sirolimus and Acute-Coronary-Syndrome

Biodegradable polymer biolimus-eluting stents (BP-BES) may be associated with better outcomes in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) compared to other current-generation limus-eluting stents (LES).. To compare BP-BES with other current-generation LES in ACS patients undergoing PCI.. We pooled individual data of Non-ST-segment elevation (NSTE)-ACS patients from two large randomized controlled trials (GLASSY and TWILIGHT). The BP-BES groups consisted mostly of GLASSY patients, while the control group (other current-generation LES) included exclusively TWILIGHT patients. The primary outcome was major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, or stent thrombosis; the key secondary outcome was target-vessel failure (TVF). To account for trial design differences, outcomes were assessed at 3 months (short-term) and between 3 and 12 months (long-term) after PCI and subsequently pooled to estimate the 12-month hazards.. Of 7107 and 6053 NSTE-ACS patients included in the short- and long-term analysis, 32.7% and 36.5% received a BP-BES, respectively. Risk of MACE associated with BP-BES versus other LES was similar at short-term (1.1% vs 1.3%, adjusted HR 0.86, 95%CI 0.53-1.38), lower at long-term (1.7% vs 3.1%, adjusted HR 0.49, 95%CI 0.34-0.72), and lower in the entire 12-month period (pooled adjusted HR 0.61, 95%CI 0.45-0.82). The cumulative 12-month risk of TVF was reduced with BP-BES (adjusted HR 0.52, 95%CI 0.38-0.70).. BP-BES was associated with lower 12-month risks of MACE and TVF compared to other current generation LES among NSTE-ACS patients treated with abbreviated or standard ticagrelor-based DAPT. These non-randomized findings are hypothesis-generating.. Differences in clinical outcomes may exist between biodegradable polymer biolimus-eluting stents (BP-BES) and other current-generation limus-eluting stent (LES) in patients with acute coronary syndrome (ACS). We pooled individual data of about 7000 Non-ST-segment elevation ACS patients undergoing PCI and treated with ticagrelor with or without aspirin from two large randomized controlled trials (GLASSY and TWILIGHT). BP-BES patients derived very largely from GLASSY and other LES patients from TWILIGHT. In this population, BP-BES compared to other current generation LES, were associated with a lower 12-month risk of major adverse cardiovascular events and target-vessel failure.

Topics: Absorbable Implants; Acute Coronary Syndrome; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Sirolimus; Stents; Ticagrelor; 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

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 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

In the drug-eluting stent (DES) era, patients with acute coronary syndrome (ACS) had a higher risk of early stent thrombosis compared with stable patients. The present study aimed to evaluate whether the same is true for the bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA, USA).. We assessed the relationship between the incidence of definite/probable scaffold thrombosis (ScT) (overall ScT and early ScT) and ACS percentage with the latest publications, including the most recent large randomised controlled trials. Out of a total study population of 13,708 devices in 45 trials, overall ScT was observed in 185 devices (1.35%) at a weighted mean follow-up period of 9.4 months, while early ScT was reported in 125 devices (0.97%) out of 12,896 devices in 44 trials. Meta-regression analysis demonstrated no significant correlation between overall/early ScT and the percentage of patients with ACS (overall ScT: R2=0.030, p=0.255; early ScT: R2=0.067, p=0.090).. ACS appeared to have little impact on the incidence of ScT after the implantation of BVS. Further clinical study is warranted to investigate the predictors of ScT using multivariate analysis with sufficient statistical power.

Topics: Absorbable Implants; Acute Coronary Syndrome; Coronary Angiography; Drug-Eluting Stents; Female; Humans; Incidence; Male; Myocardial Infarction; Sirolimus; Thrombosis; Treatment Outcome

Device technology in interventional cardiology is continuously evolving. Self-expandable (SE) coronary artery stents were the first device to be implanted within a human coronary artery. However, because of their initial limitations, balloon-expandable (BE) stents were predominantly developed and used in the last 30 years. Unfortunately, in challenging anatomical settings such as bifurcation lesions, large, ectatic or aneurysmal vessels, tapered vessels or vasoconstricted arteries, outcomes with BE stents are not always optimal. The Stentys (Stentys SA, Paris, France) SE nitinol stents were initially developed for the treatment of coronary bifurcation lesions. The understanding of the underlying mechanism involved in incomplete stent apposition and subsequent stent thrombosis led to the introduction of self-apposing stents in the treatment of acute coronary syndrome in order to overcome the limitations of drug-eluting stents in presence of high thrombus burden. In this regard, Stentys allows a progressive stent expansion which could reduce the rates of incomplete stent apposition by conforming to vascular remodeling. Enhancing the advantages of this technology by adding the release of an antiproliferative drug to prevent restenosis is even more attractive and potentially effective. Recently, the results of the new Stentys sirolimus-eluting stent have been reported. This article provides an overview of the pathobiological rational, device characteristics and results of the new Stentys self-expandable sirolimus-eluting stent.

Topics: Acute Coronary Syndrome; Alloys; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus

Despite drug eluting stents (DES), as compared to bare metal stents, have reduced in-stent restenosis, complex and long lesions remains a challenge for interventional cardiologist. Their treatment is often associated with an unfavorable outcome, related to in-stent restenosis, stent thrombosis, and target lesion revascularization. These complications may derive from the contact between metallic structures and coronary artery endothelium, and consequent overexpression of platelet activating factors, growth factors, and inflammatory cytokines. Recently, an additional mechanism has emerged as new cause of these complications: "stent fracture." Several factors are involved in this phenomenon including material and stent platform, target vessel features, stent implantation technique, and implant duration. We reported a case of 69 years old man with rare early and complex DES fractures on right coronary that caused acute coronary syndrome 36 hr after a previous percutaneous coronary intervention.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Stenosis; Device Removal; Drug-Eluting Stents; Follow-Up Studies; Humans; Italy; Male; Myocardial Infarction; Prosthesis Failure; Retreatment; Risk Assessment; Sirolimus; Treatment Outcome

To compare the efficacy of rapamycin-eluting stents (RES) and paclitaxel-eluting stents (PES) in patients undergo percutaneous coronary intervention.. RES and PES differ significantly with respect to polymer coating and antiproliferative drugs. It is not yet clear whether there are any differences between RES and PES with regard to clinical outcomes.. Systematic searches were conducted of randomized, controlled trials (RCTs) comparing RES with PES in Medline and the Cochrane Database of systematic reviews. A meta-analysis was done of all available randomized studies comparing PES with RES. Information on study design, inclusion and exclusion criteria, number of patients and clinical outcomes was extracted by two investigators. Disagreements were resolved by consensus. The primary outcome was reintervention, target lesion revascularization (TLR) and target vessel revascularization (TVR). Stent restenosis, myocardial infarction (MI) and all-cause mortality were secondary endpoints.. Twenty-one RCTs of RES versus PES with a total number of 10,147 patients were included in this meta-analysis. Indication for angioplasty was either acute coronary syndrome or stable angina. The mean follow-up period ranged from 6 to 24 months. The rates of TLR were 4.9% vs. 7.0%; p = 0.0009 and the rates of TVR were 5.1 vs. 8.3%; p < 0.001 for RES vs. PES, respectively. The incidence of stent restenosis was 3.9% for RES vs. 5.3% for PES; p = 0.004. Rates of MI and all-cause mortality were comparable.. This meta-analysis demonstrates that, as compared to PES, RES seems to be associated with a lower risk of reintervention and stent restenosis. The risk of MI and all-cause death was similar between the two stents.

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Coronary Restenosis; Drug-Eluting Stents; Follow-Up Studies; Humans; Myocardial Infarction; Paclitaxel; Randomized Controlled Trials as Topic; Risk Factors; Sirolimus; Treatment Outcome

To evaluate by optical coherence tomography neointimal healing response after implantation of cobalt-chromium-based titanium-nitride-oxide-coated (TiNO) stents and platinum-chromium-based biodegradable-polymer-coated everolimus-eluting stents (EES) in patients with acute coronary syndrome.. Patients were randomized (1:1) to receive either a TiNO-stent or EES. Optical coherence tomography images were obtained at 30-day (cohort A, n = 52) and 6-month (cohort B, n = 30) follow-up. The primary endpoint was the percentage of uncovered struts per patient.. In cohort A, the percentage of uncovered struts was lower with TiNO-stents vs EES (3.2% vs 19.6%, P <.001). The percentage of malapposed struts was 0.4% in the TiNO-group and 2.1% in the EES group (P <.001). In cohort B, the percentage of uncovered struts was also lower with TiNO-stents (0.0% vs 8.7%, (P <.001). The percentage of malapposed struts was 0% in the TiNO-stent group and 0.3% in the EES group, (P=.008). None of the patients had repeat revascularization during the 6 months of follow-up.. Following percutaneous intervention for acute coronary syndrome, TiNO stent implantation was associated with a lower percentage of uncovered and malapposed struts per patient, compared with EES, at early and mid-term follow-up. This study is registered under ClinicalTrials.gov, with number NCT02464397.

Topics: Acute Coronary Syndrome; Chromium; Coronary Vessels; Drug-Eluting Stents; Everolimus; Humans; Nitric Oxide; Percutaneous Coronary Intervention; Sirolimus; Titanium; Tomography, Optical Coherence; 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 (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

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

This study aimed to compare the strut coverage between Orsiro ultrathin struts biodegradable polymer sirolimus-eluting stents (O-SES) and Xience thin struts durable polymer everolimus-eluting stents (X-EES) in acute coronary syndrome (ACS) patients using optical coherence tomography (OCT). In BIOSTEMI trial, O-SESs were superior to X-EESs with respect to target lesion failure in ACS patients. However, there were few reports comparing intravascular imaging between the two stents in ACS. Between August 2016 and February 2020, 49 lesions from 49 ACS patients who underwent OCT-guided percutaneous coronary intervention were enrolled. We compared vascular healing using OCT between O-SESs and X-EESs at 8 months after stenting. The protocol was approved by the Osaka Rosai Hospital ethics committee. Among 49 lesions, the X-EES group consisted of 24 lesions and the O-SES of 25 lesions. The percentage of covered strut, the percentage of malapposed strut and mean neointimal thickness at 8 months were evaluated. In the 8-month OCT analysis, the proportion of covered strut was significantly higher in the O-SES group than in in the X-EES group (97.3% vs. 92.5%; p = 0.010). On the other hand, there were no significant differences in the frequency of malapposed strut (0.4% vs 0.3%, p = 0.609). The O-SES group had the significantly thinner neointima compared to the X-EES group (60 μm vs 84 μm, p = 0.001). Compared to X-EESs, O-SESs showed better strut coverage and thinner neointima in ACS patients at 8 months follow-up. Ultra-thin strut and silicon carbide passive coating may play a key role in better vascular healing.

Topics: Absorbable Implants; Acute Coronary Syndrome; Coronary Vessels; Drug-Eluting Stents; Humans; Neointima; Percutaneous Coronary Intervention; Polymers; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Comparative data of durable polymer (DP) versus biodegradable polymer (BP) drug-eluting stents (DES) are limited in patients presenting with acute coronary syndrome (ACS) undergoing complex percutaneous coronary intervention (PCI).. We sought to evaluate the efficacy and safety of DP-DES and BP-DES in ACS patients receiving complex PCI.. This study was a post hoc analysis of the HOST-REDUCE-POLYTECH-ACS trial. ACS patients were randomly assigned 1:1 to DP-DES or BP-DES in the HOST-REDUCE-POLYTECH-ACS trial. Complex PCI was defined as having at least 1 of the following features: ≥3 stents implanted, ≥3 lesions treated, total stent length ≥60 mm, bifurcation PCI with 2 stents, left main PCI, or heavy calcification. Patient-oriented (POCO, a composite of all-cause death, non-fatal myocardial infarction, and any repeat revascularisation) and device-oriented composite outcomes (DOCO, a composite of cardiac death, target vessel myocardial infarction, or target lesion revascularisation) were evaluated at 12 months.. Among 3,301 patients for whom full procedural data were available, 1,140 patients received complex PCI. Complex PCI was associated with higher risks of POCO and DOCO. The risks of POCO were comparable between DP-DES and BP-DES in both the complex (HR 0.87, 95% confidence interval [CI]: 0.57-1.33; p=0.522) and non-complex (HR 0.83, 95% CI: 0.56-1.24; p=0.368; p for interaction=0.884) PCI groups. DOCO was also not significantly different between DP-DES and BP-DES in both the complex (HR 0.74, 95% CI: 0.43-1.27; p=0.278) and non-complex (HR 0.67, 95% CI: 0.38-1.19; p=0.175; p for interaction=0.814) PCI groups.. In ACS patients, DP-DES and BP-DES showed similar clinical outcomes irrespective of PCI complexity.

Topics: Absorbable Implants; Acute Coronary Syndrome; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

Early inflammation following acute ST-segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PCI) affects myocardial infarct (MI) size and left ventricular remodeling. The mammalian target of rapamycin (mTOR) is involved in the enhanced inflammatory response and its inhibition has exerted beneficial effects on MI size in preclinical models of acute MI.. The CLEVER-ACS (Controlled Level Everolimus in Acute Coronary Syndromes) trial evaluated the effects of targeting inflammation by mTOR inhibition in patients with STEMI undergoing PCI.. CLEVER-ACS was a randomized, multicenter, international, double-blind, placebo-controlled trial. A total of 150 patients with STEMI undergoing PCI were randomly assigned to oral everolimus (days 1-3: 7.5 mg daily; days 4-5: 5.0 mg daily) or placebo for 5 days. The primary endpoint was the change in MI size. The secondary endpoint was the change in microvascular obstruction (MVO) from baseline (12 hours to 5 days after PCI) to 30 days as assessed by cardiac magnetic resonance imaging.. The changes in MI size from baseline to 30 days, the primary endpoint, were -14.2 g (95% CI: -17.4 to -11.1 g) and -12.3 g (95% CI: -16.0 to -8.7 g) in the everolimus and placebo groups (P = 0.99). Corresponding changes in MVO were -4.8 g (95% CI: -6.7 to -2.9 g) and -6.3 g (95% CI: -8.7 to -4.0 g) in the everolimus and placebo groups (P = 0.14). Adverse events did not differ between the study groups.. Among STEMI patients undergoing PCI, early mTOR inhibition with everolimus did not reduce MI size or MVO at 30 days. (CLEVER-ACS [Controlled Level Everolimus in Acute Coronary Syndromes; NCT01529554).

Topics: Acute Coronary Syndrome; Everolimus; Humans; Inflammation; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus; ST Elevation Myocardial Infarction; TOR Serine-Threonine Kinases; Treatment Outcome

Thin-strut biodegradable polymer sirolimus-eluting stents (BP-SES) have been shown to reduce target lesion failure (TLF) at one-year follow-up compared with durable polymer everolimus-eluting stents (DP-EES) among patients with acute coronary syndrome (ACS). The long-term clinical benefits of thin-strut BP-SES over DP-EES in ACS patients after complete degradation of the polymer coating remain uncertain.. We performed a post-hoc subgroup analysis of ACS patients included into the BIOSCIENCE randomized trial (NCT01443104). The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction or clinically indicated target lesion revascularization, at 5 years.. Among 2119 patients enrolled between March 2012 and May 2013, 1131 (53%) presented with ACS. The 5-year cumulative incidence of TLF was significantly lower in patients with ACS compared to chronic coronary syndrome [16.5% vs. 22.9%; rate ratio (RR), 0.69; 95% confidence interval (CI), 0.57-0.85; p < 0.001]. At 5 years, TLF occurred similarly in ACS patients treated with BP-SES and DP-EES (16.9% vs. 16.0%; RR, 1.04; 95% CI, 0.78-1.41; p = 0.78). The individual components of the primary endpoint did not differ between ACS patients treated with BP-SES or DP-EES at 5 years. Overall, there was no interaction between clinical presentation and treatment effect.. In a subgroup analysis of the BIOSCIENCE trial, we found no difference in long-term outcomes between ACS patients treated with BP-SES or DP-EES at 5 years.

Topics: Absorbable Implants; Acute Coronary Syndrome; Drug-Eluting Stents; Everolimus; Humans; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Sirolimus; Treatment Outcome

Topics: Acute Coronary Syndrome; Aged; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Incidence; Male; Middle Aged; Percutaneous Coronary Intervention; Postoperative Hemorrhage; Republic of Korea; Risk Factors; Sirolimus; Ticagrelor; Time Factors

This study was conducted to use optical coherence tomography (OCT) to compare vascular healing between bioresorbable polymer (BP) and durable polymer (DP) everolimus-eluting stents (EES) in patients with acute coronary syndromes (ACS).. Whether BP-EES induce better vascular healing compared to contemporary DP-EES remains controversial, especially for ACS.. In this prospective, randomized, non-inferiority trial, we used OCT to compare 6-month vascular healing in patients with ACS randomized to BP versus DP-EES: percent strut coverage (primary endpoint, non-inferiority margin of 2.0%) and neointimal thickness and percent neointimal hyperplasia (NIH) volume. As an exploratory analysis, morphological factors related to the endpoints and the effect of underlying lipidic plaque on stent healing were evaluated.. Six-month strut coverage of BP-EES was not non-inferior compared to those of DP-EES in ACS patients. Good stent apposition and expansion were independently associated with better vascular healing.

Topics: Absorbable Implants; Acute Coronary Syndrome; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

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

A recent clinical trial demonstrated that optical frequency domain imaging (OFDI) guidance in percutaneous coronary intervention (PCI) is noninferior to intravascular ultrasound (IVUS) guidance in patients with coronary artery disease with regard to target vessel failure (composed of cardiac death, myocardial infarction attributed to the target vessel, and clinically-driven target vessel revascularization) at 12 months. The impact of OFDI guidance in PCI for patients with acute coronary syndrome (ACS) remains uncertain.. OPINION ACS is a multicenter, prospective, randomized, controlled, open-label, parallel group, non-inferiority trial in Japan. Eligible patients will be randomly assigned to receive either OFDI- or IVUS-guided PCI. PCI is performed using the sirolimus-eluting stent in accordance with certain OFDI and IVUS criteria for optimal stent deployment. All patients will undergo follow-up angiography and OFDI imaging at 8 months. The primary endpoint is the minimum lumen area, as measured by OFDI at 8 months.. The OPINION ACS trial outcomes will provide insights regarding the impact of OFDI-guided PCI on in-stent restenosis at 8 months in patients with ACS.

Topics: Acute Coronary Syndrome; Aged; Drug-Eluting Stents; Equivalence Trials as Topic; Female; Humans; Japan; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Randomized Controlled Trials as Topic; Sirolimus; Surgery, Computer-Assisted; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Discontinuing aspirin after short-term dual antiplatelet therapy (DAPT) was evaluated as a bleeding reduction strategy. However, the strategy of ticagrelor monotherapy has not been exclusively evaluated in patients with acute coronary syndromes (ACS).. To determine whether switching to ticagrelor monotherapy after 3 months of DAPT reduces net adverse clinical events compared with ticagrelor-based 12-month DAPT in patients with ACS treated with drug-eluting stents.. A randomized multicenter trial was conducted in 3056 patients with ACS treated with drug-eluting stents between August 2015 and October 2018 at 38 centers in South Korea. Follow-up was completed in October 2019.. Patients were randomized to receive ticagrelor monotherapy (90 mg twice daily) after 3-month DAPT (n = 1527) or ticagrelor-based 12-month DAPT (n = 1529).. The primary outcome was a 1-year net adverse clinical event, defined as a composite of major bleeding and adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, or target-vessel revascularization). Prespecified secondary outcomes included major bleeding and major adverse cardiac and cerebrovascular events.. Among 3056 patients who were randomized (mean age, 61 years; 628 women [20%]; 36% ST-elevation myocardial infarction), 2978 patients (97.4%) completed the trial. The primary outcome occurred in 59 patients (3.9%) receiving ticagrelor monotherapy after 3-month DAPT and in 89 patients (5.9%) receiving ticagrelor-based 12-month DAPT (absolute difference, -1.98% [95% CI, -3.50% to -0.45%]; hazard ratio [HR], 0.66 [95% CI, 0.48 to 0.92]; P = .01). Of 10 prespecified secondary outcomes, 8 showed no significant difference. Major bleeding occurred in 1.7% of patients with ticagrelor monotherapy after 3-month DAPT and in 3.0% of patients with ticagrelor-based 12-month DAPT (HR, 0.56 [95% CI, 0.34 to 0.91]; P = .02). The incidence of major adverse cardiac and cerebrovascular events was not significantly different between the ticagrelor monotherapy after 3-month DAPT group (2.3%) vs the ticagrelor-based 12-month DAPT group (3.4%) (HR, 0.69 [95% CI, 0.45 to 1.06]; P = .09).. Among patients with acute coronary syndromes treated with drug-eluting stents, ticagrelor monotherapy after 3 months of dual antiplatelet therapy, compared with ticagrelor-based 12-month dual antiplatelet therapy, resulted in a modest but statistically significant reduction in a composite outcome of major bleeding and cardiovascular events at 1 year. The study population and lower than expected event rates should be considered in interpreting the trial.. ClinicalTrials.gov Identifier: NCT02494895.

