization [TLR]).. LMCA stenting was successfully performed in all patients. In-hospital mortality was 3.5%, with no in-hospital non-fatal MI or emergency coronary artery bypass grafts. During the follow-up period, the all-cause mortality rate was 7.9%, with 3.5% cardiac-related deaths. TLR was performed in 7.9% of patients, and the MACE rate was 14.9%. All non-surviving patients were at high surgical risk (EuroSCORE > 6) and had a significantly higher EuroSCORE than surviving patients that patients with a EuroSCORE < or = 11 had significantly improved survival rates over those with a EuroSCORE > 11 (p < 0.0001). Moreover, most of the patients who died of cardiac causes were diabetic (71.4% vs. 26.6%; p < 0.05). Acute coronary syndromes, as clinical presentation, and non-ostial LMCA disease were also significantly more common within non-surviving patients (100% vs. 67%; p < 0.05, and 92.3% vs. 66.3%; p = 0.05, respectively).. Stenting of unprotected LMCA appears to be associated with a favorable mid-term outlook, especially in selected patients.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Paclitaxel; Predictive Value of Tests; Prognosis; Prospective Studies; Risk Factors; Sirolimus; Stents; Survival Rate; Treatment Outcome

To evaluate the impact of cilostazol on neointimal hyperplasia after drug-eluting stent (DES) implantation for long coronary lesions, we performed a randomized multicenter prospective study comparing triple antiplatelet therapy (aspirin, clopidogrel, and cilostazol; triple group, n = 250) and dual antiplatelet therapy (aspirin and clopidogrel; standard group, n = 250) for 6 months in patients with long lesions (> or =25 mm) requiring a long DES (> or =32 mm). The primary end point was in-stent late loss at 6-month angiography. The 2 groups had similar baseline clinical and angiographic characteristics. In-stent late loss (0.22 +/- 0.48 mm vs 0.32 +/- 0.51 mm, p = 0.031) and in-segment late loss (0.34 +/- 0.49 mm vs 0.51 +/- 0.49 mm, p = 0.001) at 6-month follow-up angiography were significantly lower in the triple group versus the standard group. There was a trend toward lower rates of in-segment restenosis in the triple group versus the standard group (6.7% vs 11.2%, p = 0.104). Target lesion revascularization (TLR; 2.8% vs 6.8%, p = 0.036) and major adverse cardiac events (2.8% vs 7.6%, p = 0.016), including death, myocardial infarction, and TLR at 9 months were significantly lower in the triple group than in the standard group. At 9 months, the 2 groups had similar rates of stent thrombosis (0.4% vs 0.4%, p = 0.999), death (0% vs 0.8%, p = 0.499), and myocardial infarction (0.4% vs 0.4%, p = 0.999). In conclusion, cilostazol significantly reduced late loss at 6 months after DES implantation and the occurrence of TLR and major adverse cardiac events in patients with long coronary lesions.

Topics: Aged; Aspirin; Cilostazol; Clopidogrel; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug Delivery Systems; Drug Therapy, Combination; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Platelet Aggregation Inhibitors; Sirolimus; Stents; Tetrazoles; Ticlopidine; Time Factors; Treatment Outcome; Tunica Intima

Although the increased utilization of drug-eluting stents is well supported by multiple studies with clinical trial data for many patient and lesion subsets, their use to treat diseased saphenous vein graft (SVG) lesions is much less well substantiated. We sought to ascertain and compare 12-month target vessel revascularization (TVR) rates for sirolimus-eluting Cyphertrade mark stents and bare-metal stents (BMS) when utilized to treat stenoses in diseased SVGs.. Therefore, we conducted a multicenter matched-control study in patients treated for de novo SVG lesions with Cypher or BMS, matching for reference vessel diameter, stent length, diabetes and number of stents utilized. The primary study endpoint was TVR at 12 months.. Three hundred and fifty patients were matched, with patient age = 69 +/- 9 years, 77% male, 39% diabetics, SVG age = 119 +/- 75 months, reference vessel diameter = 3.3 +/- 0.4 mm, target lesion length = 17.4 +/- 8.4 mm (p = NS for all between-group comparisons). Twelve-month TVR was modestly reduced with Cypher stenting (6.8% vs. 11.8%; p = 0.14) due to a trend toward a reduction in binary restenosis (7.4% vs. 13.6%; p = 0.08). Twelve-month survival was 95.3% and 96.4% in the Cypher and BMS groups, respectively (p = 0.79).. Cypher stents appear to modestly reduce TVR without apparent safety risk compared with BMS when applied to the treatment of diseased SVGs. In conjunction with other available studies, these data support Cypher stent use in this setting.

Topics: Aged; Angioplasty, Balloon, Coronary; Case-Control Studies; Coronary Artery Bypass; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Middle Aged; Postoperative Complications; Saphenous Vein; Sirolimus; Treatment Outcome

We examined the impact of gender on outcomes of patients undergoing percutaneous coronary intervention using sirolimus-eluting stents (SES).. Although gender-specific differences in outcome after implantation of bare-metal stents (BMS) have been described, there are no data assessing outcomes of women treated with SES.. We performed a patient-level pooled analysis from 4 randomized SES versus BMS trials (RAVEL [Randomized Comparison of a Sirolimus-Eluting Stent with a Standard Stent for Coronary Revascularization], SIRIUS [SIRolImUS-coated Bx Velocity balloon expandable stent in the treatment of patients with de novo coronary artery lesions], E-SIRIUS [Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries], and C-SIRIUS [Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries]) and analyzed outcomes as a function of gender.. Of 1,748 patients, 1,251 were men and 497 were women. A total of 878 patients were randomized to SES (629 men and 249 women), and 870 patients were randomized to BMS (622 men and 248 women). Compared with men, women were older and more frequently had diabetes mellitus, hypertension, and congestive heart failure. Although overall clinical outcomes were similar in both genders, treatment with SES was associated with significant (p < 0.0001) reductions in rates of in-segment binary restenosis both in women (6.3% vs. 43.8%) and in men (6.4% vs. 35.6%), resulting in a significant reduction in 1-year major adverse cardiac events, driven by a lower incidence of target lesion revascularization/target vessel revascularization in both genders. By multivariable analysis, female gender was not an independent predictor of in-segment binary restenosis or clinical outcomes regardless of stent type.. In this analysis, despite less favorable baseline clinical and angiographic features in women compared with men, the angiographic and clinical benefits of SES were independent of gender.

Topics: Aged; Angina, Unstable; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Sex Factors; Sirolimus; Treatment Outcome

The aim of this intravascular ultrasound (IVUS) study was to assess the efficacy of the AXXESS Plus stent system for the treatment of bifurcation coronary lesions.. The AXXESS Plus is a novel bifurcation drug-eluting stent, comprised of a self-expanding flare-shaped stent platform and bioabsorbable polymer coating that releases Biolimus A9.. Data were obtained from the AXXESS PLUS trial, a prospective, multicenter, nonrandomized, single-arm study to evaluate safety and efficacy. Six-month follow-up IVUS analysis was available in 49 cases. Volumetric analysis using Simpson's method within the AXXESS stent, and cross-sectional analysis at the ostium of main branch and/or side branch was performed. Impact of bifurcation angle on stent expansion at the carina was also evaluated.. Within the AXXESS stent, neointimal volume obstruction percentage was 2.3% +/- 2.2%, with a minimum lumen area of 7.9 +/- 2.6 mm(2). Lumen area was 5.2 +/- 1.7 mm(2) at main branch ostium, and 4.0 +/- 1.5 mm(2) at side branch ostium. In two cases, incomplete stent apposition was observed at the proximal edge of the AXXESS stent. In one case, a gap between the AXXESS stent and an additional stent was observed. Greater bifurcation angle inversely correlated with smaller stent area at side branch ostium (r = -0.54, P = 0.03) but not at main branch ostium (r = -0.2, P = 0.29).. This novel self-expanding, drug-eluting bifurcation stent demonstrated effective lesion coverage along with significant neointimal suppression equivalent to current generation balloon-expandable drug-eluting stent technology.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Hyperplasia; Male; Middle Aged; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

We compared two consecutive series of patients treated with sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES).. Two hundred and ninety-five patients with 590 coronary lesions were treated with 274 SES and 379 PES. Patients with symptoms or positive dobutamine stress echocardiography were subjected to repeat coronary angiography.. During a follow-up of 13.3 +/- 5.7 months, the incidence rate of major adverse cardiac events (MACE) was 4.1%, including, 1 death, 4 Q-wave myocardial infarctions, 2 late angiographic stent thromboses, 3 subacute stent thromboses, and 11 target vessel revascularizations (TVR), and was not significantly different between SES (n = 5) and PES (n = 7). Stent overlapping was found to be an independent predictor of both MACE (odds ratio = 0.078, P = 0.02) and TVR (odds ratio = 0.077, P = 0.02). Follow-up symptoms- or ischemia-driven angiography was performed in 45 patients. Only vessel size was a predictor of stent restenosis (P = 0.02), independent of stent type. Late loss was independently predicted by postdilatation of stent (beta =-0.24, P = 0.03), but not by type of stent (P = 0.14) or other parameters. Edge restenosis was seen in 8 patients subjected to lesion predilatation. The restenosis pattern after SES implantation was focal, but diffuse (n = 1) or proliferative (n = 1) restenosis, and in-stent aneurysm formation (n = 1) was also seen with PES.. Despite a trend for a higher incidence of MACE with PES, no significant differences between the two stent types were detected. Diffuse restenosis was seen only with PES, and edge restenosis only in lesions with balloon predilatation before stent implantation. Stent overlapping was an independent predictor of both TVR and MACE.

Topics: Blood Vessel Prosthesis Implantation; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Female; Humans; Male; Middle Aged; Paclitaxel; Prospective Studies; Sirolimus; Stents; Treatment Outcome

Compared with bare metal stents, sirolimus-eluting and paclitaxel-eluting stents have been shown to markedly improve angiographic and clinical outcomes after percutaneous coronary revascularization, but their performance in the treatment of de novo coronary lesions has not been compared in a prospective multicenter study.. To compare the safety and efficacy of sirolimus-eluting vs paclitaxel-eluting coronary stents.. Prospective, randomized comparative trial (the REALITY trial) conducted between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months.. Ninety hospitals in Europe, Latin America, and Asia.. A total of 1386 patients (mean age, 62.6 years; 73.1% men; 28.0% with diabetes) with angina pectoris and 1 or 2 de novo lesions (2.25-3.00 mm in diameter) in native coronary arteries.. Patients were randomly assigned in a 1:1 ratio to receive a sirolimus-eluting stent (n = 701) or a paclitaxel-eluting stent (n = 685).. The primary end point was in-lesion binary restenosis (presence of a more than 50% luminal-diameter stenosis) at 8 months. Secondary end points included 1-year rates of target lesion and vessel revascularization and a composite end point of cardiac death, Q-wave or non-Q-wave myocardial infarction, coronary artery bypass graft surgery, or repeat target lesion revascularization.. In-lesion binary restenosis at 8 months occurred in 86 patients (9.6%) with a sirolimus-eluting stent vs 95 (11.1%) with a paclitaxel-eluting stent (relative risk [RR], 0.84; 95% confidence interval [CI], 0.61-1.17; P = .31). For sirolimus- vs paclitaxel-eluting stents, respectively, the mean (SD) in-stent late loss was 0.09 (0.43) mm vs 0.31 (0.44) mm (difference, -0.22 mm; 95% CI, -0.26 to -0.18 mm; P<.001), mean (SD) in-stent diameter stenosis was 23.1% (16.6%) vs 26.7% (15.8%) (difference, -3.60%; 95% CI, -5.12% to -2.08%; P<.001), and the number of major adverse cardiac events at 1 year was 73 (10.7%) vs 76 (11.4%) (RR, 0.94; 95% CI, 0.69-1.27; P = .73).. In this trial comparing sirolimus- and paclitaxel-eluting coronary stents, there were no differences in the rates of binary restenosis or major adverse cardiac events.. ClinicalTrials.gov Identifier: NCT00235092.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Implants; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Stents; Survival Analysis; Treatment Outcome

The aim of this study was to assess neointimal hyperplasia following sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) implantation in a patients with complex coronary disease.. Between January to December 2004, 70 patients were enrolled in this study (SES = 37; PES = 33. The primary objective was to assess the efficacy of SES and PES on neointimal proliferation inhibition in patients with complex coronary lesions by volumetric 3D intravascular ultrasound (IVUS) assessment at six-month follow-up.. Baseline clinical, demographic or angiographic characteristics were well balanced in both groups. All procedures as well as hospitalisation were uneventful. The percentage of B2/C lesions in our study was > 90% in both groups. The IVUS-assessed in-stent mean neointimal hyperplasia volume was significantly lower in lesions treated with SES compared to PES (4.1 +/- 11 mm3 vs. 17.4 +/- 23 mm3, p < 0.002) at 6 month follow-up. No difference in both MACE (3.0 versus 6.0%, p = NS) and restenosis (5.4 versus 9.1%, p = NS) were found. The in-segment late loss at six month was 0.26 mm in the SES and 0.48 mm in the PES group (p = NS).. The present study showed reduced neointimal proliferation after sirolimuseluting as compared to paclitaxel-eluting stents in patients with complex coronary artery disease. Both SES and PES were associated with low rate of angiographic restenosis or major adverse cardiovascular events.

Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Drug Delivery Systems; Female; Humans; Hyperplasia; Male; Middle Aged; Paclitaxel; Prospective Studies; Sirolimus; Stents; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional; Vascular Patency

The purpose of this study was to evaluate the long-term outcomes of bifurcation coronary lesions treated with a novel technique called "balloon alignment T-stenting".. The optimal technique for the treatment of bifurcation coronary disease has not yet been established.. Twenty-six patients with bifurcation coronary lesions were treated with currently available drug-eluting stent (DES) platforms. This was a pilot study to determine the long-term efficacy of a novel technique, "balloon alignment T-stenting". Based on this technique we performed 6-month anniversary angiography to determine restenosis rates for both main and side branch lesions treated.. Twenty-six main branches and 27 side branches were treated with this novel technique. Angiographic 6-month follow up was available for all 26 patients treated. There were no postprocedural mortalities and no cases of postprocedural stent thrombosis during the follow-up period. At 6-month anniversary angiography, no evidence of main branch restenosis was seen. However, there were 2 cases of side branch restenosis for a total side branch restenosis rate of 7.4%. Target lesion revascularization for the 26 patients in the study was 7.6%. The total major adverse cardiac event rate for the group as a whole was 15.4%, with 2 periprocedural non-Q-wave myocardial infarctions and 2 target lesions requiring revascularization at 6 months.. Using currently available DES platforms, the data compiled from this small, single-center pilot study suggest that balloon alignment T-stenting may represent a reasonable approach for the treatment of bifurcation coronary artery disease. However, more comprehensive, larger-scale trials will be required to validate these preliminary findings.

Topics: Aged; Coronary Artery Disease; Drug Delivery Systems; Female; Humans; Male; Methods; Middle Aged; Sirolimus; Stents; Treatment Outcome

Outcomes remain relatively unfavorable for stent-based coronary intervention of lesions with long diseased segments. This study compared sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) for long coronary lesions.. The present randomized, multicenter, prospective study compared the use of long (> or =32 mm) SES with PES in 500 patients with long (> or =25 mm) native coronary lesions. The primary end point of the trial was the rate of binary in-segment restenosis according to follow-up angiography at 6 months. The SES and PES groups had similar baseline characteristics. Lesion length was 33.9+/-11.6 mm in the SES group and 34.5+/-12.6 mm in the PES group (P=0.527). The in-segment binary restenosis rate was significantly lower in the SES group than in the PES group (3.3% versus 14.6%; relative risk 0.23; P<0.001). In-stent late loss of lumen diameter was 0.09+/-0.37 mm in the SES group and 0.45+/-0.55 mm in the PES group (P<0.001). In patients with restenoses, a pattern of focal restenosis was more common in the SES group than in the PES group (100% versus 53.3%, P=0.031). Consequently, SES patients had a lower rate of target-lesion revascularization at 9 months (2.4% versus 7.2%, P=0.012). The incidence of death (0.8% in SES versus 0% in PES, P=0.499) or myocardial infarction (8.8% in SES versus 10.8% in PES, P=0.452) at 9 months of follow-up was not statistically different between the 2 groups.. For patients with long native coronary artery disease, SES implantation was associated with a reduced incidence of angiographic restenosis and a reduced need for target-lesion revascularization compared with PES implantation.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Equipment Design; Female; Follow-Up Studies; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Retreatment; Sirolimus; Treatment Outcome

Aim of this study was to investigate the effects of implantation of different coronary drug-eluting stents on trafficking of central (T(CM)) or effector (T(EM)) memory T cells in the coronary sinus of patients with coronary artery disease (CAD) undergoing percutaneous coronary revascularization. Thirty-two patients presenting with stable coronary disease and angiographically proven stenosis of left descending coronary artery were randomly assigned to treatment with rapamycin-eluting, paclitaxel-eluting or bare metal stents. Heparinized blood samples were obtained from the coronary sinus either before or 20 min after stent implantation. Mononuclear cells were stained with mAbs specific for CD3, CD4, CD8, CD45R0, and CD27 molecules. Analysis of surface phenotype was performed by four-color flow cytometry and data on both CD4+ and CD8+ T(CM) and T(EM) cells were expressed either as absolute cell numbers/microL of blood or as percentages relative to the corresponding total memory T cell populations in the individual patients. We found that the number of CD8+ T(EM), as defined by CD3+CD45R0+CD8+CD27- phenotype, was significantly reduced in patients receiving a rapamycin-eluting stent as compared with basal values. Conversely, the number of CD8+ T(CM) (CD3+CD45R0+CD8+CD27+) was increased in the same treatment group after the revascularization procedure. No changes in the absolute number of CD4+ and CD8+ total (T(CM) plus T(EM)) memory T cells before and after the procedure were observed. These findings suggest that rapamycin eluted from medicated coronary stents rapidly induce a redistribution of memory CD8+ T lymphocyte subsets, with a significant decrease of T(EM) and a corresponding increase of T(CM) increase circulating within the coronary sinus. This anti-inflammatory effect could partially explain the reduction of coronary in-stent restenosis rate associated with the clinical use of this type of device.

Topics: Aged; CD8-Positive T-Lymphocytes; Cell Movement; Coronary Artery Disease; Flow Cytometry; Humans; Immunologic Memory; Immunosuppressive Agents; Middle Aged; Paclitaxel; Sirolimus; Stents

We conducted this trial to assess whether a sirolimus-eluting stent (SES) produces similar results to a paclitaxel-eluting stent (PES) when used in the real world of interventional cardiology.. Several drug-eluting stents have been shown to exert a beneficial effect on restenosis when used in the treatment of coronary artery disease. Any potential superiority of one drug over the others, however, is still unknown.. To evaluate whether a PES or an SES is superior in daily practice, we randomized all patients suitable to receive a drug-eluting stent in our institution. Clinical follow-up was obtained after at least six months.. A total of 202 patients were included in this trial. One hundred patients received a PES and 102 received an SES. Procedural success was 99% in both groups. Incidence of major adverse cardiac events at follow-up (mean 7 +/- 2 months) was 4% with the PES and 6% with the SES (p = 0.8). The need for target lesion revascularization was very low in both groups (1% with the PES and 3% with the SES).. Our results confirm that the high success rate obtained with both stents in randomized trials can be replicated in routine clinical practice. In this small group of patients we were unable to show any advantage of one stent over the other.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Prospective Studies; Sirolimus; Stents; Treatment Outcome

We sought to determine the real-world incidence of angiographically confirmed and possible stent thrombosis (ST) in an unrestricted population during the first 30 days after bare-metal stent (BMS), sirolimus-eluting stent (SES), and paclitaxel-eluting stent (PES) implantation.. Current data on ST in drug-eluting stents (DES) have come from randomized trials with strict entry criteria, which limits their generalizability to daily practice.. The study population comprised three sequential cohorts of 506 consecutive patients with BMS, 1,017 consecutive patients with SES, and 989 consecutive patients treated with PES.. In the first 30 days after stent implantation, 6 BMS (1.2%, 95% confidence interval [CI] 0.5% to 2.6%; p = 0.9), 10 SES (1.0%, 95% CI 0.5% to 1.8%), and 10 PES (1.0%, 95% CI 0.6% to 1.9%) patients developed angiographically proven ST. Multiple potential risk factors were identified in most patients with ST. Bifurcation stenting in the setting of acute myocardial infarction was an independent risk factor for angiographic ST in the entire population (odds ratio [OR] 12.9, 95% CI 4.7 to 35.8, p < 0.001). In patients with DES who had angiographic ST, 30-day mortality was 15%, whereas another 60% suffered a nonfatal myocardial infarction; no further deaths occurred during six months of follow-up. Including possible cases, 7 BMS (1.4%, 95% CI 0.7% to 2.8%), 15 SES (1.5%, 95% CI 0.9% to 2.4%), and 16 PES (1.6%, 95% CI 1.0% to 2.6%) patients had ST.. The unrestricted use of SES or PES is associated with ST rates in the range expected for BMS. Stent thrombosis was associated with a high morbidity and mortality. Bifurcation stenting, when performed in patients with acute myocardial infarction, was associated with an increased risk of ST.

Topics: Aged; Antibiotics, Antineoplastic; Antineoplastic Agents, Phytogenic; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Cohort Studies; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Equipment Design; Female; Follow-Up Studies; Humans; Incidence; Male; Middle Aged; Multivariate Analysis; Paclitaxel; Postoperative Complications; Sirolimus; Stents; Survival Analysis; Time Factors; Treatment Outcome

We compared the risk of stent thrombosis (ST) after drug-eluting stents (DES) versus bare-metal stents (BMS), and tested the hypothesis that the risk of DES thrombosis is related to stent length.. Whether DES increase the risk of ST remains unclear. Given the very low restenosis rate after drug-eluting stenting, longer stents are frequently implanted for the same lesion length in comparison to BMS.. We included in a meta-analysis 10 randomized studies comparing DES and BMS. Overall, 5,030 patients were included (2,602 were allocated to DES and 2,428 to BMS). The risk of thrombosis after DES versus BMS was compared, and the relationship between the rate of DES thrombosis and stent length was evaluated.. Incidence of ST was not increased in patients receiving DES (0.58% vs. 0.54% for BMS; odds ratio: 1.05; 95% confidence interval [CI]: 0.51 to 2.15; p = 1.000). The overall rate of ST did not differ significantly between patients receiving sirolimus- or paclitaxel-eluting stents (0.57% vs. 0.58%; p = 1.000). We found a significant relation between the rate of ST and the stented length (Y = -1.455 + 0.121 X; 95% CI for beta: 0.014 to 0.227; R = 0.716; p = 0.031). In patients with DES, mean stented length was longer in those suffering ST (23.4 +/- 8.1 mm vs. 21.3 +/- 4.1 mm, p = 0.025).. Drug-eluting stents do not increase the risk of ST, at least under appropriate anti-platelet therapy. The risk of ST after DES implantation is related to stent length.

Topics: Antibiotics, Antineoplastic; Antineoplastic Agents, Phytogenic; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Thrombosis; Equipment Design; Follow-Up Studies; Humans; Paclitaxel; Postoperative Complications; Risk Factors; Sirolimus; Statistics as Topic; Stents; Treatment Outcome

We sought to determine the safety and efficacy of using multiple overlapping drug-eluting stents (DES) in patients with diffuse left anterior descending coronary artery (LAD) disease.. Diffuse LAD disease represents a therapeutic challenge. Results after coronary artery bypass surgery are suboptimal, whereas the use of bare metal stents is limited by high rates of restenosis. The introduction of DES prompted treatment of long diffuse disease with multiple overlapping stents.. All consecutive patients with de novo diffuse LAD disease treated with more than 60-mm long DES from April 2002 to March 2004 were analyzed.. The study population consisted of 66 patients. Thirty-nine patients were treated with sirolimus-eluting stents (SES), average length 84 +/- 22 mm, and 27 patients with paclitaxel-eluting stents (PES), average length 74 +/- 14 mm. The number of stents implanted per patient was 2.8 +/- 0.7, whereas the mean total stent length for the LAD treatment was 80 +/- 20 mm. Angiographic as well as procedural success was achieved in 95% of cases. Eleven (16.6%) patients had in-hospital non-Q-wave myocardial infarction (five SES and six PES), and one patient developed intraprocedural stent thrombosis. All patients had clinical follow-up, and 52 patients (79%) had an angiographic follow-up at six months. Hierarchical major adverse cardiac event rate was 15% (7.5% for SES and 7.5% for PES). No patients died, one patient had non-Q-wave myocardial infarction (non-index vessel), and 10 patients (15%) underwent target vessel revascularization.. The implantation of multiple overlapping DES in patients with a diffusely diseased LAD is relatively safe and associated with good midterm clinical outcomes.

Topics: Administration, Topical; Aged; Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Sirolimus; Stents; Treatment Outcome

Diabetes mellitus is a well-known risk factor for future adverse cardiac events after coronary intervention with conventional metal stents. In this study, the impact of sirolimus-eluting stents (SES) were evaluated in a consecutive group of diabetic patients undergoing elective percutaneous coronary treatment and compared to a population treated with bare metal stents.. From April 2002, a policy of routine SES implantation has been instituted in our hospital. During 1 year of enrollment, a total of 112 consecutive diabetic patients with de novo coronary lesions were electively treated with SES (SES group). A similar group for comparison comprised 118 consecutive patients treated with bare metal stents in the preceding period (the pre-SES group). After 1-year follow-up, the cumulative rate of major adverse cardiac events (death, myocardial infarction, and any repeat revascularization) was 17.3% in the SES group versus 30.2% in the pre-SES group (hazard ratio, 0.54 [95% confidence interval, 0.32-0.91]; p = 0.02), mainly due to a marked reduction in the need for repeat revascularization (10.2% versus 23.5%; hazard ratio, 0.40 [95% confidence interval, 0.21-0.78]; p = 0.007).. Routine utilization of SES for diabetic patients significantly reduces the rate of adverse cardiac events at 1 year compared to bare metal stents.

Topics: Aged; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coronary Artery Disease; Coronary Restenosis; Diabetes Complications; Drug Delivery Systems; Female; Humans; Male; Middle Aged; Myocardial Infarction; Proportional Hazards Models; Prospective Studies; Reoperation; Risk Factors; Sirolimus; Stents; Treatment Outcome

The aim of the study was to compare the angioplasty mechanisms of drug (sirolimus)-eluting stent (DES) implantation and vascular brachytherapy (VBT) for the treatment of in-stent restenosis (ISR) as assessed by intravascular ultrasound (IVUS).. We performed IVUS in 53 patients (28 DES, 25 VBT) before and after angioplasty of ISR and at 6-month follow-up. Cross-sectional areas of the external elastic membrane, the stent, and the lumen were measured. Plaque + media, peristent plaque, and intimal hyperplasia areas were calculated, respectively.. Clinical and IVUS baseline characteristics did not differ between groups at baseline. After the index procedure, the lumen at the stent site was smaller in the DES group (DES 6.7 +/- 2.0 mm2 vs VBT 7.5 +/- 2.2 mm2, P = .042). Because of less intimal hyperplasia (DES 0.2 +/- 0.5 mm2 vs VBT 0.7 +/- 0.7 mm2, P = .043), the lumen dimensions revealed no difference between groups at follow-up (DES 6.5 +/- 2.3 mm2 vs VBT 6.8 +/- 2.2 mm2, P = .374). At the reference site, the index procedure led to a similar increase of plaque + media (DES 0.9 +/- 0.9 mm2 vs VBT 0.6 +/- 1.2 mm2, P = .150). At follow-up, the plaque + media was significantly smaller in the DES group (DES 8.0 +/- 6.6 mm2 vs VBT 9.9 +/- 7.8 mm2, P = .013).. Drug-eluting stent for the treatment of ISR more effectively inhibits neointima formation when compared with VBT. Yet insufficient stent expansion might be a reason for device failure and should be avoided. At the reference site, lumen loss by an increased plaque burden, as has been well recognized following VBT, is not present with DES.

Topics: Aged; Angioplasty, Balloon; Beta Particles; Brachytherapy; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug Implants; Female; Follow-Up Studies; Humans; Hyperplasia; Male; Middle Aged; Sirolimus; Stents; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

Randomized clinical trials have shown that sirolimus-eluting stents (SESs) decrease restenosis rates compared with bare metal stents (BMSs), but their efficacy among patients who have diabetes mellitus remains to be established. This study investigated the effect of SES implantation in a high-risk population (i.e., patients who had diabetes and small coronary vessel disease). For this purpose, we analyzed outcomes of the subset of patients who had diabetes and were enrolled in the SES-SMART, a randomized trial that compared the results of implantation of SESs and BMSs in small coronary arteries. Twenty-nine patients who had diabetes were originally randomized to receive SESs and 45 patients received BMSs. The use of SESs was associated with approximately 60% decreases in the relative incidence of in-segment angiographic restenosis (63% vs 25%, p = 0.003) and in-segment late loss (0.76 vs 0.28 mm, p <0.002). Angiographic patterns of restenosis were more favorable in the SES group. SES implantation was associated with a 15% absolute decrease in adverse clinical events. In patients who had insulin-dependent diabetes mellitus, SESs showed a high in-segment restenosis rate (40%) that was principally due to persistent restenosis. In conclusion, in diabetics with small coronary arteries, SES implantation significantly reduces the incidence of the 8-month angiographic restenosis rate compared with BMSs.

Topics: Aged; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Disease-Free Survival; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Postoperative Complications; Single-Blind Method; Sirolimus; Stents; Survival Rate; Treatment Outcome

A total of 91 patients with 112 lesions received 2.25-mm sirolimus-eluting stents (SESs), and these lesions were compared with those treated with SESs of > or =2.5-mm diameter in the same procedure (n = 109). The reference diameters were 1.88 +/- 0.34 and 2.52 +/- 0.57 mm, respectively (p <0.01). At follow-up, the late lumen loss was 0.07 +/- 0.48 mm for the 2.25-mm SES versus 0.03 +/- 0.38 mm for the larger SES (p = 0.5), and the binary restenosis rate was 10.7% versus 3.9%, respectively (p = 0.1). The 12-month target lesion revascularization rate was 5.5%. In conclusion, 2.25-mm SESs were associated with low rates of clinical and angiographic late complications.

Topics: Aged; Coronary Artery Disease; Equipment Design; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Middle Aged; Radiography; Registries; Sirolimus; Stents; Treatment Outcome

We assessed the safety and effectiveness of the sirolimus-eluting stent (SES) in treating single de novo long lesions in small native coronary arteries compared to an identical bare metal stent (BMS).. The SES was previously demonstrated to reduce restenosis significantly. However, patients with long lesions in small vessels have not been well studied and may define a group at very high risk.. The Canadian Study of the Sirolimus-Eluting Stent in the Treatment of Patients With Long De Novo Lesions in Small Native Coronary Arteries (C-SIRIUS) was a multicenter, randomized, double-blind trial comparing SES versus identical BMS. The primary end point was in-stent minimal lumen diameter (MLD) at eight months. Secondary end points included angiographic restenosis at 8 months, target lesion revascularization (TLR), and major adverse cardiac events (MACE) at 270 days.. A total of 100 patients were enrolled at eight Canadian sites. The in-stent MLD at eight months was 2.46 +/- 0.37 mm in the SES compared with 1.49 +/- 0.75 mm in the BMS (a 65% increase, p < 0.001). Angiographic restenosis occurred in 1 of 44 SES patients (2.3%, with no in-stent restenosis) and in 23 of 44 BMS patients (52.3%, p < 0.001). At 270 days, there were two clinically driven TLRs in the SES (4%) and nine in the BMS (18%, p = 0.05). The Kaplan-Meier estimate of freedom from MACE at 270 days was 96.0% for SES patients and 81.7% for BMS patients (p = 0.029).. Patients with long lesions in small vessels are at very high risk of restenosis. In these patients, the SES dramatically reduces the risk of restenosis at eight months, translating into an excellent clinical outcome at nine months.

Topics: Angioplasty, Balloon, Coronary; Canada; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Double-Blind Method; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Stents; Survival Analysis; Treatment Outcome

Sirolimus reduces acute rejection in renal transplant recipients and prevents vasculopathy in nonhuman primates and in-stent restenosis in humans. Its effects on rejection and transplant vasculopathy in human heart transplant recipients are unknown.. In a randomized, open-label study, sirolimus was compared with azathioprine in combination with cyclosporine and steroids administered from the time of cardiac transplantation. We report 6-month rejection rates (primary end point), 12-month safety and efficacy data, and 6- and 24-month graft vasculopathy data in 136 cardiac allograft recipients randomly assigned (2:1) to sirolimus (n=92) or azathioprine (n=44). At 6 months, the proportion of patients with grade 3a or greater acute rejection was 32.4% for sirolimus 3 mg/d (P=0.027), 32.8% for sirolimus 5 mg/d (P=0.013), and 56.8% for azathioprine. Patient survival at 12 months was comparable among groups. Intracoronary ultrasound at 6 weeks, 6 months, and 2 years demonstrated highly significant progression of transplant vasculopathy in azathioprine-treated patients. At 6 months, a highly significant absence of progression in intimal plus medial proliferation and significant protection against luminal encroachment was evident in sirolimus-treated patients, and these effects were sustained at 2 years.. Sirolimus use from the time of transplantation approximately halved the number of patients experiencing acute rejection. The measurable development of transplant vasculopathy at 6 months and 2 years in patients receiving azathioprine was not observed in patients receiving sirolimus.

Topics: Acute Disease; Adult; Azathioprine; Coronary Artery Disease; Creatinine; Follow-Up Studies; Graft Rejection; Heart Transplantation; Humans; Immunosuppressive Agents; Infections; Lipids; Sirolimus; Survival Analysis; Ultrasonography

The aim of this study was to establish safety and feasibility of oral Rapamycin at two doses-2 mg and 5 mg-in achieving low rates of repeat target lesion revascularization (TLR) in de novo native coronary artery lesions.. Drug-eluting stents have shown the ability to limit restenosis. Oral Rapamycin is an alternative strategy that can target multiple coronary lesions suitable for treatment with any approved metal stent and at potentially lower cost.. The Oral Rapamune to Inhibit Restenosis (ORBIT) study is an open-label study of 60 patients with de novo lesions treated with bare metal stents in up to two vessels. After a loading dose of 5 mg, patients received a daily dose of 2 mg (n = 30) and 5 mg (n = 30) for 30 days. Six-month angiographic, intravascular ultrasound (IVUS), and clinical follow-up were conducted.. Baseline clinical and procedural characteristics were similar: 10% of patients in the 2-mg group and 30% in the 5-mg group did not complete the course; 43% in the 2-mg group and 66% in the 5-mg group had side effects. At six-month follow-up, late loss (0.6 +/- 0.5 mm vs. 0.7 +/- 0.5 mm; p = NS), in-stent binary restenosis (7.1% vs. 6.9%; p = NS), in-stent percent volume obstruction by IVUS (29% vs. 24%; p = NS), and clinically driven TLR (14.3% vs. 6.9%; p = NS) were similar in 2-mg and 5-mg groups.. Oral Rapamycin for the prevention of restenosis is safe, feasible, and associated with low rates of repeat revascularization. Although associated with certain side effects, it may be considered for patients undergoing multivessel stents if proven in larger randomized studies.

Topics: Administration, Oral; Aged; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Middle Aged; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional

Percutaneous coronary revascularization of small vessels is associated with a high restenosis rate. Sirolimus-eluting stents reduce restenosis in simple and previously untreated lesions of large coronary arteries, but their outcomes in small vessels have not been adequately investigated.. To determine whether sirolimus-eluting stents are associated with a reduced 8-month rate of angiographic restenosis in comparison with an uncoated stent.. This was a randomized, multicenter, single-blind, prospective trial performed with 257 patients undergoing percutaneous coronary revascularization for ischemic heart disease, and who had a previously untreated atherosclerotic lesion located in a small segment with a diameter of 2.75 mm or less, in 20 Italian centers between August 2002 and December 2003.. Patients were randomly assigned to receive a sirolimus-eluting stent (129 patients) or an uncoated stent having an identical architecture and radiographic appearance (128 patients).. The primary end point was the 8-month binary in-segment restenosis rate; secondary end points included procedural success and the 8-month rate of major adverse cardiac and cerebrovascular events.. The mean (SD) reference diameter of the treated segment was 2.2 (0.28) mm; the lesion length, 11.84 (6.15) mm. After 8 months, the binary in-segment restenosis rate was 53.1% (60/113) in the patients receiving an uncoated stent and 9.8% (12/123) in those receiving a sirolimus-eluting stent (relative risk [RR], 0.18; 95% confidence interval [CI], 0.10-0.32; P<.001). Fewer patients randomized to sirolimus-eluting stents experienced major adverse cardiac events (12/129 [9.3%] vs 40/128 [31.3%]; RR, 0.30; 95% CI, 0.15-0.55; P<.001) mainly because of a reduction in target lesion revascularization (9/129 [7%] vs 27/128 [21.1%]; RR, 0.33; 95% CI, 0.14-0.70; P = .002) and myocardial infarction (2/129 [1.6%] vs 10/129 [7.8%]; RR, 0.20; 95% CI, 0.01-0.93; P = .04).. The use of sirolimus-eluting stents to treat atherosclerotic lesions in small coronary arteries reduces restenosis and may also reduce major adverse cardiac events.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Radiography; Single-Blind Method; Sirolimus; Stents

From April 16, 2002 to October 16, 2002, 10 consecutive patients with coronary disease on chronic dialysis were treated with sirolimus-eluting stents. Diabetes was present in 30% and half of the patients had multivessel coronary disease. On average, patients had been on dialysis for 5 years prior to the procedure (range: 2-15 years). Five patients were on hemodialysis and 5 patients were on peritoneal dialysis. Overall, 18 lesions were treated with 1.9 +/- 1.1 sirolimus-eluting stents per patient. At a mean follow-up of 403 days, there were no cases of death, myocardial infarction, or target lesion revascularization.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Prospective Studies; Renal Dialysis; Sirolimus; Stents; Treatment Outcome

The safety and efficacy of sirolimus-eluting stenting have been demonstrated, but the outcome of patients treated with this novel technology beyond the first year remains unknown. We sought to evaluate the angiographic, intravascular ultrasound (IVUS), and clinical outcomes of patients treated with sirolimus-eluting stents 2 years after implantation.. This study included 30 patients treated with sirolimus-eluting Bx Velocity stenting (slow release [SR], n=15, and fast release [FR], n=15) in São Paulo, Brazil. Twenty-eight patients underwent 2-year angiographic and IVUS follow-up. No deaths occurred during the study period. In-stent late loss was slightly greater in the FR group (0.28+/-0.4 mm) than in the SR group (-0.09+/-0.23 mm, P=0.007). No patient had in-stent restenosis. At 2-year follow-up, only 1 patient (FR group) had a 52% diameter stenosis within the lesion segment, which required repeat revascularization. The target-vessel revascularization rate for the entire cohort was 10% (3/30) at 2 years. All other patients had < or =35% diameter stenosis. Angiographic lumen loss at the stent edges was also minimal (in-lesion late loss was 0.33+/-0.42 mm [FR] and 0.13+/-0.29 mm [SR]). In-stent neointimal hyperplasia volume, as detected by IVUS, remained minimal after 2 years (FR= 9.90+/-9 mm3 and SR=10.35+/-9.3 mm3).. This study demonstrates the safety and efficacy of sirolimus-eluting Bx Velocity stents 2 years after implantation in humans. In-stent lumen dimensions remained essentially unchanged at 2-year follow-up in the 2 groups, although angiographic lumen loss was slightly higher in the FR group. Restenosis "catch-up" was not found in our patient population.

Topics: Combined Modality Therapy; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Delayed-Action Preparations; Follow-Up Studies; Humans; Sirolimus; Stents; Treatment Outcome; Ultrasonography

Cardiac transplantation vasculopathy is the leading cause of late death in heart transplantation recipients. Rapamycin is an immunosuppressant drug with potent antiproliferative and antimigratory effects. We investigated whether rapamycin could prevent progression of graft vasculopathy in 46 patients (age, 54+/-10 years; 4.3+/-2.3 years after transplantation) with severe disease.. At annual cardiac catheterization, patients were randomly assigned to treatment with rapamycin (n=22) versus continued current immunosuppression (n=24). Clinical characteristics including recipient age and sex, underlying cause of congestive heart failure, donor age and sex, and ischemic time were recorded. Cardiac catheterization was graded with the use of a semiquantitative scale and repeated annually. Clinically significant adverse events were defined as death, need for angioplasty or bypass surgery, myocardial infarction, and a >25% worsening of the catheterization score. These events were monitored as primary study end points. Anti-HLA class I and II antibody production and lymphocyte growth assays were measured with each biopsy. Patients selected for rapamycin had azathioprine or mycophenolate mofetil discontinued and were given rapamycin. Outcomes were compared by means of log-rank analysis. There were no significant differences in baseline characteristics. Duration of follow-up was comparable (rapamycin, 689+/-261; control, 630+/-207 days; NS). In the rapamycin group, 3 patients reached primary end points versus 14 patients in the control group (P<0.001). There was no difference in baseline or subsequent anti-HLA class I or II antibody production.. In this patient cohort with cardiac vasculopathy, treatment with rapamycin slowed disease progression probably by its antiproliferative and antimigratory effects.

Topics: Arterial Occlusive Diseases; Autoantibodies; Cardiac Catheterization; Cohort Studies; Coronary Artery Disease; Cyclosporine; Disease Progression; Female; Graft Rejection; Heart Transplantation; Humans; Immunosuppressive Agents; Infections; Male; Middle Aged; Neoplasms; Prospective Studies; Renal Insufficiency; Sirolimus; Survival Analysis; Treatment Outcome

Drug eluting stents represent one of the fastest growing fields in interventional cardiology today. From a recent study, the sirolimus eluting stent (SES) (CYPHER, Cordis, Johnson & Johnson) appear to demonstrate a remarkable efficacy and safety in preventing restenosis. From the present study, the authors reported clinical experience of SES in 40 consecutive patients with coronary artery disease (CAD) between 25th June and 11th October, 2002. The mean age was 59 +/- 12.16 years (mean +/- SD) and 80 per cent of the patients were male. The majority of the patients had chronic stable angina and most percutaneous coronary interventions were performed by elective procedure (85%). Thirty-five per cent of the patients had single vessel disease and 42.5 per cent of the patients had double vessel disease. The authors successfully implanted 52 (69.3%) SES in 75 target lesions revascularization. Twenty-four (60%) of the patients had more than 1 vessel intervention. Twenty-seven (67.5%) of the patients had complete revascularization by percutaneous coronary intervention (PCI) and only 16 of 27 patients (59.3%) who had complete revascularization with SES. The SES were usually implanted at middle part of the left anterior descending artery (MLAD) (11 lesions), proximal part of the left anterior descending artery (PLAD) (8 lesions), middle part of the right coronary artery (MRCA) (8 lesions) and middle part of the left circumflex artery (MLCX) (6 lesions). The authors had to cover plaque entirely with SES, so SES implantation usually took longer than the bare stent (BS). The authors followed the initial clinical outcome of the patients within 1 month after discharge. Few adverse clinical events were found during 1 month follow-up because SES have a very low rate of restenosis in the short-term so, we have to follow-up the patients over a longer period and will report the clinical outcome in the next study.

Topics: Aged; Blood Vessel Prosthesis Implantation; Coronary Artery Disease; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Middle Aged; Outcome Assessment, Health Care; Sirolimus; Stents; Thailand

The present study reports on the clinical outcome of 31 consecutive patients with left main coronary artery disease treated with a sirolimus-eluting stent. The implantation of this stent was associated with abolition of post-discharge fatal events and percutaneous reintervention.

Topics: Aged; Blood Vessel Prosthesis Implantation; Coronary Artery Disease; Drug Implants; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Postoperative Complications; Reoperation; Sirolimus; Stents; Survival Analysis; Treatment Outcome

Sirolimus-eluting stents have been developed to prevent restenosis in the treatment of coronary artery disease. We investigated the risk of restenosis with use of sirolimus-eluting stents compared with bare-metal stents to assess possible differences.. We enrolled 352 patients in whom one coronary artery required treatment, with diameter 2.5-3.0 mm and lesion length 15-32 mm. We randomly assigned patients sirolimus-eluting stents (n=175) or bare-metal stents (control, n=177). At 8 months we assessed differences in minimum lumen diameter and binary restenosis within the lesion (restenosis of > or =50% diameter, including 5 mm vessel segments proximal and distal to stented segment). Patients were also followed up for 9 months for major adverse cardiac events. Analysis was by intention to treat.. Stent implantation was successful in 100% of sirolimus-stent patients and 99.4% of controls. The mean diameter of treated coronary arteries was 2.55 mm (SD 0.37) and mean lesion length was 15.0 mm (6.0). Multiple stents were implanted in 170 (48%) patients. At 8 months, minimum lumen diameter was significantly higher with sirolimus-eluting stents than with control stents (2.22 vs 1.33 mm, p<0.0001). The rate of binary restenosis was significantly reduced with sirolimus-eluting stents compared with control stents (5.9 vs 42.3%, p=0.0001). Significantly fewer patients with sirolimus-eluting stents had major adverse cardiac events at 9 months than did controls (8.0 vs 22.6%, p=0.0002), due mainly to a lower need for target-lesion revascularisations (4.0 vs 20.9%, p<0.0001).. Sirolimus-eluting stents are better than bare-metal stents for treatment of single long atherosclerotic lesions in a coronary vessel smaller than 3 mm in diameter.

Topics: Angioplasty, Balloon; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Female; Humans; Immunosuppressive Agents; Male; Metals; Middle Aged; Sirolimus; Stents; Treatment Outcome

The goal of this intravascular ultrasound investigation was to provide a more detailed morphological analysis of the local biological effects of the implantation of a sirolimus-eluting stent compared with an uncoated stent.. In the RAVEL trial, 238 patients with single de novo lesions were randomized to receive either an 18-mm sirolimus-eluting stent (Bx VELOCITY stent, Cordis) or an uncoated stent (Bx VELOCITY stent). In a subset of 95 patients (sirolimus-eluting stent=48, uncoated stent=47), motorized intravascular ultrasound pullback (0.5 mm/s) was performed at a 6-month follow-up. Stent volumes, total vessel volumes, and plaque-behind-stent volumes were comparable. However, the difference in neointimal hyperplasia (2+/-5 versus 37+/-28 mm3) and percent of volume obstruction (1+/-3% versus 29+/-20%) at 6 months between the 2 groups was highly significant (P<0.001), emphasizing the nearly complete abolition of the proliferative process inside the drug-eluting stent. Analysis of the proximal and distal edge volumes showed no significant difference between the 2 groups in external elastic membrane or lumen and plaque volume at the proximal and distal edges. There was also no evidence of intrastent thrombosis or persisting dissection at the stent edges. Although there was a higher incidence of incomplete stent apposition in the sirolimus group compared with the uncoated stent group (P<0.05), it was not associated with any adverse clinical events at 1 year.. Sirolimus-eluting stents are effective in preventing neointimal hyperplasia without creating edge effect and without affecting the plaque burden behind the struts.

Topics: Blood Vessel Prosthesis Implantation; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Double-Blind Method; Drug Administration Routes; Female; Follow-Up Studies; Humans; Hyperplasia; Male; Middle Aged; Sirolimus; Stents; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional; Vascular Patency

Early results of sirolimus-eluting stent implantation showed a nearly complete abolition of neointimal hyperplasia. The question remains, however, whether the early promising results will still be evident at long-term follow-up. The objective of our study was to evaluate the efficiency of sirolimus-eluting stent implantation for up to 2 years of follow-up.. Fifteen patients with de novo coronary artery disease were treated with 18-mm sirolimus-eluting Bx-Velocity stents (Cordis) loaded with 140 microg sirolimus/cm2 metal surface area in a slow release formulation. Quantitative angiography (QCA) and intravascular ultrasound (IVUS) were performed according to standard protocol. Sirolimus-eluting stent implantation was successful in all 15 patients. During the in-hospital course, 1 patient died of cerebral hemorrhage after periprocedural administration of abciximab, and 1 patient underwent repeat stenting after 2 hours because of edge dissection that led to acute occlusion. Through 6 months and up to 2 years of follow-up, no additional events occurred. QCA analysis revealed no significant change in stent minimal lumen diameter or percent diameter stenosis, and 3-dimensional IVUS showed no significant deterioration in lumen volume. In 2 patients, additional stenting was performed because of significant lesion progression remote from the sirolimus-eluting stent.. Sirolimus-eluting stents showed persistent inhibition of neointimal hyperplasia for up to 2 years of follow-up.

Topics: Abciximab; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Blood Vessel Prosthesis Implantation; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Implants; Female; Follow-Up Studies; Humans; Hyperplasia; Immunoglobulin Fab Fragments; Immunosuppressive Agents; Male; Middle Aged; Platelet Aggregation Inhibitors; Reoperation; Sirolimus; Stents; Time; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

The sirolimus-eluting stent (SES) is emerging as a potential solution for the prevention of restenosis. Although the outcome of side branches after stenting with an uncoated metal stent (UMS) has been reported, the fate of side branches after SES implantation is unknown. Furthermore, the absence of spontaneous recanalization of occluded side branches following intracoronary brachytherapy has been previously described and has been related to a delayed healing process. We assessed the procedural and 6-month follow-up angiograms of 238 patients enrolled in the RAVEL study, a double-blind controlled trial of the SES versus the UMS. Any side branch seen on the preprocedure angiogram and subsequently covered by the stent was evaluated. The side branch Thrombolysis In Myocardial Infarction (TIMI) flow grade was assessed at baseline and at follow-up by 2 observers. One hundred twenty-eight patients with > or =1 side branches were identified (63 patients in the SES group with 118 side branches, 65 patients in the UMS group with 124 side branches). Side branch occlusion occurred after stenting in 12 branches (10%) in the SES group and in 9 branches (7%) in the UMS group (p = NS). Of these occluded branches, spontaneous recanalization was observed in 11 branches (92%) in the SES group and in 6 branches (67%) in the UMS group at follow-up angiography (p = NS). Thus, the fate of side branches after SES implantation is favorable and at least as good as after UMS implantation.

Topics: Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Combined Modality Therapy; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Double-Blind Method; Follow-Up Studies; Humans; Immunosuppressive Agents; Predictive Value of Tests; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional

Provisional stenting is preferred for bifurcation lesion; however, certain anatomical substrate does require two stents as a part of dedicated stent technique. Here, the present study evaluated outcomes of ultra-thin (60 µm) Supra family sirolimus-eluting stent (SES) (Sahajanand Medical Technologies Limited, Surat, India) for dedicated bifurcation lesions using nano-crush technique at 12 months angiographic follow-up.. This was prospective, single-center observational study which enrolled patients with de novo bifurcation lesion and underwent angioplasty with Supra family SES using nano-crush technique at a tertiary care center in India, between March-2017 and February-2019. Primary endpoint at 12 months was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (CD-TLR). Secondary endpoints included patient-oriented composite endpoint (POCE), all-cause death, any revascularization, clinically driven target vessel revascularization, stent thrombosis, periprocedural and spontaneous MI, and device failure.. The study enrolled total 63 patients with a mean age of 62.5±4.9 years and had male dominance (89%). Left main (LM) bifurcation and non-LM bifurcation were observed in 21 (33%) and 42 (67%) patients, respectively. Total 50 (80%) patients had Medina class- 1,1,1. At 12 months, TLF occurred in 4 (6%) patients which included one cardiac death (1.5%), two (3.0%) TV-MI, and one CD-TLR (1.5%). POCE was observed in 6 (9.6%) patients. Stent failure was seen in 2 (3.1%) patient and one patient (1.5%) developed late stent thrombosis. Twelve months angiographic follow-up indicated intact stent patency in all other patients. On multivariate analysis, LM bifurcation, renal dysfunction, LM bifurcation with renal dysfunction, ejection fraction (<35%) and calcified lesion were found as predictors of TLF.. Dedicated stenting with ultra-thin Supra family SES for complex bifurcation lesion using nano-crush technique reported acceptable clinical outcomes among real-world patients and can be performed safely with ease without any procedural complications.

