cardiovascular-agents and Coronary-Restenosis

Drug-delivery systems in cardiovascular applications regularly include the use of drug-eluting stents and drug-coated balloons to ensure sufficient drug transfer and efficacy in the treatment of cardiovascular diseases. In addition to the delivery of antiproliferative drugs, the use of growth factors, genetic materials, hormones and signaling molecules has led to the development of different nanoencapsulation techniques for targeted drug delivery. The review will cover drug delivery and coating mechanisms in current drug-eluting stents and drug-coated balloons, novel innovations in drug-eluting stent technologies and drug encapsulation in nanocarriers for delivery in vascular diseases. Newer technologies and advances in nanoencapsulation techniques, such as the use of liposomes, nanogels and layer-by-layer coating to deliver therapeutics in the cardiovascular space, will be highlighted.

Topics: Cardiovascular Agents; Coronary Restenosis; Drug Delivery Systems; Drug-Eluting Stents; Humans; Stents; Treatment Outcome

Since their introduction Drug Coated Balloons (DCBs) have slowly gained their spot into everyday cath-lab practice, first for treatment of in-stent restenosis (ISR), more recently for small vessels disease; today a growing body of evidence start supporting their use in more complex lesions, from bifurcations, to large vessels, to acute lesions. Although the new generation of DCBs showed a better performance and safety than the older one, the drug of choice has always been the Paclitaxel; last year some concerns were raised on the safety of Paclitaxel devices, in particular the balloons mining their use. Recently Sirolimus ventured in the DCBs world, making its appearance on cath-lab shelves and becoming a good alternative to Paclitaxel (DCB).

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Humans; Paclitaxel; Treatment Outcome

The issue of small coronary artery atherosclerosis represents an intriguing aspect of coronary artery disease, which is related with higher rates of peri- and post-procedural complications and impaired long-term outcome. This problem is further complicated by the unclear definition of small coronary vessel. Recent randomized controlled trials have provided new data on possible novel interventional treatment of small coronary vessels with drug-coated balloons instead of traditional new-generation drug-eluting stent implantation. Also, the conservative management represents a therapeutic option in light of the results of the recent ISCHEMIA trial. The current article provides an overview of the most appropriate definition, interventional management, and prognosis of small coronary artery atherosclerosis.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Myocardial Revascularization; Percutaneous Coronary Intervention; Risk Factors; Treatment Outcome

This study aimed to compare the effectiveness of drug-coated balloons (DCB) with everolimus-eluting stents (EES) in the treatment of in-stent restenosis (ISR) and the differential relative effect of DCB in patients with drug-eluting stents (DES)-ISR and bare metal stents (BMS)-ISR.. The efficiency and safety of DCB and EES need to be assessed for the treatment of ISR.. A systematic literature search was conducted using PubMed and EMBASE to identify all relevant studies. Angiographic results and clinical events were separately assessed. Subgroup meta-analyses were performed according to the type of restenosed stent.. Six randomized trials with 1134 patients were included. The overall pooled outcomes indicated that DCB was associated with lower minimum lumen diameter (mean difference (. DCB was inferior to EES in DES-ISR and comparable in BMS-ISR in terms of angiographic results and clinical events.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Treatment Outcome

Individual randomized trials comparing drug-eluting balloons (DEB) versus everolimus-eluting stents (EES) for in-stent restenosis (ISR) were underpowered for clinical end-points. The objective of this study was to compare the clinical outcomes of DEB versus EES for any ISR.. Electronic databases were searched for randomized trials which compared DEB versus EES for any ISR (i.e., drug eluting or bare metal stents). Summary estimate risk ratios (RRs) were constructed using a DerSimonian and Laird random effects model.. Five trials with 962 patients were included. In-segment minimum lumen diameter (MLD) was lower with DEB (standardized mean difference -0.24, 95% confidence interval [CI] -0.46 - -0.01) on angiographic follow-up at a mean of 8.6 months. There was no statistically significant difference in the risk of target vessel revascularization (TVR) at 1 year (RR 1.15, 95% CI 0.60-2.19), but TVR was increased with DEB at 3 years (RR 1.87, 95% CI 1.15-3.03). The risk of target lesion revascularization (TLR) was statistically increased with DEB (RR 2.17, 95% CI 1.13-4.19) at a mean of 24.4 months. There was no difference in the risk of MI, stent thrombosis, cardiac mortality and all-cause mortality between both groups.. In patients with any type of ISR, DEB was associated a similar risk of TVR at 1-year, but increased risk of TVR and TLR at longer follow-up, as compared with EES. The quality of evidence was moderate, suggesting the need for further randomized trials with longer follow-up to confirm the role of DEB in the management of ISR.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Stents; Time Factors; Treatment Outcome

Percutaneous coronary intervention (PCI) of small-vessel coronary artery disease (SVD) is associated with increased risk of restenosis. The use of drug-coated balloons (DCBs) in SVD has received limited study.. To assess the outcomes of DCB in the treatment of SVD compared with the standard of care.. We performed a meta-analysis of all studies published between January 2000 and September 2018 reporting the outcomes of DCB versus other modalities in the treatment of de novo SVD.. Seven studies with 1,824 patients (1,938 lesions) were included (four randomized controlled trials and three observational studies). During a mean follow-up of 14.5 ± 10 months, DCBs were associated with a similar risk of target lesion revascularization (TLR) (OR: 0.99, 95% CI: 0.54, 1.84, P = 97) and major adverse cardiovascular events (MACE) (OR: 0.86, 95% CI: 0.51, 1.45, P = 0.57) compared with drug-eluting stents (DES). During a mean follow-up of 7 ± 1.5 months, DCBs were associated with a significantly lower risk of TLR (OR: 0.19, 95% CI 0.04-0.88, P = 0.03) and binary restenosis (OR: 0.17, 95% CI 0.08-0.37, P = <0.00001) compared with noncoated balloon angioplasty.. The use of DCBs in SVD is associated with comparable outcomes when compared with DES and favorable outcomes when compared with balloon angioplasty.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Observational Studies as Topic; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Treatment Outcome

Even in the drug-eluting stent era, ostial lesion of the right coronary artery (RCA) still remains therapeutic challenge for interventional cardiologists. Case Series Case 1 (76 y.o. male) with angina on effort underwent transradial stent-less percutaneous coronary intervention (PCI) using rotational atherectomy (RA) followed by drug-coated balloon (DCB) dilation alone (RA/DCB) against a calcified de novo RCA ostial lesion. Case 2 (86 y.o. female) with recurrent unstable angina and hemodialysis underwent transfemoral RA/DCB against a severe repeat in-stent restenosis probably due to calcified nodule in the RCA ostium. In the both patients, PCI was successfully completed under intravascular ultrasound imaging (IVUS) guidance without complications. Follow-up CAG performed 4-5 months after the procedure revealed no significant lumen narrowing in the both RCA ostial lesions.. The both cases suggest that stent-less PCI using RA/DCB under IVUS might be an alternative revascularization therapy of choice for calcified RCA ostial lesions.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Equipment Design; Female; Humans; Male; Treatment Outcome; Ultrasonography, Interventional; Vascular Calcification

This article will review the major clinical trials related to coronary intervention that were released in 2018. Areas of interest include lesion assessment, novel stent design, acute coronary syndromes (ACSs), and major breakthroughs in chronic total occlusion interventions.. The benefit of intracoronary imaging and hemodynamic assessment was demonstrated by multiple studies, which found improved procedural and clinical outcomes in patients who underwent advanced assessment of intracoronary lesions. The optimal use of drug-coated balloons in coronary disease still remains unclear with conflicting data regarding the benefit of DCB over everolimus-eluting stents for the treatment of in-stent restenosis. Trials in bioresorbable scaffolds also saw a high level of interest after the ABSORB IV trial showed promising results with changes in implantation technique. Multiple studies evaluated complete revascularization versus infarct-related only revascularization in patients with ACS; however, data was conflicting in regard to what is the best strategy. Lastly, the EUROCTO study was released in 2018 and was the first trial to show symptomatic benefit of revascularization of chronic total occlusions.. The ESC/EACTS guidelines on complete versus partial revascularization, treatment of in-stent restenosis, and revascularization during cardiogenic shock were updated to reflect data obtained from trials released in 2018.

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

After the introduction of drug eluting stent (DES) the rate of in-stent restenosis (ISR) has decreased if compared to the BMS era; however, treatment of patients with ISR remained a major issue for the interventional cardiologist. DES has been largely used with good results also as second layer for the treatment of ISR, but the overall percentage of patients suffering from restenosis still remains high, especially in some subgroups of patients as ones with diabetes mellitus (DM). In this clinical scenario, drug coated balloon (DCB) has been gaining an important role for the treatment of ISR. In fact, it allows to release an antiproliferative drug, namely paclitaxel, without the addition of a second metallic strut, which can lead to a persistent inflammatory stimulus and further narrow the vessel. This could be an advantage in patients with an already increased systemic inflammatory burden and stiffer vessels as those with DM. Despite differences in terms of efficacy and safety between DES and DCB have already been evaluated in different clinical trials, just few of these focused on diabetic patients. The aim of this paper is to review the available data for treatment of ISR both with DES, DCB, and a comparison between these two devices, in patients affected by DM. © 2017 Wiley Periodicals, Inc.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Diabetes Mellitus; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Stents; Treatment Outcome

The benefit of drug-eluting stents (DES) versus drug-coated balloons (DCB) in coronary artery in-stent restenosis (ISR) for the prevention of target lesion revascularization (TLR), stent thrombosis, and mortality remains uncertain. Our aim was to synthesize the available evidence from randomized clinical trials (RCTs) and observational studies that directly compare second-generation drug-eluting stents (SG-DES) and DCB for the treatment of coronary ISR.. Medline, Embase, and Cochrane Central were searched for RCTs or observational studies, published up to March 15, 2017. A random effects model meta-analysis investigating clinical and angiographic outcomes was conducted for RCTs and observational studies that compared SG-DES versus DCB for the treatment of ISR.. Ten studies and 2,173 patients were included in this meta-analysis. The two treatment strategies were proven equal with regards to TLR, myocardial infarction, stent thrombosis, and cardiac mortality in both randomized and observational studies. No difference was found among RCTs for all-cause mortality, while in observational studies, patients who were treated with SG-DES had a lower mortality compared to DCB (OR: 0.47; 95% CI: 0.27-0.83). In the pooled analysis also (RCTs and observational studies), SG-DES were associated with lower all-cause mortality compared to DCB. Patients treated with SG-DES were also superior in terms of minimal lumen diameter (standardized mean difference: 0.39; 95% CI: 0.12-0.66).. The two treatment strategies are equal for the treatment of ISR, while the difference in all-cause mortality might be potentially explained by baseline differences in the two groups among real-world studies.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Stents; Time Factors; Treatment Outcome

Restenosis is a pathologic re-narrowing of a coronary artery lesion after mechanical injury. Its pathophysiological mechanisms have not been fully elucidated at present, but are thought to include inflammation, vascular smooth muscle cell (VSMC) proliferation, and matrix remodeling, beginning with insufficient endothelium healing. Restenosis presents with angina symptoms or acute coronary syndromes and lead to a revascularization, either with coronary artery bypass or repeat percutaneous coronary intervention. Some studies have reported that hypoadiponectinemia has been an independent risk factor for the onset of acute coronary syndromes and restenosis. Accumulating evidence shows that low concentrations of adiponectin may be involved in impairing endothelium functions, inflammation, and VSMC proliferation that lead to restenosis. Preclinical studies have proven that adiponectin promotes endothelium healing, effectively inhibits inflammation, and maintains contractile phenotypes of VSMCs, indicating that it may be developed as a new therapeutic target for the treatment of restenosis.

Topics: Adiponectin; Animals; Cardiovascular Agents; Cell Proliferation; Coronary Restenosis; Drug Delivery Systems; Humans; Metabolism, Inborn Errors; Muscle, Smooth, Vascular; Treatment Outcome

This review will focus on our approach for the treatment of refractory in-stent restenosis.. The discovery of bare metal stents over three decades ago set a milestone in the evolution of percutaneous coronary intervention, which is currently the most widely performed procedure for the treatment of symptomatic coronary disease. However, the broad utilization of stents resulted in the new phenomenon of in-stent restenosis (ISR). Over the years, there has been an increase of the incidence of ISR despite continued improvement of drug-eluting stent (DES) technology. The mechanism of ISR is multifactorial, including biological, mechanical, patient, and operator-related factors. The most common factor is aggressive neointimal proliferation and neoatherosclerosis. ISR presentation is not benign, and treatment is challenging, especially in cases of DES-ISR. We review available therapy modalities for ISR, including medical therapy, scoring balloons, atheroablative therapies, repeat DES, vascular brachytherapy, drug-coated balloons, and coronary artery bypass grafting.

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

In the era of drug-eluting stents, large-scale randomized trials and all-comer registries have shown excellent clinical results. However, even the latest-generation drug-eluting stent has not managed to address all the limitations of permanent metallic coronary stents, such as the risks of target lesion revascularization, neoatherosclerosis, preclusion of late lumen enlargement, and the lack of reactive vasomotion. Furthermore, the risk of very late stent, although substantially reduced with newer-generation drug-eluting stent, still remains. These problems were anticipated to be solved with the advent of fully biodegradable devices. Fully bioresorbable coronary scaffolds have been designed to function transiently to prevent acute recoil, but have retained the capability to inhibit neointimal proliferation by eluting immunosuppressive drugs. Nevertheless, long-term follow-up data of the leading bioresorbable scaffold (Absorb) are becoming available and have raised a concern about the relatively higher incidence of scaffold thrombosis. To reduce the rate of clinical events, improvements in the device, as well as implantation procedure, are being evaluated. This review will focus on the current CE-mark approved bioresorbable scaffolds, their basic characteristics, and clinical results. In addition, we summarize the current limitations of bioresorbable scaffold and their possible solutions.

Topics: Absorbable Implants; Cardiovascular Agents; Clinical Trials as Topic; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Diffusion of Innovation; Forecasting; Humans; Neointima; Percutaneous Coronary Intervention; Polymers; Risk Factors; Treatment Outcome

Drug-eluting balloon (DEB) has become an alternative option to drug-eluting stent (DES) for the treatment of in-stent restenosis (ISR). However, the effect of drug-eluting balloon with regular bare-mental stent (BMS) in de novo coronary artery disease (CAD) is unclear. This meta-analysis aimed to evaluate the efficacy of DEB with regular BMS compared to BMS or DES in de novo CAD.. Randomized controlled trials (RCTs) assessing the efficacy of DEB+BMS in comparison with BMS or DES were obtained by searching the PubMed, EMBASE, and Cochrane Library databases through January 2016. Primary endpoints were major adverse cardiac events (MACEs) and late lumen loss (LLL). Secondary endpoints included death, myocardial infarction (MI), target lesion revascularization (TLR), stent thrombosis (ST), binary restenosis, and minimum lumen diameter (MLD). Dichotomous and continuous data were presented as odds ratios (ORs) and mean differences (MDs) with 95% confidence intervals (CIs), respectively, and analyzed using a random-effects model.. A total of 14 RCTs involving 2281 patients were included in this meta-analysis. DEB+BMS showed significantly less MACEs (OR: 0.67, 95%CI 0.45 to 0.99, P = 0.04) and reduced LLL (MD: -0.30 mm, 95%CI: -0.48 mm to -0.11 mm, P = 0.001) compared with BMS. Meanwhile, treatment with DEB+BMS had disadvantages over DES in terms of MACEs (OR: 1.94, 95%CI 1.24 to 3.05, P = 0.004), LLL (MD: 0.20 mm, 95%CI: 0.07 mm to 0.33 mm, P = 0.003), TLR (OR: 2.53, 95% CI 1.36 to 4.72, P = 0.003), and MLD (MD: -0.25 mm, 95%CI: -0.42 mm to -0.09 mm, P = 0.003).. This limited evidence demonstrated that treatment with DEB+BMS appears to be effective in de novo CAD. In addition, DEB+ BMS clearly showed superiority to BMS, but is inferior to DES in the treatment of patients with de novo CAD. Hence, DES (especially new generation DES) should be recommended for patients with de novo CAD.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Databases, Factual; Drug-Eluting Stents; Humans; Myocardial Infarction; Odds Ratio; Randomized Controlled Trials as Topic

The drug coated balloon (DCB) platform offers several theoretical benefits over stent-based technologies. It allows the homogenous transfer of an anti-proliferative drug to reduce neo-intimal hyperplasia whilst potentially maintaining normal vessel anatomy and function. They also avoid the introduction of an additional stent layer in the context of in-stent restenosis. The data pertaining to the treatment of de-novo coronary disease still favors the new generation of drug eluting stents. DCB may, however, have a role in the context of challenging coronary anatomy and small vessel disease where results with stent insertion are poor. The body of evidence supporting the role of DCB in the treatment of in-stent restenosis is more substantial and appears to yield similar results to DES without the introduction of an additional stent layer. Further trials are required to clarify the ideal duration of dual anti-platelet treatment following DCB use and to further elucidate the ideal clinical context for their use.

Topics: Cardiovascular Agents; Clinical Trials as Topic; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans

Restenosis is one of the main complications in patients undergoing coronary or peripheral revascularization procedures and is the leading cause for their long-term failures. Cilostazol is the only pharmacotherapy that showed an adequate efficacy for preventing restenosis in randomized, controlled studies after coronary or peripheral revascularization procedures. The present review sums up the main clinical evidence supporting the use of cilostazol after revascularization interventions, focusing on all its benefits, warnings, and administration schedules.

Topics: Cardiovascular Agents; Cilostazol; Coronary Artery Disease; Coronary Restenosis; Endovascular Procedures; Humans; Peripheral Arterial Disease; Recurrence; Risk Factors; Tetrazoles; Treatment Outcome

The drug-coated balloon (DCB) has emerged as an additional tool in the arsenal of interventional cardiology devices; it delivers antiproliferative drugs to local arterial tissue by single prolonged coated balloon angioplasty inflation, and prevents restenosis, leaving no implant behind. This strategy theoretically decreases the risk of late inflammatory response to device components, without preventing positive remodelling. DCBs, when used carefully and with a good technique, may have a role in the treatment of lesion subsets, such as in-stent restenosis, small vessel disease or side branch bifurcations, in which the implantation of a drug-eluting stent is not desirable or is technically challenging. Using the latest evidence regarding the effectiveness of the currently available DCBs, this review will discuss the rationale for DCB use, and the effectiveness of DCBs in different clinical and lesion settings, and will give practical tips for their correct use in everyday clinical practice.

Topics: Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Equipment Design; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Risk Factors; Treatment Outcome

In-stent restenosis (ISR) is the narrowing of a stented coronary artery lesion. The mean time from percutaneous coronary intervention (PCI) to ISR was 12 months with drug-eluting stents (DES) and 6 months with bare metal stents (BMS). ISR typically presents as recurrent angina. The use of DES has significantly reduced the rate of ISR compared with BMS. Predictors of ISR include patient, lesion, and procedural characteristics. Intravascular ultrasound, optical coherence tomography, and fractional flow reserve are important tools for the anatomic and hemodynamic assessment of ISR. Treatment options for ISR include percutaneous coronary intervention with DES.

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Disease-Free Survival; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Treatment Outcome

The aim of this meta-analysis was to evaluate the efficacy of drug-eluting balloons (DEBs) plus bare-metal stents (BMS) for the treatment of de-novo coronary lesions.. Eleven trials involving 1279 patients were included in this study. The main endpoints were as follows: late lumen loss (LLL), binary restenosis, stent thrombosis (ST), and major adverse cardiovascular events (MACEs). The definition of MACEs was a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR). Compared with BMS alone, DEB plus BMS showed a lower risk for LLL (P=0.007) and MACEs (P=0.010). There were no significant differences in binary restenosis (P=0.212), ST (P=0.199), death (P=0.141), MI (P=0.439), and TLR (P=0.340). Compared with drug-eluting stents (DES), DEB plus BMS could increase the risk of LLL (P=0.002) and MACEs (P=0.026). The risks of binary restenosis (P=0.113), ST (P=0.832), death (P=0.115), MI (P=0.831), and TLR (P=0.111) were similar between DEB plus BMS and DES.. DEB plus BMS was better than BMS alone in reducing LLL and MACEs, especially when dilatation was performed after stenting for de-novo coronary lesions, but it was inferior to DES. Therefore, the treatment strategy with DEB plus BMS should not be recommended for de-novo coronary lesions, except for patients who have contraindications for DES.

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Humans; Metals; Myocardial Infarction; Odds Ratio; Paclitaxel; Randomized Controlled Trials as Topic; Risk Factors; Stents; Time Factors; Treatment Outcome

Stent fracture has been recognized as one cause of stent failure and has been associated with in-stent restenosis and stent thrombosis, even in 2nd-generation drug-eluting stents. Given the wide use of drug-eluting stents and paucity of contemporary data available concerning stent fracture, we reviewed clinical studies and the Food and Drug Administration's Manufacturer and User Device Experience (MAUDE) database to analyze the current trends, mechanisms, predictors, outcomes and treatment for stent fracture.