Topics: Acute Coronary Syndrome; Aspirin; Cardiovascular Diseases; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Sirolimus; Ticlopidine

Complete revascularization in patients with an acute coronary syndrome and multivessel disease is superior compared to culprit-only treatment. However, it is unknown whether direct complete or staged complete revascularization should be pursued.. The BIOVASC study is an investigator-initiated, prospective, multicenter, randomized, 2-arm, international, open-label, noninferiority trial. We will randomize 1,525 patients 1:1 to immediate complete revascularization (experimental arm) or culprit-only plus staged complete revascularization (control arm). Patients will be enrolled in approximately 30 sites in Belgium, Italy, the Netherlands, and Spain. The primary end point is a composite of all-cause mortality, nonfatal myocardial infarction, any unplanned ischemia-driven revascularization (excluding staged procedures in the control arm at the predetermined time), and cerebrovascular events (MACCE) at 1 year post index procedure.. The BIOVASC study aims to further refine the treatment algorithm for acute coronary syndrome patients with multivessel disease in terms of optimal timing for complete revascularization (Clinicaltrials.gov NCT03621501).

Topics: Absorbable Implants; Acute Coronary Syndrome; Drug-Eluting Stents; Equivalence Trials as Topic; Humans; Multicenter Studies as Topic; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Randomized Controlled Trials as Topic; Sirolimus

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

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

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

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

Ticagrelor monotherapy after short-term dual-antiplatelet therapy (DAPT) may optimize ischemic and bleeding risks, particularly for acute coronary syndrome (ACS) patients, because its strategy is less potent than ticagrelor-based DAPT but more potent than aspirin or clopidogrel monotherapy.. The TICO randomized open-label trial will evaluate whether ticagrelor monotherapy following 3-month DAPT is superior to 12-month ticagrelor-based DAPT in terms of net adverse clinical events (NACE) including efficacy and safety in ACS patients treated with ultrathin bioresorbable polymer sirolimus-eluting stents (BP-SES). Patients undergoing BP-SES implantation for ACS treatment will be randomized in a 1:1 fashion to the (1) ticagrelor monotherapy group after 3-month DAPT; or the (2) 12-month DAPT group. The primary endpoint is NACE within 12 months of percutaneous coronary intervention, which includes major adverse cardiac and cerebrovascular events (MACCE) plus major bleeding as defined by Thrombolysis in Myocardial Infarction. MACCE includes the composite of all-cause death, myocardial infarction, stent thrombosis, stroke, and target vessel revascularization. Secondary endpoints included each component of the primary endpoint.. The TICO trial is an ongoing trial evaluating the efficacy and safety of ticagrelor monotherapy following 3-month DAPT exclusively in ACS patients treated with uniform BP-SES. It may provide novel insights regarding the need for adjusted use of DAPT for rebalancing risk-benefit in current practice and changing from the conventional concept of aspirin maintenance to a ticagrelor-based regimen in the management of ACS.

Topics: Acute Coronary Syndrome; Adult; Aged; Coronary Angiography; Drug-Eluting Stents; Dual Anti-Platelet Therapy; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Sirolimus; Ticagrelor; Treatment Outcome; Young Adult

Coronary bifurcations are encountered in about 15% to 20% of percutaneous coronary interventions (PCIs). They are considered technically challenging and associated with worse clinical outcomes than nonbifurcation lesions. The BiOSS LIM C is a dedicated bifurcation balloon expandable stent made of cobalt-chromium alloy (strut thickness 70 μm) releasing sirolimus (1.4 μg/mm) from the surface of a biodegradable coating comprised of a copolymer of lactic and glycolic acids.. The aim of the randomized, multicenter, open-label, controlled POLBOS III trial is to compare BiOSS LIM C with limus second-generation drug-eluting stents (DES) in the treatment of non-left main stem coronary bifurcations (ClinicalTrials.gov NCT03548272).

Topics: Acute Coronary Syndrome; Chromium; Cobalt; Coronary Stenosis; Drug-Eluting Stents; Humans; Multicenter Studies as Topic; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Research Design; Self Expandable Metallic Stents; Sirolimus; 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

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

Topics: Acute Coronary Syndrome; Cardiovascular Agents; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Hemorrhage; Humans; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

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

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

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

Presentation with acute coronary syndromes (ACS) constitutes a high-risk subset of patients with worse outcome after percutaneous coronary intervention. We report clinical outcomes in subjects with ACS from the BIOFLOW V trial (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) comparing an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent (BP-SES) with a thin strut (81 μm) durable polymer everolimus-eluting stent (DP-EES).. Among 1334 patients randomized to 2:1 treatment with either BP-SES or DP-EES, 677 (50.7%) ACS patients without ST-segment-elevation myocardial infarction (MI; 454 BP-SES and 223 DP-EES) were identified in the retrospective post hoc analysis. The primary end point of 12-month target lesion failure, individual component end points, and stent thrombosis were evaluated. Recurrent MI was defined as a ≥50% increase of creatine kinase-myocardial band or in the absence of creatine kinase-myocardial band, troponin >50% increase over previous level and >3× the upper limit of normal). All events were adjudicated by a blinded independent clinical events committee. Overall, baseline clinical, angiographic, and procedural characteristics of the ACS population were similar between the 2 treatment groups. At 12 months, target lesion failure occurred in 5.6% (24/426) of BP-SES patients versus 11.0% (23/209) in DP-EES patients ( P=0.02); target lesion failure composite components were cardiac death, 0% versus 1.0% ( P=0.11); target vessel-related MI, 3.5% versus 9.7% ( P=0.003); and clinically driven target lesion revascularization, 2.8% versus 3.4% ( P=0.80). Spontaneous target vessel MI was 0.5% (2/425) for BP-SES versus 2.4% (5/206) for DP-EES ( P=0.041). Stent thrombosis rates at 1 year were similar (0.5% versus 1.0%; P=0.601).. In the ACS subgroup population of the BIOFLOW V study, treatment with BP-SES compared with DP-EES was associated with a significantly lower rate of 12-month target lesion failure, a difference driven by significantly lower periprocedural MI and spontaneous MI. These findings support treatment with an ultrathin strut BP-SES in ACS patients undergoing percutaneous coronary intervention.. URL: https://www.clinicaltrials.gov . Unique identifier: NCT02389946.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Cardiovascular Agents; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

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 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

Long-term outcome of drug-eluting stents (DES) for ST-elevation myocardial infarction (STEMI) versus non-ST-elevation acute coronary syndrome (NSTE-ACS) remains unclear. This study sought to compare the long-term outcomes of biodegradable polymer-coated DES in patients with STEMI versus NSTE-ACS.. We explored a post hoc analysis of the 5-year outcome of the CREATE trial in the subgroup of patients with STEMI (n=318) versus NSTE-ACS (n=1223) who were implanted with biodegradable polymer-coated DES. The primary outcome was the rate of major adverse cardiac events (MACE) at 5 years. Clopidogrel and aspirin for 6 months followed by chronic aspirin therapy were recommended.. STEMI patients showed a trend of increase in MACE (8.7% vs. 6.8%, log rank p=0.289) compared to NSTE-ACS patients at 5 years, and a greater risk of cardiac death (5.4% vs. 2.1%, log rank p=0.003), mainly driven by the higher cardiac death rate within the first month after stent placement (log rank p=0.003) and the last year of follow-up (log rank p=0.001). No significant difference in stent thrombosis was found between them (3.1% vs. 2.5%, log rank p=0.653). Prolonged clopidogrel therapy (>6 months) showed no effect on risk of MACE or stent thrombosis between the two groups (both p for interaction >0.1).. STEMI patients have a higher risk of cardiac mortality compared with NSTE-ACS patients after biodegradable polymer-coated DES placement, primarily attribute to more cardiac deaths that happened within the first month after the event and the last year of follow-up.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Anti-Bacterial Agents; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Polymers; Sirolimus; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome

Although a true clinical challenge, high bleeding risk patients with an acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) have never been specifically studied. Leaders Free ACS, a pre-specified Leaders Free sub-study, determined efficacy, and safety of a combination of 1-month dual anti-platelet therapy (DAPT) with implantation of either a polymer-free Biolimus-A9-coated stent (BA9-DCS) or a bare-metal stent (BMS) in these patients.. Leaders Free included 2466 patients undergoing PCI who had at least 1 of 13 pre-defined factors for an increased bleeding risk. Of these, 659 ACS patients were included in this analysis (BA9-DCS 330, BMS 329). At 12-month follow-up, treatment with the BA9-DCS was more effective (clinically driven target-lesion revascularization 3.9 vs. 9.0%, P = 0.009) and safer (cumulative incidence of cardiac death, myocardial infarction, or definite or probable stent thrombosis 9.3 vs. 18.5%, P = 0.001), driven by significantly lower rates of cardiac mortality (3.4 vs. 6.9%, P = 0.049) and myocardial infarction (6.9 vs. 13.8%, P = 0.005).. We believe that the results of this sub-analysis from the Leaders Free trial are likely to significantly impact clinical practice for high bleeding risk patients presenting with an ACS: the use of a BMS can, in our view, no longer be recommended, and, given the paucity of available data for second-generation DES with shortened DAPT in these patients, the BA9-DCS should currently be considered as the device with the strongest evidence to support its use for this indication.

Topics: Acute Coronary Syndrome; Aged; Double-Blind Method; Drug Therapy, Combination; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Hemorrhage; Humans; Immunosuppressive Agents; Male; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Risk Factors; Sirolimus; ST Elevation Myocardial Infarction; 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

The aim of the present study was to evaluate vascular healing of the bioengineered COMBO Dual Therapy Stent compared with a cobalt-chromium (CoCr) everolimus-eluting stent (EES) as assessed by optical coherence tomography in patients with acute coronary syndromes.. CD34+ cells promote endothelial repair after vascular injury. The bioengineered COMBO Dual Therapy Stent combines CD34+ cell-capturing technology with abluminal sirolimus release, but more data from clinical studies evaluating the vascular response are needed.. In a prospective randomized multicenter clinical trial, 60 patients with acute coronary syndromes were randomized 1:1 to COMBO or CoCr EES implantation. The primary endpoint was the percentage of uncovered stent struts per stent. Stent assessment by optical coherence tomography was performed at baseline and at 60 days, followed by independent core laboratory analysis.. The percentage of uncovered struts per stent was higher with the COMBO than the CoCr EES at 60 days (median 14.7% vs. 7.7%; p = 0.04). However, no significant difference in uncovered stent struts was observed in the strut level-based analysis at 60 days, which also accounted for clustering (COMBO vs. CoCr EES; 13.6% vs. 6.9%; p = 0.09; generalized linear mixed models-adjusted analysis). Neointimal thickness at 60 days was lower with the COMBO compared with the CoCr EES (median 30.17 vs. 50.26 μm; p = 0.02; stent-level analysis). There were no significant differences in the frequency of major adverse cardiac events and each component of major adverse cardiac events within the study population between the 2 groups at 30, 60, 180, 360, and 540 days post-procedure. No target vessel stent thrombosis has been documented within 540 days.. The present multicenter, prospective clinical study for the first time compared the vascular response of the bioengineered COMBO Dual Therapy Stent with a CoCr EES in patients early after acute coronary syndrome by using intracoronary optical coherence tomographic analysis. The percentage of uncovered stent struts per stent was somewhat higher after COMBO versus CoCr EES implantation as detected by optical coherence tomography, associated with reduced neointimal thickness.

Topics: Acute Coronary Syndrome; Aged; Antibodies; Antigens, CD34; Cardiovascular Agents; Chromium Alloys; Coronary Vessels; Drug-Eluting Stents; Endothelial Cells; 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; United States; 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

The GLOBAL LEADERS trial is a superiority study in patients undergoing percutaneous coronary intervention, with a uniform use of Biolimus A9-eluting stents (BES) and bivalirudin. GLOBAL LEADERS was designed to assess whether a 24-month antithrombotic regimen with ticagrelor and one month of acetylsalicylic acid (ASA), compared to conventional dual antiplatelet therapy (DAPT), improves outcomes.. Patients (n >16,000) are randomised (1:1 ratio) to ticagrelor 90 mg twice daily for 24 months plus ASA ≤100 mg for one month versus DAPT with either ticagrelor (acute coronary syndrome) or clopidogrel (stable coronary artery disease) for 12 months plus ASA ≤100 mg for 24 months. The primary outcome is a composite of all-cause mortality or non-fatal, new Q-wave myocardial infarction at 24 months. The key safety endpoint is investigator-reported class 3 or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) definitions. Sensitivity analysis will be carried out to explore potential differences in outcome across geographic regions and according to specific angiographic and clinical risk estimates.. The GLOBAL LEADERS trial aims to assess the role of ticagrelor as a single antiplatelet agent after a short course of DAPT for the long-term prevention of cardiac adverse events, across a wide spectrum of patients, following BES implantation.

Topics: Acute Coronary Syndrome; Adenosine; Adolescent; Adult; Aged; Aged, 80 and over; Aspirin; Drug Combinations; Drug-Eluting Stents; Female; Hemorrhage; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Sirolimus; Ticagrelor; Time; Treatment Outcome; Young Adult

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

In patients with coronary artery disease, treated with durable polymer-coated drug-eluting stents, the life-long presence of the polymer might delay arterial healing. Novel very thin strut biodegradable polymer stents, which leave only a bare metal stent after polymer resorption, might improve long-term outcome. We investigated in allcomers the safety and efficacy of three stents eluting either everolimus, sirolimus, or zotarolimus, often clinically used but never compared, of which the biodegradable polymer everolimus-eluting stent was never before assessed in allcomers.. The large-scale, investigator-initiated, multicentre, assessor and patient blinded, three-arm, randomised, BIO-RESORT non-inferiority trial was done at four clinical sites in the Netherlands. All-comer patients were aged 18 years or older, capable of providing informed consent, and required a percutaneous coronary intervention with drug-eluting stent implantation according to clinical guidelines or the operators' judgment. Exclusion criteria were: participation in another randomised drug or device study before reaching the primary endpoint of that study; planned surgery necessitating interruption of dual antiplatelet therapy within the first 6 months; known intolerance to components of the investigational product or medication required; uncertainty about the adherence to follow-up procedures or an assumed life expectancy of less than 1 year; or known pregnancy. Web-based computer-generated allocation sequences randomly assigned patients (1:1:1) to treatment with very thin strut biodegradable polymer everolimus-eluting or sirolimus-eluting stents (which differ substantially in type, amount, distribution, and resorption speed of their respective coating), or thin strut durable polymer zotarolimus-eluting stents. The primary endpoint was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularisation) at 12 months of follow up with a very thin strut biodegradable polymer of either everolimus-eluting or sirolimus-eluting stents, compared with durable polymer zotarolimus-eluting stents, analysed by intention to treat (non-inferiority margin 3·5%). This trial was registered with ClinicalTrials.gov, number NCT01674803.. From Dec 21, 2012, to Aug 24, 2015, 3514 patients were enrolled and analysed, of whom 2449 (70%) had acute coronary syndromes, which included 1073 (31%) ST-elevation myocardial infarctions. 12 month follow-up of 3490 (99%) patients (three lost to follow-up; 21 withdrawals) was available. The primary endpoint was met by 55 (5%) of 1172 patients assigned to everolimus-eluting stents, 55 (5%) of 1169 assigned to sirolimus-eluting stents and 63 (5%) of 1173 assigned to zotarolimus-eluting stents. Non-inferiority of the everolimus-eluting stents and sirolimus-eluting stents compared with zotarolimus-eluting stents was confirmed (both -0·7% absolute risk difference, 95% CI -2·4 to 1·1; upper limit of one sided 95% CI 0·8%, p. At 12 month follow-up, both very thin strut drug-eluting stents with dissimilar biodegradable polymer coatings (eluting either everolimus or sirolimus) were non-inferior to the durable polymer stent (eluting zotarolimus) in treating allcomers with a high proportion of patients with acute coronary syndromes. The absence of a loss of 1 year safety and efficacy with the use of these two biodegradable polymer-coated stents is a prerequisite before assessing their potential longer-term benefits.. Biotronik, Boston Scientific, and Medtronic.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Anti-Bacterial Agents; Coronary Disease; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Netherlands; Percutaneous Coronary Intervention; Polymers; Sirolimus; Treatment Outcome

Dual antiplatelet therapy (DAPT) is a fundamental treatment that optimizes clinical outcomes after percutaneous coronary intervention, especially in patients with acute coronary syndrome (ACS). Although current international guidelines recommend DAPT for at least 12 months after implantation of a drug-eluting stent in patients with ACS, these recommendations are not based on randomized controlled trials dedicated to ACS population.. The SMART-DATE trial is a prospective, multicenter, randomized, and open-label study to demonstrate the noninferiority of 6-month DAPT compared with 12 months or longer DAPT in patients with ACS undergoing percutaneous coronary intervention. A total of 2,700 patients will undergo prospective, random assignment to either of the DAPT duration groups. To minimize the bias from different stent devices, the type of stents will be randomly assigned (everolimus-eluting stents, zotarolimus-eluting stents, or biolimus A9-eluting stents). The primary end point is a composite of all-cause death, myocardial infarction, and cerebrovascular events at 18 months after the index procedure. The major secondary end points are definite/probable stent thrombosis defined by the Academic Research Consortium and bleeding defined by Bleeding Academic Research Consortium type 2-5.. The SMART-DATE randomized trial is the first study exploring the safety of 6-month DAPT compared with conventional 12-month or longer DAPT dedicated to patients with ACS after second-generation drug-eluting stent implantation.

Topics: Acute Coronary Syndrome; Adult; Aspirin; Clopidogrel; Drug Monitoring; Drug-Eluting Stents; Everolimus; Female; Hemorrhage; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Republic of Korea; Sirolimus; Ticlopidine; Time Factors; Treatment Outcome

To assess three-year clinical outcome following randomised use of the second-generation Resolute zotarolimus-eluting stent (ZES) and the XIENCE V everolimus-eluting stent (EES). For Resolute ZES and randomised use, outcome data ≥3 years are relatively scarce.. The TWENTE trial examined 1,391 patients with stable angina or non-ST-elevation acute coronary syndromes, of whom 21.6% were diabetics, 70.1% had complex B2 or C lesions and 77.4% had "off-label" indications for DES use. Three-year follow-up data were obtained in 1,381 patients (99.3%; 10 withdrawals). Adverse clinical events were independently adjudicated. The primary endpoint target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction and clinically indicated target vessel revascularisation, was 12.1% for Resolute ZES and 13.4% for XIENCE V EES (p=0.50). Cardiac death rates were 1.9% vs. 3.5% (p=0.06); the other individual components of TVF also showed no significant between-group differences. The rates of definite-or-probable stent thrombosis (1.4% vs. 1.6%, p=0.82) and very late stent thrombosis (0.6% vs. 0.4%, p=1.0) did not differ between the groups.. Three-year follow-up data of patients included in the randomised TWENTE trial demonstrated similar and sustained safety and efficacy of Resolute ZES and XIENCE V EES.