Topics: Aged; Coronary Artery Disease; Death; Drug-Eluting Stents; Humans; Kidney Diseases; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Stents; Thrombosis; Treatment Outcome

The aim of this study is to evaluate the long-term safety and efficacy of the 2.25 mm bioresorbable-polymer sirolimus-eluting Ultimaster stent in a Japanese patient population. Treatment of coronary artery disease in very small vessels is associated with an increased risk for cardiac events. The CENTURY JSV study is a prospective, multicenter, single-arm study. Seventy patients with stable and unstable coronary artery disease with a coronary lesion eligible for implantation with a 2.25 mm stent were enrolled in this study. Patients underwent clinical follow-up through 5-year after the PCI procedure. The mean age was 70.4 ± 9.2 years. The prevalence of diabetes mellitus was 37.1%, all not insulin dependent. The incidence of major adverse cardiac events, defined as cardiac death, target vessel myocardial infarction (MI), and clinically driven target lesion revascularization (CD-TLR) at 5 years was 5.7%. A non-Q wave MI was noted in 1.4% and 4.3% underwent a CD-TLR. There was no stent thrombosis during the entire follow-up period. No cardiac events were reported between 2 and 5 years. This is the first study to demonstrate safety and effectiveness for 5 years after treatment of very small coronary disease with 2.25 mm-diameter DES.Clinical trial registration: UMIN000012928.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; East Asian People; Humans; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Treatment Outcome

Remodeling of the coronary arteries is a common feature in severe cases of Kawasaki disease (KD). This pathology is driven by the dysregulated proliferation of vascular fibroblasts, which can lead to coronary artery aneurysms, stenosis, and myocardial ischemia. We undertook this study to investigate whether inhibiting fibroblast proliferation might be an effective therapeutic strategy to prevent coronary artery remodeling in KD.. We used a murine model of KD (induced by the injection of the Candida albicans water-soluble complex [CAWS]) and analyzed patient samples to evaluate potential antifibrotic therapies for KD.. We identified the mechanistic target of rapamycin (mTOR) pathway as a potential therapeutic target in KD. The mTOR inhibitor rapamycin potently inhibited cardiac fibroblast proliferation in vitro, and vascular fibroblasts up-regulated mTOR kinase signaling in vivo in the CAWS mouse model of KD. We evaluated the in vivo efficacy of mTOR inhibition and found that the therapeutic administration of rapamycin reduced vascular fibrosis and intimal hyperplasia of the coronary arteries in CAWS-injected mice. Furthermore, the analysis of cardiac tissue from KD fatalities revealed that vascular fibroblasts localizing with inflamed coronary arteries up-regulate mTOR signaling, confirming that the mTOR pathway is active in human KD.. Our findings demonstrate that mTOR signaling contributes to coronary artery remodeling in KD, and that targeting this pathway offers a potential therapeutic strategy to prevent or restrict this pathology in high-risk KD patients.

Topics: Animals; Coronary Artery Disease; Coronary Vessels; Disease Models, Animal; Humans; Mice; Mucocutaneous Lymph Node Syndrome; Sirolimus; TOR Serine-Threonine Kinases

Topics: Atherectomy, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Treatment Outcome

The polymer-free biolimus coated stent (BioFreedom) was shown to be superior to bare metal stents in the LEADERS FREE randomized trial in high bleeding risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT). However, there is limited outcome data with this device in an all-comers' population.. We conducted a prospective single-arm study of patients undergoing percutaneous coronary intervention with the polymer-free biolimus coated stent in 25 centers in France with wide inclusion criteria including multivessel disease, complex lesions, and acute coronary syndromes. The primary endpoint was the incidence of target lesion failure (TLF), a composite of cardiac death or target-vessel myocardial infarction (MI) or clinically indicated target lesion revascularization (ci-TLR) at 1-year. The patient population was classified according to the presence (or not) of HBR criteria according to the recent ARC-HBR definition.. Between April 2019 and April 2020, 1497 patients were enrolled. TLF occurred in 101 (6.9%) patients, including cardiac death in 35 (2.4%), target vessel MI in 20 (1.4%) and ci-TLR in 65 (4.5%) of them. There were 491 HBR patients (32.8%) and 1006 non-HBR patients. The median duration of DAPT was 74 days in the HBR group versus 348 days in the non-HBR group (p < 0.0001). TLF occurred in 44 (9.2%) of the HBR group and in 57 (5.8%) of the non-HBR group (relative risk 1.62 [95% confidence interval: 1.10-2.41], p = 0015). Compared to the non-HBR group, HBR patients had higher rates of cardiac death (4.4% vs. 1.4%, p = 0.0005) and target vessel MI (2.9% vs. 0.6%, p = 0.0003), but similar rates of ci-TLR. BARC 3-5 bleeding occurred in 6.2% of the HBR group versus 1.4% of the non-HBR group (p < 0.0001).. In this multicenter all-comers study, HBR patients treated with a polymer-free biolimus coated stent had, compared to non-HBR patients, an increased risk of cardiac death and MI, and despite a shorter duration of DAPT, continued to have higher rates of BARC 3-5 bleeding.

Topics: Coronary Artery Disease; Death; Drug-Eluting Stents; France; Hemorrhage; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

Little is known about intravascular imaging predictors of cardiac events after drug-eluting stent (DES) implantation in hemodialysis (HD) patients. We aimed to reveal the association between calcified nodules (CN) and target lesion failure (TLF) in HD patients after DES implantation.. We enrolled 114 HD patients who underwent DES implantation between October 2016 and October 2020. The patients were divided into a CN group (39%, 44 patients) and a non-CN group (61%, 70 patients). The primary endpoint was the incidence of TLF, including cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization.. HD duration was longer, and the calcium burden was higher in the CN group than in the non-CN group. Over a median follow-up of 607 days [interquartile range: 349-965 days], the cumulative incidence curve showed that the CN group had a significantly higher incidence of TLF than the non-CN group (31.8% vs. 11.4% within 3 years, p = 0.008).　On Fine-Gray sub-distribution hazard model analysis, the CN group was associated with an increased rate of TLF (hazard ratio [HR]: 2.86; 95% confidence interval [CI]: 1.21-6.75, p = 0.016). An in-stent CN was observed in 73% of the lesions with target lesion revascularization in the CN group, whereas no in-stent CN was observed in the non-CN group (p = 0.026).. CN was an independent predictor of TLF in patients undergoing HD. In-stent CN was an important cause of TLF after DES implantation in CN lesions in HD patients; therefore, a different strategy should be considered for treating the lesions.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Renal Dialysis; Sirolimus; Treatment Outcome

We aimed to evaluate the long-term outcomes of the novel NeoVas sirolimus-eluting bioresorbable scaffold (BRS) for the treatment of de novo coronary artery disease.. The long-term safety and efficacy of the novel NeoVas BRS are still needed to be elucidated.. A total of 1103 patients with de novo native coronary lesions for coronary stenting were enrolled. The primary endpoint of target lesion failure (TLF) was defined as a composite of cardiac death (CD), target vessel myocardial infarction (TV-MI), or ischemia-driven-target lesion revascularization (ID-TLR).. A three-year clinical follow-up period was available for 1,091 (98.9%) patients. The cumulative TLF rate was 7.2% with 0.8% for CD, 2.6% for TV-MI, and 5.1% for ID-TLR. Additionally, 128 (11.8%) patient-oriented composite endpoint and 11 definite/probable stent thromboses (1.0%) were recorded.. The extended outcomes of the NeoVas objective performance criterion trial demonstrated a promising 3-year efficacy and safety of the NeoVas BRS in low-risk patients with low complexity in terms of lesions and comorbidities.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

Topics: Absorbable Implants; Coronary Artery Disease; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Pilot Projects; Polymers; Prosthesis Design; Sirolimus; Treatment Outcome; Troponin

A decade ago, the iopromide-paclitaxel coated balloon (iPCB) was added to the cardiologist's toolbox to initially treat in-stent restenosis followed by the treatment of de novo coronary lesions. In the meantime, DES technologies have been substantially improved to address in-stent restenosis and thrombosis, and shortened anti-platelet therapy. Recently, sirolimus-coated balloon catheters (SCB) have emerged to provide an alternative drug to combat restenosis.. The objective of this study is to determine the safety and efficacy of a novel crystalline sirolimus-coated balloon (cSCB) technology in an unselective, international, large-scale patient population. Percutaneous coronary interventions of native stenosis, in-stent stenosis, and chronic total occlusions with the SCB in patients with stable coronary artery disease or acute coronary syndrome were included. The primary outcome variable is the target lesion failure (TLF) rate at 12 months, defined as the composite rate of target vessel myocardial infarction (TV-MI), cardiac death or ischemia-driven target lesion revascularization (TLR). The secondary outcome variables include TLF at 24 months, ischemia driven TLR at 12 and 24 months and all-cause death, cardiac death at 12 and 24 months.. Since there is a wealth of patient-based all-comers data for iPCB available for this study, a propensity-score matched analysis is planned to compare cSCB and iPCB for the treatment of de novo and different types of ISR. In addition, pre-specified analyses in challenging lesion subsets such as chronic total occlusions will provide evidence whether the two balloon coating technologies differ in their clinical benefit for the patient.. ClinicalTrials.gov Identifier: NCT04470934.

Topics: Angioplasty; Cardiovascular Agents; Clinical Trials as Topic; Constriction, Pathologic; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Paclitaxel; Sirolimus; Treatment Outcome

This study aimed to investigate the association between a combination of elevated triglyceride (TG) and reduced high-density lipoprotein cholesterol (HDL-C) levels and target lesion revascularization (TLR) following everolimus-eluting stent (EES) implantation. The adverse impact of clinical, lesion, and procedural characteristics on TLR in patients with elevated TG and reduced HDL-C levels was also assessed.. We retrospectively collected data on 3,014 lesions from 2,022 consecutive patients, who underwent EES implantation at Koto Memorial Hospital. Atherogenic dyslipidemia (AD) is defined as a combination of non-fasting serum TG ≥ 175 mg/dL and HDL-C ＜40 mg/dL.. AD was observed in 212 lesions in 139 (6.9%) patients. The cumulative incidence of clinically driven TLR was significantly higher in patients with AD than in those without AD (hazard ratio [HR] 2.31, 95% confidence interval [CI] 1.43-3.73, P=0.0006). Subgroup analysis showed that AD increased the risk of TLR with the implantation of small stents (≤ 2.75 mm). Multivariable Cox regression analysis showed that AD was an independent predictor of TLR in the small EES stratum (adjusted HR 3.00, 95% CI 1.53-5.93, P=0.004), whereas the incidence of TLR was similar in the non-small-EES stratum, irrespective of the presence or absence of AD.. Patients with AD had a higher risk of TLR after EES implantation, and this risk was greater for lesions treated with small stents.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Hypertriglyceridemia; Lipoproteins, HDL; Lipoproteins, LDL; Myocardial Infarction; Percutaneous Coronary Intervention; Retrospective Studies; Risk Factors; Sirolimus; Stents; Treatment Outcome

Data about the long-term performance of new-generation ultrathin-strut drug-eluting stents (DES) in challenging coronary lesions, such as left main (LM), bifurcation, and chronic total occlusion (CTO) lesions are scant.. The international multicenter retrospective observational ULTRA study included consecutive patients treated from September 2016 to August 2021 with ultrathin-strut (<70 µm) DES in challenging de novo lesions. Primary endpoint was target lesion failure (TLF): composite of cardiac death, target-lesion revascularization (TLR), target-vessel myocardial infarction (TVMI), or definite stent thrombosis (ST). Secondary endpoints included all-cause death, acute myocardial infarction (AMI), target vessel revascularization, and TLF components. TLF predictors were assessed with Cox multivariable analysis.. Of 1801 patients (age: 66.6 ± 11.2 years; male: 1410 [78.3%]), 170 (9.4%) experienced TLF during follow-up of 3.1 ± 1.4 years. In patients with LM, CTO, and bifurcation lesions, TLF rates were 13.5%, 9.9%, and 8.9%, respectively. Overall, 160 (8.9%) patients died (74 [4.1%] from cardiac causes). AMI and TVMI rates were 6.0% and 3.2%, respectively. ST occurred in 11 (1.1%) patients while 77 (4.3%) underwent TLR. Multivariable analysis identified the following predictors of TLF: age, STEMI with cardiogenic shock, impaired left ventricular ejection fraction, diabetes, and renal dysfunction. Among the procedural variables, total stent length increased TLF risk (HR: 1.01, 95% CI: 1-1.02 per mm increase), while intracoronary imaging reduced the risk substantially (HR: 0.35, 95% CI: 0.12-0.82).. Ultrathin-strut DES showed high efficacy and satisfactory safety, even in patients with challenging coronary lesions. Yet, despite using contemporary gold-standard DES, the association persisted between established patient- and procedure-related features of risk and impaired 3-year clinical outcome.

Topics: Aged; Coronary Artery Disease; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Retrospective Studies; Sirolimus; Stents; Stroke Volume; Treatment Outcome; Ventricular Function, Left

The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer. The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world setting.. The HELIOS registry is a prospective, multicenter, cohort study conducted at 38 centers across China between November 2018 and December 2019. A total of 3060 consecutive patients were enrolled after application of minimal inclusion and exclusion criteria. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, non-fatal target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 1-year follow-up. Kaplan-Meier methods were used to estimate the cumulative incidence of clinical events and construct survival curves.. A total of 2998 (98.0%) patients completed the 1-year follow-up. The 1-year incidence of TLF was 3.10% (94/2998, 95% closed interval: 2.54-3.78%). The rates of cardiac death, non-fatal target vessel MI and clinically indicated TLR were 2.33% (70/2998), 0.20% (6/2998), and 0.70% (21/2998), respectively. The rate of stent thrombosis was 0.33% (10/2998). Age ≥60 years, diabetes mellitus, family history of coronary artery disease, acute myocardial infarction at admission, and device success were independent predictors of TLF at 1 year.. The 1-year incidence rates of TLF and stent thrombosis were 3.10% and 0.33%, respectively, in patients treated with HELIOS stents. Our results provide clinical evidence for interventional cardiologists and policymakers to evaluate HELIOS stent.. ClinicalTrials.gov, NCT03916432.

Topics: Cardiovascular Agents; Cohort Studies; Coronary Artery Disease; Drug-Eluting Stents; Humans; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Registries; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The Genoss DES™ is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt- chromium stent platform and thin strut. Although the safety and effectiveness of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the aim of this prospective, multicenter trial was to evaluate the clinical safety and effectiveness of the Genoss DES™ in all-comer patients undergoing percutaneous coronary intervention.. The Genoss DES registry is a prospective, single-arm, observational trial for evaluation of clinical outcomes after Genoss DES™ implantation in all-comer patients undergoing percutaneous coronary intervention from 17 sites in South Korea. The primary endpoint was a device-oriented composite outcome of cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) at 12 months.. A total of 1,999 patients (66.4 ± 11.1 years of age; 72.8% male) were analyzed. At baseline, 62.8% and 36.7% of patients had hypertension and diabetes, respectively. The implanted stent number, diameter, and length per patient were 1.5 ± 0.8, 3.1 ± 0.5 mm, and 37.0 ± 25.0 mm, respectively. The primary endpoint occurred in 1.8% patients, with a cardiac death rate of 1.1%, target vessel-related MI rate of 0.2%, and clinically driven TLR rate of 0.8%.. In this real-world registry, the Genoss DES™ demonstrated excellent safety and effectiveness at 12 months among all-comer patients undergoing percutaneous coronary intervention. These findings suggest that the Genoss DES™ may be a viable treatment option for patients with coronary artery disease.

Topics: Coronary Artery Disease; Death; Drug-Eluting Stents; Female; Humans; Male; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Treatment Outcome

Ultrathin strut coronary drug-eluting stents (DES) have demonstrated improved safety and efficacy in large contemporary trials. The evaluation of an ultrathin strut DES in a post-market United States (US) patient population was undertaken.. The purpose of this post-approval study is to confirm that the clinical performance of an ultrathin strut bioresorbable polymer sirolimus-eluting stent (BP SES) in clinical practice is similar to that observed with BP SES in the BIOFLOW V pivotal trial.. BIOFLOW VII is a prospective, multicenter, single-arm US post-market approval study to confirm the clinical performance of BP SES in a real-world setting. The primary endpoint of 1-year target lesion failure (TLF) was compared with a performance goal of 6.9% based on an adapted BIOFLOW V trial BP SES TLF rate and TLF rates from other US market-released DES utilizing the Society for Cardiovascular Angiography and Interventions definition for peri-procedural myocardial infarction (MI). Subjects undergoing percutaneous coronary intervention with BP SES were consented within 24 h post-index procedure with planned follow-up through 5 years.. Among 556 enrolled patients, clinical demographics included: 34.7% female, 35.6% with diabetes mellitus, and 56.8% with acute coronary syndromes. The average stent length (mean ± standard deviation) was 20.2 ± 11.8 mm, and the mean number of stents per patient was 1.3 ± 0.6. Procedure success was 99.1% (551/556), and device success was 99.9% (689/690). Among 531 subjects included in the primary endpoint analysis, the 1-year rate of TLF rate was 1.7% (9/531), and the primary endpoint was met compared with the performance goal (p < 0.0001, 95% confidence interval: 0.69%, 3.43%). Rates of target vessel MI and clinically driven target lesion revascularization were 1.3% (7/531) and 0.9% (5/531), with no occurrence of cardiac death. Definite stent thrombosis was observed for two cases (0.4%; 2/556) with one acute (≤24 h) and one late (>30 days and ≤1 year) event.. In a post-approval study, 1-year clinical outcomes with BP SES were consistent with prior trials supporting the safety and effectiveness of ultrathin BP SES.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Sirolimus; Treatment Outcome

Drug-coated balloons (DCB) represent 1 of the most promising innovations in interventional cardiology and may represent a valid alternative to drug-eluting stents. Currently, some sirolimus-coated balloons (SCB) are being investigated for several coronary artery disease applications.. This study sought to understand the role of a novel SCB for the treatment of coronary artery disease.. EASTBOURNE (All-Comers Sirolimus-Coated Balloon European Registry) is a prospective, multicenter, investigator-driven clinical study that enrolled real-world patients treated with SCB. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were procedural success, myocardial infarction (MI), all-cause death, and major adverse clinical events (a composite of death, MI, and TLR). All adverse events were censored and adjudicated by an independent clinical events committee.. A total population of 2,123 patients (2,440 lesions) was enrolled at 38 study centers in Europe and Asia. The average age was 66.6 ± 11.3 years, and diabetic patients were 41.5%. De novo lesions (small vessels) were 56%, in-stent restenosis (ISR) 44%, and bailout stenting occurred in 7.7% of the patients. After 12 months, TLR occurred in 5.9% of the lesions, major adverse clinical events in 9.9%, and spontaneous MI in 2.4% of the patients. The rates of cardiac/all-cause death were 1.5% and 2.5%, respectively. The primary outcome occurred more frequently in the ISR cohort (10.5% vs 2.0%; risk ratio: 1.90; 95% CI: 1.13-3.19). After multivariate Cox regression model, the main determinant for occurrence of the primary endpoint was ISR (OR: 5.5; 95% CI: 3.382-8.881).. EASTBOURNE, the largest DCB study in the coronary field, shows the safety and efficacy of a novel SCB in a broad population of coronary artery disease including small vessels and ISR patients at mid-term follow-up. (The All-Comers Sirolimus-Coated Balloon European Registry [EASTBOURNE]; NCT03085823).

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Restenosis; Humans; Middle Aged; Myocardial Infarction; Registries; Sirolimus; Treatment Outcome

Genoss drug-eluting stent (DES) (Genoss Company Limited) is a new ultrathin sirolimus-eluting stent with an abluminal biodegradable polymer and a cobalt-chromium platform.. The aim of this study was to evaluate vascular healing and neointimal coverage after implantation of the Genoss DES using optical coherence tomography (OCT) 6 months postimplantation.. From August 22, 2019 to June 17, 2020, this multicenter, observational, investigator-initiated study enrolled 20 patients who underwent OCT examination 6 months after Genoss DES implantation and provided informed consent. An analyst, blinded to the patients' and procedural information analyzed OCT images at an independent core laboratory.. Of the 20 patients, 19 with 27 stents in 21 lesions from 21 vessels were included in the analysis, while one patient withdrew consent and was unwilling to undergo follow-up OCT. OCT analysis was performed 204.4 ± 31.9 days after Genoss DES implantation. A total of 4285 stent struts from 661 cross-sections were analyzed. Strut tissue coverage was observed in 98.7 ± 4.3% of struts, with 0.1 ± 1.2% malapposed struts per lesion. The mean thickness of neointimal hyperplasia (NIH) on the covered struts was 0.12 ± 0.04 mm.. Six months after stent implantation, most Genoss DES struts were covered with a thin layer of NIH that was evenly distributed along the stent length. This pilot study evaluated the outcomes of 6 months dual antiplatelet therapy in the context of ultrathin strut stents, providing insight into developing ethical standards and a scientific foundation for conducting an adequately designed clinical trial.

Topics: Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Humans; Neointima; Percutaneous Coronary Intervention; Pilot Projects; Polymers; Prosthesis Design; Sirolimus; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Coronary Artery Disease; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Stents; Treatment Outcome

We sought to understand the clinical outcomes of dissections left untreated after sirolimus drug-coated balloon (DCB) angioplasty.. DCB may be a valuable alternative to stents for the treatment of native coronary lesions, but the risk of having a dissection after DCB-angioplasty is not negligible. While type A and B dissections can be safely treated conservatively, some debate exists regarding type C dissections. We previously showed the safety of dissections left untreated after second-generation paclitaxel-DCB. However, the fate of dissections after sirolimus-DCB angioplasty has not been investigated so far.. EASTBOURNE is a prospective, multicenter, international, investigator-driven study aiming to explore the safety and efficacy of a novel sirolimus-DCB. This study enrolled a consecutive, all-comer population of coronary artery disease patients and is the largest prospective study on DCB so far. Primary endpoints of the study, target-lesion revascularization (TLR), and other clinical endpoints at 12 months, have been presented elsewhere. This is a prespecified subgroup analysis of the patients left with not-flow limiting dissection after DCB angioplasty, with complete 12 months follow-up and comparison between patients left with a dissection versus patients with DCB used for de novo lesions.. Between September 2016 and November 2020, a total of 2123 patients were enrolled at 38 study centers. Seventy-three patients were left with nonflow limiting dissections (43 type A, 27 type B, 3 type C) and underwent complete 1-year clinical follow-up. In the nondissection group, 1110 patients had de-novo coronary artery disease while 900 had in-stent restenosis. Baseline characteristics were similar between the groups, while the dissection group was associated with longer lesions (23.8 vs. 18.4 mm, p < 0.001) and more frequent use of predilation (100 vs. 91.4%, p = 0.016). At 12-month follow-up, no significant differences among the groups were found, with a total of 1.25% TLR in the dissection cohort versus 5.6% in the de-novo cohort (p = 0.13), and an overall rate of major adverse cardiovascular events of 4.4% versus 10.1% (p = 0.18). Total death (1.5 vs. 2.6, p = 0.87), cardiac death, myocardial infarction (0% vs. 2.5%, p = 0.35), and bleedings did not differ significantly among the groups as well.. In this subgroup analysis of the EASTBOURNE study of consecutive patients treated with new-generation sirolimus DCB, dissections left untreated after angioplasty did not lead to an increase in adverse events.

Topics: Angioplasty, Balloon; Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Artery Disease; Drug-Eluting Stents; Humans; Paclitaxel; Prospective Studies; Sirolimus; Treatment Outcome

Topics: Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Pneumonia; Sirolimus; Treatment Outcome

To investigate the clinical outcomes after biodegradable-polymer (BP) and durable-polymer (DP) everolimus-eluting stent (EES) implantation in hemodialysis (HD) patients with coronary artery disease. We enrolled 221 consecutive HD patients successfully treated with EES implantation for coronary lesions. Over the following 2 years, we assessed the incidence of target lesion revascularization (TLR) and major adverse cardiac event (MACE), defined as the composite endpoint of TLR, all-cause mortality, or myocardial infarction. We performed a propensity-score matching analysis and collected follow-up coronary angiography data. There were 91 patients in the BP-EES group and 130 in the DP-EES group. Male sex and diabetes rates were significantly lower in the BP-EES group than in the DP-EES group. A debulking device was less frequently used in the BP-EES group than in the DP-EES group (7.6% vs. 21.5%, p = 0.006). TLR occurred in 38 patients, while stent thrombosis was observed in 3 patients; 19 patients died. TLR and MACE rates at 2 years were comparable between the two groups (19.2% in the BP-EES group vs. 20.4% in the DP-EES group, p = 0.73 and 26.9% vs. 34.2%, p = 0.93, respectively). In the propensity-score-matched cohort, TLR and MACE rates were similar between the two groups (19.2% in the BP-EES group vs. 18.1% in the DP-EES group, p = 0.69, and 26.9% vs. 30.2%, p = 0.66, respectively). Restenosis rates at follow-up angiography were similar between the two groups (p = 0.79). In hemodialysis patients, BP-EES and DP-EES showed similar 2-year clinical outcomes.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Male; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Renal Dialysis; Sirolimus; Treatment Outcome

The role of circulating progenitor cells (CPC) in vascular repair following everolimus-eluting stent (EES) implantation is largely unknown. The aim of the study was to investigate the relationship between temporal variation in CPC levels following EES implantation and the degree of peri-procedural vascular damage, and stent healing, as measured by optical coherence tomography (OCT).Methods and Results: CPC populations (CD133+/KDR+/CD45low) included patients with stable coronary artery disease undergoing stent implantation, and were evaluated using a flow cytometry technique both at baseline and at 1 week. OCT evaluation was performed immediately post-implantation to quantify the stent-related injury and at a 9-month follow up to assess the mid-term vascular response. Twenty patients (mean age 66±9 years; 80% male) with EES-treated stenoses (n=24) were included in this study. Vascular injury score was associated with the 1-week increase of CD133+/KDR+/CD45low (β 0.28 [95% CI 0.15; 0.41]; P<0.001) and with maximum neointimal thickness at a 9-month follow up (β 0.008 [95% CI 0.0004; 0.002]; P=0.04). Inverse relationships between numbers of uncoated and apposed struts for the 9-month and the 1-week delta values of CD133+/KDR+/CD45low (β -12.53 [95% CI -22.17; -2.90]; P=0.011), were also found.. The extent of vessel wall injury influences early changes in the levels of CPC and had an effect on mid-term vascular healing after EES implantation. Early CPC mobilisation was associated with mid-term strut coverage.

Topics: Aged; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Sirolimus; Tomography, Optical Coherence; Treatment Outcome; Vascular System Injuries

The aim of this analysis was to assess the effect of the coronary revascularization strategy during index admission on clinical outcomes among patients undergoing percutaneous coronary intervention (PCI) with multivessel coronary artery disease (MVD).. The value of complete revascularization (CR) over incomplete revascularization (IR) in MVD patients is not fully established.. Patients with MVD defined as ≥2 major epicardial vessels with ≥50% stenosis were selected from the observational all-comer e-Ultimaster registry. Patients were treated with a sirolimus-eluting thin-strut coronary stent. Completeness of revascularization was physician assessed at the index procedure or an eventually staged procedure during the index hospitalization. Outcomes measures at 1 year were target lesion failure (TLF) (composite of cardiac death, target vessel-related myocardial infarction [MI], and clinically driven target lesion revascularization [TLR]), and patient-oriented composite endpoint (POCE) (all-cause mortality, MI, or revascularization). The inverse probability of treatment weights (IPTW) methodology was used to perform a matched analysis.. The registry recruited 37,198 patients of whom 15,441 (41.5%) had MVD. CR on hospital discharge was achieved in 7413 (48.0%) patients and IR in 8028 (52.0%) patients. Mean age was 64.6 ± 11.1 versus 65.7 ± 11.0 years (p < 0.01), male gender 77.9% and 77.3% (p = 0.41) and diabetes 31.3% versus 33.4% (p = 0.01) for CR and IR, respectively. Chronic stable angina patients more commonly underwent CR (47.6% vs. 36.8%, p < 0.01). After propensity weighted analysis, 90.5% of CR patients were angina-free at 1 year compared with 87.5% of IR patients (p < 0.01). TLF (3.3% vs. 4.4%; p < 0.01), POCE (6.8% vs. 10.8%; p < .01), and all-cause mortality (2.3% vs. 3.1%; p < .01) were all lower in CR patients.. A physician-directed use of a CR strategy utilizing sirolimus-eluting thin-strut stent results in optimized clinical outcomes and less angina in an all-comer population. Our findings suggest that a CR should be aimed for.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Registries; Risk Factors; Sirolimus; Treatment Outcome

The primary objective was to assess the performance of a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer in an all comer population. The secondary objective was to detail differences in contemporary percutaneous coronary intervention (PCI) practice worldwide.. e-Ultimaster was an all-comer, prospective, global registry (NCT02188355) with independent event adjudication enrolling patients undergoing PCI with the study stent. The primary outcome measure was target lesion failure (TLF) at 1 year, defined as the composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularisation. Data were stratified according to 4 geographical regions.. A total of 37 198 patients were enrolled (Europe 69.2%, Asia 17.8%, Africa/Middle East 6.6% and South America/Mexico 6.5%) and 1-year follow-up was available for 35 389 patients (95.1%). One-year TLF occurred in 3.2% of the patients, ranging from 2% (Africa/Middle East) to 4.1% (South America/Mexico). In patients with acute coronary syndrome, potent P2Y. In this investigation with worldwide representation, contemporary PCI using a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer was associated with low 1-year TLF across clinical presentations and continents. Suboptimal adherence to current recommendations around antiplatelet and lipid lowering treatments was detected.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Humans; Lipids; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Registries; Sirolimus; Stents; Treatment Outcome

Long 48 mm drug-eluting stents (DES) used to treat long coronary lesions decreases the number of stents needed and avoids stent overlapping. Disadvantages include difficulty in delivery and size discrepancy between proximal and distal stent landing zones. The present study analyzed the rate of procedural, immediate angiographic, and 1-year clinical outcomes of long diffuse coronary artery lesions treated with 48 mm everolimus-eluting stents (EES) and compared the clinical outcomes with multiple overlapping DES.. This retrospective analysis included 213 patients with 228 lesions treated with at least one 48 mm EES at 2 hospitals in Taiwan.. About 40.4% of the lesions had moderate-severe calcification and 20.2% had acute angulation. The mean lesion length was 49.2 ± 18.1 mm. In 161 lesions requiring a single 48 mm EES, 67.1% had a discrepancy between proximal and distal reference diameter of ≥0.5 mm and 36% had a discrepancy of ≥1.0 mm. The procedural success rate was 98.6%. Target-vessel failure (TVF) rate at 1 year was 4.2%. Cardiac death occurred in 3 patients. The rates of target-vessel myocardial infarction (TV-MI), target-vessel revascularization (TVR) and definite/ probable stent thrombosis were 1.4%, 3.3%, and 0.9%, respectively. After adjusting patient variables by propensity score matching, no significant difference was found for cardiac death, TVF, TV-MI, and clinically driven TVR.. Use of 48 mm EES to treat long coronary lesions in clinically and anatomically complex patients is safe and effective. In the propensity score-matched analysis, the 48 mm EES and multiple stents have comparable clinical outcomes.

Topics: Coronary Artery Disease; Coronary Vessels; Death; Drug-Eluting Stents; Everolimus; Humans; Kaplan-Meier Estimate; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Sirolimus; Stents; Treatment Outcome

Topics: Absorbable Implants; Arteries; Coronary Artery Disease; Humans; Iron; Prosthesis Design; Sirolimus; Treatment Outcome

Coronary artery aneurysms after drug eluting stents are rare. We present a case series of type II coronary aneurysms after implantation of Everolimus eluting stents including patients developing giant aneurysms with a toxic course.. Over a span of 3.5 years at our center 2572 patients were implanted Everolimus eluting stents out of which 4 patients developed coronary type II aneurysms an incidence of 0.00156 whereas 5838 patients were implanted Sirolimus eluting 2nd generation stents out of which 2 patients developed similar aneurysms with an incidence of 0.00034. The slight increase in incidence in Everolimus stents does not reach statistical significance (p = 0.054) and is limited by single centre non randomized study. We also propose a hypothesis that the slight increase in the incidence maybe due to allergy to Methacrylate present in Everolimus eluting Xience stent's primer which is absent in other Sirolimus eluting stents used at our center but that needs to be further investigated. We also found some patients who developed giant aneurysms including Left main aneurysms. In our series operative repair of these patients had better outcomes than covered stent deployment but larger trials maybe needed to confirm the same.. Coronary artery aneurysms after stent implantation are rare but occasionally giant aneurysms are formed with a toxic course. The incidence and morphology of aneurysms after Everolimus and Sirolimus eluting stent deployment do not differ much.

Topics: Aged; Cardiovascular Agents; Coronary Aneurysm; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; India; Male; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

This study aims to evaluate the clinical application value of two materials, drug-eluting stent, and biodegradable stent, in the treatment of coronary heart disease. The results show that the therapeutic effects of drug-eluting stents and biodegradable stents are similar. Both treatment methods have high safety and effectiveness. The ideal coronary artery stent should have good biocompatibility, safety, and possibility.

Topics: Absorbable Implants; Biocompatible Materials; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

Patients undergoing complex percutaneous coronary intervention (PCI) are at higher risk of adverse outcomes, but data are scarce in the era of newer-generation coronary stents.. We sought to compare the clinical outcomes after complex PCI with a bioresorbable-polymer sirolimus-eluting stent (BP-SES) versus a durable-polymer everolimus-eluting stent (DP-EES).. Patients (n = 2350) from BIOFLOW-II, -IV, and -V randomized trials were categorized into non-complex PCI vs. complex PCI. Complex PCI had at least one of the following criteria: multi-vessel PCI, ≥ 3 lesions treated, ≥ 3 stents implanted, total stent length ≥ 60 mm. Endpoints were target lesion failure (TLF: cardiac death, target-vessel myocardial infarction [TV-MI], or target lesion revascularization [TLR]) and probable/definite stent thrombosis (ST) at three years.. Patients with complex PCI (n = 348) were older and presented more often with acute coronary syndrome than non-complex PCI patients (n = 2002). Complex PCI lesions were more often type B2/C and bifurcation lesions and required more pre- and post-dilatation. Complex PCI patients had higher rates of TLF (14.6% vs. 8.1%; aHR 1.89, 95% CI [1.31-2.73], p = 0.001), TV-MI (10.2% vs. 4.4%, aHR 2.17, 95% CI [1.40-3.37], p = 0.001), and ST (1.5% vs. 0.4%, p = 0.025) as compared with non-complex PCI. TLF was not lower with BP-SES as compared to DP-EES in complex PCI (12.6% vs 18.2%, p = 0.16).. Patients undergoing complex PCI with the newer-generation DES still sustain a higher risk of TLF, TV-MI and stent thrombosis as compared with non-complex PCI. This adverse outcome was not significantly modified by the stent platform (BP-SES vs. DP-EES).. Clinicaltrial.gov NCT01356888, NCT01939249, NCT02389946, https://clinicaltrials.gov/show/NCT01356888 ; https://clinicaltrials.gov/show/NCT01939249 ; https://clinicaltrials.gov/show/NCT02389946 .

Topics: Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Mitochondrial Proton-Translocating ATPases; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus; Treatment Outcome

An alteration in extracellular matrix (ECM) production by vascular smooth muscle cells is a crucial event in the pathogenesis of vascular diseases such as aging-related, atherosclerosis and allograft vasculopathy. The human target of rapamycin (TOR) is involved in the synthesis of ECM by vascular smooth muscle cells. TOR inhibitors reduce arterial stiffness, blood pressure, and left ventricle hypertrophy and decrease cardiovascular risk in kidney graft recipients and patients with coronary artery disease and heart allograft vasculopathy. Other drugs that modulate ECM production such as cilostazol and colchicine have also demonstrated a beneficial cardiovascular effect. Clinical studies have consistently shown that cilostazol confers cardiovascular protection in peripheral vascular disease, coronary artery disease, and cerebrovascular disease. In patients with type 2 diabetes, cilostazol prevents the progression of subclinical coronary atherosclerosis. Colchicine reduces arterial stiffness in patients with familial Mediterranean fever and patients with coronary artery disease. Pathophysiological mechanisms underlying the cardioprotective effect of these drugs may be related to interactions between the cytoskeleton, TOR signaling, and cyclic adenosine monophosphate (cAMP) synthesis that remain to be fully elucidated. Adult vascular smooth muscle cells exhibit a contractile phenotype and produce little ECM. Conditions that upregulate ECM synthesis induce a phenotypic switch toward a synthetic phenotype. TOR inhibition with rapamycin reduces ECM production by promoting the change to the contractile phenotype. Cilostazol increases the cytosolic level of cAMP, which in turn leads to a reduction in ECM synthesis. Colchicine is a microtubule-destabilizing agent that may enhance the synthesis of cAMP.

Topics: Cilostazol; Colchicine; Coronary Artery Disease; Cyclic AMP; Diabetes Mellitus, Type 2; Humans; Muscle, Smooth, Vascular; Sirolimus; Tetrazoles; Vascular Diseases

The most common treatment for obstructive coronary artery disease (CAD) is the implantation of a permanent drug-eluting stent (DES). Not only has this permanency been associated with delayed healing of the artery, but it also poses challenges when treating subsequent re-narrowing due to in-stent restenosis (ISR). Drug-coated balloons (DCBs) provide a potential solution to each of these issues. While their use has been primarily limited to treating ISR, in recent years, DCBs have emerged as an attractive potential alternative to DESs for the treatment of certain de novo lesions. However, there remain a number of concerns related to the safety and efficacy of these devices. Firstly, unlike DESs, DCBs necessitate a very short drug delivery window, favouring a higher drug loading. Secondly, while the majority of coronary DCBs in Europe are coated with paclitaxel, the potential mortality signal raised with paclitaxel DCBs in peripheral interventions has shifted efforts towards the development of limus-eluting balloons. The purpose of this paper is to provide a computational model that allows drug delivery from DCBs and DESs to be investigated and compared. We present a comprehensive computational framework that employs a 2D-axisymmetric geometry, incorporates two nonlinear phases of drug binding (specific and non-specific) and includes the influence of diffusion and advection, within a multilayer arterial wall. We utilise this framework to (i) simulate drug delivery from different types of balloon platform; (ii) explore the influence of DCB application time; (iii) elucidate the importance on release kinetics of elevated pressure during DCB application; (iv) compare DCB delivery of two different drugs (sirolimus and paclitaxel) and; (v) compare simulations of DESs versus DCBs. Key measures of comparison are related to safety (drug content in tissue, DC) and efficacy (specific binding site saturation, %SBSS) markers. Our results highlight the pros and cons of each device in terms of DC and %SBSS levels achieved and, moreover, indicate the potential for designing a DCB that gives rise to sufficiently similar safety and efficacy indicators as current commercial DESs.

Topics: Coated Materials, Biocompatible; Coronary Artery Disease; Drug-Eluting Stents; Humans; Paclitaxel; Sirolimus; Stents; Treatment Outcome

Dual-antiplatelet treatment (DAPT) has conventionally been prescribed for 1 year after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. Recent evidence suggests that a duration of only 6 months may be equally safe and effective when using contemporary DES options.. The aim of this study was to assess clinical outcomes in patients treated with the BioMatrix biodegradable-polymer coated biolimus-eluting stent (BP-BES; Biosensors International) who received only 6 months of DAPT.. This prospective "all-comers" registry enrolled 2038 patients in France. Following PCI, DAPT was started for a recommended period of 6 months. Patients were followed up at 6 and 24 months. The primary endpoint of major adverse cardiac and cerebrovascular event (MACCE) was a composite of all-cause death, cerebrovascular accidents, non-fatal myocardial infarction, or clinically driven target-vessel revascularization. Secondary endpoints included stent thrombosis (ST) and major bleeding (MB).. The mean age of the study population was 67 ± 10.5 years and 77% of patients were male. Follow-up data were available in 96.9% and 95.3% of patients at 6 and 24 months, respectively. At 6 months, the incidences of MACCE, ST, and MB were 3.1%, 0.3%, and 0.4%, respectively. At 24 months, 21.2% of patients were still on DAPT and the cumulative incidences of MACCE, ST, and MB were 9.7%, 0.54%, and 0.79%, respectively.. In this unselected population of patients undergoing PCI with a BP-BES, a 6-month duration of DAPT after implantation is safe and effective.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Female; Hemorrhage; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Prospective Studies; Registries; Sirolimus; Treatment Outcome

A polymer-free biolimus A9-coated stent (PF-BCS) may achieve better arterial healing than a durable polymer drug-eluting stent owing to its polymer-free feature.Methods and Results: This multicenter, prospective, observational study enrolled 105 patients (132 lesions) who underwent PF-BCS (51 patients, 71 lesions) or durable polymer everolimus-eluting stent (DP-EES, 54 patients, 61 lesions) implantation. Serial coronary angioscopy (CAS) and optical coherence tomography (OCT) examinations were performed at 1 and 12 months, and the serial vessel responses were compared between PF-BCS and DP-EES. The primary outcome measure was the incidence of subclinical intrastent thrombus on CAS. The secondary outcome measures were: adequate strut coverage (≥40 μm) on OCT and maximum yellow color grade on CAS. The incidence of thrombus was high at 1 month (100% vs. 93%, P=0.091), but decreased at 12 months (18% vs. 25%, P=0.56), without a significant difference between PF-BCS and DP-EES. The adequate strut coverage rate was significantly higher (84±14% vs. 69±22%, P<0.001) and yellow color was significantly less intense (P=0.012) at 12 months in PF-BCS than in DP-EES; however, they were not significantly different at 1 month (adequate strut coverage: 47±21% vs. 50±17%, P=0.40; yellow color: P=0.99).. Although the thrombogenicity of PF-BCS was similar to that of DP-EES, the adequate coverage and plaque stabilization rates of PF-BCS were superior to those of DP-EES at 12 months.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Sirolimus; Thrombosis; Treatment Outcome

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Treatment Outcome

Clinical evidence demonstrating the impact of statins for preventing late target lesion revascularization (TLR) after newer-generation drug-eluting stent implantation and differences in the effect of statins on late TLR according to pre-interventional vessel remodeling and vessel size is limited. We retrospectively evaluated 1193 de novo lesions in 720 patients who underwent everolimus-eluting stent implantation using intravascular ultrasound from January 2010 to December 2012. The primary endpoint was late TLR. Lesions were divided into the statin group (n = 825) and non-statin group (n = 368). The incidence of late TLR was significantly lower in the statin than non-statin group (1.7% vs. 5.2%, respectively; p = 0.001), and within the statin group, it was significantly lower in the follow-up low-density lipoprotein cholesterol (LDL-C) < 100 than ≥ 100 mg/dL level subgroup (1.0% vs. 3.6%, respectively; p = 0.006). Furthermore, in positive remodeling lesions and non-small vessel size lesions, the incidence of late TLR was significantly lower in the statin than non-statin group (1.6% vs. 8.5% and 1.3% vs. 5.3%, respectively; p = 0.001 and p = 0.004). Lowering the LDL-C level using statins was more effective for preventing late TLR after everolimus-eluting stent implantation. Evaluating pre-interventional vessel remodeling patterns and vessel size might be helpful to stratify lesions at high risk of late TLR.

Topics: Cholesterol, LDL; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Risk Factors; Sirolimus; Treatment Outcome

Tetrilimus (Sahajanand Medical Technologies Limited, Surat, India) is a biodegradable polymer-coated everolimus-eluting stent with cobalt-chromium stent platform and ultra-thin (60 µm) strut thickness. We aimed to report 1-year safety and clinical performance of Tetrilimus everolimus-eluting stent in patients with coronary artery disease in "real-world" clinical practice.. The PERFORMance of biodegradable polymer-coated ultra-thin EVERolimuseluting stents was an observational, multicenter, single-arm, and investigator-initiated retrospective registry. All "real-world" patients who had received Tetrilimus everolimuseluting stent between July-2015 and October-2016 at four study centers were analyzed. The data were collected retrospectively either by extraction from existing databases in consecutive fashion where index and follow-up data existed or the follow-up was obtained by telephonic contact. Primary endpoint was 1-year incidence of target lesion failure, which was defined as a composite endpoint of cardiac death, myocardial infarction, and target lesion revascularization by percutaneous or surgical methods. The Academic Research Consortium-defined stent thrombosis was assessed as additional safety endpoint.. During the study period, 815 Tetrilimus everolimus-eluting stents (1.4 ± 0.5 stent/ patient) were implanted to treat 735 coronary lesions (1.1 ± 0.3 stent/lesion) in 594 patients (mean age: 55.6 ± 12.1 years). The cumulative incidence of target lesion failure at 1-year follow-up was 3.7%, which included 9 (1.5%) cardiac deaths, 8 (1.4%) myocardial infarctions, and 5 (0.8%) target lesion revascularizations. There were 5 (0.8%) cases of probable stent thrombosis and 4 (0.7%) cases of possible stent thrombosis at 1-year follow-up.. Low incidences of target lesion failure and stent thrombosis at 1-year followup indicates that biodegradable polymer-coated ultra-thin Tetrilimus everolimus-eluting stents may have encouraging safety and efficacy in unselected real-world patients with coronary artery disease, including those with high-risk characteristics and complex lesions.

Topics: Absorbable Implants; Adult; Aged; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Registries; Retrospective Studies; Sirolimus; Stents; Thrombosis; Treatment Outcome

BACKGROUND Use of drug-coated balloons (DCB) is an important research topic. Many companies are quickly developing new, cutting-edge technologies and means to deliver drugs. Moreover, interest is growing in use of sirolimus-coated balloons, a promising technology in the "leaving nothing behind" era. This, in combination with interest in lesion preparation and intravascular imaging, creates a promising future for DCB for years to come. CASE REPORT A 72-year-old patient presented with NSTEMI. Coronary angiography showed a subtotal stenosis of the right coronary artery (RCA). PCI was performed on the native RCA and, given the patient's failure to adhere to the drug regimen, he was treated with a metal-free PCI strategy. After using a novel lesion preparation technique with cutting balloon and high-pressure non-compliant balloon, a novel Sirolimus DCB was used. Final angiography and OCT run showed good luminal gain despite diffuse dissections. To assess vascular healing, we performed coronary angiography 5 weeks later, which demonstrated an excellent result, with absence of residual dissection and further luminal gain compared to the index procedure. CONCLUSIONS The use of a novel lesion preparation technique (cutting balloon and high-pressure highly non-compliant balloon) in combination with guidance by intravascular imaging and the use of a new sirolimus-coated balloon may attract attention in the interventional cardiology community and stimulate discussion on lesion preparation and use of drug-coated balloons.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Humans; Male; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome

To investigate the effectiveness of metformin and atorvastatin in preventing in-stent restenosis (ISR) on coronary patients with type 2 diabetes mellitus with percutaneous coronary intervention within 8 to 12 months after rapamycin-eluting stent implantation. A total of 1278 consecutive patients implanted with rapamycin-eluting stent from January 2012 to December 2019, who underwent coronary computed tomography or coronary angiography within 8 to 12 months. The patients were categorized into atorvastatin 20 mg, or atorvastatin 20 mg + metformin 1.5/d, or atorvastatin 40 mg + metformin 1.5/d groups. The clinical characteristics of the 3 groups were compared. The correlation between variables and ISR was analyzed. A total of 701 patients participated in the study. The ratio of ISR/nonstenosis (P = .039) and fasting blood sugar (P = .001) differed significantly in the 3 groups. Logistic regression showed that d, L, different therapeutic agents, and dosage groups were independent risk factors of ISR. The longer L and smaller d may increase ISR incidence with 8 to 12 months after percutaneous coronary intervention. Both metformin and atorvastatin are beneficial in reducing stent restenosis by a dose-dependent manner. An increasing dose of atorvastatin and a combination of metformin decreases the incidence of ISR in patients.

Topics: Atorvastatin; Blood Glucose; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Diabetes Mellitus, Type 2; Drug-Eluting Stents; Humans; Metformin; Percutaneous Coronary Intervention; Risk Factors; Sirolimus; Stents; Treatment Outcome

This study aimed to investigate the relationship between immediate incomplete stent apposition (ISA) detected by intravascular ultrasound (IVUS) and midterm stent failure.. Stent failure is one of serious clinical events related to percutaneous coronary intervention (PCI). The previous studies using optical coherence tomography showed that ISA could be associated with stent thrombosis. However, the association between immediate ISA detected by IVUS and stent failure has not been fully investigated.. We included 396 lesions that underwent elective PCI, and divided those into the appropriate stent apposition (ASA) group (n = 290) and the ISA group (n = 106). The primary endpoint was stent failure, which was defined as a composite of ischemia-driven target lesion revascularization and stent thrombosis. We compared clinical and lesion characteristics between the two groups, and performed a multivariate COX hazard analysis to investigate the association between immediate ISA and stent failure.. The median follow-up duration was 1296 days. The Kaplan-Meier curves revealed the higher incidence of stent failure in the ISA group than in the ASA group (p < 0.001). The multivariate stepwise COX hazard analysis showed that immediate ISA (hazard ratio 4.97, 95% confidence interval 1.31-18.82, p = 0.018) was significantly associated with stent failure. When we set the cut-off value of the immediate ISA distance as 0.25 mm, the distance ≥ 0.25 mm had 68.8% sensitivity and 85.0% specificity to predict stent failure.. Immediate ISA detected by IVUS was associated with midterm stent failure. We should pay attention to reduce immediate ISA for improving the midterm outcomes.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Failure; Sirolimus; Stents; Thrombosis; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Drug-eluting stents (DES) significantly improved angiographic and clinical outcomes compared with bare-metal stents in patients with diabetes. The clinical effects of BioMime sirolimus-eluting stent (SES) in patients with diabetes have not been evaluated. Therefore, we compared the efficacy of BioMime DES in coronary artery disease (CAD) patients with versus without diabetes.. This prospective analytical study compared angiographic in-segment late loss and clinical effectiveness of BioMime SES stents in treating patients with (patients: 77 and lesions: 83) versus without (patients: 154 and lesions: 162) diabetes. The purpose of this study was the comparison of angiographic in-segment late loss at 12 months. Major adverse cardiac events (MACEs) were also monitored as secondary outcomes 24 months after the index procedure.. Of 231 patients enrolled in the study, the mean age was 63.3 years and 153 patients were male. Angiographic follow-up rate was 84.8% (patients: 196) and intravascular ultrasound (IVUS) follow-up rate was 67.9% (patients: 157) at 12 months. Diabetic patients were comparable to nondiabetic patients for 12-month in-segment late loss (0.01 ± 0.31 mm for the nondiabetes group versus 0.04 ± 0.11 mm for the diabetes group; P = 0.158; P < 0.05). At 24 months, MACEs, including death, myocardial infarction and ischemic-driven target lesion revascularization were not statistically different between the two treatment groups.. BioMime SES stents in treating patients with diabetes were comparable in reducing angiographic restenosis at 12 months and MACEs at 24 months compared to nondiabetic patients with CAD.