Topics: Cardiovascular Agents; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Prosthesis Design; Prosthesis Failure; Risk Factors; Treatment Outcome

Bioresorbable vascular scaffolds (BVS) are considered the fourth revolution in Interventional Cardiology, thus promising to address some of the pending issues with current-generation drug eluting stents (DES). Notably, most of the potential advantages of BVS over other current devices are due to a peculiar vascular response, called "vascular restoration therapy". The emerging data from real-world expanded use registries suggest that BVS use is feasible in a wide variety of patients (from low- to high- risk), and lesions (from simplex to complex). However, few safety concerns with currently available BVS have arised from initial experiences all over the word. Data from ongoing large-scale randomized controlled trials will be able to demonstrate whether BVS improve patient early and long-term outcomes compared to best-in-class DES.

Topics: Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome

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

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

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

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

Drug-coated balloons are a new tool for the treatment of patients with coronary artery disease. The main feature of this technology is a rapid and homogenous transfer of an antiproliferative drug (paclitaxel) to the vessel wall just at the time of balloon inflation, when neointimal proliferation, in response to angioplasty, is the highest. Moreover, drug-coated balloons share adjuntive advantages over stents: the absence of permanent scaffold and polymer, the respect of the original coronary anatomy, and limited inflammatory stimuli, thereby allowing for short-term dual antiplatelet therapy. To this day, a lot of devices are available in the market, with limited scientific data for the vast majority of them. Thus, the Italian scientific society of interventional cardiologists GISE decided to coordinate the efforts of a group of reknown experts on the field, in order to obtain a Position Paper on the correct use of drug-coated balloons in all the settings of coronary artery disease, giving a class of indication to each one, based on the clinical evidence. This Position Paper represents a quick reference for operators, investigators, and manufactures to promote the understanding and the correct use of the drug-coated balloon technology in everyday clinical practice.

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiology; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug Administration Schedule; Drug Therapy, Combination; Equipment Design; Humans; Myocardial Infarction; Neointima; Platelet Aggregation Inhibitors; Treatment Outcome

Percutaneous coronary intervention (PCI) has become the most common revascularization procedure for coronary artery disease. The use of stents has reduced the rate of restenosis by preventing elastic recoil and negative remodeling. However, in-stent restenosis remains one of the major drawbacks of this procedure. Drug-eluting stents (DESs) have proven to be effective in reducing the risk of late restenosis, but the use of currently marketed DESs presents safety concerns, including the non-specificity of therapeutics, incomplete endothelialization leading to late thrombosis, the need for long-term anti-platelet agents, and local hypersensitivity to polymer delivery matrices. In addition, the current DESs lack the capacity for adjustment of the drug dose and release kinetics appropriate to the disease status of the treated vessel. The development of efficacious therapeutic strategies to prevent and inhibit restenosis after PCI is critical for the treatment of coronary artery disease. The administration of drugs using biodegradable polymer nanoparticles as carriers has generated immense interest due to their excellent biocompatibility and ability to facilitate prolonged drug release. Despite the potential benefits of nanoparticles as smart drug delivery and diagnostic systems, much research is still required to evaluate potential toxicity issues related to the chemical properties of nanoparticle materials, as well as to their size and shape. This review describes the molecular mechanism of coronary restenosis, the use of DESs, and progress in nanoparticle drug- or gene-eluting stents for the prevention and treatment of coronary restenosis.

Topics: Biomedical Research; Cardiovascular Agents; Chemoprevention; Coronary Restenosis; Genetic Therapy; Humans; Nanoparticles; Stents

Drug-eluting stents (DES) have revolutionized the practice of interventional cardiology over the past decade. Although their efficacy has never been called into question, concerns have been raised regarding their safety, particularly with respect to very late stent thrombosis. These valid concerns have prompted extensive research into improving stent safety, with particular interest in modifying the permanent polymer used on first-generation DES. Subsequently, various new types of coronary stent have been developed, including DES with biocompatible polymers, DES with biodegradable polymers, polymer-free DES, and completely bioresorbable scaffolds. Some of these new DES are already available in clinical practice, and others are currently undergoing clinical evaluation. Improvements in stent performance have made detecting statistically robust and clinically relevant differences between contemporary devices difficult. The wide array of available stents enables the choice of device to be tailored to the individual patient.

Topics: Animals; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Humans; Patient Selection; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Treatment Outcome

Despite significant advances in vascular biology, bioengineering, and pharmacology, restenosis remains a limitation to the overall efficacy of vascular reconstructions, both percutaneous and open. Although the pathophysiology of intimal hyperplasia is complex, a number of drugs and molecular tools have been identified that can prevent restenosis. Moreover, the focal nature of this process lends itself to treatment with local drug administration. This article provides a broad overview of current and future techniques for local drug delivery that have been developed to prevent restenosis after vascular interventions.. A systematic electronic literature search using PubMed was performed for all accessible published articles through September 2012. In an effort to remain current, additional searches were performed for abstracts presented at relevant societal meetings, filed patents, clinical trials, and funded National Institutes of Health awards.. The efficacy of local drug delivery has been demonstrated in the coronary circulation with the current clinical use of drug-eluting stents. Until recently, however, drug-eluting stents were not found to be efficacious in the peripheral circulation. Further pursuit of intraluminal devices has led to the development of balloon-based technologies, with a recent surge in trials involving drug-eluting balloons. Early data appear encouraging, particularly for treatment of superficial femoral artery lesions, and several devices have recently received the Conformité Européene mark in Europe. Investigators have also explored the periadventitial application of biomaterials containing antirestenotic drugs, an approach that could be particularly useful for surgical bypass or endarterectomy. In the past, systemic drug delivery has been unsuccessful; however, there has been recent exploration of intravenous delivery of drugs designed specifically to target injured or reconstructed arteries. Our review revealed a multitude of additional interesting strategies, including >65 new patents issued during the past 2 years for approaches to local drug delivery focused on preventing restenosis.. Restenosis after intraluminal or open vascular reconstruction remains an important clinical problem. Success in the coronary circulation has not translated into solutions for the peripheral arteries. However, our literature review reveals a number of promising approaches, including drug-eluting balloons, periadventitial drug delivery, and targeted systemic therapies. These and other innovations suggest that the future is bright and that a solution for preventing restenosis in peripheral vessels will soon be at hand.

Topics: Animals; Cardiac Catheters; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug Carriers; Drug-Eluting Stents; Endovascular Procedures; Equipment Design; Humans; Hyperplasia; Neointima; Percutaneous Coronary Intervention; Peripheral Vascular Diseases; Secondary Prevention; Treatment Outcome; Vascular Access Devices

Cardiovascular diseases (CVD) are one of the leading causes of death across the globe. Pathogenesis of coronary artery disease (CAD) is lead by the progression of atherosclerotic lacerations in coronary arteries. Percutaneous coronary intervention (PCI) using balloon angioplasty was introduced in 1979 and was majorly used in the treatment of these lesions. Introduction of bare metal stents (BMS) has revolutionized stenting procedures overcoming elastic recoil and reducing restenosis commonly associated with balloon angioplasty, but follow up studies have shown 20-30% prevalence of in-stent restenosis (ISR), this led to the development of drug eluting stents (DES). But long-term follow up studies have shown increased liability of stent thrombosis. Boosting the development of safer and effective DES expounding for therapies like biodegradable polymer based DES, polymer free DES, bioresorbable DES and combination DES to collectively reduce neointimal hyperplasia and promote endothelial healing. In dual-DES development, a combination employing an anti-restenotic agent (for preventing VSMC's proliferation), which is released for the first few weeks, and then the second drug a pro-healing agent (promoting re-endothelialization) released after a month would be ideal. Growing understanding in the areas of polymer therapeutics, nanoscale surface modifications and gene therapy would assist in the delivery of multiple drugs, which would further help in the design of promising therapeutic strategies for the treatment of CAD using stent based therapies.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug Carriers; Drug Combinations; Drug-Eluting Stents; Humans; Hyperplasia; Neointima; Prosthesis Design; Time Factors; Treatment Outcome; Wound Healing

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

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

Local drug delivery for the treatment of vascular disease has been studied for many years. In coronary artery disease, drug eluting stents are routinely deployed. However, with concerns regarding late thrombosis, and clinical applications where stenting is not desirable, such as peripheral vascular disease, a new direction to "leave nothing behind" has emerged. In Europe, paclitaxel-coated balloons have shown promise in reducing restenosis in both peripheral and coronary applications. However, a number of technical, economic and regulatory limitations of the current devices have been identified. Local or targeted fluid delivery of drugs may offer a relatively simple solution.

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug Administration Routes; Drug Delivery Systems; Drug-Eluting Stents; Humans; Prosthesis Design; Treatment Outcome

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

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

Magnetic guidance is a physical targeting strategy with the potential to improve the safety and efficacy of a variety of therapeutic agents--including small-molecule pharmaceuticals, proteins, gene vectors, and cells--by enabling their site-specific delivery. The application of magnetic targeting for in-stent restenosis can address the need for safer and more efficient treatment strategies. However, its translation to humans may not be possible without revising the traditional magnetic targeting scheme, which is limited by its inability to selectively guide therapeutic agents to deep localized targets. An alternative two-source strategy can be realized through the use of uniform, deep-penetrating magnetic fields in conjunction with vascular stents included as part of the magnetic setup and the platform for targeted delivery to injured arteries. Studies showing the feasibility of this novel targeting strategy in in-stent restenosis models and considerations in the design of carrier formulations for magnetically guided antirestenotic therapy are discussed in this review.

Topics: Angioplasty; Animals; Arterial Occlusive Diseases; Cardiovascular Agents; Constriction, Pathologic; Coronary Restenosis; Drug Delivery Systems; Humans; Magnetics; Prosthesis Design; Recurrence; Stents

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

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

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

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

To perform a systematic review and meta-analysis of studies reporting outcomes after drug-eluting stent (DES) implantation in chronic total occlusions (CTOs).. A review of publications and online databases in January 2010 retrieved 17 published studies that reported outcomes after DES implantation in CTOs: eight uncontrolled studies, seven nonrandomized comparative studies with bare-metal stents (BMS), one post-hoc analysis of a randomized trial, and one randomized trial. Data were pooled using random-effects meta-analysis models.. All published studies evaluated sirolimus- or paclitaxel-eluting stents. All studies reporting comparative angiographic outcomes revealed less binary angiographic restenosis with DES implantation compared to BMS (odds ratio: 0.15, 95% CI: 0.08, 0.26). Over a mean follow-up period of 18.9±16.5 months, the cumulative incidence of death, myocardial infarction, or stent thrombosis was similar between DES and BMS in all studies. Target lesion revascularization (odds ratio: 0.13, 95% CI: 0.06, 0.26) and target vessel revascularization (odds ratio 0.18, 95% CI: 0.11, 0.31) at 6-12 months were consistently lower among DES-treated patients. Similar patterns of safety and efficacy event rates were also observed in studies reporting>12 month outcomes.. Compared with BMS, treatment of chronic total coronary occlusions with DES is associated with significant reductions in angiographic and clinical restenosis with similar safety. The consistency and magnitude of treatment effect across both individual trials and the pooled analysis establish DES as the preferred therapy for percutaneous revascularization of CTOs.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Patient Selection; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

First generation drug-eluting stents have shown differential efficacy in high-risk patient subsets at one year. It is unclear whether these differences endure over the medium- to long-term. We compared the five-year clinical efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in a population of high-risk patients.. The patient cohorts of the ISAR-DESIRE, ISAR-DIABETES, and ISAR-SMART-3 randomized trials were followed up for five years and data were pooled. The primary efficacy endpoint of the analysis was the need for target lesion revascularization (TLR) during a five-year follow-up period. The primary safety endpoint was the combination of death or myocardial infarction (MI) after five years.. A total of 810 patients (405 patients in the SES group and 405 patients in the PES group) was included. Over five years TLR was reduced by 39% with SES compared with PES stent (hazard ratio [HR] 0.61; 95% confidence interval [CI] 0.44-0.85; P = 0.004). No difference was observed according to death or MI rates between the two groups (HR 1.10; 95% CI 0.80-1.50; P = 0.57). Definite stent thrombosis occurred in 0.2% (n = 1) in the SES group and in 1.6% (n = 6) in the PES group (HR 0.16; 95% CI 0.02-1.34; P = 0.12).. In high-risk patient subsets the lower rate of 12-month TLR observed with SES in comparison PES is maintained out to five years. In terms of safety, although there was no difference in the overall incidence of death or MI, there was a trend towards more frequent stent thromboses with PES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Events contributing to restenosis after coronary interventions include platelet aggregation, inflammatory cell infiltration, growth factor release, and accumulation of smooth muscle cells (SMCs) and extracellular matrix (ECM). The ECM is composed of various collagen subtypes and proteoglycans and over time constitutes the major component of the mature restenotic plaque. The pathophysiology of collagen accumulation in the ECM during arterial restenosis is reviewed. Factors regulating collagen synthesis and degradation, including various cytokines and growth factors involved in the process, may be targets for therapies aimed at prevention of in-stent restenosis.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Collagen; Collagenases; Coronary Restenosis; Coronary Stenosis; Cytokines; Enzyme Inhibitors; Humans; Integrins; Intercellular Signaling Peptides and Proteins; Matrix Metalloproteinase Inhibitors; Protein-Lysine 6-Oxidase; Signal Transduction; Stents

The high rate of restenosis associated with percutaneous coronary intervention (PCI) procedures can be reduced with the implantation of metallic stents into the stenotic vessels. The knowledge that neointimal formation can result in restenosis after stent implantation led to the development of drug-eluting stents (DES) which require long lasting antiplatelet therapy to avoid thrombotic complications. In the last years, the drug-eluting balloon (DEB) technology has emerged as an alternative option for the treatment of coronary and peripheral arteries. Clinical studies demonstrated the safety and effectiveness of DEB in various clinical scenarios and support the use of paclitaxel-eluting balloons for the treatment of in-stent restenosis, of small coronary arteries and bifurcations lesions. The protocols of DEB studies suggest that the dual antiplatelet therapy with aspirin and clopidogrel of four weeks after DEB is safe and effective.

Topics: Angioplasty, Balloon, Coronary; Aspirin; Cardiovascular Agents; Clopidogrel; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Drug Therapy, Combination; Equipment Design; Evidence-Based Medicine; Humans; Patient Selection; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Risk Assessment; Risk Factors; Ticlopidine; Time Factors; Treatment Outcome

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

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

To assess the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) compared to the TAXUS paclitaxel-eluting stent (PES) in women at two years.. In this pooled analysis, a cohort of 395 women and 906 men was studied by using patient level and lesion level clinical data from SPIRIT II and SPIRIT III studies. Women enrolled in these two studies had higher demographic and lesion risk characteristics than their male counterparts. In-stent and in-segment late loss (LL) was significantly less in the women in the EES group compared to the women in the PES group (in-stent 0.15+/-0.44 mm vs. 0.45+/-0.51 mm; P<0.01, in-segment 0.09+/-0.46 mm vs. 0.29+/-0.40 mm; P<0.01). In women, EES compared to PES resulted in significant reductions in major adverse cardiac events (MACE) (8.5% vs 16.4%; p=0.02) and in target vessel failure (TVF) (11.2% vs 19.5%; p=0.02) at two years. In men, a significant difference was seen in in-stent LL and in-stent % diameter stenosis (DS) favouring EES (in-stent LL 0.14+/-0.33 mm vs. 0.28+/-0.47 mm; P<0.01, in-stent %DS 9.28+/-13.86 vs. 13.64+/-18.31; P<0.01). MACE rates at two years were lower in males treated with EES compared to PES (6.7% vs. 10.9%; p=0.03). The interaction between gender and stent type was not found to be significant for MACE at two years.. In this pooled analysis of two randomised trials, at two years, EES compared to PES resulted in reduced angiographic LL, fewer MACE and TVF events in women and reduced angiographic LL and %DS and fewer MACE events in men.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Assessment; Risk Factors; Sex Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Percutaneous transvascular coronary angioplasty and stenting is one of the most commonly employed interventional procedures for the treatment of occlusive coronary artery disease. The common long-term complication of this treatment is re-stenosis occuring at the site of the atherosclerotic lesion following stenting. The rate of re-stenosis within 6 months could be as high as 20-30% of patients resulting in increased morbidity and tremendous costs to the health care system. The incidence has been somewhat reduced with the development of drug eluting stents, releasing drugs like paclitaxel, sirolimus, zotarolimus and everolimus with varied sustained release profiles. However the long-term benefits from large studies are still controversial and delayed onset of thrombosis is a major ongoing concern and lifelong anti-platelets therapy has been suggested clinically in patients bearing such pharmacological stents. Drug-eluting polymeric bioresorbable stent is being considered to hold immense promise to effectively address such pertinent complications mainly because of its improved biocompatibility, transient nature of supporting the intervened artery, eliminating local effect and damage of permanent metals, allowing smoother restoration of vasoreactivity and physiologic healing, and higher local drug delivery capacity in comparison to permanent metallic stents. In this article we review the current standpoint of drug eluting metallic stent, which has so long been considered as a major medical innovation in the field of pharmaceutical sciences, and its rapid evolution to pharmacological bioresorbable stent in order to promote proper vascular remodeling and achieve better risk-benefit ratio under diverse clinical challenges.

Topics: Absorbable Implants; Animals; Cardiovascular Agents; Chemistry, Pharmaceutical; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Delayed-Action Preparations; Drug-Eluting Stents; Humans; Metals; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Prosthesis Design; Risk Factors; Treatment Outcome

Since the first clinical angioplasty by Gruntzig in 1977, restenosis has been the primary drawback of percutaneous coronary intervention (PCI). In the balloon era. restenosis was correlated with elastic recoil and negative remodeling of the arterial wall. Later, introduction of stents proved to be a significant advance in reducing the elastic recoil and negative remodeling at the treatment site but stimulated proliferation, migration of smooth muscle cells, and neointimal hyperplasia, thereby generating a new type of restenosis, in-stent restenosis. Brachytherapy and drug-eluting stents (DES) may be considered the two breakthroughs against neointimal hyperplasia. However, concerns about stent thrombosis and incomplete elimination of in-stent restenosis with DES in complex lesions and patients justify the pursuit of research in this field. Non-stent based local drug delivery and particularly the use of paclitaxel-eluting balloons could be one of these strategies. We aimed to review the concept, preclinical-, and clinical data available with non-stent based local drug delivery and, in particular, with paclitaxel-eluting balloons.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Equipment Design; Humans; Hyperplasia; Paclitaxel; Prosthesis Design; Thrombosis; Treatment Outcome

Various systemic pharmacological approaches have been evaluated to reduce the risk of restenosis after coronary angioplasty, with or without stent, in the general population and in diabetic patients who are at increased risk for such complication. The aim of the present paper is to describe the effects of the main pharmacological classes on the risk of restenosis, the need for new revascularisation procedures and the incidence of major clinical events (MACE: death, myocardial infarction, revascularisation). We will analyse the role of antiplatelet agents, omega-3 fatty acids, statins, anti-inflammatory compounds, immunomodulators, anti-oxidants, glitazones and, finally, classical antidiabetic drugs such as metformin and insulin. Whenever possible, we will focus our attention on the results obtained in the diabetic population.