Topics: Acute Coronary Syndrome; Aged; Angina, Stable; Antineoplastic Agents; Cardiovascular Diseases; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Longitudinal Studies; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Percutaneous Coronary Intervention; Reoperation; Sirolimus; Thrombosis; Treatment Outcome

Patients at high bleeding risk would benefit from a shorter dual antiplatelet therapy after PCI. Compared to first-generation devices, the design of newer generation drug-eluting stents may facilitate more rapid anatomical and functional healing of stented vessel based on thinner stent platforms, biodegradable/biocompatible polymers and rapid drug elution.. Forty-four non-diabetic patients with acute coronary syndrome (ACS) and culprit lesion in the LAD were randomized to receive either biodegradable polymer sirolimus-eluting stent (BP-SES) or durable polymer zotarolimus-eluting stent (DP-ZES). Neointimal strut coverage was examined using optical coherence tomography, and vasodilator response on invasive thermodilution-derived coronary flow reserve (CFR) at 3-month follow-up. The primary endpoints were percent uncovered struts and CFR. A total of 425 cross-sections (4,897 struts) were analyzed in the BP-SES group, and 425 cross-sections (5,467 struts) in the DP-ZES group. The percent uncovered struts was lower in the BP-SES group compared with the DP-ZES group, both at strut level (3.9% vs. 8.9%, respectively, P<0.001), and stent level (3.9 ± 3.2% vs. 8.9 ± 6.9%, respectively, P=0.019). No significant difference was found between the 2 groups regarding CFR (3.0 ± 1.3 vs. 3.2 ± 1.0, respectively, P>0.05).. In non-diabetic patients with ACS, BP-SES provided slightly better stent strut coverage at 3 months compared with DP-ZES, but neither stent was fully covered. No difference in vasodilator response was seen.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Biodegradable Plastics; Double-Blind Method; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Prospective Studies; Sirolimus; Vasodilation

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

The aim of this substudy of the SORT OUT IV trial was to compare clinical outcomes among patients with acute coronary syndromes (ACS) and stable angina pectoris (SAP) treated with everolimus-eluting stents (EES) or sirolimus-eluting stents (SES).. We performed a post hoc subgroup analysis of data from SORT OUT IV. Of 2,705 patients, 1,178 (43.5%) patients had ACS and were treated with EES (n=580) or SES (n=598), and 1,527 (56.5%) patients had SAP and were treated with EES (n=773) or SES (n=754). The primary composite endpoint was major adverse cardiac events (MACE): cardiac death, myocardial infarction (MI), stent thrombosis, or target vessel revascularisation within 18 months. Hazard ratios (HR) and 95% confidence intervals (CI) were calculated for the endpoints. At 18-month follow-up, patients with ACS had higher rates of MACE compared to patients with SAP (8.1% versus 6.7%; HR=1.23, 95% CI: 0.93-1.62). MACE did not differ significantly between ACS patients treated with EES or SES (7.3% versus 8.9%; HR=0.81, 95% CI: 0.54-1.22) nor between SAP patients treated with EES or SES (6.9% versus 6.5%; HR=1.05, 95% CI: 0.71-1.55).. EES and SES performed similarly with respect to MACE at 18-month follow-up in patients with ACS and SAP.

Topics: Acute Coronary Syndrome; Aged; Angina, Stable; Chi-Square Distribution; Coronary Stenosis; Coronary Thrombosis; Denmark; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The use of drug-eluting stents (DES) in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) is controversial and not yet endorsed in clinical guidelines.. This was an a priori planned post hoc analysis involving 754 NSTE-ACS patients from the randomised BASKET-PROVE trial (sirolimus-eluting stent vs. everolimus-eluting stent vs. bare metal stent in large-vessel stenting). The primary endpoint was the combined two-year rate of cardiovascular death or non-fatal myocardial infarction (MI). Secondary endpoints were each component of the primary endpoint, and clinically indicated target vessel revascularisation (TVR) and stent thrombosis. Compared to patients with BMS, those treated with SES and EES had a strong trend towards lower two-year rates of the primary endpoint (HR: 0.31 [CI: 0.11-0.90], p=0.03, and HR: 0.74 [CI: 0.44-1.24], p=0.25), and of TVR (HR: 0.58 [CI: 0.29-1.15], p=0.12) and (HR: 0.52 [CI: 0.34-0.78], p=0.002). When the SES and EES groups were combined and compared to BMS, significant reductions in both cardiovascular death/MI and TVR were found.. Compared with BMS, use of DES in NSTE-ACS patients undergoing stent implantation in large vessels was associated with a reduction in both TVR and the combined endpoint consisting of cardiovascular death/MI. Thus, DES use improves both efficacy and safety. These findings support the use of DES in NSTE-ACS patients.

Topics: Acute Coronary Syndrome; Aged; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Proportional Hazards Models; Sirolimus; Stents; Thrombosis; Treatment Outcome

Coronary vasodilator dysfunction has been reported after drug-eluting stent (DES) implantation. Recent ESC guidelines suggest that transthoracic echocardiography (TTE) may be considered for assessment of coronary flow reserve (CFR) and microvascular disease in patients with stable angina, but its reliability has not been tested in patients with DES. We sought to assess the agreement between TTE (CFRTTE) and invasive thermodilution-derived CFR (CFRThermodilution) as well as their association with index of microcirculatory resistance (IMR) in mid-term follow-up after percutaneous coronary intervention for acute coronary syndrome.. CFRTTE and CFRThermodilution were assessed 3 months after DES implantation in the left anterior descending artery in 24 patients. Patients with haemodynamically significant epicardial stenosis (fractional flow reserve <0.75) were excluded. Correlation between the two methods was good (r = 0.71, P < 0.001), but CFRThermodilution (mean ± SD) tended to be higher (3.17 ± 1.00 vs. 2.87 ± 0.72; mean difference 0.29, 95% confidence interval -0.06 to 0.59). In Bland-Altman analysis, there was a trend towards a greater difference in the range of higher invasive values. Nevertheless, TTE was successful in discriminating moderately impaired CFR (≤2.5) (P = 0.001) and severely impaired CFR (≤2.0) (P < 0.001) when compared with an invasive method. No association between either CFR measurements vs. IMR measurement was detected, suggesting that in addition to microcirculatory function, CFR also accounts for epicardial vasodilator function in the absence of haemodynamically significant stenosis.. TTE is a feasible and reliable method for the assessment of CFR and vasodilator dysfunction after DES implantation. Values obtained with this method successfully find abnormal CFR confirmed with the invasive thermodilution method.

Topics: Acute Coronary Syndrome; Coronary Circulation; Drug-Eluting Stents; Echocardiography; Female; Hemodynamics; Humans; Immunosuppressive Agents; Male; Microcirculation; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Risk Factors; Sirolimus; Thermodilution; Treatment Outcome; Vasodilation

To our knowledge, no randomised study has compared rates of uncovered stent struts in everolimus (EES) vs. new-generation zotarolimus-eluting (ZES-R) stents in acute coronary syndrome (ACS). The aim of our study was to evaluate the completeness of neointimal coverage with optical coherence tomography (OCT) in ACS patients treated with drug-eluting stents (DES) comparing EES versus new-generation ZES-R.. All eligible ACS patients admitted to four Italian centres with a clinical indication for culprit lesion intervention were randomised 1:1 to EES or ZES-R. The primary study endpoint was the percentage of uncovered stent struts evaluated by optical coherence tomography (OCT) at six months. Secondary endpoints were the percentage of malapposed stent struts, percent neointimal hyperplasia cross-sectional area (CSA) and major adverse cardiac events (MACE) at six months. A total of 60 patients were randomised to EES (n=29) or ZES-R (n=31). No differences were observed in baseline characteristics between the two groups. Overall, 31.7% presented with STEMI, of which 68.4% were anterior. The other patients comprised 41.7% NSTEMI and 26.7% troponin-negative ACS. A mean of 1.3±0.6 lesions were treated per patient, with a mean of 1.3±0.5 stents per lesion. At 30 days there was one sudden death. Six-month OCT analysis was performed in 25 lesions in the EES group and in 24 lesions in the ZES-R group. There was no difference in the primary endpoint of uncovered stent struts between groups (EES 6.42% [3.27, 9.57] vs. ZES-R 7.07% [3.22, 10.92]; p=0.80). Furthermore, there were no differences between groups in the percentage of malapposed stent struts, either with (EES 1.19% [0.34, 2.04] vs. ZES-R 0.85% [0.40, 1.30]; p=0.49) or without coverage (EES 1.06% [0.12, 2.01] vs. ZES-R 0.24% [0.05, 0.44]; p=0.09). Percent neointima CSA was similar in both groups (EES 37.0% [18.6, 55.3] vs. ZES-R 26.6% [18.4, 34.8]; p=0.31). At six-month clinical follow-up, no additional patients died or suffered MI. There were four MACE in the EES group and one in the ZES-R group.. In our study, in patients presenting with ACS, both EES and ZES-R had low percentages of malapposed and uncovered stent struts at six-month OCT analysis.

Topics: Acute Coronary Syndrome; Aged; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Single-Blind Method; Sirolimus; Tomography, Optical Coherence

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

Drug-eluting stents (DES) were first used on-label - in simple patients with low clinical risk and easily accessible lesions. Currently, DES are increasingly used off-label - in complex patients undergoing percutaneous coronary interventions (PCI) with historically higher event risk. Therefore, our aim was to investigate whether patients with off-label indications for DES use had similar outcomes compared to patients who were treated for on-label indications only. We analysed two-year follow-up data of 1,387 TWENTE trial patients, treated with second-generation everolimus-eluting XIENCE V or zotarolimus-eluting Resolute stents, and compared off-label vs. on-label DES use with regard to the following clinical endpoints: cardiac death, myocardial infarction (MI), periprocedural MI (≤48 hrs), and target vessel revascularisation (TVR). Patients with off-label DES use (n=1,033; 74.5%) had more diabetes (22.9% vs. 17.5%; p=0.032), previous MI (35.9% vs. 22.3%; p<0.001), type B2/C lesions (84.7% vs. 62.7%; p<0.001), and acute coronary syndromes (57.8% vs. 33.3%; p<0.001). Nevertheless, cardiac death and TVR rates were similar to those of patients with on-label DES use (p>0.8). Following off-label DES use, there was a higher incidence of PMI (5.0% vs. 1.4%; p=0.003), of which only 1.1% reached creatine kinase levels >5x the upper limit of normal (ULN). Despite differences in risk profile, patients with off-label DES use did not differ from patients with on-label DES use in clinical endpoints other than periprocedural MI. These largely positive findings underline the favourable safety profile of second-generation DES.

Topics: Acute Coronary Syndrome; Calcinosis; Creatine Kinase; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Female; Humans; Kidney Failure, Chronic; Male; Middle Aged; Myocardial Infarction; Off-Label Use; Patient Outcome Assessment; Percutaneous Coronary Intervention; Severity of Illness Index; Sirolimus

Outcome data are limited in patients with ST-segment elevation acute myocardial infarction (STEMI) or other acute coronary syndromes (ACSs) who receive a drug-eluting stent (DES). Data suggest that first generation DES is associated with an increased risk of stent thrombosis when used in STEMI. Whether this observation persists with newer generation DES is unknown. The study objective was to analyze the two-year safety and effectiveness of Resolute™ zotarolimus-eluting stents (R-ZESs) implanted for STEMI, ACS without ST segment elevation (non-STEACS), and stable angina (SA).. Data from the Resolute program (Resolute All Comers and Resolute International) were pooled and patients with R-ZES implantation were categorized by indication: STEMI (n=335), non-STEACS (n=1416), and SA (n=1260).. Mean age was 59.8±11.3 years (STEMI), 63.8±11.6 (non-STEACS), and 64.9±10.1 (SA). Fewer STEMI patients had diabetes (19.1% vs. 28.5% vs. 29.2%; P<0.001), prior MI (11.3% vs. 27.2% vs. 29.4%; P<0.001), or previous revascularization (11.3% vs. 27.9% vs. 37.6%; P<0.001). Two-year definite/probable stent thrombosis occurred in 2.4% (STEMI), 1.2% (non-STEACS) and 1.1% (SA) of patients with late/very late stent thrombosis (days 31-720) rates of 0.6% (STEMI and non-STEACS) and 0.4% (SA) (P=NS). The two-year mortality rate was 2.1% (STEMI), 4.8% (non-STEACS) and 3.7% (SA) (P=NS). Death or target vessel re-infarction occurred in 3.9% (STEMI), 8.7% (non-STEACS) and 7.3% (SA) (P=0.012).. R-ZES in STEMI and in other clinical presentations is effective and safe. Long term outcomes are favorable with an extremely rare incidence of late and very late stent thrombosis following R-ZES implantation across indications.

Topics: Acute Coronary Syndrome; Aged; Angina, Stable; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Sirolimus; Time Factors; Treatment Outcome

Incomplete stent endothelialization is associated with late and very late stent thrombosis. In a post hoc analysis of the BASE-ACS trial, we sought to assess neointimal coverage and coronary flow reserve (CFR) 9 months after implantation of titanium-nitride-oxide-coated bioactive stents (BAS) versus everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS). In the BASE-ACS trial, 827 patients with ACS were randomized to receive either BAS or EES. In the current study, we examined neointimal growth and strut coverage by optical coherence tomography and CFR by trans-thoracic echocardiography in 28 consecutive non-diabetic patients with the culprit lesion in the left anterior descending coronary artery. The primary endpoints were binary stent strut coverage and CFR at 9-month follow-up. A total of 13 patients were included in the BAS group (2,033 struts); 15 in the EES group (2,898 struts). Binary stent strut coverage was higher and malapposed struts lower with BAS versus EES (99.4 vs 89.2, and 0.2 vs 4.6%, respectively, p < 0.001 for both). Neointimal hyperplasia thickness was greater with BAS versus EES (274.2 vs 100.1 μm, respectively, p < 0.001). CFR was lower with EES versus BAS (2.2 ± 0.8 vs. 3.0 ± 0.5, respectively, p = 0.001). Abnormal CFR (<2.5) were detected in 10 patients in the EES group versus one in the BAS group (p = 0.002). The current study demonstrated that in patients with ACS, BAS resulted in improved neointimal stent strut coverage and better coronary vasodilator function as compared with EES at 9-month follow-up.

Topics: Acute Coronary Syndrome; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Circulation; Coronary Vessels; Drug-Eluting Stents; Echocardiography, Doppler, Color; Echocardiography, Doppler, Pulsed; Everolimus; Humans; Hyperplasia; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Single-Blind Method; Sirolimus; Stents; Time Factors; Titanium; Tomography, Optical Coherence; Treatment Outcome; Vasodilation

The BASE-ACS trial demonstrated an outcome of the titanium-nitride-oxide-coated bioactive stents (BAS) statistically non-inferior to that of the everolimus-eluting stents (EES) at 12-month follow-up in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of the BASE-ACS trial with particular focus on stent-oriented versus patient-oriented outcome at 24-month follow-up.. A total of 827 patients with ACS were randomly assigned to receive either BAS (417) or EES (410). Stent-oriented outcome was defined as a composite of cardiac death, target vessel-related non-fatal myocardial infarction, or ischemia-driven target lesion revascularization. Patient-oriented outcome was defined as a composite of all-cause death, any non-fatal myocardial infarction, or any revascularization.. Clinical follow-up for 24 months was completed in 406 (97.4%) patients in the BAS group and in 398 (97.1%) in the EES group. Stent-oriented outcome at 24-month follow-up occurred at similar frequencies in the two stent groups (10.1% for BAS versus 11.2% for EES, P=0.53). Likewise, patient-oriented outcome at 24-month follow-up was similar in the two groups (16.3% versus 19.8%, respectively, P=0.2).. In patients presenting with ACS, the rates of both stent-oriented and patient-oriented outcomes at 24-month follow-up in the BAS group were similar to those in the EES group.

Topics: Acute Coronary Syndrome; Aged; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Ischemia; Patient Outcome Assessment; Percutaneous Coronary Intervention; Prospective Studies; Single-Blind Method; Sirolimus; Stents; Titanium; 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

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

To compare clinical outcomes among patients with acute coronary syndrome treated with zotarolimus-eluting and sirolimus-eluting stents in the SORT OUT III trial.. Currently, only limited data allow direct comparison of clinical outcomes among patients with acute coronary syndrome treated with a second-generation drug-eluting stent (DES) eluting zotarolimus vs. a first-generation DES eluting sirolimus.. Patients with acute coronary syndrome (n=1052) were randomized to treatment with zotarolimus-eluting (n=506) or sirolimus-eluting (n=546) stents and followed for 18 months. The primary composite endpoint, major adverse cardiac events (MACE), was defined as a composite of cardiac death, myocardial infarction or target vessel revascularization.. Zotarolimus-eluting stent treatment compared to sirolimus-eluting stent treatment was associated with increased rates of MACE (8·7% vs. 5·0%; hazard ratio (HR), 1·78; 95% confidence interval (CI), 1·10-2·88; P=0·02) and TVR (6·8% vs. 3·9%; HR, 1·77; 95% CI, 1·03-3·04; P=0·04), while all-cause death, cardiac death, myocardial infarction and definite stent thrombosis did not differ significantly. In the same trial, stable angina pectoris patients (n=1206) were randomized to zotarolimus-eluting (n=614) and sirolimus-eluting (n=592) stents with similar results.. With and without acute coronary syndromes, patients treated with the sirolimus-eluting stent had better clinical outcomes than those treated with the zotarolimus-eluting stent.

Topics: Acute Coronary Syndrome; Angina, Stable; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Sirolimus; Treatment Outcome

Titanium-nitride-oxide-coated bioactive stents (BAS) have demonstrated a favourable outcome when compared with paclitaxel-eluting stents in patients with acute myocardial infarction (MI). In a prospective randomised non-inferiority study design, we compared the safety and efficacy of BAS versus everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS).. We randomised 827 patients with ACS (1:1) to either BAS (417) or EES (410). The primary endpoint was a composite of cardiac death, non-fatal MI or ischaemia-driven target lesion revascularisation (TLR) at 12-month follow-up. Analyses were performed by intention to treat. At 12-month follow-up, the primary composite endpoint occurred in 9.6% of patients in the BAS group and 9.0% of those in the EES group (HR [hazard ratio] 1.04, 95% CI [confidence interval] 0.81-1.32, p=0.81, p for non-inferiority =0.001). Non-fatal MI was significantly less frequent in the BAS as compared with the EES group (2.2% vs. 5.9%, p=0.007). However, the individual rates of cardiac death and ischaemia-driven TLR were similar between the two groups (1.9% vs. 1.0%, p=0.39, and 6.5% vs. 4.9%, p=0.37, respectively).. In patients presenting with ACS, BAS achieved a clinical outcome that was non-inferior to EES at 12-month follow-up.

Topics: Acute Coronary Syndrome; Adult; Aged; Angioplasty, Balloon, Coronary; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Platelet Aggregation Inhibitors; Prospective Studies; Sirolimus; Stents; Titanium

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

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

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

This study sought to compare the clinical outcomes of everolimus-eluting stents (EES) versus paclitaxel-eluting stents (PES) in patients with acute coronary syndromes (ACS) and stable coronary artery disease (CAD).. Although randomized trials have shown superiority of EES to PES, the safety and efficacy of EES in ACS is unknown.. We performed a patient-level pooled analysis from the prospective, randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV, and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) trials in which 2,381 patients with ACS and 4,404 patients with stable CAD were randomized to EES or to PES. Kaplan-Meier estimates of death, myocardial infarction (MI), ischemia-driven target lesion revascularization, and stent thrombosis were assessed at 2 years and stratified by clinical presentation (ACS vs. stable CAD).. At 2 years, patients with ACS compared with stable CAD had higher rates of death (3.2% vs. 2.4%, hazard ratio [HR]: 1.37 [95% confidence interval (CI): 1.02 to 1.85], p = 0.04) and MI (4.9% vs. 3.4%, HR: 1.45 [95% CI: 1.14 to 1.85], p = 0.02). In patients with ACS, EES versus PES reduced the rate of death or MI (6.6% vs. 9.3%, HR: 0.70 [95% CI: 0.52 to 0.94], p = 0.02), stent thrombosis (0.7% vs. 2.9%, HR: 0.25 [95% CI: 0.12 to 0.52], p = 0.0002), and ischemia-driven target lesion revascularization (4.7% vs. 6.2%, HR: 0.69 [95% CI: 0.48 to 0.99], p = 0.04). In patients with stable CAD, EES reduced the rate of death or MI (4.5% vs. 7.1%, HR: 0.62 [95% CI: 0.48 to 0.80], p = 0.0002), stent thrombosis (0.7% vs. 1.8%, HR: 0.34 [95% CI: 0.19 to 0.62], p = 0.0002), and ischemia-driven target lesion revascularization (3.9% vs. 6.9%, HR: 0.55 [95% CI: 0.42 to 0.73], p < 0.0001).. Treatment with EES versus PES provides enhanced safety and efficacy regardless of the acuity of the clinical syndrome being treated and appears to mitigate the increased risk of stent thrombosis associated with ACS. (A 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]; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions [SPIRIT III]; NCT00180479; 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 [SPIRIT IV]; NCT00307047; A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice: the COMPARE Trial [COMPARE]; NCT01016041).