Topics: Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prospective Studies; Sirolimus; Stents; Treatment Outcome

The purpose of this study was to evaluate the performance of biodegradable polymer sirolimus and ascorbic acid eluting stent systems with four commercially available drug-eluting stents (DES). We investigated the characterization of mechanical properties by dimension, foreshortening, recoil, radial force, crossing profile, folding shape, trackability, and dislodgement force. Additionally, we identify the safety and efficacy evaluation through registry experiments. Each foreshortening and recoil of D + Storm® DES is 1.3 and 3.70%, which has better performance than other products. A post-marketing clinical study to evaluate the performance and safety of D + Storm® DES is ongoing in real-world clinical settings. Two hundred one patients were enrolled in this study and have now completed follow-up for up to 1 month. No major adverse cardiovascular event (MACE) occurred in any subjects, confirming the safety of D + Storm® DES in the clinical setting. An additional approximately 100 subjects will be enrolled in the study and the final safety profile will be assessed in 300 patients. In conclusion, this study reported the objective evaluation of DES performance and compared the mechanical responses of four types of DES available in the market. There is little difference between the four cardiovascular stents in terms of mechanical features, and it can help choose the most suitable stent in a specific clinical situation if those features are understood. Graphical abstract.

Topics: Absorbable Implants; Ascorbic Acid; Coronary Artery Disease; Drug-Eluting Stents; Humans; Polymers; Prosthesis Design; Sirolimus; Treatment Outcome

Limus-eluting stents have become the mainstay for percutaneous coronary intervention (PCI). However, even with the latest generation drug-eluting stent, in-stent restenosis and very late stent thrombosis remain a concern. The Selution SLR™ drug-coated balloon (DCB) is a novel sirolimus-coated balloon that provides a controlled release of the antiproliferative drug. Herein we evaluated its performance in a real-world patient cohort with complex coronary artery lesions.. Patients undergoing PCI using the Selution SLR™ DCB were analyzed from the prospective SIROOP registry. We evaluated procedural success and clinical outcomes, including major adverse cardiovascular event (MACE), cardiac death, target vessel myocardial infarction and target lesion revascularization.. From September 2020 to April 2021, we enrolled 78 patients (87 lesions) treated using a "DCB only" strategy. The mean age was 66.7 ± 10.4 years and 28 (36%) presented with an acute coronary syndrome. Almost all lesions were type B2/C 86 (99%) and 49 (63%) had moderate to severe calcifications. Procedural success was 100%. After a median follow-up of 11.2 months (interquartile range: 10.0-12.6), MACE occurred in 5 (6.8%) patients. No acute vessel closure was observed.. In complex coronary lesions, a "DCB only" strategy using the Selution SLR™ DCB is not just safe and feasible, but also seems to be associated with a low rate of MACE at 1-year follow-up. Our promising results warrant further evaluation in a dedicated comparative trial.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Metals; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

Topics: Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Sirolimus; Treatment Outcome

Topics: Absorbable Implants; Angioscopy; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Sirolimus; Staining and Labeling; Stents; Tomography, Optical Coherence; Treatment Outcome

The purpose of this study was to assess early and late vascular healing in response to bioresorbable-polymer sirolimus-eluting stents (BP-SESs) for the treatment of patients with ST-elevation myocardial infarction (STEMI) and stable coronary artery disease (CAD). A total of 106 patients with STEMI and 101 patients with stable-CAD were enrolled. Optical frequency-domain images were acquired at baseline, at 1- or 3-month follow-up, and at 12-month follow-up. In the STEMI and CAD cohorts, the percentage of uncovered struts (%US) was significantly and remarkably decreased during early two points and at 12-month (the STEMI cohort: 1-month: 18.75 ± 0.78%, 3-month: 10.19 ± 0.77%, 12-month: 1.80 ± 0.72%; p < 0.001, the CAD cohort: 1-month: 9.44 ± 0.78%, 3-month: 7.78 ± 0.78%, 12-month: 1.07 ± 0.73%; p < 0.001 respectively). The average peri-strut low-intensity area (PLIA) score in the STEMI cohort was significantly decreased during follow-up period (1.90 ± 1.14, 1.18 ± 1.25, and 1.01 ± 0.72; p ≤ 0.001), whereas the one in the CAD cohort was not significantly changed (0.89 ± 1.24, 0.67 ± 1.07, and 0.64 ± 0.72; p = 0.59). In comparison with both groups, differences of %US and PLIA score at early two points were almost disappeared or close at 12 months. The strut-coverage and healing processes in the early phase after BP-SES implantation were significantly improved in both cohorts, especially markedly in STEMI patients. At 1 year, qualitatively and quantitatively consistent neointimal coverage was achieved in both pathogenetic groups.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Sirolimus; Stents; Tomography, Optical Coherence; Treatment Outcome

A polymer-free biolimus-eluting stent (PF-BES) and a zotarolimus-eluting stent (ZES) recently showed similar clinical profiles and appear to be competing options in specific clinical settings of patients undergoing percutaneous coronary intervention (PCI). Whether they perform similarly also in complex procedural settings as coronary bifurcation lesions remains unaddressed.. All consecutive patients undergoing coronary bifurcation PCI with PF-BES or the new iteration of the ZES from three large multicenter real-world registries were included. The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis (ST). Multiple analyses to adjust for baseline differences were carried out including propensity-score matching, propensity-score stratification and inverse-probability-weighting. Outcomes are reported according to Cox proportional hazard models censored at 400-day follow-up.. 1169 patients treated with PF-BES (n = 440) or ZES (n = 729) on the main branch of a coronary bifurcation lesion were included (mean age 69 ± 11 years, 75.4% male, 53.8% acute coronary syndrome at presentation, 26.6% left main bifurcation, median dual antiplatelet therapy duration 12 [range 12-12] months). MACE, all-cause death, TLR and ST tended towards non-statistically higher rates with the PF-BES as compared to the ZES. Higher MI and target vessel revascularization occurrence was observed with PF-BES.. In this large contemporary cohort of patients undergoing coronary bifurcation PCI, the occurrence of MACE was non-statistically different with the use of PF-BES and ZES devices. However, differences favoring the ZES device that may entail clinical relevance were observed. Further studies are needed to confirm these findings and explore whether they remain valid when a short dual antiplatelet therapy is adopted.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Infant; Male; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

To compare stent recoil (SR) of the thin-strut durable-polymer Zotarolimus-eluting stent (dp-ZES) and the ultrathin-strut bioabsorbable-polymer Sirolimus-eluting stent (bp-SES) in chronic total occlusions (CTOs) and to investigate the predictors of high SR in CTOs.. Newer ultrathin drug eluting stent might be associated with lower radial force and higher elastic recoil due to the thinner strut design, possibly impacting on the rate of in-stent restenosis and thrombosis.. Between January 2017 and November 2019, consecutive patients with CTOs undergoing percutaneous coronary intervention were evaluated. Only patients treated with dp-ZES or bp-SES were included and stratified accordingly. Quantitative coronary angiography analysis was used to assess absolute SR, relative SR, absolute focal SR, relative focal SR, high absolute, and high relative focal SR.. A total of 128 lesions (67 treated with dp-ZES and 61 with bp-SES) in 123 patients were analyzed. Between bp-SES and dp-ZES no differences were found in absolute SR (p = .188), relative SR (p = .138), absolute focal SR (p = .069), and relative focal SR (p = .064). High absolute and high relative focal SR occurred more frequently in bp-SES than in dp-ZES (p = .004 and p = .015). Bp-SES was a predictor of high absolute focal SR (Odds ratio [OR] 3.29, 95% confidence interval [CI] 1.50-7.22, p = .003]. High-pressure postdilation and bp-SES were predictors of high relative focal SR (OR 2.22, 95% CI 1.01-4.86, p = .047; OR 2.74, 95% CI 1.24-6.02, p = .012, respectively).. Both stents showed an overall low SR. However, ultra-thin strut bp-SES was a predictor of high absolute and high relative focal SR.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Treatment Outcome

To evaluate healing response at strut-level and cross-section level after implanting an ultra-thin strut, everolimus-eluting stent with biodegradable polymer (Tetrilimus) using optical coherence tomography (OCT) at 3 and 6 months.. This was prospective, multi-centre, single-arm, and investigator-initiated study performed at seven Indian sites between January, 2017 and September, 2018. OCT evaluations were performed in 57 patients who underwent Tetrilimus stent implantation. Follow-up OCT was scheduled at 3 months for first 16 patients and at 6 months for 41 patients. Primary outcomes included degree of strut coverage, malapposition and thickness of neointimal hyperplasia (NIH) over covered struts.. Sixty one Tetrilimus stents were implanted to treat 59 lesions in 57 patients. Paired (baseline and follow-up) OCT data was available for 12 patients and 30 patients at 3 and 6 months, respectively. At 3 months, rapid early healing was indicated by 95.48% covered struts per lesion with very low (0.11 ± 0.06 mm) NIH. At 6 months, NIH accumulation was greater (0.21 ± 0.07 mm) as compared to 3 months. 99.77% of struts per lesion were covered at 6 months. There was a very symmetrical healing as shown by very low eccentricity index. There was no difference in vascular healing between stents with small to moderate size vessels (≤3.00 mm) and large size vessels (>3.00 mm).. Present study demonstrated nearly complete endothelization and low NIH accumulation at 3 and 6 months following implantation of ultra-thin strut everolimus-eluting biodegradable polymer-coated Tetrilimus stent. Moreover, though being an ultra-thin strut stent, there was no difference in vascular healing and eccentricity after implantation of the Tetrilimus stents with smaller and larger diameters.

Topics: Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Humans; Neointima; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Stents; Tomography, Optical Coherence; Treatment Outcome

Ultrathin bioresorbable polymer sirolimus-eluting stents (BP-SESs) may easily lead to acute recoil. This study investigated acute recoil after BP-SES implantation on the basis of intravascular ultrasound (IVUS).. We enrolled 40 consecutive stents. Absolute acute recoil by quantitative coronary angiography was defined as the difference between the mean diameter of the last inflated balloon (X) and mean lumen diameter of the BP-SES immediately after balloon deflation (Y). Percent (%) acute recoil was defined as (X-Y)×100/X. IVUS was performed within the culprit lesion. Plaque eccentricity, % plaque burden and calcification grade score were assessed using IVUS. Calcification grade was scored on the basis of quadrants. On the basis of the median acute recoil value of 5.0%, the stents were divided into two groups: low (LAR, n = 20) and high % acute recoil (HAR, n = 20).. Mean % acute recoil was 5.8 ± 5.3%. Plaque eccentricity, % plaque burden and stent/artery ratio were significantly higher in the HAR group than in the LAR group. Significant differences in % acute recoil were not observed regarding the types of stent diameter. In multivariate logistic regression and multiple linear regression analysis, plaque eccentricity and % plaque burden in the culprit plaque were significant positive predictors for the occurrence of % acute recoil. No significant differences, including clinical outcomes, were found between both groups at follow-up.. Acute recoil of BP-SESs may be influenced by an eccentric plaque with a large burden, which did not affect long-term outcomes. However, the present study might suggest the proper strategy (e.g. a more exhaustive plaque preparation) before BP-SES implantation in a case with these IVUS characteristics.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Outcome Assessment, Health Care; Sirolimus; Ultrasonography, Interventional

Permanent drug-eluting stents are associated with a steady increase in late complications attributed to persistent inflammation and poor vessel remodelling. Bioresorbable scaffolds have been developed to overcome such long-term limitations by providing temporary vessel support and disappearing thereafter. We aimed to assess the long-term outcomes of an absorbable metallic scaffold at 5 years.. BIOSOLVE-II is an international, multi-centre, first-in-human study assessing the safety and performance of the sirolimus-eluting absorbable metal scaffold DREAMS 2G (commercial name Magmaris) in patients with a maximum of two de novo lesions. After 3 years, follow-up was extended to 5 years with the endpoints of target lesion failure and rate of definite or probable stent thrombosis.. A total of 123 patients with 123 lesions were enrolled. Lesions were 12.6 ± 4.5 mm long and 2.7 ± 0.4 mm in diameter, 43.4% were class B2/C lesions, and calcification was moderate to severe in 10.6%. At 5 years, 5.4% of patients had stable angina and 94.6% had no symptoms or ischaemia. Target lesion failure rate was 8.0% [95% confidence interval:4.2;14.9], reflecting 2 cardiac deaths, 2 target-vessel myocardial infarctions, and 6 clinically driven target lesion revascularizations (TLRs). Only one target lesion failure occurred beyond 3 years: a target-vessel myocardial infarction with clinically driven TLR on post-procedure day 1157. One additional non-cardiac death beyond 3 years due to renal failure was reported on day 1777. No definite or probable scaffold thrombosis was observed.. The Magmaris scaffold showed favourable long-term safety and clinical performance with low target lesion failure rates and absence of definite or probable scaffold thrombosis throughout 5 years.

Topics: Absorbable Implants; Coronary Artery Disease; Humans; Metals; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

T-Flex registry was designed to investigate the safety and clinical performance of the ultrathin (60 µm) strut biodegradable polymer-coated sirolimus-eluting stent (SES) with a unique long dual Z (LDZ) link design on a cobalt-chromium stent platform (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in a real-world all-comer population including high-risk subgroups.. This was an observational, multicenter, single-arm, and investigator-initiated retrospective registry. A total of 1,203 patients treated with an ultrathin biodegradable polymer-coated SES, irrespective of lesion complexity, comorbidities, and acute presentation were analyzed from May 2016 to January 2017. The primary endpoint was the one-year incidence of target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction (TV-MI), and clinically-indicated target lesion revascularization (CI-TLR). Stent thrombosis was assessed as an additional safety endpoint.. At the one-year follow-up, TLF was observed in 3.8% [95% confidence interval (CI) 2.9-5.1] patients, composed of 0.6% (95% CI: 0.3-1.3) cardiac death, 1.3% (95% CI: 0.8-2.2) TV-MI, and 1.9% (95% CI: 1.3-2.9) CI-TLR. In the high-risk subgroups, TLF at one-year was 6.8% (95% CI: 4.6-9.8) in patients with diabetes, 5.2% (95% CI: 3.4-8) in patients with small-vessel disease, 6.1% (95% CI: 3.9-9.6) in patients with ST-elevation myocardial infarction, and 4.5% (95% CI: 2.4-8.3) in patients with total occlusion. During follow-up, stent thrombosis was reported in 0.8% (95% CI: 0.4-1.5) patients in the overall population.. Low event rates of TLF and stent thrombosis at one-year follow-up indicate that this ultrathin biodegradable polymer-coated SES has encouraging safety and clinical performance in real-world all-comer populations as well as in high-risk subgroups.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Registries; Retrospective Studies; Risk Factors; Sirolimus; Treatment Outcome

Despite numerous studies supporting the outperformance of ultrathin-strut bioresorbable polymer sirolimus-eluting stent (Orsiro SES, Biotronik AG), the generalizability of the study results remains unclear in the Asian population. We sought to evaluate the clinical outcomes of the Orsiro SES in unselected Thai population.. The Thailand Orsiro registry was a prospective, open-label clinical study evaluating all patients with obstructive coronary artery disease implanted with Orsiro SES. The primary endpoint was target lesion failure (TLF) at 12 months. TLF is defined as a composite of cardiac death, target vessel myocardial infarction (TVMI), emergent coronary artery bypass graft (CABG), and clinically driven target lesion revascularization (CD-TLR). Patients with diabetes, small vessels (≤ 2.75 mm), chronic total occlusions (CTOs), and acute myocardial infarction (AMI) were pre-specified subgroups for statistical analysis.. A total of 150 patients with 235 lesions were included in the analysis. Half of the patients (53.3%) presented with AMI, and 24% had diabetes. Among 235 lesions, 93(39.4%) were small vessels, and 24(10.2%) were chronic total occlusions. The primary endpoint, TLF at 12 months, occurred in eight patients (5.3%), predominately caused by cardiac death. By contrast, the incidences of TVMI and CD-TLR were null. The outcomes in pre-specified subgroup were not different from the overall population (all p > 0.05). One definite late stent thrombosis(0.7%) was incidentally observed during primary percutaneous coronary intervention to the non-target vessel.. The safety and efficacy of the ultrathin strut sirolimus-eluting stent in unselected cases are confirmed in the Thailand Orsiro registry. Despite the high proportion of pre-specified high-risk subgroups, the excellent stent performance was consistent with the overall population. Trial Registration TCTR20190325001.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Thailand; Time Factors; Treatment Outcome

Topics: Cell- and Tissue-Based Therapy; Coronary Artery Disease; Genetic Therapy; Humans; Sirolimus

Coronary artery disease (CAD) is chiefly characterized by atherosclerosis and plaque formation in coronary arteries. The aim of this study was to evaluate the correlation of coronary anatomy as a predictor of restenosis and stent thrombosis in coronary artery disease (CAD) patients 5 years after percutaneous coronary intervention (PCI).. In this prospective study, 1070 patients with stent restenosis or stent thrombosis over past 5 years were enrolled. Coronary angiography was performed to evaluate coronary restenosis and stent thrombosis 5 years after PCI. Stent restenosis was defined as >50% angiographic in-stent lumen reduction. Stent thrombosis was defined as sudden complete occlusion of stent presenting with acute myocardial infarction in that territory. Demographic data, clinical features and anatomic factors were prospectively reviewed. Baseline, procedural, and post-procedural characteristics of patients were recorded for analysis.. Among demographic characteristics, cardiovascular risk factors (hypertension and diabetes mellitus) and anatomic factors were predictive risk factors for restenosis/thrombosis, p=0.001. The most common site for stent restenosis was proximal to the mid part of the LAD artery, followed by RCA and LCX. A greater diameter of LCX, a greater angle of LM-LAD than LM-LCX and left dominancy increase the incidence of LAD stent restenosis/thrombosis. In this study, the least common restenosis/thrombosis rate in relation to the total number of PCI was in the Ramus intermedius artery.. The outcomes of the study indicated that anatomic factors can predict increased risk of restenosis among CAD patients who underwent PCI.

Topics: Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Humans; Incidence; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Stents; Treatment Outcome

Reports of long-term outcomes of patients treated with drug-eluting stents in total coronary occlusions are limited. We analysed clinical outcomes of patients treated with the zotarolimus-eluting Resolute stent (R-ZES) implanted in coronary total occlusions versus non-occluded lesions.. Patients treated with R-ZES and included in four trials (RESOLUTE All Comers, RESOLUTE International, RESOLUTE China RCT, and RESOLUTE China Registry) were pooled and divided into three groups - patients with chronic total occlusions (CTO), patients with total occlusions that had occurred recently (rec-TO), and patients without total occlusions (non-TO). Clinical outcomes at five years were analysed. Of 5,487 patients treated with R-ZES in these trials, 8.0% had CTOs, 8.5% rec-TOs and 83.5% non-TOs. Patients had a mean age of 62.8 years, approximately 25% were female and 30% were diabetics. TLF was similar in the three groups at five years (TLF was 13.2%, 12.5% and 13.3% in the CTO, rec-TO and non-TO groups, respectively, p=0.96). Stent thrombosis tended to occur more frequently for rec-TO compared to CTO and non-TO patients (2.6% vs 1.2% and 1.3%, respectively, p=0.11).. In this large population of patients who had R-ZES implanted, five-year clinical outcomes were similar whether or not the stents were implanted in total occlusions.

Topics: Cardiovascular Agents; China; Coronary Artery Disease; Coronary Occlusion; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

Patients at high risk of bleeding requiring percutaneous coronary intervention (PCI) need careful evaluation of both their thrombotic and their bleeding risks. In these patients, a polymer-free metallic stent coated with biolimus-A9 (BA9-DCS) followed by 1‑month dual antiplatelet therapy (DAPT) could be a safe option; however, real-world data are still lacking. We analyzed the performance of the device in a real-world scenario.. Patients assessed as being at high risk of bleeding with an indication for PCI were treated with BA9-DCS and DAPT consisting of aspirin (100 mg/day) and clopidogrel (75 mg/day) for at least 1 month, followed by either oral anticoagulation or single antiplatelet therapy. No exclusion criteria were used. The primary endpoint was the occurrence of an adverse event after PCI, i.e. severe bleeding requiring hospitalization, ischemic or hemorrhagic stroke, clinically driven stent thrombosis, myocardial infarction or cardiac death.. Overall, 89 patients were enrolled in this study [median age 75 (66-81) years; 27 females (30%)] and 171 interventions were performed. During a median follow-up of 203 (145-273) days the primary endpoint occurred in 20 patients (23%): 12 (13%) had clinically significant bleeding, four (5%) ischemic stroke and four (5%) died from cardiac causes related neither to stent thrombosis nor to acute myocardial infarction. Female gender emerged as the only statistically significant predictor of an adverse event (adjusted hazard ratio (HR) 3.3; 95% confidence interval (CI): 1.2-8.7, p = 0.017).. In real-world patients at high risk of bleeding, implantation of the polymer-free metallic stent coated with Biolimus-A9 (Biofreedom®; Biosensors Europe, Morges, Switzerland) followed by 1 -month DAPT showed encouraging results without any stent thrombosis.. HINTERGRUND: Patienten mit hohem Blutungsrisiko, bei denen eine perkutane Koronarintervention (PCI) notwendig ist, müssen sorgfältig bezüglich ihres Thrombose- wie auch Blutungsrisikos beurteilt werden. Bei ihnen könnte der Einsatz eines mit Biolimus A9 beschichteten polymerfreien Metallstents (BA9-DCS) mit nachfolgender 1‑monatiger dualer Plättchenhemmung („dual antiplatelet therapy“ [DAPT]) eine sichere Option sein. Es fehlen allerdings immer noch Daten aus der Praxis. Daher haben wir den BA9-DCS unter Realbedingungen untersucht.. Patienten mit hohem Blutungsrisiko und Indikation zur PCI wurden mit BA9-DCS und einer DAPT (Acetylsalicylsäure 100 mg/Tag und Clopidogrel 75 mg/Tag für mindestens 1 Monat) behandelt, worauf eine orale Antikoagulation oder einfache Plättchenhemmung folgte. Ausschlusskriterien gab es nicht. Als primärer Endpunkt wurde der Eintritt eines unerwünschten Ereignisses nach PCI definiert (schwere Blutung mit erforderlicher Krankenhausaufnahme, ischämischer oder hämorrhagischer Schlaganfall, klinisch begünstigte Stentthrombose, Myokardinfarkt oder kardial bedingter Tod).. Insgesamt 89 Patienten wurden in die Studie eingeschlossen (medianes Alter 75 [66–81] Jahre; 27 weiblich [30 %]); es wurden 171 Interventionen durchgeführt. In einem medianen Follow-up von 203 (145–273) Tagen wurde der primäre Endpunkt bei 20 Patienten (23 %) erreicht: 12 (13 %) hatten eine klinisch relevante Blutung, 4 (5 %) einen ischämischen Schlaganfall und 4 (5 %) verstarben kardial bedingt, wobei die Ursache weder mit einer Stentthrombose noch mit einem akuten Myokardinfarkt zusammenhing. Weibliches Geschlecht erwies sich als einziger statistisch signifikanter Prädiktor für ein unerwünschtes Ereignis (adjustierte Hazard Ratio [HR] 3,3; 95 %-Konfidenzintervall [KI]: 1,2–8,7, p = 0,017).. Bei Patienten unter Realbedingungen mit hohem Blutungsrisiko lieferte die Implantation des mit Biolimus A9 beschichteten polymerfreien Metallstents (Biofreedom®, Biosensors Europe, Morges, Schweiz) gefolgt von einer 1‑monatigen DAPT vielversprechende Ergebnisse, ohne dass es zu einer Stentthrombose kam.

Topics: Aged; Coronary Artery Disease; Drug Therapy, Combination; Drug-Eluting Stents; Europe; Female; Humans; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Sirolimus; Switzerland; Treatment Outcome

Quantitative flow ratio (QFR) has been validated as an accurate surrogate of standard wire-based fractional flow reserve. The clinical and angiographic outcomes of the Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS) have been previously studied and reported. We investigate the functional performance of the Fantom BRS.. The FANTOM II trial prospectively enrolled 240 patients with stable coronary artery disease or unstable angina, of which 235 patients received the Fantom BRS and were included in the present analysis. We performed an independent serial QFR analysis of the target vessel at baseline, post-percutaneous coronary intervention (PCI), and at 6- or 9-month and 24-month follow-up, using a QFR threshold ≤0.80 to define functional ischemia.. QFR was analyzable in 178 patients at baseline, 185 post-PCI, 178 at 6- or 9-month follow-up, and 30 at 24-month follow-up. At baseline, 119 patients (66.9%) had a QFR ≤0.80, whereas 12 (6.5%) post-PCI, 13 (7.3%) at 6- or 9-month follow-up, and 3 (10.0%) at 24-month follow-up had a QFR ≤0.80. QFR improved from baseline to post-PCI, and decreased from post-PCI up to 24-month follow-up. During follow-up period, 28 patients (11.9%) had target vessel revascularization, of which 21 had analyzable QFR and 16 patients (76.1%) had QFR ≤0.80 at the time of revascularization.. Off-line serial QFR assessment demonstrated that around 30% patients did not have functionally significant lesions at baseline and the time with target vessel revascularization. PCI with the Fantom BRS improved functional ischemia with a slight decrease in QFR values over 24 months.

Topics: Absorbable Implants; Coronary Angiography; Coronary Artery Disease; Fractional Flow Reserve, Myocardial; Humans; Percutaneous Coronary Intervention; Predictive Value of Tests; Sirolimus; Treatment Outcome

Use of drug coated balloons (DCBs) in coronary intervention is escalating. There is a plethora of data on Paclitaxcel-DCB. However, when it comes of stents, Limus-drugs are preferred over Paclitaxel. There is very limited data on Sirolimus coated balloons (SCB). MagicTouch-SCB (Concept Medical, FL) elutes Sirolimus via nano-technology and have been used in our centers since March 2018. We report a mid-term follow-up with this relatively novel-technology.. We retrospectively analyzed all patients treated with MagicTouch-SCB between March-2018 and February-2019. Results are reported as cardiac-death, target-vessel myocardial-infarction (TVMI), target lesion revascularization (TLR) and Major Adverse Cardiac Events (MACE). During the study period, 288-patients (373-lesions) with a mean age of 65.8 were treated with MagicTouch-SCB. 84% (n = 241) were male, 155 (54%) were in the setting of acute coronary syndrome, 38% (n = 110) had diabetes and 62% (n = 233) were in de-novo lesions. Most lesions treated were in the LAD/diagonal-system (n = 170; 46%). Pre-dilatation was performed in 92% (n = 345) of cases. Bailout stenting was required in 9% lesions (n = 35). The mean diameter and length of SCBs were 2.64 ± 0.56 mm and 24 ± 8.9 mm respectively. During a median follow-up of 363 days (IQR: 278-435), cardiac death and TVMI occurred in 5-patients (1.7%) and 10-patients (3.4%) respectively, TLR per-lesion was 12%. The MACE rate was 10%. There were no documented cases of acute vessel closure.. The results from mid-term follow-up with this relatively new technology SCB is encouraging with a low rates of hard endpoints and acceptable MACE rates despite complex group of patients and lesion subsets.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Female; Humans; Male; Middle Aged; Paclitaxel; Retrospective Studies; Sirolimus; Treatment Outcome

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Treatment Outcome

This study aimed to evaluate the early vascular response of ultra-thin strut bioresorbable polymer sirolimus-eluting stents (BP SES) using optical frequency domain imaging (OFDI). Ultra-thin strut BP SES have superior outcomes in terms of efficacy and safety endpoints when compared to other thin strut new-generation stents. However, the factors contributing to the superiority of BP SES over other thin strut new-generation stents are unclear. A total of 32 patients with multivessel disease requiring staged procedures at 1 month were enrolled from 3 cardiovascular institutions; of these, 31 were immediately assessed by OFDI (n = 31). All patients were assessed at 1 month after ultra-thin strut BP SES implantation. The primary endpoint was % of uncovered struts. A total of 1723 cross sections (17,014 struts) were analyzed at baseline and 1 month after percutaneous coronary intervention. The % uncovered struts at 1-month follow-up was 7.7% (4.0, 13.8). Furthermore, the covered strut % (88.4% and 80.4%, P = 0.013) and malapposition rate (2.7% and 4.3%, P = 0.012) were significantly different between the 60-μm and 80-μm stents. Ultra-thin strut BP SES implantation may feasibly achieve early vascular responses due to the ultra-thin struts. This may ultimately lead to lower stent thrombosis and target lesion failure rates.Clinical trial registration University Hospital Medical Information Network Clinical Trials Registry (No. UMIN000033406).

Topics: Absorbable Implants; Aged; Aged, 80 and over; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The purpose of the EASTBOURNE registry is to evaluate the immediate and long-term clinical performance of a novel sirolimus-coated balloon (SCB) in a real-world population of patients with coronary artery disease. We here present the prespecified interim analysis after the enrollment of the first 642 patients who obtained 1-year clinical follow-up.. EASTBOURNE is a prospective, international, multicenter, all-comer investigator-driven clinical registry, which is enrolling consecutive patients treated with SCB at 42 European and Asiatic centers. Primary study endpoint is target-lesion revascularization (TLR) at 12 months. Secondary endpoints are procedural success and major adverse cardiac events through 36 months.. Diabetes mellitus was present in 41% of patients. Acute coronary syndrome was present in 45% of patients and de novo lesions were 55%; 83% of the in-stent restenosis (ISR) patients had drug-eluting stents restenosis. Lesion predilatation was performed in 95% of the cases and bailout stenting occurred in 7.5%. So far, 642 patients have a complete 12-month follow-up. TLR occurred in 2.5%, myocardial infarction in 2.3%, total death in 1% and major adverse cardiac events in 5.8% of patients. A prespecified analysis of comparison between ISR and de-novo lesions showed a significantly higher occurrence of TLR in the ISR population (5.4 vs. 0.2%, P = 0.0008).. The current interim analysis of 12-month follow-up of the EASTBOURNE registry shows good immediate performance and an adequate and encouraging safety profile through 12 months for this novel SCB.

Topics: Aged; Angioplasty, Balloon, Coronary; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Prospective Studies; Registries; Sirolimus; Time Factors; Treatment Outcome

In this state-of-the-art review, we present the findings and a critical analysis of the Leaders Free trial program, evaluating outcomes of a new stent-generation based on polymer-free technology, in this case the BioFreedom

Topics: Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

The Orsiro cobalt-chromium stent platform (Biotronik, Bülach, Switzerland) is one of the first devices in the era of ultrathin struts. However, data regarding the efficacy of Orsiro stent in patients with challenging anatomical conditions obtained from daily clinical practice are scant.. We retrospectively reviewed the long-term outcomes, defined as target lesion revascularization (TLR), target vessel revascularization (TVR), stent thrombosis (ST) and cardiovascular (CV) mortality over a six years period, in 1161 consecutive patients (mean age 64.3 ± 11.2 years old, 681 males) treated with 2327 Orsiro stents in our institution who presented with challenging anatomic/angiographic features.. The mean number of implanted stents was 1.7 ± 2.1 whereas the mean stent diameter and length were 3.6 ± 1.1 and 32.7 ± 15.6 mm, respectively. Mean follow-up duration was 35.6 ± 17 months (range 1-77 months); 923 patients (79.5%) reached the 3-year follow-up. The global rates of TLR, TVR, ST and CV mortality were 0.1%, 1.37%, 0.002%, and 1.9%, respectively with scarce statistically significant differences in multivessel disease, severe calcification, and lesion length > 41 mm. Multivariate regression analysis revealed that age, stent dislodgement, early stent thrombosis (p = 0.001) and lesion length ≥ 41 mm (p = 0.001) were independent predictors of TVR. Similarly, the occurrence of TLR was independently predicted by age, severe calcification, use of IVUS and Rotablator (p = 0.002), early stent thrombosis, LM bifurcation and length ≥ 41 mm (p = 0.001).. The Orsiro stent confirmed a very high efficacy profile in all anatomical scenarios with very low rates of clinically driven TLR and TVR, CV mortality and ST at 3-years.

Topics: Absorbable Implants; Aged; Coronary Artery Disease; Drug-Eluting Stents; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Retrospective Studies; Sirolimus; Treatment Outcome

Recent improvements in coronary stent design have focussed on thinner struts, different alloys and architecture, more biocompatible polymers, and shorter drug absorption times. This study evaluates safety and efficacy of a newer generation thin-strut cobalt chromium sirolimus-eluting coronary stent (SES, Ultimaster) in comparison with a second-generation thicker strut stainless steel biolimus-eluting stent (BES, Nobori) in percutaneous coronary intervention (PCI) practice.. A propensity score analysis was performed to adjust for differences in baseline characteristics of 8137 SES patients and 2738 BES patients of two PCI registries (e-Ultimaster and NOBORI 2). An independent clinical event committee adjudicated all endpoint-related adverse events.. The use of SES, as compared with BES was associated with a significantly lower rate of myocardial infarction (MI) (1.2% vs 2.2%; P = 0.0006) and target vessel-related MI (1.1% vs 1.8%; P = 0.002) at 1 year. One-year composite endpoints of all predefined endpoints were lower in patients undergoing SES implantation (target lesion failure: 3.2% vs 4.1%; P = 0.03, target vessel failure: 3.7% vs 5.0%; P = 0.003, patient-oriented composite endpoint 5.7% vs 6.8%; P = 0.03). No significant differences between SES and BES were observed in all-cause death (2.0% vs 1.6%; P = 0.19), cardiac death (1.2% vs 1.2%; P = 0.76) or stent thrombosis (0.6% vs 0.8%; P = 0.43).. These findings suggest an improved clinical safety and efficacy of a newer generation thin-strut SES as compared with a second-generation thicker strut BES.

Topics: Aged; Biocompatible Materials; Chromium Alloys; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Equipment Failure Analysis; Female; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Postoperative Complications; Prosthesis Design; Registries; Sirolimus; Survival Analysis

Polymer-free biolimus A9-coated coronary stent (DCS) has novel features which lead to the expectation of better arterial healing. However, comparisons of intravascular status between DCS and drug-eluting stents (DES), and robust real-word clinical assessments of DCS have been lacking to date.. From September 2017 to September 2018, we evaluated the intra-vascular status of 74 DCS implanted in 55 lesions from 43 patients using coronary angioscopy (CAS) approximately one year after implantation from a cohort of 219 lesions in 158 patients. We set 239 second-generation durable-polymer DES (DP-DES) implanted in 211 lesions from 180 patients from a cohort of 2652 lesions in 1914 patients as the control. Angioscopic images were analyzed to determine (1) the dominant degree of neointimal coverage (NIC) over the stent; (2) the heterogeneity of NIC; (3) yellow color grade of the stented segment; and (4) the presence of intra-stent thrombus. The primary outcome was the incidence of thrombus and secondary outcomes were the other CAS findings, and the 1-year clinical outcomes which included target lesion revascularization (TLR) and major adverse cardiac events (MACE). To minimize inter-group differences in baseline characteristics, propensity score matching was performed for clinical outcomes.. Incidence of thrombus adhesion was similar in DCS and DP-DES groups (28.4% versus 22.6%, p=0.31). However, the dominant NIC grade was significantly higher in DCS (p<0.001), while NIC was more heterogeneous in DCS than in DP-DES (p=0.001). Maximum yellow color grade was similar (p=0.22). After propensity score matching, 202 lesion pairs from 146 patient pairs were retained for analysis. The cumulative incidence of TLR (4.6% versus 3.8%, p=0.38) and MACE (11.6% versus 11.7%, p=0.84) was similar for DCS and DP-DES.. DCS showed thrombus adhesion and clinical outcomes at 1 year similar to DP-DES. DCS can thus be used with similar safety and efficacy as DP-DES.

Topics: Absorbable Implants; Angioscopy; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

The aim of SiBi study was to evaluate the early vascular healing and neointimal coverage after implantation of ultrathin (60 μm) biodegradable polymer-coated Tetriflex (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) sirolimus-eluting stent (SES) using optical coherence tomography (OCT) at 4 to 6 weeks after implantation.. SiBi was a single-center, observational, investigator-initiated study. From January 15, 2018 to April 15, 2018, total 29 consecutive patients who had consented and underwent OCT examination at 4-6 weeks after Tetriflex SES implantation were enrolled. All OCT images were analyzed at an independent core laboratory by analysts who were blinded to patient and procedural information.. Of 29 patients, four patients were excluded, as those OCT images were technically inadequate for analysis. Therefore, 25 patients were included in final OCT analysis. Average OCT analysis was performed after 35.3 ± 5 days of Tetriflex implantation. Total 14,024 stent struts in 1,520 cross sections were analyzed. Strut tissue coverage was observed in 91.26 ± 5.53% of struts and malapposed struts were seen in 0.89 ± 1.67%. The mean neointimal hyperplasia (NIH) thickness on the covered struts was 50 ± 30 μm.. A large percentage of struts were found to be covered with thin layer of NIH evenly distributed along the stent length at around 1 month from stent implantation. The results of this pilot study serve as ethical and scientific backbone to conduct an adequately powered clinical trial to evaluate outcomes of short dual-antiplatelet therapy in context of ultrathin strut stent.

Topics: Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Humans; Neointima; Percutaneous Coronary Intervention; Pilot Projects; Polymers; Sirolimus; Stents; Tomography, Optical Coherence; Treatment Outcome

This study explores the safety and efficacy of thin strut MeRes100 sirolimus-eluting bioresorbable vascular scaffold (BRS) in patients with de novo coronary artery lesions.. In interventional cardiology, the emergence of BRS technology is catalyzing the next paradigm shift.. The MeRes-1 Extend was a multicenter, prospective, single-arm, open-label study enrolling 64 patients in Spain, Macedonia, Brazil, South Africa, Malaysia, and Indonesia. The safety endpoint was major adverse cardiac events (MACE) which composed of cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (ID-TLR). The imaging efficacy endpoint was mean in-scaffold late lumen loss (LLL) evaluated by quantitative coronary angiography (QCA). Optical coherence tomography (OCT) imaging was performed at baseline and 6-month follow-up.. A total of 69 target lesions were identified in 64 enrolled patients (mean age 58.30 ± 9.02 years). Of the treated lesions, 49 (71.01%) lesions were of type B2/C. Procedural and device success was achieved in 64 and 62 patients, respectively. At 2-year follow-up, MACE was reported in one patient (1.61%) in the form of ID-TLR. There was no case of MI, cardiac death or scaffold thrombosis through 2-year. In a subset of 32 patients, paired QCA showed mean in-scaffold LLL of 0.18 ± 0.31 mm at 6-month follow-up. In a subset of 21 patients, OCT revealed 97.95 ± 3.69% strut coverage with mean scaffold area of 7.56 ± 1.79 mm. The clinical and imaging outcomes of MeRes-1 Extend trial demonstrated favorable safety and efficacy of MeRes100 sirolimus-eluting BRS in patients with de novo coronary artery lesions.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

The ideal drug-eluting stent (DES) for the treatment of unprotected left main coronary artery (ULMCA) is unknown. We compared percutaneous coronary intervention (PCI) using durable polymers versus early-generation, thicker strutted and coated bioabsorbable polymers for ULMCA disease.. Patients who underwent ULMCA PCI (893 patients) from April 2008 to November 2014 were identified from the Grand-DES registry. The primary end point was 3-year target lesion failure (TLF) after propensity score matching.. The final analysis included 754 patients (84.4%) and 139 patients (15.6%) in the durable and bioabsorbable polymer group, respectively. The groups differed significantly in lesion and procedural characteristics. Propensity score-matched analysis revealed a trend toward a lower 3-year TLF in the durable polymer group (log rank p=0.071). Independent predictors of 3-year TLF were chronic kidney disease, presentation with acute myocardial infarction, and a two-stenting technique for ULMCA lesions. Definite/probable stent thrombosis rates at 3-years were low in both groups (0.8% vs. 0.7%, p=0.925).. The safety of ULCMA PCI was excellent, and durable and bioabsorbable polymer DES provided similar clinical outcomes at 3-year follow-up. Landmark analysis revealed that the durable polymer group had a lower TLF rate from 9 months. Further studies are needed to confirm these results.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Registries; Sirolimus; Treatment Outcome

Although thin-strut drug-eluting stents (DES) with a more flexible design are easily obtainable, data regarding using ultralong DES (≥40 mm) for long coronary lesions are limited in the literature. Therefore, the current study assessed the safety and efficacy of an ultralong (≥40 mm) and ultrathin (60 μm) biodegradable polymer-coated sirolimus-eluting stent (SES), Supralimus Grace, with a unique Long Dual Z-link (LDZ-link) design (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in real-world patients with long coronary lesions.. The assigned stents were implanted in 684 patients. The primary endpoint was target lesion failure (TLF), which is a composite of cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularization (TLR), whereas periprocedural secondary endpoints included device failure (failure of stent delivery, change of stent, and stent fracture) and patient-oriented composite endpoint (POCE), which is a composite of all deaths, any MI, and any revascularization, and stent thrombosis (ST). These outcomes were analyzed at one-year follow-up and during the procedure.. The patients' mean age was 52.7±15.9 years; 537 (78.5%) were males. 626 (91.5%) patients suffered from acute coronary syndrome and 58 (8.5%) patients from chronic coronary syndrome (CSS). 989 lesions were removed. The mean numbers of lesions and stents implanted per patient were 1.3±0.2 mm and 1.4±0.3 mm, respectively. TLF occurred in 42 (6.1%) as a result of cardiac death, target vessel MI, and TLR in 9 (1.3%), 20 (2.9%), and 13 (1.9%) patients, respectively. POCE was observed in 131 patients (19.1%) at one-year follow-up, mainly in 63 (9.2%) patients because of any revascularization. Stent failure was seen in 21 patients (3.1%) as a result of delivery failure (2.2%), edge dissection (0.8%), and fracture (0.1%). Definite and probable ST were observed in 8 (1.1%) and 9 (1.3%) patients, respectively.. Ultralong (≥40 mm), ultrathin (60 μm) Supralimus Grace stent can be safely implanted in vessels having long and multiple lesions.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

[Figure: see text].

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Polymers; Sirolimus; Stents; Treatment Outcome

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

Topics: Coronary Artery Disease; Drug-Eluting Stents; Humans; Sirolimus; Treatment Outcome

Patients with diabetes mellitus (DM) represents a challenging subset of population as they experience worse outcomes after percutaneous coronary intervention than patients without diabetes. We evaluated the 2-year efficacy and safety profile of the Abluminus DES+ in patients with diabetes within the population enrolled in the large multicenter en-ABL e-registry.. Multicenter, prospective, all-comers registry performed in 31 centers in India. We analyze patients according to the diagnosis of DM and insulin dependency (ID or Non-ID): non-DM (1641 patients), NIDDM (721 patients), IDDM (138 patients). The primary endpoint was a composite of device-oriented major adverse cardiac events (MACE): cardiac death, target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)/ target vessel revascularization (TVR) at 2-year. Stent thrombosis (ST) at any time point was also recorded.. The MACE rate at 2-year follow-up was 3.0% in the overall population with DM patients showing a higher rate of primary endpoint compared to non-DM (4.4% vs. 2.4%, P=0.025). Rate of cardiac death was actually low and consistent between the 2 groups (1.7% vs. 0.9%, P=0.100). At 2-year follow-up, the rate of ST was 0.9% in DM patients versus 0.5% in non-DM, P=0.213.. At 2-year follow-up, the Abluminus DES+ technology that merges the features of a sirolimus coated balloon with those of a bioresorbable polymer drug eluting stent appears to be safe and effective. This safety/efficacy profile was consistent in patients with or without DM.

Topics: Coronary Artery Disease; Diabetes Mellitus, Type 2; Drug-Eluting Stents; Humans; Prospective Studies; Sirolimus

To compare Orsiro biodegradable-polymer sirolimus-eluting stent (Orsiro BP-SES) with durable-polymer everolimus-eluting stent (DP-EES) regarding target lesion failure (TLF) after rotational atherectomy (RA), with a focus on small stents (diameter ≤ 3 mm) where Orsiro BP-SES has 60 µm strut thickness, while DP-EES remains with 81 µm strut thickness.. New-generation drug-eluting stent (DES) is superior to early-generation DES in all percutaneous coronary intervention (PCI) settings including RA. Recently, the Orsiro BP-SES was superior to a DP-EES in an all comer's population.. Among patients who underwent RA at a single center, 121 were treated with Orsiro BP-SES and 164 with DP-EES (Promus and Xience). Those treated with other stent types, presenting with acute myocardial infarction or had a chronic total occlusion were excluded. Incidence of TLF was assessed.. After 2 years, the TLF rate in Orsiro BP-SES and DP-EES groups was 10% and 18%, respectively (adjusted HR 0.55, 95%CI 0.26-1.16, p = 0.115). The rate of TLF was significantly lower in small Orsiro BP-SES with ultra-thin struts as compared to DP-EES with the same diameters (adjusted HR 0.19, 95% CI 0.04-0.87, p = 0.032), driven by lower rates of clinically driven target lesion revascularization (log-rank p = 0.022). Age (p = 0.035), total stent length (p = 0.007) and diabetes mellitus (p = 0.011) emerged as independent predictors of TLF in the whole population.. In the whole cohort, Orsiro BP-SES and DP-EES had comparable rates of long-term TLF after RA. In the small stent subgroup, the Orsiro BP-SES with ultra-thin struts showed significant lower rate of TLF at 2 years.

Topics: Absorbable Implants; Aged; Atherectomy, Coronary; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Polymers; Prosthesis Design; Retrospective Studies; Sirolimus; Treatment Failure; Treatment Outcome

While thinner struts are associated with improved clinical outcomes in bare-metal stents (BMS), reducing strut thickness may affect drug delivery from drug-eluting stents (DES) and there are limited data comparing otherwise similar thin and thick strut DES. We assessed 2-year outcomes of patients treated with a thin strut (84-88um) cobalt-chromium, biodegradable polymer, Biolimus A9-eluting stent (CoCr-BP-BES) and compared these to patients treated with a stainless steel, biodegradable polymer, Biolimus A9-eluting stent (SS-BP-BES).. In total, 1257 patients were studied: 400 patients from 12 centres receiving ≥1 CoCr-BP-BES in the prospective Biomatrix Alpha registry underwent prespecified comparison with 857 patients who received ≥1 Biomatrix Flex SS-BP-BES in the LEADERS study (historical control). The primary outcome was major adverse cardiac events (MACE)-cardiac death, myocardial infarction (MI), or clinically driven target vessel revascularization (cd-TVR). Propensity analysis was used to adjust for differences in baseline variables and a landmark analysis at day-3 to account for differences in periprocedural MI definitions.. At 2-year follow-up, propensity-adjusted analysis showed the thin strut (84-88um) Biomatrix Alpha CoCr-BP-BES was associated with improved clinical outcomes compared with the thicker strut (114-120um) Biomatrix Flex SS-BP-BES.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Anti-Inflammatory Agents; Chromium Alloys; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Registries; Sirolimus; Stainless Steel; Treatment Outcome

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Molecular Weight; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Treatment Outcome

To compare 10-year outcomes after implantation of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) for left main coronary artery (LMCA) stenosis. Very long-term outcome data of patients with LMCA disease treated with drug-eluting stents (DES) have not been well described. In 10-year extended follow-up of the MAINCOMPARE registry, we evaluated 778 patients with unprotected LMCA stenosis who were treated with SES (n = 607) or PES (n = 171) between January 2000 and June 2006. The primary composite outcome (a composite of death, myocardial infarction [MI] or target-vessel revascularization [TVR]) was compared with an inverse-probability-of-treatment-weighting (IPTW) adjustment. Clinical events have linearly accumulated over 10 years. At 10 years, there were no significant differences between SES and PES in the observed rates of the primary composite outcome (42.0% vs. 47.4%; hazard ratio [HR] 0.85; 95% confidence interval [CI] 0.66-1.10), and definite stent thrombosis (ST) (1.9% vs. 1.8%; HR 1.02, 95% CI 0.28-3.64). In the IPTW-adjusted analyses, there were no significant differences between SES and PES in the risks for the primary composite outcome (HR 0.89, 95% CI 0.65-1.14) or definite ST (adjusted HR 1.05, 95% CI 0.29-3.90). In patients who underwent DES implantation, high overall adverse clinical event rates (with a linearly increasing event rate over time) were observed during extended follow-up. At 10 years, there were no measurable differences in outcomes between patients treated with SES vs. PES for LMCA disease. The incidence of stent thrombosis was quite low and comparable between the groups.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Humans; Paclitaxel; Sirolimus; Stents; Treatment Outcome

The DESSOLVE III OCT substudy aimed to compare serially neointimal hyperplasia volume obstruction (%VO) between the thin-strut MiStent with early polymer elimination and nine-month sustained drug release from microcrystalline sirolimus and the durable polymer-coated everolimus-eluting XIENCE stent at six and 24 months after implantation.. The efficacy endpoint was %VO, calculated as abluminal neointimal volume/stent volume. Thirty-six patients (MiStent 16 patients, 16 lesions; XIENCE 20 patients, 22 lesions) underwent serial OCT evaluation at both six and 24 months. At six months, mean abluminal %VO was significantly lower in the MiStent group than in the XIENCE group (14.54±3.70% vs 19.11±6.70%; p=0.011), whereas the difference in %VO between the two groups decreased at 24 months (20.88±5.72% vs 23.50±7.33%; p=0.24). There was no significant difference in percentage malapposed struts and percentage uncovered struts between the two groups at both time points.. In the serial comparative OCT analysis of the MiStent versus the XIENCE, the MiStent showed a more favourable efficacy for preventing neointimal formation with comparable strut tissue coverage, as compared with the XIENCE at six months, but this difference in %VO decreased at 24 months so that the difference in neointima at 24 months was no longer significant.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Hyperplasia; Neointima; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Stents; Tomography, Optical Coherence; Treatment Outcome

To assess the long-term outcomes of patients treated with sirolimus-eluting Stentys stent in a real-life setting.. Few data regarding the safety and effectiveness of self-apposing sirolimus-eluting Stentys stent are available.. 278 patients (30% stable coronary artery disease, 70% acute coronary syndromes, and 54% on unprotected left main) treated with sirolimus eluting Stentys stent were retrospectively included in the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease multicenter registry. Major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, target lesion revascularization, stent thrombosis) were the primary end-point, single components of MACE were the secondary ones.. After 13 months (interquartile range 5-32), MACE was 14%. Stent thrombosis occurred in 3.9% of the patients (2.5% definite stent thrombosis and 1.4% probable stent thrombosis), 66% of them presenting with ST-segment elevation myocardial infarction (STEMI) at admission. Cardiovascular death, target lesion revascularization and myocardial infarction was 4.7%, 8.3%, and 7.2%, respectively. At multivariate analysis, risk of MACE was increased by diabetes (hazard ratios 4.76; P = 0.002) but was not affected by the indication leading to sirolimus-eluting Stentys stent implantation (marked vessel tapering vs. coronary ecstasies, hazard ratios 0.74, P = 0.71).. Sirolimus-eluting Stentys stent may represent a potential solution for specific coronary anatomies such as bifurcation, ectasic, or tapered vessels. Risk of stent thrombosis appears related to clinical presentation with STEMI and to anatomic features, stressing the importance of the use of intracoronary imaging for self-expandable stents implantation.