Topics: Angioplasty, Balloon, Coronary; Anti-Inflammatory Agents; Antioxidants; Belgium; Cardiovascular Agents; Coronary Restenosis; Coronary Thrombosis; Diabetes Complications; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Evidence-Based Medicine; Fatty Acids, Omega-3; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypoglycemic Agents; Immunologic Factors; Incidence; Meta-Analysis as Topic; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Stents

Coronary stenting is routinely utilized to treat symptomatic obstructive coronary artery disease. However, the efficacy of bare metal coronary stents has been historically limited by restenosis, which is primarily due to excessive neointima formation. Drug-eluting stents (DES) are composed of a stainless steel backbone encompassed by a polymer in which a variety of drugs that inhibit smooth muscle cell proliferation and excessive neointima formation are incorporated. DES have significantly reduced the incidence of restenosis but are also associated with a small (approximately 0.5% per year) but significant risk of late stent thrombosis. In that regard, estrogen-eluting stents have also undergone clinical evaluation in reducing restenosis with the additional potential benefit of enhancing reendothelialization of the stent surface to reduce stent thrombosis. Estrogen directly promotes vasodilatation, enhances endothelial healing, and prevents smooth muscle cell migration and proliferation. Due to these mechanisms, estrogen has been postulated to reduce neointimal hyperplasia without delaying endothelial healing. In animal studies, estrogen treatment was effective in decreasing neointimal hyperplasia after both balloon angioplasty and stenting regardless of the method of drug delivery. The first uncontrolled human study using estrogen-coated stents demonstrated acceptable efficacy in reducing late lumen loss. However, subsequent randomized clinical trials did not show superiority of estrogen-eluting stents over bare metal stents or DES. Further studies are required to determine optimal dose and method of estrogen delivery with coronary stenting and whether this approach will be a viable alternative to the current DES armamentarium.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Clinical Trials as Topic; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Estrogens; Evidence-Based Medicine; Humans; Prosthesis Design; Thrombosis; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon; Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug Carriers; Equipment Design; Evidence-Based Medicine; Humans; Peripheral Vascular Diseases; Treatment Outcome

Treatment of patients with in-stent restenosis (ISR) remains a challenge. We sought to compare results of sirolimus-eluting stents (SES) with those of bare-metal stents (BMS) in patients with ISR.. The results obtained in the stent arm of two randomized studies were analyzed. The RIBS I study (450 patients with ISR) allocated 224 patients to BMS; the RIBS II study (150 patients with ISR) allocated 76 patients to SES. Complete 1-year follow-up was obtained in all 300 patients treated with stents.. Although inclusion/exclusion criteria were identical in the two studies, when compared with patients in the BMS group, patients in the SES arm had more adverse baseline characteristics, more diffuse lesions, and smaller vessels. However, late angiographic findings including in-segment recurrent restenosis rate (11 vs. 38%, P < 0.001), minimal lumen diameter (2.52 vs. 1.63 mm, P < 0.001), and late loss (0.13 vs. 1.04 mm, P < 0.001) were significantly better after SES. The 1-year event-free survival was also significantly improved in the SES group (88 vs. 78%, P < 0.05), as the result of a lower requirement for repeated revascularizations (10.5 vs. 19.6%, P < 0.05). Prespecified subgroup analyses were consistent with the main outcome measures. After adjusting for (a) imbalances in baseline characteristics (restenosis OR 0.11 [95% confidence interval (CI) 0.03-0.36]; adverse events hazard ratios (HR) 0.33 [95% CI 0.13-0.84]) and (b) the propensity score (restenosis OR 0.08 [95% CI 0.03-0.28]; adverse events HR 0.24 [95% CI 0.09-0.66]), results of the SES group were superior to those obtained in the BMS group.. When compared with BMS, SES improved the long-term clinical and angiographic outcome of patients with ISR.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Metals; Middle Aged; Odds Ratio; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Sirolimus; Stents; Time Factors; Treatment Outcome

Recent studies and editorials have stirred controversy and generated tremendous publicity in the lay press related to the safety of drug-eluting stents (DES) for the treatment of coronary artery disease. Questions have been raised regarding the risks of late, or very late stent thrombosis with DES. The purpose of this editorial and review of stent thrombosis is to illuminate some counterpoints to some of the attention surrounding the issues of late DES thrombosis. The risks of DES stent thrombosis versus BMS may have been overstated by flawed studies. Late stent thrombosis does occur with both BMS and DES, and may or may not be modestly higher with DES. The time course of very late "DES thrombosis," suggests that persistent plaque ruptures and disease progression in the target vessel may cause some, or many of these events. There is still much to be learned about the biology of DES. Although there is a small risk of late thrombosis with DES, there is little question that this technology provides benefit to the vast majority of patients compared with prior revascularization strategies, using balloon angioplasty, BMS, or bypass surgery. Substantial resources should be devoted to creating more biocompatible DES systems, and to minimizing the risks of both early and late stent thrombosis.

Topics: Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Humans; Metals; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Stents; Time Factors

(Drug-eluting stents substantially reduce the incidence of restenosis after percutaneous coronary interventions.) The cytostatic drugs however not only inhibit the proliferation of smooth muscle cell and neointima proliferation but also delay the endothelisation of the stent struts. It may result in persistent inflammatory reaction and also in stent thrombosis. The trials comparing the efficacy of drug-eluting and bare metal stents, and also that of the two drug-eluting stent brands are reviewed. The efficacy of the two brands of drug-eluting stents in prevention of restenosis is almost equal. Late stent thrombosis is more frequent after drug eluting, than after bare metal stents. This rare, but severe complication may develop if drug-eluting stents are used in off-label indications and anatomic situations. In order to avoid late stent thrombosis devices should be used as labelled, the platelet inhibitory treatment should be more efficacious and longlasting than these days. Thorough information about the importance of adherence to prescribed treatment should be delivered to the patients and to the medical community as well.

Topics: Cardiovascular Agents; Cell Proliferation; Coronary Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Humans; Stents; Time Factors

Coronary artery bypass grafting (CABG) has played an important role in the treatment of ischemic heart disease. Recently, the introduction of a drug-eluting stent (DES) has decreased the incidence of restenosis after percutaneous intervention (PCI). PCI with a DES is being increasingly performed, whereas the number of patients for whom CABG has been indicated has decreased over the last few years in Japan and the United States. According to a report, the number of patients undergoing CABG will not decrease in the future due to its usefulness in the treatment of multi-vessel lesions. We have also reviewed how CABG should be improved. For this purpose, it may be important to carry out less invasive CABG by the off-pump method and to improve the long-term results obtained by CABG with an internal thoracic artery graft and complete revascularization. Hence, CABG may achieve better long-term results compared with PCI and continued future application of CABG.

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coronary Artery Bypass; Coronary Restenosis; Humans; Myocardial Ischemia; Stents

Percutaneous intervention using balloon angioplasty accompanied by stent implantation has become the predominant procedure to treat occlusive coronary and peripheral vascular disease. Unfortunately, restenosis associated with intimal hyperplasia and arterial remodeling at the stented site occurs within 6 months in 20 to 30% of cases. To address this problem, the concept of utilizing a stent as the vehicle to deliver agents locally and limit the overexuberant tissue response related to its placement has been developed. Targeting excess arterial wall smooth muscle cell proliferation, preclinical studies have demonstrated the efficacy of two drugs, paclitaxel and rapamycin, in both in vitro and in vivo animal studies. Early, as well as large, randomized clinical studies using polymer-coated, drug-eluting stents have clearly demonstrated a significant and dramatic efficacy in reducing restenosis rates and improving clinical outcomes compared with the use of the bare stent for revascularization procedures. Despite the low incidence of late thrombosis associated with the rapamycin- and paclitaxel-eluting stents, some concerns remain (such as the need for sustained anticoagulant therapy), providing the impetus for developing coated stents that promote rather than inhibit endothelial healing in order to limit the restenotic response.

Topics: Animals; Cardiovascular Agents; Cardiovascular Diseases; Coronary Restenosis; Drug Design; Drug Evaluation, Preclinical; Humans; Models, Biological; Randomized Controlled Trials as Topic; Stents

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

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

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

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

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Coronary Disease; Coronary Restenosis; Drug Implants; Humans; Myocardial Infarction; Paclitaxel; Randomized Controlled Trials as Topic; Saphenous Vein; Sirolimus; Stents; Treatment Outcome

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

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

The introduction and widespread use of coronary stents have been the most important advancement in the percutaneous treatment of coronary artery disease since the introduction of balloon angioplasty. Coronary artery stents reduce the rate of angiographic and clinical restenosis compared to balloon angioplasty. This angiographic restenosis was further reduced with the introduction of drug-eluting stents and hence further reduction in the frequency of major adverse cardiac events. Herein we present a comprehensive and up-to-date review about the use of drug-eluting stents in the treatment of coronary artery disease.

Topics: Anti-Inflammatory Agents; Antineoplastic Agents; Cardiovascular Agents; Clinical Trials as Topic; Coronary Restenosis; Drug Delivery Systems; Humans; Immunosuppressive Agents; Prosthesis Design; Receptor Protein-Tyrosine Kinases; Stents

Drug-eluting stents (DES) are playing an increasingly important role in the treatment of coronary artery disease. These new devices work by releasing controlled amounts of pharmacological agents with anti-restenosis properties at the implantation site. Most of them use polymer coating as a drug carrier, but concerns about long-term negative effects of a permanent polymer coating have stimulated the development of non-polymer DES or DES based on bioabsorbable polymers. Several randomized studies with DES have demonstrated their superiority over bare metal stents mostly in selected patients and lesion subsets. Accumulating evidence is showing significant differences in performance between currently used DES. These differences are more pronounced in complex, high-risk subsets of patients and lesions and should be considered during the process of DES selection for the individual patient. Interventional cardiologists have learned that patients who receive DES require a more prolonged antiplatelet therapy, but the optimal length and regimen are still unclear and further investigations are needed. Major advances in interventional cardiology have caused a dramatic shift away from aorto-coronary bypass surgery and an increase in the complexity of percutaneous coronary interventions. Observational and specifically designed randomized studies are currently addressing the issue of the role of DES in complex situations including in-stent restenosis, ostial and bifurcation lesions, chronic occlusions, small vessels, long lesions, saphenous vein grafts, multivessel disease, left main disease, acute myocardial infarction and diabetes mellitus. Although definitive answers are still to come from ongoing research, available data support the use of DES in most of these situations.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Diabetic Angiopathies; Drug Administration Routes; Humans; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Stents

Percutaneous coronary intervention (PCI) has become the most important revascularization method in the treatment of coronary artery disease. The major problem in PCI has been renarrowing of the dilated vessel after the procedure (restenosis). The best results in the prevention of restenosis have been obtained by covering the stent with drugs that inhibit cellular growth, thus limiting excessive scar formation inside of the stent. With drug-eluting stents, restenosis has been reduced to one-tenth compared with balloon angioplasty and to one-fourth compared to bare metal stents. Due to drug-eluting stents, PCI is an alternative to bypass surgery. However, restenosis will remain a challenge due to the increased number of procedures and more difficult disease treated with PCI.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug Administration Routes; Humans; Randomized Controlled Trials as Topic; Stents

Five-year outcomes after coronary stenting are determined by restenosis of the original stented lesion during the first year and, later, by disease progression at non-stented segments, owing to either gradual progression of atherosclerosis or instability of vulnerable plaques. Drug-eluting stents have demonstrated potent anti-restenosis benefits in a variety of lesion types and high-risk patients, including complex long lesions and diabetic patients. It is likely that this benefit will translate into improved 5-year outcomes, with reduction in need for repeat revascularization in many patients and possibly reduced incidence of myocardial infarction and death, especially in diabetic patients, in whom the risk for occlusive restenosis and 5-year death and myocardial infarction rates are known to be higher after bare-metal stents. Future studies will determine the role of drug-eluting stents in preventing adverse outcomes owing to later disease progression. Such strategies and proposed clinical trials may include identification and prophylactic stenting of individual vulnerable plaques or coronary segments, and comparisons with coronary artery bypass surgery for complete revascularization success. While the outlook for benefit of drug-eluting stents in 5-year outcomes is hopeful, it is likely that a true improvement in these outcomes will be realized more from a judicious use of drug-eluting stents coupled with other proven aggressive secondary prevention therapies.

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Clinical Trials as Topic; Coated Materials, Biocompatible; Coronary Disease; Coronary Restenosis; Diabetes Mellitus; Disease Progression; Humans; Stents; Treatment Outcome

Restenosis remains a problem following percutaneous coronary intervention in patients with coronary artery disease. Drug-eluting stents (DES), which combine mechanical and pharmacologic properties, have been shown to prevent or reduce neointimal growth after deployment. This review describes the TAXUS paclitaxel-eluting stent clinical trial expansion program (TAXUS Express, Boston Scientific, Natick, MA). This program comprises the largest data set of randomized controlled trials (RCTs) of DES to date, with over 6,200 patients enrolled since 2000. The program includes treatment of de novo lesions, as well as higher-risk lesion and patient populations. In this review, we discuss the results from the TAXUS family of randomized clinical trials, and compare the findings with data from TAXUS registries. The data from the randomized clinical trials suggest that the paclitaxel-eluting stent provides consistent and durable benefits across multiple lesion and patient types. Evidence from peri-and post-approval registries, where patient populations are more heterogeneous than those eligible and included in the RCTs, corroborate these findings, with overall low rates of cardiac events, including reinterventions.

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Humans; Paclitaxel; Randomized Controlled Trials as Topic; Research Design; Stents; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Cost-Benefit Analysis; Drug Delivery Systems; Humans; Stents

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Drug Delivery Systems; Humans; Stents

Topics: Cardiovascular Agents; Coronary Artery Bypass; Coronary Artery Disease; Coronary Restenosis; Humans; Stents; Treatment Outcome

Intervention in coronary artery disease is an area of cardiology where novel drugs, in the form of drug-eluting stents (DES), are being used increasingly commonly. DES are used across the whole range of coronary intervention, from stable angina patients with single or multivessel disease, acute coronary syndromes and acute myocardial infarction (i.e. primary angioplasty). Most recently, they are being tested in a particularly challenging subset of patients, those experiencing symptoms due to restenosis within a previously stented area of vessel (in-stent restenosis, ISR). This article summarises the rationale for the use of DES, across all these areas, focussing specifically on the emerging results of trials and registries examining the effectiveness of DES in acute myocardial infarction (AMI) and ISR. Drug-eluting stents represent a significant shift in the use of locally-delivered drugs in interventional cardiology. On the basis of encouraging trial data, including in the specific areas of in-stent restenosis and myocardial infarction, their use is becoming extremely widespread in place of bare-metal (drug-free) stents. This change is happening despite their high costs, relatively short follow-up data and concerns of possible unwanted effects, because of the weight of evidence that they are superior in preventing restenosis in many patient groups. This reduction is highly significant in angiographic terms and, to a lesser degree, in the prevention of clinically important restenosis requiring revascularisation, but not clearly in terms of overall mortality.

Topics: Animals; Cardiovascular Agents; Combined Modality Therapy; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Equipment Design; Humans; Stents

Stent therapy (versus balloon angioplasty alone) provides predictable outcomes following percutaneous coronary intervention (PCI), in both the immediate, periprocedural setting and in durable (6-12 month) follow-up, in patients with target vessel reference diameters greater than or equal to 3.0 mm. The rate of positive outcomes for stenting, versus balloon angioplasty, is less robust for smaller (< 3.0 mm) coronary vessels. Specific attributes of stent design, including strut thickness and metal alloy composition, influence stent performance characteristics, particularly in smaller coronary vessels. Polymer-based drug elution from stents may reduce or eliminate the inflammatory-neointimal proliferative response provoked by stent deployment but the drug delivery platform remains critically important. The best drug-eluting stent (DES) platform for small coronary vessel applications is one incorporating low profile, enhanced flexibility, and ease of deployment (balloon expandability), as well as providing adequate endoluminal surface coverage for scaffolding and uniform drug delivery. DES specifically designed for small-vessel application will become the standard for small vessel PCI.

Topics: Angioplasty, Balloon; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Equipment Design; Humans; Stents

Percutaneous coronary intervention continues to revolutionize the treatment of coronary atherosclerosis. Restenosis remains a significant problem but may at last be yielding to technologic advances. The examination of neointimal hyperplasia in injured animal artery models has helped in our understanding of angioplasty and stenting mechanisms, and as drug-eluting stent (DES) technologies have arrived, they too have been advanced through the study of animal models. These models are useful for predicting adverse clinical outcomes in patients with DESs because suboptimal animal model studies typically lead to problematic human trials. Similarly, stent thrombosis in animal models suggests stent thrombogenicity in human patients. Equivocal animal model results at six or nine months occasionally have been mirrored by excellent clinical outcomes in patients. The causes of such disparities are unclear but may result from differing methods, including less injury severity than originally described in the models. Ongoing research into animal models will reconcile apparent differences with clinical trials and advance our understanding of how to apply animal models to clinical stenting in the era of DESs.

Topics: Animals; Cardiovascular Agents; Clinical Trials as Topic; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Disease Models, Animal; Humans; Hyperplasia; Stents; Tunica Intima

Topics: Atherectomy, Coronary; Brachytherapy; Cardiovascular Agents; Catheterization; Coronary Restenosis; Drug Implants; Genetic Therapy; Humans; Stents

This head-to-head, multicenter, randomized trial investigated the safety and efficacy of Restore (Cardionovum, Bonn, Germany) drug-coated balloon (DCB) angioplasty in an Asian patient population with coronary drug-eluting stent in-stent restenosis (DES-ISR).. A total of 240 patients with coronary DES-ISR were treated with Restore DCB or with SeQuent® Please (Braun, Melsungen, Germany) DCB. This trial used nine-month in-segment late lumen loss (LL) as the primary endpoint. Secondary endpoints included two-year clinical event rates.. Patient, lesion, and procedural characteristics in both treatment groups were similar. Nine-month in-segment LL was 0.38 ± 0.50 mm with Restore vs. 0.35 ± 0.47 mm with SeQuent® Please (p for non-inferiority = 0.02). The two-year follow-up rates were 95.8 % (115/120) in the Restore group and 94.2 % (113/120) in the SeQuent® Please group. Both groups had similar one- and two-year target lesion failure (TLF) rates (13.3 % vs. 12.6 %; p = 0.87 at one year, 14.8 % vs. 15.0 %; p = 1.0 at two years). Moreover, the all-cause mortality and myocardial infarction rates were 0 and 3.5 % (4/120) in the Restore group and 0.9 % (1/120) and 3.5 % (4/120) in the SeQuent® Please group, respectively. Additional analyzing of vessel quantitative flow ratio (QFR) did also show noninferior outcomes for one explicit treatment bunch.. The two-year follow-up indicated sustained long-term clinical safety and efficacy for both devices on the basis of QFR value.

Topics: Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Drug-Eluting Stents; Humans; Paclitaxel; Time Factors; Treatment Outcome

Drug-coated balloon (DCB) angioplasty with paclitaxel-eluting devices is an established treatment for coronary in-stent restenosis (ISR). Biolimus A9™ (BA9), a sirolimus analogue with enhanced lipophilicity, may facilitate enhanced local drug delivery into vascular tissue. A novel DCB coated with Biolimus A9™ represents an alternative to traditional paclitaxel- and sirolimus-coated devices. Hence, we sought to investigate the safety and efficacy of this novel DCB in the treatment of coronary ISR.. REFORM (NCT04079192) is a prospective, multicenter, single blind, randomized controlled trial comparing the BA9-DCB (Biosensors Europe SA, Morges, Switzerland) to the paclitaxel-coated SeQuent® Please DCB (Braun Melsungen AG, Germany) in the treatment of coronary ISR. A total of 201 patients with coronary artery disease and an indication for interventional treatment of ISR in a bare-metal stent (BMS) or drug-eluting stent (DES) have been randomized 2:1 to receive treatment with the BA9- or the paclitaxel-DCB comparator. Patients were enrolled across 24 investigational centers in Europe and Asia. The primary endpoint is percent diameter stenosis (%DS) of the target segment as assessed by quantitative coronary angiography (QCA) at 6 months. Key secondary endpoints are in-stent late lumen loss, binary restenosis, target lesion failure, target vessel failure, myocardial infarction and death at 6 months. Subjects will be followed for 24 months from enrolment.. The REFORM trial will seek to prove that the BA9-DCB is non-inferior to the standard paclitaxel-DCB comparator in the treatment of coronary ISR with respect to %DS at 6 months and has similar safety characteristics.

Topics: Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Humans; Paclitaxel; Pharmaceutical Preparations; Prospective Studies; Single-Blind Method; Sirolimus; Treatment Outcome

We investigated the clinical efficacy of a paclitaxel-coated balloon (PCB) with a novel matrix coating and reduced drug concentration in comparison with a widely used PCB with iopromide excipient.. We prospectively enrolled patients with restenosis in drug-eluting stents. All patients were treated with a novel low-dose PCB with citrate-based excipient (Agent PCB). Angiographic follow-up was scheduled at 6-8 months. Outcomes were compared against those of patients treated with iopromide excipient PCB (SeQuent Please PCB) enrolled in a trial with identical inclusion and exclusion criteria. The primary endpoint was percent diameter stenosis (%DS) at follow-up angiography. The primary hypothesis was that the investigational device would be non-inferior to the control device (ClinicalTrials.gov Identifier: NCT02367495).. In patients with DES restenosis, angioplasty with a novel PCB with citrate-based excipient was non-inferior to PCB with iopromide excipient in terms of angiographic outcome.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Constriction, Pathologic; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Humans; Middle Aged; Paclitaxel; Prospective Studies; Stents; Treatment Outcome

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

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

This study sought to compare the efficacy and clinical safety of the LONGTY drug-coated balloon (DCB) with those of SeQuent Please DCB in patients with in-stent restenosis (ISR).. Although DCB technologies have evolved, little is known about the clinical efficacy of the new-generation LONGTY DCB.. This was a prospective, multicenter, randomized, noninferiority trial comparing LONGTY DCB with SeQuent Please DCB in patients with ISR. The primary endpoint was target lesion late lumen loss at 9 months' follow-up.. A total of 211 patients with ISR from 13 Chinese sites were included (LONGTY DCB, n = 105; SeQuent Please DCB, n = 106). Device success was achieved in all patients. At the 9 month angiographic follow-up, target lesion late lumen loss was 0.35 ± 0.42 mm with LONGTY and 0.38 ± 0.45 mm with SeQuent Please (p for noninferiority <.001). The target lesion revascularization rates at 1 year were similar in both DCB groups (15.24 vs. 13.21%; p = .673). Over an extended follow-up of 2 years, the clinical endpoints, including cardiac death, myocardial infarction, and thrombus rate, were extremely low and similar in both groups.. In this multicenter, head-to-head, randomized trial, the new-generation LONGTY DCB was noninferior to the SeQuent Please DCB for the primary endpoint of target lesion late lumen loss at 9 months.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; China; Coated Materials, Biocompatible; Coronary Restenosis; Drug-Eluting Stents; Humans; Paclitaxel; Prospective Studies; Time Factors; Treatment Outcome

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

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

Drug-coated balloons (DCB) may avoid stent-associated long-term complications. This trial compared the clinical outcomes of patients with non-ST-elevation myocardial infarction (NSTEMI) treated with either DCB or stents.. A total of 210 patients with NSTEMI were enrolled in a randomised, controlled, non-inferiority multicentre trial comparing a paclitaxel iopromide-coated DCB with primary stent treatment. The main inclusion criterion was an identifiable culprit lesion without angiographic evidence of large thrombus. The primary endpoint was target lesion failure (TLF; combined clinical endpoint consisting of cardiac or unknown death, reinfarction, and target lesion revascularisation) after nine months. Secondary endpoints included total major adverse cardiovascular events (MACE) and individual clinical endpoints. Mean age was 67±12 years, 67% were male, 62% had multivessel disease, and 31% were diabetics. One hundred and four patients were randomised to DCB, 106 to stent treatment. In the stent group, 56% of patients were treated with BMS, 44% with current-generation DES. In the DCB group, 85% of patients were treated with DCB only whereas 15% underwent additional stent implantation. During a follow-up of 9.2±0.7 months, DCB treatment was non-inferior to stent treatment with a TLF rate of 3.8% versus 6.6% (intention-to-treat, p=0.53). There was no significant difference between BMS and current-generation DES. The total MACE rate was 6.7% for DCB versus 14.2% for stent treatment (p=0.11), and 5.9% versus 14.4% in the per protocol analysis (p=0.056), respectively.. In patients with NSTEMI, treatment of coronary de novo lesions with DCB was non-inferior to stenting with BMS or DES. These data warrant further investigation of DCB in this setting, in larger trials with DES as comparator (ClinicalTrials.gov Identifier: NCT01489449).