Topics: Acute Coronary Syndrome; Antineoplastic Agents, Phytogenic; Confidence Intervals; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Male; Middle Aged; Netherlands; Odds Ratio; Paclitaxel; Sirolimus; Time Factors; Treatment Outcome; United States

We sought to evaluate the early drug-eluting stent (DES) era, characterized by widespread device use.. Contemporary clinical practice incorporating more selective DES use can only be assessed by understanding the early DES era.. All patients receiving DES during the first 3 waves of the Evaluation of Drug Eluting Stents and Ischemic Events (EVENT) Registry (2004-2006) were evaluated. The primary end point was a composite of death, myocardial infarction (MI), and urgent revascularization at discharge and death, MI, or target lesion revascularization (TLR) at 1 year. The composite end point at each time point was compared across waves. Multivariable logistic regression was used for in-hospital outcomes and multivariable Cox regression was used for 1-year end points.. Ninety-two percent of EVENT patients received at least one DES. One third of patients were treated for Acute Coronary Syndromes (ACS) (33.8%), and later waves included lower lesion complexity. Across waves there was more frequent clopidogrel loading, a decrease in heparin and an increase in bivalirudin use (all P < .01). The primary composite end point of in-hospital death, MI or urgent revascularization occurred in 7.2% of patients, and did not differ across waves. Despite remarkably high levels of routine DES usage, the composite end point of death, MI, or TLR at 1 year averaged 13.5% and did not differ across waves. After adjustment, no statistically significant effect of wave on composite bleeding (P = .068) as well as in-hospital TLR (P = .053) was noted. At 1 year, wave was associated with a lower likelihood of TLR in the adjusted model (HR 0.81, P = .03).. The high-adoption DES era was associated with favorable outcomes, decreasing bleeding rates and changes in antithrombotic approach.

Topics: Acute Coronary Syndrome; Coronary Restenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Hospital Mortality; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Paclitaxel; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome; United States

The effect of atorvastatin 10 mg vs 40 mg in clopidogrel resistance and clinical events after coronary stenting was compared in patients with acute coronary syndrome (ACS).. Platelet aggregation was measured before clopidogrel administration and 4 h, 24 h, 5 days, and 8 months later in 130 ACS patients. Stented patients were randomly assigned to atorvastatin either 10 mg (n=65) or 40 mg (n=65), and received an oral loading dose of 300 mg of clopidogrel followed by 75 mg/day for 8 months. Measurement of platelet aggregation was done by the turbimetric method. The mean % changes in inhibition of platelet aggregation were 35.5 +/-8.3, 50.9 +/-10.1, 38.3 +/-8.3, 40.0 +/-6.8 in the Atorvastatin 10 mg Group and 31.0 +/-7.6, 43.7 +/-9.8, 45.0 +/-10.3, 43.5 +/-7.8 (4 h, 24 h, 5 days, and 8 months, respectively, after 300 mg of clopidogrel pretreatment) in the Atorvastatin 40 mg Group with no significant differences between the 2 groups. Cardiovascular events showed no significant differences during the follow-up.. Atorvastatin 10 mg or 40 mg co-administered with clopidogrel for 8 months did not affect the antiplatelet potency of clopidogrel and showed no significant differences in the clinical events in ACS patients.

Topics: Acute Coronary Syndrome; Adult; Aged; Anticholesteremic Agents; Atorvastatin; Clopidogrel; Dose-Response Relationship, Drug; Drug Resistance; Drug Therapy, Combination; Drug-Eluting Stents; Female; Follow-Up Studies; Heptanoic Acids; Humans; Korea; Male; Middle Aged; Platelet Aggregation; Platelet Aggregation Inhibitors; Prospective Studies; Pyrroles; Single-Blind Method; Sirolimus; Ticlopidine; Time Factors

Ultra-thin strut polymer-free sirolimus-eluting stent (UPF-SES) have two novel characteristics, ultra-thin strut and polymer-free coating, which have the potential to achieve early re-endotherialization. However, a little is known whether early vascular healing of UPF-SES can be achieved in patients with acute coronary syndrome (ACS). The aim of this study was to evaluate the vascular healing after an implantation of UPF-SES in patients with ACS using optical coherence tomography (OCT) at 3 months after the stent implantation. From September 2020 and January 2021, a total of 31 consecutive patients presenting with ACS who underwent OCT-guided percutaneous coronary intervention (PCI) and 3 month follow-up OCT examination were enrolled in the USUI-ACS study. The endpoints of this study were neointimal strut coverage, malapposition, and mean neointimal hyperplasia (NIH) thickness at 3 month follow-up. Over a mean follow-up of 91 days after the initial PCI, the follow-up OCT was examined. The median percentage of covered struts was 98.4% and malapposed struts 0%, and the mean NIH thickness was 80 μm. UPF-SES exhibited an excellent early vascular healing at 3 months in patients with ACS.

Topics: Acute Coronary Syndrome; Coronary Vessels; Drug-Eluting Stents; Humans; Neointima; Percutaneous Coronary Intervention; Polymers; Sirolimus; Stents; Tomography, Optical Coherence; Treatment Outcome

Topics: Acute Coronary Syndrome; Angioplasty, Balloon; Angioplasty, Balloon, Coronary; Arteries; Coronary Angiography; Coronary Vessels; Humans; Sirolimus; 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

Cardiovascular disease (CVD) with significant involvement of coronary artery disease (CAD) remains a major cause of death and disability among the diabetic population. Although percutaneous coronary intervention (PCI) continues to evolve, type 2 diabetes mellitus (T2DM) is a well-established marker of poor clinical prognosis after PCI, which is mainly attributed to the rapid progression of atherosclerosis requiring recurrent revascularizations. Hence, the use of bioresorbable materials could provide some solution to this problem.. There were no significant differences between the diabetic and nondiabetic populations in primary endpoints or main secondary endpoints (TLF, scaffold restenosis, death from any reason, and other cardiovascular events) either in the Ultimaster or Magmaris group. At a 1-year-follow-up, the primary endpoint in the DM t.2 population was recorded in 2.7% Ultimaster vs. 5.1% Magmaris, respectively. At the same time, the TLF occurred in the diabetic group in 4.1% Magmaris and 3.3% in the Ultimaster arm, respectively.. Both, Ultimaster and Magmaris revealed relative safety and efficiency at a one-year follow-up in the diabetic population in ACS settings. The observed rates of TLF were low, which combined with a lack of in-stent thrombosis suggests that both investigated devices might be an interesting therapeutic option for diabetics with ACS. Nevertheless, further large randomized clinical trials are needed to confirm fully our results.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Thrombosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Magnesium; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Polymers; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The COMBO biodegradable polymer sirolimus-eluting stent includes endothelial progenitor cell capture (EPC) technology for rapid endothelialization, which may offer advantage in acute coronary syndromes (ACS). We sought to analyze the performance of the COMBO stent by ACS status and ACS subtype.. The COMBO collaboration (n = 3614) is a patient-level pooled dataset from the MASCOT and REMEDEE registries. We evaluated outcomes by ACS status, and ACS subtype in patients with ST segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) versus unstable angina (UA). The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Secondary outcomes included stent thrombosis (ST).. We compared 1965 (54%) ACS and 1649 (46.0%) non-ACS patients. ACS presentations included 40% (n = 789) STEMI, 31% (n = 600) NSTEMI, and 29% (n = 576) UA patients. Risk of 1-year TLF was greater in ACS patients (4.5% vs. 3.3%, HR 1.51 95% CI 1.01-2.25, p = 0.045) without significant differences in definite/probable ST (1.1% vs 0.5%, HR 2.40, 95% CI 0.91-6.31, p = 0.08). One-year TLF was similar in STEMI, NSTEMI, and UA (4.8% vs 4.8% vs. 3.7%, p = 0.60), but definite/probable ST was higher in STEMI patients (1.9% vs 0.5% vs 0.7%, p = 0.03). Adjusted outcomes were not different in MI versus UA patients.. Despite the novel EPC capture technology, COMBO stent PCI was associated with somewhat greater risk of 1-year TLF in ACS than in non-ACS patients, without significant differences in stent thrombosis. No differences were observed in 1-year TLF among ACS subtypes.

Topics: Acute Coronary Syndrome; Angina, Unstable; Coronary Thrombosis; Drug-Eluting Stents; Endothelial Progenitor Cells; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors

This study sought to evaluate the clinical outcomes of patients treated with magnesium-based bioresorbable scaffolds (MgBRS) in the context of acute coronary syndromes (ACS) at long-term follow-up (24 months). The study also aims to investigate the MgBRS performance by angiography and the healing and bioresorption pattern by optical coherence tomography (OCT) at 18 months.. Between December 2016 and December 2018, a total of 90 patients admitted for ACS and treated with MgBRS (Magmaris, Biotronik AG, Bülach, Switzerland) were enrolled in a multicenter prospective study. Clinical follow-up was performed in all patients at 24 months and angiographic and OCT follow-up in 51.5% of patients at 18 months. Serial OCT was available in 33 patients (36.7%).. At a 2-year follow-up, 88.8% were free of symptoms, no cardiac death was reported, and the device-oriented composite event (DOCE): consisting of cardiac death, target vessel myocardial infarction, and target lesion revascularization (TLR) was 13.3%. Stent thrombosis and TLR were observed in 2.2 and 11.1%, respectively. Binary restenosis was observed in 21.7% of cases and in-stent late lumen loss was 0.61 ± 0.75 mm. By serial OCT imaging, the minimal lumen area was significantly reduced greater than 40% (from 6.12 ± 1.59 to 3.5 ± 1.55 mm2, p < .001). At follow-up, area stenosis was 44.33 ± 23.07% and half of the patients presented indiscernible struts. The principal observed mechanism of restenosis was scaffold collapse.. At long-term follow-up, MgBRS implantation in ACS patients showed a high rate of DOCE, mainly caused by clinically driven TLR. MgBRS restenosis was caused by scaffold collapse in most of the cases.

Topics: Absorbable Implants; Acute Coronary Syndrome; Coronary Angiography; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Tomography, Optical Coherence; 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

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

Sirolimus-coated balloons (SCBs) represent a novel therapeutic option for both in-stent restenosis (ISR) and de novo coronary lesions treatment, especially in small vessels. Our registry sought to evaluate the procedural and clinical outcomes of such devices in a complex acute coronary syndrome (ACS) clinical setting.. In the SELFIE prospective registry, SCB showed a good safety and efficacy profile for the treatment of coronary lesions, both ISR and/or de novo in small vessels, in a complex ACS population of patients at the 11 ± 7 months follow-up.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Italy; Male; Outcome and Process Assessment, Health Care; Registries; Sirolimus; ST Elevation Myocardial Infarction

The goal of this study was to evaluate the performance of the Inspiron. It was a prospective, single-center registry. To represent clinical practice, all patients undergoing percutaneous coronary intervention were included in this registry. There were no exclusion criteria. Clinical follow-ups were performed at twelve months. The endpoints were the occurrence of all-cause death, definite stent thrombosis, and new revascularization.. Between November 2017 and May 2019, 790 patients were included (1067 lesions). The mean age was 60.42 ± 14.94 years, and 74.7% presented with acute coronary syndrome. Diabetes mellitus was present in 43.9% of patients, and previous myocardial infarction and previous percutaneous coronary intervention were present in 17.9% and 11.3%, respectively. Angiographic success was achieved in 99.1%. The incidence of all-cause death was 11.5% (6.2% in-hospital and 5.3% in the follow-up) and definitive stent thrombosis was 0.2%. New revascularization was performed in only 5.8% (target lesion revascularization: 2.2%; progression of disease in another lesion: 3.6%). Based on the multivariate regression analysis, only chronic renal failure was an independent predictor of adverse events (OR: 3.3; 95% CI: 1.22-8.92).. The result of this single-center registry demonstrates the safety and excellent performance of the Inspiron

Topics: Acute Coronary Syndrome; Biodegradable Plastics; Brazil; Chromium Alloys; Coated Materials, Biocompatible; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Outcome and Process Assessment, Health Care; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Registries; Reoperation; Sirolimus

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

This study aimed to evaluate real-world clinical outcome of patients needing short dual antiplatelet therapy (S-DAPT) following PCI with Ultimaster® thin-strut, biodegradable polymer sirolimus-eluting stent (BP-SES), which was supposed to induce faster stent endothelialization and reduce device thrombogenicity.. In this sub-group analysis of patients enrolled in the ULISSE registry, two groups were identified: 1) patients discharged with S-DAPT (≤3-month) due to high bleeding risk or need for urgent major non-cardiac surgery and 2) patients discharged with recommended DAPT (R-DAPT) duration (≥6-month). The primary ischemic-safety and bleeding-safety endpoints were TLF (composite of cardiac-death, target vessel MI, and clinically driven target lesion revascularization), and BARC major bleedings (≥type-3a) at 1-year follow-up. To account for events occurring before DAPT discontinuation we performed 3-month landmark analysis.. 82 patients (5%) were discharged with ≤3-month DAPT (57 ± 27 days), and 1558 patients (94%) were discharged with ≥6-month DAPT (318 ± 75 days). No significant differences between S-DAPT and R-DAPT group were observed in TLF at 1-year (7.9% vs. 4.6%). The rate of BARC major bleeding resulted significantly higher in S-DAPT group (3.9% vs. 0.3%; p = 0.001), with the majority of bleeding events occurring within 3 months. The landmark analysis showed no significant differences in BARC major bleedings between groups (1.4% vs. 0.3%; p = 0.142).. As compared to those treated with R-DAPT (≥6-month), patients needing -S-DAPT (≤3-month) after PCI with Ultimaster® BP-SES had similar rates of 1-year TLF and BARC major bleedings following early DAPT discontinuation.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Aged, 80 and over; Drug-Eluting Stents; Follow-Up Studies; Humans; Immunosuppressive Agents; Italy; Middle Aged; Platelet Aggregation Inhibitors; Polymers; Registries; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

We aimed to corroborate clinical evidence on the safety and efficacy of the ultrathin-strut biodegradable-polymer sirolimus-eluting Orsiro stent in an all-comer population including high-risk subgroups.. The nationwide, prospective, all-comer BIOFLOW-III Satellite Registry was conducted at 18 Italian sites. High-risk subgroups [diabetes, small vessels (≤2.75 mm), acute myocardial infarction (AMI), and chronic total occlusions (CTOs)] were prespecified. The primary endpoint was target lesion failure (TLF) at 12 months, a composite of cardiac death, target vessel myocardial infarction (MI), emergent coronary artery bypass graft, and clinically driven target lesion revascularization (TLR).. In all, 601 patients were enrolled (31.9% diabetes, 34.6% AMIs) with 736 lesions (37.2% small vessels, 5.7% CTOs, and 15.5% bifurcation lesions). Cumulative TLF rate at 12 months was 4.6% [95% confidence interval (CI) 3.2-6.6]: 6.9% (95% CI 4.1-11.6) in the diabetic patients, 5.0% (95% CI 2.7-9.1) in acute MI subgroup, 4.2% (95% CI 2.3-7.7) in small vessels, and 5.3% (95% CI 1.4-19.7) in CTOs. At 18-month follow-up, TLF, target vessel revascularization, and clinically driven TLR rates in the overall population were 5.2% (95% CI 3.7-7.4), 1.8% (95% CI 1.0-3.3), and 1.6% (95% CI 0.8-3.1), respectively. Probable stent thrombosis rate was 0.5% (95% CI 0.1-1.4), whereas no definite stent thrombosis was observed.. The study results confirmed the excellent clinical performance of the Orsiro drug-eluting stents at 18 months in the whole all-comer population and in the prespecified high-risk subgroups.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Italy; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome

To report long-term results of a novel sirolimus-eluting stent with biodegradable polymer BACKGROUND: Newer generation drug-eluting stents are characterized by thin struts, improved platform design and highly biocompatible polymer carrying the antiproliferative drug. The RapstromTM stent, sharing these features, showed promising outcomes in preclinical models and in a first-in-man trial.. The present study is a multicenter, non-randomized post-market registry, including patients with de novo coronary artery disease treated with implantation of one or more Rapstrom stents. Primary endpoint of the study was the rate of major adverse cardiac events (MACE) at three-year follow-up.. 1073 patients were enrolled, with a high prevalence of diabetes (35%) and acute coronary syndrome at presentation (82%); at three-year follow up, MACE rate was 14.8%, with a low incidence of definite or probable stent thrombosis (0.75%).. These data confirm the good clinical performance of the Rapstrom stent, supporting the concept that the combination of thin struts and biodegradable polymer is associated with positive clinical outcomes.

Topics: Absorbable Implants; Acute Coronary Syndrome; Cardiovascular Agents; Comorbidity; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Humans; Incidence; Percutaneous Coronary Intervention; Prevalence; Product Surveillance, Postmarketing; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The optimal approach to coronary bifurcation treatment by percutaneous coronary intervention (PCI) is still a subject of debate, and dedicated bifurcation stents are one of the proposed solutions.. The aim of this report was to assess the effectiveness and safety profile of a new dedicated bifurcation stent - sirolimus-eluting BiOSS LIM C® (Balton, Poland) at the first three months of a 12-month registry.. This is a two-centre registry, which enrolled patients with non-ST elevation acute coronary syndrome (NSTE-ACS) and stable angina. Provisional T-stenting is the obligatory strategy of the treatment. Angiographic control is planned at 12 months. The primary endpoint is the cumulative rate of cardiac death, myocardial infarction (MI), and target lesion revas-cularisation (TLR) at 12 months.. A total of 48 patients with lesions in coronary bifurcations were enrolled (mean age 67.9 ± 8.9 years, 14.6% female). There were 20.8% of patients with NSTE-ACS, 93.8% with hypertension, 35.4% with diabetes, 52.1% had previous MI, and 47.9% and 14.6% underwent prior PCI and coronary artery bypass grafting, respectively. The device success rate was 100%. The side branch was treated with an additional classical drug-eluting stent implantation in 18.8% of cases. The periprocedural MI (MI type 4a) was observed in two (4.2%) cases. At three months there was one (2.1%) case of TLR. No death, MI, or stent thrombosis were observed in the follow-up period.. Bifurcation treatment with a single dedicated bifurcation stent (BiOSS LIM C®) is feasible and highly successful (100% implantation success rate). The short-term clinical outcomes are very promising, also in distal left main stenosis. The 12-month observations are pending.

Topics: Acute Coronary Syndrome; Aged; Angina, Stable; Chromium; Cobalt; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Poland; Registries; Sirolimus; Treatment Outcome

This study sought to determine the 1-year clinical effectiveness and safety of a biodegradable, polymer-containing Biolimus A9™-eluting stent (BES) in Korean patients with acute coronary syndrome (ACS).. A total of 1000 ACS patients with 1251 lesions who underwent implantation of BESs at 22 centers in Korea were enrolled between May 2011 and July 2013. We assessed major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinical-driven target vessel revascularization at 12 months.. Patient mean age was 62.6±11.4 years. 72.8% of the patients were male, 28.5% had diabetes, 32.8% had multi-vessel disease (MVD), and 47.9% presented with acute MI (AMI). The mean global registry of acute coronary events risk score of all patients was 103.0±27.6. The number of stents per patient was 1.3±0.6. The incidences of MACE and definite stent thrombosis at 12 months were 3.9% and 0.2%, respectively. On multivariate Cox-regression analysis, age ≥65 years was identified as an independent predictors of 1-year MACE (hazard ratio=2.474; 95% confidence interval=1.202-5.091). Subgroup analyses revealed no significant differences in the incidence of MACE between patients with and without diabetes (4.3% vs. 3.7%, p=0.667), between those who presented with and without AMI (4.4% vs. 3.4%, p=0.403), and between those with and without MVD (4.6% vs. 3.5%, p=0.387).. Our study demonstrated excellent 1-year clinical outcomes of BES implantation in patients at low-risk for ACS.