Topics: Acute Coronary Syndrome; Aged; Antibiotics, Antineoplastic; Cardiovascular Diseases; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Percutaneous Coronary Intervention; Postoperative Complications; Registries; Retrospective Studies; Sirolimus; ST Elevation Myocardial Infarction; Thrombosis; Treatment Outcome

The ULISSE registry evaluated the real-world performance of the Ultimaster® biodegradable polymer sirolimus-eluting stent (BP-SES) in a multicenter-independent cohort of patients undergoing percutaneous coronary intervention, including a large proportion of diabetes mellitus (DM) patients.. In this subgroup analysis, 1,660 consecutive patients, 2,422 lesions, treated with BP-SES enrolled in the ULISSE registry were divided in two groups: DM (485 patients, 728 lesions) and non-DM (1,175 patients, 1,694 lesions). Primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac-death, target-vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) at 1-year. Secondary endpoint was TLR at 1-year.. At 1-year follow-up TLF occurred in 5% overall patients and was significantly higher in DM patients (8 vs. 3.7%; p = .001), due to more cardiac deaths (3.4 vs. 1.1%; p = .002). TLR occurred in 3.2% overall patients, and it was not significantly higher in DM compared to non-DM patients (4.4 vs. 2.8%; p = .114). The incidence of stent thrombosis was low and similar between groups (0.4 vs. 0.9%; p = .526). Insulin-treated DM (ITDM) patients showed higher rate of TLF as compared to non-ITDM patients (13 vs. 6.5%; p = .041), but similar rate of TLR (6 vs. 4%; p = .405). After adjustment for relevant comorbidities, DM was not significantly associated with TLF or cardiac death in patients undergoing BP-SES implantation.. This study is the first all-comers evaluation of BP-SES in DM patients. Our findings show that DM patients, mostly those with ITDM, still represent a vulnerable population and experience significantly higher rate of TLF. Overall BP-SES efficacy is considerable, although not statistically significant higher rate of TLR is still present in DM compared to non-DM patients.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Italy; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

This study sought to determine clinical outcomes between treatment groups over long-term follow-up.. The safety and efficacy of a ridaforolimus-eluting stent (RES) was evaluated in the BIONICS (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) and NIREUS (BioNIR Ridaforolimus Eluting Coronary Stent System [BioNIR] European Angiography Study) trials, demonstrating noninferiority of RES in comparison with a zotarolimus-eluting stent (ZES) regarding 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss, respectively.. Patient-level data from the BIONICS (N = 1,919) and NIREUS (N = 302) randomized trials were pooled, and outcomes in patients implanted with RES and ZES compared. Broad inclusion criteria allowed enrollment of patients with acute coronary syndromes and complex lesions. The primary endpoint was the 2-year rate of TLF or clinically driven target lesion revascularization.. A total of 2,221 patients (age 63.2 ± 10.3 years; 79.7% men) undergoing percutaneous coronary intervention with RES (n = 1,159) or ZES (n = 1,062) were included. Clinical and angiographic characteristics were similar between groups. At 2 years, the primary endpoint of TLF was similar among patients implanted with RES and ZES (7.0% vs. 7.2%; p = 0.94). Rates of target lesion revascularization (4.8% RES vs. 4.1% ZES; p = 0.41) and target vessel-related myocardial infarction (3.1% RES vs. 3.8% ZES; p = 0.52) did not differ between groups. The overall rate of stent thrombosis was also similar (0.5% RES vs. 0.9% ZES; p = 0.39).. In a pooled analysis of 2 randomized trials, 2-year clinical outcomes were similar between patients undergoing percutaneous coronary intervention with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of a broad population of patients with coronary artery disease.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The objective of this study was to assess regional and ethnic differences in an unselected patient population treated with polymer-free sirolimus-eluting stents (PF-SES) in Asia and Europe.. Two all-comers observational studies based on the same protocol (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were combined for data analysis to assure sufficient statistical power. The primary endpoint was the accumulated target lesion revascularization (TLR) rate at 9-12 months.. Of the total population of 7243 patients, 44.0% (3186) were recruited in the Mediterranean region and 32.0% (2317) in central Europe. The most prominent Asian region was South Korea (17.6%, 1274) followed by Malaysia (5.7%, 413). Major cardiovascular risk factors varied significantly across regions. The overall rates for accumulated TLR and MACE were low with 2.2% (140/6374) and 4.4% (279/6374), respectively. In ACS patients, there were no differences in terms of MACE, TLR, MI and accumulated mortality between the investigated regions. Moreover, dual antiplatelet therapy (DAPT) regimens were substantially longer in Asian countries even in patients with stable coronary artery disease as compared to those in Europe.. PF-SES angioplasty is associated with low clinical event rates in all regions. Further reductions in clinical event rates seem to be associated with longer DAPT regimens.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Ethnicity; Europe; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Malaysia; Male; Mediterranean Region; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prognosis; Prospective Studies; Republic of Korea; Sirolimus

To analyze the 3-year outcomes of the biodegradable polymer cobalt-chromium sirolimus-eluting stent (EXCROSSAL) in CREDIT II AND III TRIALS.. Though approved by CFDA, the long-term safety and efficacy of EXCROSSAL is still unknown.. CREDIT II was a randomized trial comparing the EXCROSSAL versus EXCEL stents in patients with up to two de novo coronary lesions, and CREDIT III was a prospective, single-arm study evaluating the efficacy and safety of EXCROSSAL in broad types of de novo coronary artery lesions. We pooled the 3-year follow-up data of the EXCROSSAL arm of the CREDIT II and CREDIT III Trials. The primary outcome was 3-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (CI-TLR). The patient-oriented composite endpoint (PoCE) (all-cause death, all MI, or any revascularization) and stent thrombosis (ST) were also analyzed.. A total of 833 patients were included in this study. The incidence of TLF and PoCE in the 3-year follow-up were 7.6% and 12.5%, respectively. ST occurred in 0.6% of patients. In the subgroup analyses, TLF was significantly higher in small target vessels, multi-lesion PCI, and multi-vessel disease.. The 3-year follow-up analysis confirmed low rates of TLF and ST in EXCROSSAL, which is similar to the most widely used new generation durable polymer drug-eluting stent.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Chromium Alloys; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

We aimed to evaluate the safety and efficacy of Nano+™ (Lepu Medical, Beijing, China) stent implantation in all-comer patients at the 1-year follow-up.. The Nano+™ stent is a novel polymer-free sirolimus-eluting stent polymer that employs nanoporous stent surface technology to control drug-delivery. The Nano+™ stent is one of the most widely used drug-eluting stent (DES) in China.. A total of 2,481 consecutive patients were included in the multicenter and prospective NANO registry. In this study, the primary endpoint was target lesion failure (TLF) at 1-year follow-up, defined as a composite of cardiac death, target vessel nonfatal myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR). The safety endpoint was the occurrence of definite or probable stent thrombosis (ST).. Up to 40.2% of patients presented with acute myocardial infarction (AMI). A total of 63.9% of the 2,904 lesions were American College of Cardiology/American Heart Association (ACC/AHA) type B2 or C lesions. One-year follow-up data were available for 98.4% of patients. The 1-year rate of TLF was 3.1% with rates of 1.3, 1.8, and 0.4% for clinically driven TLR, cardiac death, and TV-MI, respectively. ST occurred in 0.4% of patients. Diabetes mellitus, AMI, left ventricular ejection fraction <40% and long lesions (>40 mm) were independent predictors of 1-year TLF.. The 1-year clinical outcomes were excellent for Nano+™ polymer-free SES implantation in an all-comer patient population. Follow-up will be extended up to 5 years, to further elucidate the potential long-term clinical benefits.. URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02929030.

Topics: Aged; Cardiovascular Agents; China; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Nanopores; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Surface Properties; Time Factors; Treatment Outcome

A large trial established the favorable profile of a new polymer-free biolimus A9-eluting stent (PF-BES) with a 1-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. This is the first study comparing outcomes for a 1-month versus longer DAPT strategies following PF-BES-percutaneous coronary intervention (PCI).. All patients undergoing PF-BES-PCI (January 2016 to July 2018) were included in the multicenter CHANCE registry. Patients were stratified according to DAPT strategy at discharge (planned 1-month vs. planned >1-month). Primary outcomes were the 390-day estimates of a patient-oriented and of a device-oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularization; DOCE: cardiac death, target vessel-MI or ischemia-driven target lesion revascularization). Landmark analyses from 1-month post-PCI were carried.. Following PF-BES-PCI, 328(40.3%) and 485(59.6%) patients were discharged with 1-month and longer DAPT (12 months [6-12]), respectively. Patients with a previous or index MI were less likely to be discharged on 1-month DAPT. Patients prescribed with 1-month DAPT were more likely to be at HBR than those with longer DAPT (90.2% vs. 69.9%, p = .001). No between-groups differences in the primary outcomes (planned 1-month vs. planned >1-month DAPT: POCE 11.9% vs. 13.2%, p = .747; DOCE: 4.8% vs. 8.1%, p = .500) were observed, also after adjusting for confoundings (POCE: adjusted-hazard ratio [adj-HR] 1.26, 95%CI 0.74-2.13; DOCE: adj-HR 1.00, 95%CI 0.49-1.99). Landmark analyses showed similar results.. In a large all-comers registry of PF-BES PCI, no interaction of planned DAPT strategy (1-month vs. >1-month) with outcomes was found. This observation warrants investigation in adequately powered randomized studies (ClinicalTrials.gov NCT03622203).

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug Administration Schedule; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Female; Humans; Italy; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Registries; Sirolimus; Time Factors; Treatment Outcome

1例主诉为"活动后胸闷、胸痛2 d"的13岁7月龄患儿就诊于安徽医科大学第二附属医院儿科。经病史询问、心脏彩超及冠状动脉造影检查，诊断为川崎病、右侧冠状动脉慢性完全闭塞性病变。成功于局部麻醉下进行经皮腔内冠状血管成形术及冠状动脉内雷帕霉素洗脱支架植入术。.

Topics: Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Humans; Mucocutaneous Lymph Node Syndrome; Sirolimus; Treatment Outcome

To test the long-term efficacy of a sirolimus-coated balloon (SCB).. Nanoluté was a prospective registry to evaluate the clinical performance of a novel SCB (Concept Medical Research Private Limited, India) for the treatment of de novo coronary lesions and in-stent restenosis (ISR). We here present the 24 months clinical data.. All patients treated with SCB for any type of coronary indication between July 2012 and September 2015 were enrolled at Indian centers and clinically followed up to 24 months. Primary endpoints were major adverse cardiovascular events (MACE) defined as a composite of cardiac death, target lesion revascularization (TLR), and target vessel-myocardial infarction (MI).. A total of 484 SCBs were used in 408 patients to treat 435 lesions. In detail, the SCB was used for 183 patients with ISR, 185 with de novo small vessel disease, and 40 with de novo large vessel disease. Mean balloon length and diameter (average ± SD) were 22.3 ± 7.1 mm and 2.7 ± 0.40 mm, respectively. All patients with 24 months follow-up were included. Overall MACE rate was 4.2% (n = 17) with three cardiac deaths (0.7%), 13 TLR (3.2%), and one MI (0.2%).. The Nanoluté prospective registry is the first long-term clinical evidence of the safety and feasibility of this type of SCB, both in patients with ISR or de novo lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Equipment Design; Female; Humans; India; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The objective of this post hoc analysis was to analyze real-world dual antiplatelet therapy (DAPT) regimens following polymer-free sirolimus-eluting stent (PF-SES) implantations in an unselected patient population.. Patient-level data from two all-comers observational studies (ClinicalTrials.gov Identifiers: NCT02629575 and NCT02905214) were pooled and analyzed in terms of their primary endpoint. During the data verification process, we observed substantial deviations from DAPT guideline recommendations. To illuminate this gap between clinical practice and guideline recommendations, we conducted a post hoc analysis of DAPT regimens and clinical event rates for which we defined the net adverse event rate (NACE) consisting of target lesion revascularization (TLR, primary endpoint of all-comers observational studies) all-cause death, myocardial infarction (MI), stent thrombosis (ST), and bleeding events. A logistic regression was utilized to determine predictors why ticagrelor was used in stable coronary artery disease (CAD) patients instead of the guideline-recommended clopidogrel.. For stable CAD, the composite endpoint of clinical, bleeding, and stent thrombosis, i.e., NACE, between the clopidogrel and ticagrelor treatment groups was not different (5.4% vs. 5.1%, p = 0.745). Likewise, in the acute coronary syndrome (ACS) cohort, the NACE rates were not different between both DAPT strategies (9.2% vs. 9.3%, p = 0.927). There were also no differences in the accumulated rates for TLR, myocardial infarction ([MI], mortality, bleeding events, and stent thrombosis in elective and ACS patients. The main predictors for ticagrelor use in stable CAD patients were age < 65 years, smaller vessels, treatment of ostial and calcified lesions, and in-stent restenosis.. Within the framework of a post hoc analysis based on a real-world, large cohort study, there were no differences in the combined endpoint of major adverse cardiac events (MACE), bleeding and thrombotic events for clopidogrel and ticagrelor in stable CAD or ACS patients. Despite the recommendation for clopidogrel by the European Society of Cardiology (ESC), real-world ticagrelor use was observed in subgroups of stable CAD patients that ought to be explored in future trials.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Female; Guideline Adherence; Hemorrhage; Humans; Male; Middle Aged; Multicenter Studies as Topic; Observational Studies as Topic; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Practice Patterns, Physicians'; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

This study aimed to assess the prognostic ability of SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) Score II (SS-II) in LM and/or TVD patients undergoing biodegradable polymer-based drug-eluting stents (BP-DES) in the multi-central randomized PANDA III trial.. A total of 723 patients in PANDA III population were enrolled in this study. According to SS-II tertiles, patients were stratified as follow: SS-II ≤ 23 (n = 224), 23 < SS II ≤ 31 (n = 255), SS II > 31 (n = 244). The predictive abilities for 2-year cardiac death were compared between angiographic scores and scores combining both angiographic and clinical variables.. Mean anatomic SS was 20.6 ± 9.4, SS-II for PCI was 28.7 ± 8.6. During 2-year follow up, cardiac death (0.00% vs. 1.7% vs. 4.3%, p = 0.003) and target lesion failure (5.9% vs. 9.1% vs. 13.6%, p = 0.020) was significantly higher in the upper tertile group than in intermedian and low tertile. At multivariate analysis, SS-II for PCI was an independent risk factor of cardiac death (Hazard ratio: 2.41, 95%CI: 1.47-3.97, p < 0.005) and TLF (Hazard ratio: 1.29, 95%CI: 1.01-1.65, p = 0.040). The ROC curve analysis showed that SS-II for PCI had better ability than other SYNTAX scoring systems to predict cardiac death (AUC: 0.746, 95%CI:0.63-0.87, p = 0.010).. The SS-II had superiority than other SYNTAX scoring systems in predicting 2-year cardiac death in LM and/or TVD patients undergoing PCI with biodegradable polymer drug-eluting stents.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Prognosis; Risk Factors; Sirolimus; Treatment Outcome

The aim of this study was to determine 1-year safety and efficacy after treatment with the COMBO and Orsiro stents.. The COMBO stainless-steel stent has an anti-CD34. For this analysis we included European patients from the COMBO collaboration, a patient-level pooling of 2 prospective all-comers registries of COMBO stent implantation (n = 2,775), and all patients randomized to the Orsiro stent (n = 1,169) from the Dutch BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) randomized trial. The main outcome of interest was 1-year target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization evaluated using propensity score-matched analysis.. At baseline, COMBO patients were older and had more insulin-treated diabetes, renal insufficiency, and other comorbidities. However, Orsiro patients included more current smokers and more acute coronary syndrome presentations. Orsiro patients also received longer stents and had more complex target lesions. After propensity score-matched analysis (n = 862/arm), 1-year target lesion failure occurred in 4.1% of COMBO-treated and 2.7% of Orsiro-treated patients (hazard ratio: 1.55; 95% confidence interval: 0.92 to 2.62; p = 0.10). Definite stent thrombosis occurred in 0.5% of COMBO-treated and 0.5% of Orsiro-treated patients (p = 0.99).. A propensity score-matched comparison of all comers treated with the COMBO or Orsiro stent showed no statistically significant differences. Stent thrombosis risk was low and similar between the stents. (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population [BIO-RESORT], NCT01674803; MASCOT-Post Marketing Registry [MASCOT], NCT02183454; Prospective Registry to Assess the Long-term Safety and Performance of the Combo Stent [REMEDEE Reg], NCT01874002).

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Databases, Factual; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Propensity Score; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The bifurcation optimization stent system (BiOSS) LIM (Balton, Warsaw, Poland) stent is a dedicated coronary bifurcation stent. Its unique construction is developed in accordance with the anatomy of the coronary bifurcations, thus eliminating the carina displacement as a mechanism of side branch ostium compromise. Since its development in 2008, the BiOSS stent underwent several changes with the latest version created of sirolimus eluting cobalt-chromium stent. Results from registries and randomized clinical trials showed that implantation of the BiOSS stent is safe and effective with comparable results for major adverse cardiovascular events (MACE) and target lesion revascularisation rates between the BiOSS and regular drug-eluting stent groups. This stent provides alternative for coronary bifurcation treatment, especially when there is a large difference in diameter between the main vessel and the main branch.

Topics: Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Humans; Prosthesis Design; Registries; Sirolimus; Stents; Treatment Outcome

The FLEX-LONG study assessed the safety and clinical outcomes of ultra-long (44 mm/48 mm) biodegradable polymer-coated Supraflex (Sahajanand Medical Technology Pvt. Ltd., Surat, India) sirolimus-eluting stents (SES) in real-world patients with complex, long coronary artery lesions.. It was an investigator-initiated, retrospective, non-randomized, observational and single-center study, which evaluated one-year results of 141 patients who had undergone implantation of at least one ultra-long (44 mm/48 mm) Supraflex SES. The incidence of major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR), at one-year follow-up was considered as primary outcome. Stent thrombosis was analyzed as a safety outcome.. The mean age of the study population was 56.2±9.6 years and 78.0% (110/141) patients were male. The study analyzed high risk patients, including 62 (44.0%) hypertensive and 60 (42.6%) diabetic patients. Total 147 target lesions were treated, including 25 (17.0%) total occlusions. Total 51 (34.7%) and 96 (65.3%) Supraflex SES of 44 mm and 48 mm were implanted, respectively. Average stent length and diameter were 46.6±1.9 mm and 3.4±0.2 mm, respectively. One-year follow-up was obtained in 100% of patients. There was one probable stent thrombosis after three weeks. At one-year follow-up, 99.3% of patients remained event free.. The results of the FLEX-LONG study support the use of ultra-long (44 mm/48 mm) Supraflex SES, in the treatment of high-risk real-world patients. The stent appeared to be safe and effective at one-year with low clinical events in complex, long coronary artery lesions.

Topics: Absorbable Implants; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Hypercholesterolemia; Hypertension; Immunosuppressive Agents; Male; Middle Aged; Prosthesis Design; Retrospective Studies; Sirolimus; Smokers; Thrombosis; Treatment Outcome

Newer generation drug-eluting stents have significantly improved outcomes in patients undergoing percutaneous coronary intervention by reducing the risk of restenosis and stent thrombosis. In comparison with first-generation ones, contemporary drug-eluting stents have thinner struts and more biocompatible polymers, which reduce inflammation, promote endothelialization and decrease neointimal proliferation. The Ultimaster™/Ultimaster™ Tansei™ coronary stent system is a cobalt-chromium, biodegradable polymer, sirolimus-eluting stent (Terumo, Tokyo, Japan) that received the Conformitè Européenne mark approval for clinical use in 2014/2018. This device has been the object of intense clinical evaluation in controlled randomized studies and observational registries. In this article, we analytically reviewed the available clinical data with a focus on the latest real-world evidence that demonstrates excellent performance in all of the clinical subsets.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Treatment Outcome

There is a scarcity of comparative studies between Endeavor Resolute®-zotarolimus-eluting stent (R-ZES) and Resolute Integrity®-ZES (I-ZES) during long-term follow-up periods. Although the stent alloy and the polymer of these two ZESs are similar, the platform and the design of these two stents are different. This study was conducted to compare the efficacy and safety of these two different ZESs in the all-comer Korean patients who underwent percutaneous coronary intervention (PCI) during a 3-year follow-up period.. This study was performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki. In this single-center, retrospective, and all-comer patients' cohort study, a total of 889 patients who underwent PCI with R-ZES (n=394) or I-ZES (n=495) were enrolled. The primary endpoint was the occurrence of major adverse cardiac events (MACEs) defined as all-cause death, nonfatal myocardial infarction (MI), any repeat revascularization including target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR, and the secondary endpoint was stent thrombosis (ST) at 3 years.. To adjust for any potential confounders, the propensity score-adjusted multivariable analysis was performed using the logistic regression model (C-statistics=0.689). The cumulative incidence rates of MACEs [adjusted hazard ratio (aHR), 1.341; 95% confidence interval (CI), 0.615-2.922; p=0.461], all-cause death, nonfatal MI, any repeat revascularization, and ST (aHR, 2.090; 95% CI, 0.163-26.77; p=0.571) were similar between the two groups during the 3-year follow-up period.. R-ZES and I-ZES demonstrated comparable efficacy and safety after PCI during a 3-year follow-up period. However, these results can perhaps be more precisely defined by other large and long-term follow-up studies in the future. (Anatol J Cardiol 2020; 23: 268-76).

Topics: Asian People; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Republic of Korea; Retrospective Studies; Risk Factors; Sirolimus

The BIOFLOW-III Canada registry aimed to evaluate the safety and efficacy of Orsiro sirolimus-eluting stents (SES) with biodegradable polymer, in an all-comers patient population.. We conducted a prospective, non-randomized, multi-center, observational all-comers registry of patients undergoing percutaneous coronary intervention (PCI) with Orsiro SES at two high-volume Canadian centers. The primary endpoint was one-year target lesion failure (TLF) defined as a composite of cardiac death, target-vessel myocardial infarction (MI), coronary artery bypass grafting and clinically driven target lesion revascularization. Four subgroups were pre-defined: i) diabetic patients; ii) small vessels (≤2.75 mm); iii) chronic total occlusions (CTO) and iv) acute MI.. From May 2014 to July 2016, 250 patients (mean age 66.2 ± 10.8 years, 75.6% males, 30% diabetes) underwent PCI with Orsiro SES for 385 coronary lesions. The mean stent diameter was 2.98 ± 0.50 mm and the mean stent length was 22 ± 8 mm. Clinical device and procedural success rates were with 99.5% and 97.6%, respectively. The overall one-year TLF rate was 2.8% [95% confidence interval (CI) 1.4-5.8%], whereas TLF rates were 4.1% [95%CI 1.3-12.2%], 3.2% [95%CI 1.2-8.4%], 8.3% [95%CI 2.2-29.4%], and 2.6% [95%CI 0.7-9.9%] in patients with diabetes, small vessels, CTO, and acute MI, respectively. One case of possible stent thrombosis (ST) was reported (0.4% [95%CI 0.1-2.8%]), while no cases of definite/probable ST was observed at one year.. Our data provide further evidence of the safety and clinical performance of Orsiro SES in an unselected, real-world, complex patient population.. The BIOFLOW-III Canada registry is a prospective, non-randomized, multi-center, observational all-comers registry designed to evaluate the safety and performance of the Orsiro SES in non-selected, real-world patients. A total of 250 patients (mean age 66.2 ± 10.8 years, 75.6% males, 30% diabetes) who underwent PCI with Orsiro SES, were enrolled at two high-volume Canadian centers. The overall rate of TLF at one year was 2.8% [95%CI 1.4-5.8%], whereas TLF rates were 4.1%, 3.2%, 8.3%, and 2.6% in patients with diabetes, small vessels ≤2.75 mm, CTO, and acute MI, respectively. No case of definite/probable ST was observed.

Topics: Absorbable Implants; Aged; Canada; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The Absorb bioresorbable vascular scaffold (Abbott Vascular) does not have an artifact on computed tomography coronary angiography (CTCA); the extent/location of the stent in situ can only be assessed by localizing its radiopaque platinum markers in a non-contrast CTCA. The characteristic appearance of BVS on CTCA should be interpreted as the footprint of a resorbed BVS, instead of a calcified plaque.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Follow-Up Studies; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Treatment Outcome

Endeavor®-zotarolimus-eluting stent (E-ZES) was the first ZES to be developed, and Resolute integrity®-ZES (I-ZES) has been developed more recently. Comparative studies on long-term usage of these two ZESs have been rare.. The aim of this study was to compare the efficacy and safety of E-ZES and I-ZES during a long-term follow-up of patients who underwent percutaneous coronary intervention (PCI).. A total of 767 patients who underwent PCI with E-ZES or I-ZES were eligible for this study. The primary endpoint was the occurrence of major adverse cardiac events (MACEs), defined as the composite of all-cause death, non-fatal myocardial infarction (MI), and any repeat revascularization. The secondary endpoint was stent thrombosis (ST).. After propensity score-matched (PSM) analysis, two PSM groups (193 pairs, n = 386, C-statistic = 0.824) were generated. During the 3-year follow-up period, the cumulative incidence of MACEs (hazard ratio [HR], 0.837; 95% confidence interval [CI], 0.464-1.508; p = 0.553) and ST (HR, 0.398; 95% CI, 0.077-2.052; p = 0.271) was similar for the E-ZES and I-ZES groups. Additionally, the cumulative incidences of all-cause death, cardiac death, non-fatal MI, and any repeat revascularization were not significantly different between the two groups.. Although I-ZES utilizes a more advanced stent platform, stent design, and polymer system than E-ZES, both the ZESs showed comparable efficacy and safety during the 3-year follow-up period in this single-center, all-comers registry. However, further large-scaled, randomized, well-controlled trials with long-term follow-up are needed to verify these results.

Topics: Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

Patients with chronic kidney disease (CKD are frequently excluded from coronary artery disease trials. The aim of this assessment was to study the clinical outcomes of polymer-free sirolimus-eluting stent implantations in patients with impaired renal function.Large-scale, international, single-armed, multicenter, 'all comers' observational studies (ClinicalTrials.gov Identifier: NCT02629575 and NCT02905214) were used for this post-hoc subgroup analysis to compare the clinical outcomes in patients with normal renal function (NRF) to those with renal insufficiency (CKD, dialysis dependence). The accumulated target lesion revascularization rate was the primary endpoint at 9 to 12 months whereas the accumulated major adverse cardiac event, stent thrombosis (ST) and procedural success rates were part of the secondary endpoints.There were 6791 patients with NRF, whereas 369 patients had CKD and 83 patients were dialysis dependent. The target lesion revascularization rate at 9 to 12 months was significantly higher in dialysis patients (2.1% vs 3.3% vs 6.7%, P = .011). The accumulated major adverse cardiac events rates in the dialysis and in the CKD group were significantly higher as compared to patients with NRF (13.3% vs 4.0%, P < .001; 6.5% vs 4.0%, P = .024). Finally, ST rates (NRF: 0.7%, CKD: 0.6%, dialysis: 1.3%) were not statistically different between subgroups (P = .768). All-cause cumulative mortality rates were 3.3% (CKD) and 4.0% (dialysis) respectively.Percutaneous coronary interventions with polymer-free, ultra-thin strut sirolimus-eluting stents have comparable revascularization rates in CKD and dialysis dependent patients as compared to percutaneous coronary interventions with other 2nd generation drug-eluting stents. ST and all-cause mortality rates were low as compared to available literature references.

Topics: Aged; Asia; Coronary Artery Disease; Drug-Eluting Stents; Europe; Female; Humans; Male; Prosthesis Design; Renal Insufficiency; Sirolimus; Treatment Outcome

Diabetic patients are frequently affected by coronary artery disease (CAD) and are at increased risk of CAD-related adverse events, even after drug-eluting stent (DES) implantation. If currently available DES have similar safety and efficacy in diabetic and nondiabetic patients is still debated. This prospective, multicenter registry showed similar 3-year outcome in patients undergoing different DES implantation, although diabetic patients, especially those requiring insulin treatment, had significantly higher risk of adverse events than nondiabetic patients. Specific efforts to improve the performance of DES in diabetic patients are mandatory to adequately address the unsolved issue of diabetic patients affected by CAD.

Topics: Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Humans; Myocardial Infarction; Prospective Studies; Registries; Sirolimus; Stents; Treatment Outcome; Water

RENASCENT is a prospective, multi-center first-in-human clinical study to evaluate the clinical performance of the novel sirolimus-eluting 150-μm strut thickness FORTITUDE® BRS for percutaneous coronary intervention of single de novo coronary lesions.. FORTITUDE® BRS was tested in a prospective study in Italy and Colombia. Study objectives were in-scaffold angiographic late lumen loss (LLL) measured by quantitative coronary angiography and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction or ischemia driven target lesion revascularization (TLR) at 9- and 24-months with clinical results up to 36-months.. A total of 63 patients were enrolled. All patients underwent lesion pre-dilatation and 22 patients (34.9%) underwent post-dilatation. Clinical device and procedural success was 98.4% (62/63 patients) and 96.8% (61/63 patients) respectively. At 9-months, TVF occurred in 3/61 (4.9%) of the patients including 2 peri-procedural MI and one ischemia-driven TLR. Between 9- to 24-months, ischemia-driven TLR occurred in 3 additional patients (4.9%) including 1 patient who presented with very late ST after stopping all medications. There were no further TVF between 24- and 36-months.. In this multi-center prospective study, the FORTITUDE® BRS was shown to be safe and effective in the treatment of single coronary lesions with low levels of TVF and LLL at 9- and 24-months. It was shown to be clinically safe upto 36-months follow-up.

Topics: Absorbable Implants; Cardiovascular Agents; Colombia; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Italy; Molecular Weight; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

We aimed to assess the safety and efficacy of the DynamX Novolimus-Eluting Coronary Bioadaptor System, a novel device that initially acts as a second-generation drug-eluting stent, but after six months frees the vessel through uncaging elements.. This multicentre study enrolled 50 patients with single de novo lesions. In-device acute lumen gain was 1.61±0.34 mm, and device and procedure success was 100%. Up to 12 months, two target lesion failures occurred: both were cardiac deaths (day 255 and day 267 post procedure). No definite or probable device thrombosis was observed. Mean late lumen loss was 0.12±0.18 mm in-device and 0.11±0.16 mm in-segment. Per intravascular ultrasound, the mean device area and mean vessel area increased significantly by 5% and 3%, respectively, while the mean lumen area was maintained. Stationary optical coherence tomography in seven patients demonstrated restoration of cyclic pulsatility, with an approximate lumen area variance of 11% between systole and diastole.. The DynamX bioadaptor showed drug-eluting stent-like acute performance and safety and efficacy up to one year. Positive remodelling with an increase of vessel and device area while maintaining the mean lumen area was demonstrated. Long-term follow-up and randomised trials are required to assess the benefit of this device on events beyond one year.

Topics: Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

The ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) demonstrated comparable performance to durable-polymer everolimus-eluting stent (DP-EES) in randomized controlled trials. The purpose of this study was to evaluate the performance of a BP-SES compared with a DP-EES in calcified or small vessel lesions, which represent higher risk of restenosis.. From the pooled BIOFLOW (BIOFLOW-II, IV, and V; BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions ) randomized controlled trials, a total of 1553 BP-SES and 784 DP-EES patients with valid 1-year follow-up data were available. Coronary lesions were assessed for the presence of moderate-to-severe calcification or small vessels (reference vessel diameter, ≤2.75 mm) by core laboratory analysis. One-year clinical outcomes were assessed with or without the lesion subsets between BP-SES and DP-EES.. Baseline characteristics were similar between the groups. Among patients with small vessel disease, target lesion failure (8.0% versus 12.4%;. Among patients with more complex disease representing a higher risk of target lesion failure, the effectiveness of an ultrathin-strut BP-SES compared with a thin-strut DP-EES was maintained through 1 year. Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01356888, NCT01939249, NCT02389946.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Vascular Calcification

Diabetes mellitus is a risk for increased incidence of adverse clinical events after percutaneous coronary intervention. However, the difference in the incidence of adverse clinical events according to stent type in patients with diabetes remains to be elucidated. In the present study, we aimed to compare the clinical outcomes between patients treated with the biodegradable polymer sirolimus-eluting stents (BP-SES) and the durable polymer everolimus-eluting stents (DP-EES) among patients with diabetes.. Among 631 lesions in 510 consecutive patients treated with either BP-SES or DP-EES, 165 lesions in 141 patients with diabetes mellitus and stable angina pectoris were identified and classified into the BP-SES group (48 lesions in 44 patients) and the DP-EES group (117 lesions in 100 patients). The incidence of adverse clinical events after stent implantation was compared between the 2 groups.. There was no significant difference in the prevalence of conventional risk factors, lesion characteristics, and procedural characteristics between the 2 groups. During median 386 [334-472] days follow-up, the incidence of target lesion revascularization (11.4 vs. 2.0%, p = 0.003) and device-oriented clinical endpoint (13.6 vs. 6.0%, p = 0.035) in the BP-SES group was significantly greater than that in the DP-EES group. A univariate model demonstrated that the BP-SES usage was significantly associated with the higher incidence of target lesion revascularization (odds ratio, 6.686; 95% confidence interval, 1.234-36.217; p = 0.028).. BP-SES was associated with the greater incidence of TLR than the DP-EES in patients with diabetes mellitus. Further studies with larger cohorts and longer follow-up are required to confirm the present results.

Topics: Aged; Angina, Stable; Cardiovascular Agents; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Coronary Aneurysm; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Treatment Outcome

Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients.. Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention.. Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (. Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier NCT03647475.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug Administration Schedule; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Female; Hemorrhage; Humans; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; United States

We aimed to assess long-term safety and performance of the Orsiro sirolimus-eluting coronary stent with biodegradable polymer in a large unselected population and in pre-specified subgroups.. BIOFLOW-III is a prospective, multicenter, international, observational registry with follow-up visits scheduled at 6 and 12 months, and at 3 and 5 years (NCT01553526).. 1356 patients with 1738 lesions were enrolled. Of those, 392 (28.9%) declined to participate in the study extension from 18 months to 5 years, 37 (2.7%) withdrew consent, and 89 (6.6%) were lost to follow-up. At 5-years, Kaplan-Meier estimates of target lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, coronary artery bypass grafting and clinically driven target lesion revascularization was 10.0% [95% confidence interval (CI): 8.4; 12.0] in the overall population, and 14.0% [95% CI: 10.5; 18.6], 10.3% [95% CI: 7.8; 13.5], 1.8% [95% CI: 0.3; 12.0], and 11.3% [95% CI: 8.5; 15.1] in the pre-defined risk groups of patients with diabetes mellitus, small vessels ≤2.75 mm, chronic total occlusion, and acute myocardial infarction. Definite stent thrombosis was observed in 0.3% [95% CI: 0.1; 0.9] of patients.. These long-term outcomes provide further evidence on the safety and performance of a sirolimus-eluting biodegradable polymer stent within daily clinical practice. The very low definite stent thrombosis rate affirms biodegradable polymer safety and performance.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Artery Disease; Coronary Occlusion; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Polyesters; Prospective Studies; Prosthesis Design; Recurrence; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To assess the performance of the commercially available Magmaris sirolimus-eluting bioresorbable scaffold (BRS) with invasive imaging at different time points.. Coronary BRS with a magnesium backbone have been recently studied as an alternative to polymeric scaffolds, providing enhanced vessel support and a faster resorption rate. We aimed to assess the performance of the commercially available Magmaris sirolimus-eluting BRS at different time points.. A prospective, single-center, nonrandomized study was performed at the Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. Six patients with stable de novo coronary artery lesions underwent single-vessel revascularization with the Magmaris sirolimus-eluting BRS. Invasive follow-up including intravascular imaging using optical coherence tomography (OCT) was performed at different time points.. At a median of 8 months (range 4-12 months) target lesion failure occurred in one patient. Angiography revealed a late lumen loss of 0.59 ± 0.39 mm, a percentage diameter stenosis of 39.65 ± 15.81%, and a binary restenosis rate of 33.3%. OCT showed a significant reduction in both minimal lumen area (MLA) and scaffold area at the site of the MLA by 43.44 ± 28.62 and 38.20 ± 25.74%, respectively. A fast and heterogeneous scaffold degradation process was found with a significant reduction of patent struts at 4-5 months.. Our findings show that the latest iteration of magnesium BRS suffers from premature dismantling, resulting in a higher than expected decrease in MLA.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Female; Humans; Magnesium; Male; Middle Aged; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Optical coherence tomography (OCT) was used to assess serial changes in severe acute stent malapposition (ASM) after drug-eluting stent (DES) implantation.. The maximal depth and axial lengths of ASM after DES implantation were serially quantified at percutaneous coronary intervention (PCI), and at 3 and 12-month follow-up, for 100 lesions in 96 patients. Severe ASM was defined as a maximal malapposed depth ≥400 μm or maximal malapposed axial length ≥1 mm.. Of the 100 lesions, 23 lesions (23%) had a severe ASM depth at PCI. At 3 months, the maximal depth decreased to <400 μm in 12 of 23 lesions (52%). At 12 months, the maximal depth further decreased to <400 μm in 8 of the remaining 11 lesions (73%). Similarly, of 53 lesions (53%) with a severe ASM length at PCI, the maximal length decreased to 0 mm in 26 (49%) but remained severe in 17 lesions (32%) at 3 months. At 12 months, 9 of the 17 remaining lesions (53%) further decreased to 0 mm. The cut-off values for the maximal malapposed depth and length to predict the absence of stent malapposition at 12 months were 565 μm at PCI and 165 μm at 3 months, and were 2.7 mm at PCI and 0.1 mm at 3 months, respectively.. Half of the severe ASM cases resolved within 3 months, and another half resolved during 3-12 months of follow-up. Our findings provide a better understanding of the time-dependent natural course of severe ASM using OCT.

Topics: Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Equipment Failure Analysis; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Fitting; Sirolimus; Time Factors; Tomography, Optical Coherence

To assess the long-term safety and efficacy of the Resolute zotarolimus-eluting stent (R-ZES).. The R-ZES has been associated with low rates of adverse events over short-intermediate term follow-up. However, reliable assessment of the safety and efficacy of any implanted device requires long-term evaluation.. The RESOLUTE US trial was a prospective, observational study conducted at 116 U.S. sites and enrolled patients with de novo coronary lesions. Patients were followed clinically for 5 years with independent event adjudication and data monitoring.. A total of 1,402 patients (1,573 lesions) were enrolled; 34% had diabetes mellitus and 75% had ACC type B2/C lesions. The 5-year rate of target lesion failure (TLF) was 12.3%, target lesion revascularization was 6.5%, target vessel myocardial infarction was 3.2%, and cardiac death was 4.1%. Dual antiplatelet therapy usage was 94% at 1 year and 47% at 5 years, with a 0.1% and 0.5% respective incidence of definite or probable stent thrombosis. The 5-year rate of TLF was 16.9% among patients with diabetes mellitus and 14.7% in patients with at least one small (≤2.5 mm) vessel treated. Covariates independently associated with 5-year TLF in multivariable analysis included diabetes mellitus (odds ratio [OR] 1.89, p < .001), prior coronary artery bypass grafting (OR 2.28, p < .001), prior myocardial infarction (OR 1.85, p = .002), and smaller reference vessel diameter (OR 1.75, p = .004).. Results from the fully adjudicated and monitored RESOLUTE US trial demonstrate long-term 5-year safety and efficacy of the R-ZES stent among a relatively low-risk population of patients, including a 0.5% rate of stent thrombosis at 5 years.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Recurrence; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; United States

A large trial established the favourable clinical profile of a new polymer-free biolimus A9-eluting stent (PF-BES) with a one-month dual antiplatelet therapy (DAPT) regimen in patients at high bleeding risk (HBR). We aimed to evaluate the real-world patterns of indications, DAPT strategies and outcomes for the PF-BES following this evidence.. CHANCE is a multicentre registry including all patients who underwent percutaneous coronary intervention (PCI) with at least one PF-BES. The reasons for the PF-BES PCI and planned antithrombotic regimens were collected. Primary outcomes were the 390-day Kaplan-Meier estimates of patient-oriented and device-oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularisation [TVR]; DOCE: cardiac death, target vessel MI or ischaemia-driven target lesion revascularisation [ID-TLR]). Between January 2016 and July 2018, 858 patients (age 74±10 years, 64.6% male, 58.7% acute coronary syndrome presentation) underwent PF-BES PCI. The main reasons for the physicians' choice of PF-BES reflected a perceived HBR in 77.7% of patients. One-month DAPT was planned in 40.3% of patients. At 390-day follow-up (median 340 days, interquartile range: 187-390 days), the estimated incidence of POCE was 13.1% (any MI 3.7%, any TVR 3.4%) and of DOCE was 7.1% (TV-MI 3.6%, ID-TLR 1.4%), while the 390-day estimate of any bleeding event was 11.1% (BARC 3-5 bleeding 3.0%).. In a large all-comers registry, PF-BES was used mostly in HBR patients, frequently followed by a very short DAPT regimen. The reported outcomes suggest a favourable safety and efficacy profile for the PF-BES in a real-world clinical setting. ClinicalTrials.gov identifier: NCT03622203.

Topics: Aged; Aged, 80 and over; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Sirolimus; Treatment Outcome

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Sirolimus; Stents; Treatment Outcome

Evaluate safety and efficacy of polymer-free biolimus-eluting stents (PF-BESs) versus ultrathin stents in unprotected left main (ULM) or bifurcation.. PF-BESs due to reduced length of dual antiplatelet therapy (DAPT) are increasingly used. However, there are limited data about safety and efficacy for ULM or bifurcation.. We selected all-patients treated for ULM or bifurcation from two multicenter real life registries (RAIN [NCT03544294] evaluating ultrathin stents, CHANCE [NCT03622203] appraising PF-BES). After propensity score with matching, the primary endpoint was major adverse cardiac events (MACE; a composite of all-cause death, myocardial infarction, target lesion revascularization [TLR], and stent thrombosis [ST]), while its components along with target vessel revascularization (TVR) secondary endpoints.. Three thousand and three patients treated with ultrathin stents and 446 with PF-BESs, resulting respectively in 562 and 281 after propensity score with matching (33 and 22%, respectively, with ULM disease). After 12 (8-20) months, rates of MACE were similar (9 vs. 8%, p = 0.56) without difference in TLR and ST (3.0 vs. 1.7%, p = .19 and 1.8 vs. 1.1%, p = .42). These results were consistent for ULM group (3 vs. 1.7% and 1.8 vs. 1.1%, p = .49 and .76), for non-ULM group (2.1 vs. 3.4%, p = .56 and 1.2 vs. 1.7%, p = .78) and for two-stent strategy (8.7 vs. 4.5% and 4.3 vs. 3.2%, p = .75 and .91). Among patients treated with 1 month of DAPT in both groups, those with ultrathin stents experienced higher rates of MACE related to all-cause death (22 vs. 12%, p = .04) with higher although not significant rates of ST (3 vs. 0%, p = .45).. PF-BES implanted on ULM or BiF offered freedom from TLR and ST comparable to ultrathin stents. PF-BESs patients assuming DAPT for 1 month experienced a lower despite not significant incidence of ST.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Clinical Protocols; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Propensity Score; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors

Patients with diabetes mellitus (DM) have worse outcomes after percutaneous coronary intervention (PCI). Recent evidences suggest a differential impact of insulin-treated and noninsulin-treated DM on prognosis. We evaluated the clinical outcome of diabetic patients after PCI with polymer-free biolimus-eluting stent from the RUDI-FREE Registry, investigating a possible different prognostic impact of insulin-treated and noninsulin-treated DM. A total of 1,104 consecutive patients who underwent PCI with polymer-free biolimus-eluting stent, enrolled in the RUDI-FREE observational, multicenter, single-arm registry, were stratified by diabetic status; diabetic population was further divided on the basis of insulin treatment. Primary end points of the study were target lesion failure (TLF; composite of cardiac death, target vessel myocardial infarction, target lesion revascularization) and major adverse cardiac and cerebrovascular events (composite of cardiac death, stroke, and myocardial infarction). Multiple ischemic adverse events were also single-handedly considered as secondary end points. At 1 year, TLF was significantly higher in the diabetic cohort, as compared with nondiabetic patients (6.0% vs 3.1%, p 0.022). None of the end points resulted significantly different between nondiabetics and noninsulin-treated diabetic patients. Divergently, compared with nondiabetic, insulin-treated diabetic patients faced significant higher rates of TLF (10.8% vs 3.1%, p 0.003), major adverse cardiac and cerebrovascular events (10.8% vs 3.4%, p 0.004), and of most of the analyzed adverse events. In conclusion, patients with DM had a higher risk of TLF compared with nondiabetics; nonetheless, the worse outcome of the diabetic population seems to be driven by the insulin-treated diabetic subpopulation. This finding suggests a different risk profile of insulin-treated and noninsulin-treated diabetic patients in the modern era of PCI.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Hypoglycemic Agents; Immunosuppressive Agents; Insulin; Male; Percutaneous Coronary Intervention; Polymers; Prognosis; Prospective Studies; Prosthesis Design; Registries; Sirolimus

To prospectively evaluate safety and efficacy of the ultrathin strut biodegradable polymer-coated Supraflex sirolimus-eluting stent (S-SES) in 'real world' patient population requiring percutaneous coronary intervention (PCI).. National, prospective, multicentre, single-arm, all-comers, observational registry of 469 patients treated with S-SES from July 2015 and November 2016 in 11 centres in UK. Primary endpoint was target lesion failure (TLF) at 12 months (cardiac death, target vessel myocardial infarction (MI) or clinically driven target lesion revascularisation (TLR)). Secondary endpoints included safety and performance outcomes at 12 months-overall stent thrombosis (ST), all-cause mortality, any MI, target vessel failure (TVF) and major adverse cardiac events (MACE-composite of cardiac death, MI, emergent or repeat revascularisation).. At 12 months, the primary endpoint occurred in 11 (2.4%) of 466 patients, consisting of 4 (0.9%) cardiac deaths, 3 (0.6%) target vessel MI and 7 (1.5%) TLR. Secondary endpoints findings included all-cause mortality in 6 (1.3%), TVF of 14 (3%), no definite ST, 1 (0.2%) probable ST and 3 (0.6%) possible ST. Overall MACE was observed in 18 (3.9%).. The S-FLEX UK registry showed that the S-SES is safe with a low incidence of TLF in routine clinical practise in patients with coronary artery disease being treated by PCI.

Topics: Absorbable Implants; Aged; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Time Factors; Treatment Outcome; United Kingdom

The BiOSS LIM stent is a dedicated device for the treatment of bifurcation lesions that present a proximal and distal part with two different diameters and a middle zone with two connecting struts facilitating side branch rewiring. In this study, after implanting the BiOSS LIM stent in the left main, rewiring to the side branch was easier compared to standard metallic stent. The device may be very useful in the treatment of bifurcation lesions for provisional stenting strategies or for two-stent strategies such as T-stenting or T-and-Protruding (TAP).

Topics: Constriction, Pathologic; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Humans; Sirolimus; Stents; Treatment Outcome

Although a number of drug-eluting stents have been developed with different design, composition, and polymers, the search for an ideal drug-eluting stent is ongoing. The Tetriflex (Sahajanand Medical Technology, Surat, India) is a newer-generation, ultrathin (60 µm) biodegradable polymer-coated sirolimus-eluting stent (SES) designed with a unique long dual Z-link on a cobalt-chromium alloy. The present registry aimed to evaluate the safety and clinical outcomes of the Tetriflex SES at 6-month post-implantation.. This was an investigator-initiated, retrospective, multicenter, single-arm, observational registry conducted at five tertiary-care centers in India. A total of 1,269 consecutive patients with coronary artery disease who underwent implantation of at least one Tetriflex SES between March 2017 and March 2018 were included. The primary outcome was considered a composite of cardiac death, myocardial infarction and target-lesion revascularization (TLR) at 6-month follow-up. Stent thrombosis was evaluated as a safety outcome at 6-month follow-up.. The mean age of patients was 54.99±10.80 years. Among 1,515 lesions treated with 1,682 Tetriflex SES, 58.3% were type C lesions. Six-month follow-up was done for 1,245 of 1,269 (98.1%) patients. At 6 months, composite events had occurred in 31 (2.5%) patients, consisting of ten (0.8%) cardiac deaths, 16 (1.3%) myocardial infarctions, and five (0.4%) TLRs. Stent thrombosis was observed in seven (0.56%) cases at 6 months. A subgroup analysis between diabetic and nondiabetic patients did not reveal any statistically significant difference for clinical outcomes at 6-month follow-up.. The results of the current registry outline the safety and effectiveness of the Tetriflex SES in real-world patients, as it displayed favorable clinical outcomes at 6-month follow-up, with low incidence of TLR and stent thrombosis.

Topics: Adult; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Occlusion; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Incidence; India; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Retrospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Lesion length is a major predictor of adverse outcomes after percutaneous coronary intervention. Long lesions often require multiple stents with variable overlap, which increases the probability of geographical miss and the incidence of mechanical complications, such as side-branch occlusion, restenosis, and stent thrombosis. These pitfalls may be avoided by use of an ultra-long device.. We retrospectively assessed the performance of the 48-mm Xience Xpedition everolimus-eluting stent (EES) at our institution.. A total of 123 patients (mean age: 60.94 years, n = 93 [76%] male) with 129 lesions were identified. Lesions (n = 69, 53.5%) were located in the left anterior descending artery, the right coronary artery (n = 47, 36.4%), and the circumflex artery (n = 8, 6.2%); 83 lesions involved a major side branch. The majority were treated with a provisional single-stent strategy. Other characteristics included significant tortuosity in 15 lesions (11.6%) and moderate-to-heavy calcification in 46 lesions (35.7%). In all cases, balloon pre-dilatation was performed before stent insertion. Successful delivery and deployment of the 48-mm EES device was achieved in 100% of the patients. The mean number of stents per lesion was 1.4, while the mean total stent length was 58 ± 17.3 mm and mean stent diameter, 3.00 ± 0.67 mm. The procedural success rate was 99.2%. The 30-day major cardiac adverse event (MACE) rate was 0.8%, while the 12-month MACE was 3.3%.. The Xience 48-mm EES device appears to be safe and efficacious with a low clinical event rate at the 12-month follow-up. Where feasible, this would support the use of the ultra-long 48-mm platform in lieu of multiple overlapping shorter devices.

Topics: Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Sirolimus; Treatment Outcome

Percutaneous coronary intervention (PCI) in coronary artery disease (CAD) with very small vessels remains challenging. The aim of this study is to evaluate the safety and effectiveness of the 2.25-mm diameter Ultimaster sirolimus-eluting stent in the treatment of Japanese patients with CAD due to lesions in very small vessels. The CENTURY JSV study is a prospective, multicentre, single-arm study. Seventy patients with lesions deemed suitable for implantation of a 2.25-mm diameter stent were enrolled at seven hospitals in Japan. Patients underwent clinical follow-up at 1-, 9-month, 1-, and 2-year after the PCI procedure. The primary endpoint was the major adverse cardiac event (MACE), a composite of cardiac death, target vessel myocardial infarction (MI), and clinically driven target lesion revascularization (TLR) free rate at 9-month following the procedure. The MACE-free rate was 97.1%, and the lower limit of the two-sided 95% confidence interval (CI) was 90.1%, which exceeded the threshold of 80% set as the performance goal. Angiographic in-stent and in-segment late loss at 9-month were 0.22 ± 0.31 and - 0.02 ± 0.34 mm, respectively. Between 9 months and 2 years, two additional TLRs occurred. Stent thrombosis, bleeding and vascular complication did not occur throughout 2 years. The 2.25-mm diameter Ultimaster

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Sirolimus; Survival Analysis; Treatment Outcome

Diabetes mellitus is known to be associated with worse clinical outcomes in patients with coronary artery disease (CAD) undergoing percutaneous coronary interventions (PCI) with drug-eluting stents (DES). Defining the optimal duration of dual antiplatelet therapy (DAPT) after DES implantation is still under debate. The objective of this subgroup analysis of the all-comers ISAR 2000 registry was to assess the safety and efficacy of a short DAPT (<6 month) versus a longer DAPT (>6 month) in patients with diabetes electively treated with the polymer-free sirolimus-coated ultrathin strut drug-eluting stent (PF-SES).. Patients who received the PF-SES were investigated in a multicenter all-comers observational study. The primary endpoint was the 9‑month target lesion revascularization (TLR) rate, whereas secondary endpoints included the 9‑month major adverse cardiac event (MACE) and procedural success rates.. In all, 167 patients were treated with DAPT for ≤6 months (S-DAPT group) and 350 patients underwent DAPT treatment for 12 months (L-DAPT group). There was no significant difference in the overall MACE rate (4.6% vs. 3.1%, p = 0.441), the 9‑month accumulated stent thrombosis rates (0.8% vs. 0.3%, p = 0.51), or the accumulated rate of bleeding complications (5.3% vs. 3.4%, p = 0.341).. PF-SES are safe and effective in daily clinical routine with low rates of TLR and MACE in patients with diabetes and stable disease. Our data suggest that extending the duration of DAPT beyond 6 months does not improve MACE or TLR at 9 months in patients with stable CAD (ClinicalTrials.gov Identifier NCT02629575).