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Metals; Middle Aged; Non-ST Elevated Myocardial Infarction; Paclitaxel; Prosthesis Design; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional

Treatment of in-stent restenosis of coronary stents is challenging. The use of drug-coated balloons (DCB) is a promising technique to treat in-stent restenosis without adding another metal layer. The aim of the AGENT ISR randomised trial is to evaluate angiographic and clinical outcomes in patients with ISR of a previously treated lesion who were treated with either a DCB with a new coating formulation (Agent) or a standard DCB (SeQuent Please).. AGENT ISR is a multicentre, randomised, open-label, non-inferiority study comparing the Agent and SeQuent Please DCB. A total of 125 patients (mean age ~68 years, 18% female) with in-stent restenosis of a previously treated lesion <28 mm in length were randomised at 11 sites in Europe to Agent (n=65) or SeQuent Please (n=60). The primary endpoint, six-month in-stent late lumen loss, in the Agent group (0.397±0.43 mm [n=51]) was non-inferior to that of the SeQuent Please group (0.393±0.536 mm [n=49]), as the two-sided upper 95% confidence boundary for the difference between groups was less than the pre-specified non-inferiority margin of 0.20 (difference 0.004, 95% CI [-0.189, 0.196]; pnon-inferiority=0.046). At one year, mortality was 3.1% in Agent and 1.7% in SeQuent Please patients (p>0.99), target lesion revascularisation 7.7% versus 10.0% (p=0.89), and stent thrombosis 0% versus 3.3% (p=0.44). Similar improvements in quality of life were seen in the two groups.. In this head-to-head comparison of two DCB, Agent proved to be non-inferior to SeQuent Please for in-stent late lumen loss at six months.. NCT02151812 (http://clinicaltrials.gov/).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Paclitaxel; Quality of Life; Treatment Outcome

The pathomechanisms underlying restenosis of the bioabsorbable sirolimus-eluting metallic scaffold (Magmaris) remain unknown. Using serial optical coherence tomography, we investigated causes of restenosis, including the contribution of late scaffold recoil versus neointimal hyperplasia.. Patients enrolled in BIOSOLVE-II undergoing serial angiography and optical coherence tomography (post-intervention and follow-up: 6 months and/or 1 year) were analyzed. Patients were divided into 2 groups according to angiographic in-scaffold late lumen loss (LLL) <0.5 or ≥0.5 mm. End points were late absolute scaffold recoil and neointimal hyperplasia area as assessed by optical coherence tomography.. In addition to neointimal hyperplasia, late scaffold recoil contributed significantly to LLL of sirolimus-eluting absorbable metal scaffolds. The extent of late scaffold recoil was dependent on the underlying plaque morphology and was the highest among fibrotic lesions. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01960504.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Restenosis; Coronary Vessels; Female; Fibrosis; Humans; Male; Metals; Middle Aged; Myocardial Ischemia; Neointima; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

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

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

Bioresorbable vascular scaffolds (BVS) are promising alternatives to metallic drug-eluting stents (DES) in percutaneous coronary interventions. Absorb BVS was comparable to XIENCE (DES) for patient- and device-oriented composite endpoints through 1 year post-procedure. Mid-term results showed increased rates of device-oriented events with Absorb. The objective of this study was to evaluate the long-term safety and effectiveness of Absorb BVS compared with XIENCE metallic DES when implanted in patients in Japan with de novo coronary artery lesions.Methods and Results:ABSORB Japan randomized 400 patients into either Absorb (n=266) or XIENCE (n=134) treatment arm. Through 5-year follow-up, the composite endpoints of DMR (death, myocardial infarction [MI], and all revascularization), target vessel failure (TVF), major adverse cardiac events (MACE), target lesion failure (TLF), and cardiac death/all MI were evaluated. Individual endpoints included death, MI, coronary revascularization, and scaffold/stent thrombosis. There were no significant differences in the composite or individual endpoint outcomes between the Absorb and XIENCE arms through 5 years or between 3 and 5 years. Numerically lower TVF, MACE, and all MI rates were observed for the Absorb vs. XIENCE arm after 3 years. No scaffold/stent thrombosis was reported beyond 3 years. Post-procedure imaging subgroups showed comparable event rates.. Following resorption of the scaffold, between 3 and 5 years post-procedure, the Absorb BVS performed comparably to XIENCE in all patient- and device-oriented endpoints (ClinicalTrials.gov, #NCT01844284).

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Male; Metals; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Risk Factors; Single-Blind Method; Time Factors; Treatment Outcome

This study sought to compare the performance of a novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in patients with de novo lesions.. Small vessel coronary artery disease (SVD) represents one of the most attractive fields of application for DCB. To date, several devices have been compared with drug-eluting stents in this setting, with different outcomes.. The PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) trial was an international, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo SVD lesions were randomized to DCB or EES. Primary study endpoint was in-lesion late lumen loss (LLL) at 6 months (independent core laboratory), with the noninferiority between the 2 arms hypothesized. Secondary endpoints were minimal lumen diameter, percent diameter stenosis at angiographic follow-up, and the occurrence of major adverse cardiac events at 12 months.. Between May 2015 and May 2018, a total of 232 patients were enrolled at 5 centers. After a median of 189 (interquartile range: 160 to 202) days, in-lesion LLL was significantly lower in the DCB group (0.04 vs. 0.17 mm; p = 0.001 for noninferiority; p = 0.03 for superiority). Percent diameter stenosis and minimal lumen diameter were not significantly different. At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group (p = 0.55). There was a numerically higher incidence of spontaneous myocardial infarction (4.7% vs. 1.9%; p = 0.23) and vessel thrombosis (1.8% vs. 0%; p = 0.15) in the DES arm.. In this multicenter randomized clinical trial in patients with de novo SVD lesions, a new-generation DCB was found superior to EES in terms of LLL as the angiographic pattern and comparable in terms of clinical outcome. (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818).

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Germany; Humans; Pharmaceutical Preparations; Prospective Studies; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome

To investigate the relative performance of treatment with a paclitaxel-eluting balloon (PEB) compared with an everolimus-eluting stent (EES) for in-stent restenosis (ISR) in patients with diabetes mellitus (DM).. ISR remains a challenge in contemporary clinical practice, particularly in patients with DM.. In the multicenter randomized DARE trial, patients with BMS or DES ISR were randomized in a 1:1 fashion to treatment with a PEB or an EES. Patients underwent angiographic follow-up after 6 months. For the purpose of this analysis, the relative performance of PEB versus EES in diabetic patients was investigated.. Of 278 patients enrolled in DARE, 88 (32%) had DM, of whom 46 were randomized to EES and 42 to PEB treatment. Of patients with DM, 48 (55%) had DES-ISR. Angiographic follow-up was available in 30 patients (72%) in the PEB group and 36 patients (78%) in the DES group. There were no differences in terms of 6-months minimal lumen diameter in diabetic patients treated with EES (1.46 ± 0.66 mm) versus PEB (1.78 ± 0.58 mm, P = 0.15). Adverse events at one year follow-up were similar in both groups, with Major Adverse Events (MAE, death, target vessel MI, or TVR) occurring in 17.4% in the EES group versus 11.9% in the PEB group, P = 0.44.. In patients with ISR and DM, use of a PEB resulted in similar 6-months in-segment minimal lumen diameter and comparable rates of MAE. In-segment late loss at 6 months was significantly lower in the PEB arm. Although larger trials in DM patients with ISR are necessary, PEB is a promising treatment option obviating the need for additional stent implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Diabetes Mellitus; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Netherlands; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome

To assess the long-term safety and clinical efficacy of the Genous endothelial progenitor cell capturing stent (ECS) compared with the TAXUS Liberté paclitaxel-eluting stent (PES) in lesions with a high risk of restenosis.. Instead of the use of cytotoxic or cytostatic drugs in drug-eluting stents, a "pro-healing" approach in ECS may overcome impeded healing response due to delayed functional endothelialization of the stent struts.. In the prospective, randomized TRIAS pilot study 193 patients with coronary artery lesions carrying a high risk of restenosis were included (ECS: n = 98, PES: n = 95). The primary focus of this analysis was target vessel failure (TVF) at 5 years. Dual antiplatelet therapy was prescribed for ≥1 month after ECS and for ≥6 months after PES.. At 5 years follow-up, no significant differences were found in TVF (ECS 24% vs. PES 29%, risk difference 95% confidence interval (RDCI) -17.3% to 7.4%). Between 2 and 5 years after the index procedure, low numbers of TVF were observed in ECS compared with PES (ECS 4% vs. PES 16%, RDCI -20.8% to -2.3%). There was no definite stent thrombosis in ECS compared with four patients in the PES group.. This is the first randomized study providing very long-term clinical efficacy and safety of the ECS in lesions carrying a high risk of restenosis. At 5 years follow-up, TVF rates in ECS group are numerically lower compared with PES due to an increase of events between 2 and 5 years after the index procedure.

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Endothelial Progenitor Cells; Humans; Paclitaxel; Percutaneous Coronary Intervention; Pilot Projects; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Re-Epithelialization; Risk Factors; Time Factors; Treatment Outcome

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

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

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

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

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

The authors sought to evaluate the relative performance of a drug-eluting balloon (DEB) and a drug-eluting stent (DES) in patients with any (bare-metal or drug-eluting stent) in-stent restenosis (ISR).. The treatment of ISR remains challenging in contemporary clinical practice.. In a multicenter randomized noninferiority trial, patients with any ISR were randomly allocated in a 1:1 fashion to treatment with a DEB (SeQuent Please paclitaxel-eluting balloon, B. Braun Melsungen, Melsungen, Germany), or a DES (XIENCE everolimus-eluting stent, Abbott Vascular, Santa Clara, California). The primary endpoint was noninferiority in terms of in-segment minimal lumen diameter (MLD) at 6-month angiographic follow-up. Secondary endpoints included angiographic parameters at 6 months and clinical follow-up up to 12 months.. A total of 278 patients, of whom 56% had DES-ISR, were randomized at 8 sites to treatment with DEB (n = 141) or DES (n = 137). As compared with DEB, DES was associated with larger MLD and lower % stenosis immediately post-procedure (1.84 ± 0.46 vs. 1.72 ± 0.35; p = 0.018; and 26 ± 10% vs. 30 ± 10%; p = 0.03). Angiographic follow up was completed at 196 ± 53 days in 79% of patients. With respect to the primary endpoint of in-segment MLD at 6 months, DEB was noninferior to DES (DEB 1.71 ± 0.51 mm vs. DES 1.74 ± 0.61 mm; p for noninferiority <0.0001). Target vessel revascularization at 12-month follow-up was similar in both groups (DES 7.1% vs. DEB 8.8%; p = 0.65).. In patients with ISR, treatment with DEB was noninferior compared with DES in terms of 6-month MLD. There were no differences in clinical endpoints, including target vessel revascularization up to 12 months. Therefore, use of a DEB is an attractive treatment option for in-stent restenosis, withholding the need for additional stent implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Netherlands; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Reoperation; 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 treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug-eluting stents (DES) have limited efficacy due to increased rates of instent-restenosis, mainly caused by late lumen loss. Drug-coated balloons (DCB) are a promising technique because native vessels remain structurally unchanged. Basel Stent Kosten-Effektivitäts Trial: Drug-Coated Balloons vs. Drug-Eluting Stents in Small Vessel Interventions (BASKET-SMALL 2) is a multicenter, randomized, controlled, noninferiority trial of DCB vs DES in native SVD for clinical endpoints. Seven hundred fifty-eight patients with de novo lesions in vessels <3 mm in diameter and an indication for percutaneous coronary intervention such as stable angina pectoris, silent ischemia, or acute coronary syndromes are randomized 1:1 to angioplasty with DCB vs implantation of a DES after successful initial balloon angioplasty. The primary endpoint is the combination of cardiac death, nonfatal myocardial infarction, and target-vessel revascularization up to 1 year. Secondary endpoints include stent thrombosis, Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding, and long-term outcome up to 3 years. Based on clinical endpoints after 1 year, we plan to assess the noninferiority of DCB compared to DES in patients undergoing primary percutaneous coronary intervention for SVD. Results will be available in the second half of 2018. This study will compare DCB and DES regarding long-term safety and efficacy for the treatment of SVD in a large all-comer population.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheterization; Cardiac Catheters; Cardiovascular Agents; Clinical Protocols; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Equipment Design; Europe; Female; Humans; Male; Middle Aged; Prospective Studies; Research Design; Risk Factors; Severity of Illness Index; Time Factors; Treatment Outcome

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

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

This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES).. Treatment of patients with DES-ISR remains a challenge.. The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study.. A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01). Three-year clinical follow-up was obtained in all enrolled patients (100%). The combined clinical outcome measure of cardiac death, myocardial infarction and target lesion revascularization was significantly reduced in the EES arm (19 [12.3%] vs. 31 [20.1%]; p = 0.04; hazard ratio: 0.57 [95% confidence interval: 0.34 to 0.96]), driven by a lower need for target lesion revascularization (11 [7.1%] vs. 24 [15.6%]; p = 0.015; hazard ratio: 0.43 [95% confidence interval: 0.21 to 0.87]). The need for "late" (>1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms.. The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Retreatment; Risk Factors; Spain; Time Factors; Treatment Outcome

The efficacy of paclitaxel-eluting balloon catheters (PEB) and drug-eluting stents for treatment of bare-metal stent restenosis (BMS-ISR) have been demonstrated in several studies with follow-up times of 9 to 12 months; however, the long-term outcomes of ISR treatment are less defined.. We aimed to compare the long-term efficacy of PEB and everolimus-eluting stents (EES) for the treatment of BMS-ISR.. We analyzed 3-year clinical follow-up data from patients included in the TIS randomized clinical study. A total of 136 patients with BMS-ISR were allocated to receive treatment with either PEB or EES (68 patients with 74 ISR lesions per group).. The PEB and EES groups did not significantly differ in major adverse cardiac events-free survival (MACE; P = .211; including individual events: CV death: P = .622; myocardial infarction: P = .650 or target vessel revascularization: P = .286) at 3-year clinical follow-up. No event-free survival differences were found between the groups regarding overall mortality (P = .818), definite stent thrombosis (P = .165) or the second MACE (P = .270).. At the 3-year follow-up, no significant differences in clinical outcomes were found between iopromide-coated PEB and EES for the treatment of BMS-ISR. (ClinicalTrials.gov; https://clinicaltrials.gov; NCT01735825).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Metals; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Progression-Free Survival; Prospective Studies; Prosthesis Design; Retreatment; Risk Factors; Stents; Time Factors

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

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

The aim of the present study was to evaluate the angiographic efficacy, clinical safety, and effectiveness of the Restore paclitaxel-coated balloon in a randomized trial designed to enable the approval of the new device in China.. Drug-coated balloon (DCB) angioplasty offers an effective treatment for in-stent restenosis. Restore is a new DCB with a SAFEPAX shellac-ammonium salt excipient that can avoid drug washing off during catheter delivery to the target lesion site.. In the noninferiority RESTORE ISR China (Compare the Efficacy and Safety of RESTORE DEB and SeQuent Please in Chinese Patient With Coronary In-stent Restenosis) trial, eligible patients with first occurrence of drug-eluting stent ISR were randomized to the Restore DCB or SeQuent Please DCB in a 1:1 ratio stratified by diabetes. Angiographic and clinical follow-up was planned at 9 months and 1 year, respectively, in all patients. The study was powered for the primary endpoint of 9-month in-segment late loss.. Between May 2016 and July 2017, a total of 240 subjects at 12 sites were randomized to either the Restore group (n = 120) or the SeQuent Please group (n = 120). Nine-month in-segment late loss was 0.38 ± 0.50 mm with Restore versus 0.35 ± 0.47 mm with SeQuent Please; the 1-sided 97.5% upper confidence limit of the difference was 0.17 mm, achieving noninferiority of Restore compared with SeQuent Please (p for noninferiority = 0.02). Both DCBs had similar 1-year rates of target lesion failure (13.3% vs. 12.6%; p = 0.87).. In this head-to-head randomized trial, the Restore DCB was noninferior to the SeQuent Please DCB for the primary endpoint of 9-month in-segment late loss. (Compare the Efficacy and Safety of RESTORE DEB and SeQuent Please in Chinese Patient With Coronary In-stent Restenosis; NCT02944890).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; China; Coated Materials, Biocompatible; Constriction, Pathologic; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Equipment Design; Female; Humans; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Risk Factors; Time Factors; Treatment Outcome

The aim of this study was to evaluate the angiographic efficacy and clinical outcomes of the Restore paclitaxel-coated balloon in a randomized trial designed to enable its approval with an indication for small-vessel disease (SVD).. Higher rates of restenosis and stent thrombosis limit the effectiveness of drug-eluting stent (DES) treatment of SVD. Whether a drug-coated balloon (DCB)-only strategy is effective in de novo SVD is not yet established.. In the noninferiority RESTORE SVD China trial, eligible patients with reference vessel diameter ≥2.25 and ≤2.75 mm were randomized to the Restore DCB or the RESOLUTE Integrity DES in a 1:1 ratio stratified by diabetes and number of lesions treated. Patients with RVD ≥2.00 and <2.25 mm were enrolled in a nested very small vessel registry. Angiographic and clinical follow-up were planned at 9 months and 1 year, respectively, in all patients. The study was powered for the primary endpoint of 9-month in-segment percentage diameter stenosis.. Between August 2016 and June 2017, a total of 230 subjects at 12 sites were randomized to the DCB group (n = 116) or DES group (n = 114); 32 patients were treated with the DCB in the very small vessel cohort. Nine-month in-segment percentage diameter stenosis was 29.6 ± 2.0% with the DCB versus 24.1 ± 2.0% with the DES; the 1-sided 97.5% upper confidence limit of the difference was 10.9%, achieving noninferiority of the DCB compared with the DES (p for noninferiority < 0.001). The DCB and DES had comparable 1-year rates of target lesion failure (4.4% vs. 2.6%, p = 0.72).. In this multicenter randomized trial, the Restore DCB was noninferior to the RESOLUTE DES for 9-month in-segment percentage diameter stenosis. (Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease; NCT02946307).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; China; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

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

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

The primary objective of this study was to evaluate the safety and effectiveness of the Mirage (Manli Cardiology, Singapore) bioresorbable microfiber sirolimus-eluting scaffold compared with the Absorb (Abbott Vascular, Santa Clara, California) bioresorbable vascular scaffold in the treatment of stenotic target lesions located in native coronary arteries, ranging from ≥2.25 to ≤4.0 mm in diameter. Secondary objectives were to establish the medium-term safety, effectiveness, and performance of the Mirage device.. The current generation of bioresorbable scaffolds has several limitations, such as thick square struts with large footprints that preclude their deep embedment into the vessel wall, resulting in protrusion into the lumen with microdisturbance of flow. The Mirage sirolimus-eluting bioresorbable microfiber scaffold is designed to address these concerns.. In this prospective, single-blind trial, 60 patients were randomly allocated in a 1:1 ratio to treatment with a Mirage sirolimus-eluting bioresorbable microfiber scaffold or an Absorb bioresorbable vascular scaffold. The clinical endpoints were assessed at 30 days and at 6 and 12 months. In-device angiographic late loss at 12 months was quantified. Secondary optical coherence tomographic endpoints were assessed post-scaffold implantation at 6 and 12 months.. Median angiographic post-procedural in-scaffold minimal luminal diameters of the Mirage and Absorb devices were 2.38 mm (interquartile range [IQR]: 2.06 to 2.62 mm) and 2.55 mm (IQR: 2.26 to 2.71 mm), respectively; the effect size (d) was -0.29. At 12 months, median angiographic in-scaffold minimal luminal diameters of the Mirage and Absorb devices were not statistically different (1.90 mm [IQR: 1.57 to 2.31 mm] vs. 2.29 mm [IQR: 1.74 to 2.51 mm], d = -0.36). At 12-month follow-up, median in-scaffold late luminal loss with the Mirage and Absorb devices was 0.37 mm (IQR: 0.08 to 0.72 mm) and 0.23 mm (IQR: 0.15 to 0.37 mm), respectively (d = 0.20). On optical coherence tomography, post-procedural diameter stenosis with the Mirage was 11.2 ± 7.1%, which increased to 27.4 ± 12.4% at 6 months and remained stable (31.8 ± 12.9%) at 1 year, whereas the post-procedural optical coherence tomographic diameter stenosis with the Absorb was 8.4 ± 6.6%, which increased to 16.6 ± 8.9% and remained stable (21.2 ± 9.9%) at 1-year follow-up (Mirage vs. Absorb: d. At 12 months, angiographic in-scaffold late loss was not statistically different between the Mirage and Absorb devices, although diameter stenosis on angiography and on optical coherence tomography was significantly higher with the Mirage than with the Absorb. The technique of implantation was suboptimal for both devices, and future trials should incorporate optical coherence tomographic guidance to allow optimal implantation and appropriate assessment of the new technology, considering the novel mechanical properties of the Mirage.