Topics: Acute Coronary Syndrome; Aged; Drug-Eluting Stents; Female; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Proportional Hazards Models; Republic of Korea; Sirolimus; Time Factors; Treatment Outcome

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

Topics: Absorbable Implants; Acute Coronary Syndrome; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Polymers; Sirolimus

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

Women with acute myocardial infarction (MI) undergoing mechanical reperfusion remain at increased risk of adverse cardiac events and mortality compared with their male counterparts. Whether the benefits of new-generation drug-eluting stents (DES) are preserved in women with acute MI remains unclear.. To investigate the long-term safety and efficacy of new-generation DES vs early-generation DES in women with acute MI.. Collaborative, international, individual patient-level data of women enrolled in 26 randomized clinical trials of DES were analyzed between July and December 2016. Only women presenting with an acute coronary syndrome were included. Study population was categorized according to presentation with unstable angina (UA) vs acute MI. Acute MI included non-ST-segment elevation MI (NSTEMI) or ST-segment elevation MI (STEMI).. Randomization to early- (sirolimus- or paclitaxel-eluting stents) vs new-generation (everolimus-, zotarolimus-, or biolimus-eluting stents) DES.. Composite of death, MI or target lesion revascularization, and definite or probable stent thrombosis at 3-year follow-up.. Overall, the mean age of participants was 66.8 years. Of 11 577 women included in the pooled data set, 4373 (37.8%) had an acute coronary syndrome as clinical presentation. Of these 4373 women, 2176 (49.8%) presented with an acute MI. In women with acute MI, new-generation DES were associated with lower risk of death, MI or target lesion revascularization (14.9% vs 18.4%; absolute risk difference, -3.5%; number needed to treat [NNT], 29; adjusted hazard ratio, 0.78; 95% CI, 0.61-0.99), and definite or probable stent thrombosis (1.4% vs 4.0%; absolute risk difference, -2.6%; NNT, 46; adjusted hazard ratio, 0.36; 95% CI, 0.19-0.69) without evidence of interaction for both end points compared with women without acute MI (P for interaction = .59 and P for interaction = .31, respectively). A graded absolute benefit with use of new-generation DES was observed in the transition from UA, to NSTEMI, and to STEMI (for death, MI, or target lesion revascularization: UA, -0.5% [NNT, 222]; NSTEMI, -3.1% [NNT, 33]; STEMI, -4.0% [NNT, 25] and for definite or probable ST: UA, -0.4% [NNT, 278]; NSTEMI, -2.2% [NNT, 46]; STEMI, -4.0% [NNT, 25]).. New-generation DES are associated with consistent and durable benefits over 3 years in women presenting with acute MI. The magnitude of these benefits appeared to be greater per increase in severity of acute coronary syndrome.

Topics: Acute Coronary Syndrome; Aged; Angina, Unstable; Antineoplastic Agents, Phytogenic; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Middle Aged; Mortality; Myocardial Infarction; Myocardial Revascularization; Non-ST Elevated Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Randomized Controlled Trials as Topic; Recurrence; Sirolimus; ST Elevation Myocardial Infarction; Treatment Outcome

First-generation drug-eluting stents (DES) have reduced short-term stent failure as compared to bare-metal stents due to the inhibition of neointima hyperplasia, but instead increased the risk of very-late stent failure. Although better outcomes have been reported for second-generation DES than for first-generation DES, the difference in the angioscopic findings at 1-year follow-up has not been adequately elucidated among second-generation DES.. Consecutive 161 patients who received angioscopic examination at 1 year after implantation of second-generation DES, i.e. Nobori biolimus-eluting stents (Terumo, Tokyo, Japan) (N-BES, n=25), Xience everolimus-eluting stents (Abbot Vascular, Santa Clara, CA, USA; X-EES, n=95), or Resolute zotarolimus-eluting stents (Resolute Integrity; Medtronic, Minneapolis, MN, USA; R-ZES, n=41), in de novo native coronary lesions were analyzed.. Maximum neointima coverage grade (N-BES, 0.9±0.3; X-EES, 1.2±0.4; R-ZES, 1.5±0.5; p<0.001) was the highest in R-ZES and lowest in N-BES. Heterogeneity score was higher in R-ZES than in N-BES (N-BES, 0.8±0.4; X-EES, 0.9±0.4; R-ZES, 1.1±0.5; p=0.007). Maximum yellow color grade and prevalence of thrombus were not different. Multivariate analysis demonstrated that only stent type was associated with maximum neointima coverage grade; stent type and total stent length were associated with heterogeneity score; and stenting for acute coronary syndrome (ACS) and total stent length were associated with maximum yellow color grade.. Neointima coverage and heterogeneity were mainly determined by stent type even among second-generation DES, while yellow color was determined mainly by whether target lesion was of ACS.

Topics: Acute Coronary Syndrome; Aged; Aged, 80 and over; Angioscopy; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Neointima; Sirolimus; Thrombosis; 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 purpose of this registry is to report the immediate and long-term safety and efficacy of the Biotronik Orsiro stent in an unselected population during everyday practice.. Between May 2012 and June 2013, 246 consecutive coronary angioplasty procedures were performed using at least one Orsiro drug-eluting stent, in 225 patients and 303 lesions.. Diabetes was present in 34.7% of patients. Procedures were non-elective percutaneous coronary intervention (PCI) in 17.1% of cases and acute coronary syndromes were 55.1%. Radial vascular access was used in 78% of cases, multivessel PCI was performed in 19.5% of the procedures. In 81.6% of cases lesions were B2/C type, 20.7% of procedures had bifurcation lesions. Procedural success was 99.6%. No acute thrombosis occurred. Clinical follow-up median period was 24.3 (±8.28) months and FU was available in 93.7% of patients. Death for any cause occurred in 11 patients (5.2%), 6 of them were non cardiac-related. Cardiac-related death rate was 2.4%. Two patients had in-stent restenosis. The overall target lesion failure rate was 3.3%.. This observational data regards our experience with Biotronik Orsiro stent in an unselected population. This initial data, although limited by a mainly clinical follow-up and restricted number of patients, confirms the good clinical performance of this sirolimus-eluting stent with a biodegradable polymer in everyday practice, including complex lesions, according to current larger studies in the literature.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Registries; Sirolimus; Treatment Outcome

Comparative data on long-term safety and efficacy of bioresorbable-polymer-BES versus durable-polymer-EES/ZES in ACS setting have hitherto been lacking. We sought to assess the safety and efficacy of bioresorbable-polymer-biolimus-A9-eluting stents (BES) compared with thin-strut-durable-polymer-everolimus- and zotarolimus-eluting stents (EES/ZES) in patients with acute coronary syndrome (ACS) undergoing PCI.. Between 2007 and 2012, 1,547 patients were implanted with new-generation drug-eluting stents (DES). Out of these, 369 received BES and 1,178 EES/ZES. The primary endpoint was probable/definite stent thrombosis (ST) while the secondary endpoint was a composite of all-cause death, myocardial infarction (MI), target vessel revascularization (TVR) and definite ST up to 5 years. As stent assignment was not random, we performed a propensity score matching (PSM), with 1:3 ratio, to account for potential confounders. Primary analysis demonstrated no significant differences between both groups for the primary endpoint of ST (BES vs.. 1.6% vs. 1.9%; mean-event-time = 1,797 days vs. 1,795 days, respectively; P = 0.75) and composite safety endpoint (BES vs.. 12.5% vs. 12.9%; mean-event-time = 1,631 days vs. 1,620 days, respectively; P = 0.88). Results regarding the 5-year-ST- and safety endpoint remained non-significant after PSM (P = 0.85, P = 0.56; respectively). After stratification based on cardiovascular risk, no difference regarding ST and composite outcome measure has been documented between both stent groups in high-risk- and low-risk patients. The type of stent did neither predict ST (HR 1.11, 95%CI 0.45-2.74, P = 0.82) nor composite safety endpoint (HR 0.93, 95%CI 0.67-1.30, P = 0.69).. Long-term safety and efficacy of bioresorbable-polymer-BES and durable-polymer-EES/ZES appear comparable in patients with ACS. © 2016 Wiley Periodicals, Inc.

Topics: Absorbable Implants; Acute Coronary Syndrome; Coronary Angiography; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Middle Aged; Polymers; Prosthesis Design; Retrospective Studies; Sirolimus; Treatment Outcome

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

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

Topics: Acute Coronary Syndrome; Antineoplastic Agents; Coronary Angiography; Coronary Thrombosis; Drug Therapy, Combination; Drug-Eluting Stents; Everolimus; Humans; Immunosuppressive Agents; Male; Middle Aged; Platelet Aggregation Inhibitors; Prosthesis Failure; Sirolimus; Tomography, Optical Coherence

The aim was to assess the effectiveness and safety profile of a new dedicated bifurcation stent - sirolimus-eluting BiOSS LIM® (Balton, Poland) in 12-month Registry.. The optimal approach to coronary bifurcations treatment by percutaneous coronary intervention (PCI) has been still a subject of debate. Dedicated bifurcation stents are one of the proposed solutions.. This was the international, 3-center registry, which enrolled patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) and stable angina. Provisional T-stenting was the obligatory strategy of the treatment. Angiographic control was planned at 12 months. The primary endpoint was cumulative rate of death, myocardial infarction (MI) and target lesion revascularization (TLR) at 12 months.. A total of 60 patients with coronary bifurcations were enrolled (mean age 66.4 ± 11 years, 28.3% of female). There were 21.7% of patients with NSTE-ACS, 78.3% with hypertension, 38.3% with diabetes, 28.3% had previous MI, and 46.7% and 10% underwent prior revascularization, respectively, PCI and coronary artery bypass graft. The device success rate was 100%. Side branch was treated with an additional classical drug-eluting stent implantation in 23.3% of cases. At 12 months, the cumulative major adverse cardiovascular events rate was 11.7%. During follow-up (11 ± 1 months) there was 1 non-cardiac death (1.7%), 1 non-ST-elevated myocardial infarction (1.7%) due to restenosis and no case of stroke or in-stent thrombosis. Overall TLR was 8.3% (clinically driven TLR - 1.7%, angiographically driven - 6.6%). Mean late lumen loss was as follows: In main vessel - 0.35 ± 0.33 mm, in main branch - 0.34 ± 0.27 mm and in side branch - 0.18 ± 0.38 mm.. Dedicated bifurcation stent BiOSS® LIM proved to be feasible device, with promising safety and long-term clinical effectiveness in the treatment of coronary bifurcation lesions, including distal left main stem stenosis.

Topics: Acute Coronary Syndrome; Aged; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Female; Follow-Up Studies; Humans; Male; Prosthesis Design; Registries; Sirolimus

Topics: Acute Coronary Syndrome; Coronary Angiography; Coronary Vessel Anomalies; Coronary Vessels; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus

Topics: Acute Coronary Syndrome; Angioplasty; Coronary Restenosis; Drug-Eluting Stents; Humans; Male; Middle Aged; Myocytes, Smooth Muscle; Platelet Aggregation Inhibitors; Polytetrafluoroethylene; Sirolimus; Tomography, Optical Coherence

The optimal duration of dual antiplatelet therapy (DAPT) remains controversial in patients with acute coronary syndrome (ACS). We sought to compare outcomes after the implantation of zotarolimus-eluting stent (ZES) between patients with ACS who received clopidogrel-based DAPT for >6months and those treated for ≤6months.. From a registry of patients treated with ZESs between October 2005 and January 2010, 1740 patients with ACS were selected for the present analysis. Landmark analyses were performed for ACS patients who were event-free at 6months follow-up (n=1674). The primary outcome was a major adverse cardiac and cerebrovascular event (MACCE), including all-cause death, myocardial infarction (MI), target vessel revascularization (TVR), stent thrombosis, or stroke. We also performed adjustments for the baseline characteristics of patients, using their propensity-score matching (n=469 pairs).. During a median follow-up of 22.5months, the rate of MACCE was 6.4% in patients with DAPT >6months (n=1140) and 4.7% in patients with DAPT ≤6months (n=534) (adjusted hazard ratio [HR] 1.05; 95% confidence interval [CI] 0.61-1.82; p=0.86). After propensity-score matching, DAPT >6months was not found to be associated with a lower incidence of MACCE compared with DAPT ≤6months (adjusted HR 0.80, 95% CI 0.44-1.45, p=0.46). The rates of all-cause death or MI, TVR, stent thrombosis, and stroke also did not differ significantly between two groups.. DAPT for >6months do not seem to be associated with improved clinical outcomes in patients with ACS undergoing percutaneous coronary intervention (PCI) with ZES.

Topics: Acute Coronary Syndrome; Aged; Cause of Death; Clopidogrel; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Republic of Korea; Sirolimus; Ticlopidine; Treatment Outcome

Diabetes is associated with aggressive atherosclerosis, leading to an increased risk of in-stent restenosis and stent thrombosis. Bioresorbable scaffolds (BRS) are a new technology for the treatment of coronary lesions that might be beneficial due to their dissolving character, especially in diabetic patients.. This study was designed to evaluate feasibility and mid-term clinical outcome of the implantation of PLLA-based, everolimus-eluting BRS for the treatment of coronary lesions in a diabetic all-comers population.. All patients of an all-comers registry with diabetes eligible for BRS implantation were included. Outcome parameters were target vessel failure (TVF), major adverse cardiac events (MACE) including target lesion revascularization (TLR), cardiac death, and myocardial infarction. Follow-up was conducted via telephone and/or office visit.. A total of 120 diabetic patients were included. Of all diabetics, 35.0% had insulin-dependent diabetes, and all other patients were treated with oral antidiabetics or dietary modification. The median age was 67 (59-72) years and 26.7% were female. Patients underwent coronary angiography due to acute coronary syndrome in 50.8%. Of 127 lesions, 60.6% were B2/C lesions according to ACC/AHA classification. The 6-month rates of TVF, TLR, and MACE were 8.9, 2.7, and 8.4%, respectively.. This evaluation confirms reasonable clinical outcome of bioresorbable vascular scaffold implantation in a high-risk diabetic population with predominately complex lesions during daily clinical practice. Nevertheless, long-term data are required for final evaluation.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Angiography; Coronary Stenosis; Diabetic Angiopathies; Drug-Eluting Stents; Feasibility Studies; Female; Follow-Up Studies; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Registries; Risk Assessment; Severity of Illness Index; Sirolimus; Survival Rate; Treatment Outcome

Topics: Acute Coronary Syndrome; Aged; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Prosthesis Design; Sirolimus; Tomography, Optical Coherence

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Restenosis; Delayed Diagnosis; Diagnosis, Differential; Drug-Eluting Stents; Graft Occlusion, Vascular; Humans; Immunosuppressive Agents; Male; Postoperative Complications; Sirolimus; Tomography, Optical Coherence; Ultrasonography, Interventional

The safety of BVS implantation in patients with a high risk for early thrombotic complications has not been studied. We report on the outcomes of patients with acute coronary syndromes (ACS) treated with bioresorbable, everolimus-eluting, vascular scaffolds (BVS).. 150 consecutive patients with ACS (194 lesions) treated with BVS between May 2012 and July 2013 were compared with a control group composed of 103 consecutive patients (129 lesions) who underwent everolimus drug-eluting stent (DES) implantation in the same time period. The incidence of major adverse cardiac events (MACE: death, non-fatal myocardial infarction, or reintervention) before discharge, at one month and six months was evaluated. Clinical characteristics and presentation were similar between groups. Procedural characteristics were also similar between groups, except for the use of glycoprotein IIb/IIIa inhibitors (p<0.01). Procedural success was obtained in all but two patients in the BVS group. In-hospital, 30-day and six-month MACE rates were similar between both groups (all p>0.5), with most complications occurring during the first ten days. Definite or probable in-stent/scaffold thrombosis occurred in two BVS patients and one DES patient during the index admission and it occurred in another patient in each group in the first month after BVS/DES implantation. In multivariate analysis, BVS utilisation did not influence the incidence of MACE (p>0.9).. BVS implantation for patients with ACS is safe, with outcomes comparable with those of drug-eluting metal stents.

Topics: Acute Coronary Syndrome; Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Sirolimus; Time Factors; Treatment Outcome

Detailed long-term changes of the neointima in sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) are still unclear.. We consecutively enrolled 14 patients (18 SES) and 12 patients (13 PES) who underwent optical coherence tomography (OCT) serially at eight months and 18 months after stent implantation. For 18 SES and 13 PES, OCT was used to visualise 2,486 and 1,361 stent struts at the eight-month and 2,199 and 1,309 stent struts at the 18-month follow-up, respectively. The OCT parameters, including incidence of uncovered and malapposed struts (uncovered and malapposed percentage), average neointimal hyperplasia thickness (NIH thickness) and %NIH volume obstruction, which was defined as ([mean NIH area*stent length]/[mean stent area*stent length])100, and qualitative analysis of the neointima were compared between SES and PES and also compared between the eight- and 18-month follow-up for SES and PES, respectively. The uncovered and malapposed percentage was significantly higher in SES than PES at the eight- and 18-month follow-up, and the NIH thickness and %NIH volume obstruction were lower in SES than PES at both follow-ups. The uncovered and malapposed percentage decreased in both SES and PES between the eight- and 18-month follow-up. Percent NIH volume obstruction and NIH thickness in SES significantly increased from the eight- to 18-month follow-up; however, those parameters significantly decreased in PES. The incidence of high signal with peri-strut low-intensity areas increased in SES but decreased in PES from the eight- to 18-month follow-up.. Uncovered and malapposed struts were reduced in both SES and PES, while the neointimal hyperplasia and qualitative changes showed different patterns.

Topics: Acute Coronary Syndrome; Aged; Antineoplastic Agents; Cohort Studies; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Disease Progression; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Retrospective Studies; Sirolimus; Tomography, Optical Coherence

This study aimed to investigate the long-term safety and efficacy of everolimus-eluting stents (EES) compared with other limus-eluting stents and bare metal stents (BMS) in ACS patients.. There have been concerns about the long-term safety of drug-eluting stents in the setting of acute coronary syndrome.. The study cohort included 1,612 patients presenting with acute coronary syndrome who underwent BMS, SES, E-ZES, or EES implantation. End points included probable or definite stent thrombosis and major adverse cardiovascular events (MACE), defined as a composite of all-cause death, Q-wave myocardial infarction, and target lesion revascularization up to 3 years.. The overall MACE rates were significantly higher for both BMS and SES, but not E-ZES, when compared with EES (EES vs. BMS: HR 2.68, 95% CI 1.91-3.78, P <0.001; EES vs. SES: HR 1.75, 95% CI 1.24-2.47, P = 0.001 and EES vs.. HR 1.08, 95% CI 0.65-1.77, P = 0.72). Stent thrombosis rates were similar for EES, E-ZES, and BMS but higher for SES throughout the 3-year follow-up (EES vs. BMS: HR 1.02, 95% CI: 0.31-3.35, P = 0.973; EES vs. SES: HR 4.90, 95% CI: 1.75-13.69, P = 0.002 and EES vs.. HR 1.63, 95% CI 0.37-7.31, P = 0.449).. There was an improvement in the long-term outcome for MACE with EES when compared to earlier-generation stents, but this was comparable with the 2nd-generation E-ZES. There was no additional risk of early or late stent thrombosis in EES when compared with BMS.