Topics: Coronary Artery Disease; Diabetes Complications; Diabetes Mellitus; Dinucleoside Phosphates; Drug-Eluting Stents; Humans; Male; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Sirolimus; Treatment Outcome

The RESOLUTE-DIABETES CHINA study was specifically designed to investigate the safety and efficacy of Resolute zotarolimus-eluting stents (ZES; Medtronic, Santa Rosa, CA, USA) in the treatment of diabetic coronary lesions in the Chinese population.. In all, 945 patients with de novo native coronary lesions and type 2 diabetes mellitus were recruited at 32 cardiac centers across the Chinese mainland and were implanted with Resolute ZES. The primary endpoint was target vessel failure (TVF); secondary endpoints were clinical outcomes, namely all-cause death, stroke, bleeding, target lesion revascularization (TLR), target vessel revascularization (TVR), non-TVR, and stent thrombosis (ST). The follow-up period for all endpoints was 12 months after the procedure.. In all, 933 patients (98.73%) had clinical follow-up at 12 months. The rate of TVF was 11.60%, whereas the rate of occurrence of secondary endpoints was 5.47%, with four patients (0.43%) having subacute or late ST. There were no significant differences in TVF rates comparing patients with different HbA1c levels or receiving different glucose control treatments (all P > 0.05). Patients with multivessel lesions had higher TVF rates (95% confidence intervals) than those with single-vessel lesions (16.76% [12.10%-22.97%) vs 9.72% [7.79%-12.11%], respectively; P = 0.006). There were no significant differences in TVF rates in patients with or without small vessels, bifurcated lesions, or chronic total occlusions (all P > 0.05). [Correction added on 17 January 2019, after first online publication: in the second sentence of Results section, "TLF" was changed to "TVF".].. Resolute ZES may perform well in the Chinese diabetic population, especially in those with poor glucose control, complex lesions, and certain unfavorable clinical features. Further studies are needed to determine why ZES perform well in this population.

Topics: Coronary Artery Disease; Diabetes Mellitus, Type 2; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prospective Studies; Safety; Sirolimus; Treatment Outcome

The aim of the Nanoluté registry was to observe the clinical performance of a novel sirolimus coated balloon (SCB) (Concept Medical Research Private Limited, India) for the treatment of coronary de-novo and restenotic lesions.. All patients treated with SCB between July 2012 and September 2015 were enrolled at Indian centres and clinically followed for 1, 3, 6 and 12 months post-procedure. Primary endpoints were procedural success and device-oriented adverse cardiac events (DOCE) at 12 months. DOCE were defined as a composite of cardiac death, target lesion revascularization (TLR) and target vessel-myocardial infarction.. A total of 394 SCB were used in 332 patients to treat 356 lesions. In-stent restenosis and small coronary vessel disease occurred in 46% and 43% of the patients respectively. Mean balloon length and diameter (average ± SD) were 21.83 ± 6.70 mm and 2.69 ± 0.45 mm respectively. All patients with 1 year follow-up were included. Overall DOCE rate was 4.2% (n = 14) which included death 0.3% (n = 1), TLR 3.6% (n = 12) and myocardial infarction 0.3% (n = 1).. The Nanoluté prospective registry, is the first clinical evidence of the safety and feasibility of this type of SCB, both in patients with in-stent restenosis or de novo lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Equipment Design; Feasibility Studies; Female; Humans; India; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Registries; Retreatment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

We attempted to test the feasibility of application of the MADS classification system in the largest stent trial to date and evaluate the preliminary clinical implications of this approach.. In the randomized GLOBAL LEADERS trial, testing two different antiplatelet strategies in patients undergoing PCI with bivalirudin and biolimus-eluting stents, the e-CRF was dedicated to bifurcation treatment according to the MADS classification. Based on this e-CRF, the techniques used for bifurcations treatment in GLOBAL LEADERS were described and compared with two large, all-comer registries of bifurcations treatment (I-BIGIS and COBIS), used as historical controls.. Among 15,991 patients enrolled in the trial, 22,921 lesions treated at the index and staged procedure were available for analysis and 2,757 of these lesions were bifurcations and 7 were trifurcation lesions. The e-CRF-based MADS classification was achieved in 2,757 of these lesions (100%). 80.3% of bifurcations were treated using a single stent, 18.9% using 2 stents and 0.7% using 3 stents. Overall, the "main across side first" approach (A) was used in 77.4% with the "side branch first" approach (S) being the second most frequently used technique (10.2%). A single stent was used in the majority of the "A" approach (87.9%). A reduction in the use of 2-stent techniques (from 33.9 to 18.9%) was observed between GLOBAL LEADERS and I-BIGIS. The "A" approach was the most frequently used technique in GLOBAL LEADERS, while in COBIS the "S" strategy was most frequently employed.. Application of the MADS classification through an e-CRF was feasible in the largest stent trial today and provided useful information about the trends observed overtime in the treatment of bifurcation lesions.

Topics: Antithrombins; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Feasibility Studies; Hirudins; Humans; Peptide Fragments; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prosthesis Design; Randomized Controlled Trials as Topic; Recombinant Proteins; Sirolimus; Terminology as Topic; Treatment Outcome

We sought to determine the 1-year clinical follow-up in patients treated with the thin strut (71 μm) bioabsorbable polymer-coated sirolimus-eluting stent (BP-SES) vs durable coating everolimus eluting stent (DP-EES) in daily clinical routine.. Presence of durable polymers may be associated with late/very late stent thrombosis occurrence and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety.. Interventional Cardiology Network Registry is a prospective, multicenter, observational registry of 21,400 consecutive patients treated with PCI since 2010. We analyzed 4,670 patients treated with either a BP-SES (ALEX, Balton, Poland) or DP-EES (XIENCE, Abbott, USA) with available 1-year clinical follow-up using propensity-score matching. Outcomes included target vessel revascularization (TVR) as efficacy outcome and all cause death, myocardial infarction (MI), and definite/probable stent thrombosis as safety outcomes.. After propensity score matching, 1,649 patients treated with BP-SES and 1,649 patients treated with DP-EES were selected. Procedural and clinical characteristics were similar between both groups. There was no significant difference between tested groups in in-hospital mortality. One-year follow-up demonstrated comparable efficacy outcome, TVR (BP-SES 5.9% vs DP-EES 4.6% P = 0.45), as well as comparable safety outcomes, all cause death, MI and definite/probable stent thrombosis.. In this multicenter registry, the BP-SES thin strut biodegradable polymer-coated sirolimus-eluting stent demonstrated comparable clinical outcomes at 1-year after implantation to the DP-EES. These data support the relative safety and efficacy of DP-SES in a broad range of patients undergoing percutaneous coronary intervention.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Poland; Polymers; Propensity Score; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To compare the effectiveness and safety of self-expandable, sirolimus-eluting Stentys stents (SES) and second-generation drug-eluting stents (DES-II) for the treatment of the unprotected left main (ULM).. SES may provide a valuable option to treat distal ULM, particularly when significant caliber gaps with side branches are observed.. Patients from the multicenter SPARTA (clinicaltrials.gov: NCT02784405) and FAILS2 registries were included. Propensity-score with matching was performed to account for the lack of randomization. Primary end-point was the rate of major adverse cardiovascular events (MACE, a composite of all cause death, myocardial infarction, target lesion revascularization [TLR], unstable angina and definite stent thrombosis [ST]). Single components of MACE were the secondary end-points.. Overall, 151 patients treated with SES and 1270 with DES-II were included; no differences in MACE rate at 250 days were observed (9.8% vs. 11.5%, P = 0.54). After propensity score with matching, 129 patients treated with SES and 258 with DES-II, of which about a third of female gender, were compared. After a follow-up of 250 days, MACE rate did not differ between the two groups (9.9% vs. 8.5%, P = 0.66), as well as the rate of ULM TLR (1.6% vs. 3.1%, P = 0.36) and definite ST (0.8% vs. 1.2%, P = 0.78). These results were consistent also when controlling for the treatment with provisional vs. 2-stents strategies for the ULM bifurcation.. SES use for ULM treatment was associated with a similar MACE rate compared to DES-II at an intermediate-term follow-up. SES might represent a potential option in this setting.

Topics: Aged; Aged, 80 and over; Alloys; Cardiovascular Agents; Comparative Effectiveness Research; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Self Expandable Metallic Stents; Sirolimus; Time Factors; Treatment Outcome

Topics: Coronary Artery Disease; Drug-Eluting Stents; Humans; Metals; Sirolimus; Stents

Primary percutaneous coronary intervention (PCI) during acute ST-segment elevation myocardial infarction (STEMI) represents a thrombotic milieu and is associated with delayed healing after stenting. The pro-healing combination sirolimus eluting endothelial progenitor cell (EPC) capture stents encourage early endothelialization after stenting and may be beneficial in the STEMI population. We aim to evaluate the clinical outcomes one year and beyond for patients with STEMI who received the combination sirolimus eluting EPC capture stents during primary PCI.. All STEMI patients implanted with combination sirolimus eluting EPC capture stents during primary PCI from November 2013 to December 2016 were enrolled. The primary outcome was target lesion failure (TLF) at in-hospital, one-month, one-year and beyond one year.. A total of 260 consecutive STEMI patients (283 lesions) were implanted with 313 combination sirolimus eluting EPC capture stents during primary PCI. Mean age was 56.1 ± 11.2 years and 88.8% were male. One in ten patients (10.9%) had cardiogenic shock on presentation, 7.3% needed mechanical ventilation and 7.7% had intra-aortic balloon pump inserted. A total of 97.9% of lesions achieve final TIMI 3 flow. Device success was seen in all patients. At extended follow up period (median 23.4 months), the clinical outcomes were TLF 8.8%, major adverse cardiovascular events 10.8%, cardiac mortality 4.2%, target vessel myocardial infarction 3.4%, target lesion revascularization 3.8%, and definite stent thrombosis 1.9%.. This study demonstrated acceptable clinical outcomes for an all-comers STEMI patients undergoing primary PCI with the use of combination sirolimus eluting EPC cell capture stents.

Topics: Aged; Antibodies, Monoclonal; Antigens, CD34; Cardiovascular Agents; Cell Adhesion; Coronary Artery Disease; Drug-Eluting Stents; Endothelial Progenitor Cells; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Sirolimus; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome

The study reports the final 5-year safety and effectiveness outcomes of the novel abluminal groove-filled biodegradable polymer-coated FIREHAWK sirolimus-eluting stent in a large patient cohort.. The TARGET clinical program was conducted to evaluate the performance of the FIREHAWK stent, and this objective performance criterion study pooled long-term safety and efficacy data from three TARGET trials for greater statistical power to analyze low-frequency events.. Patient-level pooled data from 1,007 individuals in the TARGET I randomized controlled trial (n = 227), TARGET I long lesion cohort (n = 50), and TARGET II registry (n = 730) were prospectively collected and analyzed. The primary endpoint, target lesion failure (TLF), was defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), and ischemia-driven indicated target lesion revascularization (ID-TLR) at 5 years. All patients were exclusively treated with the FIREHAWK stent and had annual follow-up visits for up to 5 years.. Among 947 patients (94.0%) who completed the 5-year clinical follow-up, the 5-year TLF event rate was 8.1%; the events included 18 cardiac deaths, 36 TV-MIs, and 33 ID-TLRs. Only four (0.4%) very late probable or definite stent thrombosis events were observed beyond 1 year after stent implantation. In the subgroup analysis, lesion length ≥ 30 mm was associated with higher long-term TLF incidence, while the use of a predilation-sizing-postdilation technique showed no significant effect on long-term outcomes.. Five-year results demonstrate the continuing safety and efficacy of the FIREHAWK Stent, with relatively lower incidence of thrombotic events.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; China; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Polymers; Sirolimus

Polymer-free amphilimus-eluting stents (PF-AES) represent a novel elution-technology in coronary stenting. We aimed to assess 1-year clinical outcomes of PF-AES as compared to latest-generation permanent polymer zotarolimus-eluting stents (PP-ZES) in a real-world all-comers setting.. A prospective registry of patients treated with either PF-AES or PP-ZES between 2014 and 2016 was conducted. The primary outcome was defined as major adverse cardiac and cerebrovascular events (MACCE), and the secondary outcome was defined as target-lesion failure (TLF) at 1 year. To account for measured confounders, a propensity-score adjusted Cox proportional-hazard model was built to evaluate clinical outcomes.. Our study suggests that implantation of PF-AES was safe and effective in real-world patients, with low-rates of MACCE and TLF at 1 year. Our data needs to be confirmed by a large trial to evaluate the clinical outcomes of this novel polymer-free, eluting-technology used in PF-AES.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Propensity Score; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Current drug-eluting stents have abluminal polymer coating; however, thrombus formation in these compared with that in uniformly coated stents remains controversial. We evaluated thrombus formation and early endothelialization after using abluminal biodegradable polymer-coated sirolimus- (BP-SES), and everolimus-eluting stents (BP-EES) versus a durable polymer-coated everolimus-eluting stent (DP-EES) in an in vivo setting. BP-SES, BP-EES, and DP-EES (n = 6 each) were implanted in coronary arteries of 12 mini-pigs that were then sacrificed after 7 and 10 days. Stents were stained with hematoxylin and eosin, and a combined Verhoeff and Masson trichrome stain. Areas of fibrin deposition were digitally detected and measured with off-line morphometric software. Stents were investigated for re-endothelialization by transmission electron microscopy. At 7 days, histological analysis revealed the lowest area of fibrin deposition in BP-SES (BP-SES vs. BP-EES vs. DP-EES; 0.10 ± 0.06 mm2 vs. 0.15 ± 0.07 mm2 vs. 0.19 ± 0.06 mm2, p = 0.0004). At 10 days, the area of fibrin deposition was significantly greater in DP-EES (0.13 ± 0.04 mm2 vs. 0.14 ± 0.05 mm2 vs. 0.19 ± 0.08 mm2, p = 0.007). Endothelial cells in BP-SES demonstrated a significantly greater number of tight junctions than those in DP-EES according to by transmission electron microscopy for both days (p<0.05). Various parameters, including an inflammatory reaction and neointimal formation, were comparable among the groups at 7 and 10 days. An abluminal biodegradable polymer-coated SES showed the least fibrin deposition and greatest endothelial cell recovery at an early stage following implantation in the coronary arteries of mini-pigs.

Topics: Absorbable Implants; Animals; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Endothelial Cells; Everolimus; Fibrin; Models, Animal; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Swine; Swine, Miniature; Thrombosis; Treatment Outcome

Although bioresorbable polymer sirolimus-eluting Ultimaster stents (BP-SESs) are likely useful for percutaneous coronary interventions (PCIs), the clinical data from real-world cases are insufficient. Furthermore, the predictors of adverse clinical outcomes after BP-SES implantation have not been fully investigated.. This study evaluated the 1-year clinical outcomes after BP-SES implantation in real-world PCI cases and identified the predictors of adverse outcomes.. In this single-center, all-comers study, we consecutively implanted BP-SESs in all patients who required coronary stents between October 2015 and August 2016. We conducted a clinical follow-up assessment of these patients.. The sample comprised 1,727 patients; 67% were men, the mean age was 72 years, and 37% had diabetes. Of the 2,085 lesions detected, 88% were type B2/C lesions, 4% were chronic total occlusions (CTOs), and 23% were bifurcations. The cumulative incidences of target lesion revascularization (TLR) and target lesion failure (TLF) at 1-year were 2.4% and 5.2%, respectively. A multivariate analysis revealed that hemodialysis (HD) (hazard ratio [HR] 8.40) and CTO (HR 4.21) were independent predictors of TLR. Stent sizes ≤2.5 mm were not associated with either TLR or TLF.. The current study indicates that patients on HD and those with CTO were more likely to experience adverse clinical outcomes after BP-SES implantation. In contrast, small vessel diameter was not significantly related to adverse outcomes. The 1-year clinical outcomes after BP-SES implantation were found to be favorable among all-comer PCI cases, including patients receiving HD and those with in-stent restenosis.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Cardiovascular Agents; Chronic Disease; Coronary Artery Disease; Coronary Occlusion; Drug-Eluting Stents; Female; Humans; Japan; Kidney Diseases; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Renal Dialysis; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Absorbable Implants; Adult; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Stenosis; Humans; Inferior Wall Myocardial Infarction; Male; Percutaneous Coronary Intervention; Predictive Value of Tests; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Background Polymer-free drug-eluting stents are based on different technologies for drug binding and release without the use of polymer coatings. It is unknown whether different polymer-free drug-eluting stents are comparable in terms of safety and efficacy profiles. Methods and Results Polymer-free BioFreedom biolimus-eluting stents (BES) and polymer-free Cre8 amphilimus-eluting stents (AES) were investigated in 2 recent multicenter registries including 2320 all-comer patients undergoing percutaneous coronary interventions at 22 Italian centers. Using propensity score matching, safety and efficacy outcomes were compared among 1280 patients (640 matched pairs) treated with BioFreedom BES or Cre8 AES. The primary end point was target lesion failure-a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization (TLR). At 1 year, target lesion failure occurred in 4.0% of BES and 4.2% of AES-treated patients (hazard ratio [HR] 0.98, 95% CI, 0.57-1.70). Risks of cardiac death (2.0% versus 2.1%; HR, 1.03; 95% CI, 0.47-2.26), target vessel myocardial infarction (0.8% versus 0.3%; HR, 1.89; 95% CI, 0.50-6.80), TLR (1.5% versus 2.2%; HR, 0.74; 95% CI, 0.34-1.62), and definite/probable stent thrombosis (0.9% versus 0.8%; HR, 1.17; 95% CI, 0.36-3.81) were comparable in patients treated with BioFreedom BES and Cre8 AES. A differential treatment effect by diabetes mellitus status was observed, indicating a benefit of AES in patients with diabetes mellitus ( P interaction=0.003). Conclusions The present study shows that BioFreedom BES and Cre8 AES have favorable and comparable safety and efficacy profiles in all-comer patients undergoing percutaneous coronary intervention. Further evaluation in large-scale, randomized trials are necessary to confirm our findings.

Topics: Aged; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Italy; Male; Middle Aged; Observational Studies as Topic; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The COMBO stent (OrbusNeich Medical, Ft. Lauderdale, Florida) is a new-generation bio-engineered drug eluting stent, combining an abluminal coating of a bioabsorbable polymer matrix for sustained release of sirolimus and luminal anti-CD34 coating for endothelial progenitor cell capture and rapid endothelialization.. The Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) registry was a prospective post-marketing study conducted from June 2014-May 2017 across 60 centers globally. Patients were eligible if COMBO stent implantation was attempted, and they received dual antiplatelet therapy (DAPT) per local guidelines. Follow-up was conducted by trained research staff at 1, 6 and 12 months by phone or clinic visit to capture clinical events and DAPT cessation events. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, non-fatal myocardial infarction not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization.. A total of 2614 patients were enrolled over the study period with 96.7% completion of 1-year follow-up. The mean age of enrolled patients was 62.9 ± 11.2 years and 23.0% were female. Diabetes mellitus was present at baseline in 33.5%. A total of 56.1% patients underwent PCI for acute coronary syndrome (ACS). The 1-year primary endpoint of TLF occurred in 3.4% patients (n = 88). Definite stent thrombosis occurred in 0.5% patients (n = 12).. The MASCOT post marketing registry provides comprehensive safety and efficacy outcomes following contemporary PCI using the novel COMBO stent in an all-comer population. This platform is associated with low rates of 1-year TLF and ST. CLINICALTRIALS.. NCT02183454.

Topics: Bioengineering; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Product Surveillance, Postmarketing; Prosthesis Design; Registries; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

The Magmaris bioresorbable magnesium scaffold was successfully tested in in-vitro and in clinical premarket studies. Subsequently the Magmaris postmarket program aimed to review intraprocedural data of at least 2000 patients to assess user preferences, guideline adherence and intraprocedural performance in clinical routine.. This international multicentre survey encompasses data from 356 hospitals across 45 countries. As part of the certification for Magmaris implantation, each hospital had to complete consecutive post-market evaluation forms of their first 10 commercial Magmaris patients.. From June 2016 to May 2018, data on 2018 implantations were collected. Main reasons for selecting Magmaris was patients' life expectancy (67%, n = 1359) and low or not calcified lesions, (67%, n = 1357). Magmaris was successfully deployed in 99% of cases (n = 1995), predilatation was performed in 95% (n = 1922) and post-dilatation in 87% (n = 1756). Physicians rated the overall performance and the pushability as good or very good in 96% of cases (n = 1799). Guide wire friction, trackability, and conformability were rated as good or very good in 94% of cases, and crossability in 93%. The majority of patients were scheduled to receive dual antiplatelet therapy for up to 12 months.. Generally, implantation guidelines were adhered to and theoretical advantages of the metal scaffold observed in in-vitro tests have translated into practice with good intraprocedural performance outcomes, confirming the controlled roll-out of this novel technology into clinical practice.. The Magmaris 2000 program includes the first commercial cases at each hospital. Overall, data on 2018 implantations were collected. The high rate of pre- and post-dilatation as well as other parameters confirm that generally the implantation guidelines are adhered to and the good intraprocedural performance (rated as good or very good in 96%) confirm the theoretical advantages of a metallic scaffold in practice.

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Guideline Adherence; Humans; Life Expectancy; Magnesium; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Practice Patterns, Physicians'; Product Surveillance, Postmarketing; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

There are limited data comparing clinical outcomes among new-generation drug-eluting stents (DES) in ST-segment elevation myocardial infarction (STEMI) patients with multivessel coronary artery disease (MVD) who underwent primary percutaneous coronary intervention (PCI) with culprit-only or multivessel PCI. We investigated 1-year clinical outcomes between biodegradable-polymer (BP)-coated biolimus-eluting stent (BES) and durable-polymer (DP)-coated DES in STEMI patients with MVD who underwent two different reperfusion strategies.. A total of 4255 patients were enrolled and divided into two groups, a culprit-only (n = 2571, BP- [n = 264] or DP-DES [n = 2307]) or a multivessel PCI group (n = 1684, BP- [n = 145] or DP-DES [n = 1539]). The primary endpoint was major adverse cardiac events (MACE) defined as all-cause death, recurrent myocardial infarction (re-MI), and total repeat revascularization. The secondary endpoint was the incidence of definite or probable stent thrombosis (ST).. BP-BES and DP-DES showed a similar 1-year adjusted hazard ratio (HR) for MACE (culprit-only, adjusted hazard ratio [HR], 1.114; p = 0.740; multivessel, HR, 0.564; p = 0.167) and ST (culprit-only, HR, 1.110, p = 0.891; multivessel, HR, 0.375; p = 0.402). The adjusted HR for all-cause death, re-MI, and repeat revascularization were similar between the two groups. In the total population, the culprit-only PCI group showed a higher incidence of total repeat revascularization than the multivessel PCI group.. BP-BES and DP-DES showed comparable safety and efficacy in STEMI patients with MVD who underwent primary PCI with two different reperfusion strategies during a 1-year follow-up period.

Topics: Aged; Coated Materials, Biocompatible; Cohort Studies; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Retrospective Studies; Sirolimus; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome

This prospective, patient-level analysis assessed the safety and efficacy of NeoVas sirolimus-eluting bioresorbable scaffold (BRS) in patients with coronary lesions. Furthermore, to meet China Food and Drug Administration requirements, we conducted an objective performance criterion study by pooling all patients implanted with the NeoVas BRS in a previous randomized controlled trial (RCT) and registry trial.. Drug-eluting stent-related permanent vessel caging by metallic struts may lead to several complications associated with percutaneous coronary intervention. BRSs reportedly result in more stent thromboses (ST) in comparison to everolimus-eluting stents. The NeoVas (Lepu Medical, Beijing, China) is a novel sirolimus-eluting poly-l-lactic acid (PLLA)-based BRS whose safety and efficacy remains to be fully elucidated.. Patient-level data derived from 1,103 patients with de novo native coronary lesions in the NeoVas RCT (n = 278) and NeoVas registry (n = 825) were prospectively collected, pooled, and analyzed. The primary outcome was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven-target lesion revascularization. The patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization was also analyzed.. The 12-month rate of TLF in 1,103 patients (follow-up rate, 99.8%) was 3.0%, significantly lower than the performance goal of 8.5% (P < 0.0001). Furthermore, 50 (5.4%) PoCEs and five definite/probable ST (0.5%) were recorded.. This pooled, patient-level analysis indicates that the NeoVas BRS has promising 1-year efficacy and safety profiles.

Topics: Absorbable Implants; Acute Coronary Syndrome; Adolescent; Adult; Aged; Cardiovascular Agents; China; Coated Materials, Biocompatible; Coronary Artery Disease; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Young Adult

New generation bioresorbable scaffolds (BRS) promise to improve the outcomes of current generation BRS technologies by decreasing wall thickness while maintaining structural strength. This study aimed to compare the biomechanical behavior and vascular healing profile of a novel thin-walled (98 μm) sirolimus-eluting ultrahigh molecular weight BRS (Magnitude, Amaranth Medical) to the Absorb everolimus-eluting bioresorbable vascular scaffold (Abbott Vascular).. In vitro biomechanical testing showed lower number of fractures on accelerated cycle testing over time (at 21K cycles = 20.0 [19.0-21.0] in Absorb versus 0.0 [0.0-1.0] in Magnitude-BRS). Either Magnitude (n = 43) or Absorb (n = 22) was implanted in 65 coronary segments of 22 swine. Scaffold strut's coverage was evaluated using serial optical coherence tomography (OCT) analysis. At 14 days, Magnitude-BRS demonstrated a higher percentage of embedded struts (97.7% [95.3, 100.0] compared to Absorb (57.2% [48.0, 76.0], p = 0.003) and lower percentage of uncovered struts (0.0% [0.0, 0.0] versus Absorb 5.5% [2.6, 7.7], p = 0.02). Also, it showed a lower percent late recoil (-1.02% [-4.11, 3.21] versus 4.42% [-1.10, 8.74], p = 0.04) at 28 days. Histopathology revealed comparable neointimal proliferation and vascular healing responses between two devices up to 180 days.. A new generation thin walled (98-μm) Magnitude-BRS displayed a promising biomechanical behavior and strut healing profile compared to Absorb at the experimental level. This new generation BRS platform has the potential to improve the clinical outcomes shown by the current generation BRS.

Topics: Absorbable Implants; Animals; Coronary Angiography; Coronary Artery Disease; Disease Models, Animal; Drug-Eluting Stents; Immunosuppressive Agents; Percutaneous Coronary Intervention; Polyesters; Prosthesis Design; Reference Values; Sirolimus; Swine; Tissue Scaffolds; Tomography, Optical Coherence

To evaluate the angiographic performance of a novel sirolimus-coated balloon (SCB) in de novo coronary lesions.. Out of an all-comer prospective registry of patients treated with the SCB at our center from April 2016 to September 2017, we selected those treated for a de novo stenosis on a native vessel, with a scheduled angiographic control at at least 4 months after the index procedure. We performed a centralized, blinded core-lab adjudicated quantitative coronary angiography analysis. Primary endpoint was late lumen loss. Secondary endpoints were binary restenosis and target-lesion revascularization.. A total of 27 patients with native coronary arteries treated with SCB and with angiographic follow-up entered the study; seven patients were excluded because a stent was implanted at the lesion site during the index procedure. The degree of calcification (assessed with coronary angiography) was high in six patients (30%) and the average lesion length was 20.52 ± 6.88 mm. The reference vessel diameter was 2.32 ± 0.44 mm and the percentage diameter stenosis was 67 ± 12. Procedural success was obtained in all patients. After a median of 6.6 ± 2.5 months, late lumen loss was 0.09 ± 0.34 mm and the percentage diameter stenosis was 31 ± 18. We observed two cases (10%) of binary restenosis which underwent subsequent target-lesion revascularization: in one a drug-eluting stent was implanted, whereas the other patient was treated with paclitaxel-coated balloon. No myocardial infarction or death was observed during follow-up.. The use of a novel SCB in native coronary arteries was associated with good angiographic outcome at 6-month follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Female; Humans; Italy; Male; Middle Aged; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to investigate the incidence of binary restenosis and its predictors in patients with ostial lesions of the right coronary artery (RCAos) who underwent percutaneous coronary intervention (PCI). RCAos are associated with a high incidence of restenosis, and the implantations of drug-eluting stents for RCAos have not been fully elucidated. The study participants included 75 patients (72.3 ± 9.5 years, 72% men) who underwent PCI for RCAos at our institution between November 2001 and May 2017. The angle between the greater curvature of the aortic wall and the right coronary artery take-off in the diastolic and systolic phases in the left anterior oblique position view was investigated. Clinical outcome was defined as binary restenosis at follow-up coronary angiography. We also evaluated target lesion failure (TLF) defined as a composite of cardiac mortality, target vessel myocardial infarction, and target lesion revascularization (TLR). The incidence of binary restenosis was 48.0% (n = 36) of the entire cohort. The incidence of TLF was 49.3% (n = 37) of the entire cohort, which was mainly driven by TLR (36.0%, n = 27). The area under the curve of the gap-angle ratio [(difference between the maximum and minimum angles)/(minimum angle); GAR] for binary restenosis was 0.73, and the cutoff value was 0.306 (sensitivity 67%, specificity 82%). The patients were divided into two groups: a low-GAR (< 0.306; n = 30) and high-GAR group (> 0.306; n = 45). Binary restenosis was more frequent in the high-GAR group than in the low-GAR group (76.7% vs. 28.9%, p = 0.007). The cumulative rate of TLF was significantly higher in the high-GAR group when compared with the low-GAR group (53.3% vs. 40.0%, p = 0.01), which was mainly driven by TLR (56.7% vs. 22.2%, p = 0.01). High-GAR (> 0.306) [OR 2.66 (1.34-5.31), p = 0.005] and stent under expansion [OR 2.37 (1.10-5.11), p = 0.03] were found to be independent predictors of binary restenosis after adjustment for multiple confounders. Multivariable analysis also revealed that high-GAR (> 0.306) [OR 2.06 (1.02-4.14), p = 0.03] and stent under expansion [OR 2.82 (1.28-6.19), p = 0.01] were independent predictors of TLF. We suggest that GAR (> 0.306) predicts binary restenosis and TLF in patients undergoing PCI for RCAos.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Japan; Male; Percutaneous Coronary Intervention; Postoperative Complications; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The ULISSE registry has demonstrated the real-world performance of the Ultimaster biodegradable polymer sirolimus-eluting stent (BP-SES) in a large cohort of patients undergoing percutaneous coronary intervention, including a large proportion of patients presenting with acute myocardial infarction (AMI).. We performed a subgroup analysis of the ULISSE registry in AMI patients and compared the outcomes of this vulnerable cohort with that of patients presenting without AMI (non-AMI). The primary end point was the incidence of 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (TLR).. Of 1,660 patients included in the ULISSE registry, 381(23%) presented with AMI, 207(54.3%) non-ST elevation myocardial infarction, and 174(45.7%) ST-elevation myocardial infarction. Compared with non-AMI patients, those with AMI were more frequently female and smokers, with lower left ventricular ejection fraction (LVEF) and chronic kidney disease requiring dialysis. At 1 year, TLF rate was significantly higher in AMI than non-AMI patients (7.9 vs. 4.1%; HR 1.98, CI 95% 1.22-3.23; p = .005) driven by higher rate of cardiac death (4.0 vs. 1.1%; HR 3.59, CI 95% 1.64-7.88; p = .01) and TV-MI (2.8 vs 0.9%; HR 2.99,CI 95% 1.22-7.37; p = .01), without differences in TLR rate (4.3 vs. 2.9%,HR 0.66, CI95% 0.35-1.25; p = .2). At multivariate Cox regression analysis, eGFR <40 mL/min (HR: 2.868) and LVEF <40% (HR: 2.394) were the only independent predictors of TLF.. In AMI patients, Ultimaster BP-SES implantation was associated with higher rate of TLF and definite stent thrombosis compared with non-AMI patients. The high incidence of adverse events was mainly driven by the unfavorable baseline risk profile.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Italy; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Progression-Free Survival; Prosthesis Design; Recurrence; Registries; Retrospective Studies; Risk Factors; Sirolimus; Time Factors

Topics: Cardiovascular Agents; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Humans; Italy; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Although the proof of concept of the bioresorbable vascular scaffold (BRS) is well documented, device-related adverse outcomes with first-generation BRS indicate longer-term surveillance. The current study provides insights into the safety and performance of the MeRes100, a novel second-generation sirolimus-eluting BRS, beyond one-year up to three-year follow-up (FU).. A total of 108 enrolled patients with de novo coronary artery lesions who underwent implantation of MeRes100 as part of the first-in-human MeRes-1 trial were followed up clinically beyond one year at two and three years and with multiple modality imaging at six months and two years. At three-year FU, the cumulative major adverse cardiac events rate was 1.87%, in the form of two ischaemia-driven target lesion revascularisations. No scaffold thrombosis was reported. Between six months and two years at quantitative coronary angiography, in-segment late lumen loss (LLL) (0.15±0.22 mm vs. 0.23±0.32 mm; p=0.18) and in-scaffold LLL (0.13±0.22 mm vs. 0.24±0.34 mm; p=0.10) changed insignificantly. IVUS subset analysis revealed a non-significant reduction in mean lumen area (6.17±1.28 mm2 vs. 5.47±1.50 mm2; p=0.21) and minimum lumen area (5.14±1.19 mm2 vs. 4.05±1.42 mm2; p=0.10) at two years compared to post-procedural measurements. OCT subset analysis demonstrated 99.24±2.27% neointimal strut coverage.. The extended outcomes of the MeRes-1 trial demonstrated sustained efficacy and safety of the MeRes100 BRS with maintained lumen patency up to two years by multimodality imaging and no very late scaffold thrombosis up to three-year clinical FU.The MeRes-1 trial is registered at the Clinical Trials Registry-India. CTRI Number: CTRI/2015/04/005706.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Follow-Up Studies; Humans; India; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome

The purpose of the present study was to compare mid-term results of using drug-eluting stents 'NanoMed' and Orsiro. Within the framework of an ongoing randomized prospective study we carried out an intermediate analysis of clinical and angiographic data of 520 patients after coronary artery stenting. The duration of the follow-up period amounted to 6.8±0.2 months. The patients were randomly assigned to the study and control groups each consisting of 260 patients with implanted stents 'NanoMed' and Orsiro, respectively. The obtained findings demonstrated that the main baseline clinical, demographic, and angiographic parameters had no statistically significant differences. The primary endpoint was achieved in 6.1 and 5.3% of cases in the study and control group, respectively (p=0.7). One case of acute in-stent thrombosis was revealed in each group. Cardiac mortality amounted to 0.7% and 0.3% in the study and control group, respectively (p>0.9). Repeat interventions on the target lesion were performed in 2.7 versus 3.4% of cases in the study and control group, respectively (p=0.6). Hence, the comparative analysis of using 'NanoMed' and Orsiro stents in the mid-term period revealed no statistically significant differences.. Целью исследования послужило сравнение среднеотдаленных результатов использования стентов c лекарственным покрытием 'НаноМед' и Orsiro. В рамках продолжающегося рандомизированного проспективного исследования проведен промежуточный анализ клинических и ангиографических данных 520 пациентов после стентирования коронарных артерий в период наблюдения 6,8±0,2 месяца. В исследуемую и контрольную группы были рандомизированно включены по 260 пациентов с имплантированными стентами 'НаноМед' и Orsiro соответственно. В результате исследования выявлено, что основные исходные клинико-демографические и ангиографические показатели статистически значимо не различались. Первичная конечная точка достигнута в 6,1 и 5,3% в исследуемой и контрольной группах соответственно (р=0,7). Выявлено по одному случаю острого тромбоза стента. Кардиальная летальность составила 0,7% в исследуемой и 0,3% в контрольной группе (р>0,9). Повторные вмешательства на целевом поражении выполнены в исследуемой и контрольной группах соответственно в 2,7 против 3,4% случаев (р=0,6). Таким образом, при сравнительном анализе использования стентов 'НаноМед' и Orsiro в среднеотдаленном периоде не выявлено статистически значимой разницы.

Topics: Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

Long and diffuse coronary lesions (LDCLs) are routinely subjected to percutaneous management, but long‑term clinical outcomes and complication predictors with the use of contemporary stents and techniques remain undetermined.. The aim of the study was to address long‑term effects of percutaneous management of LDCLs, using contemporary devices and optimization techniques.. Long and diffuse coronary lesion was defined as a lesion requiring an implantation of 30 mm or longer total stent(s) length (TSL) into one coronary artery (bailouts excluded). There were 290 LDCL interventions with the use of newer generation drug‑eluting stents (DESs; cobalt chromium everolimus- or zotarolimus-eluting stents) performed between January 2013 and January 2016.. The mean (SD) TSL was 55.5 (16.8) mm. The use of intravascular ultrasound / optical coherence tomography was 17.1%, rotablation, 6.9%, and noncompliant balloon, 88.9%. The median (range) follow‑up duration was 831 (390-1373) days. All‑cause mortality and cardiac death rates were 11.7% and 6.9%, respectively. The myocardial infarction (MI) rate was 6.6%, including target‑vessel MI in 4.1%. The rate of clinically‑driven repeat revascularization was 13.8%, and of definite or probable LDCL stent thrombosis, 7.2%. Overall patient‑oriented adverse event rate (any death, MI, or repeat revascularization) was 25.5%, and device‑oriented rate (cardiac death, target vessel‑MI, or target lesion restenosis), 13.4%. Adverse outcome predictors were chronic kidney disease, acute coronary syndrome as an indication for the procedure, chronic heart failure with reduced left ventricular ejection fraction, multivessel disease, and coexisting peripheral artery disease, but not lesion‑related factors, such as bifurcation, calcification, chronic total occlusion, or TSL.. Adverse outcomes following contemporary LDCL management using newer generation DESs in routine clinical practice are associated with clinical patient characteristics rather than lesion characteristics or TSL. We identified high‑risk patient cohorts that may benefit from enhanced surveillance.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Practice Guidelines as Topic; Sirolimus; Treatment Outcome

Although drug-eluting stents (DES) have outclassed the use of bare metal stents, the safety and efficacy of DES at long-term follow-up has still been conflicting because of increased occurrence of late or very late restenosis and stent thrombosis after DES implantation. Hence, the present study was aimed to evaluate the 3-year safety and clinical performance of biodegradable polymer-coated ultra-thin (60 µm) sirolimus-eluting stent (SES) in real-world patients with coronary artery disease (CAD).. This was a physician-initiated, retrospective, single-centre, observational study that included 237 consecutive patients who had previously undergone implantation of only Supraflex SES (Sahajanand Medical Technologies Pvt Ltd, Surat, India) for the treatment of CAD. Follow-up was received after 1 year and 3 years of stent implantation. The primary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI) and target lesion revascularisation (TLR). Stent thrombosis was considered as a safety endpoint.. The mean age of patients was 64.1 ± 10.2 years, and 192 (81.0%) patients were male. The average stent length and diameter were 24.4 ± 9.0 mm and 3.1 ± 0.4 mm, respectively. The cumulative MACE rate at 3 years follow-up was 6.5% which included 4 (1.8%) cardiac deaths, 6 (2.8%) MI, and 4 (1.8%) TLR. There were 2 (0.9%) cases of stent thrombosis.. Treatment of patients with CAD in real-world clinical practice was associated with sustained clinical safety and low rates of restenosis, stent thrombosis and MACE up to 3 years after Supraflex SES implantation.

Topics: Aged; Biodegradable Plastics; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; India; Male; Middle Aged; Myocardial Infarction; Outcome and Process Assessment, Health Care; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Sirolimus; Survival Analysis

Recent stent developments aimed to reduce and eliminate the long-term inflammatory response include thinner struts, modifications to stent design and the development of bioresorbable polymers (BP). We aimed to summarize the main findings and to discuss the established and the potential benefits of the Orsiro BP sirolimus-eluting stents in everyday clinical use. We have reviewed the available evidence on the clinical performance of the Orsiro BP drug-eluting stents. Orsiro BP sirolimus-eluting stents is clinically proven and showed noninferiority against major drug-eluting stents and provides high safety and efficacy profile at long-term follow-up. Furthermore, it may be the preferred treatment option in specific subgroups as acute coronary syndrome, as shown in the BIOFLOW V trial.

Topics: Absorbable Implants; Chromium Alloys; Clinical Trials as Topic; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Sirolimus

Normalized optical density (NOD) measured by optical coherence tomography represents neointimal maturity after coronary stent implantation and is correlated with morphologic information provided by both light and electron microscopy. We aimed to test the hypothesis that even second generation drug-eluting stents (DESs) are problematic in terms of neointimal maturity. We implanted bare-metal stents (BMS: n = 14), everolimus-eluting stents (EESs: n = 15) or zotarolimus-eluting stents (ZESs: n = 12) at 41 sites in 32 patients with stable coronary artery disease. OCT was performed at up to 12 months of follow-up, and the average optical density of neointima covering struts was evaluated. NOD was calculated as the optical density of stent-strut covering tissue divided by the optical density of the struts. We also measured circulating CD34+ /CD133+ /CD45low cells, and serum levels of stromal cell-derived factor (SDF)-1, interleukin (IL)-8 and matrix metalloproteinase (MMP)-9 at baseline and follow-up. NOD was lower in the EES (0.70 ± 0.06) group than in the BMS (0.76 ± 0.07, P < 0.05) and ZES (0.76 ± 0.06, P < 0.05) groups. The mean neointimal area (R = 0.33, P < 0.05) and mean neointimal thickness (R = 0.37, P < 0.05) were correlated with NOD. Although NOD was not correlated with percent changes in circulating endothelial progenitor cells, and the levels of SDF-1 and IL-8, it was negatively correlated with the change in MMP-9 level (R = - 0.51, P < 0.01). Neointimal maturity might be lower at EES sites than BMS or ZES sites. This might lead to impaired neointimal tissue growth and matrix degradation. These results suggest a specific pathophysiology after DES implantation.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Chemokine CXCL12; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Endothelial Progenitor Cells; Everolimus; Female; Humans; Interleukin-8; Male; Matrix Metalloproteinase 9; Middle Aged; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular Remodeling

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Humans; Sirolimus; Stents

Patients with diabetes mellitus (DM) remain at higher risk of restenosis after percutaneous coronary intervention despite the use of contemporary drug-eluting stents. The Cre8 amphilimus-eluting stent (AES) has shown promising results in DM patients. Whether this holds true irrespective of patient's clinical and angiographic complexity is unknown.. Five hundred and ninety five consecutive patients (738 lesions) undergoing AES implantation were included in the INVESTIG8 multicenter registry. Patients were stratified according to DM status and further stratified according to patients' complexity. The prespecified primary endpoint was target lesion failure (TLF)-defined as the composite of cardiac death, target-vessel myocardial infarction, and target lesion revascularization (TLR).. DM patients were more often complex as compared to non-DM patients (70% vs. 61%, P = 0.015). At 18-month follow-up, there was a trend to a higher TLF rate in DM than in non-DM patients (6.9% vs. 3.5%, P = 0.063). This was largely driven by a markedly higher risk of TLF among complex DM patients as compared to simple DM patients (8.9% vs. 2.4%, P = 0.053). A multivariate analysis identified complexity (HR 6.11, 95% CI: 1.42-26.2) but not DM (HR 1.59; 95% CI 0.71-3.56) as an independent predictor of TLF. Of note, TLR rates were similar between DM and non-DM patients (3.3% vs. 1.9%, P = 0.228).. In this real-world, multicenter registry the Cre8 AES showed favorable clinical outcomes in DM patients. Increased risk of TLF appears to be driven by patients' complexity rather than DM status. These findings will need to be confirmed in a large-scale randomized trial.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Diabetes Mellitus; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Recurrence; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Objective To evaluate the 1-year clinical outcomes of patients who received the Resolute Onyx™ stent. Methods This was a single-centre, retrospective registry analysis that reviewed the clinical data from all patients who were implanted with a Resolute Onyx™ stent between March 2015 and February 2016. Clinical follow-up was performed at 1 year post-implantation. Results A total of 252 patients received a Resolute Onyx™ stent and two patients were lost to follow-up. The mean age of the cohort was 66.9 years and 113 (45.2%) had diabetes mellitus. Thirty-eight patients (15.2%) had left main disease and 73 (29.2%) had three-vessel disease. A total of 175 patients (70.0%) had small vessel disease (<2.75 mm) and 210 (84.0%) had long lesions (>20 mm). The 1-year target lesion failure was 4.4% (11 of 250), cardiovascular death occurred in eight patients (3.2%), ischaemia-driven target lesion revascularization was undertaken in five patients (2.0%) and stent thrombosis occurred in one patient (0.4%). Conclusion The Resolute Onyx™ stent showed a favourable 1-year clinical performance in a real-world population.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Registries; Retrospective Studies; Sirolimus; Survival Analysis; Time Factors; Treatment Outcome

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to assess the efficacy of a biolimus A9-eluting stent in patients with a right coronary artery (RCA) ostial lesion. Ostial lesions of the RCA have been a limitation of percutaneous coronary intervention even in the drug-eluting stent (DES) era. However, clinical outcomes after the deployment of a second generation DES to an RCA ostial lesion with intravascular ultrasound (IVUS) guidance have not been fully elucidated. From September 2011 to March 2013, 74 patients were enrolled in 17 centers from Japan. RCA ostial lesion was defined as de novo significant stenotic lesion located within 15 mm from ostium. IVUS was used for all cases to confirm the location of ostium and evaluate stent coverage of ostium. Patients with hemodialysis were excluded. The primary endpoint is a major adverse cardiac event (MACE) at 1 year. Forty two percent of patients had multi-vessel disease. Angiographically severe calcification was observed in 26% of the lesions. The mean stent diameter was 3.3 ± 0.3 mm (3.5 mm, 72%, 3.0 mm, 25%, and 2.75 and 2.5 mm, 3%), stent length was 17.5 ± 5.8 mm, and dilatation pressure of stenting was 15.6 ± 4.1 atm. RCA ostium was covered by stent in all lesions in IVUS findings. Post dilatation was performed for 64% of lesions (balloon size 3.7 ± 0.6 mm). MACE rate at 1 year was 5.4% (target lesion revascularization 5.4%, myocardial infarction 1.2%, and no cardiac death). The biolimus A9-eluting stent for RCA ostial lesions with IVUS guidance showed favorable results at 1-year follow-up.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Registries; Sirolimus; Treatment Outcome; Ultrasonography, Interventional

The objective of this study was to compare the safety and efficacy of a polymer-free sirolimus coated, ultrathin strut drug eluting stent (PF-SES) to its uncoated bare-metal stent (BMS) platform of identical stent architecture.. Recently published randomized trials comparing BMS to DES with a focus on shortened dual-antiplatelet therapy reported incidences of stent thrombosis (ST) and bleeding complications (LEADERS FREE) in favor of drug eluting stents (DES).. Data of previously published large-sale, international, single-armed, multicenter, observational studies of ultra-thin PF-SES, and BMS were propensity score (PS) matched for selected lesion morphological and cardiovascular risk factors to compare target lesion revascularization (TLR), myocardial infarction, cardiac death, major adverse cardiac events (MACE), bleeding complications and ST rates. Primary endpoint in both studies was TLR at 9 months.. At 9 months the rates of TLR was significantly lower in the PF-SES group as compared with patients treated with the BMS analogue of identical stent design (1.4% vs. 4.6%, P = 0.005). Likewise the 9-month MACE rates were lower in the PF-SES group (3.2% vs. 8.7%, P = 0.001) whereas there were no differences in the accumulated ST rates (0.5% vs. 1.5%, P = 0.109). Overall accumulated bleeding incidences (BARC 1-5) were not significantly different between PF-SES and BMS patients (1.8% vs. 2.7%, p = 0.388).. PF-SES are superior over analogue BMS of identical stent architecture in daily clinical routine with lower rates of TLR and MACE in a PS-matched, unselected patient population without differences in accumulated ST rates and bleeding frequencies given the currently favored postprocedural comedication (ClinicalTrials.gov Identifier NCT02629575).