Topics: Absorbable Implants; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Female; Humans; Indonesia; Malaysia; Male; Middle Aged; Multimodal Imaging; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Drug eluting stents reduce the risk of in-stent restenosis but delay healing of the vascular wall. Recent data on late and very late stent thrombosis after drug-eluting stent (DES) implantation have raised concerns about the long-term safety. High lipophilicity of paclitaxel promotes rapid cellular uptake and prolongs its action. This makes paclitaxel a very promising candidate for local drug therapy intended to inhibit the proliferative and migratory processes involved in restenosis following PCI.. In a prospective randomized trial, we compared the efficacy of the new catheter based delivery of fluid paclitaxel after bare metal stenting with that of drug eluting stents in patients at high risk for in-stent restenosis.. We conducted a prospective, randomized trial comparing the local delivery of fluid paclitaxel after bare metal stent implantation (DDB+BMS group) with the implantation of drug eluting stent (DES group) (1:1) in 68 patients at high risk for in-stent restenosis. The primary end points were in-stent late lumen loss and binary restenosis rate ›50%. Secondary end points were procedure success and composite clinical end points (major adverse cardiac events and revascularization of the target lesion) 6months after intervention. At 6months, follow-up angiography showed an in-stent late lumen loss of 1.0±1.3mm in (DDB+BMS group) versus 0.94±1.3mm in DES group (P=.743) without statistically significant difference in the cumulative overall rate of major cardiac events between both groups. DES subgroup analysis showed in-stent late lumen loss of 0.09±0.3mm in everolimus eluting stent (EES) subgroup patients that was statistically significant in comparison with (DDB+BMS group, n=30) (P=.033) and paclitaxel eluting stent (PES, n=19) subgroup patients (P=.006).Target lesion revascularization was 0% in EES subgoup patients, 36.7% in DDB+BMS group patients and 47.7% in PES subgroup patients (P=.026).. Paclitaxel either in fluid form used in drug delivery balloons or in polymerized form used in drug eluting stents was ineffective in reducing neointimal proliferation, in-stent restenosis, and clinical events. EES was superior compared with PES and catheter based delivery of fluid paclitaxel after bare metal stent implantation regarding primary and secondary end points.

Topics: Adolescent; Adult; Aged; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Egypt; Female; Humans; Male; Metals; Middle Aged; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Stents; Time Factors; Treatment Outcome; Young Adult

The aim of this study was to compare neointimal modification with scoring balloon pre-dilation before drug-coated balloon (DCB) versus DCB standard therapy in patients presenting with drug-eluting stent (DES) restenosis.. DCB angioplasty for the treatment of coronary drug-eluting stent restenosis has demonstrated encouraging results. The efficacy of DCB treatment relies on rapid initial drug transfer and tissue retention of the antiproliferative drug. Neointimal modification with scoring balloon pre-dilation may enhance the efficacy of DCB therapy.. In this randomized, open-label, active-controlled trial, 252 patients with clinically significant DES restenosis were enrolled at 4 centers in Germany. Patients undergoing DCB angioplasty were randomly assigned to treatment with scoring balloon pre-dilation or standard therapy. The primary endpoint of the study was in-segment percentage diameter stenosis on 6- to 8-month follow-up angiography. The secondary endpoints included binary angiographic restenosis and late lumen loss on follow-up angiography, the combined incidence of death or myocardial infarction, target lesion revascularization, and target lesion thrombosis at 1 year.. Follow-up angiographic data at 6 to 8 months were available for 203 patients (80.6%). Scoring balloon pre-dilation compared with standard therapy showed significantly lower rates with respect to the primary endpoint (35.0 ± 16.8% vs. 40.4 ± 21.4%; p = 0.047) and binary angiographic restenosis (18.5% vs. 32.0%; p = 0.026). Late lumen loss was numerically lower after scoring balloon pre-dilation compared with standard therapy (0.31 ± 59 mm vs. 0.41 ± 0.74 mm; p = 0.27). There was no difference between the groups in the incidence of death or myocardial infarction (4.0% vs. 3.4%; p = 0.73). Scoring balloon versus standard therapy showed comparable rates of target lesion revascularization (16.2% vs. 21.8%; p = 0.26). No target lesion thrombosis occurred out to 1 year.. In patients presenting with drug-eluting stent restenosis, neointimal modification with scoring balloon improves the antirestenotic efficacy of DCB therapy. (Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4 [ISAR-DESIRE 4]; NCT01632371).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Neointima; Percutaneous Coronary Intervention; Prosthesis Design; Therapeutics; Time Factors

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

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

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

This study sought to investigate the effect of post-dilatation on angiographic and intracoronary imaging parameters in the setting of primary percutaneous coronary intervention comparing the everolimus-eluting bioresorbable scaffold (BRS) with the everolimus-eluting metallic stent (EES).. Routine post-dilatation of BRS has been suggested to improve post-procedural angiographic and subsequent device-related clinical outcomes.. In the ABSORB STEMI TROFI II trial, 191 patients with ST-segment elevation myocardial infarction were randomly assigned to treatment with BRS (n = 95) or EES (n = 96). Minimal lumen area and healing score as assessed by optical coherence tomography at 6 months were compared between BRS- and EES-treated patients stratified according to post-dilatation status.. Primary percutaneous coronary intervention with post-dilatation was performed in 48 (50.5%) BRS- and 25 (25.5%) EES-treated lesions. There were no differences in baseline characteristics and post-procedural minimal lumen diameter between groups. In the BRS group, lesions with post-dilatation were associated with a trend toward a smaller minimal lumen area at 6 months (5.07 ± 1.68 mm. In the setting of selected patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with BRS or EES, post-dilatation did not translate into larger lumen area or improved arterial healing at follow-up. (ABSORB STEMI: The TROFI II; NCT01986803).

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Male; Metals; Middle Aged; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; ST Elevation Myocardial Infarction; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

The aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR).. Angioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR treatment. The Virtue angioplasty balloon (Caliber Therapeutics, New Hope, Pennsylvania) delivers sirolimus in a nanoencapsulated liquid formulation. This clinical trial is the first to examine a sirolimus-eluting balloon for ISR.. In this prospective, single-arm feasibility study at 9 European centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up.. Procedural success in the intention-to-treat population was 100%. The primary safety endpoint was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) assessed at 30 days (0%, n = 50). The primary performance endpoint was in-segment late lumen loss (LLL) at 6 months (0.31 ± 0.52 mm; n = 47). Secondary 6-month endpoints include binary restenosis (19.1%), diameter stenosis (30.3 ± 19.9%), and major adverse cardiac events (MACE) (10.2%, n = 49). In the 36-patient per-protocol population (excluding major protocol violations and previously stented ISR), LLL was 0.12 ± 0.33 mm at 6 months. Clinical outcomes at 1 year for the intention-to-treat group were 12.2% TLF and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE.. This first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes that warrant further evaluation in dedicated randomized studies.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Equipment Design; Europe; Feasibility Studies; Female; Humans; Intention to Treat Analysis; Male; Middle Aged; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Sirolimus; Stents; Time Factors; Treatment Outcome

The aim of this study was to investigate the efficacy and safety of the hybrid ultrathin-strut sirolimus-eluting stent (SES) with biodegradable polymer compared with the thin-strut everolimus-eluting stent (EES) with durable polymer in successfully recanalized chronic total occlusions (CTOs).. The introduction of drug-eluting stents revolutionized the treatment of CTOs. However, limited data are available on new-generation drug-eluting stents with biodegradable polymer in CTOs.. In this multicenter trial, patients were randomized, after successful CTO recanalization, to either SES or EES. The primary noninferiority endpoint was in-segment late lumen loss (noninferiority margin 0.2 mm). Secondary endpoints included in-stent late lumen loss and clinical endpoints.. Overall, 330 patients were included. At 9 months, angiography was available in 281 patients (85%). Duration of occlusion ≥3 months was 92.5%, with mean stent length of 52.4 ± 28.1 mm versus 52.3 ± 26.5 mm in the SES and EES groups. The primary noninferiority endpoint, in-segment late lumen loss, was not met for SES versus EES (0.13 ± 0.63 mm vs. 0.02 ± 0.47 mm; p = 0.08, 2-sided; difference 0.11 mm; 95% confidence interval: -0.01 to 0.25 mm; p. This randomized trial failed to show noninferiority of hybrid SES relative to EES in terms of in-segment late lumen loss in successfully recanalized CTOs. Furthermore, a statistically significantly higher rate of binary restenosis was found with SES.

Topics: Absorbable Implants; Aged; Belgium; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Netherlands; Percutaneous Coronary Intervention; Polymers; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

Incomplete neointimal coverage and malapposed struts after stenting are associated with increased risk of stent thrombosis. We aimed to evaluate neointimal coverage early after Resolute zotarolimus-eluting stent (R-ZES) implantation using optical coherence tomography (OCT). A total of 20 patients with de novo native coronary lesions with R-ZES were enrolled. Among these patients, 20 stented lesions in 19 patients were evaluated at 1, 2, and 3 months after R-ZES implantation. The strut apposition and neointimal coverage were evaluated by OCT. Neointimal hyperplasia (NIH) thickness and percentage of covered struts and the proportion of incompletely apposed struts were measured at 1-mm intervals. The mean percentages of covered stent struts were over 85 % within 3 months (88.4 ± 6.3 % at 1 month, 95.5 ± 5.5 % at 2 months, 93.6 ± 3.5 % at 3 months). The percentages of incompletely apposed struts were not significantly different among the groups (4.4 ± 4.2 % at 1 month, 1.9 ± 1.9 % at 2 months, 3.1 ± 2.2 % at 3 months, p = 0.51). Mean NIH thickness (38.9 ± 8.1 μm at 1 month, 70.6 ± 18.8 μm at 2 months, 54.1 ± 5.9 at 3 months, p = 0.0016) was thickest in the 2 months group. Most of all OCT findings within 2 months demonstrated neointimal coverage with low signal intensity. The neointimal coverage of ZES-R was over 85 % within 3 months. These data may support shorter requirement of dual antiplatelet therapy duration with R-ZES.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Japan; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prospective Studies; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The efficacy of DEB in modifying the high restenosis risk associated with BMS implantation is doubtful. Optical coherence tomography (OCT) may allow precise assessment of neointimal formation after stent implantation. We performed a single-center, prospective, 1:2 randomized trial comparing BMS implantation alone (BMS group) vs. additional DEB (DEB group). DEB patients were further randomized 1:1 to DEB before stenting (pre-DEB group), or after stenting (post-DEB group). Primary endpoint was OCT-assessed neointimal hyperplasia (expressed both as mean in-stent neointimal area and as percentage obstruction of the mean stent area) at 6 months. Secondary endpoints were the percentage of uncovered and malapposed stent struts. Thirty patients were enrolled and randomized to BMS (n = 10), pre-DEB (n = 10), post-DEB (n = 10). At 6-month OCT follow-up, DEB significantly reduced neointimal area compared with BMS: mean neointimal area 2.01 ± 0.89 vs. 3.03 ± 1.07 mm(2) (p = 0.02), percentage area obstruction 24.56 ± 12.50 vs. 37.51 ± 12.26 % (p = 0.02). The percentage of uncovered and malapposed stent struts did not differ significantly between BMS and DEB. In the comparison between pre-DEB and post-DEB, no significant difference was observed for both primary and secondary endpoints. In de novo coronary lesions treated with BMS, DEB use could be associated with a mild reduction in neointimal hyperplasia at 6 months; this effect could be unrelated to the timing of DEB dilation (pre- or post-stenting).. http://www.clinicaltrials.gov . Identifier: NCT01057563.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Female; Humans; Hyperplasia; Male; Metals; Middle Aged; Neointima; Percutaneous Coronary Intervention; Prospective Studies; Risk Factors; Rome; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Scoring balloons produce excellent acute results in the treatment of in-stent restenosis (ISR), fibro-calcific and bifurcation lesions but have not been shown to affect the restenosis rate. A novel paclitaxel-coated scoring balloon (SB) was developed and tested to overcome this limitation.. SB were coated with paclitaxel admixed with a specific excipient. Patients at four clinical sites in Germany and one in Brazil with ISR of coronary bare metal stent (BMS) were randomized 1:1 to treatment with either a drug-coated or uncoated SB. Baseline and 6-month follow-up quantitative coronary angiography was performed by an independent blinded core lab and all patients will be evaluated clinically for up to one year. The primary endpoint was angiographic in-segment late lumen loss (LLL). Secondary endpoints included the rate of clinically driven target lesion revascularization (TLR), composite of major adverse cardiovascular events (MACE), stent thrombosis and other variables. Sixty-one patients were randomized (28 uncoated and 33 drug-coated SB); mean age 65 years, males 72%, and presence of diabetes 39%. At 6-month angiography, in-segment LLL was 0.48 ± 0.51 mm in the uncoated SB group versus 0.17 ± 0.40 mm in the drug-coated SB group (P = 0.01; ITT analysis). The rate of binary restenosis was 41% in the uncoated SB group versus 7% in the drug-coated SB group (P = 0.004). The MACE rate was 32% with the uncoated SB vs. 6% in the drug-coated SB group (P = 0.016). This difference was primarily due to the reduced need for clinically driven TLR in the coated SB group (3% vs. 32% P = 0.004).. A novel paclitaxel-coated coronary SB has been developed and successfully used in a first-in-human randomized controlled trial [ClinicalTrials.gov Identifier: NCT01495533]. © 2015 Wiley Periodicals, Inc.

Topics: Aged; Angioplasty, Balloon, Coronary; Brazil; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Female; Germany; Humans; Male; Metals; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Retreatment; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome

In primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI), stenting has proved to reduce the need for repeat revascularization compared with balloon angioplasty alone. The incidence of cardiac death or recurrent myocardial infarction, though, is not reduced by stenting. This is in part attributable to stent-related complications like stent thrombosis which may occur even years after implantation. A strategy of drug coated balloon (DCB) angioplasty without stenting would abolish the potential disadvantages of stent implantation while reducing the probability of restenosis observed in plain old balloon angioplasty. Our aim is to evaluate the efficacy and safety of a DCB only strategy versus drug-eluting stents (DES) in PPCI for STEMI.. The REVELATION trial is a prospective, single center, randomized study, in which 120 patients presenting with STEMI will be allocated to treatment with a DCB versus DES. Appertaining to the established prognostic value of fractional flow reserve (FFR) rather than angiographic lesion severity, the functional assessment of the infarct-related lesion by FFR at 9 months after initial treatment is the primary end point. Assuming an FFR value of 0.90 after stenting and an increased risk of adverse events if post-PCI FFR <0.85, we decided to accept an FFR value of ≥0.85 after DCB only at follow-up as noninferiority margin. Secondary end points include major adverse cardiac events up to 5-year follow-up.. Our trial will address the efficacy and safety of DCB angioplasty versus DES in the setting of PPCI for STEMI. The REVELATION trial will introduce the recognized prognostic significance of physiologic assessment of the infarct-related lesion by FFR at 9 months follow-up as primary end point. © 2015 Wiley Periodicals, Inc.

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheterization; Cardiac Catheters; Cardiovascular Agents; Clinical Protocols; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Echocardiography; Fractional Flow Reserve, Myocardial; Humans; Netherlands; Paclitaxel; Prospective Studies; Prosthesis Design; Recurrence; Research Design; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome

To compare the incidence and predictors of target lesion revascularisation (TLR) and non-TLR after percutaneous coronary intervention with drug-eluting stents (DES).. We pooled patient-level data on 6,137 patients (Resolute zotarolimus-eluting stent: 5,016, XIENCE everolimus-eluting stent: 1,121) in the RESOLUTE Global Program. At three years, clinically driven TLR, unplanned non-TLR, and no revascularisation occurred in 186, 618, and 5,333 patients, respectively. On multivariate analysis, predictors of both TLR and non-TLR were pre-procedure diameter stenosis (%) (odds ratio [OR] 1.01, 95% confidence interval [CI] [1.01-1.02], and OR 0.99 [0.99-1.00]), diabetes (OR 1.46 [1.07-1.99], and OR 1.37 [1.15-1.64]), and prior PCI (OR 1.42 [1.01-2.00], and OR 1.41 [1.18-1.68]). Baseline characteristics associated with TLR only were prior coronary artery bypass graft surgery (OR 2.85 [1.91-4.27]), in-stent restenosis (OR 2.35 [1.43-3.83]), age (OR 0.98 per year [0.97-1.00]), hypertension (OR 1.64 [1.10-2.44]), and pre-procedure reference vessel diameter (OR 0.74 per mm [0.55-0.99]). Baseline characteristics associated with non-TLR only were lesion location (left anterior descending vs. all others) (OR 0.70 [0.59-0.83]), and hyperlipidaemia (OR 1.42 [1.15-1.75]).. The cumulative incidence of non-TLR at three years in patients treated with current-generation DES was almost three times higher than TLR.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Incidence; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

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

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

The PEPCAD China ISR trial investigated the safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty in an Asian patient population with coronary drug-eluting stent in-stent restenosis (DES-ISR).. A total of 220 patients with coronary DES-ISR were treated with PCB angioplasty or with paclitaxel-eluting stents (PES). This randomized (1:1), single-blind prospective multicenter trial in a Chinese population used 9-month in-segment late lumen loss (LLL) as the primary endpoint. Secondary endpoints included the 24-month clinical event rates.. Both treatment groups were similar in terms of patient, lesion, or procedural characteristics. After the 12-month follow-up evaluation, additional clinical events only occurred in the PES study group. The combined rate of all-cause mortality and myocardial infarction (MI) in the PCB group was significantly lower than that in the PES group (3.7% vs. 11.8%, P = 0.03). Additional subgroup analyses of 9-month in-segment LLL and 2-year target lesion failure in patients with diabetes, small vessels, diffuse ISR, and stent margin restenosis did not show more favorable results for one specific treatment group.. The 2-year follow-up demonstrated sustained long-term clinical efficacy for both devices. PCB angioplasty was associated with significantly lower overall and cardiovascular mortality/MI rates in patients with DES-ISR lesions while avoiding the use of additional metal layers for drug release (ClinicalTrials.gov identifier: NCT 01622075).