Topics: Acute Coronary Syndrome; Aged; Antineoplastic Agents; Cause of Death; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Washington

Pathology studies have shown delayed arterial healing in culprit lesions of patients with acute coronary syndrome (ACS) compared with stable coronary artery disease (CAD) after placement of drug-eluting stents (DES). It is unknown whether similar differences exist in-vivo during long-term follow-up. Using optical coherence tomography (OCT), we assessed differences in arterial healing between patients with ACS and stable CAD five years after DES implantation.. A total of 88 patients comprised of 53 ACS lesions with 7864 struts and 35 stable lesions with 5298 struts were suitable for final OCT analysis five years after DES implantation. The analytical approach was based on a hierarchical Bayesian random-effects model. OCT endpoints were strut coverage, malapposition, protrusion, evaginations and cluster formation. Uncovered (1.7% vs. 0.7%, adjusted p=0.041) or protruding struts (0.50% vs. 0.13%, adjusted p=0.038) were more frequent among ACS compared with stable CAD lesions. A similar trend was observed for malapposed struts (1.33% vs. 0.45%, adj. p=0.072). Clusters of uncovered or malapposed/protruding struts were present in 34.0% of ACS and 14.1% of stable patients (adj. p=0.041). Coronary evaginations were more frequent in patients with ST-elevation myocardial infarction compared with stable CAD patients (0.16 vs. 0.13 per cross section, p=0.027).. Uncovered, malapposed, and protruding stent struts as well as clusters of delayed healing may be more frequent in culprit lesions of ACS compared with stable CAD patients late after DES implantation. Our observational findings suggest a differential healing response attributable to lesion characteristics of patients with ACS compared with stable CAD in-vivo.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Tomography, Optical Coherence; Treatment Outcome; Tubulin Modulators; Wound Healing

The study interrogated an autopsy registry to investigate the histopathologic features of early stent thrombosis (ST) in patients presenting with acute coronary syndrome (ACS).. The occurrence of early ST following percutaneous coronary intervention (PCI) for ACS remains a clinical problem despite advances in stent technology in both bare-metal and drug-eluting stents.. Sixty-seven stented coronary lesions from 59 patients who presented with ACS and died within 30 days were included. Stented segments were cross sectioned at 3 to 4 mm intervals and evaluated by light microscopy, and morphometric analysis was performed.. Early ST (<30 days of PCI) was identified in 34 (58%) of the 59 patients. Early ST was dependent on the underlying plaque morphology and underlying thrombus burden: presence of necrotic core prolapse was more frequent in thrombosed lesions compared with patent lesions (70% vs. 43%, p = 0.045) and maximal underlying thrombus thickness was significantly greater in thrombosed versus patent lesions. All 3 patients with false lumen stenting had ST. Detailed analysis revealed that the percent of necrotic core prolapse, medial tear, or incomplete apposition was significantly greater in the early ST compared with patent group (28% vs.11%, p < 0.001; 27% vs. 15% p = 0.004; and 34% vs. 18% p = 0.008, respectively). Multivariate analysis revealed that maximal depth of strut penetration, % strut with medial tear, and % struts with incomplete apposition were the primary indicators of early ST.. The current autopsy study highlights the impact of thrombus burden and suboptimal stent implantation in unstable lesions as a trigger of early ST, suggesting that improvement in implantation technique and refinement of stent design may improve clinical outcomes of ACS patients.

Topics: Acute Coronary Syndrome; Aged; Autopsy; Cause of Death; Coronary Thrombosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Male; Percutaneous Coronary Intervention; Prosthesis Failure; Retrospective Studies; Sirolimus; Survival Rate; Time Factors; Ultrasonography, Interventional; United States

Topics: Acute Coronary Syndrome; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Percutaneous Coronary Intervention; Sirolimus

Topics: Acute Coronary Syndrome; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Percutaneous Coronary Intervention; Sirolimus

The BASE-ACS trial demonstrated an outcome of titanium-nitride-oxide-coated bioactive stents (BAS) that was statistically non-inferior to that of everolimus-eluting stents (EES) at 12-month follow-up, in patients presenting with acute coronary syndrome (ACS) who underwent early percutaneous coronary intervention (PCI). We explored a post-hoc analysis of the 12-month outcome of the BASE-ACS trial in the subgroup of patients with ST-elevation myocardial infarction (STEMI) versus non-ST-elevation ACS (non-STEACS).. A total of 827 patients with ACS (321 STEMI) were randomly assigned to receive either BAS or EES. The primary endpoint was a composite of cardiac death, non-fatal myocardial infarction (MI) and ischemia-driven target lesion revascularization (TLR) at 12-month follow-up.. The 12-month cumulative incidence of the primary endpoint was similar between the two subgroups (9% versus 9.5%, in STEMI versus non-STEACS patients respectively, P=0.90). The 12-month rate of cardiac death was significantly higher in the STEMI subgroup as compared with the non-STEACS subgroup (2.8 versus 0.6%, respectively, P=0.01). However, the rates of non-fatal MI, ischemia-driven TLR, definite stent thrombosis, and non-cardiac death were all statistically matched between the two subgroups (P>0.05 for all).. In the current post-hoc analysis of the BASE-ACS trial based on the infarction type, the 12-month outcome of patients who underwent early PCI for ACS was slightly worse in the setting of STEMI as compared with non-STEACS, as reflected by a significantly higher rate of cardiac death.

Topics: Acute Coronary Syndrome; Aged; Anticoagulants; Coated Materials, Biocompatible; Combined Modality Therapy; Coronary Restenosis; Disease-Free Survival; Drug-Eluting Stents; Everolimus; Female; Follow-Up Studies; Heart Diseases; Humans; Incidence; Male; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; Myocardial Ischemia; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Postoperative Complications; Randomized Controlled Trials as Topic; Sirolimus; Titanium; Treatment Outcome

Since their apparition, first generation drug-eluting stents (DESs) have raised concerns regarding the risk of late and very late stent thrombosis as compared to bare metal stents and require prolonged dual antiplatelet therapy. Aside from delayed strut endothelialisation, positive vessel remodelling and late stent mal-apposition due to chronic inflammation may be a leading cause for these stent thromboses. In fact, the persistence of the durable polymer after complete drug release is responsible for local hypersensitivity and inflammatory reactions. Third generation DESs with biocompatible or biodegradable polymer have subsequently been developed to address this issue. In this article, we evaluate and discuss the results of two recent publications investigating safety and efficacy of a third generation DES with biodegradable polymer as compared to first and second generation DESs with durable polymer.

Topics: Absorbable Implants; Acute Coronary Syndrome; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Sirolimus

Previous research suggests that the early benefit from revascularization with drug-eluting stents might diminish over time.. We performed an extended analysis of a previously identified cohort of 6440 patients who underwent percutaneous coronary intervention between April 1, 2003 and March 31, 2005 using a prospective provincial clinical registry in Alberta, Canada. We compared rates of death, and of death or repeat revascularization among the 6440 patients receiving either drug-eluting (sirolimus- and paclitaxel) stents or bare-metal stents. We determined risk-adjusted hazard ratios at moments in time with a spline analysis using Cox proportional hazards modelling.. During the 8 years of observation, the relative risks for death or the composite outcome of death or repeat revascularization varied over time. There was an early finding of better outcomes associated with drug-eluting stents in the first year after implantation. Thereafter, there was no significant benefit associated with drug-eluting stents compared with bare-metal stents with 8 years of follow-up. At 30 days, the adjusted hazard ratio was 0.38 (95% confidence interval [CI], 0.18-0.81) for death and 0.27 (95% CI, 0.14-0.54) for the composite outcome of death or repeat revascularization. By 8 years, the adjusted hazard ratio of death or the composite outcome was 1.15 (95% CI, 0.97-1.36) and 1.01 (95% CI, 0.87-1.17), respectively.. Revascularization with first-generation drug-eluting stents is associated with better outcomes within the first year only. Thereafter, the risk of death or repeat revascularization is similar between drug-eluting stents and bare-metal stents.

Topics: Acute Coronary Syndrome; Aged; Alberta; Angioplasty, Balloon, Coronary; Cohort Studies; Coronary Stenosis; Drug-Eluting Stents; Equipment Failure; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Paclitaxel; Patient Outcome Assessment; Propensity Score; Proportional Hazards Models; Prospective Studies; Registries; Risk; Sirolimus; Stents; Survival Rate; Time Factors

Topics: Absorbable Implants; Acute Coronary Syndrome; Coated Materials, Biocompatible; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Sirolimus

Thrombosis is a rare but serious complication of stent implantation in atherosclerotic arteries, affecting both bare-metal and drug-eluting stents. Diagnostic criteria for stent thrombosis have recently been updated with the time and probability of the event being considered as crucial parameters. To be considered as "definite", the diagnosis of stent thrombosis has to be confirmed by angiography or histology. This statement position has clearly rendered more difficult the clinical assessment of stent thrombosis in randomised clinical trials. Considering these limitations, stent thrombosis represents a dramatic complication for both patients and cardiologists. In coronary plaques, thrombosis is often associated with death, acute coronary syndromes and arrhythmias. For these reasons, the pharmacological improvement of this outcome represents a "hot-topic" field for research. Among several medications, statins have been shown to potentially reduce the incidence of coronary stent thrombosis in humans. However, randomised clinical trials focussing on "definite" diagnosis are still needed to confirm these promising results. In addition, the use of statins in patients implanted with stents in other arteries is largely unexplored. Finally, statin-eluting stents (only tested in pigs) have to be evaluated in other animal models and human beings. Therefore, a clear recommendation on the use of statins to prevent stent thrombosis is not available and caution should be used. The "pleiotropic" anti-atherosclerotic properties of statins might represent a crucial investigation field to pathophysiologically clarify the role of statins in stent complications.

Topics: Acute Coronary Syndrome; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Paclitaxel; Prosthesis Design; Sirolimus; Stents

The goal of this study was to compare the long-term clinical outcome between everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) in patients with acute coronary syndromes (ACS).. EES have not been directly compared with SES in ACS patients to date.. Between 2004 and 2009, 1,746 consecutive ACS patients (ST-segment elevation ACS [STE-ACS]: 33.5%; non-ST-segment elevation ACS [NSTE-ACS]: 66.5%) were treated with EES (n=903) or SES (n=843). Using propensity score matching, clinical outcome was compared among 705 matched pairs of ACS patients treated with EES and SES.. Through 3 years, the primary endpoint-the composite of death, myocardial infarction (MI), and target vessel revascularization (TVR)-occurred in 13.8% of EES- and 17.7% of SES-treated ACS patients (hazard ratio [HR]: 0.72, 95% confidence interval [CI]: 0.54 to 0.95, p=0.02). The difference in favor of EES was driven by a lower risk of TVR (5.7% vs. 8.8%, HR: 0.65, 95% CI: 0.43 to 0.98, p=0.04) and a trend toward a lower risk of MI (2.1% vs. 3.3%, HR: 0.56, 95% CI: 0.29 to 1.12, p=0.10). The risk of death (7.2% vs. 8.8%, HR: 0.75, 95% CI: 0.50 to 1.10, p=0.14) showed no difference between EES and SES. The treatment effect in favor of EES for the primary endpoint was similar for patients with STE-ACS (16.4% vs. 18.5%, HR: 0.80, 95% CI: 0.50 to 1.27) and NSTE-ACS (12.4% vs. 17.3%; HR: 0.67, 95% CI: 0.47 to 0.96; pfor interaction=0.56) and across major subgroups. Definite (0.4% vs. 1.8%, p=0.03), and definite or probable stent thrombosis (3.4% vs. 6.1%, p=0.02) were less frequent among EES- than SES-treated ACS patients.. Among patients with ACS, the unrestricted use of EES is associated with improved clinical outcome compared with SES during long-term follow-up to 3 years. Notably, the risk of stent thrombosis was lower among EES-treated ACS patients.

Topics: Acute Coronary Syndrome; Confidence Intervals; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Propensity Score; Risk Assessment; Sirolimus; Statistics as Topic; Surveys and Questionnaires; Time Factors; Treatment Outcome

To obtain long-term follow-up data of the sirolimus-eluting coronary stent (SES) and to determine factors associated with clinical events and target vessel revascularization (TVR).. Between 2002 and 2005, 5,946 patients were treated with at least one SES. A follow-up after a median of 4.1 years was obtained in 5,247 patients (88.2 %). During the follow-up, death occurred in 9.2 % of patients, nonfatal myocardial infarction in 5.9 %, nonfatal stroke in 2.2 % and MACCE (death/myocardial infarction/stroke) in 16.3 %. Any TVR was performed in 20.3 %. Independent predictors of MACCE were: older age (p < 0.0001), renal insufficiency (p < 0.0001), prior myocardial infarction (p < 0.0001), diabetes mellitus (p < 0.0001), cardiogenic shock (p = 0.0002), three-vessel disease (p = 0.0012), reduced left ventricular function (p = 0.0048), target vessel = bypass graft (p = 0.0122), indication for treatment = ACS (p = 0.0181) and PCI before implantation (p = 0.0308). Independent predictors of TVR were target vessel = coronary bypass (<0.0001), two- or three-vessel disease (p < 0.0001), ostial lesions (p < 0.0001), total length of SES implanted (p = 0.0012) and older age being a protective factor (p = 0.0187).. Long-term follow-up of the SES in clinical practice showed clinical event rates that were comparable to randomized trials with a MACCE rate of 16.3 % and TVR rate of 20.3 %.

Topics: Acute Coronary Syndrome; Aged; Angina, Stable; Drug-Eluting Stents; Female; Follow-Up Studies; Germany; Humans; Male; Middle Aged; Prospective Studies; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To investigate the incidence of cardiac events in octogenarians who underwent percutaneous coronary intervention (PCI) with stenting, as well as to evaluate the efficacy and safety of drug-eluting stents (DES) in this population.. The study included 6,129 consecutive patients who underwent PCI with stenting from 2000 to 2005 in our centre, of whom 291 (4.7%) were octogenarians. After adjusting for confounders, age ≥80 years appeared a significant predictor of high mortality at 30 days (adjusted hazard ratio [aHR] 1.92, 95% CI 1.23-3.01), and four years (aHR 2.25, 95% CI 1.77-2.85). No differences were seen with respect to incident myocardial infarction (MI), but target lesion (63.2 vs. 32.6 per 1,000 person-years at one year and 27.9 vs. 16.6 per 1,000 person-years at four years) and vessel (83.1 vs. 52.9 per 1,000 person-years at one year and 37.7 vs. 25.0 per 1,000 person-years at four years) revascularisation rates were lower in octogenarians. When comparing DES with bare metal stents (BMS) in octogenarians, mortality and MI rates were comparable, but there was a significantly lower incidence of target lesion revascularisation at one- (9.5 vs. 0.6 per 1,000 person-years, aHR 0.07, 95% CI 0.01-0.57) and four-year (3.4 vs. 0.7 per 1,000 person-years, aHR 0.16, 95% CI 0.04-0.59) follow-up in patients who received a DES.. Octogenarians undergoing PCI with stenting have an increased mortality risk, whereas the rates of repeat revascularisation in octogenarians are lower. This study suggests that the benefit of DES in reducing revascularisation rates is extended to elderly patients.

Topics: Acute Coronary Syndrome; Age Factors; Aged; Aged, 80 and over; Antibiotics, Antineoplastic; Antineoplastic Agents, Phytogenic; Cohort Studies; Coronary Artery Disease; Coronary Thrombosis; Drug-Eluting Stents; Equipment Failure; Female; Humans; Longitudinal Studies; Male; Middle Aged; Netherlands; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prospective Studies; Risk Factors; Sirolimus; Stents; Treatment Outcome

Recent studies have reported the development of neoatherosclerosis inside stents and subsequent acute coronary syndrome secondary to disruption of neointimal hyperplasia. The aim of the study was to compare the characteristics of neointimal hyperplasia and its time course between bare metal stents (BMSs) and drug-eluting stents (DESs) using optical coherence tomography. A total of 138 stents were divided into 3 groups according to the follow-up period: early phase, <9 months (25 BMSs and 27 DESs); intermediate phase, ≥9 and <48 months (18 BMSs and 43 DESs); and delayed phase, ≥48 months (13 BMSs and 12 DESs). Optical coherence tomographic analysis included the presence of lipid-laden intima, percentage of lipid-rich plaque, and signal attenuation. The optical coherence tomographic findings were compared between the BMSs and DESs in each period, and the difference between the periods was also determined. In the early phase, a greater incidence of lipid-laden plaque (37% vs 8%, p = 0.02) and a greater percentage of lipid-rich plaque (12.9 ± 25.1% vs 1.2 ± 4.3%, p = 0.01) were found in the DESs than in the BMSs. In the intermediate phase, the DES group continuously showed a significantly greater incidence of lipid-laden plaque (63% vs 28%, p = 0.03) and greater percentage of lipid-rich plaque (24.8 ± 28.1% vs 4.1 ± 7.3%, p <0.01). In addition, signal attenuation was greater in the DES group, suggesting early changes in neointimal hyperplasia properties. In the delayed phase, lipid-laden plaque was the predominant type in both groups. In conclusion, lipid-rich neoatherosclerosis develops inside stents earlier in DESs than in BMSs. After 48 months, most restenotic stents will have developed lipid-laden neointima in both groups.

Topics: Acute Coronary Syndrome; Atherosclerosis; Coronary Angiography; Coronary Artery Disease; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Hyperplasia; Immunosuppressive Agents; Incidence; Male; Massachusetts; Middle Aged; Myocardial Ischemia; Myocardial Revascularization; Neointima; Sirolimus; Time Factors; Tomography, Optical Coherence

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Sirolimus; Stents; Titanium

Drug-eluting stents (DES) have proven to be effective for reducing the rate of restenosis, whereas stent thrombosis (ST) after DES implantation has raised safety concerns. Everolimus-eluting stents (EES) are a new generation of DES that have demonstrated safety and efficacy compared with first-generation DES. However, the use of EES in patients presenting with acute coronary syndrome (ACS) has not been adequately investigated. We compared the clinical outcomes between the ACS and non-ACS groups treated with EES. A total of 335 consecutive patients who received EES implantation between January 2010 and January 2011 were investigated (ACS; n = 172, non-ACS; n = 163). Clinical outcome data were obtained for 94.3% of the patients. Follow-up angiography was performed in 58.5% of all patients. The median follow-up period was 8 months in both groups. Clinical outcomes were not statistically different between the groups. The rate of target lesion revascularization (TLR) was 2.5% in the ACS group and 3.8% in the non-ACS group (P = 0.37). MACE occurred in 8.2% of the ACS group and 10.2% of the non-ACS group (P = 0.54). A definite ST was identified in one patient in each group (P = 0.75). The unadjusted cumulative event rates estimated by the Kaplan-Meier method and the log-rank test showed no significant difference between the groups for TLR, target vessel revascularization (TVR), all-cause death, or MACE. In conclusion, EES was safe and efficacious for patients presenting with ACS, as well as for those with non-ACS during a mid-term follow-up period.

Topics: Acute Coronary Syndrome; Aged; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Male; Middle Aged; Retrospective Studies; Sirolimus; Treatment Outcome

The inflammatory responses after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) remain poorly understood; therefore, this study aims to investigate the changes of metabolic parameters and systematic inflammatory status of circulating mononuclear cells (MNC) in patients after percutaneous treatment with DES implantation.. Twenty-seven patients with acute coronary syndrome who would undergo PCI with DES implantation were consecutively recruited and treated with standard drug therapy from the start of hospitalization. Metabolic parameters including total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein improved significantly after 12 weeks of standard medication, whereas the plasma levels of interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), macrophage migration inhibitory factor (MIF), and matrix metalloproteinase-9 (MMP-9) increased (P=0.012, 0.035, 0.062 and 0.112, respectively, compared to the baseline). The NF-κB DNA binding activity in MNC increased significantly compared to the baseline (P=0.015), whereas IκB-β and PPAR-γ were significantly suppressed (P=0.046 and 0.002, respectively). There were strong correlations among the changes of metabolic parameters and the changes of proinflammatory factors; however, none of them is statistically significant.. Standard drug therapy can improve the metabolic parameters but fail to restrain the proinflammatory state after PCI with DES implantation. Longer term endpoint-based studies are still needed for further exploration of the relationship between inflammatory factors and clinical cardiovascular events in the era of DES.