Topics: Aged; Aged, 80 and over; Asia; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Europe; Female; Humans; Male; Metals; Middle Aged; Percutaneous Coronary Intervention; Postoperative Complications; Probucol; Propensity Score; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to compare neointima proliferation in three drug-eluting stents (DES) produced by the same company (Balton, Poland) which are covered with a biodegradable polymer and elute sirolimus (concentration: 1.0 and 1.2 µg/mm

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Hyperplasia; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Polymers; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The aim of the study was to capture the evolution of neointima after implantation of a biodegradable polymer-coated, sirolimus-eluting, cobalt-chromium coronary stent system (BP-DES).. Optical coherence tomography (OCT) suggests that in-stent neointimal morphology influences clinical outcomes after DES implantation.. Sixty patients treated with single BP-DES implantation were examined by quantitative coronary angiography (QCA) and OCT at 3, 6, and 12-month follow-up.. Median late lumen loss by QCA (mm) was 0.04 (IQR 0, 0.08), 0.17 (IQR 0, 0.32), and 0.14 (IQR 0.07, 0.31) at 3, 6, and 12-month follow-up respectively (P = 0.03). OCT cross-section multilevel analysis showed uncovered struts in 3.90%, 1.78%, and 0.02% of struts respectively (P = 0.03). The corresponding malapposition rates were 0.12%, 0.04%, and 0%. Lipid-rich neointima was observed only at 12-month follow-up in one restenotic lesion (0.77% cross-sections) that was accountable for the only target vessel revascularization. The homogeneous pattern was prevalent at all three time points, but its incidence displayed an upward trend (3 months: 59%; 6 months: 71%; 12 months: 88%) despite no difference in neointimal volume between 6 and 12 months. Conversely, a trend could be observed of decreasing incidence of heterogeneous pattern as the follow-up length increased.. In this study of a single-type BP-DES, the majority of stent struts were covered within 3 months from implantation. While the quantitative neointimal accumulation plateaued at 6 months with no further significant increase beyond 6 months, the neointima continued to evolve qualitatively and mature along with better strut coverage between 6 and 12 months after implantation.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Poland; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

To assess clinical outcomes of Amphilimus Sirolimus-Eluting Stents (A-SES) as compared to Zotarolimus-Eluting Stents (ZES) in complex real-world diabetic patients.. Patients with diabetes mellitus represent one of the most challenging scenarios with high rates of restenosis and stent thrombosis in the current era of drug-eluting stents. Hence, we assessed the safety of A-SES versus ZES in complex diabetic patients.. In this observational study, we analyzed all consecutive patients with diabetes mellitus referred to our center from November 2012 to November 2014. The primary outcome was target-lesion failure at 1-year follow-up.. A total of 165 consecutive diabetic patients underwent percutaneous coronary intervention with A-SES or ZES for stable coronary artery disease in our tertiary center. Using the Kaplan Meier method the cumulative incidence of target-lesion failure was 6.7% (5.9% A-SES versus 7.5% ZES, p=0.19) at 1-year follow-up. Event-free survival at 1year follow-up was similar (89.4% A-SES vs. 83.3% ZES, p=0.29). Interestingly, we did not find any cases of definite-, and only one case of probable stent thrombosis in this high risk cohort.. In this real-world registry, A-SES and ZES seems to be associated with promising 1-year clinical safety outcomes following PCI in a contemporary cohort of high-risk diabetic patients. Our results should be considered hypothesis generating, as the clinical safety of A-SES has to be confirmed in a large trial.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Netherlands; Percutaneous Coronary Intervention; Progression-Free Survival; Prosthesis Design; Registries; Retrospective Studies; Risk Factors; Sirolimus; Time Factors

Topics: Aged; Antibodies; Antigens, CD34; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Postoperative Complications; Prosthesis Design; Prosthesis Failure; Randomized Controlled Trials as Topic; Registries; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The applicability of Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores to left main coronary artery disease (CAD) has been questioned. A simplified alternative is needed for guiding decision making.. We evaluated the prognostic value of a simplified angiographic classification in comparison with a Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score-based approach for patients with left main CAD undergoing drug-eluting stent implantation. The proposed approach classified left main CAD as either extensive (n=819), defined as left main bifurcation lesions with an involvement of ostial left circumflex artery or as any left main lesion plus multivessel CAD, or limited (n=453), defined as ostial/midshaft lesions or left main bifurcation lesions without an involvement of ostium of left circumflex artery, alone or plus 1-vessel disease. The databases from 4 prospective Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease studies were pooled, and the primary outcome was a major adverse cardiac event, defined as death, myocardial infarction, or repeat revascularization. During follow-up (median 38 months; interquartile range, 36-61 months), the risk for major adverse cardiac event was significantly higher with extensive than with limited left main CAD (adjusted hazard ratio, 2.13; 95% confidence interval, 1.54-2.94;. Compared with Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores, the simpler angiographic approach provided better discrimination for future cardiovascular events in patients with left main CAD undergoing drug-eluting stent implantation.

Topics: Aged; Cardiovascular Agents; Clinical Decision-Making; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Coronary Vessels; Databases, Factual; Decision Support Techniques; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Patient Selection; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Tremendous efforts have been made to establish the concept of vascular restoration therapy with a fully bioresorbable scaffold for coronary artery disease. With an improved scaffold design and technologies, the novel NeoVas scaffold has shown promising clinical performance at 6 months follow-up.. The aim of this study was to investigate the 1 year clinical outcomes and multislice computed tomography (MSCT) angiographic results after implantation of the NeoVas scaffold in patients with single de novo coronary artery lesions.. The NeoVas first-in-man study was a prospective, two-center, single-arm study enrolling 31 patients who were eligible for the treatment. The composite endpoint of target lesion failure (TLF)-defined as cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularization (TLR)-was assessed. Of the 31 patients scheduled for 1 year clinical follow-up, 29 patients received MSCT examinations.. At 1 year follow-up, there was only 1 (3.2%) TLF, attributed to 1 patient who suffered ischemia-driven TLR at 181 days postprocedure. No cardiac deaths or scaffold thrombosis were observed. MSCT analysis demonstrated excellent vessel patency, with a median in-scaffold lumen area of 10.6 mm. This study demonstrated the safety and efficacy of the NeoVas scaffold for patients with single de novo coronary artery lesions at 1 year of follow-up. Noninvasive MSCT data confirmed vessel patency and the maintenance of vessel dimensions following implantation of the NeoVas bioresorbable sirolimus-eluting scaffold.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; China; Computed Tomography Angiography; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Male; Middle Aged; Multidetector Computed Tomography; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

Innovations in drug eluting stent designs make it increasingly important to develop models for differentiating performance through spatial definition of drug, receptor binding and cell state.. Two designs of sirolimus analog eluting stents were implanted into porcine coronary arteries for 28, 60 or 90 days (n = 9/time point), durable coating (Xience) and deployable absorbable coating (MiStent). Explanted arteries were evaluated for drug content (n = 3/time point) by LC-MS/MS and for drug and target protein (mTOR) distributions by immunofluorescence (IF, n = 6/time point). A computational model was developed to predict drug release and arterial distribution maps.. Both stents released the majority of drug load by 28 days, with different tissue retention efficiencies (91.4 ± 4.9% MiStent versus 21.5 ± 1.9% Xience, P < 0.001). Computational modeling of MiStent coating deployment and microcrystal dissolution recapitulated in vivo drug release and net tissue content and predicted that >98.5% of deployed drug remains crystalline through 90 days. Immunofluorescence and computational modeling showed peristrut drug localization for both stents, with similar peaks, but high interstrut levels only at sites of coating deployment from the absorbable coating. Co-localization of mTOR-IF with drug-IF for both devices showed persistent drug effects, though with differential drug-receptor pharmacokinetics.. Immunofluorescence and computational modeling provide insights into drug distribution and binding status that can help differentiate drug delivery technologies. Herein we found that tissue deployment of slow dissolving crystalline drug particles results in temporally and spatially more uniform drug delivery to interstrut zones that might otherwise be under-dosed without excess peristrut drug.

Topics: Absorbable Implants; Animals; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Vessels; Drug Delivery Systems; Drug Liberation; Drug-Eluting Stents; Humans; Sirolimus; Swine

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Female; Humans; Magnesium; Middle Aged; Prosthesis Design; Sirolimus; ST Elevation Myocardial Infarction; Tomography, Optical Coherence; Treatment Outcome

The present study aimed to evaluate the efficacy and safety of polymer-free drug-coated BioFreedom stent implantation in comparison to coronary artery bypass graft (CABG) before major noncardiac surgery.. In a multicenter registry, 55 patients required revascularization before major noncardiac surgery that should not be delayed >6 months. Of them, 27 underwent BioFreedom stent implantation and 28 underwent CABG. Primary outcomes included rate of noncardiac surgery, time from revascularization to noncardiac surgery, and occurrence of composite outcomes (all-cause death, myocardial infarction, stent thrombosis, stroke, repeat revascularization, or major bleeding).. The rate of major noncardiac surgery was significantly higher in the BioFreedom group (92.6%) than in the CABG group (64.3%; p=0.027). Time from revascularization to noncardiac surgery was significantly shorter in the BioFreedom group (38.0 days) than in the CABG group (73.0 days; p=0.042). During the hospitalization for revascularization period, the occurrence of primary outcomes did not differ between the groups. However, the BioFreedom group showed a shorter hospitalization period and lower total treatment cost than the CABG group. During the hospital stay for noncardiac surgery, the occurrence of composite outcome was not significantly different between groups (4% vs. 0%; p>0.999): stroke occurred in only 1 case, and there were no cases of death or stent thrombosis in the BioFreedom group.. This study demonstrated that BioFreedom stenting as a revascularization strategy before major noncardiac surgery might be feasible and safe in selected patients with less severe coronary artery diseases.

Topics: Aged; Coronary Artery Bypass; Coronary Artery Disease; Drug-Eluting Stents; Female; Hemorrhage; Humans; Male; Middle Aged; Myocardial Infarction; Sirolimus; Stroke; Treatment Outcome

Early-generation drug-eluting stents (DESs) have been shown to accelerate neoatherogenesis. Limited optical coherence tomography (OCT) data on the very long-term neoatherosclerotic progression after DES implantation are available.. The aim of this study was a serial OCT evaluation of neoatherosclerosis at three and nine years after implantation of sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs).. Consecutive patients undergoing elective percutaneous coronary intervention with SES (Cypher, Cordis) or PES (Taxus, Boston Scientific) were included in this single-centre, longitudinal study. OCT analysis was performed after three and nine years by an independent core laboratory.. A total of 39 OCT recordings were assessed at three years after the index procedure; of them, 22 (eight SES and 14 PES) OCT pullbacks were evaluated in a paired analysis at three and nine years post implantation. Overall, neoatheroscle-rosis was identified in 23.1% of stents at three years and in 30.8% at nine years after the index procedure (p = 0.289). No features of significant neoatherosclerotic progression were found in either group between three- and nine-year assessment.. At nine years after implantation of early-generation DES no significant neoatherosclerotic progression was observed among patients with uneventful follow-up at three years after PCI, as assessed by OCT. These observations need to be confirmed in larger studies including the current generation of DESs.

Topics: Aged; Atherosclerosis; Coronary Artery Disease; Coronary Restenosis; Disease Progression; Drug-Eluting Stents; Female; Humans; Longitudinal Studies; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Postoperative Period; Sirolimus; Tomography, Optical Coherence

Delayed healing and endothelial dysfunction may occur with drug-eluting stents (DES), promoting accelerated infiltration of lipids in the neointima and development of neoatherosclerosis (NA). Pathology data suggest durable polymer (DP) of DES to play a major role in this process. Whether biodegradable polymer (BP) may address these issues is uncertain. We compared in vivo vessel healing and NA of current generation BP- or DP-DES using serial optical coherence tomography (OCT) assessments.. Ninety patients with multivessel coronary artery disease were randomized 1:1 to BP everolimus-eluting stents (EES, Synergy) or DP zotarolimus-eluting stents (ZES, Resolute Integrity). Co-primary endpoints were the maximum length of uncovered struts at 3 months (powered for non-inferiority) and the percentage of patients presenting with frames of NA at 18 months (powered for superiority) as measured by OCT. The maximum length of uncovered struts at 3 months was 10 ± 8 mm in the BP-EES group and 11 ± 7 mm in the DP-ZES group (mean difference -1 mm; upper 97.5% confidence interval +2 mm; P = 0.05 for non-inferiority; P = 0.45 for superiority). The percentage of patients presenting with frames of NA at 18 months was low and similar between BP-EES and DP-ZES groups (11.6% vs. 15.9%; P = 0.56). There was no stent thrombosis in both groups at 24 months.. BP-EES and DP-ZES showed a similar healing response at 3 months and a low incidence of NA at 18 months. Biocompatible polymers, regardless of whether they are durable or biodegradable, may favourably impact the long-term vascular response to current-generation DES.

Topics: Absorbable Implants; Aged; Atherosclerosis; Biocompatible Materials; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Sirolimus; Time Factors; Tomography, Optical Coherence; Wound Healing

The aim of this study was to investigate whether the underlying plaque type affects the neointimal coverage after drug-eluting stent implantation.. A total of 1793 struts in 22 zotarolimus-eluting stents were assessed using optical coherence tomography imaging within 3 months of implantation. Neointimal coverage was evaluated within 5 mm from each stent edge on cross-sectional optical coherence tomography images at every 1-mm interval. The percentage of struts covered by neointima was compared among the normal segment group, the fibrous plaque group, and the lipid plaque group on the basis of the underlying plaque type.. The percentage of covered strut was significantly lower in the normal segment group than in the fibrous plaque group (35.9±30.2 vs. 57.1±31.0%, P<0.05) and the lipid plaque group (vs. 64.7±23.5%, P<0.01). The neointima was significantly thinner in the normal segment group than in the lipid plaque group (19.0±22.3 vs. 32.0±18.8 μm, P<0.01). The percentage of struts on the normal segment was significantly higher in cross-sections with a ratio of uncovered to total struts per section more than 0.3 than in cross-sections with a ratio up to 0.3 (32.4±31.7 vs. 19.5±33.8%, P<0.01).. Struts on the normal segment were less covered and had thinner neointima than struts on the lipid plaque at the stent edge within 3 months after zotarolimus-eluting stent implantation. Caution should be exercised when implanting longer drug-eluting stents to achieve uniform strut coverage in the early phase.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Fibrosis; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Sirolimus (SRL) attenuates cardiac allograft vasculopathy (CAV) progression after heart transplantation (HT) but often results in hyperlipidemia. In this study we investigated the differential effects of SRL-based and calcineurin inhibitor (CNI)-based immunosuppression on CAV progression and clinical outcomes in HT recipients.. CAV progression was assessed by coronary intravascular ultrasound (IVUS) as changes in volumetric measurements after correction to time between the first and last follow-up IVUS exams. CAV progression rate and CAV-associated events were compared between patients with mean follow-up low-density lipoprotein (LDL) <100 mg/dl (lower level or LL) and ≥100 mg/dl (higher level or HL) in the SRL and CNI groups.. We identified 227 patients on SRL (LL: 118; HL: 109) and 96 on CNI (LL: 56; HL: 40), with a median follow-up of 6.7 years. Clinical characteristics did not differ between the LL and HL groups and all patients were on statins. In the SRL arm, there were no significant differences in CAV progression rate and there were no differences in all-cause mortality and CAV-associated events between the LL and HL groups. In the CNI arm, the Δ change in plaque volume normalized to segment length and time of follow-up (PV/SL/year) (0.55 ± 0.53 vs 1.53 ± 2.32, p = 0.003) and Δ change in plaque index per year (defined as PV/vessel volume ratio) (3.1 ± 3.7% vs 6.3 ± 10.4%; p = 0.034) were significantly lower in the LL than the HL group. After adjusting for patient characteristics, HL was associated with higher rates of advanced CAV requiring coronary angioplasty (hazard ratio [HR] 3.0, 95% confidence interval [CI] 1.05 to 9.40, p = 0.040) and higher rates of all CAV-associated events (HR 2.2, 95% CI 1.10 to 4.54, p = 0.026) in these CNI-treated subjects.. Unlike CNI-based immunosuppression, the effects of SRL on attenuating CAV progression are independent of LDL cholesterol levels post-HT.

Topics: Adult; Calcineurin Inhibitors; Cholesterol, LDL; Coronary Artery Disease; Disease Progression; Drug Substitution; Female; Follow-Up Studies; Heart Transplantation; Humans; Hypercholesterolemia; Immunosuppressive Agents; Male; Middle Aged; Retrospective Studies; Sirolimus; Survival Rate; Ultrasonography, Interventional

Prolonged dual anti-platelet therapy (DAPT) is undesirable in certain patients. The biolimus-A9 drug-coated stent (BA9-DCS) has a rapid drug-elution profile allowing shortened DAPT.. The demographics, procedural data, and clinical outcomes for 505 patients presenting with an ACS to three UK centres and treated with a BA9-DCS stent (PCI-DCS) were collected, and compared to a consecutive ACS cohort of unselected patients treated in the same period with drug-eluting stents (PCI-DES).. PCI-DCS patients were older, more often female with hypertension, chronic kidney disease, severe LV dysfunction, and peripheral vascular disease more frequent than the PCI-DES cohort. PCI-DCS patients had a much higher Mehran bleed risk score (21.5 ± 7.7 vs. 15.9 ± 7.7, P < 0.0001). Baseline disease burden was greater in the PCI-DCS cohort with more left main and three vessel disease. During PCI, more stents (1.91 ± 1.1 vs. 1.57 ± 0.94, P < 0.0001), total stent length (38.2 ± 20.8 vs. 31.4 ± 20.3, P < 0.0001) and longer stents (38.2 ± 20.8 vs. 31.4 ± 20.3 mm, P < 0.0001) were used in the PCI-DCS cohort with rotational atherectomy also used more frequently. Physician-recommended DAPT duration was 2.9 ± 3.9 months for PCI-DCS patients and 11.3 ± 2.4 months for PCI-DES patients (P < 0.0001). At 12-month follow-up, definite stent thrombosis (0.6% vs. 1.1%) and TLR (3.2% vs. 2.7%) rates were similar between the two groups. After adjustment for baseline differences, there were no statistically significant differences in death and combined MACE rates at 12 months.. The outcomes of patients treated with polymer-free BA9 drug-coated stent who present with an ACS and who were deemed unsuitable for prolonged DAPT are encouraging. Further studies are warranted.

Topics: Acute Coronary Syndrome; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Preliminary Data; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; United Kingdom

Biodegradable polymer sirolimus-eluting stents (BP-SESs) have been reported to be noninferior compared with durable polymer everolimus-eluting stents (DP-EES) in a randomized clinical trial. We sought to compare the efficacy and safety of an ultrathin strut BP-SES with a DP-EES in an all-comers population.. Among 7640 consecutive patients who underwent percutaneous coronary intervention between March 2011 and June 2015, 4638 patients were exclusively treated with BP-SES (N=1896; 3137 lesions) or DP-EES (N=2742; 4468 lesions). After propensity score matching within strata of clinical indications, the final study population consisted of 2902 matched patients (BP-SES 2406 lesions and DP-EES 2368 lesions). The primary device-oriented composite end point (DOCE) included cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1 year. BP-SES (6.9%) was noninferior to DP-EES (8.0%) with respect to device-oriented composite end point (hazard ratio [HR], 0.85; 95% CI, 0.65-1.11; P for noninferiority <0.001; P for superiority=0.24). No differences in cardiac death (BP-SES, 2.3% versus DP-EES, 3.0%; HR, 0.76; 95% CI, 0.49-1.20; P=0.25), myocardial infarction (BP-SES, 4.6% versus DP-EES, 4.6%; HR, 1.00; 95% CI, 0.71-1.40; P=0.99), or target lesion revascularization (BP-SES, 2.8% versus DP-EES, 2.5%; HR, 1.11; 95% CI, 0.71-1.74; P=0.65) were observed. The rate of periprocedural myocardial infarction was comparable between the 2 groups (2.1% versus 2.2%; HR, 0.97; 95% CI, 0.59-1.58; P=0.89). The rate of definite stent thrombosis was similarly low throughout 1 year (BP-SES, 0.8% versus DP-EES, 0.8%; HR, 1.00; 95% CI, 0.45-2.22; P=1.00).. In a consecutively enrolled percutaneous coronary intervention population reflecting routine clinical practice, BP-SES was noninferior to DP-EES for device-oriented composite end point at 1 year.. URL: https://www.clinicaltrials.gov . Unique identifier: NCT02241291.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Propensity Score; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Switzerland; Time Factors; Treatment Outcome

Coronary angioscopy (CAS) is used to comprehensively evaluate vascular responses after drug-eluting stent (DES) implantation. This study sought to evaluate the capability of CAS for evaluating DES strut coverage grade and color grade of the intima compared with histological images in coronary autopsy specimens. Methods and Results: A total of 23 DES extracted from 11 autopsy hearts were imaged by CAS. All stent segments were graded as white or yellow according to the luminal surface color, and thrombus was evaluated according to a previous report. Neointimal coverage over the DES was graded as 0 (stent struts fully visible) to grade 3 (stent struts fully embedded and invisible). Of 76 segments, neointimal coverage was graded as 0 in 35 (46%), 1 in 22 (29%), 2 in 8 (11%), and 3 in 11 (14%). The neointimal thickness increased significantly with increasing neointimal coverage grade on angioscopy. Neointimal color was graded as white in 40 (53%) and yellow in 36 segments (47%). Histological analysis revealed that yellow neointima contained fibroatheroma, foam cells accumulation or superficial calcium deposition. A thrombus was identified in 13 segments. Thrombi adherent around the stent strut were partly intimal erythrocyte accumulation around the strut.. In-stent yellow segment had atherosclerotic components. CAS could evaluate vascular status comprehensively after DES implantation.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Plaque, Atherosclerotic; Sirolimus

Coronary allograft vasculopathy (CAV) is the leading cause of death after pediatric heart transplantation from 1 year postoperation. Anecdotal evidence suggests a difference in the severity of disease between UK and North America. We performed a comparative study using intravascular ultrasound (IVUS).. Consecutive IVUS procedures from a single year were included from each center. Using standardized techniques, measurement of the vessel area, lumen area, and maximal intimamedial thickening (IMT) were performed with calculation of intimal index (II) for each slice. Mean II, mean IMT, and absolute maximum IMT were calculated along the left coronary artery for each patient. Transplant demographics and treatment details were included in the analysis.. One hundred four patients were included between the 2 centers. Interobserver variability for IVUS analysis was excellent. Patients were aged mean 14.2 (SD 3.3) years at the time of the study and 9.2 (SD 6.0) years earlier post-transplant procedure. UK patients were older, at transplant for a shorter time, and demonstrated more severe CAV. Multiple regression analysis demonstrated the detrimental effect of donor age and time from transplant on CAV severity and benefits of sirolimus use.. The data show more severe CAV in the UK cohort despite significantly shorter time post-transplant. Donor age and time post-transplant were associated with more severe CAV and sirolimus use was associated with a reduction in IMT. This study demonstrates a marked difference in the prevalence of CAV in children between UK and North America. The causes are likely to be multifactorial; however, younger donors and recipients have significantly less disease.

Topics: Adolescent; Allografts; Child; Coronary Angiography; Coronary Artery Disease; Cross-Sectional Studies; Female; Graft Rejection; Heart Transplantation; Humans; Immunosuppressive Agents; Male; North America; Postoperative Complications; Prevalence; Risk Factors; Sirolimus; Ultrasonography, Interventional; United Kingdom

The aim of the present study was to assess seven-year clinical outcomes of biodegradable polymer coated Supralimus sirolimus-eluting stent (S-SES) [Sahajanand Medical Technologies Pvt. Ltd., Surat, India] in real-world patients with coronary artery disease.. This observational, retrospective study was carried out in all 346 consecutive enrolled patients who underwent percutaneous coronary intervention (PCI) with the S-SES, between April 2008 and December 2009, at a single center. We analyzed major adverse cardiac events (MACE) [a composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and target vessel revascularization (TVR)] as primary outcomes at seven-year follow-up.. Out of 346 patients, seven-year follow-up was obtained in 327 (94.5%) patients and hence results were analyzed for 327 patients. At seven-year, MACE occurred in 41 (12.5%) patients, consisting of 23 (7.0%) cardiac deaths, 14 (4.3%) TLR, and 4 (1.2%) TVR. The incidence of late stent thrombosis was observed in 3 (0.9%) patients. At follow-up of seven-year, the cumulative event-free survival was found to be 84.7% by Kaplan-Meier method.. The present study demonstrated satisfactory and sustained seven-year clinical outcomes as evidenced by the low rates of MACE and ST for the biodegradable polymer coated S-SES.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

To evaluate long-term outcomes in patients undergoing either paclitaxel-eluting stents (PES) or endeavor zotarolimus-eluting stents (E-ZES) placement and to assess comparative effectiveness of PES vs. E-ZES in different "off-label" and "high-risk" patient subgroups.. PES and E-ZES are frequently used in percutaneous coronary interventions (PCIs). However, the long-term comparative effectiveness of PES vs. E-ZES in real practice is unknown.. We created a longitudinal database by linking the New York State (NYS) cardiac registries, the NYS hospital discharge file, the National Death Index, and the U.S. Census file for patients undergoing either PES or E-ZES placement from July 2008 through December 2009. All-cause mortality, acute myocardial infarction (AMI), target lesion PCI (TLPCI), and target vessel coronary artery bypass graft (TVCABG) surgery were compared for 9,264 propensity score matched patients for a 5-year follow-up period using the Kaplan-Meier method with further adjustment using Cox proportional hazards regression.. We did not detect significant differences between E-ZES and PES (reference) in 5-year mortality (adjusted hazard ratio : 1.02, 95% confidence interval : 0.91-1.14), AMI (AHR: 1.05, 95% CI: 0.90-1.22), TLPCI (AHR: 0.99, 95% CI: 0.86-1.13), and TVCABG (AHR, 1.07, 95% CI: 0.84-1.36). For six "off-label" and two "high-risk" subpopulations, we had similar findings for the two stent groups.. NYS observational data suggest that 5-year outcomes are comparable in patients receiving either PES or E-ZES placement, mirroring the findings of recent clinical trials. © 2017 Wiley Periodicals, Inc.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Comparative Effectiveness Research; Coronary Artery Disease; Databases, Factual; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; New York; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Coronary Artery Disease; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus; Stents; Treatment Outcome

The Nobori biolimus-eluting stent (BES) is a biodegradable polymer drug-eluting stent (DES). Several studies have shown its noninferiority in comparison with durable polymer DES.. We sought to investigate the efficacy and the safety of Nobori BES in an all-comer population undergoing a percutaneous coronary intervention.. A total of 12 912 patients with 19 947 coronary lesions, undergoing percutaneous coronary intervention with Nobori BES implantation at 200 centres around the world between August 2010 and December 2015, were included in this prospective registry. Patients were stratified into four groups according to the total stent length, with cutoffs at 18, 24 and 28 mm. The primary endpoint was the occurrence of major adverse cardiac events defined as the composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularization at 1 year.. At 1 year, the major adverse cardiac events rate was the highest (4.6%) in the fourth quartile of stent length (>28 mm), whereas the overall rate of the primary endpoint in the all cohort was 3.5%. Both target lesion revascularization and target vessel revascularization rates were significantly higher in patients with longer stent length was implanted (all P<0.05). The incidence of definite and probable stent thrombosis at 1 year was 0.5% in all cohort and similar across the four groups (varying from 0.4 to 0.7%, all P=NS).. Our data confirmed the efficacy and the safety of the Nobori BES in routine clinical practice. Longer stent length is associated with a higher risk of adverse cardiac events, and yet, this risk is comparable with that of other DES.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Endeavor zotarolimus-eluting stents (E-ZES) and everolimus-eluting stents (EES) as second-generation stents were approved for use in percutaneous coronary interventions (PCIs) in 2008. We aimed to evaluate the long-term outcomes of E-ZES vs. EES using New York State (NYS) cardiac registries and to compare long-term effectiveness of E-ZES vs. EES in six "off-label" and two "high-risk" subgroups.. We created a longitudinal database by linking the NYS cardiac registries, the statewide hospital discharge data, the National Death Index, and the U.S. Census file (2010) for patients receiving either E-ZES or EES from July 2008 through December 2010. We examined outcome measures of all-cause mortality, acute myocardial infarction (AMI), target lesion PCI (TLPCI), and target vessel coronary artery bypass graft (TVCABG) surgery for 13,663 propensity score matched pairs in the 6-year follow-up period. We applied Kaplan-Meier methods and Cox proportional hazards regression for further adjustment of propensity-matched pairs.. Compared with patients receiving EES, patients receiving E-ZES had a significantly higher rate of 6-year all-cause mortality (adjusted hazard ratio (AHR): 1.10, 95% confidence interval (CI): 1.04-1.17, P=0.003), AMI (AHR: 1.12, 95% CI: 1.02-1.23, P=0.01), TLPCI (AHR: 1.28, 95% CI: 1.18-1.39, P<0.001), and TVCABG (AHR: 1.47, 95% CI: 1.26-1.71, P<0.001). EES had better or similar long-term outcomes than E-ZES for the subgroups that were examined.. At 6years, patients receiving EES generally had better or comparable mortality, AMI, TLPCI, and TVCABG outcomes compared with patients receiving E-ZES.

Topics: Aged; Aged, 80 and over; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Longitudinal Studies; Male; Middle Aged; New York; Percutaneous Coronary Intervention; Registries; Sirolimus; Survival Rate; Time Factors; Treatment Outcome

Topics: Absorbable Implants; Aged; Angioscopy; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Humans; Male; Multimodal Imaging; Percutaneous Coronary Intervention; Polymers; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Long coronary artery lesions are increasingly treated with new technologies including current generation drug eluting stents (DES) despite a lack of robust data on outcomes. In the current study, patients receiving Xience V DES for very long lesions (>35 mm) compared to lesions 25-35 mm had similar outcomes. Future research should address late outcomes, stent thrombosis rates, as well as investigation of lesions greater than 60 mm.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome

Topics: Angioplasty; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Sirolimus; Taxus

We aimed to assess the safety and performance of the DREAMS 2G scaffold up to 24 months post implant.. The present study population comprises a total of 184 patients with 189 lesions who were enrolled in the prospective, multicentre BIOSOLVE-II and BIOSOLVE-III trials. Clinical follow-up was scheduled at one, six, 12, 24 and 36 months. The present report includes pooled follow-up data at six months and BIOSOLVE-II data at 24 months. Patients were 65.5±10.8 years old, and lesions were 12.5±5.1 mm long with reference diameters of 2.7±0.4 mm. Procedural success was obtained in 97.8%. At six months, the composite clinical endpoint target lesion failure was 3.3% (95% CI: 1.2-7.1), based on two cardiac deaths (1.1%, one unknown and one not device-related), one target vessel myocardial infarction (0.6%), and three clinically driven target lesion revascularisations (1.7%). For BIOSOLVE-II at 24 months, the target lesion failure rate was 5.9% (95% CI: 2.4-11.8), based on two cardiac deaths (1.7%), one target vessel myocardial infarction (0.9%) and four target lesion revascularisations (3.4%). There was no definite or probable scaffold thrombosis.. The present analysis provides additional evidence on the safety of a drug-eluting absorbable metal scaffold with promising clinical outcomes up to 24 months and absence of definite or probable scaffold thrombosis.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

The aim of this study was to evaluate the capacity of the SYNTAX Score-II (SS-II) to predict long-term mortality in patients undergoing left main percutaneous coronary intervention (LM-PCI) treated with second-generation drug-eluting stents (DES).Data from 487 consecutive patients with de novo left main coronary artery disease undergoing PCI were retrospectively studied. The patients were divided into tertiles according to the SS-II: low SS-II tertile (SS-II ≤ 22), intermediate SS-II tertile (SS-II of 23 to 30), and high SS-II tertile (SS-II ≥ 30). The survival curves were estimated by the Kaplan-Meier method. Univariate and multivariate Cox proportional hazard regression analyses were performed to evaluate the possible associations between the SS-II and the rates of long-term mortality. The predictive ability of the SS-II for mortality was assessed and compared with the SYNTAX score (SS) alone by an area under the receiver operator curve (AUC).The overall SS-II was 27.3 ± 9.1. At a mean follow-up of 5.1 years, the long-term mortality was 6.0%. The rates of mortality were 2.4%, 3.4%, and 11.6%, respectively (P < 0.0001) in the low, intermediate, and high SS-II tertiles. The cardiac mortality rates were 1.8%, 1.4%, and 8.1%, respectively (P = 0.002) among patients in the 3 groups. By multivariate analysis, SS-II was an independent predictor of the long-term mortality (hazard ratio: 1.56, 95% confidence interval: 1.05 to 2.32; P = 0.03). The AUC demonstrated a substantially higher predictive accuracy of the SS-II for mortality compared with the SS alone (AUC was 0.689 and 0.596, respectively).In patients with LM-PCI treated with a second-generation DES, the SS-II is an independent predictor of long-term mortality and demonstrates a superior predictability compared with the SS alone.

Topics: China; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Predictive Value of Tests; Proportional Hazards Models; Retrospective Studies; Risk Assessment; Risk Factors; ROC Curve; Sirolimus; Survival Rate; Treatment Outcome

The difference in clinical presentations (acute coronary syndrome [ACS] and stable coronary artery disease [SCAD]) and related angiographic morphologies of sirolimus-eluting stent (SES) failure requiring target lesion revascularization (TLR) during early-term (<1year), late-term (1-5years), and very late-term periods (>5years) remains unknown.. Among 4484 lesions undergoing SES implantation, clinically-driven TLR was performed on 105 lesions during early-term, 169 lesions during late-term, and 147 lesions during very late-term period. Angiographic morphological patterns were divided into focal or non-focal patterns and stent-edge or stent-body patterns.. The proportion of ACS substantially increased in very late TLR lesions (57.1%) from early (40.0%, p=0.01) and late TLR lesions (36.7%, p<0.001). The proportions of both stent-edge and non-focal patterns were higher in very late TLR lesions than in early and late TLR lesions. Although the stent-edge pattern tended to be more prevalent in SCAD lesions than in ACS lesions during the early- and late-term periods, it was more frequently observed in ACS lesions than in SCAD lesions during the very late-term period (65.5% vs. 47.6%, p=0.04). The non-focal pattern was more frequent in ACS lesions than in SCAD lesions during all 3 periods. However, the proportion of the non-focal pattern in ACS lesions was extremely high during the very late-term (90.5%) compared with the early- (47.6%, p<0.001) and late-term periods (48.4%, p<0.001).. Stent-related ACS became more common beyond 5years after SES implantation. Stent-edge and non-focal patterns were the main angiographic morphologies of very late SES failure, particularly causing ACS.

Topics: Acute Coronary Syndrome; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Follow-Up Studies; Humans; Percutaneous Coronary Intervention; Prosthesis Failure; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

The SLENDER Integrated Delivery System (IDS™) is an 'all-in-one' fixed-wire coronary stenting device designed for direct stenting, precluding the need for conventional guidewires and predilatation balloons. It achieves ultra-low profiles (crossing profiles as low as 0.031" / 0.79), enabling the downsizing of catheters to facilitate TRI across wider subsets of patients. Areas covered: This paper aims to evaluate the SLENDER IDS for the treatment of coronary artery disease. Expert commentary: The system represents the first advance in coronary stent delivery since the introduction of rapid-exchange stent delivery systems more than 20 years ago. SLENDER IDS has demonstrated non-inferiority compared with commercial DES, excellent long-term safety and a potentially more efficient approach to PCI where patient comfort is enhanced, procedures are streamlined and resource consumption is reduced.

Topics: Coronary Artery Disease; Drug Delivery Systems; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Time Factors; Treatment Outcome

Percutaneous coronary intervention (PCI) using drug-eluting stents (DES) is an indispensable treatment for coronary artery disease. However, to evaluate the performance of various types of stents for PCI, numerous resources are required. We extracted clinical information from free-text records and, using practice-based evidence, compared the efficacy of various DES.. We developed a text mining tool based on regular expression and applied it to PCI reports stored in the electronic health records (EHRs) of Ajou University Hospital from 2010-2014. The PCI data were extracted from EHRs with a sensitivity of 0.996, a specificity of 1.000, and an F-measure of 0.995 when compared with a sample of 200 reports. Using these data, we compared the performance of stents by Kaplan-Meier analysis and the Cox hazard proportional regression.. In the self-validation analysis comparing the first-generation to the second-generation DES, the second-generation DES was superior to the first-generation DES (hazard ratio [HR]: 0.423, 95% confidence interval [CI]: 0.284-0.630) in terms of target vessel revascularization (TVR), showing similar findings to the established results of previous studies. Among the second-generation DES, the biodegradable-polymer DES tended to be superior, with a risk of TVR (HR: 0.568, 95% CI: 0.281-1.147) falling below than that for the durable-polymer DES approximately 1 year after the index procedure. The Endeavor stent had the highest TVR risk among the newer generation DES (HR: 2.576, 95% CI: 1.273-5.210).. In this study, we demonstrated how to construct a PCI data warehouse of PCI-related parameters obtained from free-text electronic records with high accuracy for use in the post surveillance of coronary stents in a time- and cost effective manner. Post surveillance of the practice based evidence in the PCI data warehouse indicated that the biodegradable-polymer DES might have a lower risk of TVR than the durable-polymer DES.

Topics: Cardiovascular Agents; Coronary Artery Disease; Data Mining; Drug-Eluting Stents; Electronic Data Processing; Electronic Health Records; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Proportional Hazards Models; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

There is debate regarding whether smoking results in microstructural changes after stenting. The aim of this study was to evaluate the microstructural changes after stenting in patients with different smoking statuses. We retrospectively identified 220 sirolimus-eluting stents in 179 patients who underwent follow-up optical coherence tomography examination 12 months after sirolimus stenting. Subjects were classified as current smokers (CS, n = 31), smoking cessation ≤1 year (n = 36), smoking cessation >1 year (SC > 1Y, n = 27), and never smokers (NS, n = 85). The neointimal hyperplasia (NIH) area was larger in CS than in NS (1.04 ± 0.72 mm

Topics: Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Postoperative Period; Prosthesis Design; Retrospective Studies; Sirolimus; Smoking; Smoking Cessation; Tomography, Optical Coherence

The COMBO stent combines sirolimus elution with an endothelial progenitor cell-capturing layer to promote early endothelialisation. There has not been a head-to-head comparison of this novel device with any other currently used drug-eluting stent (DES). We sought to compare clinical outcome at two years after COMBO stent placement with the Resolute Integrity or PROMUS Element stent in an all-comers cohort.. Patients from the REMEDEE registry (COMBO, n=1,000) were matched with patients from the DUTCH PEERS trial (PROMUS Element/Resolute Integrity, n=1,811). Propensity score matching on 13 baseline characteristics was applied to create two balanced cohorts of patients treated with COMBO versus PROMUS Element/Resolute Integrity. Propensity score matching yielded 771 patient pairs, representing all-comers patients, with a median age of 65 years, 27% female and more than 50% of patients presenting with acute coronary syndrome. Target lesion failure (TLF), a composite of cardiac death, target vessel MI and any target lesion revascularisation, at two-year follow-up was 7.9% in COMBO and 6.4% in PROMUS Element/Resolute Integrity, HR 1.24 (95% CI: 0.85-1.81), p=0.26. Definite stent thrombosis (ST) was not significantly different between groups (0.8% vs. 0.9%, p=0.79).. In a propensity-matched analysis, the COMBO stent showed similar rates of TLF and ST at two-year follow-up compared to Resolute Integrity and PROMUS Element.

Topics: Adult; Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Registries; Risk Factors; Sirolimus; Treatment Outcome

This study sought to compare clinical outcome of polymer-free amphilimus-eluting stent (PF-AES) versus biodegradable-polymer biolimus-eluting stent (BD-BES) in "all-comer" diabetes mellitus (DM) and non-DM patients who underwent percutaneous coronary intervention.. The PF-AES has shown promising preliminary results in patients with DM.. Data from 2 multicentre-national registries (the ASTUTE and the INSPIRE-1) were used to analyse 1776 patients stratified in non-DM and DM. A double 1:1 propensity-score matched analysis (PF-AES vs. BD-BES) was performed in each group to adjust for clinical and procedural characteristics. Primary stent-efficacy and stent-safety endpoints were 1-year target-lesion revascularization (TLR) and target-lesion failure (TLF, composed of cardiac-death, target-vessel myocardial infarction and any TLR).. This matched-cohort study suggests that PF-AES has better safety and efficacy profile than BD-BES in patients with DM.

Topics: Absorbable Implants; Aged; Anti-Inflammatory Agents; Cohort Studies; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Registries; Sirolimus

The purpose of this study was to evaluate the outcomes of the novel Fantom coronary bioresorbable scaffold at 6 months.. The Fantom sirolimus-eluting bioresorbable scaffold incorporates a unique proprietary iodinated, polycarbonate copolymer of tyrosine analogs that is radiopaque, with thin struts (125 μm) that facilitate device delivery and precise target lesion treatment.. The 6-month outcomes and performance of the Fantom scaffold were evaluated in 117 patients with single de novo native coronary artery lesions of length ≤20 mm and reference vessel diameter 2.5 to 3.5 mm. The primary angiographic endpoint was mean late lumen loss at 6 months measured by quantitative coronary angiography. Procedural outcomes were categorized as short-term technical success, short-term procedural success, and clinical procedural success. The primary clinical endpoint was major adverse cardiac events at 6 months, the composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).. Short-term technical success, short-term procedural success, and clinical procedural success were achieved in 96.6%, 99.1%, and 99.1% of patients, respectively. Mean 6-month in-stent late lumen loss was 0.25 ± 0.40 mm (n = 100). Binary restenosis was present in 2 patients (2.0%). Major adverse cardiac events within 6 months occurred in 3 patients (2.6%), including no deaths, 2 MIs, and 2 TLRs (1 patient had both an MI and TLR). Scaffold thrombosis occurred in 1 patient (0.9%).. The clinical results from 117 patients enrolled in cohort A of the multicenter FANTOM II (Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold) study demonstrate favorable 6-month outcomes of this novel device in the treatment of noncomplex coronary artery disease.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Female; Humans; Male; Middle Aged; Myocardial Infarction; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Treatment Outcome

There are limited data on the frequency of and factors associated with quantitative coronary angiography (QCA)-defined longitudinal stent deformation (LSD) in various contemporary drug-eluting stents platforms. This study sought to evaluate the predictors of LSD and its long-term clinical implication.. LSD is uncommon with contemporary drug-eluting stents, regardless of the type of stent platform. LSD is mainly associated with procedural factors, especially with additional downstream procedures which require the passage of devices through the stent. Careful manipulation of poststent imaging or procedural devices is required to prevent LSD. More data are needed to clarify the impact of LSD on clinical events.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Databases, Factual; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platinum; Prosthesis Design; Prosthesis Failure; Republic of Korea; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Several devices are available for infrainguinal endovascular therapy, with drug-eluting stents (DES) among the most promising. Bioresorbable vascular scaffolds (BVS) may further improve outcomes. We have liberally used in our practice coronary DES and BVS for infrainguinal endovascular therapy and hereby report our preliminary results. We conducted an observational study by retrospectively identifying characteristics of patients undergoing infrainguinal implantation of coronary DES or BVS. We compared the risk of major adverse events (MAE: death, amputation, or target vessel revascularization [TVR]) and components of MAE in the overall sample and after propensity matching. We included a total of 204 patients (207 limbs), 148 (72.5%) treated with DES and 56 (27.5%) with BVS. Bivariate analysis showed that TVR was less common in the DES group (41.9% vs 18.4%, P = .014). However, propensity-matched analysis showed nearly identical risks of MAE, amputation, TVR, or symptom burden with DES and BVS (all P > .05). In conclusion, the present pilot experience with coronary BVS suggests that they could provide acceptable results for infrainguinal endovascular procedures, comparable to those obtained by their metallic counterpart.

Topics: Absorbable Implants; Aged; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Retrospective Studies; Risk Factors; Sirolimus; Treatment Outcome

A 65-year-old man who underwent percutaneous coronary intervention with sirolimus-eluting stents (SESs) 2 years ago was admitted with recurrent acute chest pain. Coronary angiography showed thrombotic occlusion within the SESs. After aspiration thrombectomy, multi-focal peri-stent contrast staining (PSS) was observed. Optical frequency domain imaging (OFDI) showed intracoronary thrombus, incomplete stent apposition (ISA), and multiple inter-strut hollows. Intravascular ultrasound (IVUS) images showed positive vessel remodeling. We deployed bare-metal stents in the SESs. Follow-up angiography showed no in-stent restenosis or PSS. OFDI showed well-covered stent surface with homogeneous neointima, without ISA. Additionally, IVUS images showed that the vessel remodeling had not worsened.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Prosthesis Design; Reoperation; Sirolimus; Stents; Surgery, Computer-Assisted; Time Factors; Tomography, Optical Coherence; Ultrasonography, Interventional

To evaluate the long-term prognostic value of risk scores in the setting of drug-eluting stent (DES) implantation for uLMCA.. Data on the prognostic value of novel risk scores developed to select the most appropriate revascularization strategy in patients undergoing DES implantation for uLMCA disease are relatively limited.. The study represents a patient-level pooled analysis of the ISAR-LEFT-MAIN (607 patients randomized to paclitaxel-eluting or sirolimus-eluting stents) and the ISAR-LEFT-MAIN-2 (650 patients randomized to everolimus-eluting or zotarolimus-eluting stents) randomized trials. The Syntax Score (SxScore) as well the Syntax Score II (SS-II), the EuroSCORE and the Global Risk Classification (GRC) were calculated. The primary outcome was all-cause mortality.. At a mean follow-up of 3 years there were 160 deaths (12.7%). The death-incidence was significantly higher in the upper tertiles than in the intermediate or lower ones for all risk scores (log-rank test P < 0.01 for all comparisons). The discriminatory power of a multivariable model for prediction of 3-year mortality was significantly improved after the inclusion of EuroSCORE (adjusted area under the receiver operating characteristic (ROC) curve = 0.779, 95% confidence interval 0.747 to 0.810, P = 0.008), but not after the inclusion of SxScore, SS II, or GRC.. In patients undergoing DES implantation for uLMCA disease, all evaluated risk scores were able to stratify the mortality risk at long-term follow-up. EuroSCORE was the only risk score that significantly improved the discriminatory power of a multivariable model to predict long-term mortality. © 2016 Wiley Periodicals, Inc.

Topics: Aged; Aged, 80 and over; Area Under Curve; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Decision Support Techniques; Discriminant Analysis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Paclitaxel; Patient Selection; Percutaneous Coronary Intervention; Predictive Value of Tests; Proportional Hazards Models; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; ROC Curve; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to evaluate neointimal coverage in the very early phase after second-generation drug-eluting stent (DES) implantation using optical coherence tomography (OCT). Patients who underwent staged percutaneous coronary intervention within 30 days after DES implantation were enrolled. OCT was performed to observe DES previously implanted. The median time interval from implantation to OCT examination was 21.5 days. A total of 10,625 struts of 54 stents (52 everolimus-eluting stents and 2 zotarolimus-eluting stents) in 42 lesions were analyzed. Strut tissue coverage was observed in 71.1 ± 19.2 % of the struts, malapposed struts in 2.56 ± 3.37 %, strut tissue coverage at the side branch orifice in 10.6 ± 17.2 %, and struts with protrusion in 0.95 ± 3.46 %. Mean tissue thickness on the covered struts was 39.8 ± 14.2 µm. The percentage of stent coverage was significantly lower in the overlapping segments than in the non-overlapping segments (48.4 ± 17.5 % vs. 74.4 ± 20.2 %, P < 0.05). Most of the stent struts were covered by tissue within 30 days after second-generation DES implantation. However, the percentage of strut coverage was lower in the overlapping segments than in the non-overlapping segments, suggesting that very early interruption of dual antiplatelet therapy might result in increased risk of stent thrombosis, even in second-generation DES.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Treatment Outcome

In a number of coronary bifurcation lesions, both the main vessel and the side branch (SB) need stent coverage.. To analyze the procedural performance and the impact on radiation times (RT) and contrast medium consumption (CMC) of the Axxess™ stent system (Biosensors, Switzerland) treating de novo bifurcation lesions (DBL).. One hundred and ten consecutive prospectively enrolled cases (Axxess Group) and 110 age, sex, and lesion location matched controls undergoing mandatory (Group A, n = 56) or provisional (Group B, n = 54) SB intervention were analyzed.. Although more pre-dilatation was performed in the Axxess Group (92.7% vs. 46.4% [Group A] vs. 24.1% [Group B]), and more stents were used (2.4 vs. 1.2 vs. 1.05), RT and CMC were significantly lower in the Axxess Group [7.9 min/129 ml vs. 14.2 min/209 ml vs. 7.8 min/152 ml; P < 0.001]. Final Thrombolysis In Myocardial Infarction three flow in both branches was significantly more frequent in the Axxess Group (98.2% vs. 94.6% vs. 88.9%; P = 0.02), and post-interventional troponin T elevations were the lowest in the Axxess Group. Eighty one percent of the Axxess-stents could be implanted without technical difficulties. Difficult implantations procedures were mainly related to coronary anatomy. There was no safety concerns (cardiac death, stent-thrombosis) compared to controls. Cumulative 6-months MACE rates were 11% versus 23% versus 25%. TLR rates at 6-months were 5%, 18%, and 15%, respectively.. Axxess bifurcation stent system procedures were associated with significantly less RT and CMC compared to conventional DBL therapy strategies. Difficult coronary anatomy may hinder successful implantation and a learning curve has to be considered. © 2016 Wiley Periodicals, Inc.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Case-Control Studies; Contrast Media; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Germany; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Radiation Dosage; Radiation Exposure; Radiography, Interventional; Registries; Risk Factors; Sirolimus; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome

Endothelial shear stress (ESS) may play a key role in the pathobiology of stent restenosis (SR). Nevertheless, limited data are available about ESS and its relation to SR.. We enrolled 14 patients who underwent successful percutaneous coronary intervention (PCI) in this study. Three-dimensional (3D) reconstruction of 14 coronary arteries before and after stent implantation was performed. Using computational fluid dynamics, mean ESS was calculated proximally, in tertiles within and distal to the stent, both before and after stent implantation.. Stent implantation resulted in a significant ESS decrease in the entire atherosclerotic lesion (1.83 vs. 1.26 Pa, p = 0.02). Regarding the five territories in which the entire lesion was divided, ESS decrease was marginally significant in the area of the second in-stent tertile, and in the area 5 mm distal to the stent, whereas ESS decrease was not significant in the area 5 mm proximal to the stent, and in the area of the first and third in-stent tertile. At 12 months, two patients had SR, but restenosis was not related to ESS decrease.. ESS decreases after stent implantation but not uniformly, with the major reduction being in the middle tertile of the stent, and distal to the stent. In-stent ESS decrease may create local hemodynamic conditions leading to in-stent and in-segment restenosis.

Topics: Algorithms; Computed Tomography Angiography; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Elastic Tissue; Endothelium, Vascular; Follow-Up Studies; Hemodynamics; Humans; Hydrodynamics; Image Interpretation, Computer-Assisted; Imaging, Three-Dimensional; Patient-Specific Modeling; Percutaneous Coronary Intervention; Shear Strength; Sirolimus

It has become apparent that, in comparison to metallic stents, bioresorbable vascular scaffolds (BVS) require specific implantation techniques. The aim of this study was to investigate outcomes following BVS implantation using a dedicated strategy for optimal deployment.. Four hundred consecutive lesions (264 patients) treated with the Absorb BVS were analysed. All procedures were performed based on the following principles: 1) aggressive lesion preparation; 2) high-pressure post-dilation; and 3) a low threshold for intravascular imaging. The majority of target lesions (74.8%) were type B2 or C lesions. Predilation (97.3%) and post-dilation (99.8%) were performed in almost all cases. The mean post-dilation pressure was 21±5 atm, and the total scaffold length per patient was 53.2±32.5 mm. Intravascular imaging was performed in the majority of cases (85.8%) and, when utilised after post-dilatation, a further intervention was required in 24.5% of lesions. The cumulative target lesion failure rates were 7.9% at one year and 11.6% at two years. Definite/probable scaffold thrombosis occurred in three patients (1.2% at one and two years).. Clinical outcomes following implantation of current-generation BVS, in a real-world population with a high prevalence of complex lesions, were acceptable when utilising our optimised implantation strategy.