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; China; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Single-Blind Method; Time Factors; Treatment Outcome

The aim of this prospective randomized noninferiority study was to compare the efficacy of paclitaxel-eluting balloon (PEB) catheters and everolimus-eluting stents (EES) in the treatment of bare metal stent restenosis.. A total of 136 patients were enrolled in the study. Each treatment group included 68 patients with 74 in-stent restenotic lesions. The primary end point was in-segment late lumen loss (LLL) at 12 months. Secondary end points were the incidence of binary in-stent restenosis and 12-month major adverse cardiac events. The 2-sided 95% confidence interval of LLL difference between treatments (0.149-0.558) was greater than noninferiority margin (0.12), which demonstrates both noninferiority and superiority of PEB treatment. Furthermore, the PEB group had significantly less 12-month LLL than the EES group (0.02 versus 0.19 mm; P=0.0004). The difference in the incidence of repeated binary restenosis (8.7% versus 19.12%; P=0.078) and 12-month major adverse cardiac events (10.29% versus 19.12%; P=0.213) was not significant. The 12-month LLL was significantly less in the PEB group and also in subgroups with in-stent restenosis >10 mm (0.05 versus 0.26 mm; P=0.0002) and artery diameter <3 mm (0.05 versus 0.16 mm; P=0.003) compared with the EES groups, but not in the subgroup of patients with diabetes mellitus (P=0.254). In the EES group, repetitive binary restenosis had a significantly greater chance of occurring (odds ratio=3.132; 95% confidence interval, 1.058-9.269; P=0.039), even when adjusting for other risk factors.. Treatment of bare metal stent restenosis using PEB led to significantly less 12-month LLL than the implantation of second-generation EES.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01735825.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Czech Republic; Disease-Free Survival; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Odds Ratio; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices

To investigate clinical outcomes of percutaneous coronary intervention using a sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES) compared with a permanent polymer everolimus-eluting stent, Xience (PP-EES) in patients with high risk (ST-segment elevation and non-ST-segment elevation myocardial infarction) acute coronary syndromes (ACS) enrolled in the CENTURY II trial.. CENTURY II is a prospective, multicenter, randomized, single blind, controlled trial comparing BP-SES and PP-EES, with primary endpoint of target lesion failure (TLF) at 9month post-stent implantation. Out of 1123 patients enrolled in CENTURY II trial, 264 high risk ACS patients were included in this subgroup analysis, and the clinical outcomes including target lesion failure (TLF), target vessel failure (TVF), cardiac death, myocardial infarction, and stent thrombosis were evaluated at 24months.. The baseline clinical, angiographic and procedural characteristics were similar between two groups. At 24months, TLF occurred in 6.3% of patients receiving a BP-SES and 6.5% of patients receiving a PP-EES (P=0.95); TVF was 6.3% in patients receiving a BP-SES and 9.4% in patients receiving a PP-EES (P=0.36). There were no significant differences in cardiac death, myocardial infarction and stent thrombosis rate.. BP-SES achieved similar safety and efficacy outcomes as PP-EES in this ACS subgroup of CENTURY II study, at 24-month follow-up. This finding is hypothesis-generating and needs to be confirmed in larger trials with longer follow-up.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prospective Studies; Prosthesis Design; Recurrence; Republic of Korea; Risk Factors; Single-Blind Method; ST Elevation Myocardial Infarction; Thrombosis; Time Factors; Treatment Outcome

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

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

The aim of this study was to compare the long-term efficacy of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in patients with bare-metal stent in-stent restenosis (ISR).. The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown.. The 3-year clinical follow-up (pre-specified endpoint) of patients included in the RIBS V (Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent Implantation) randomized clinical trial was analyzed. All patients were followed yearly using a pre-defined structured questionnaire.. A total of 189 patients with bare-metal stent ISR were allocated to either EES (n = 94) or DEB (n = 95). Clinical follow-up at 1, 2, and 3 years was obtained in all patients (100%). Compared with patients treated with DEB, those treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up (primary study endpoint; 2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; p < 0.001). At 3 years, the rates of cardiac death (2% vs. 1%), myocardial infarction (4% vs. 5%) and target vessel revascularization (9% vs. 5%) were similar in the DEB and EES arms. Importantly, however, at 3 years, the rate of target lesion revascularization was significantly lower in the EES arm (2% vs. 8%; p = 0.04; hazard ratio: 0.23; 95% confidence interval: 0.06 to 0.93). The need for "late" (>1 year) target vessel (3 [3.2%] vs. 3 [3.2%]; p = 0.95) and target lesion (1 [1%] vs. 2 [2.1%]; p = 0.54) revascularization was low and similar in the 2 arms. Rates of definite or probable stent thrombosis (1% vs. 0%) were also similar in the 2 arms.. The 3-year clinical follow-up of the RIBS V clinical trial confirms the sustained safety and efficacy of EES and DEB in patients treated for bare-metal stent ISR. In this setting, EES reduce the need for target lesion revascularization at very long-term follow-up. (RIBS V [Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent] [RIBS V]; NCT01239953).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Metals; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Spain; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome

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

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

Improved outcomes in patients with diabetes mellitus undergoing percutaneous coronary intervention remain an unmet clinical need. We assessed the long-term efficacy and safety of novel polymer-free sirolimus- and probucol-eluting stent in diabetic patients enrolled in intracoronary stenting and angiographic results: test efficacy of sirolimus- and probucol-eluting versus zotarolimus-eluting stents 5 trial.. In a pre-specified subgroup analysis, outcomes of diabetic patients treated with a sirolimus- and probucol-eluting stent or a second-generation zotarolimus-eluting stent were compared. The primary endpoint was a device-oriented composite outcome comprising cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularization (TLR) at 5-year follow-up. Event-free survival was assessed using the Kaplan-Meier method. Hazard ratios (HR) and 95 % confidence intervals (CI) were estimated from univariate Cox proportional hazards models.. A total of 870 patients with diabetes mellitus were treated with either a sirolimus- and probucol-eluting stent (n = 575) or a second-generation zotarolimus-eluting stent (n = 295). At 5 years, the rate of device-oriented composite endpoint was comparable between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent (32.9 versus 33.4 %, HR 0.88, 95 % CI 0.76-1.26). No significant differences were observed between the sirolimus- and probucol-eluting stent and the second-generation zotarolimus-eluting stent groups in the incidence of cardiac death (15.6 versus 16.7 % HR 0.92, 95 % CI 0.63-1.32), target-vessel MI (4.6 versus 6.6 %, HR 0.73, 95 % CI 0.40-1.34), and TLR (18.6 versus 18.8 %, HR 1.00, 95 % CI, 0.72-1.41). The rate of definite or probable stent thrombosis was low and similar in both groups (2.5 versus 2.6 %, HR 1.02, 95 % CI, 0.41-2.52).. In patients with diabetes the long-term efficacy and safety of a polymer-free sirolimus- and probucol-eluting stent were comparable to a second-generation durable polymer zotarolimus-eluting stent. Trial registration ClinicalTrials.gov NCT00598533. Registered 10 January 2008.

Topics: Aged; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Diabetic Angiopathies; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Probucol; Proportional Hazards Models; Prosthesis Design; Retreatment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Treatment of bare metal in-stent restenosis with the paclitaxel-coated balloon catheter based on the PACCOCATH® technology has yielded superior six-month angiographic and one-year clinical results compared to a paclitaxel-eluting stent. The three-year clinical follow-up is presented.. One hundred and thirty-one patients with coronary bare metal in-stent restenosis (>70%, length: <22 mm, vessel diameter: 2.5-3.5 mm) were randomly treated with the paclitaxel-coated balloon (DCB) (3 µg/mm²) or a paclitaxel-eluting stent (DES). Clinical follow-up information was requested from the patients and from their physicians. Quantitative angiographic and demographic baseline data were statistically not different between the groups. Per intention-to-treat analysis at 12 months, the lesion-related rates of major adverse cardiac events were 7.6% and 16.9% (p=0.11) while at 36 months the respective numbers were 9.1% and 18.5% (p=0.14). These differences were primarily due to reduced target lesion revascularisation (TLR) in DCB 4/66 (6.2%) compared to DES patients 10/65 (15.4%) (p=0.10). From 12 to 36 months, 1/65 (1.5%) DCB patients experienced a myocardial infarction while neither TLR nor death occurred in any study patient in either group during that period.. The six-month superiority of the paclitaxel-coated balloon compared to the paclitaxel-eluting stent in the treatment of bare metal coronary in-stent restenosis persisted throughout the three-year clinical follow-up period indicating stability of the lesions treated. (ClinicalTrials.gov Identifier: NCT00393315).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Germany; Humans; Intention to Treat Analysis; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prosthesis Design; Retreatment; Stents; Time Factors; Treatment Outcome; Vascular Access Devices

No randomized data exist regarding optical coherence tomography (OCT) evaluation immediately post-procedure and at the 3-month follow-up for platinum-chromium everolimus-eluting stents (PtCr-EES) versus cobalt-chromium everolimus-eluting stents (CoCr-EES). A total of 100 patients were randomly assigned to undergo PtCr-EES (n = 51) or CoCr-EES (n = 49) implantation. OCT was serially evaluated after stent deployment with nominal pressure and immediately post-procedure, and 3-month follow-up. The primary endpoint was the percentage of malapposed strut after nominal pressure and immediately post-procedure. Compared to the CoCr-EES, the PtCr-EES showed a lower tendency of percent malapposed strut at nominal pressure [median value (interquartile range); 4.1 % (0.5-11.7) vs. 7.6 % (2.9-13.7), p = 0.082] and immediately post-procedure [1.2 % (0-3.4) vs. 2.5 % (0.7-5.3), p = 0.051]. The percentage of cross sections with any malapposed struts was significantly lower with PtCr-EES at nominal pressure [15.0 % (5.6-39.0) vs. 23.8 % (18.2-44.4), p = 0.036] and immediately post-procedure [6.5 % (0-15.3) vs. 10.5 % (7.1-20.0), p = 0.026]. At the 3-month follow-up, both PtCr-EES and CoCr-EES showed comparable percentages of malapposed struts (0 vs. 0 %, respectively, p = 0.332) and uncovered struts (5.3 vs. 4.7 %, respectively, p = 0.829). We found a significant correlation between the immediate post-procedural percentage of malapposed struts versus the percentage of uncovered struts (r = 0.430, p < 0.001) at the 3-month follow-up. Compared to the CoCr-EES, the PtCr-EES shows a lower tendency toward a lower percentage of malapposed struts but no significant difference in strut coverage at the 3-month follow-up. The percentage of malapposed struts immediately post-procedure was correlated with strut coverage at the 3-month follow-up.

Topics: Aged; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platinum; Prospective Studies; Prosthesis Design; Republic of Korea; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Patients with diabetes mellitus (DM) remain at high risk for stent restenosis and adverse cardiovascular events in the drug-eluting stent era. The amphilimus-eluting stent (AES) is a third generation reservoir-based polymer-free drug-eluting stent that has shown promising preliminary results in patients with DM. It has been suggested that the formulation of the drug with fatty acids could not only modulate the drug release in a timely manner but also achieve convenient levels of drug concentration in diabetic cardiac cells. The aim of this trial is to assess the efficacy of the AES in patients with DM compared with the cobalt chromium everolimus-eluting stent with non-erodible polymer (EES).. This is an investigator-initiated, multicenter, randomized clinical trial, performed in patients with DM. A total of 112 diabetic patients receiving glucose-lowering agents and requiring percutaneous revascularization of a de novo lesion will be randomized in a 1:1 fashion to receive AES or EES. The primary endpoint is the neointimal volume obstruction at 9 months, evaluated by optical coherence tomography. Secondary endpoints will include strut coverage, angiographic in-stent late loss and clinical endpoints such as target vessel revascularization or probable/definite stent thrombosis. This study completed the inclusion in October 2013.. The RESERVOIR trial is an investigator-initiated trial that will evaluate whether the polymer-free AES is not inferior to the EES inhibiting the neointimal hyperplasia in patients with DM. These results are also expected to improve our knowledge of the neointimal healing process in this population (Clinicaltrials.gov number NCT01710748).

Topics: Cardiovascular Agents; Chromium Alloys; Clinical Protocols; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Fatty Acids; Humans; Neointima; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Research Design; Spain; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The aim of this study was to evaluate the extent of neointimal response after the implantation of a second-generation drug-eluting stent, zotarolimus-eluting stent (ZES-ER, Endeavor Resolute) or everolimus-eluting stent (EES, Xience V), using intravascular ultrasound (IVUS) in diabetic patients.. In all, 154 diabetic patients with de-novo coronary lesions were randomized to be implanted with a ZES-ER or EES, and the angiographic follow-up at 9 months combined with a complete IVUS study was available for 96 patients with 101 lesions.. Baseline demographic and lesion parameters were similar in both groups at index percutaneous coronary intervention. On follow-up angiography, in-stent late lumen loss and minimal lumen diameter were not different between the two groups. On IVUS study, neointimal hyperplasia volume [median (interquartile range): ZES-ER vs. EES; 2.25 mm (0.57-6.25) vs. 1.59 mm (0.45-8.37), P=0.615] and in-stent percentage of volume obstruction [median (interquartile range): ZES-ER vs. EES; 1.16% (0.33-3.61) vs. 0.77% (0.29-4.01), P=0.615] showed similar results between the two groups.. In diabetic patients, the second-generation drug-eluting stents, ZES-ER and EES, were comparable in inhibiting neointimal proliferation.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Diabetic Angiopathies; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Pilot Projects; Predictive Value of Tests; Prosthesis Design; Republic of Korea; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

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

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

The PLATINUM China clinical trial evaluated the safety and effectiveness of the thin-strut, everolimus-eluting, platinum-chromium PROMUS™ Element™ stent (PtCr-EES) (Boston Scientific, Marlborough, MA) for the treatment of patients in China.. Clinical outcomes from the PtCr-EES have not been evaluated in patients from China, nor has it been directly compared with the second-generation stainless steel paclitaxel-eluting TAXUS Liberté stent (PES) in a randomized head-to-head trial. Methods In this prospective, multicenter, single-blind, superiority trial, patients with a single de novo atherosclerotic coronary artery lesion were randomized 1:3 to receive either the PES or PtCr-EES. The primary endpoint was in-stent late loss at 9 months.. Among 127 PES and 373 PtCr-EES patients (71.2% male; mean age 57.3 years), the primary endpoint of 9-month in-stent late loss was 0.40 ± 0.45 mm for PES versus 0.11 ± 0.36 mm for PtCr-EES (P < 0.001). In-stent % diameter stenosis was 22.20 ± 16.00% for PES versus 11.06 ± 13.86% for PtCr-EES (P < 0.001) at 9 months. The 1-year rate of death/MI was 1.6% (2/127) for PES versus 0% (0/371) for PtCr-EES (P = 0.06) and target vessel revascularization was 4.7% (6/127) for PES versus 2.7% (10/371) for PtCr-EES (P = 0.26). No stent thromboses occurred at 12 months in either group.. In the largest prospective angiographic evaluation conducted to date with this stent, the PROMUS Element PtCr-EES was superior to the TAXUS Liberté PES for the primary endpoint of late loss at 9 months, with low rates of clinical events at 1 year. Clinical follow-up will continue to 2 years.

Topics: Adult; Aged; Cardiovascular Agents; China; Chromium; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Platinum; Prospective Studies; Prosthesis Design; Single-Blind Method; Time Factors; Treatment Outcome

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

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

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

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

The aim of APPOSITION III was to evaluate the feasibility and performance of the STENTYS Self-Apposing¨ stent (STENTYS S.A., Paris, France) in the setting of primary percutaneous coronary intervention (PCI).. APPOSITION III was an international, prospective, multicentre registry. The study population consisted of 965 patients. The rate of the primary endpoint major adverse cardiac events (MACE), defined as the composite of cardiac death, recurrent target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularisation (CD-TLR), at one year was 9.3%. One-year cardiac death rate was 2.0%, TV-MI rate was 1.3%, CD-TLR rate was 7.4% and definite/probable stent thrombosis (ST) rate was 3.5% (definite ST 2.8%). An interim safety analysis of in-hospital outcomes in the first 400 patients showed higher event rates if post-dilation was not performed, and post-dilations became highly recommended in the remaining cohort. Patients undergoing post-dilation eventually showed a numerically lower one-year MACE rate (8.4% vs. 11.3%, p=0.137). One-year TV-MI (0.8% vs. 2.5%, p=0.027) and definite ST (1.9% vs. 5.0%, p=0.010) rates were significantly lower if post-dilation was performed, with the divergence occurring at <30 days.. The use of the STENTYS Self-Apposing¨ stent in the setting of primary PCI was feasible and associated with acceptable cardiovascular event rates which improved when post-dilation was performed.

Topics: Cardiovascular Agents; Coronary Restenosis; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Registries; Stents; Treatment Outcome

This study sought to investigate the long-term comparative efficacy and safety of paclitaxel-eluting balloon (PEB), paclitaxel-eluting stent (PES), or balloon angioplasty (BA) for the treatment of drug-eluting stent restenosis.. The optimal treatment of drug-eluting stent restenosis remains unknown. Although PEB has shown encouraging results, the long-term clinical efficacy and safety of PEB remains poorly defined.. A total of 402 patients with clinically significant restenosis in limus-eluting stents were randomly assigned to receive PEB (n = 137), PES (n = 131), or BA (n = 134). For this analysis, PEB versus PES and PEB versus BA were compared. The primary efficacy and safety endpoints were target lesion revascularization and the composite of death or myocardial infarction.. At a median follow-up of 3 years, the risk of target lesion revascularization was comparable with PEB versus PES (hazard ratio [HR]: 1.46, 95% confidence interval [CI]: 0.91 to 2.33; p = 0.11) and lower with PEB versus BA (HR: 0.51, 95% CI: 0.34 to 0.74; p < 0.001). The risk of death/myocardial infarction tended to be lower with PEB versus PES (HR: 0.55, 95% CI: 0.28 to 1.07; p = 0.08), due to a lower risk of death (HR: 0.38, 95% CI: 0.17 to 0.87; p = 0.02). The risk of death/myocardial infarction was similar with PEB versus BA (HR: 0.96, 95% CI: 0.46 to 2.0; p = 0.91).. At 3 years, the use of PEB as compared with PES to treat patients with limus-eluting stent restenosis has similar efficacy and safety. PEB remains superior to BA. The sustained efficacy without trade-off in safety supports the role of PEB as treatment option for patients with drug-eluting stent restenosis. (Intracoronary Stenting and Angiographic Results: Drug Eluting Stent In-Stent Restenosis: 3 Treatment Approaches [ISAR-DESIRE 3]; NCT00987324).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheterization; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Equipment Design; Humans; Italy; Kaplan-Meier Estimate; Paclitaxel; Predictive Value of Tests; Prospective Studies; Risk Factors; Time Factors; Treatment Outcome

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

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

The intention this PEPCAD-DES (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter) study update was to demonstrate the safety and efficacy of paclitaxel-coated balloon (PCB) angioplasty in patients with DES-ISR at 3 years.. In the PEPCAD-DES trial late lumen loss and the need for repeat target lesion revascularization (TLR) was significantly reduced with PCB angioplasty compared with plain old balloon angioplasty (POBA) in patients with drug-eluting stent in-stent restenosis (DES-ISR) at 6 months. We evaluated whether the clinical benefit of reduced TLR and major adverse cardiac events (MACE) was maintained up to 3 years.. A total of 110 patients with DES-ISR in native coronary arteries with reference diameters ranging from 2.5 mm to 3.5 mm and lesion lengths ≤22 mm were randomized to treatment with either PCB or POBA in a multicenter, randomized, single-blind clinical study. With a 2:1 randomization, 72 patients were randomized to the PCB group and 38 patients to the POBA group. At baseline, there were lesions with at least 2 stent layers in PCB (52.8%, 38 of 72) and POBA (55.3%, 21 of 38) patients.. At 36 months, the TLR rates were significantly lower in the PCB group compared with the POBA control group (19.4% vs. 36.8%; p = 0.046). Multiple TLRs in individual patients were more frequent in the POBA group compared with the PCB group (more than 1 TLR: POBA, 13.2%; PCB, 1.4%; p = 0.021). The 36-month MACE rate was significantly reduced in the PCB group compared with the POBA group (20.8% vs. 52.6%, log-rank p = 0.001).. PCB angioplasty was superior to POBA for the treatment of DES-ISR patients in terms of MACE and TLR for up to 36 months. There was no late catch-up phenomenon. (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter [PEPCAD-DES]; NCT00998439).

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Retreatment; Risk Factors; Single-Blind Method; Time Factors; Treatment Outcome

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

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

We aimed to evaluate the role of drug-eluting balloon SB inflation, using the novel DANUBIO balloon, after placement of a drug-eluting stent in the main branch in patients with bifurcation lesions.. Fifty-two patients with bifurcation lesions suitable for stenting were enrolled in the DEBSIDE trial at eight French centres between May 2012 and July 2013. Two patients were excluded from the trial because of significant protocol deviations. Systematic Nile PAX stent placement was followed by final drug-eluting balloon inflation, using the DANUBIO balloon, according to the size of the side branch. Clinical follow-up was scheduled at one, six, and twelve months and an angiographic control at six months. The primary endpoint was six-month late lumen loss (LLL) at the ostium of the side branch. Secondary endpoints were main branch (MB) LLL, binary restenosis of the SB and MB, and clinically driven revascularisation rates for both branches. The procedural success rate was 100%. Angiographic control at six months post-procedure was performed in 48 patients (96%). Two patients with no reported clinical events refused the angiographic control. At six-month follow-up the primary endpoint of side branch LLL was -0.04±0.34 mm and the secondary endpoint of MB LLL was 0.54±0.60 mm. There was only one myocardial infarction (2%) and no reported cardiac deaths. Only one patient (2%) had a non-clinically driven target lesion revascularisation (TLR) at the level of the side branch combined with a main branch revascularisation.. Systematic final inflation of a DANUBIO balloon in the side branch after placement of a Nile PAX stent in the main branch for the treatment of a bifurcation lesion is safe and effective and results in very low LLL and a low restenosis rate at the side branch ostium. The DEBSIDE clinical trial was registered at the United States National Institute of Health website (NCT01485081).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; France; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Time Factors; Treatment Outcome

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

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

Persistence of stent polymer coating has been associated with incomplete endothelialization, expansive vessel remodeling, neoatherosclerosis, and delayed healing associated with inflammation that may contribute to late adverse events.. The BICARE (Lepu Medical, Beijing, China) stent is a novel polymer-free, nanotechnology-based stent eluting sirolimus and probucol. As a first in human feasibility study, patients with a single de novo native coronary stenosis <30 mm in length and with reference vessel diameter from 2.5 to 4.0 mm underwent revascularization with the BICARE stent. The primary endpoint of target lesion failure (TLF) was assessed at 30 days. Secondary endpoints included in-stent late lumen loss and proportion of uncovered or malapposed stent struts by optical coherence tomography at 4-month angiographic surveillance.. Among 32 consecutive patients (age, 55.7 ± 8.7 years; men, 62.5%; diabetes, 18.8%), the average baseline reference vessel diameter and lesion length were 2.85 ± 0.48 mm and 15.0 ± 5.6 mm, respectively. At 30 days there was no occurrence of TLF. At 4 months (angiographic follow-up, N=32), angiographic in-stent late loss was 0.14 ± 0.19 mm, and the in-stent binary restenosis rate was 3.1%. Complete strut coverage was 98.2% with 0.2% malapposition among 16,751 analyzed struts. At 18 months, TLF occurred in 3 (9.4%) patients related to repeat revascularization with no adverse safety events identified.. The preliminary feasibility and safety of a polymer-free, dual-drug eluting stent are demonstrated by absence of early adverse safety events and favorable angiographic suppression of neointimal hyperplasia. Stent imaging suggests favorable healing with extensive stent strut coverage and very low malapposition. These findings further inform comparison with biopermanent polymer DES.