Topics: Acute Coronary Syndrome; Drug-Eluting Stents; Female; Humans; Inflammation; Inflammation Mediators; Interleukin-6; Leukocytes, Mononuclear; Lipid Metabolism; Male; Matrix Metalloproteinase 9; NF-kappa B; Sirolimus; Treatment Outcome

We evaluated the efficacy and safety of a biolimus- eluting biodegradable polymer-coated stent (BES) in patients with ST-segment elevation and non ST-segment elevation acute myocardial infarction (AMI).. This was an observational study involving a single centre patient registry. We compared the rates of cardiac death, myocardial infarction, target vessel revascularization (TVR) and composite end point of cardiac death and myocardial infarction at 24 months in 106 patients who received BES versus 94 patients who received an otherwise similar bare metal stent (BMS) during percutaneous coronary intervention for AMI. There was no significant difference in the rate of cardiac death (0.9% versus 7.4%; P = 0.09), myocardial infarction (4.7% versus 3.2%; P = 0.69), stent thrombosis (0.9% versus 3.2%; P = 0.30) or cardiac death and myocardial infarction (5.7% versus 10.6%; P = 0.30) between the two groups. The rate of TVR was significantly higher in the BMS group (1.9% versus 8.5%; P = 0.04), with patients receiving BMS being four times more likely to require TVR.. The use of BES in selected patients with AMI appears to be safe and is associated with significantly reduced rate of TVR, when compared with an otherwise similar BMS.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Anti-Bacterial Agents; Death; Drug-Eluting Stents; Female; Humans; Male; Metals; Middle Aged; Myocardial Infarction; Observation; Polymers; Registries; Retrospective Studies; Safety; Sirolimus; Stents; Treatment Outcome

The aim of this study was to ascertain the 1-year incidence of stent thrombosis (ST) and major bleeding (MB) in a large, unselected population treated with sirolimus-eluting stents (SES).. Stent thrombosis and MB are major potential complications of drug-eluting stent implantation. Their relative incidence and predisposing factors among large populations treated worldwide are unclear.. The SES were implanted in 15,147 patients who were entered in a multinational registry. We analyzed the incidence of: 1) definite and probable ST as defined by the Academic Research Consortium; and 2) MB, with the STEEPLE (Safety and efficacy of Enoxaparin in PCI) definition, together with their relation to dual antiplatelet therapy (DAPT) and to 1-year clinical outcomes.. The mean age of the sample was 62 ± 11 years, 30.4% were diabetic, 10% had a Charlson comorbidity index ≥3, and 44% presented with acute coronary syndrome or myocardial infarction. At 1 year, the reported compliance with DAPT as recommended by the European Society of Cardiology guidelines was 86.3%. Adverse event rates were: ST 1.0%, MB 1.0%, mortality 1.7%, myocardial infarction 1.9%, and target lesion revascularization 2.3%. Multivariate analysis identified 9 correlates of ST and 4 correlates of MB. Advanced age and a high Charlson index were associated with an increased risk of both ST and MB. After ST, the 7-day and 1-year all-cause mortality was 30% and 35%, respectively, versus 1.5% and 10% after MB. Only 2 of 13,749 patients (0.015%) experienced both MB and ST during the entire 1-year follow-up period.. In this worldwide population treated with ≥1 SES, the reported compliance with DAPT was good, and the incidence of ST and MB was low. Stent thrombosis and MB very rarely occurred in the same patient. (The e-SELECT Registry: a Multicenter Post-Market Surveillance; NCT00438919).

Topics: Acute Coronary Syndrome; Age Factors; Comorbidity; Coronary Thrombosis; Drug-Eluting Stents; Female; Follow-Up Studies; Hemorrhage; Humans; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Myocardial Revascularization; Platelet Aggregation Inhibitors; Registries; Sirolimus

To investigate the safety and efficacy of everolimus-eluting stents (EES) in a real world population, including those with high-risk characteristics and complex lesions.. In this report, we analyze 2-year outcomes in 500 consecutive unselected patients treated with EES between April 2007 and March 2008. All patients were followed for 2 years for adverse events.. There were 995 EES deployed in 792 lesions. The indication for the coronary procedure was acute coronary syndrome in 94.2% of patients. Bifurcations were involved in 21% of lesions, 3.5% degenerated vein grafts, 2.7% left main stem stenoses, 33% multivessel disease, 4.5% in-stent restenosis, and 79.1% AHA/ACC classification B2/C lesions. The major adverse cardiac event rate (composite of cardiovascular death, acute myocardial infarction, target lesion revascularization) was 10.6%. Target lesion revascularization was required in 4.0% patients, 1.4% for in-stent thrombosis. These event rates are comparable with studies involving lower risk patients and less complex coronary lesions.. The use of EES, even in this real world, high-risk population, continues to demonstrate safety and efficacy rates comparable with current studies in more selected patient groups and, therefore, may justify current practice to utilize EES in "off label" situations.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Medical Audit; Middle Aged; New Zealand; Postoperative Complications; Sirolimus; Treatment Outcome

Drug-eluting stents (DES) reduce the need for repeat target revascularization (TVR) compared with bare metal stents (BMS) but are more costly. The objective was to evaluate the cost-effectiveness of DES versus BMS.. We evaluated clinical outcomes and costs of care over 3 years in 1147 undergoing BMS before the availability of DES and 1247 DES patients at Wake Forest University Baptist Medical Center from 2002 to 2005. Costs for index stenting, TVR, and clopidogrel use were assessed. The 2 groups were well matched for baseline characteristics. Index stenting costs were $1846 higher per patient for DES versus BMS ($1737 more to $1950 more). At 3 years, absolute TVR rates were 15.2 per 100 DES patients and 24.1 per 100 BMS patients, and as a result, cumulative TVR-related costs were $2065 less per patient for DES versus BMS ($3001 less to $1134 less). Including the cost of clopidogrel, the incremental cost-effectiveness ratio per TVR avoided with DES was $4731 through 1 year, $4703 through 2 years, and $6379 through 3 years.. At 3 years, the higher index cost of DES versus BMS was completely offset by lower TVR-related costs. However, because of extended clopidogrel use for DES, the incremental cost-effectiveness ratio per TVR avoided ranged from $4703 to $6379 over 3 years. These unadjusted observational findings provide support for the continued use of DES in routine practice but highlight the important impact of prolonged dual antiplatelet use on the cost-effectiveness of this technology.

Topics: Acute Coronary Syndrome; Aged; Blood Vessel Prosthesis Implantation; Coronary Restenosis; Cost-Benefit Analysis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Postoperative Complications; Sirolimus

Topics: Acute Coronary Syndrome; Angina Pectoris; Angioplasty, Balloon, Coronary; Angioscopy; Animals; Biomedical Research; Cardiac Imaging Techniques; Cardiovascular Agents; Career Choice; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Diagnostic Imaging; Drug-Eluting Stents; Female; Humans; Male; Sirolimus; Thrombosis; Tunica Intima; Ultrasonography, Interventional

Topics: Acute Coronary Syndrome; Antineoplastic Agents, Phytogenic; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Immunosuppressive Agents; Male; Paclitaxel; Sirolimus

To investigate the efficacy of implantation of sirolimus-eluting stents (SES) in the ostium of coronary arteries.. We assigned 96 patients with lesions located in ostias of the coronary circulation to receive a SES or a bare-metal stent (BMS).. At follow-up the late lumen loss was 0.07 mm in the SES versus 1.06 mm in the BMS group (p<0.001); -0.04 mm versus 0.11 mm (p = 0.12) in the neighbour ostium. The rate of target lesion revascularisation was 2% with SES and 39% with BMS (p<0.001), and major adverse cardiac events (MACE) 6% versus 41% (p = 0.001).. In patients with ostial coronary lesions the angiographic outcome is improved and the long-term MACE rate is low after SES compared with BMS implantation.

Topics: Acute Coronary Syndrome; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Metals; Middle Aged; Randomized Controlled Trials as Topic; Sirolimus; Stents; Thrombosis

Drug-eluting coronary stents (DES) have gained widespread use for the treatment of coronary artery disease. However, because of safety concerns and frequent "off-label" use data from "real life," registries are necessary to monitor indications and outcome of DES in daily clinical practice.. We evaluated data from the German Cypher Stent Registry. A total of 10,894 patients treated with at least one sirolimus-eluting stent (SES) at 152 hospitals were included. Follow-up at a median of 6.4 months was available in 10,006 patients (92%). Median age was 64.8 years and 75.5% were male. Per lesion a mean of 1.09 +/- 0.41 SES were implanted with a mean length of 21.1 +/- 11.5mm. During follow-up, death rate was 1.8% and the rates of myocardial infarction or stroke were 2.1% and 0.5%. Any target vessel revascularization (TVR) was performed in 8.0% of patients. Independent predictors for death, myocardial infarction, or stroke were: cardiogenic shock, acute coronary syndromes, reduced left ventricular function, renal insufficiency, diabetes mellitus, advanced age, three-vessel disease, degree of stenosis, and prior myocardial infarction. Predictors for a TVR were: two- or three-vessel disease, target vessel = coronary bypass, advanced age, stent diameter, ostial lesions, indication in-stent restenosis, renal failure, and target vessel = left anterior descended artery.. These results demonstrate that SES use in clinical practice is safe and effective. The main predictors of clinical events during follow-up are clinical parameters whereas as predictors of TVR mainly are angiographic parameters.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Confidence Intervals; Coronary Artery Bypass; Coronary Artery Disease; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Germany; Humans; Immunosuppressive Agents; Logistic Models; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Prospective Studies; Registries; Renal Insufficiency; Risk Factors; ROC Curve; Severity of Illness Index; Shock, Cardiogenic; Sirolimus; Stroke; Treatment Outcome; Ventricular Function, Left

This paper studies in-stent restenosis (ISR) after percutaneous coronary intervention (PCI) following bare-metal stent (BMS) and drug-eluting stent (DES) in all consecutive patients between 2004 and 2007 undergoing PCI for ISR lesions at our centre.. We compared the clinical presentation, pattern and angiographic outcomes in 838 patients with BMS ISR (487) and SES ISR (351). About 18% of the patients presented with acute coronary syndrome with 2% presenting as ST elevation myocardial infarction, similar in both groups. Angiographic pattern was predominantly focal with SES ISR (47%SES ISR vs. 19% BMS ISR; p<0.001) and diffuse with BMS ISR (SES ISR 16% vs. BMS ISR 36%; p=0.003). In our series the use of balloon angioplasty was higher for the treatment of SES ISR patients as compared to BMS ISR (41.6% vs. 18.3%; p<0.001) and the usage of stent was higher in BMS ISR patients (38.6% vs. 23.4%; p<0.001). Angiographic recurrent restenosis with conventional treatment in a consecutive series of patients was 38.6% and target lesion revascularisation was seen in 33.6%. These outcomes were seen slightly higher in SES ISR group (41.1% vs. 36.9%, p=ns). We have identified unstable angina at presentation (OR 3.02; 95%CI: 1.58-5.77, p=0.001), focal pattern of ISR (OR 0.50; 95% CI: .25-.99, p=0.04), stent usage (OR .25; 95% CI .13-.47, p<0.001), and baseline% diameter stenosis (OR1.03; 95%CI: 1.03-1.06, p=0.01) as independent predictors of BMS ISR recurrent restenosis. Unstable angina, focal pattern of ISR, reference vessel diameter, and% diameter stenosis were shown to be independent predictors of SES ISR.. ISR is not a benign condition, and one fifth of the patients presented with acute coronary syndrome. The pattern of restenosis is predominantly non-focal with BMS ISR and focal with SES ISR. Recurrent restenosis rates are high following conventional treatment and further optimal therapies mainly with SES ISR needs to defined.

Topics: Acute Coronary Syndrome; Aged; Angina, Unstable; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Japan; Logistic Models; Male; Metals; Middle Aged; Odds Ratio; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Stents; Time Factors; Treatment Outcome

Percutaneous treatment of old, degenerated saphenous vein grafts (SVG) is associated with a high likelihood of major adverse cardiac events. When an acute coronary syndrome (ACS) develops in a patient with old SVG, fresh thrombus may superimpose on an old, degenerative atheroma: a sudden increase in the athero-thrombotic burden ensues with consequent, frequent total occlusion of the lumen. In this scenario, transluminal recanalization of the graft is usually associated with the highest chance of distal embolization and no-reflow and positioning of an embolic protection device (EPD) is almost mandatory. However, distal EPD are difficult to place when the vessel is totally occluded and do not completely avoid distal embolization. We report two cases of totally occluded SVG in patients admitted for ACS that were recanalized with the aid of a proximal EPD system with angiographic and clinical success.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Drug-Eluting Stents; Embolism; Equipment Design; Everolimus; Female; Filtration; Graft Occlusion, Vascular; Humans; Male; Metals; Middle Aged; Prosthesis Design; Saphenous Vein; Sirolimus; Stents; Thrombectomy; Thrombosis; Treatment Outcome; Vascular Patency

Optimal treatment strategies for restenosis of sirolimus-eluting stents (SES) have not been adequately addressed yet.. During the 3-year follow-up of 12 824 patients enrolled in the j-Cypher registry, 1456 lesions in 1298 patients underwent target-lesion revascularization (TLR). Excluding 362 lesions undergoing TLR for stent thrombosis or TLR using treatment modalities other than SES or balloon angioplasty (BA), 1094 lesions with SES-associated restenosis in 990 patients treated with either SES (537 lesions) or BA (557 lesions) constituted the study population for the analysis of recurrent TLR and stent thrombosis after the first TLR. Excluding 24 patients with both SES- and BA-treated lesions, 966 patients constituted the analysis set for the mortality outcome. Cumulative incidence of recurrent TLR in the SES-treated restenosis lesions was significantly lower than that in the BA-treated restenosis lesions (23.8% versus 37.7% at 2 years after the first TLR; P<0.0001). Among 33 baseline variables evaluated, only hemodialysis was identified to be the independent risk factor for recurrent TLR by a multivariable logistic regression analysis. After adjusting for confounders, repeated SES implantation was associated with a strong treatment effect in preventing recurrent TLR over BA (odds ratio, 0.44; 95% confidence interval, 0.32 to 0.61; P<0.0001). The 2-year mortality and stent thrombosis rates between the SES- and the BA-treated groups were 10.4% versus 10.8% (P=0.4) and 0.6% versus 0.6%, respectively.. Repeated implantation of SES for SES-associated restenosis is more effective in preventing recurrent TLR than treatment with BA, without evidence of safety concerns.

Topics: Acute Coronary Syndrome; Aged; Aged, 80 and over; Angioplasty, Balloon; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Japan; Male; Middle Aged; Myocardial Revascularization; Prospective Studies; Registries; Renal Dialysis; Risk Factors; Secondary Prevention; Sirolimus

Neointimal formation can protect against thrombosis after sirolimus-eluting stent (SES) implantation; however, promoters of neointimal formation are unknown.. Six-month follow-up angioscopy was performed in 141 consecutive patients with SES implantation. All patients received aspirin (100 mg) and ticlopidine (200 mg) daily until angioscopy. We defined 2 grades of neointimal coverage as follows: insufficient coverage including no or partial neointimal coverage of stent struts, and sufficient coverage. The possible promoters of neointimal formation that were evaluated in this study were the condition of coronary artery disease (stable angina or acute coronary syndrome); angioscopic markers, including visible thrombus and plaque color (white or yellow); serum markers, including low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, fasting blood glucose, hemoglobin A(1c), high-sensitive C-reactive protein, and fibrinogen; blood pressure and smoking; intervention markers, including stent size and length and intravascular ultrasound measurements; and medication, including statins, anticoagulants, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, calcium antagonists, and β-blockers.. Univariate analysis revealed that high-sensitive C-reactive protein, plaque color, and the condition of coronary artery disease were significantly correlated with the grade of neointimal coverage. Multivariate analysis using these 3 parameters revealed that only acute coronary syndrome (vulnerable disease) significantly promoted neointimal coverage.. Vulnerable disease may promote neointimal coverage after SES implantation.

Topics: Acute Coronary Syndrome; Aged; Angioscopy; C-Reactive Protein; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Image Processing, Computer-Assisted; Immunosuppressive Agents; Male; Middle Aged; Sirolimus; Tunica Intima

The use of drug-eluting stents in patients with acute coronary syndrome (ACS), particularly those with acute myocardial infarction (AMI), is controversial owing to concerns about late adverse events. We evaluated the long-term safety of sirolimus-eluting stent implantation in patients with ACS. Of 10,778 patients treated exclusively with a sirolimus-eluting stent in the j-Cypher registry, the 3-year outcomes of 2,308 patients with ACS (953 patients with AMI) were compared to those of 8,470 patients without ACS. Compared to patients without ACS, the patients with ACS had a significantly greater adjusted risk of death or myocardial infarction (hazard ratio [HR] 1.24, 95% confidence interval [CI] 1.12 to 1.37, p <0.0001) and definite or probable stent thrombosis (HR 1.43, 95% CI 1.11 to 1.82, p = 0.006) within the first year after sirolimus-eluting stent implantation. However, after 1 year, patients with ACS no longer had a greater risk of death or myocardial infarction (HR 1.01, 95% CI 0.90 to 1.13, p = 0.87) and stent thrombosis (HR 1.32, 95% CI 0.92 to 1.86, p = 0.13). Of the patients with ACS, those with AMI had a greater risk of death or myocardial infarction (HR 1.33, 95% CI 1.12 to 1.6, p = 0.001) and stent thrombosis (HR 1.57, 95% CI 1.05 to 2.39, p = 0.03) than those with unstable angina pectoris within the first year. However, they had a similar risk of death or myocardial infarction (HR 1.00, 95% CI 0.78 to 1.22, p = 0.83) and stent thrombosis (HR 0.83, 95% CI 0.38 to 1.6, p = 0.59) after 1 year. The risk of late adverse events >1 year after sirolimus-eluting stent implantation was similar between those with and without ACS and between those with AMI and those with unstable angina pectoris.

Topics: Acute Coronary Syndrome; Aged; Aged, 80 and over; Cause of Death; Coronary Angiography; Diagnosis, Differential; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Japan; Male; Retrospective Studies; Sirolimus; Survival Rate; Treatment Outcome

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Humans; Male; Middle Aged; Predictive Value of Tests; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Drug-eluting stents have been shown to reduce the incidence of restenosis and target vessel revascularization (TVR) compared with bare metal stents (BMSs); however, the long-term efficacy of sirolimus-eluting stent (SES) implantation in patients with acute coronary syndrome (ACS) has not been well established. We have investigated the long-term clinical outcome of SES in patients with ACS.. Consecutive 245 patients with ACS treated by primary stenting within 24 hours after onset were enrolled. There were 128 patients treated with SES and 117 patients were treated with BMS. We evaluated the incidence of major cardiac events (MACE; total death, nonfatal myocardial infarction, TVR) at 3 years, comparing with 8-month clinical outcome.. Eight-month clinical follow-up shows a significantly lower incidence of TVR in the SES group, 3.1% in the SES group versus 9.4% in the BMS group (P = 0.04). At 3-year clinical follow-up, there was no significant difference in the rate of TVR between the two groups, 8.4% versus 12.4% (P = 0.37). Cumulative incidence of total MACE was 9.2% in the SES group compared with 15.9% in the BMS group (P = 0.18). Only one case of stent thrombosis was observed in the SES (late thrombosis), while two cases of stent thrombosis occurred in the BMS group (late and very late thrombosis; P = 0.55).. SES implantation in patients with ACS is associated with favorable long-term clinical outcome with no excess of late stent thrombosis. Further long-term clinical follow-up will be warranted to confirm the safety and efficacy of SES.

Topics: Acute Coronary Syndrome; Aged; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Prospective Studies; Risk Factors; Sirolimus; Stents; Time Factors

We aimed to evaluate the risk of definite stent thrombosis with bare-metal stents (BMS) and drug-eluting stents (DES) in patients treated for acute coronary syndromes.. Acute coronary syndromes (ACS) have been reported as increasing the risk for stent thrombosis.. Between January 2000 and December 2005, 5,816 consecutive patients underwent percutaneous coronary intervention for de novo lesions with a single stent type. These patients consisted of 3 sequential groups of BMS (n = 2,248), sirolimus-eluting stents (n = 822) and paclitaxel-eluting stents (n = 2,746). In total, 3,485 patients presented with an ACS.. After a median follow-up of 1,394 days, patients with ACS had a definite stent thrombosis rate of 2.5% versus 1.0% in patients with stable angina (propensity score-adjusted hazard ratio [HR]: 2.80, 95% confidence interval [CI]: 1.72 to 4.56). ACS patients had a higher risk of early and late stent thrombosis, although the increased risk of very late stent thrombosis was only present in ACS patients treated with DES. In stable patients, any stent thrombosis resulted in a significant increase in mortality (adjusted HR: 4.0, 95% CI: 1.7 to 9.3), although this was particularly evident for late or very late stent thrombosis; in contrast only early stent thrombosis significantly increased mortality in patients with acute coronary syndrome patients (adjusted HR: 2.0, 95% CI: 1.0 to 4.1).. Patients with acute coronary syndromes are at higher risk of early and late stent thrombosis with either BMS or DES, although very late stent thrombosis seems to be uniquely associated with DES. The clinical sequelae of late and very late stent thrombosis are more pronounced in stable patients.