Topics: Absorbable Implants; Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Cohort Studies; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Treatment Outcome

Few studies have directly compared vascular responses to second-generation drug-eluting stents (DESs). We performed optical coherence tomography examinations in 56 consecutive patients with implanted single stent [19 cobalt-chromium everolimus-eluting stents (CoCr-EES), 22 platinum-chromium EES (PtCr-EES), and 15 resolute zotarolimus-eluting stents (R-ZES)] for de novo lesions, and who did not have restenosis at their 9-month follow-up. Neointimal thickness (NIT), stent apposition, and neointimal coverage were assessed in every strut. A neointimal unevenness score [(NUS), maximum NIT/average NIT in the same cross-section] was determined for every 1-mm cross-section (CS). A total of 8350 struts and 1159 CSs were analyzed. The CoCr- and PtCr-EES had significantly fewer malapposed struts compared to the R-ZES (CoCr-EES: 0.19 % vs. PtCr-EES: 0.19 % vs.. 0.61 %, p = 0.007). Furthermore, the PtCr-EES had a lower frequency of uncovered struts compared to the others (CoCr-EES: 2.0 % vs. PtCr-EES: 1.4 % vs.. 2.3 %, p = 0.047). The NUS correlated with the frequency of uncovered struts (p < 0.001, r = 0.54). The EESs demonstrated more homogenous neointimal growth, as shown in the NUS, compared to the R-ZES [CoCr-EES: 1.66 (1.38-1.97) vs. PtCr-EES: 1.67 (1.41-2.00) vs.. 1.94 (1.56-2.28), p < 0.001]. Our results demonstrate that unevenness neointimal growth may relate with strut coverage after second-generation DES implantation. The PtCr-EES had a high frequency of strut coverage with a homogeneous neointima, suggesting fewer risks for stent thrombosis.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Metals; Middle Aged; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Long-term clinical outcomes of new-generation drug-eluting stents in complex anatomic and clinical settings are not well defined. This study assessed the impact of patient and lesion complexity on 2-year outcomes after coronary revascularization with ultrathin strut biodegradable-polymer (BP) sirolimus-eluting stents (SES) versus durable-polymer (DP) everolimus-eluting stents (EES). In a prespecified analysis of the BIOSCIENCE randomized trial (NCT01443104), complex patients (911 of 2,119; 43%) were defined by the presence of acute ST-elevation myocardial infarction (MI); left ventricular ejection fraction ≤30%; renal dysfunction; insulin-treated diabetes; treatment of ostial lesion, bypass graft, unprotected left main lesion; or 3-vessel intervention. The primary end point was target lesion failure (TLF), a composite of cardiac death, target vessel MI, and clinically indicated target lesion revascularization. At 2 years, complex compared with simple patients had a greater risk of TLF (14.5% vs 7.4%, risk ratio 2.05, 95% confidence interval 1.56 to 2.69; p <0.001). The difference was sustained beyond 1 year on landmark analysis. Complex patients had higher rates of the patient-oriented composite end point of death, any MI, or any revascularization (23% vs 14.4%; p <0.001) as well as definite stent thrombosis (1.6% vs 0.4%, p = 0.006). There were no differences in TLF and patient-oriented composite end point between the BP-SES versus DP-EES, consistently among simple and complex patients. In conclusion, patient and lesion complexity had a durable adverse impact on clinical outcomes throughout 2 years of follow-up in this all-comers randomized trial. Safety and efficacy of new-generation BP-SES and DP-EES were comparable, irrespective of complexity status.

Topics: Absorbable Implants; Aged; Antibiotics, Antineoplastic; Comorbidity; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Hypoglycemic Agents; Insulin; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prognosis; Prospective Studies; Prosthesis Design; Randomized Controlled Trials as Topic; Renal Insufficiency, Chronic; Severity of Illness Index; Sirolimus; ST Elevation Myocardial Infarction; Stroke Volume; Treatment Outcome; Ventricular Dysfunction, Left

Previous studies have demonstrated that patients with small coronary artery lesions are at increased risk for late cardiac events after percutaneous coronary intervention. It remains uncertain whether second-generation drug-eluting stents have an advantage over first-generation drug-eluting stents in patients with small vessel lesions. Our aim was to compare in the 3-year clinical impact between second-generation everolimus-eluting stents (EES) and first-generation sirolimus-eluting stents (SES) in small vessel lesions. Four-hundred forty-four patients with small vessel lesions defined as reference diameter <2.5 mm were treated with EES (237 patients, 265 lesions) or SES (207 patients, 220 lesions) and completed 3-year follow-up. We compared the major adverse clinical events (MACE) between the two groups. EES had no significant impact on the MACE rate compared with SES (4.6 vs. 7.2%, p = 0.14). No significant differences were observed in the individual components of cardiac death (1.7 vs. 1.9%, p = 0.78), myocardial infarction (1.3 vs. 3.4%, p = 0.12), and ischemia-driven target lesion revascularization (2.3 vs. 4.6%, p = 0.13) in EES and SES, respectively. Stent thrombosis, however, was significantly less in the EES group than in the SES group (0.7 vs. 3.4%, HR: 0.53, 95% CI 0.38-0.88, p < 0.05). EES implantation did not significantly impact 3-year MACE rates compared to SES implantation in small vessel lesions. A significant reduction in the overall rate of stent thrombosis was observed in recipients of EES. While the SES group showed increasing rates of late and very late thrombosis, the EES group did not. EES offers a safe and effective treatment for small vessel lesions.

Topics: Aged; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Revascularization; Percutaneous Coronary Intervention; Regression Analysis; Retrospective Studies; Risk Factors; Sirolimus; Treatment Outcome

Arterial repair delays after intracoronary implantation of Cypher sirolimus-eluting stents (SES), a representative first-generation drug-eluting stent. It remains unclear whether this delay would catch up with bare metal stents (BMS) during extremely long observation. The aim of this study was angioscopic observation of extremely late arterial repair after Cypher SES implantation.. Thirty-seven SES and 17 BMS were implanted into 22 and 9 patients with angina pectoris, respectively. Duration after implantation (DAI) ranged from 3 to 10.5years in both stents. Coronary angioscopy revealed neointimal stent coverage (NSC), presence of in-stent yellow plaque (YP), and mural thrombi (MT). NSC was semi-quantified into 4 grades (grade 0, no coverage; grade 1, thin coverage; grade 2, thick coverage; grade 3, fully embedded into neointima).. In the BMS-implanted lesions (BMSL), NSC was either grade 1 (24%) or grade 3 (74%), with rare YP and no MT. In the SES-implanted lesions (SESL), NSC was various, i.e. grade 0 (5%), grade 1 (59%), grade 2 (22%), and grade 3 (14%). YP and MT were observed in 27 and 24% of in SESL, respectively. In SESL with DAI>8years (n=5), NSC was either grade 1 (40%) or grade 3 (60%), although YP and MT were more frequently observed (60 and 40%, respectively).. Arterial repair after SES implantation caught up with BMS at around 8years with regards to NSC, although prevalence of YP and MT remained still greater in SESL than BMSL at extremely late phase.

Topics: Aged; Aged, 80 and over; Angioscopy; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Self Expandable Metallic Stents; Sirolimus; Time Factors; Treatment Outcome

Kissing-balloon technique (KBT) is commonly performed during percutaneous coronary intervention of distal unprotected left main coronary artery (ULM) aiming at obtaining optimal opening of the side branch (left circumflex artery; LCX) ostium. Nonetheless, detailed evaluation of vascular response to stents in LCX ostium is lacking. We therefore evaluated the vascular response to different drug-eluting stents (DES) in ostial LCX after ULM by means of optical coherence tomography (OCT).. We prospectively enrolled 38 consecutive patients with ULM disease, who were treated with single-stent procedure using DES, crossover the ULM-left anterior descending artery (LAD) followed by KBT. Twelve patients were treated with sirolimus-eluting stents (SES) and 26 patients were treated with everolimus-eluting stents (EES). OCT was conducted at post-PCI and 9-month follow-up. We evaluated the DES-vessel interactions and number of stent struts at the side branch (LCX) ostium (SO) at post-PCI, and compared the narrowing of ostial area at LCX between SES and EES.. Post-procedure, the number of stent struts at SO was significantly higher in SES compared to EES (median 14.47% vs 0.19%, p<0.001). The narrowing of LCX ostial area at follow-up was more pronounced in SES compared with EES (29.16% vs 2.46%, respectively, p<0.001). Linear regression analysis showed a high correlation between the number of stent struts in LCX ostium and ostial area narrowing (r=0.771, p<0.001).. OCT showed differences between EES- and SES-vessel interactions at ULM bifurcation PCI. Number of LCX ostium struts at post-PCI impacted the narrowing of ostial area at 9-month follow-up.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular Resistance

Efficacy and safety data on biodegradable polymer-coated biolimus-eluting stent (BP-BES) are currently limited to 5 years. We evaluated longer term (8-10 years) clinical and angiographic outcomes after BP-BES implantation.. Between 2005 and 2008, 243 patients (301 lesions) underwent BP-BES implantation. The primary clinical outcome measure was defined as any target lesion revascularisation (TLR). Absolute serial angiographic studies without any concomitant TLR within 2 years after the procedure were performed in 55 patients (65 lesions) at postprocedure, mid-term (within 1 year), late term (between 1 and 2 years) and very late term (beyond 2 years).. The median follow-up duration was 9.4 years (IQR 8.2-10.2 years). The 8-year cumulative incidence of any TLR was 20.3%. The increase rate was approximately 7% per year in the first 2 years, but decelerated to approximately 1.2% per year beyond 2 years after the procedure. The minimal lumen diameter significantly decreased from postprocedure (2.63±0.44 mm) to mid-term (2.43±0.59 mm, p=0.002) and from late term (2.27±0.63 mm) to very late term (1.98±0.73 mm, p=0.002). The 8-year cumulative incidences of definite or probable stent thrombosis (ST) and major bleeding (Bleeding Academic Research Consortium (BARC) ≥3) were 0.5% and 12.0%, respectively. Definite ST was none within 10 years in the entire cohort.. The long-term clinical outcomes after BP-BES implantation were favourable, although angiographic late progression of luminal narrowing did not reach a plateau. The incidence of ST remained notably low, whereas that of major bleeding gradually increased.

Topics: Absorbable Implants; Aged; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Forecasting; Humans; Immunosuppressive Agents; Male; Myocardial Revascularization; Polymers; Prosthesis Design; Retrospective Studies; Sirolimus; Treatment Outcome

The authors evaluated the 5-year cumulative incidence of cardiovascular events following Resolute zotarolimus-eluting stent (R-ZES) implantation.. Individual trials are often underpowered to show differences for low-frequency adverse events. The R-ZES was studied in 10 prospective clinical trials, designed with identical adverse event definitions, ascertainment, and adjudication.. The RESOLUTE Global Clinical Trial Program includes 7,618 patients treated with R-ZES: RESOLUTE first-in-human study (N = 139), RESOLUTE All Comers (N = 1,140), RESOLUTE International (N = 2,349), RESOLUTE US (N = 1,402), RESOLUTE US 38 mm (N = 114), RESOLUTE Japan (N = 100), RESOLUTE Japan Small Vessel Study (N = 65), RESOLUTE Asia (N = 311), RESOLUTE China Randomized Controlled Trial (N = 198), and RESOLUTE China Registry (N = 1,800). The 5-year cumulative incidence of events was calculated.. The 5-year cumulative incidence of cardiac events was 13.4% for target lesion failure and included 5.0% cardiac death, 4.4% target vessel myocardial infarction, and 6.3% clinically driven target lesion revascularization. Dual-antiplatelet therapy at 1, 3, and 5 years was 91%, 37%, and 32%, respectively. The 5-year cumulative incidence of definite or probable stent thrombosis was 1.2%, which comprised 0.7% at 1 year and an annualized rate of 0.1% thereafter. Five-year use of dual-antiplatelet therapy varied geographically from 63% in Japan to 11% in Europe.. In the largest group of R-ZES patients examined to date, the majority of stent-related events, including target vessel myocardial infarction and stent thrombosis, occurred within the first year of implantation with much lower risks of these events out to 5 years.

Topics: Aged; Asia; Australia; Cardiovascular Agents; Clinical Trials as Topic; Coronary Artery Disease; Coronary Thrombosis; Drug Therapy, Combination; Drug-Eluting Stents; Europe; Evidence-Based Medicine; Female; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; North America; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Risk Factors; Sirolimus; South America; Time Factors; Treatment Outcome

The safety and efficacy of the second-generation biodegradable polymer Cobalt-Chromium sirolimus-eluting stent (EXCEL2) in daily clinical practice remains unknown. Additionally, to meet the China Food and Drug Administration requirements, we conducted an objective performance criterion study from the CREDIT II and CREDIT III trials.. CREDIT II was a randomized trial comparing the EXCEL2 versus EXCEL stent in patients with up to 2 de novo coronary lesions. CREDIT III was a prospective, single-arm study evaluating the efficacy and safety of EXCEL2 in broad types of de novo coronary artery lesions. This pooled analysis included patients in the CREDIT III and EXCEL2 arm of the CREDIT II trial. The primary outcome was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinical indicated target lesion revascularization (CI-TLR). The patient-oriented composite endpoint (PoCE) of all-cause death, all MI, or any revascularization was also analyzed.. A total of 833 patients were included, consisting of 625 in the CREDIT III trial and 208 in the EXCEL2 arm of the CREDIT II trial. Twelve-month TLF occurred in 6.1% patients, cardiac death in 0.4%, TV-MI in 5%, and CI-TLR in 1.1%. Additionally, 64 (7.7%) PoCE and 3 probable late stent thromboses (0.4%) were recorded.. EXCEL2 stent met the objective performance criterion on efficacy and safety with a low level of 12-month TLF as well as stent thrombosis when treating patients with de novo coronary lesions. © 2017 Wiley Periodicals, Inc.

Topics: Absorbable Implants; Adult; Aged; Cardiovascular Agents; China; Chromium Alloys; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Proportional Hazards Models; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Implantation of mammalian target of rapamycin (mTOR)-inhibitor drug-eluting stents (DESs) impairs coronary endothelial function. There are no known non-invasive biomarkers of coronary endothelial dysfunction. We aimed to assess the association between serum interleukin-1beta (IL-1β) and coronary endothelial dysfunction in patients with mTOR-inhibitor DES implantation and to investigate the association between the mTOR pathway and IL-1β. We enrolled 35 patients who had implanted DESs for coronary artery disease. At a 10-month follow-up, peripheral venous blood samples were collected to measure IL-1β levels. Coronary endothelial dysfunction was evaluated by intracoronary infusion of incremental doses of acetylcholine. Serum IL-1β levels were significantly associated with the magnitude of vasoconstriction to acetylcholine at the segment distal (P < 0.05) but not proximal to the stent. Serum IL-1β levels were positively correlated with stent length (P < 0.05). To examine the direct effects of mTOR inhibition on IL-1β release, sirolimus was incubated in cultured human umbilical vein endothelial cells (HUVECs) or coronary artery smooth muscle cells (CASMCs). Sirolimus directly increased IL-1β mRNA expression (P < 0.01) and enhanced IL-1β release into the culture media (P < 0.01) in CASMCs, but not in HUVECs. Inhibition of mTOR triggers IL-1β release through transcriptional activation in CASMCs. Serum IL-1β levels are a potential biomarker for mTOR-inhibitor DES-associated coronary endothelial dysfunction.

Topics: Aged; Biomarkers; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Endothelium, Vascular; Female; Humans; Interleukin-1beta; Japan; Linear Models; Male; Percutaneous Coronary Intervention; Sirolimus; TOR Serine-Threonine Kinases; Vasoconstriction

To compare the 1-year outcomes of a durable polymer Zotarolimus-eluting stent (ZES) versus a biodegradable polymer Biolimus-eluting stent (BES) in patients undergoing percutaneous coronary intervention.. A total of 2083 patients from 2 different registries, 1125 treated with BES in NOBORI registry and 858 received ZES in CONSTANT registry were included in this study. Clinical outcomes were compared with the use of propensity score matching (PSM). The primary endpoint was a composite of major adverse cardiovascular and cerebrovascular events (MACCEs) including cardiac death, myocardial infarction, clinically driven target lesion revascularization and stroke. Secondary end points were individual components of MACCEs as well as the incidence of stent thrombosis at 1-year follow-up.. After PSM, 699 matched pairs of patients (n=1398) showed no significant difference between BES and ZES in the risk of composite MACCEs at 1 year (2.6% vs. 1.7%; p=0.36). Cardiac death was not statistically different between groups (0.7% vs. 0.4%, p=0.73). Target lesion revascularization rate was also similar between BES and ZES (1.1% vs. 0.7%, p=0.579). Non-Q wave myocardial infarction, as well as target-vessel revascularization rate, was similar between the two groups (0.14% for BES and 0.72% for ZES). Both stent types were excellent with no cases of stent thrombosis and rate of Q wave myocardial infarction reported during the follow-up period.. In this cohort of patients treated with BES or ZES, the rate of MACCEs at 1 year was low and significantly not different between both groups.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Propensity Score; Registries; Sirolimus; Time Factors; Treatment Outcome

A recent OCT study revealed that the lack of stent strut endothelial coverage is associated with late stent thrombosis after drug-eluting stent implantation. However, the sequential changes of stent strut endothelial coverage in the extremely early period have never been reported. Serial OCTs were performed in 35 patients with 35 EES (everolimus-eluting stent)-treated de novo lesions at 0, 2, 4, and 12 weeks after EES implantation. Serial changes in quantitative parameters of the neointima (neointimal thickness, stent strut coverage, and apposition of each strut) were analyzed. Mean neointimal thickness significantly increased from 35.9 to 51.8 and 108.2 μm at 2, 4, and 12 weeks, respectively (p < 0.001 for all), and the percentage of uncovered stent struts significantly decreased from 74.7 to 19.5% and 0.4% (p < 0.001, respectively). There was no stent malapposition at 4 weeks compared with immediate post-intervention (0 vs. 5.4 %, p = 0.031). This OCT study demonstrates that neointimal coverage of stent struts progresses to about 80 % and malapposition of stent struts completely disappears at 4 weeks after EES implantation. In addition, neointimal coverage of stent struts was almost complete within 12 weeks.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Thrombosis; Tomography, Optical Coherence

Topics: Absorbable Implants; Animals; Area Under Curve; Biocompatible Materials; Coronary Artery Disease; Coronary Vessels; Drug Delivery Systems; Drug-Eluting Stents; Finite Element Analysis; Humans; Microscopy, Electron, Scanning; Patient Safety; Polymers; Sirolimus; Stents; Swine; Thrombosis

Immediately after stent/scaffold implantation, quantitative coronary angiography (QCA) in comparison to optical coherence tomography (OCT) more severely underestimates the lumen diameter (LD) in Absorb than in XIENCE. This OCT-QCA discrepancy has not been evaluated at long-term follow-up. The present study aimed to assess the accuracy of QCA with reference to OCT in Absorb as compared to XIENCE.. We assessed two-year QCA and OCT in the ABSORB Japan randomised trial (Absorb n=87, XIENCE n=44). The accuracy of QCA parameters was assessed with reference to OCT measurements. OCT-QCA luminal dimensions were compared in matched cross-sections at both edges of the scaffolds (n=127) and stents (n=78). OCT-QCA late lumen loss (LLL) was also assessed using the Bland-Altman method. The systematic error of LD on QCA in Absorb was -0.092 mm (relative difference -3.3%) with a random error of 0.473 mm, whereas in XIENCE the systematic error was -0.018 mm (-0.5%) with a random error of 0.477 mm. These OCT-QCA discrepancies did not differ between Absorb and XIENCE (p=0.275) at two-year follow-up. QCA tended to underestimate LLL more in Absorb than in XIENCE (QCA-LLL minus OCT-LLL: -0.180±0.308 mm vs. -0.058±0.322 mm, p=0.058) at two-year follow-up, although this comparison was not statistically powered.. The two-year dimensional measurements on QCA had minor and insignificant systematic errors between both devices. A discrepancy between QCA-LLL and OCT-LLL would raise a question as to whether this parameter is appropriate for the comparative assessment of device performance.

Topics: Absorbable Implants; Cardiovascular Agents; Chromium; Cobalt; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus

Topics: Coronary Artery Bypass; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome

Topics: Coronary Artery Bypass; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome

Topics: Coronary Artery Bypass; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome

This INDOLIMUS Registry sought to evaluate the safety and efficacy of the biodegradable polymer coated Indolimus(®) sirolimus-eluting coronary stent for the treatment of coronary artery disease across a wide range of patients treated in routine clinical practice, including those with high-risk characteristics and complex lesions.. First-generation drug-eluting stents utilize nonbiodegradable polymeric coatings, whose persistent presence in the arterial wall may negatively affect long-term outcomes. It has been hypothesized that persistent presence of polymer may compromise the safety of drug-eluting stents, and that therefore biodegradable polymer coatings might reduce late adverse events in an unselected patient population.. All 530 consecutive unselected patients (415 males and 115 females) included who underwent percutaneous coronary intervention at the Sri Venkateswara Institute of Medical Sciences, Tirupati, India between August 2012 and March 2013, with an in-hospital, at 30-days and at 6-months follow-up. Retrospective analysis of those data had been done.. A total of 617 lesions were treated in 530 enrolled patients (mean age 54.9 ± 10.8 years) with average stent length of 18.8 ± 6.0 mm. An average of 1.18 stents was implanted per patient. The patients' characteristics are noted as having 169 (31.9%) patients of diabetics and 215 (40.6%) hypertension. Smoking, alcoholism and tobacco chewing were found in 273 (51.5%), 130 (24.5%) and 17 (3.2%), respectively. The indications for intervention were unstable angina in 77 (14.5%) and previous myocardial infarction in 56 (10.6%) of the patients. Lesions were of type B2 in 264 (42.7%) and type C in 127 (20.6%). Stent delivery was successful in all cases and in-hospital, 30-days and 6-months follow-up of all 530 patients was obtained. The incidence of any major adverse cardiac events at in-hospital, at 30-days and at 6-months were 5 (0.94%), 8 (1.52%), and 18 (3.40%), respectively. Long term follow-up of this registry is ongoing to confirm safety and efficacy profiles.. The relatively low event rate that was observed in INDOLIMUS Registry indicates that the biodegradable polymer coated Indolimus(®) sirolimus-eluting coronary stent can achieve excellent clinical performances in a large group of patients. © 2013 Wiley Periodicals, Inc.

Topics: Absorbable Implants; Adult; Aged; Cardiovascular Agents; Chromium Alloys; Coronary Artery Disease; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; India; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Registries; Retrospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To evaluate the rate of clinical events and bleeding risk according to age in patients undergoing percutaneous coronary intervention (PCI) with a new-generation drug-eluting stent (DES) enrolled in the RESOLUTE Global Clinical Program.. This study represents a pooled analysis of five trials included in the RESOLUTE program including 5,130 patients, of whom 1,675 (32.6%) were ≥70 years old (elderly patients).. After adjusting for confounders, age ≥70 years was a significant predictor of high mortality at 30 days (0.6 vs. 0.1%, P = 0.017) and 2 years (7.2 vs. 2%, P < 0.001). No differences were seen with respect to acute myocardial infarction (MI) or target lesion and vessel revascularization rates between young and elderly patients. Bleeding rates were higher in the elderly throughout follow-up. In the elderly, 7 of the 27 (26%) patients with bleeding episodes died, with a median time between bleeding episode to death of 21 days. In the younger population, 1 patient of 17 with a bleeding episode died (400 days later).. Elderly patients undergoing PCI with a new-generation DES have increased mortality and bleeding risk, with similar rates of acute MI and repeat revascularization. Bleeding risk was higher in the elderly and strongly related to death. Target lesion failure rates were not significantly different between the two age groups, suggesting that the Resolute zotarolimus-eluting stent (R-ZES) is effective for patients younger and older than 70 years of age. R-ZES may be recommended for elderly patients when PCI with a DES is identified as a suitable option.

Topics: Age Factors; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Observational Studies as Topic; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The external lumen of a stent [defined as extra-stent lumen (ESL)] assessed by optical coherence tomography (OCT) may be related to the risk of thrombus formation after sirolimus-eluting stent (SES) implantation. An everolimus-eluting stent (EES) might provide relatively minimal inflammatory reaction and appropriate neointimal coverage. The purpose of this study was to compare the neointimal thickness and ESL between SES and EES. Patients who underwent OCT examination more than 7 months after either SES or EES implantation were enrolled. Stent area (SA), lumen area (LA), neointimal area (NIA) and neointimal thickness (NIT) of each strut were measured at 1-mm intervals between stented segments. The area, angle (summation per cross-section) and depth (maximum distance from adjacent vessel surface to the outline of stent) of ESL were analyzed. A total of 49 lesions were included (SES n = 20, EES n = 29). Mean follow-up period was 11 months. A total of 998 cross-sections and 9874 struts were analyzed. There were no differences in stent area, lumen area and neointimal area (SA: 6.01 ± 1.60 vs. 6.02 ± 1.40 mm(2), p = 0.572, LA: 5.37 ± 1.52 vs. 5.29 ± 1.34 mm(2), p = 0.692, NIA: 0.64 ± 0.49 vs. 0.72 ± 0.37 mm(2), p = 0.493). Mean NIT of SES and EES were 0.11 ± 0.05 and 0.10 ± 0.05 mm, respectively (p = 0.367). Conversely, area, angle and depth of ESL in SES group were significantly greater than those in EES group (0.20 ± 0.39 vs. 0.03 ± 0.09 mm(2), p < 0.001, 56.2 ± 59.1° vs. 20.1 ± 41.9°, p < 0.001, 0.10 ± 0.09 vs. 0.03 ± 0.03 mm, p < 0.001). OCT showed that the efficacy of neointimal growth suppression is similar between SES and EES, whereas the adverse vascular response after EES implantation is smaller than that after SES implantation.

Topics: Adult; Aged; Aged, 80 and over; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Sirolimus; Time Factors; Tomography, Optical Coherence

We aimed to assess the safety and performance of a novel sirolimus-eluting stent with biodegradable polymer under real-world conditions.. This prospective, multicentre, observational, all-comers registry enrolled 1,356 patients. The primary endpoint was target lesion failure at 12 months: it occurred in 5.1% (95% CI: 4.0-6.4) of patients in the overall population and in 7.7% (95% CI: 5.5-10.9), 5.8% (95% CI: 4.2-8.1), 1.8% (95% CI: 0.2-11.8) and 7.2% (95% CI: 5.1-10.0) of patients with diabetes mellitus, small vessels, chronic total occlusion and acute myocardial infarction, respectively.. This novel stent platform demonstrated good clinical outcomes in an all-comers population, even in predefined high-risk groups. ClinialTrials.gov identifier: NCT01553526

Topics: Absorbable Implants; Adult; Aged; Cardiovascular Agents; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Treatment Outcome

Chronic kidney disease (CKD) is an important risk factor for coronary artery disease (CAD) and cardiovascular events. Cystatin C (CysC) has been proposed as a sensitive marker for CKD. However, the predictive value of CysC for cardiovascular events in CAD patients with preserved estimated glomerular filtration rate (eGFR) is unclear. We enrolled 277 consecutive patients undergoing elective percutaneous coronary intervention with sirolimus-eluting stents (SES). Patients with an eGFR ≤60 ml/min/1.73 m(2) were excluded. Serum CysC levels were measured immediately before SES implantation. Major adverse cardiac and cerebrovascular events (MACCE) were defined as cardiovascular death, acute coronary syndrome, stroke, and hospitalization because of congestive heart failure. After a median follow-up of 63 months, 29 patients had MACCE. The subjects were divided into 2 groups based on median serum CysC levels and eGFR (0.637 mg/L and 72.43 ml/min/1.73 m(2), respectively). Kaplan-Meier curves showed that the high CysC group had a significantly higher occurrence of MACCE than the low CysC group (p = 0.006), although a low level of eGFR was not significantly associated with an increased risk for occurrence of MACCE. Multivariate analysis revealed that serum CysC levels were an independent predictor of MACCE [hazards ratio: 1.30 per 0.1 mg/L (1.01-1.63), p = 0.038]. These data suggested that serum CysC level is an independent predictor of MACCE, even in patients with preserved eGFR after elective SES implantation.

Topics: Acute Coronary Syndrome; Aged; Biomarkers; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Cystatin C; Drug-Eluting Stents; Female; Glomerular Filtration Rate; Heart Failure; Humans; Kaplan-Meier Estimate; Kidney; Male; Middle Aged; Multivariate Analysis; Percutaneous Coronary Intervention; Proportional Hazards Models; Renal Insufficiency, Chronic; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Stroke; Time Factors; Treatment Outcome; Up-Regulation

The main aim of the CORE Registry was to evaluate clinical performance of the Supralimus-Core® biodegradable polymer-coated sirolimus-eluting cobalt-chromium stent (Sahajanand Medical technologies Pvt. Ltd., Surat, India) in unselected real-world patients.. This was a multicenter, retrospective, non-randomized, single-arm study. A total of 376 consecutive patients treated with the Supralimus-Core® between April 2010 and June 2014 were enrolled. The primary-end point of the registry was major adverse cardiac events (MACE), which is a composite of cardiac death, target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI) and stent thrombosis (ST). Clinical follow-up were scheduled at 30-day and 6-month.. The mean age of enrolled patients was 54.6±10.3 years. A total of 444 lesions were treated successfully with 457 stents (1.0±0.2 per lesion). The average stent length and diameter was 24.0±8.0 mm and 3.0±0.33 mm, respectively. Out of total patients, 300 (79.8%) were male. Diabetes, hypertension and chronic totally occluded lesions were found in 95 (25.3%), 102 (27.1%) and 125 (28.2%) patients, respectively, reflecting high-risk patients involvement. The incidence of MACE at 30-day and 6-month was found to be in 4 (1.1 %) and 4 (1.1%) patients, respectively. The TLR and ST was found in 1 (0.3 %) and 1 (0.3 %) patient respectively at 6-month follow-up.. The lower incidence of MACE, TLR and ST clearly delineates safety and efficacy of Supralimus-Core sirolimus-eluting stent in "real-world" patients with complex coronary lesions.

Topics: Adult; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Polymers; Prosthesis Design; Registries; Retrospective Studies; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

A 70-year-old man underwent stent implantation for right coronary artery (RCA) lesions with a bare metal stent (BMS) and two sirolimus-eluting stents (SES). However, as both the BMS and SES stented sites developed restenosis after 13 months, he underwent target lesion revascularization using directional coronary atherectomy (DCA). On histopathology, the restenosis lesion at the SES-deployed site showed greater inflammation and less re-endothelialization than that at the BMS-deployed site. Three months later, the SES-deployed site developed a second restenosis, in which paclitaxel-eluting stents (PES) were implanted (PES-in-SES), while the BMS-deployed site was restenosis free. Five years later, restenosis was absent in these RCA lesions. However, by optical coherence tomography and/or coronary angioscopy, the PES-in-SES site in the RCA showed poor neointimal coverage over the stent struts and yellowish neointima, suggesting lipid-rich neoatheroma formation, whereas at the BMS site appropriate white neointima formation was observed. Drug-eluting stents still have problems of persistent inflammation, inappropriate neointima formation, and neoatherosclerosis. Although we are now in the era of second generation DESs in which better stent performance would be promising, we should remember that we are obliged to continue to follow-up all patients in whom first generation DESs such as SES or PES have been placed.

Topics: Aged; Angioscopy; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Immunohistochemistry; Male; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Retreatment; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

Diabetes mellitus has worse outcome after percutaneous coronary intervention.. We assessed stent thrombosis (ST), major adverse cardiac events (MACE), and major bleeding rates at 1 year after implantation of sirolimus-eluting stents (SES) in patients with diabetes mellitus in a large multicenter registry.. From May 2006 to April 2008, 15,147 unselected consecutive patients were enrolled at 320 centers in 56 countries in a prospective, observational registry after implantation of ≥ 1 SES. Source data were verified in 20% randomly chosen patients at > 100 sites. Adverse events were adjudicated by an independent Clinical Event Committee.. Complete follow-up at 1 year was obtained in 13,693 (92%) patients, 4,577 (30%) of whom were diabetics. Within diabetics, 1,238 (9%) were insulin-treated diabetics (ITD). Diabetics were older (64 vs. 62 years, P < 0.001), with higher incidence of major coronary risk factors, co-morbidities, and triple-vessel coronary artery disease. Coronary lesions had smaller reference vessel diameter (2.88 ± 0.46 vs. 2.93 ± 0.45 mm, P < 0.001) and were more often heavily calcified (26.1% vs. 22.6%, P < 0.001). At 1 year, diabetics had higher MACE rate (6.8% vs. 3.9%, P < 0.001) driven by ITD (10.6% vs. 5.5%, P < 0.001). Finally, diabetics had significant increase in ST (1.7% vs. 0.7%, P < 0.001), principally owing to ITD (3.4% vs. 1.1%, P < 0.001). There was an overall low risk of major bleeding during follow-up, without significant difference among subgroups.. In the e-SELECT registry, diabetics represented 30% of patients undergoing SES implantation and had significantly more co-morbidities and complex coronary lesions. Although 1-year follow-up documented good overall outcome in diabetics, higher ST and MACE rates were observed, mainly driven by ITD. © 2015 Wiley Periodicals, Inc.

Topics: Coronary Angiography; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Follow-Up Studies; Global Health; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Percutaneous Coronary Intervention; Postoperative Complications; Prospective Studies; Registries; Retrospective Studies; Sirolimus; Time Factors

We aimed to evaluate the long-term safety and efficacy of the STENTYS self-apposing paclitaxeleluting stent (STENTYS-PES) in bifurcation lesions in routine clinical practice.. The primary endpoint of the study was the composite major adverse cardiac events (MACE: cardiac death, myocardial infarction, clinically driven target lesion revascularisation, or emergent bypass surgery) assessed at six months after enrolment. This was reported in 21 patients (10.1%), mainly due to clinically driven target lesion revascularisation (TLR). At 12 months, 27 patients experienced MACE (13.0%).. The long-term results of OPEN II show that the STENTYS-PES is safe and effective in the treatment of all-comers with coronary bifurcation lesions.

Topics: Aged; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Risk Factors; Sirolimus; Time; Treatment Outcome

Very late stent thrombosis (VLST) is a serious complication after percutaneous coronary intervention. However, the best therapy for VLST with late-acquired incomplete stent apposition and incomplete neointimal coverage remains unknown. In these cases, neointimal coverage was nearly complete and no late-acquired malapposition was detected at 18 months after Endeavor zotarolimus-eluting stent (ZES) implantation for the treatment of VLST with late-acquired incomplete stent apposition after sirolimus-eluting stent implantation. We presented that Endeavor ZES implantation may become an attractive therapeutic strategy for the treatment of VLST with late-acquired incomplete stent apposition and incomplete neointimal coverage.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Thrombectomy; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Our objective was to clarify whether thrombogenic problems with stent struts are resolved at 3 months after 2nd-generation drug-eluting stent implantation. Twenty-one patients with stable angina pectoris having 28 (22 zotarolimus-eluting, 6 everolimus-eluting) stents with optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) were evaluated. Stent strut coverage and malapposition were evaluated by OCT immediately after PCI and at 3-month follow-up. Acute strut malapposition was observed in 26 out of 28 analyzed stents (92.9 %). At 3-month follow-up, 7 (26.9 %) of those 26 stents with strut malapposition were completely resolved, and the mean percentages of uncovered struts and malapposed struts were 8.3 and 2.0 % when analyzed by each individual stent. When analyzing a total of 30,060 struts, 807 struts (2.7 %) demonstrated acute strut malapposition. Among these, 219 struts (27.1 %) demonstrated persistent strut malapposition. On the basis of receiver-operating characteristic curve analysis, a strut-to-vessel (S-V) distance ≤160 µm on post-stenting OCT images was the corresponding cutoff point for resolved malapposed struts (sensitivity 78.1 %, specificity 62.8 %, area under the curve 0.758). The S-V distance of persistent malapposed struts on post-stenting OCT images was longer than that of resolved malapposed struts (235 ± 112 vs. 176 ± 93 µm, p < 0.01). At 3 months after PCI, the prevalence rates of uncovered and malapposed struts were relatively low in 2nd-generation drug-eluting stent. Our results suggest that OCT-guide PCI with an S-V distance ≤160 µm may be recommended especially in patients with planed short-term DAPT.

Topics: Aged; Aspirin; Clopidogrel; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Sirolimus; Thrombosis; Ticlopidine; Tomography, Optical Coherence

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Myocardial Infarction; Sirolimus; Stents; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Platelet Aggregation Inhibitors; Sirolimus

We aimed to clarify the differences in vessel healing after stenting of bifurcation lesions using sirolimus-eluting stents (SESs) or everolimus-eluting stents (EESs).. Japanese Registry Study in Comparison Between Everolimus-Eluting Stent and Sirolimus-Eluting Stent for the Bifurcation Lesion (J-REVERSE) is a prospective multicentre registry of 303 bifurcation lesions that were treated with provisional SES or EES with or without final kissing inflation. The first 115 lesions at selected study sites were predefined for inclusion in the optical coherence tomography (OCT) substudy, and 9-month follow-up OCT was conducted in 64 lesions (SES, n = 18; EES, n = 46). In addition to standard OCT parameters, stent eccentricity index (SEI; minimum divided by the maximum stent diameter), neointimal unevenness score (NUS; maximum neointimal thickness in the cross-section [CS] divided by the average neointimal thickness [NIT] of the same CS; uniformity of the neointima suppression) were averaged for each segment (proximal, bifurcation, and distal segments).. Overall, the average stent and luminal area, NIT, and frequency of uncovered struts were similar. The frequency of malapposed struts and SEI were significantly lower in the EES group than in the SES group. The EES group had a significantly smaller NUS in the proximal and distal segments.. EESs offer homogeneous vessel healing with less malapposition in the treatment of bifurcation lesions.

Topics: Aged; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Time Factors; Tomography, Optical Coherence

To compare the long-term clinical outcomes between Resolute zotarolimus-eluting stent (R-ZES) and paclitaxel-eluting stent (PES) in patients with small coronary artery disease.. Patients with a small vessel diameter are independently associated with increased risk of adverse cardiac events after drug-eluting stent implantation.. A cohort of 265 patients treated with R-ZES (185 patients with 211 lesions) or PES (80 patients with 100 lesions) in small vessel (≤2.5 mm) lesions were retrospectively analyzed. The primary end point of the study was the composite of major adverse cardiac events. The secondary end points included target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis at 3 years.. The baseline characteristics were similar between the 2 groups. In the R-ZES group, the mean stent diameter was smaller and the total stent length per lesion was longer. Major adverse cardiac events occurred in 8 (10%) patients who had received PES and in 7 (3.8%) patients who had received R-ZES (P = .07). The rates of 3-year TLR (2.2% vs 2.5%; P = 1.00) and TVR (5.4% vs 10.0%; P = .17) showed no statistically significant difference between the R-ZES and PES groups. The rate of stent thrombosis was 0.5% in the R-ZES group and 2.5% in the PES group (P = .21).. The rates of major adverse cardiac events and cardiac death were similar in the R-ZES-treated group compared with the PES-treated group.

Topics: Adult; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Retrospective Studies; Risk Factors; Sirolimus; Treatment Outcome

Little is known about the very late-phase morphological vessel characteristics within the sirolimus-eluting stent (SES).. We assessed a total of 12 patients with 15 SES implantations who underwent repeat angiographic and angioscopic procedures after 5 and 7 years. The degree of neointimal stent coverage (NSC) was classified as follows: grade 0, uncovered struts; grade 1, visible struts through a thin neointima; or grade 2, invisible struts with complete neointimal coverage. The maximum and minimum NSC grades were evaluated and the existence of in-stent thrombus was also recorded for all patients. The prevalence of a maximum NSC grade of 2 increased and that of a minimum NSC grade of 0 decreased, although there was no significant difference in prevalence between 5 and 7 years. One of four in-stent thrombus identified at 5 years had disappeared from 5 to 7 years and a new thrombus was found in another patient at 7 years. Thus, the incidence of in-stent thrombus did not change from 5 to 7 years. In one case, a thrombus was observed inside the angiographic aneurysmal change, but none of the thrombi were related to adverse events.. This angioscopic study reported gradual arterial repair and continuous delayed healing associated with subclinical thrombus formation 7 years after SES deployment.

Topics: Aged; Angioscopy; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Neointima; Reproducibility of Results; Retrospective Studies; Sirolimus; Time Factors; Tunica Intima

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Platelet Aggregation Inhibitors; Sirolimus

Topics: Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Myocardial Infarction; Sirolimus; Treatment Outcome

Second-generation drug-eluting stents (DESs) have shown higher safety and efficacy compared with first-generation DESs. This effect was achieved by improving biocompatibility using an interalia cobalt-chromium construction, thinner stent struts and biodegradable polymers.. To assess clinical and angiographic outcomes of patients receiving a novel second-generation cobalt-chromium sirolimus-eluting stent.. A total of 424 consecutive patients who received an Alex stent were enrolled in the registry from January to December 2012. The primary outcome measure was the occurrence of 12-month major cardiac adverse events, defined as cases of death, nonfatal myocardial infarction and target lesion revascularization. Quantitative coronary angiography for 240 randomly selected patients was performed by an independent Corelab.. The primary endpoint occurred in 31 of 424 patients (7.3%). The rates of death, nonfatal myocardial infarction and target lesion revascularization were 3.3, 2.6 and 3.5%, respectively. According to the definition established by the Academic Research Foundation, definitive and probable stent thrombosis (ST) occurred in 1.6% (7/424) of patients, including six cases of early ST and one case of late ST. The acute device success rate was 98.5%.. The ALEX Registry provides evidence for the safety and effectiveness of the study device in a relevant population. Quantitative analysis showed a satisfactory performance of the study device for complex coronary lesions. The 12-month rates of major cardiac adverse event and ST were similar to those of other second-generation DES registries.

Topics: Absorbable Implants; Aged; Angina, Stable; Angina, Unstable; Antibiotics, Antineoplastic; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Ischemia; Percutaneous Coronary Intervention; Polymers; Registries; Sirolimus; Treatment Outcome

Drug-eluting stents (DES) have been shown to reduce the rate of acute complications and the need for subsequent revascularization in cases where single-vessels are treated. The performance of DES in patients with multivessel disease and complex lesions, however, remains controversial. This study assessed and compared clinical outcomes following single vs. multivessel percutaneous coronary intervention (PCI), using the Supraflex sirolimus-eluting stent (SES), in an all-comers patient population.. We conducted retrospective, multicenter, all-comers, observational study of 995 patients, who underwent either single-vessel PCI (n=769 patients; group-I) or multivessel PCI (n=226 patients; group-II), treated with the biodegradable polymer coated Supraflex SES, between July-2013 and May-2014 at nine different centers in India. Pre-specified primary endpoint, rate of major adverse cardiac events (MACE) [defined as composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and non-target lesion target vessel revascularization (non-TL TVR)], was analyzed during 12 months after the post-index procedure. We also analyzed the incidence of stent thrombosis (ST) as a safety endpoint during the follow-up period, as defined by the Academic Research Consortium (ARC).. Of the whole study group, 1,242 lesions were treated in 995 patients (mean age 61.6±10.8 years; 80.0% male) with average stent length of 26.8±9.3 mm. Multivessel PCI patients were older, had a higher prevalence of arterial hypertension, were smoker, had a family history of coronary artery disease, previous stroke and previous PCI compared to single-vessel PCI patients. Follow-up was available in 99.0% (761/769) of patients with single-vessel intervention and 96.9% (219/226) of patients with multivessel intervention at the end of 12 months. In-hospital MACE was similar for both the groups [group-I, 3 (0.4%) vs. group-II, 1 (0.4%); p=1.000]. The observed MACE for group-I and group-II, at 30 days, 6 and 12 months follow-up were 9 (1.2%) vs. 2 (0.9%); p=1.000, 15 (2.0%) vs. 7 (3.2%); p=0.302 and 24 (3.2%) vs. 12 (5.5%); p=0.109, respectively. The cumulative incidence curves for MACE showed no significant differences between the two groups, at the end of 12 months (p=0.109).. Our study shows that use of the Supraflex SES in single and multivessel coronary artery disease produces good clinical outcomes during 12 months of follow-up with a low rate of revascularization, despite complex lesion morphology.

Topics: Aged; Anti-Bacterial Agents; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Retrospective Studies; Sirolimus; Thrombosis; Treatment Outcome

Topics: Adult; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Cytoreduction Surgical Procedures; Dilatation, Pathologic; Drug-Eluting Stents; Humans; Male; Myocardial Infarction; Plaque, Atherosclerotic; Prosthesis Design; Sirolimus

This study aim was to investigate the morphometric parameters of late-acquired incomplete stent apposition (ISA) following use of Cypher sirolimus-eluting stent (SES; Cordis), Taxus paclitaxel-eluting stent (PES; Boston Scientific), and Resolute zotarolimus-eluting stent (ZES; Medtronic).. Characteristics of late-acquired ISA between first-generation and second-generation drug-eluting stents (DESs) have not been systematically examined.. Late-acquired ISA was defined as separation of at least 1 stent strut from the vessel wall with evidence of blood speckle behind the strut, where poststent implantation intravascular ultrasound (IVUS) revealed complete apposition. A total of 30 late-acquired ISA cases (12 SES, 10 PES, 8 ZES) were included in this IVUS analysis. Corresponding cross-sections at post procedure were selected for comparison. Vessel, lumen, peristent tissue, and stent area were measured in the late-acquired ISA arc as referenced to stent center.. Late-acquired ISA area was 2.4 ± 1.5 mm² in SES, 2.2 ± 2.7 mm² in PES, and 0.9 ± 0.6 mm² in ZES (P=.02 for SES vs ZES). Vessel area increased from post procedure to follow-up in SES (4.6 ± 1.7 mm² to 7.0 ± 2.5 mm²; P<.01) and PES (3.6 ± 1.7 mm² to 5.7 ± 3.8 mm²; P=.06), but not in ZES. Vessel expansion was the main mechanism in SES and PES groups; however, tissue regression and stent recoil, as well as vessel expansion, also contributed to late-acquired ISA in ZES. Per-patient analyses demonstrated that vessel expansion was the predominant mechanism of late-acquired ISA in 83% of SES, 60% in PES, and 50% of ZES cases.. The magnitude and mechanism of late-acquired ISA appear to be different between first-generation and second-generation DESs, possibly due to varying vessel response to different stent component types.

Topics: Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Long Term Adverse Effects; Male; Middle Aged; Outcome and Process Assessment, Health Care; Paclitaxel; Sirolimus; Ultrasonography, Interventional; United States

Biolimus-eluting stents (BES) have similar efficacy and safety compared with cobalt chromium everolimus-eluting stents (CoCr-EES), whereas it is unclear whether the same applies to small vessel disease. We sought compare clinical outcomes between BES and CoCr-EES in patients with small vessel disease.. A total of 1,132 patients treated only with BES (612 patients) or EES (520 patients) in small vessel disease (stent size 2.5-mm) were retrospectively analyzed. We assessed the cumulative 2-year incidence of major adverse cardiovascular events (MACE), defined as a composite of cardiac death, myocardial infarction (MI), definite stent thrombosis (ST), and clinically driven target lesion revascularization (CD-TLR). The cumulative 2-year incidence of MACE was similar between the two groups (12.1% vs. 11.8%, P = 0.77). The cumulative incidence of cardiac death, CD-TLR, and definite ST were also not significantly different between both groups (3.2% vs. 3.6%, P = 0.78; 8.3% vs. 8.4%, P = 1.00; 0.33% vs. 0.21%, P = 0.66, respectively). After multivariate adjusting, the adjusted risk of BES group relative to CoCr-EES group for MACE was not significantly different (hazard ratio [HR]: 0.78, 95% confidential interval [CI]: 0.53-1.15, P = 0.20). Similarly, no significant difference in the adjusted risks for cardiac death and CD-TLR were observed between the two groups (HR: 0.62, 95% CI: 0.28-1.37, P = 0.24; HR: 0.81, 95% CI: 0.51-1.29, P = 0.38).. Two-year clinical outcomes of BES are similar to those of CoCr-EES in patients with small vessel disease. The use of BES is acceptable for small coronary artery disease. © 2015 Wiley Periodicals, Inc.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Japan; Male; Percutaneous Coronary Intervention; Postoperative Complications; Retrospective Studies; Risk Factors; Sirolimus; Survival Rate; Time Factors

The PROMUS Element Plus US Post-Approval Study (PE-Plus PAS) was a prospective, open-label, multicenter, observational study designed to examine outcomes in everyday clinical practice in patients treated with everolimus-eluting, platinum-chromium PROMUS Element Plus stents at 52 centers in the United States. This is the first report of results from this large study. The primary end point of the PE-Plus PAS was 12-month cardiac death or myocardial infarction in the more restricted population of "PLATINUM-like" patients pooled from the PE-Plus PAS, PE-PROVE (PROMUS Element European post-approval study), and PLATINUM Workhorse/Small Vessel trials. Additional clinical end points were tested in the overall PE-Plus PAS patient population. Of the 2,683 patients enrolled in PE-Plus PAS, 70% were men, mean age was 64 years, 33% had diabetes, and 29% were "PLATINUM-like." Among the PLATINUM-like patients, 12-month cardiac death or myocardial infarction was 1.8% (33 of 1,855) with an upper 1-sided 95% confidence interval of 2.3%, which was significantly less than the prespecified performance goal of 3.2% (pnoninferiority <0.001). In the overall PE-Plus population, 12-month target vessel failure (defined as death, MI, or revascularization related to the target vessel) was 6.7% (170 of 2,554), cardiac death was 1.4% (37 of 2,554), MI was 1.1% (28 of 2,554), and ARC-definite/probable stent thrombosis was 0.7% (19 of 2,554). A prespecified secondary end point of 12-month target vessel failure in diabetic patients demonstrated a rate of 4.2% (14 of 332) with an upper 1-sided 95% confidence interval of 6.03%, which was significantly less than the performance goal of 12.6% (pnoninferiority <0.001). In conclusion, in this large registry of unselected patients, coronary artery revascularization with the PROMUS Element Plus everolimus-eluting stent demonstrates favorable results with low 1-year clinical event rates.

Topics: Adult; Aged; Aged, 80 and over; Chromium; Coronary Angiography; Coronary Artery Disease; Device Approval; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Platinum; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Time Factors; Treatment Outcome; United States

Topics: Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Paclitaxel; Sirolimus; Stents; Time Factors; Treatment Outcome

Topics: Coronary Artery Disease; Drug-Eluting Stents; Humans; Polymers; Sirolimus; Stents; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Humans; Predictive Value of Tests; Prosthesis Design; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Polymer coatings on drug-eluting stents (DES) serve as a vehicle for delivery of antirestenotic drugs. Whether they influence outcomes for contemporary DES is unknown. The evolution of polymer coatings for zotarolimus-eluting stents (ZES) provides a natural experiment that facilitates such analysis. The Resolute ZES (R-ZES) uses the same antirestenotic drug as the Endeavor ZES (E-ZES) but has a more biocompatible polymer with enhanced drug release kinetics. However, there are limited data on the real-world comparative efficacy of R-ZES and the preceding E-ZES. Thus, we analyzed 17,643 patients who received either E-ZES or R-ZES from 2008 to 2014 from the British Columbia Cardiac Registry. A total of 9,869 patients (56%) received E-ZES and 7,774 patients (44%) received R-ZES. Compared with E-ZES, R-ZES was associated with lower 2-year mortality (4.1% vs 6.4%, p <0.001) and 2-year target vessel revascularization (TVR; 6.8% vs 10.7%, p <0.001). R-ZES use was an independent predictor of lower mortality rate and TVR. This was confirmed in propensity-matched analyses for 2-year mortality (hazard ratio [HR] 0.59, 95% CI 0.49 to 0.71, p <0.001) and 2-year TVR (HR 0.86, 95% CI 0.75 to 0.98, p = 0.032). Instrumental variable analyses demonstrated R-ZES to be associated with lower 2-year mortality (Δ = -2.2%, 95% CI -4.3% to -0.2%, p = 0.032) and 2-year TVR (Δ = -3.3% to 95% CI -6.1% to -0.7%, p = 0.015). Acknowledging the limitations of observational analyses, this study has shown that R-ZES was associated with lower long-term TVR and mortality. These data are reassuring for the newer R-ZES and demonstrate how polymer coatings may influence the clinical performance of DES with wider implications for future DES development and design.