Topics: Cardiovascular Agents; China; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug Combinations; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Hyperplasia; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Probucol; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

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

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

Different approaches of local intravascular drug delivery may influence endothelial and microvascular function. The aim of this trial was to study the influence of a paclitaxel coated balloon in combination with a bare metal stent (DCB + BMS) versus a bare metal stent (BMS) or a sirolimus-eluting stent (DES) on coronary restenosis and endothelial function.. This prospective trial included 77 patients with coronary de novo lesions. The patients were assigned to either one of the treatment groups. After 9 months, patients underwent angiographic follow-up including invasive measurement of coronary endothelial function. After 9 months, late lumen loss in-stent was highest in the BMS group (0.85 ± 0.73 mm), lower in DCB + BMS (0.36 ± 0.46 mm); and lowest in the DES group (0.25 ± 0.34 mm; P = 0.001 [ANOVA]). When compared to the BMS group, in-segment late lumen loss was significantly reduced in the DCB + BMS group (0.27 ± 0.43 mm vs. 0.60 ± 0.55 mm, P = 0.029) and the DES group (0.28 ± 0.40 mm, P = 0.045). Coronary flow reserve was significantly higher with the DCB + BMS treatment (3.16 ± 0.97 vs. 2.42 ± 0.99 [BMS], P = 0.036) whereas the increase in the DES group did not reach the significance level (3.06 ± 1.39, P = 0.144 vs. BMS). Parameters of endothelial function like intracoronary flow velocity and vessel diameter distal to the stented area showed similar patterns of response to adenosine, acetylcholine, and nitro in all groups.. DES and the combination of DCB + BMS showed a significant reduction of late lumen loss as compared to a BMS alone. Furthermore, both types of local drug delivery were not associated with a deterioration of microvascular function at 9 months [ClinicalTrials.gov Identifier: NCT00473499].

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Circulation; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Endothelium, Vascular; Female; Hemodynamics; Humans; Male; Metals; Microcirculation; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Time Factors; Vasodilator Agents

This study sought to perform clinical and imaging assessments of the DESolve Bioresorbable Coronary Scaffold (BCS).. BCS, which is drug eluting, may have potential advantages compared with conventional metallic drug-eluting stents. The DESolve system, designed to provide vessel support and neointimal suppression, combines a poly-l-lactic acid-based scaffold with the antiproliferative myolimus.. The DESolve First-in-Man (a non-randomized, consecutive enrollment evaluation of the DESolve myolimus eluting bioresorbable coronary stent in the treatment of patients with de novo native coronary artery lesions) trial was a prospective multicenter study enrolling 16 patients eligible for treatment. The principal safety endpoint was a composite of cardiac death, myocardial infarction, and clinically indicated target lesion revascularization. The principal imaging endpoint was in-scaffold late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 6 months. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging was performed at baseline and 6 months; multislice computed tomography (MSCT) was performed at 12 months.. Acute procedural success was achieved in 15 of 15 patients receiving a study scaffold. At 12 months, there was no scaffold thrombosis and no major adverse cardiac events directly attributable to the scaffold. At 6 months, in-scaffold LLL (by QCA) was 0.19 ± 0.19 mm; neointimal volume (by IVUS) was 7.19 ± 3.56%, with no evidence of scaffold recoil or late malapposition. Findings were confirmed with OCT and showed uniform, thin neointimal coverage (0.12 ± 0.04 mm). At 12 months, MSCT demonstrated excellent vessel patency.. This study demonstrated the feasibility and efficacy of the DESolve BCS. Results showing low in-scaffold LLL, low % neointimal volume at 6 months, no chronic recoil, and maintenance of lumen patency at 12 months prompt further study. (DESolve First-in-Man; EudraCT number 2011-000027-32).

Topics: Absorbable Implants; Aged; Aged, 80 and over; Belgium; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Lactic Acid; Male; Materials Testing; Models, Cardiovascular; Multidetector Computed Tomography; Multimodal Imaging; Myocardial Infarction; Neointima; New Zealand; Percutaneous Coronary Intervention; Polyesters; Polymers; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Time Factors; Tissue Scaffolds; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

The Cobra-P drug-eluting stent (DES) system consists of cobalt chromium alloy with bio-absorbable siloxane sol-gel matrix coating that elutes low dose paclitaxel within 6 months. The aim of this first-in-man trial was to evaluate the safety and performance of 2 doses of the Cobra-P DES.. A total of 60 lesions (54 patients) were sequentially assigned to 2 different paclitaxel doses: group A (3.7 μg/18mm, n=30) or group B (8 μg/18mm, n=30). The primary endpoint was MACE at 4 months defined as cardiac death, myocardial infarction, and target lesion revascularization.. Patient and lesion characteristics were matched between the 2 groups except for male sex. MACE at 4 months was 3.3% and 0% respectively (P=1.000) and at 1-year follow-up remained unchanged. In-stent late loss at 4 months was similar in both groups (0.36 ± 0.30mm and 0.34 ± 0.20mm P=.773).. In this FIM study, implantation of the Cobra-P low dose paclitaxel-eluting stent with a bioabsorbable sol-gel coating was proven to be feasible and safe. Moderate neointimal proliferation was observed as well as an acceptable MACE rate up to 1 year.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Cell Proliferation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Male; Middle Aged; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Time Factors; Treatment Outcome

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

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

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

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

The intention of the PEPCAD China ISR (A Prospective, Multicenter, Randomized Trial of Paclitaxel-Coated versus Paclitaxel-Eluting Stent for the Treatment of Drug-Eluting Stent In-Stent Restenosis) was to demonstrate the efficacy of paclitaxel-coated balloon (PCB) angioplasty in a non-European patient population with coronary drug-eluting stent in-stent restenosis (DES-ISR).. The treatment of DES-ISR is still challenging with no established best strategy. Moreover, there is no study on the effect of PCB in the treatment of ISR in the Chinese population.. PEPCAD China ISR was a 220-patient randomized (1:1), single-blind prospective multicenter trial conducted in China. Patients with coronary DES-ISR received either PCB (SeQuent Please, B. Braun Melsungen AG, Melsungen, Germany) or paclitaxel-eluting stent (Taxus Liberté, Boston Scientific, Natick, Massachusetts) treatment. The primary endpoint was in-segment late lumen loss at 9 months.. There were no significant baseline differences between both treatment groups in terms of patient, lesion, or procedural characteristics. At 9 months, in-segment late lumen loss in the PCB group was noninferior to that of the paclitaxel-eluting stent group (0.46 ± 0.51 mm vs. 0.55 ± 0.61 mm; difference: -0.06 mm with 95% confidence interval: -0.23 to 0.10; p for noninferiority = 0.0005). The 9-month rate of binary restenosis and 12-month composite clinical event rates were not significantly different between groups.. In a randomized trial of 220 patients, angioplasty with a PCB was noninferior to paclitaxel-eluting stent implantation when used to treat DES-ISR. On the basis of these, as well as previous randomized trial data, PCB angioplasty offers an effective treatment for DES-ISR without the necessity of implanting additional metal layers for drug release. (A Safety and Efficacy Study of Paclitaxel-Eluting Balloon to Paclitaxel-Eluting Stent [PEPCAD]; NCT01622075).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; China; Coated Materials, Biocompatible; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Recurrence; Risk Factors; Single-Blind Method; Time Factors; Treatment Outcome; Vascular Access Devices

Concern exists relating to potential attenuated efficacy of limus-eluting stents in patients with diabetes mellitus. In this respect diabetic patients with sirolimus-eluting stent (SES) failure requiring reintervention may be expected to derive particular benefit from a treatment-switch to paclitaxel-eluting stent (PES) implantation.. The aim of the current report was to investigate outcomes of patients with SES restenosis randomized to treatment with SES (same stent strategy) or PES (switch stent strategy) in the pre-specified subgroups of patients with and without diabetes mellitus.. In the setting of ISAR-DESIRE 2 trial, 450 patients with clinically significant SES restenosis were randomly assigned to receive either SES or PES. The primary end point was in-stent late loss at 6-8month follow-up angiography. Secondary endpoints were binary angiographic restenosis (diameter stenosis >50%) and target lesion revascularization (TLR), the composite of death or myocardial infarction (MI) and definite stent thrombosis at 12months.. Of 450 patients enrolled, 162 (36.0%) had a diagnosis of diabetes mellitus. In patients with diabetes 86 patients were randomly assigned to SES versus 76 to PES. In patients without diabetes 139 were assigned to SES versus 149 to PES. Late loss was comparable between SES and PES both in patients with diabetes (0.38±0.59mm vs. 0.37±0.59mm; p=0.97) and without (0.41±0.67mm vs. 0.38±0.6mm; p=0.98; pinteraction=0.89). Similarly binary restenosis was comparable between SES and PES in patients with diabetes (19.0% vs. 26.0%; p=0.32) or without (18.9% vs. 17.8%; p=0.98; pinteraction=0.36). TLR, death or MI and definite stent thrombosis were also similar in SES versus PES treatment groups regardless of diabetes status.. In cases of SES-restenosis, treatment with either repeat SES or switch to PES was associated with a comparable degree of efficacy, regardless of diabetic status.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Diabetes Complications; Drug-Eluting Stents; Female; Germany; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Patient Selection; Percutaneous Coronary Intervention; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

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

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

Little is known about the respective healing responses and clinical efficacy and safety of drug-eluting balloons (DEB) and the second generation of drug-eluting stents (DES) when used to treat in-stent restenosis (ISR). In this study, we set out to compare prospectively the healing characteristics, as assessed by optical coherence tomography (OCT), of DEB versus DES after treatment of ISR in bare metal stents (BMS).. Fifty patients with BMS ISR were randomised to treatment with a paclitaxel-eluting balloon vs. an everolimus-eluting stent (EES). The primary endpoint was the percentage of uncovered struts, assessed with OCT at nine months, as a marker of vessel wall healing. A mean of 366±135 and 636±184 struts were analysed per patient in the DEB and EES groups, respectively. The percentage of uncovered struts per patient was significantly lower with DEB vs. EES (1.4% vs. 3.1%, p=0.025). Mean neointimal hyperplasia area was 2.4±1.08 mm in DEB vs. 1.92±0.67 mm in EES (p=0.1806), while the percentage of malapposed struts per patient was very low in both groups (0.2% vs. 0.3%, p=0.699). At nine months, angiographic in-stent MLD (minimum lumen diameter) was lower (2.13 vs. 2.54 mm, p=0.006), while diameter stenosis (26.4 vs. 11.4%, p=0.002), and LLL (0.28 vs. 0.07 mm, p=0.1) were higher after DEB compared to EES. During one-year follow-up, we did not observe differences in the rates of death, TLR (target lesion revascularisation) or stent thrombosis.. DEB appears to be associated with better healing characteristics, as assessed by stent strut coverage with OCT, but tended to be slightly less effective compared to EES. These findings give support to the use of either DEB or EES as valuable treatment options for ISR.. http://www.clinicaltrials.gov. Unique identifier: NCT 01065532.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Paclitaxel; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

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

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

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

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

Overlapping first generation sirolimus- and paclitaxel-eluting stents are associated with persistent inflammation, fibrin deposition and delayed endothelialisation in preclinical models, and adverse angiographic and clinical outcomes--including death and myocardial infarction (MI)--in clinical studies.. To establish as to whether there are any safety concerns with newer generation drug-eluting stents (DES).. Propensity score adjustment of baseline anatomical and clinical characteristics were used to compare clinical outcomes (Kaplan-Meier estimates) between patients implanted with overlapping DES (Resolute zotarolimus-eluting stent (R-ZES) or R-ZES/other DES) against no overlapping DES. Additionally, angiographic outcomes for overlapping R-ZES and everolimus-eluting stents were evaluated in the randomised RESOLUTE All-Comers Trial.. Patient level data from five controlled studies of the RESOLUTE Global Clinical Program evaluating the R-ZES were pooled. Enrollment criteria were generally unrestrictive.. 5130 patients.. 2-year clinical outcomes and 13-month angiographic outcomes.. 644 of 5130 patients (12.6%) in the RESOLUTE Global Clinical Program underwent overlapping DES implantation. Implantation of overlapping DES was associated with an increased frequency of MI and more complex/calcified lesion types at baseline. Adjusted in-hospital, 30-day and 2-year clinical outcomes indicated comparable cardiac death (2-year overlap vs non-overlap: 3.0% vs 2.1%, p=0.36), major adverse cardiac events (13.3% vs 10.7%, p=0.19), target-vessel MI (3.9% vs 3.4%, p=0.40), clinically driven target vessel revascularisation (7.7% vs 6.5%, p=0.32), and definite/probable stent thrombosis (1.4% vs 0.9%, p=0.28). 13-month adjusted angiographic outcomes were comparable between overlapping and non-overlapping DES.. Overlapping newer generation DES are safe and effective, with comparable angiographic and clinical outcomes--including repeat revascularisation--to non-overlapping DES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Risk Factors; Treatment Outcome

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

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

This study sought to compare the efficacy and safety results after coronary implantation of a combined sirolimus-eluting CD34 antibody coated Combo stent (OrbusNeich Medical, Ft. Lauderdale, Florida) with the paclitaxel-eluting Taxus Liberté stent (PES) (Boston Scientific, Natick, Massachusetts). This report summarizes the first-in-man randomized, controlled multicenter REMEDEE trial (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) angiographic, intravascular ultrasound, and clinical results up to 12 months.. Drug-eluting stents have limited restenosis and reintervention but are complicated by especially late and very late stent thrombosis and accelerated neoatherosclerosis. Alternative or adjunct technologies should address these limitations.. One hundred eighty-three patients with de novo native coronary artery stenoses were randomized 2:1 to Combo stent or PES implantation. The primary endpoint is the angiographic in-stent late lumen loss at 9 months, which was tested for noninferiority between the 2 stent groups. Secondary endpoints include the occurrence of major adverse cardiac events.. The Combo stent was found to be noninferior to the PES in 9-month angiographic in-stent late lumen loss with 0.39 ± 0.45 mm versus 0.44 ± 0.56 mm (pnoninferiority = 0.0012). At 12 months, the occurrence of major adverse cardiac events was 8.9% in the Combo group and 10.2% in the PES group (p = 0.80) with no difference in mortality, occurrence of myocardial infarction, or target lesion revascularization. No stent thrombosis was reported in either group.. In the REMEDEE trial the Combo stent has shown to be effective by meeting the primary noninferiority angiographic endpoint and safe, with an overall low rate of clinical events in both stent groups, including no stent thrombosis up to 12 months.

Topics: Aged; Antibodies; Antigens, CD34; Asia; Australia; Brazil; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Endothelial Cells; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Stem Cells; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The ZOMAXX I trial tested the noninferiority of a zotarolimus-eluting coronary stent (ZoMaxx(™) ) when compared with a paclitaxel-eluting coronary stent (Taxus(™) Express(2™) ) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. Angiographic analysis at the primary endpoint of 9 months has been reported previously. The purpose of this follow-on analysis was to describe the clinical results of the ZoMaxx and Taxus cohorts of the ZOMAXX I trial after 5 years.. In the ZOMAXX I trial, 199 patients received a ZoMaxx stent and 197 patients received a Taxus stent at 29 investigative sites in Europe, Australia, and New Zealand. The two groups were generally well matched with respect to both clinical and lesional characteristics, including the incidence of diabetes (ZoMaxx 22% vs. Taxus 26%; P = 0.29), reference vessel diameter (ZoMaxx 2.79 ± 0.43 mm vs. Taxus 2.81 ± 0.46 mm; P = 0.65), and lesion length (ZoMaxx 14.9 ± 5.7 mm vs. Taxus 14.6 ± 5.5; P = 0.61). Through 5 years of follow-up, a total of 21 patients had died, six patients had withdrawn, nine had been lost to follow-up, and 13 missed their 5-year visit, leaving a total of 347 patients for analysis (169 ZoMaxx and 178 Taxus). At the 5-year time point, there were no significant differences in any clinical metric including ischemia-driven target lesion revascularization (TLR; ZoMaxx 10.6% vs. Taxus 7.1%; P = 0.29), Q-wave myocardial infarction (ZoMaxx 1.5% vs. Taxus 1.0%; P = 0.99), definite/probable stent thrombosis (ZoMaxx 1.5% vs. Taxus 3.0%; P = 0.34), and cardiac death (ZoMaxx 3.0% vs. Taxus 1.0%; P = 0.28).. After 5 years, the differences in clinical outcome between patients treated with ZoMaxx vs. Taxus stents did not reach statistical significance. However, the nominally higher rate of ischemia-driven TLR (10.6 vs. 7.1%) and the previously reported higher rate of restenosis after 9 months suggest that the ZoMaxx stent afforded less neointimal inhibition when compared with Taxus. © 2013 Wiley Periodicals, Inc.

Topics: Aged; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Myocardial Infarction; Neointima; New Zealand; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

The aim of this study was to evaluate late safety and efficacy outcomes among patients enrolled in clinical trials comparing Endeavor zotarolimus-eluting stents (E-ZES) (Medtronic, Inc., Santa Rosa, California) with first-generation drug-eluting stents (DES) and bare-metal stents (BMS).. Despite demonstration of higher angiographic luminal loss and restenosis with E-ZES compared with alternative DES, whether differences in these early angiographic measures translate into more disparate late clinical events is uncertain.. Among 3,616 patients undergoing percutaneous coronary revascularization in 5 registration trials, late safety and efficacy events were compared between E-ZES (n = 2,132) versus sirolimus- or paclitaxel-eluting stents (n = 888) or BMS (n = 596).. Compared with a parallel cohort of patients treated with first-generation DES and BMS, 5-year rates of cardiac death/myocardial infarction (MI) (5.8% vs. 8.8% DES, p = 0.003; vs. 8.4% BMS, p = 0.02) and major adverse cardiac events (16.1% vs. 20.6% DES, p = 0.009; vs. 24.6% BMS, p < 0.001) were significantly lower with E-ZES. The E-ZES was associated with significantly lower target lesion revascularization (TLR) compared with BMS (7.4% vs. 16.3%, p < 0.001) but similar to comparator DES (7.4% vs. 8.1%, p = 0.63). Despite higher TLR in the first year with E-ZES compared with DES, between 1- and 5-year follow-up, rates of cardiac death/MI, TLR, and definite/probable stent thrombosis were significantly lower with E-ZES.. Over 5 years, significant differences in cardiac death/MI and composite endpoints favored treatment with E-ZES over comparator BMS and DES. Rates of clinical restenosis and safety events, including stent thrombosis beyond the first year of revascularization, remain stable with E-ZES, leading to significant differences compared with first-generation DES.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

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

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

Patients with diabetes mellitus remain at higher risk for adverse events following percutaneous coronary intervention and the identification of the optimum drug eluting stents (DES) in these patients is of high clinical relevance. We compared effectiveness of everolimus-eluting stents (EES; Xience) versus sirolimus-eluting stents (SES; Cypher) in patients with diabetes mellitus enrolled in the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) trial.. In the setting of the ISAR-TEST-4 trial, 1304 patients with broad inclusion criteria were randomized to treatment with EES or SES. The focus of the present analysis is on a cohort of 377 patients with diabetes mellitus assigned to receive EES (n = 184) or SES (n = 193). The primary endpoint was the composite of cardiac death, myocardial infarction (MI) related to the target vessel, or target lesion revascularization (TLR) at 3-year follow-up. Secondary endpoints were parameters of angiographic and clinical restenosis (in-stent late lumen loss, binary restenosis, and TLR), all-cause mortality and definite/probable stent thrombosis.. EES was comparable to SES concerning the incidence of the primary endpoint (21% vs. 24%, respectively; relative risk = 0.87; 95% CI, 0.57-1.34; P = 0.53). Concerning the secondary endpoint, TLR at 3 years with EES versus SES stents was not statistically different (14.7% vs. 16.6%, respectively; relative risk = 0.85; 95% CI, 0.51-1.43; P = 0.55). In terms of angiographic outcomes patients treated with EES as compared to SES had significantly lower late lumen loss (0.22 ± 0.46 mm vs. 0.44 ± 0.66 mm, respectively; P < 0.001) and binary restenosis (8.4% vs. 17%, respectively; P = 0.02) at 6- to 8-month angiographic follow-up. EES was comparable to SES concerning the incidence of all-cause death (10% vs. 16%, respectively; relative risk = 0.66; 95% CI, 0.37-1.18; P = 0.16) and stent thrombosis (1.1% vs. 3.1%, respectively; P = 0.19).. In patients with diabetes mellitus enrolled in a real-world randomized control trial, EES is comparable to SES in terms of clinical efficacy and safety out to 3 years; angiographic markers of antirestenotic efficacy favored EES.