Topics: Acute Coronary Syndrome; Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

The impact of late incomplete stent apposition (ISA) post sirolimus eluting stent (SES) implantation in patients with acute coronary syndrome (ACS) on long-term clinical outcomes remains controversial. The aim of the present study was to evaluate the association between late ISA and clinical outcomes in patients with ACS compared with that with stable angina (SA).. From February 2005 to March 2007, 54 ACS patients and 83 SA patients were enrolled in this study, late ISA was determined by means of three-dimensional volumetric intravascular ultrasound (IVUS) analyses one year after SES implantation and clinical outcomes one year post IVUS were obtained in these patients.. In 219 treated lesions of the 137 patients, late ISA was documented in 25 lesions in 16 patients (20 ISA in 12 ACS patients vs. 5 ISA in 4 SA patients, P<0.001). Though lumen area in reference and stented segment, neointimal hyperplasia (NIH) area and percentage of NIH in stented segment, and external elastic membrane (EEM) area in reference segment were similar between two groups, EEM area in stented segment [(15.34+/-5.44) mm2 vs. (13.83+/-4.51) mm2, P=0.026], stented/reference segment EEM area ratio (1.13+/-0.22 vs. 1.02+/-0.18, P<0.001), plaque and media area [(8.43+/-3.93) mm2 vs. (7.01+/-2.93) mm2, P=0.002] was significantly lager in ACS group than that in SA group. Multivariable logistic analysis showed that ACS (OR 6.477 with 95% CI from 2.297 to 18.263, P<0.001) and stent length>or=23 mm (OR 3.680 with 95% CI from 1.181 to 11.469, P=0.025) were main independent factors of occurrence of late ISA. Incidence of main adverse cardiac events (MACE) one year post IVUS was similar between the two groups.. Compared with patients with SA, ACS patients had larger stented segment EEM area, plaque and media area as well as increased incidence of ISA. However, the incidence of MACE was similar in ACS and SA patients one year after IVUS.

Topics: Acute Coronary Syndrome; Aged; Angina Pectoris; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prognosis; Retrospective Studies; Sirolimus; Treatment Outcome

The aim of this study was to compare outcomes among unselected patients undergoing percutaneous coronary intervention (PCI) with either sirolimus-eluting (SES) or paclitaxel-eluting stents (PES).. Although the benefits of both SES and PES are well-established, studies comparing these stents directly have yielded conflicting results.. We used data from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry to compare in-hospital and 1-year outcomes among unselected patients undergoing nonemergent PCI with either SES or PES implantation.. Between July 2004 and June 2006, 6,035 patients underwent PCI with either SES (n = 3,443) or PES (n = 2,592) at 47 U.S. centers. Baseline clinical and angiographic characteristics were generally similar for the 2 stent types. At 1-year, there were no differences in the primary end point of cardiac death or myocardial infarction (MI) between the SES and PES groups (9.1% vs. 10.0%, p = 0.11) or in any individual end points including cardiac death, nonfatal MI, or stent thrombosis. In unadjusted analyses, target lesion revascularization (TLR) was slightly more common with SES than with PES (4.4% vs. 3.3%, p = 0.048), but this difference was no longer apparent after adjusting for baseline characteristics as well as site-related factors (adjusted hazard ratio: 1.09, 95% confidence interval: 0.78 to 1.50).. Among unselected patients undergoing PCI, adjusted rates of both ischemic complications as well as clinically important restenosis were similar for SES and PES. The unexpected finding that TLR was influenced by site characteristics suggests that the correlation between TLR and angiographic restenosis might be weaker than previously described and warrants further study.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

The incidence of definite stent thrombosis (ST) after use of drug-eluting stents (DES), as defined by the Academic Research Consortium, is known to be lower in Japan than in western countries. However, a statistical difference in the incidence of early definite ST (EDST) associated with the unrestricted use of DES has not yet been documented. Therefore, the incidence of EDST in our Japanese institute after unrestricted use of DES was retrospectively compared with those reported in western mega-studies.. During the 40 months from August 2004 to November 2007 (before approval of clopidogrel in Japan), DES were implanted in 3605 lesions in 1885 patients in our institute; lesion- and patient-associated percentages of DES use were 95.2% and 94.7%, respectively. Mean stent length per lesion was 33.2 mm, emergent procedures and ST-elevation myocardial infarctions made up 33.7% and 16.4% of the procedures, respectively, intravascular ultrasonography was used 96.0% of the time, a distal protection device for acute coronary syndrome was used 68.7% of the time, and the mean maximum inflation pressure was 19.5 atm. EDST was observed in five lesions (0.139%) in four patients (0.212%). The incidence of patient-associated EDST at our center was significantly lower than in four western mega-studies (0.736%, 66 of 8970 patients; 0.634%, 149 of 23,500; 0.595%, 52 of 8402; 0.997%, 20 of 2006) (p<0.05, <0.01, <0.05, <0.01, respectively, using a chi(2)-test).. Due to differences in procedural approaches in Japan, the incidence of EDST after unrestricted use of DES was significantly lower than in western countries.

Topics: Acute Coronary Syndrome; Angina, Unstable; Clinical Trials as Topic; Drug-Eluting Stents; Europe; Humans; Incidence; Japan; Paclitaxel; Platelet Aggregation Inhibitors; Retrospective Studies; Sirolimus; Thrombosis; Ticlopidine; United States

Drug-eluting stents (DES) have been shown to significantly reduce the incidence of restenosis and target lesion revascularization in a wide variety of clinical situations. DES have also been shown to significantly reduce neointimal hyperplasia as compared to bare-metal stents. However, the antiproliferative properties of DES also delay vascular healing and have been associated with stent malapposition, hypersensitivity reactions and late stent thrombosis. Stent thrombosis could result in myocardial infarction or death. We describe here a case report of late stent malapposition following sirolimus-eluting stent implantation observed by angiography, intravascular ultrasound, optical coherence tomography and angioscopy.

Topics: Acute Coronary Syndrome; Adult; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Foreign-Body Migration; Humans; Male; Risk Factors; Sirolimus; Tomography, Optical Coherence; Ultrasonography, Interventional

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Fatal Outcome; Humans; Male; Multiple Organ Failure; Platelet Aggregation Inhibitors; Sirolimus; Thrombosis; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Ultrasonography, Interventional

Sirolimus-eluting stents (SES) reduce restenosis and revascularization rates, compared with bare-metal stents (BMS), in elective percutaneous coronary intervention (PCI). This study investigated the safety and efficacy of SES for emergency PCI in acute coronary syndrome (ACS) patients.. The 154 consecutive patients (SES: n=77, BMS: n=77) admitted to hospital with ACS were enrolled in this study. Procedural success (%DS <50%, Thrombolysis In Myocardial Infarction grade 3), major adverse cardiac events (MACE) at 30 days and 8 months, and the incidence of stent thrombosis were evaluated. There was no difference between the groups regarding procedural success. Patients treated with SES had smaller stent diameter (SES 3.04 mm vs BMS 3.24 mm; p=0.01) and longer stent length (25.7 mm vs 21.2 mm; p=0.01). At 30 days, there was no difference between the groups in the incidence of cardiovascular events. At 8 months, patients treated with the SES had a lower rate of repeat PCI (5.6% vs 18.6%; p=0.04) and MACE (9.7% vs 27.1%; p=0.01). Stent thrombosis was no different between groups (1.4% vs 2.9%).. In emergency PCI for ACS patients, SES implantation significantly reduced cardiovascular events, compared with BMS, by decreasing the incidence of repeat PCI. The safety profile of SES is equal to that of BMS.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Disease-Free Survival; Drug-Eluting Stents; Emergency Medical Services; Female; Humans; Immunosuppressive Agents; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Recurrence; Retrospective Studies; Sirolimus; Treatment Outcome

The residual drug carriers on drug-eluting stents (DES) surfaces are considered to be one of the most significant reasons causing late thrombosis. There is no documented data currently available on the safety/benefit profile beyond 6 months of EXCEL stent, a novel sirolimus-eluting stent with biodegradable polymer coating, in treating patients with coronary artery disease (CHD).. To evaluate the long-term efficacy and safety of EXCEL stent on treating CHD patients.. Between February and March 2006, a consecutive cohort of complex patients treated with the EXCEL stent was prospectively enrolled in this single-center registry. Antiplatelet protocol was 6-month dual antiplatelet therapy with clopidogrel and aspirin followed by aspirin alone indefinitely. The primary outcome was major adverse cardiac events (MACE) at 12 months. Secondary outcomes included in-segment and in-stent late lumen loss and binary restenosis rate measured by quantitative coronary angiography (QCA) analysis at 8 months postindex PCI procedure.. A total of 100 patients with 153 lesions were included in this analysis. Most lesions (83.0%) were classified as complex (B2/C). At 12 months, four patients (4.0%) experienced MACE, which were four target-lesion revascularizations due to in-stent restenosis (ISR). All patients received follow-up up to 24 +/- 0.4 months and no cardiac death, MI, and in-stent thrombosis occurred during the 6 months of dual antiplatelet therapy or the subsequent 15 months of aspirin treatment alone. QCA analysis of 112 lesions from 75 patients showed 3.6% (4/112) in-stent lesion restenosis, 5.4% (6/112) in-segment lesion restenosis, 0.12 +/- 0.34 mm in-stent late lumen loss, and 0.08 +/- 0.35 mm in-segment late lumen loss.. In this single-center experience with complex patients and lesions, the EXCEL stent implantation with 6-month dual antiplatelet treatment proved to markedly reduce the incidence of 24-month ISR and MACE. These preliminary findings require further validation by large scale, randomized trials.

Topics: Absorption; Acute Coronary Syndrome; Adult; Aged; Aged, 80 and over; Aspirin; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Lactic Acid; Male; Middle Aged; Platelet Aggregation Inhibitors; Polyesters; Polymers; Sirolimus; Ultrasonography, Interventional

Late incomplete stent apposition (ISA) may occur after drug-eluting stent implantation, affecting long-term clinical outcomes. This study aimed to evaluate the impact of clinical presentations of coronary artery disease on late ISA after percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SES) by means of three-dimensional volumetric intravascular ultrasound (IVUS) analyses.. One hundred and thirty-seven patients with coronary artery disease received SES implantation during PCI and had repeat angiography with IVUS examination. All patients were followed up one year after the procedure.. In overall 219 treated lesions (137 patients), late ISA was identified in 25 lesions (16 patients). Clinical diagnosis of acute coronary syndrome (ACS) and use of long stents were more common in patients with than in those without late ISA. Patients with late ISA had greater external elastic membrane (EEM) area in stented segment ((15.34 +/- 5.44) vs (13.83 +/- 4.51) mm(2), P = 0.026), stented-to-reference segment EEM area ratio (1.13 +/- 0.22 vs 1.02 +/- 0.18, P < 0.001), and plaque and media area ((8.43 +/- 3.93) vs (7.01 +/- 2.93) mm(2), P = 0.002) than in those without late ISA. Multivariate Logistic regression analysis showed that clinical diagnosis of ACS and use of long stents were independent risk factors for late ISA (OR 6.477, 95% CI 2.297 - 18.263, P < 0.001; OR 3.680, 95% CI 1.181 - 11.469, P = 0.025; respectively). During one-year follow-up after IVUS examination, the rate of very late stent thrombosis tended to be higher in patients with than in those without late ISA (18.7% vs 3.3%, P = 0.051).. The occurrence of late ISA after SES implantation may be related to clinical status, use of long stents, and marked positive vessel remodeling. Late ISA tended to increase the rate of very late stent thrombosis during follow-up, highlighting the importance of long-term dual antiplatelet therapy for these patients.

Topics: Acute Coronary Syndrome; Aged; Blood Vessel Prosthesis Implantation; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Prosthesis Failure; Sirolimus; Ultrasonography, Interventional

Late stent thrombosis (>1 year after implantation) is a recognised complication involving drug-eluting stents. Stent fracture is increasingly being reported as a complication of drug-eluting stent, and in particular sirolimus-eluting stent use. We report the case of very late sirolimus-eluting stent fracture resulting in an acute coronary syndrome. This case report highlights the need for greater awareness and post-marketing surveillance to detect a potential mechanism for late stent thrombosis in the drug-eluting stent era.

Topics: Acute Coronary Syndrome; Aged; Coronary Angiography; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Male; Prosthesis Failure; Sirolimus

Percutaneous coronary intervention (PCI) of the unprotected left main coronary artery (LMCA) is controversial. In 143 patients who underwent PCI of the unprotected LMCA, 30-day mortality was compared with predicted cumulative risk-adjusted perioperative surgical mortality based on logistic European System for Cardiac Operative Risk Evaluation. One-year clinical follow-up was completed in all patients. The overall major adverse cardiac event rate at 1 year was 34.3%, reflecting the high-risk profile of the patient population. Twelve patients (8%) experienced an acute myocardial infarction and 16 (11%) underwent target lesion revascularization. In 31 patients (22%) who died during the first year, median logistic European System for Cardiac Operative Risk Evaluation was 30%. Calculated RRs showed significantly lower 30-day mortality using PCI compared with predicted surgical mortality (RR 0.54, 95% confidence interval 0.31 to 0.86). Angiographic follow-up in 90 of the 118 patients alive at 6 months showed binary restenosis of 6% in patients treated with drug-eluting stents versus 29% in patients receiving bare-metal stents (p < or =0.01). In conclusion, PCI for unprotected LMCA disease was associated with acceptable short- and medium-term outcomes in patients at low to intermediate risk of bypass surgery. Mortality remains high in very high-risk patients unsuitable for surgery. However, in selected indications, PCI of the LMCA can offer an alternative to surgery, especially when using drug-eluting stents.

Topics: Acute Coronary Syndrome; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Coronary Artery Bypass; Coronary Artery Disease; Coronary Restenosis; Female; Humans; Male; Myocardial Infarction; Outcome Assessment, Health Care; Retreatment; Risk Adjustment; Sirolimus; Stents

Age is an important predictor of mortality after percutaneous coronary intervention (PCI). The safety and efficacy of PCI with drug-eluting stents (DES) in nonagenarians have not been extensively studied.. A retrospective analysis of 889 consecutive patients identified 28 (3.1%) nonagenarians who underwent PCI with DES from May 2003 to December 2005 at our institution.. The mean age was 92 +/- 2 years, 39% were male, and 4% were diabetic. Sirolimus-eluting stents were used in 79%. A mean of 1.5 +/- 0.9 stents/patient were implanted with a total stent length of 31 +/- 20 mm. Twenty-nine percent presented with unstable angina and 39% with myocardial infarction. The angiographic success rate obtained was 100%. The 30-day mortality rate was 21%. The 6 patients who died within 30 days included 3 patients who had cardiogenic shock and one patient with critical aortic stenosis who died due to complications during percutaneous aortic valvuloplasty. The cumulative survival rate for all nonagenarians at 1 year and 3 years was (68 +/- 9)% and (61 +/- 9)%. When the four patients who were in extremis on presentation were excluded, there were no in-hospital deaths, the 30-day mortality was 8%, and the 1 year and 3 year survival rate was (79 +/- 8)% and (71 +/- 9)% for the nonagenarians. No patient had definite stent thrombosis.. The majority of the nonagenarians who underwent PCI with DES presented with acute coronary syndrome. Percutaneous coronary intervention with DES was safe in nonagenarians as there were no in-hospital deaths and acceptable 3-year survival rates when patients who were in extremis on presentation were excluded. The high-risk profile of these patients and the expected attrition of nonagenarians may contribute to their mortality rates.

Topics: Acute Coronary Syndrome; Age Factors; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Acute Coronary Syndrome; Age Factors; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Patient Selection; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

It remains unclear whether sirolimus-eluting stents (SES) have an advantage over bare metal stents (BMS) in patients on dialysis.. Percutaneous coronary intervention (PCI) using SES was performed in 54 dialysis patients with 69 lesions. A control group for comparison comprised 54 consecutive dialysis patients with 58 lesions who underwent PCI using BMS. Angiographic and clinical follow-ups were scheduled at 9 months. After the procedure, minimum lumen diameter (MLD) was similar between the 2 groups. At follow-up, the SES group had a higher MLD than the BMS group (1.98+/-0.83 mm vs 1.50+/-0.78 mm, p<0.01). In-stent restenosis rate was lower in lesions treated with SES than in those with BMS (22% vs 40%, p=0.048). However, there was no significant difference between the 2 groups for in-segment restenosis (31% vs 43%, p=0.3). During follow-up, there was no significant difference in the incidence of death, myocardial infarction or target lesion revascularization (TLR) (14% vs 21%, p=0.4) between the SES and BMS groups.. In this retrospective study, SES, in comparison with BMS, reduced in-stent restenosis in patients on dialysis. However, in-segment restenosis and TLR were not statistically different between lesions treated with SES and those with BMS.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Case-Control Studies; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Immunosuppressive Agents; Kidney Failure, Chronic; Male; Middle Aged; Regional Blood Flow; Renal Dialysis; Retrospective Studies; Sirolimus; Stents; Treatment Outcome; Vasoconstriction

Patients with metabolic syndrome (MS) are at increased risk for cardiovascular events. Although the number of patients with MS requiring coronary revascularization is increasing rapidly, the impact of MS on clinical events and restenosis in patients who undergo stent placement is not well defined. Seven hundred thirty-four consecutive patients with 734 de novo coronary lesions (<50 mm lesion length, reference vessel diameter <3.5 mm) were enrolled in this study. Four hundred thirty-seven patients were treated with bare-metal stents, and 297 patients were treated with sirolimus-eluting stents. Patients with bifurcation lesions, left main lesions, and ST-segment-elevation myocardial infarctions were excluded from the study. Patients were categorized into 3 groups: those with (1) diabetes mellitus (DM), (2) MS without DM, and (3) no MS and no DM. MS was defined according to American Heart Association and National Heart, Lung, and Blood Institute criteria (the presence of > or =3 of the following criteria: obesity, hypertension, hypertriglyceridemia, low high-density lipoprotein cholesterol, and increased fasting glucose). Clinical follow-up was performed for > or =1 year (mean 27.5 +/- 18.1 months). One hundred sixty-four patients (22%) had DM, 180 patients (25%) had MS without DM, and 390 patients (53%) had no MS and no DM. Baseline clinical and angiographic parameters were comparable among the 3 groups, including lesion length and reference vessel diameter. In patients treated with bare-metal stents, the rates of major adverse cardiac events (MACEs) at 12 months were 14% in patients without DM or MS, 18% in those with MS but no DM, and 33% in those with DM (p = 0.046). In patients treated with sirolimus-eluting stents, the MACE rates were 3% in patients without DM or MS, 4% in those with MS, and 13% in those with DM (p = 0.034). DM (odds ratio 2.14, 95% confidence interval 1.48 to 3.07, p <0.001) and bare-metal stent (odds ratio 2.51, 95% confidence interval 1.49 to 4.22, p <0.001) implantation were independent predictors of MACEs during follow-up, whereas MS was not predictive. Similarly, MS was not a predictor of target lesion revascularization. In conclusion, patients with MS did not have an increased risk for target lesion revascularization or a greater MACE rate compared with control patients during a 12 month follow-up period after bare-metal or drug-eluting stent placement. In contrast, DM is associated with significantly increased event rates.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Coronary Angiography; Coronary Disease; Coronary Restenosis; Diabetic Angiopathies; Female; Humans; Immunosuppressive Agents; Male; Metabolic Syndrome; Middle Aged; Retrospective Studies; Sirolimus; Stents