Topics: British Columbia; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Follow-Up Studies; Humans; Percutaneous Coronary Intervention; Polymers; Prognosis; Prosthesis Design; Retrospective Studies; Sirolimus; Survival Rate; Time Factors; Treatment Outcome

New-generation coronary stents including zotarolimus- and everolimus-eluting stents (ZES and EES) have been shown to decrease the risk of restenosis. The purpose of this study was to compare the safety and efficacy of ZES and EES over a 12-month clinical follow up, in routine clinical practice.. This is an observational study in which 1029 consecutive patients treated with ZES (n = 669) or EES (n = 360) were enrolled. The study endpoint was major adverse cardiac events (MACE), defined as cardiac death, nonfatal myocardial infarction (MI), and target lesion or vessel revascularization at 12 months.. Follow up was completed among 94.9% of the patients. The overall MACE occurred in 4 (0.6%) and 7 (2.0%) patients in the ZES and EES group, respectively. The occurrence of other cardiac events including nonfatal MI and target vessel or lesion revascularization was 1 (0.2%) versus 1 (0.3%) and 7 (1.1%) versus 5 (1.4%), respectively, in the ZES and EES groups of patients. Despite a slightly lower rate of MACE and cardiac death in the ZES group, the difference between these two groups was not significant (n = 0.064 for overall MACE, p = 0.129 for cardiac mortality, n = 0.999 for nonfatal MI, n = 0.468 for target vessel and n = 0.999 for target lesion revascularization).. According to our results, it could be concluded that the difference in the rate of MACE between the ZES and EES groups was not statistically significant at 12-month follow up.

Topics: Aged; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Registries; Sirolimus; Treatment Outcome

We aimed to investigate short-term outcomes of the XINSORB bioresorbable sirolimus-eluting scaffold in human coronary artery.. Bioresorbable scaffolds are considered to be the fourth milestone in percutaneous coronary intervention.. Thirty patients with symptomatic ischemic coronary disease were enrolled and treated with the XINSORB scaffolds that were 3.0 × 12, 15, and 18 mm in size. The primary angiographic endpoint was late luminal loss (LLL), whereas the primary clinical endpoint was major adverse cardiac events (MACEs) at the 6 month follow-up. In a subset of 19 patients, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) were performed at follow-up.. The success rates of the procedure and the device were both 100%. Twenty-seven patients received angiographic follow-up. All patients were clinically assessed. Neither MACEs nor stent thrombus-related events were recorded. The percentage of diameter stenosis at follow-up was similar to that at postprocedure. In-scaffold and periscaffold LLL were 0.17 ± 0.12 and 0.13 ± 0.24 mm, respectively. No in-stent restenosis was detected. IVUS showed that the mean areas of the lumen, scaffold, and neointima at follow-up were 6.27 ± 0.69, 6.48 ± 0.70, and 0.20 ± 0.09 mm(2) , while in-device stenosis was 3.1 ± 1.3%. OCT showed that 97.9% of the struts presented a preserved box, while 2.1% had an open box after 6 months. A total of 95.9% of the struts were covered by neointima.. This first-in-human study demonstrates the effectiveness and safety of the XINSORB scaffold in treating single de novo coronary lesions.

Topics: Absorbable Implants; Adult; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Stenosis; Coronary Vessels; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Drug-eluting stents (DES) are widely used for the treatment of coronary artery disease, and a sirolimus-eluting stent (SES; Cypher) was the first DES introduced into clinical practice. Although pathological reactions of coronary arteries to SES have been described in autopsy cases, there are few reports regarding calcification of the coronary arteries after SES implantation. The present report describes the findings of an autopsy conducted 16 months after SES implantation that showed remarkable persistent calcification. In addition, previously reported pertinent pathological findings are also described.

Topics: Aged, 80 and over; Angioplasty, Balloon, Coronary; Autopsy; Calcinosis; Coronary Artery Disease; Drug-Eluting Stents; Fatal Outcome; Female; Heart Arrest; Humans; Percutaneous Coronary Intervention; Sirolimus; Time Factors

The aim of this study is to indicate differences of side branch jailing between the left main (LM)-left anterior descending artery (LAD) stenting and the LM-left circumflex artery (LCx) stenting. Thirty-one patients who underwent single-stenting using a two-link ten-crowns biolimus-eluting stent (Japanese design of BES, J-BES) and subsequent kissing balloon dilation (KBD) on an LM bifurcation with optical coherence tomography (OCT) were divided into two groups according to the stented vessel. Bifurcation angles were measured by three-dimensional (3D) quantitative coronary analysis. The jailing pattern on a side branch ostium was evaluated by stent-enhanced 3D-OCT. Incomplete stent apposition (ISA) after KBD was compared between the stented vessels. The to-be-stented angle of the LM-LCx stenting (n = 11) was significantly steeper than that of the LM-LAD stenting (n = 20) (132.6° ± 16.9° vs. 150.7° ± 10.6°, p < 0.01). The incidence of the free carina type, which has no stent links bridging from a carina, in the LM-LCx stenting was significantly higher than that in the LM-LAD stenting (90.9 vs. 45.0 %, p = 0.02). The percentage of ISA at the bifurcation segment in the LM-LCx stenting was significantly smaller than that in the LM-LAD stenting (4.4 ± 8.2 vs. 12.7 ± 9.2 %, p = 0.0003). This study showed, by higher incidence of the favorable configuration, that the LM-LCx stenting achieved a smaller percentage of ISA than the LM-LAD stenting. These insights may help guide LM bifurcation stenting with J-BES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Imaging, Three-Dimensional; Japan; Male; Middle Aged; Prosthesis Design; Radiographic Image Interpretation, Computer-Assisted; Retrospective Studies; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

To evaluate, in the FLEX Registry, clinical outcomes of an ultrathin (60 µm) biodegradable polymer-coated Supraflex sirolimus-eluting stent (SES) for the treatment of coronary artery disease. Additionally, to determine the vascular response to the Supraflex SES through optical coherence tomography (OCT) analysis.. Multicentre, single-arm, all-comers, observational registry of patients who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India.. 995 patients (1242 lesions) who were treated with the Supraflex SES, between July 2013 and May 2014, at nine different centres in India. A total of 47 participants underwent OCT analysis at 6 months' follow-up.. Percutaneous coronary intervention with Supraflex SES, PRIMARY AND SECONDARY OUTCOME MEASURES: The primary endpoint-the rate of major adverse cardiac events (defined as a composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR))-was analysed during 12 months.. At 12 months, the primary endpoint occurred in 36 (3.7%) of 980 patients, consisting of 18 (1.8%) cardiac deaths, 16 (1.6%) MI, 7 (0.7%) TLR and 2 (0.2%) cases of non-target lesion target vessel revascularization. In a subset of 47 patients, 1227 cross-sections (9309 struts) were analysed at 6 months by OCT. Overall, a high percentage of struts was covered (98.1%), with a mean neointimal thickness of 0.13 ± 0.06 µm.. The FLEX Registry evaluated clinical outcomes in real-world and more complex cohorts and thus provides evidence that the Supraflex SEX can be used safely and routinely in a broader percutaneous coronary intervention population. Also, the Supraflex SES showed high percentage of stent strut coverage and good stent apposition during OCT follow-up.

Topics: Absorbable Implants; Aged; Antibiotics, Antineoplastic; Cardiovascular Diseases; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; India; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Neointima; Percutaneous Coronary Intervention; Polymers; Registries; Sirolimus; Tomography, Optical Coherence

Topics: Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Percutaneous Coronary Intervention; Sirolimus

To investigate the long-term clinical outcomes of biolimus-eluting stents with biodegradable polymers in real-world clinical practice.. Long-term clinical outcomes of biolimus-eluting stents have not been clearly established.. A total of 824 all-comer patients (971 lesions) treated with unrestricted implantation of a biolimus-eluting stent with a biodegradable polymer were prospectively enrolled. Patients were divided into complex (413 patients) versus noncomplex (411 patients) groups according to the complexity of coronary lesions. Long-term clinical outcomes for stent efficacy (target lesion revascularization) and safety (composite of cardiac death, target lesion-related myocardial infarction, and definite or probable stent thrombosis) were compared between the two groups during 5 years of follow-up.. The complex group showed higher rates of decreased left ventricular ejection fraction, impaired renal function, previous history of myocardial infarction, and diabetes mellitus compared to the noncomplex group. In the overall population, the 5-year cumulative rate of target lesion revascularization was 4.8% (8.3% in the complex group vs 1.6% in the noncomplex group, P < 0.001). For stent safety, the 5-year cumulative rate for a composite of cardiac death, target lesion-related myocardial infarction, and stent thrombosis was 2.5% overall (3.9% in the complex group vs 1.1% in the noncomplex group, P = 0.010). Overall 5-year cumulative rate of stent thrombosis was 0.4% (0.5% in the complex vs 0.2% in the noncomplex group, P = 0.561) with no very late stent thrombosis (VLST).. Biodegradable polymer-based biolimus-eluting stents showed favorable efficacy and safety in all-comer patients during 5 years of follow-up.

Topics: Absorbable Implants; Aged; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Polymers; Prospective Studies; Registries; Sirolimus; Treatment Outcome

Topics: Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Sirolimus

Topics: Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Sirolimus

Topics: Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Sirolimus

Topics: Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Sirolimus

Few studies have investigated the clinical outcomes of rotational atherectomy (RA) prior to and during the drugeluting stent (DES) era. The goal of this study was to assess the long-term outcome after RA followed by DES and bare metal stent (BMS) implantation in complex calcified coronary lesions and to compare the outcomes among various DESs.This was a single center retrospective observational study. Consecutive 406 patients who underwent elective RA followed by BMS or DES implantation at our institution from 2001 to 2011 were included. This study compared the long-term outcomes after treatment with RA among BMS and 3 different DESs (sirolimus-eluting stent, paclitaxel-eluting stent, and everolimus-eluting stent) implantation.The mean follow-up period was 4.6 years. Patients with DES were older and exhibited more vessel disease, longer lesion length, and smaller vessel size. Patients with BMS had a significantly higher rate of target lesion revascularization, restenosis, and larger late lumen loss than those with DES. Composite events including mortality, ACS, and target vessel revascularization were significantly higher in the BMS-RA group than in the DES-RA group. After adjustment, BMS remained an independent predictor of MACE and ACS plus death in patients treated with RA. However, there were no significant differences in late lumen loss, restenosis rate, and MACE among the 3 DES.The combination of DES-RA has a favorable effect in both the angiographic and clinical outcomes compared with BMS-RA. However, no significant differences in late loss and events rates were observed among the 3 DES groups.

Topics: Aged; Atherectomy, Coronary; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Incidence; Japan; Male; Paclitaxel; Percutaneous Coronary Intervention; Prognosis; Retrospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Diabetes mellitus (DM) was broadly acknowledged as a risk factor for adverse events after coronary stent implantation. However, the role of DM in patients treated with second-generation cobalt-chromium sirolimus-eluting stents (CoCr-SES) was less known.. A total of 4720 patients available for 3-year follow-up in the prospective FOCUS registry were subdivided into the DM group and the non-DM group to assess the effect of DM on the clinical outcomes after CoCr-SES implantation both before and after propensity score matching.. The rates of major adverse cardiovascular event was low (<10%) in both DM and non-DM groups but significantly greater in the DM group after matching (9.6% versus 6.1%; p = 0.005). Although the soft endpoints including target vessel revascularization (2.3% versus 2.3%; p = 0.938) and target lesion revascularization (1.2% versus 1.1%; p = 0.828) was not significantly different between two groups, the hard endpoints represented by cardiovascular death or myocardial infarction (7.3% versus 5.3%; p = 0.012) demonstrated a significant increase in the DM group.. This subgroup analysis demonstrated that DM significantly increased the risk of adverse events after implantation of CoCr-SES, but the general safety and efficacy performance of CoCr-SES in both diabetic and non-diabetic patients was satisfying and comparable with other types of new-generation drug-eluting stents.

Topics: Aged; Chromium; Cobalt; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Sirolimus; Treatment Outcome

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Self Expandable Metallic Stents; Sirolimus; Vasoconstriction

Although some clinical studies have revealed adverse clinical and angiographic outcomes of early-generation overlapping drug-eluting stents (DES), the safety and efficacy of overlapping newer-generation DES for long narrowings have not been well established. This study aimed to compare angiographic and 1-year clinical outcomes between a long single stent (LSS) and overlapping double stents (ODS) in patients treated with newer-generation DES for similarly long narrowings. We analyzed 8 to 10 months angiographic and 1-year clinical outcomes of 112 lesions of 105 patients with long (30 to 38 mm) narrowings treated with everolimus-eluting stent, a newer-generation DES, using LSS or ODS. We divided our patients into LSS group (46 patients with 49 lesions) and ODS group (59 patients with 63 lesions). As a result, the rates of freedom from major adverse cardiac events (92.9% vs 93.1%, p = 0.91) and target lesion revascularization (94.5% vs 95.1%, p = 0.79) during 1-year follow-up were similar between the 2 groups. There was no stent thrombosis observed between the 2 groups. In conclusion, everolimus-eluting stent provided similar angiographic and 1-year clinical outcomes regardless of overlap status in long narrowings.

Topics: Aged; Antineoplastic Agents, Phytogenic; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Paclitaxel; Percutaneous Coronary Intervention; Postoperative Complications; Prosthesis Design; Retrospective Studies; Sirolimus; Survival Rate; Time Factors; Treatment Outcome

Our aim was to investigate one-year outcomes in patients treated with bioresorbable scaffolds (BRS) for "off-label" versus currently "established" indications.. Consecutive patients treated with BRS between May 2012 and September 2014 in two centres were retrospectively recruited. Patients who met inclusion criteria as defined by the ABSORB III study were allocated to the established indication group (ESTG; 21 patients with 35 lesions) and the remaining patients to the off-label group (OFLG; 168 patients with 225 lesions). Target vessel failure (TVF) and ischaemia-driven target lesion revascularisation (id-TLR) at one year were evaluated in both groups. Patients in the OFLG had a higher prevalence of diabetes mellitus and longer lesion length. Predilatation, post-dilatation and intracoronary imaging were conducted in the majority of patients. At one-year follow-up, TVF (0% vs. 7.8%, p=0.32) and id-TLR (0% vs. 4.5%, p=0.31) occurred only in the OFLG with no adverse events in the ESTG. Definite stent thrombosis occurred in two OFLG patients (1.3%).. In a real-world setting, the majority (88.9%) of patients were treated with BRS for off-label indications. Off-label use of BRS appears to be associated with an acceptable occurrence of outcomes considering the greater complexity of this patient group.

Topics: Absorbable Implants; Adult; Aged; Aged, 80 and over; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Off-Label Use; Percutaneous Coronary Intervention; Registries; Sirolimus; Treatment Outcome

The long-term clinical impact of polymer-free sirolimus-eluting stents (PF-SES) in unselected patients undergoing percutaneous coronary intervention (PCI) still remains poorly investigated. We studied the long-term clinical impact of PF-SES in a large cohort of unselected patients receiving PCI therapy at two tertiary care centers in India.. A total of 3213 patients received PCI with drug-eluting stents during the period from December 2004 to September 2011. Among these, those receiving PF-SES implantation were retrospectively included in this registry. The primary endpoint in our study was the occurrence of major adverse cardiac events (MACE), defined as the composite of death/myocardial infarction (MI) and target lesion revascularization, whereas the main secondary endpoints were cardiac death/MI and definite/probable stent thrombosis.. A total of 1213 patients (83.8% men, 31.8% diabetics) with 1658 lesions (52.5% B2/C, according to the American College of Cardiology/American Heart Association classification) were studied. After a median follow-up of 1160 days, MACE occurred in 10.0% of patients, whereas the rates of cardiac death/MI and definite/probable ST were found to be 5.4 and 1.9%, respectively. The incidence of MACE was more common in patients aged at least 65 years [hazard ratio (HR)=1.69, 95% confidence interval (CI)=1.13-2.52, P=0.01] and diabetics (HR=1.71, 95% CI=1.18-2.47, P=0.004). The incidence of cardiac death/MI was more common in patients aged at least 65 years (HR=2.21, 95% CI=1.32-3.70, P=0.003). The baseline risk profile did not impact the occurrence of target lesion revascularization.. In this large cohort of unselected PCI patients treated in India, PF-SES shows a sustained safety and efficacy at long-term follow-up.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Incidence; India; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Registries; Retrospective Studies; Risk Factors; Sirolimus; Tertiary Care Centers; Time Factors; Treatment Outcome

We compared outcomes of percutaneous coronary intervention patients who received biodegradable-polymer biolimus-eluting stents with those who received durable-polymer everolimus-eluting stents. At Tehran Heart Center, we performed a retrospective analysis of the data from January 2007 through December 2011 on 3,270 consecutive patients with coronary artery disease who underwent percutaneous coronary intervention with the biodegradable-polymer biolimus-eluting stent or the durable-polymer everolimus-eluting stent. We excluded patients with histories of coronary artery bypass grafting or percutaneous coronary intervention, acute ST-segment-elevation myocardial infarction, or the implantation of 2 different stent types. Patients were monitored for 12 months. The primary endpoint was a major adverse cardiac event, defined as a composite of death, nonfatal myocardial infarction, and target-vessel and target-lesion revascularization. Durable-polymer everolimus-eluting stents were implanted in 2,648 (81%) and biodegradable-polymer biolimus-eluting stents in 622 (19%) of the study population. There was no significant difference between the 2 groups (2.7% vs 2.7%; P=0.984) in the incidence of major adverse cardiac events. The cumulative adjusted probability of major adverse cardiac events in the biodegradable-polymer biolimus-eluting stent group did not differ from that of such events in the durable-polymer everolimus-eluting stent group (hazard ratio=0.768; 95% confidence interval, 0.421-1.44; P=0.388). We conclude that in our patients the biodegradable-polymer biolimus-eluting stent was as effective and safe, during the 12-month follow-up period, as was the durable-polymer everolimus-eluting stent.

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Registries; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

Our case reports the first migration of a stent already deployed at high pressure in the main vessel during a 2-stent strategy for a bifurcation lesion using T and protrusion technique. The Kissing balloon was not optimal and could have led to an insufficient strut/cell opening and then to LAD stent pulled back into the artery tree. This case report highlights the importance of an optimal Kissing Balloon in two stent bifurcation technique.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Device Removal; Drug-Eluting Stents; Everolimus; Foreign-Body Migration; Humans; Male; Middle Aged; Sirolimus; Treatment Outcome

Several studies have revealed that glucose fluctuations provoke oxidative stress that leads to endothelial cell dysfunction, progression of coronary atherosclerosis, and plaque vulnerability. However, little is known regarding their effect on neointimal growth after stenting in patients with coronary artery disease (CAD). We aimed to investigate the effects of glucose fluctuations on neointimal growth after everolimus-eluting stent (EES) implantation.. This study examined 50 patients who underwent a 9-month follow-up using optical coherence tomography (OCT) after EES implantation. Glucose fluctuation was expressed as the mean amplitude of glycemic excursion (MAGE), and was determined via continuous glucose monitoring before stenting. At the OCT follow-up, we evaluated the percentage of uncovered struts and three-dimensional uniformity of neointimal distribution by calculating the mean neointimal thickness (NIT) within 360 equally-spaced radial sectors for every 1-mm cross-sectional OCT analysis, and assessed the incidence of major adverse cardiovascular events (MACE).. We evaluated 60 lesions in 50 patients. Linear mixed effect models were used to explore the influence of different variables on variability in NIT and the percentage of uncovered struts and to adjust for covariates. Univariate analysis showed that MAGE was most strongly correlated with the previously mentioned OCT measurements (coefficient β ± standard error = 0.267 ± 0.073 and 0.016 ± 0.003, t = 3.668 and 6.092, both P < 0.001, respectively). In multivariate analysis, MAGE had the strongest effect on variability in NIT (coefficient β ± standard error = 0.239 ± 0.093, P = 0.014) and the percentage of uncovered struts (coefficient β ± standard error = 0.019 ± 0.004, P < 0.001). Five lesions in four patients required target lesion revascularization (10.0 %) at a mean duration of 9 months after EES implantation. Compared to non-MACE cases, cases of MACE exhibited a significantly higher MAGE (99 vs. 68; P = 0.004), maximum NIT (580 vs. 330 µm; P = 0.002), and variability in NIT (100 vs. 65; P = 0.007), although there was no significant difference in these groups' HbA1c levels.. Glucose fluctuation may affect vessel healing after EES implantation in patients with CAD who are receiving lipid-lowering therapy. Therefore, glucose fluctuations may be an important target for secondary prevention after coronary stenting, which is independent of dyslipidemia control.

Topics: Adult; Aged; Aged, 80 and over; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Glucose; Humans; Male; Middle Aged; Sirolimus; Time Factors; Tomography, Optical Coherence

Both bare-metal stents (BMS; the first-generation coronary stent) and zotarolimus-eluting stents (ZES; a second-generation drug-eluting stent [DES]) have been widely utilized to treat coronary heart disease. However, the long-term comparative effectiveness of BMS and ZES remains unclear. The purpose of this study was to evaluate long-term comparative effectiveness of BMS versus ZES.. We created a longitudinal database by linking the New York State (NYS) cardiac registries, statewide hospital discharge data, the National Death Index (NDI), and the U.S. Census file (2010) for patients receiving either BMS or ZES during the 2008-2009 period. We examined the rates of all-cause mortality, acute myocardial infarction (AMI), target-lesion PCI (TLPCI), and target-vessel coronary artery bypass graft (TVCABG) surgery for a follow-up period of 4.5 years. A total of 10,443 propensity score matched pairs were compared using the Kaplan-Meier method and Cox proportional hazards regression adjusting for patient risk factors.. We found that patients receiving ZES had a lower rate of 4.5-year mortality (adjusted hazard ratio AHR: 0.68, 95% confidence interval CI: 0.63-0.73), AMI (AHR: 0.89, 95% CI: 0.80-0.98), and TVCABG (AHR: 0.84, 95% CI: 0.71-0.99) but a similar rate of TLPCI (AHR: 1.02, 95% CI: 0.93-1.12). For "off-label" and "high-risk" subgroups, ZES was associated with improved mortality and generally better or non-inferior AMI, TLPCI, and TVCABG outcomes relative to BMS.. Compared with BMS, ZES was associated with lower long-term mortality, AMI and TVCABG. (J Interven Cardiol 2016;29:265-274).

Topics: Aged; Aged, 80 and over; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Longitudinal Studies; Male; Metals; Middle Aged; New York; Percutaneous Coronary Intervention; Propensity Score; Proportional Hazards Models; Registries; Sirolimus; Treatment Outcome

Prolonged dual anti-platelet therapy (DAPT) may cause excess bleeding in certain patients. The biolimus-A9 drug-coated stent (BA9-DCS) has a rapid drug-elution profile allowing shortened DAPT. Data were gathered on the early experience implanting this stent in drug-eluting stent eligible patients deemed to be at high risk of bleeding.. The demographics, procedural data and clinical outcomes were gathered prospectively for 249 patients treated with a BA9-DCS stent at 2 UK centres, and compared to a cohort of patients treated in the same period with drug-eluting stents (PCI-DES).. Operator-defined BA9-DCS indications included warfarin therapy, age, and anaemia. Patients receiving a BA9-DCS were older (71.6±11.8 vs. 64.8±11.6yrs, p<0.001), more often female (38.2 vs. 26.8%, P<0.001), and more likely to have comorbidity including chronic kidney disease or poor LV function than PCI-DES patients. The baseline Mehran bleed risk score was also significantly higher in the BA9-DCS group (19.4±8.7 vs. 13.1±5.8, p<0.001). Of the BA9-DCS cohort, 95.5% of patients demonstrated disease fitting NICE criteria for DES placement. The number of lesions treated (1.81±1.1 vs. 1.58±0.92, p = 0.003), total lesion length (32.1±21.7 vs. 26.1±17.6mm, p<0.001), number of stents used (1.93±1.11 vs. 1.65±1.4, p = 0.007) and total stent length (37.5±20.8 vs. 32.4±20.3, p<0.01) were greater for BA9-DCS patients. DAPT was prescribed for 3.3±3.9 months for BA9-DCS patients and 11.3±2.4 months for PCI-DES patients (p<0.001). At follow up of 392±124 days despite the abbreviated DAPT course stent related event were infrequent with ischemia-driven restenosis PCI (2.8 vs. 3.4%, p = 0.838), and stent thrombosis (1.6 vs. 2.1%, p = 0.265) rates similar between the BA9-DCS ad PCI-DES groups. After propensity scoring all clinical end-points were similar between both cohorts.. This early experience using polymer-free BA9 drug-coated stents in drug-eluting stent type patients at risk of bleeding are encouraging. Further studies are warranted.

Topics: Aged; Aged, 80 and over; Aspirin; Coronary Artery Disease; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Propensity Score; Prospective Studies; Risk Factors; Sirolimus; Treatment Outcome

Percutaneous coronary intervention (PCI) for unprotected left main truncus (LMT) lesions is controversial. Inoperable status with advanced age, renal dysfunction, frailty, or patient request may require an unprotected left main PCI. PCI for LMT is not recommended in the typical clinical situation; however, when it is the only feasible option, the performance is not bad. We demonstrated the result of a cobalt-chromium everolimus-eluting stent (CoCr-EES) in the LMT stenting and serial changes via micro-computed tomography (μCT). μCT is an established imaging technique used for high-resolution, non-destructive assessment of vascular samples. The technique has drawn increasing interest for investigations of atherosclerotic arteries in both humans and animal models. There are no reports regarding the linkage between clinical results and μCT images.. Between January 2009 and December 2014, we recruited 118 consecutive, unprotected LMT stenting cases in our institution. We examined the clinical outcomes and angiographic results with a CoCr-EES compared with a first-generation drug-eluting stent. The primary endpoint of this registry was the rate of one-year major adverse cardiac events (MACE). The one-year MACE rate was 2.54%; this did not include the CoCr-EES. We established LMT bifurcation models (mini-crush and culotte) using a CoCr-EES and obtained μCT images of the CoCr-EES. The images showed no deformation or strut apposition.. CoCr-EES performed well in LMT in our institution and according to μCT. μCT images may be useful for anatomical simulation in stent deployment.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Japan; Male; Percutaneous Coronary Intervention; Retrospective Studies; Sirolimus; Treatment Outcome; X-Ray Microtomography

Our aim was to assess vascular response after polymer-free sirolimus-eluting stent (SES) implantation by using an optical coherence tomography (OCT)-derived vascular healing score (HS), quantifying the deficiency of healing.. In a prospective, multicentre, single-arm, open-label study, OCT examinations were performed at three months in 45 patients (47 lesions). Per protocol, 24 lesions which had not reached adequate vascular healing according to study criteria were scheduled for OCT examination at six months. The HS was calculated at two time points. Serial OCT imaging demonstrated that the proportion of covered stent struts increased from a median of 87.1% at three months to 98.6% at six months (p<0.001). The neointimal thickness increased from a median of 82.8 µm to 112.2 µm (p<0.001), whereas the median percentages of malapposed struts were 0.2% and 0.0% at the two respective time points. Neointimal volume obstruction increased from 6.3% to 12.8%, and the HS decreased from a median of 28.1 at three months to 2.4 at six months.. In patients who had inadequate vascular healing three months after polymer-free SES implantation, serial OCT showed almost complete vascular healing at six months.

Topics: Absorbable Implants; Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Polymers; Sirolimus; Tomography, Optical Coherence

Previous studies have associated issues such as incomplete stent apposition with delayed healing and adverse events (stent thrombosis). The aim of this study was to evaluate the impact of strut apposition and stent type on the progression of stent strut coverage.. We evaluated in vivo in porcine models the follow-up response and coverage characteristics of well-apposed and malapposed segments of drug-eluting stents (DES) (CYPHER, PROMUS Element and Orsiro) and the Absorb bioresorbable vascular scaffold (BVS) by optical coherence tomography (OCT) sequentially, at baseline, and at one week and four weeks of follow-up. Supporting results were provided by histological analysis performed at four-week follow-up and computer simulation describing the shear characteristics around apposed and non-apposed struts. A total of 325 cross-sections containing 3,166 struts were analysed. The extent of malapposition decreased over time as a result of neointimal healing (from 7.1% at baseline to 0% at four weeks; p=0.03). At one week, 13.6% of struts in well-apposed segments were still uncovered versus 19.2% of struts in malapposed cross-sections and 77.8% of NASB struts (p<0.01). At four-week follow-up, 3.1% of struts were uncovered in well-apposed cross-sections vs. 1.6% in malapposed cross-sections and 35.7% of NASB struts (p<0.01). A comparison of the apposed segments revealed that the thin-strut Orsiro had only 1.3% of uncovered struts at one week while PROMUS Element, CYPHER and BVS had 6.6%, 48.4% and 16.2% of struts still uncovered, respectively.. This study shows that early coverage is influenced by stent apposition as well as platform strut characteristics (stent type). At four weeks, NASB struts remained a focus of delayed endothelialisation.

Topics: Angioplasty, Balloon, Coronary; Animals; Computer Simulation; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Humans; Models, Animal; Neointima; Prosthesis Design; Sirolimus; Swine; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

Topics: Angioscopy; Antineoplastic Agents, Phytogenic; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Neointima; Paclitaxel; Prosthesis Design; Sirolimus

It has not been established whether the achievement of optimal medical therapy (OMT) before implantation of a drug-eluting stent has a clinical benefit for patients with stable coronary artery disease (CAD). This study included 3,004 patients with CAD treated with drug-eluting stent from 123 Japanese participating centers. The achievement of OMT was defined as control of blood pressure <130/80 mm Hg, hemoglobin A1c <7.0%, and low-density lipoprotein cholesterol <100 mg/dl. The primary end point was target vessel failure, a composite of death related to the target vessel, myocardial infarction, or clinically driven revascularization at 24 months after stent implantation. Immediately before the procedure, only 548 patients (18.2%) had achieved all 3 target criteria (the achieved OMT group), whereas the remaining 2,456 patients failed to achieve one or more criteria (the non-OMT group). At 24 months, the incidence of target vessel failure was 7.0% in the achieved OMT group versus 10.0% in the non-OMT group (hazard ratio 0.68, 95% CI 0.48 to 0.96, p = 0.03). The incidence of non-Q-wave myocardial infarction was also lower in the achieved OMT group than in the non-OMT group (0.5% vs 1.5%, p = 0.08). Multivariate logistic regression analysis identified that hemoglobin A1c <7.0% was the only protective predictor of 24-month target vessel failure (odds ratio 0.56, 95% CI 0.43 to 0.73, p <0.01). In conclusion, this study demonstrated that in patients with stable CAD scheduled for stent implantation, achievement of OMT before percutaneous coronary intervention significantly reduced subsequent cardiac events. Achievement of OMT is still insufficient in modern clinical practice.

Topics: Adrenergic beta-Antagonists; Aged; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Antibiotics, Antineoplastic; Antineoplastic Agents, Phytogenic; Blood Pressure; Cholesterol, LDL; Coronary Angiography; Coronary Artery Disease; Diabetes Mellitus; Drug-Eluting Stents; Dyslipidemias; Female; Glycated Hemoglobin; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypertension; Hypoglycemic Agents; Japan; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Randomized Controlled Trials as Topic; Risk Reduction Behavior; Sirolimus

Stent delivery failure may occur especially when treating complex coronary artery stenosis. XLIMUS (CARDIONOVUM GmbH, Bonn, Germany) is a new sirolimus-eluting stent (SES) with the following features: 1) cobalt chromium stent platform, with low (73 μm) strut thickness, (2) biodegradable polymer, and 3) potent antiproliferative drug (Sirolimus). Preliminary data suggest that XLIMUS SES may be ideal for the treatment of complex lesions.. In this registry, we assessed the deliverability, safety, and efficacy of percutaneous coronary interventions (PCI) using the XLIMUS SES in patients undergoing elective PCI in native coronary vessels for complex de novo lesions, including severe calcification, severe tortuosity, and chronic total occlusion. The primary objective of the study is the delivery success of the XLIMUS SES. The secondary objective is the 1-year rate of major adverse cardiac events (MACE; including all-cause death, nonfatal myocardial infarction, and repeat revascularization).. A total of 200 consecutive patients with 255 lesions were included. Delivery success was obtained in 196 (98%) patients and in 251 (98.4%) lesions. The XLIMUS SES was successfully implanted on the first attempt with a single guidewire in 176 (88%) patients and in 208 (81.6%) lesions. Additional techniques to facilitate stent delivery (i.e., buddy wire, anchoring-balloon, or GuideLiner catheter) were necessary in 47 (18.4%) lesions. Failure in XLIMUS SES implantation occurred in 4 (1.6%) lesions. MACE rate at 1 year was 9%.. This registry supports the positive performance of the XLIMUS SES in the treatment of complex coronary artery lesions.

Topics: Aged; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Italy; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Registries; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

Renal insufficiency (RI) is an independent risk factor for the adverse cardiovascular events. Long-term clinical outcome of percutaneous coronary intervention (PCI) in patients with RI is unknown especially in the era of first generation drug-eluting stents (DES). This study aims at comparing clinical outcomes between sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) based on large scaled registry.. Patients who underwent PCI with DES from January 2004 to December 2009 in the Catholic University of Korea-PCI (COACT) registry were prospectively enrolled. A group of 1,033 patients with RI, defined as estimated glomerular filtration rate under 60 mL/min, were analyzed. Major adverse cardiac events (MACE), including all-cause death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR) according to the type of stents were compared.. Median follow-up period was 810 days (interquartile range: from 361 to 1,354 days). A group of 612 (59.2%) patients were treated with SES and 421 (40.8%) patients were treated with PES. The PES vs. SES group had significantly higher rate of MACE (35.9% vs. 28.3%, p = 0.01). In multivariate Cox hazard regression analysis, PES vs. SES group had significantly higher rate of MACE (adjusted hazard ratio [AHR] 1.29, 95% confidence interval [CI] 1.02-1.64, p = 0.033), particularly pronounced by all-cause death (AHR 1.34, 95% CI 1.008-1.770; p = 0.044). In further analysis with propensity score matching, overall findings were consistent.. In patients with RI, PCI using PES provides poorer clinical outcomes than SES in terms of MACE and all-cause death.

Topics: Aged; Antineoplastic Agents, Phytogenic; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Renal Insufficiency; Republic of Korea; Risk Factors; Sirolimus; Survival Rate; Time Factors

Adhesion molecules play an important role in inflammation, atherosclerosis and coronary artery disease (CAD). These molecules are expressed on the surface of dysfunctional endothelial cells, causing inflammatory cells from the circulation to adhere and migrate through the endothelium. Their expression is upregulated in acute coronary syndrome (ACS) and after percutaneous coronary intervention (PCI). The contact between stent struts and endothelium upregulates endothelial cell gene expression, endothelial cell activation and inflammation. The paclitaxel or sirolimus eluting stents inhibited expression of adhesion molecules in several studies and reduced the incidence of major adverse cardiac events (MACE) after drug-eluting stent (DES) over bare metal stent (BMS) implantation. Therefore, we propose that elevated serum levels of the soluble adhesion molecules after primary PCI in patients treated with BMS or DES implantation versus drug-coated balloon (DCB) application to the vulnerable coronary plaque might be a predictor of MACE and further adverse outcomes. Consequently, DCB-only strategy in patients with ACS might be a superior approach in comparison to BMS implantation and non-inferior approach when compared to DES implantation.

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Atherosclerosis; Cell Adhesion Molecules; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Drug-Eluting Stents; Endothelial Cells; Humans; Inflammation; Intercellular Adhesion Molecule-1; Metals; P-Selectin; Paclitaxel; Percutaneous Coronary Intervention; Sirolimus; Up-Regulation; Vascular Cell Adhesion Molecule-1

The unique physical properties of optical coherence tomography (OCT) make it a useful technique in the study of restenosis mechanisms. In fact, OCT is able to differentiate between neointimal proliferation and neoatherosclerosis within the stent. We report a rare case of occlusive neoatherosclerosis presenting beyond one year after a successful drug-eluting stent implantation. The impact of OCT findings in the clinical decision making process is emphasized.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Occlusion; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Hypolipidemic Agents; Male; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Retreatment; Sirolimus; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Absorbable Implants; Coronary Artery Disease; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Sirolimus; Treatment Outcome

Rapamycin, an mTOR inhibitor affects senescence through suppression of senescence-associated secretory phenotype (SASP). We studied the safety and feasibility of low-dose rapamycin and its effect on SASP and frailty in elderly undergoing cardiac rehabilitation (CR). 13 patients; 6 (0.5mg), 6 (1.0mg), and 1 patient received 2mg oral rapamycin (serum rapamycin <6ng/ml) daily for 12 weeks. Median age was 73.9±7.5 years and 12 were men. Serum interleukin-6 decreased (2.6 vs 4.4 pg/ml) and MMP-3 (26 vs 23.5 ng/ml) increased. Adipose tissue expression of mRNAs (arbitrary units) for MCP-1 (3585 vs 2020, p=0.06), PPAR-γ (1257 vs 1166), PAI-1 (823 vs 338, p=0.08) increased, whereas interleukin-8 (163 vs 312), TNF-α (75 vs 94) and p16 (129 vs 169) decreased. Cellular senescence-associated beta galactosidase activity (2.2% vs 3.6%, p=0.18) tended to decrease. We observed some correlation between some senescence markers and physical performance but no improvement in frailty with rapamycin was noted. (NCT01649960).

Topics: Adipose Tissue; Aged; Aged, 80 and over; Aging; beta-Galactosidase; Cellular Senescence; Chemokine CCL2; Coronary Artery Disease; Cyclin-Dependent Kinase Inhibitor p16; Cyclin-Dependent Kinase Inhibitor p21; Female; Frail Elderly; Gait; Humans; Immunosuppressive Agents; Interleukin-6; Interleukin-8; Male; Matrix Metalloproteinase 3; Percutaneous Coronary Intervention; Phenotype; Pilot Projects; Plasminogen Activator Inhibitor 1; PPAR gamma; RNA, Messenger; Sirolimus; Treatment Outcome; Tumor Necrosis Factor-alpha; Walk Test

Although previous optical coherence tomography (OCT) studies reported that restenosis tissue after implantation of a drug-eluting stent (DES) was composed of a variety of cells, the clinical significance of morphologic characteristics for in-stent neointimal tissue as assessed by OCT has not been clarified. We experienced a patient with stable angina who underwent percutaneous coronary intervention with a 2.5 × 18-mm DES implantation 6 months before the OCT examination. OCT imaging showed a mild intimal hyperplasia (39 % neointimal hyperplasia) with eccentric, heterogeneous tissue, predominantly of low signal intensity. Seventeen months after the initial procedure, OCT revealed a significant increase in percent neointimal hyperplasia of 58 %, with morphologically different intimal tissue of concentric homogeneous high intensity in the stented segments. This finding suggests that low-intensity intimal tissue morphology detected by OCT could be a morphometric predictor of late neointimal tissue growth after DES implantation.

Topics: Aged; Chest Pain; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Everolimus; Humans; Hyperplasia; Male; Neointima; Percutaneous Coronary Intervention; Sirolimus; Tomography, Optical Coherence

Arterial plaque rupture and thrombus characterise ST-elevation myocardial infarction (STEMI) and may aggravate delayed arterial healing following durable polymer drug-eluting stent (DP-DES) implantation. Biodegradable polymer (BP) may improve biocompatibility. We compared long-term outcomes in STEMI patients receiving BP-DES vs. durable polymer sirolimus-eluting stents (DP-SES).. We pooled individual patient-level data from three randomised clinical trials (ISAR-TEST-3, ISAR-TEST-4 and LEADERS) comparing outcomes from BP-DES with DP-SES at four years. The primary endpoint (MACE) comprised cardiac death, MI, or target lesion revascularisation (TLR). Secondary endpoints were TLR, cardiac death or MI, and definite or probable stent thrombosis. Of 497 patients with STEMI, 291 received BP-DES and 206 DP-SES. At four years, MACE was significantly reduced following treatment with BP-DES (hazard ratio [HR] 0.59, 95% CI: 0.39-0.90; p=0.01) driven by reduced TLR (HR 0.54, 95% CI: 0.30-0.98; p=0.04). Trends towards reduction were seen for cardiac death or MI (HR 0.63, 95% CI: 0.37-1.05; p=0.07) and definite or probable stent thrombosis (3.6% vs. 7.1%; HR 0.49, 95% CI: 0.22-1.11; p=0.09).. In STEMI, BP-DES demonstrated superior clinical outcomes to DP-SES at four years. Trends towards reduced cardiac death or myocardial infarction and reduced stent thrombosis require corroboration in specifically powered trials.

Topics: Absorbable Implants; Aged; Antibiotics, Antineoplastic; Coronary Artery Disease; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus; Thrombosis; Treatment Outcome

To assess the clinical outcome at 1-year follow-up of real-world patients with long coronary lesions treated with the 38 mm Xience Prime (Abbott Vascular) everolimus-eluting stent (EES).. Long-lesions present special challenges to the interventional cardiologists, including increased risk of restenosis, periprocedural injury, geographical miss, and stent deliverability. Indeed, results obtained with shorter stent in the treatment of simpler lesions are of limited applicability to longer stents.. Consecutive patients presenting with a long coronary lesion treated by percutaneous coronary intervention with at least one implanted 38 mm EES were enrolled in the study. Their clinical data were prospectively registered. Major adverse cardiac events (MACE) were defined as a composite of cardiac death, nonfatal myocardial infarction (according to the Universal Definition) and target vessel revascularization. Stent thrombosis was defined according to the Academic Research Consortium criteria.. Overall, 203 real-world patients (152 men, 68 ± 9 years) were enrolled in the P38 Study. At 1-year follow-up, 6 (3.0%) patients had died from cardiac causes, 7 (3.4%) had a nonfatal myocardial infarction and 8 (3.9%) underwent target vessel revascularization, yielding a 10.3% cumulative rate of MACE. Two patients had a stent thrombosis (one definite and one probable). No significant differences in event rates were found between patients with and without an additional stent implanted overlapping the 38 mm one.. The use of a new-generation polymer-based 38 mm EES in a real-world population with unselected long lesions is associated with excellent procedural results and good clinical outcomes at 12-month follow-up.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To compare the early clinical outcomes between ABSORB bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA) and cobalt chromium everolimus-eluting stents in real-world patients with mostly complex disease.. BVS represents the most interesting development in the drug-eluting stent field over recent years with promising results emerging from clinical trials. Available data however on the use of the ABSORB in real-world patients is limited.. All patients (n = 92) treated with BVS and 1296 patients treated with EES were included in this study. Propensity score matching was performed to adjust for differences in baseline clinical characteristics, yielding 92 patient pairs (BVS = 92 patients with 137 lesions and EES = 92 patients with 124 lesions). Clinical outcomes were examined between the 2 groups at 6-months.. In both groups, most lesions were classified as either B2 or C (83.9% vs. 77.4%, P = 0.19). Predilatation (97.8% vs. 75.8%, P < 0.01) as well as postdilation (99.3% vs. 77.4%, P < 0.01) was more common in the BVS group. Clinical outcomes at 6-months were similar between the two groups with respect to both target lesion revascularization (3.3% vs. 5.4%, P = 0.41) and major adverse cardiac events (defined as the composite of target vessel revascularization, follow-up myocardial infraction and all-cause death) (3.3% vs. 7.6%, P = 0.19).. ABSORB BVS for the treatment of complex lesions appears to be associated with good procedural and early clinical outcomes similar to those observed with conventional drug-eluting stents. Larger studies with long-term follow-up are required in order to fully assess the role of BVS in the treatment of such lesions and how this compares with that of conventional stents. © 2014 Wiley Periodicals, Inc.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Italy; Logistic Models; Male; Middle Aged; Myocardial Infarction; Propensity Score; Prosthesis Design; Retrospective Studies; Risk Factors; Sirolimus; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

We conducted a retrospective comparison of the long-term clinical and angiographic outcomes of 281 consecutive nonrandomized severely calcified lesions in 221 patients treated with a sirolimus-eluting stent (SES; CYPHER Bx VELOCITY) or a paclitaxel-eluting stent (PES; TAXUS Express) placed after rotablation between August 2004 and February 2009. The clinical safety endpoint, comprising the incidence of cardiac death, nonfatal recurrent myocardial infarction, and definite stent thrombosis, in 164 patients after exclusive SES placement (4.9 % with a mean clinical follow-up period of 1396 ± 763 days) was not significantly different from that after exclusive PES placement in 51 patients (2.0 %, 1011 ± 605 days; p = 0.364 and p < 0.001, respectively). The cumulative clinical safety endpoint-free ratio after exclusive SES placement was not significantly different from that after PES placement (p = 0.61, by log-rank test). The angiographic efficacy endpoint (binary restenosis: diameter stenosis >50 % at follow-up angiography) in the 169 lesions placed using SES (20.1 % with a mean angiographic follow-up period of 669 ± 605 days) was not significantly different from that in the 40 lesions using PES (17.5 %; 498 ± 320 days) (p = 0.707). In univariate analysis, SES use did not relate to the efficacy endpoint (p = 0.707). Thus, our small single-center study showed that the long-term clinical and angiographic outcomes after SES placements for severely calcified lesions after rotablation were not significantly different from those after PES placement.

Topics: Aged; Aged, 80 and over; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Retrospective Studies; Sirolimus; Treatment Outcome; Vascular Calcification

Advances in percutaneous coronary intervention (PCI) have improved the outcomes of patients with coronary artery diseases. The advent of drug-eluting stents (DES) has dramatically reduced the rate of revascularization. The first-generation DES has yielded the main role of PCI to the second-generation DES; however, many patients had been implanted with the first-generation DES, sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). Therefore, it is of importance to detect the long-term clinical outcomes in patients who underwent PCI with SES or PES. We analyzed data from our PCI cohort who underwent PCI with first-generation DES at Juntendo University Hospital between August 2004 and June 2010. The index procedure was analyzed when patients underwent multiple PCIs. Patients who were implanted with both SES and PES were excluded from this study. The study ended on December 31, 2011. The primary outcome was a composite of all-cause mortality and acute coronary syndrome (ACS). The secondary outcome was the rate of target lesion revascularization (TLR) and stent thrombosis. We analyzed data from 861 consecutive patients who underwent implantation of SES or PES. The median follow-up period was 1671 days (interquartile range 1081 and 2105). Kaplan-Meier curves for the primary endpoint did not significantly differ between the two groups (p = 0.8). The incidence of stent thrombosis was 1.4 and 1.8 per 1,000 person-years in the SES and PES groups, respectively (p = 0.9). The rate of TLR was significantly lower in the SES, than the PES group (12.6 and 38.3 per 1,000 person-years, p = 0.03). The rate of TLR was lower in the group treated with SES than PES, but the primary outcome comprising all-cause mortality and ACS was comparable between the two groups.

Topics: Acute Coronary Syndrome; Aged; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Mortality; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Thrombosis; Treatment Outcome

To report the six-month angiographic and two-year clinical outcome data from the first-in-man study with the Ultimaster DES, a thin-strut cobalt-chromium sirolimus-eluting stent (SES) with an innovative abluminal-gradient-coated bioresorbable polymer.. CENTURY is a multicentre, single-arm, prospective study that enrolled 105 patients (113 lesions) with coronary artery disease. All patients were scheduled to have an angiographic follow-up at six months, while 45 and 20 patients respectively had IVUS and OCT assessments. The primary endpoint was six-month in-stent late lumen loss. Secondary endpoints included clinical, IVUS and OCT outcomes. Clinical follow-up is available up to two years and will continue up to five years. Procedural success was 97.1% and device success was 100%. Angiographic late loss at six months was 0.04±0.35 mm, also reflected in a low binary restenosis rate of 0.9% and confirmed by IVUS-assessed neointimal volume obstruction of 1.02±1.62%. The mean strut coverage assessed by OCT was 96.2% with 1.66±4.02 malapposed stent struts. There were no deaths in the study, three (2.9%) periprocedural and one (0.9%) spontaneous myocardial infarction, not related to the target vessel. At one and two years, the target lesion failure rate was 3.8% and 5.7%, while the TLR rate was 1.9% and 2.8%, respectively. There was one acute definite stent thrombosis.. The Ultimaster™ novel bioresorbable polymer sirolimus-eluting stent demonstrated good performance, including high procedural success and strong suppression of neointimal proliferation at six months. Good safety and effectiveness were shown up to two years in the studied population.

Topics: Absorbable Implants; Aged; Antibiotics, Antineoplastic; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Ischemia; Neointima; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Sirolimus; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Everolimus drug-eluting stents (EES) are superior to early-generation drug-eluting stents (DES), releasing sirolimus (SES) or paclitaxel (PES) in preventing stent thrombosis (ST). Since an impaired LVEF seems to increase the risk of ST, we aimed to investigate the difference in outcome of patients with varying LVEF using EES versus early-generation DES.. In a prospective cohort study, we compared the risk of ST in patients in three LVEF subgroups: normal (LVEF >50%), mildly impaired (LVEF >40% and ≤50%) and moderate-severely impaired (LVEF ≤40%). Within these various LVEF groups, we compared EES with SES and PES after adjustment for baseline differences.. We assessed a cohort of 5363 patients, with follow-up of up to 4 years and available LVEF. Overall definite ST occurred in 123 (2.3%) patients. ST rates were higher in the LVEF moderate-severely impaired group compared with the normal LVEF group (2.8% vs 2.1%; HR 1.82; CI 1.10 to 3.00). Especially early ST (EST) was more frequent in the moderate-severely impaired LVEF group (HR 2.20; CI 1.06 to 4.53). Overall rates of definite ST were lower in patients using EES compared with patients using SES or PES in all LVEF groups. Interaction terms were not statistically significant. ST rates were higher in the moderate-severely impaired LVEF group compared with the normal LVEF group when using SES or PES, but not significantly different when using EES.. EES was associated with a lower risk of definite ST compared with early-generation DES. This lower risk was independent of LVEF, even though ST rates were higher in patients with a moderate-severely impaired LVEF.. MEC-2013-262.

Topics: Cardiovascular Agents; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Humans; Incidence; Kaplan-Meier Estimate; Percutaneous Coronary Intervention; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Severity of Illness Index; Sirolimus; Stroke Volume; Switzerland; Time Factors; Treatment Outcome; Ventricular Dysfunction, Left; Ventricular Function, Left

Bioresorbable vascular scaffolds (BVS) have become an emerging tool to treat coronary artery disease. However, the current use of BVS is still widely restricted to stable patients and non-complex lesions. In real-world practice patients are far more complex than those with simple type A lesions and the extended use of BVS to complex lesions and high-risk patients needs to be evaluated. Therefore, we sought to investigate the feasibility and performance of BVS in a broad spectrum of patients.. 106 patients underwent in total 193 BVS implantations. We assessed the device-related (cardiac death, target vessel myocardial infarction, ischemia-driven target lesion revascularization) and patient-related (all-cause death, any reinfarction and any revascularization) composite outcomes.. 90 % of patients (n = 95) had at least one of the following characteristics: >65 years (35 %), ACS (42 %), tortuous vessels (13 %), calcified (17 %) or thrombotic lesions (12 %), lesions defined as AHA type B2/C (42 %), bifurcations (16 %), chronic total occlusions (9 %) or restenosis (14 %). There was no evidence of significant edge dissection, huge thrombus load or incidence of scaffold dislodgement or scaffold disruption in optical coherence tomography pullbacks. Out of 10,157 struts evaluated within 1,117 cross-sections, 302 were classified as malapposed (2.9 %). During a mean follow-up of 147 ± 119 days the rate of device-related events was 2.0 %, whereas patient-related composite events occurred in 6.1 %.. Our results strongly suggest that BVS implantation is feasible in a wide spectrum of patients and complex anatomy of coronary lesions. Long-term outcome of BVS should be further investigated in unrestricted settings in randomized controlled trials.

Topics: Absorbable Implants; Adult; Aged; Blood Vessel Prosthesis; Coronary Artery Disease; Drug-Eluting Stents; Equipment Failure Analysis; Everolimus; Feasibility Studies; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Prosthesis Design; Retrospective Studies; Sirolimus; Switzerland; Tissue Scaffolds; Treatment Outcome