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

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

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

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

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

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

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

This study aimed to evaluate the safety and efficacy of using the second-generation DIOR drug-coated balloons (DCB) as an adjunct to plain old balloon angioplasty (POBA) for the treatment of de novo coronary lesions.. Valentines II was designed as a prospective, multicentre, multinational, web-based registry. Eligible patients with stable or unstable angina, and/or documented ischaemia on stress testing with de novo lesions of >50% stenosis were prospectively enrolled. Patients underwent POBA followed by DCB treatment. In cases of suboptimal angiographic success (Thrombolysis In Myocardial Infarction [TIMI] flow <3 and/or residual stenosis of >30%), additional bail-out bare metal stenting (BMS) was left at the operator's discretion. The primary endpoint was major adverse cardiac events (MACE; all-cause death, myocardial infarction [MI], target vessel revascularisation [TVR] and vessel thrombosis) at six to nine months. A subset of patients underwent angiographic follow-up. One hundred and nine lesions in 103 patients were treated. Mean age was 62.6±10.2 years; 79.6% were men. Lesion stenosis at baseline and post treatment was 83.3±9.5% and 10.4±10.6%, respectively. Procedural success was 99%. Coronary dissections occurred in 14.7%, and bail-out BMS implantation was required in 13 patients (11.9%). Mean follow-up was 7.5 months; follow-up rate was 99%. Cumulative MACE at follow-up was 8.7%, with 1% all-cause death, 1% MI, 6.9% overall TVR, of which 2.9% were target lesion revascularisations, and no vessel thrombosis. Angiographic follow-up on a subset of patients (n=35) demonstrated late luminal loss of 0.38±0.39 mm for both the in-balloon and in-segment analyses.. The Valentines II trial demonstrates the feasibility of using a second-generation DIOR DCB as adjunct to POBA in de novo coronary lesions. This approach achieved high procedural success with acceptable rates of bail-out stenting and low MACE rates at mid-term follow-up, and offers an attractive alternative for revascularisation of patients who are unsuitable candidates for drug-eluting stents.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prospective Studies; Time Factors; Treatment Outcome

The one-year outcome of lesions in small coronary arteries by using a paclitaxel-iopromide-coated (3 µg/mm²) balloon catheter (DCB) has yielded good six-month angiographic and one-year clinical data. We now report the three-year clinical follow-up.. One hundred and twenty patients with >70% stenoses <22 mm in length in small coronary vessels (vessel diameter: 2.25-2.8 mm) were treated with the DCB. The primary endpoint was angiographic in-segment late lumen loss. The secondary endpoints encompassed all other angiographic and clinical data up to three years post intervention. In total 82/120 (68.3%) patients with a vessel diameter of 2.35±0.19 mm were treated with the DCB only, and 32/120 (26.7%) patients required additional bare metal stent (BMS) deployment. Both the 12- and 36-month major adverse cardiac event rates were 5/82 (6.1%) for DCB only and 12/32 (37.5%) for DCB+BMS, primarily due to the need for target lesion revascularisation in 4/82 (4.9%) patients and 9/32 (28.1%) (p<0.001) patients, respectively. Total MACE rate after 36 months was 18/120 (15%; intention-to-treat).. Treatment of small vessel coronary artery disease with a paclitaxel-iopromide-coated balloon exhibited good six-month angiographic and one-year clinical data that persisted during the three-year follow-up period. Randomised trials will clarify its role as an alternative to drug-eluting stents in the treatment of small vessel coronary artery disease. (ClinicalTrials.gov Identifier: NCT00404144).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Prosthesis Design; Time Factors; Treatment Outcome

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

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

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

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

The Orsiro Hybrid sirolimus-eluting stent is a newly developed third-generation drug-eluting stent, featuring a unique dual-polymer mix. An active bioabsorbable polymer delivers the anti-proliferative drug, sirolimus, via controlled release, while a passive biocompatible polymeric coating shields the metallic strut from surrounding tissue, preventing interaction. To date, the Orsiro Hybrid sirolimus-eluting stent has excelled in terms of late lumen loss at 9 months in a first-in-man single-arm trial. However, the efficacy and safety data for Orsiro Hybrid sirolimus-eluting stents in a broader population of all-comers are limited. The present study offers an angiographic and clinical comparison of the Orsiro Hybrid sirolimus-eluting stent and the Resolute Integrity zotarolimus-eluting stent in the treatment of patients with coronary artery disease.. The ORIENT trial is a multicenter, randomized, open-label, parallel-arm study designed to demonstrate the non-inferiority of the Orsiro Hybrid sirolimus-eluting stent relative to the Resolute Integrity zotarolimus-eluting stent. A total of 375 patients with a spectrum of coronary artery disease will undergo prospective, random assignment to a Orsiro Hybrid sirolimus-eluting stent or Resolute Integrity zotarolimus-eluting stent (2:1 ratio), for a primary endpoint of in-stent late lumen loss at 9 months by quantitative coronary angiography. Secondary 12-month clinical endpoints are death, target lesion revascularization, target vessel revascularization, myocardial infarction, stent thrombosis and target lesion failure (a composite of cardiac death, target lesion revascularization and target vessel-related myocardial infarction).. The ORIENT trial is the first study to date comparing the Orsiro Hybrid sirolimus-eluting stent with the Resolute Integrity zotarolimus-eluting stent for efficacy and safety in a population of all-comers with coronary artery disease.. Clinicaltrials.gov NCT01826552.

Topics: Cardiovascular Agents; Clinical Protocols; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Republic of Korea; Research Design; Sirolimus; Time Factors; Treatment Outcome

The aim of the study was to compare long-term follow-up results of crush versus culotte stent techniques in coronary bifurcation lesions.. The randomized Nordic Stent Technique Study showed similar 6-month clinical and 8-month angiographic results with the crush and culotte stent techniques of de novo coronary artery bifurcation lesions using sirolimus-eluting stents. Here, we report the 36-month efficacy and safety of the Nordic Stent Technique Study.. A total of 424 patients with a bifurcation lesion were randomized to stenting of both main vessel and side branch with the crush or the culotte technique and followed for 36 months. Major adverse cardiac events-the composite of cardiac death, myocardial infarction, stent thrombosis, or target vessel revascularization-were the primary endpoint.. Follow-up was complete for all patients. At 36 months, the rates of the primary endpoint were 20.6% versus 16.7% (p = 0.32), index lesion restenosis 11.5% versus 6.5% (p = 0.09), and definite stent thrombosis 1.4% versus 4.7% (p = 0.09) in the crush and the culotte groups, respectively.. At 36-month follow-up, the clinical outcomes were similar for patients with coronary bifurcation lesions treated with the culotte or the crush stent technique. (Nordic Bifurcation Study. How to Use Drug Eluting Stents [DES] in Bifurcation Lesions? NCT00376571).

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Finland; Humans; Latvia; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Scandinavian and Nordic Countries; Sirolimus; Time Factors; Treatment Outcome

To evaluate long-term patterns of luminal changes after implantation of different types of drug-eluting stents (DES), we analyzed the serial angiographic outcomes of patients implanted with zotarolimus-eluting stents (ZES), sirolimus-eluting stents (SES), or paclitaxel-eluting stents (PES).. Little is known regarding long-term luminal changes after DES implantation.. As a subgroup analysis of the ZEST trial, we performed complete angiographic evaluation immediately after the procedure and at 9 months and 2 years in 111 patients with 165 lesions (36 patients with ZES, 40 with SES, and 35 with PES).. Baseline clinical, angiographic, and procedural characteristics were similar among the three groups. Quantitative angiographic analysis revealed significant decreases in minimal luminal diameter 9 months after stent implantation in the ZES (from 2.71 ± 0.49 to 2.21 ± 0.42 mm, P < 0.001), SES (from 2.79 ± 0.49 to 2.58 ± 0.57 mm, P < 0.001), and PES (from 2.66 ± 0.45 to 2.19 ± 0.52 mm, P < 0.001) groups. However, significant late improvements with different degree in luminal diameter were observed between 9 months and 2 years in the ZES (from 2.21 ± 0.42 to 2.39 ± 0.58 mm, P = 0.001), SES (from 2.58 ± 0.57 to 2.66 ± 0.60 mm, P = 0.039), and PES (from 2.19 ± 0.52 to 2.43 ± 0.52 mm, P < 0.001) groups.. Serial angiographic follow-up study revealed a biphasic luminal response after DES implantation, characterized by an early progression phase for the first 9 months and a late regression phase from 9 months to 2 years.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Linear Models; Male; Middle Aged; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Republic of Korea; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

We sought to evaluate the efficacy and safety of paclitaxel-coated balloon plus bare-metal stenting (BMS) in chronic total occlusions (CTOs).. Drug-eluting stent implantation after recanalization of CTOs is limited by the occurrence of restenosis and risk for late stent thromboses.. In this prospective, bicenter trial we treated 48 patients after successful chronic total occlusion (CTO) recanalization in a native coronary artery with paclitaxel-coated balloon plus BMS. Patients were matched according to stent length, reference diameter, and diabetes mellitus with 48 patients treated with Taxus stent implantation. Dual antiplatelet therapy was prescribed for 6 months. Angiographic (clinical) follow-up was obtained after 6 (12) months. Primary endpoint was in-stent late lumen loss.. There was no difference in patient baseline characteristics or procedural results. Stent length was 59.7 ± 32.4 mm (16-151 mm) for paclitaxel-coated balloon plus BMS versus 56.2 ± 25.9 mm (16-132 mm) for Taxus stent. Late loss was statistically not different within the stent with 0.64 ± 0.69 mm versus 0.43 ± 0.64 mm (difference 0.20 mm, 95% confidence interval -0.07 to 0.47, P = 0.14) and at the occlusion site with 0.33 ± 0.69 mm versus 0.26 ± 0.70 mm, respectively. Restenosis rate was 27.7% compared with 20.8% (P = 0.44) and the combined clinical endpoint (cardiac death, myocardial infarction attributed to the target vessel, target lesion revascularization) was 14.6% versus 18.8% (P = 0.58), respectively.. In conclusion, for patients with complex CTOs in native coronary arteries the use of paclitaxel-coated balloon after bare-metal stenting was associated with similar clinical results and a nonsignificantly higher in-stent late loss compared with a matched population with paclitaxel-eluting stent implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Chi-Square Distribution; Chronic Disease; Coated Materials, Biocompatible; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug Therapy, Combination; Drug-Eluting Stents; Equipment Design; Female; Germany; Humans; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Stents; Time Factors; Treatment Outcome

Polymer-free sirolimus- and probucol-eluting stents (Real Dual drug-eluting stents [DES]) is as effective as first-generation DES in treating coronary artery stenosis. It is unknown whether sirolimus-eluting stents containing biodegradable polymer (Excel) would be superior to real Dual DES. This study aimed to investigate the difference in target vessel revascularization (TVR) at 12 months in patients with coronary artery disease treated by the implantation of Dual DES or Excel stents.. Three hundred and forty-six patients with de novo coronary artery disease were recruited from six centers in China and randomly assigned to either the Dual DES or the Excel group. The primary endpoint was the occurrence of TVR at 12 months. The secondary endpoint was angiographic in-stent restenosis and late lumen loss at 13 months. Stent thrombosis (ST) served as the safety endpoint. Dual anti-platelet therapy (DAPT) was prescribed for 6 months.. Clinical follow-up for 12 months and repeat angiography at 13 months were available in 100% and >90% of patients, respectively. The ISR and in-stent late loss were significantly different between the Excel (3.1%, 0.09 ± 0.11 mm) and the Dual DES (19.5%, 0.36 ± 0.32 mm, P < 0.001, P < 0.001, respectively) groups. The TVR (3.5%) in the Excel group was significantly less than in the Dual DES group (13.9%, P = 0.001). The ST rate beyond 12 months in the Dual DES group was 0%, and this was 1.2% in the Excel group (P = 0.499).. The Excel stent was statistically superior to the Dual DES in terms of restenosis, late loss, and TVR for long lesions.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Chi-Square Distribution; China; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Disease-Free Survival; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Probucol; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

This study sought to determine the effect of rotational atherectomy (RA) on drug-eluting stent (DES) effectiveness.. DES are frequently used in complex lesions, including calcified stenoses, which may challenge DES delivery, expansion, and effectiveness. RA can adequately modify calcified plaques and facilitate stent delivery and expansion. Its impact on DES effectiveness is widely unknown.. The ROTAXUS (Rotational Atherectomy Prior to TAXUS Stent Treatment for Complex Native Coronary Artery Disease) study randomly assigned 240 patients with complex calcified native coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120, standard therapy group). Stenting was performed using a polymer-based slow-release paclitaxel-eluting stent. The primary endpoint was in-stent late lumen loss at 9 months. Secondary endpoints included angiographic and strategy success, binary restenosis, definite stent thrombosis, and major adverse cardiac events at 9 months.. Despite similar baseline characteristics, significantly more patients in the standard therapy group were crossed over (12.5% vs. 4.2%, p = 0.02), resulting in higher strategy success in the rotablation group (92.5% vs. 83.3%, p = 0.03). At 9 months, in-stent late lumen loss was higher in the rotablation group (0.44 ± 0.58 vs. 0.31 ± 0.52, p = 0.04), despite an initially higher acute lumen gain (1.56 ± 0.43 vs. 1.44 ± 0.49 mm, p = 0.01). In-stent binary restenosis (11.4% vs. 10.6%, p = 0.71), target lesion revascularization (11.7% vs. 12.5%, p = 0.84), definite stent thrombosis (0.8% vs. 0%, p = 1.0), and major adverse cardiac events (24.2% vs. 28.3%, p = 0.46) were similar in both groups.. Routine lesion preparation using RA did not reduce late lumen loss of DES at 9 months. Balloon dilation with only provisional rotablation remains the default strategy for complex calcified lesions before DES implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Time Factors; Treatment Outcome; Vascular Calcification

The present study was designed to examine the five-year angiographic follow-up of MACE-free patients enrolled in the PRISON II study.. In the PRISON II study a total of 200 patients were randomised to either bare metal stents (BMS) or sirolimus-eluting stents (SES) after successful recanalisation of total coronary occlusions (TCO). Patients free of MACE with available angiography at six months were approached for repeated angiography at five years. The primary endpoint was in-stent very late luminal loss (VLLL) at five years. The secondary endpoint was additional late luminal loss (ALLL) between six months and five years. At five years, repeated angiography was performed in 72 patients, 50/82 (61%) in the SES group and 22/58 (38%) in the BMS group. In-stent VLLL was lower in the SES group (0.19 mm ± 0.72 vs. 0.51 mm ± 0.71, p=0.09) compared to the BMS group and in-segment VLLL was comparable in both groups (0.01 mm±0.58 vs. 0.03 mm ± 0.73, p=0.89). Late catch-up in lumen diameter was observed in the SES group with a trend towards increased ALLL compared to the BMS group (in-stent, 0.35 mm ± 0.88 vs. 0.04 mm ± 0.81, p=0.16; in-segment, 0.20 mm ± 0.74 vs. -0.05 mm ± 0.73, p=0.19).. At five-year angiographic follow-up, late catch-up was observed after successful recanalisation of TCOs treated with SES. Despite a late catch-up, the angiographic results of SES were superior in-stent and similar in-segment compared to BMS.

Topics: Adult; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Metals; Middle Aged; Netherlands; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome

The use of a drug-eluting balloon for the treatment of de novo coronary artery lesions remains to be evaluated. A previous trial in patients with stable and unstable angina comparing a bare metal stent mounted on a drug-eluting balloon with a sirolimus-eluting stent failed to meet the prespecified non-inferiority criteria versus the sirolimus-eluting stent. The stent struts of a bare metal stent pre-mounted on a drug-eluting balloon may prevent the appropriate delivery of drugs to the vessel wall and may result in reduced efficacy. In the present study we will therefore evaluate the efficacy of a drug-eluting balloon for treating de novo coronary artery lesions using a strategy designed to uniformly deliver drug to the vessel with a bare metal stent.. The Comparison of Drug-Eluting Balloon first study is a prospective, randomized, open-label trial designed to demonstrate the non-inferiority of first using a drug-eluting balloon (Sequent please; B. Braun, Melsungen, Germany) followed by a bare metal stent (Coroflex Blue; B. Braun) compared with using a drug-eluting stent (Resolute Integrity; Boston Scientific, Natick, MA, USA) for de novo coronary artery lesions. The primary endpoint of the study is in-segment late loss at 9 months measured by quantitative coronary angiography. Secondary endpoints include angiographic findings such as angiographic success, device success, binary angiographic restenosis, and clinical outcomes such as procedural success, all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization, and stent thrombosis. A total of 180 patients will be enrolled in the study.. The Comparison of Drug-Eluting Balloon first study will evaluate the clinical efficacy, angiographic outcomes and safety of a drug-eluting balloon first followed by a bare metal stent compared with a drug-eluting stent for the treatment of de novo coronary artery lesions.. Clinical Trials.gov: NCT01539603.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Protocols; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Metals; Myocardial Infarction; Prospective Studies; Prosthesis Design; Republic of Korea; Research Design; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The aim of this randomized-controlled trial is to compare biolimus A9-eluting stent (Nobori) to sirolimus eluting stent (Cypher).. The Nobori coronary stent is coated only abluminally with a biodegradable polymer, poly-lactic acid, and the antiproliferative agent biolimus A9. This stent has been studied in randomized trials versus Taxus Express and Taxus Liberte and showed noninferiority and superiority for in-stent late loss. This is the first randomized trial of Nobori stent versus Cypher stent.. We conducted a randomized (3:2), controlled trial comparing Nobori and Cypher, in 335 patients (198 Nobori and 137 Cypher) at 15 centers in Japan. Patients with de-novo lesions in up to two native coronary arteries were considered for enrollment. The primary endpoint was freedom from target vessel failure (TVF), a composite of cardiac death, myocardial infarction, and target vessel revascularization at 9 months.. At 9 months, the primary endpoint of freedom from TVF was 92.6% in Nobori and 93.8% in Cypher arm (noninferiority test P < 0.001). As main secondary endpoints, the in-stent late loss was 0.12 ± 0.30 mm and 0.14 ± 0.34 mm in Nobori and Cypher stents, respectively. Target lesion revascularization was 0.5% in Nobori and 3.9% in Cypher treated patients (P = 0.04). Definite and probable stent thromboses were not recorded in any patient.. Despite the relatively small number of patients, this well controlled clinical trial confirmed the primary hypothesis of non-inferiority of the Nobori biolimus A9-eluting stent to the Cypher sirolimus-eluting stent for freedom from TVF. Both stents showed excellent midterm results.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Japan; Lactic Acid; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polyesters; Polymers; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

The Oral Rapamycin in ARgentina (ORAR) III trial is a randomized study comparing a strategy of oral rapamycin (OR) plus bare-metal stent (BMS) versus a strategy of drug-eluting stents (DES) in patients with de novo coronary lesions. The purpose of this study was to assess the 3 years cost-effectiveness outcome of each strategy.. OR after BMS has been associated with reduction of target vessel revascularization (TVR) although its value in long-term efficacy in comparison with DES is unknown.. In three hospitals in Buenos Aires, Argentina, 200 patients were randomized to OR plus BMS (n = 100) or DES (n = 100). Primary objectives were costs and effectiveness. Cost analysis included in-hospital and follow-up costs. Safety was defined as the composite of death, myocardial infarction (MI), and stroke. Efficacy was defined as TVR.. Baseline characteristics between groups were similar. The 3-year follow-up rate was 99%. Cardiac mortality was 2% and 5% in OR group and DES group, respectively (P = 0.44). The composite of death, MI and stroke rate was 11% in OR group and 20% in DES group (P = 0.078). TVR rate was 14.5% in OR group and 17.6% in DES group (P = 0.50), respectively. Three year cumulative costs were significantly lower in the OR arm as compared to the DES arm (P = 0.0001) and DES strategy did not result cost-effective according to the non-inferiority test.. At 3 years follow-up, there were no differences in effectiveness between the two strategies, and DES strategy was not more cost-effective as compared to OR plus BMS.

Topics: Administration, Oral; Aged; Argentina; Cardiovascular Agents; Chi-Square Distribution; Combined Modality Therapy; Coronary Artery Disease; Coronary Restenosis; Cost Savings; Cost-Benefit Analysis; Drug Costs; Drug-Eluting Stents; Female; Health Care Costs; Hospital Costs; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Stroke; Time Factors; Treatment Outcome

To compare the safety and efficacy of the new Coroflex™ Please stents with conventional Taxus™ Liberte stents in patients with coronary artery lesions.. The Coroflex™ Please stent is a new version of paclitaxel-eluting stent, and observational cohort studies have reported similar angiographic and clinical outcomes as with the first-generation stents. However, it has not been directly compared with the early generation paclitaxel-eluting stents in a multicenter, prospective, and randomized study.. We randomly assigned 319 patients to receive Coroflex™ Please stents (159 patients; 198 lesions) or Taxus™ Liberte stents (160 patients; 232 lesions). The primary end point was angiographic in-segment late luminal loss at 9 months.. Most baseline clinical and angiographic characteristics were similar between these two groups. The Coroflex™ Please and Taxus™ Liberte stents showed similar in-segment late loss (0.40 ± 0.53 mm vs. 0.39 ± 0.52 mm, P = 0.98) and rates of in-segment binary restenosis (22.2% vs. 18.8%, P = 0.48) at 9 months. After clinical follow-up for 12 months, the two groups had similar rates of death (1.3% vs. 1.3%, P > 0.99), myocardial infarction (3.8% vs. 7.5%, P = 0.22), stent thrombosis (2.5% vs. 1.9%, P = 0.72), and target-lesion revascularization (7.5% vs. 7.5%, P = 0.99).. The Coroflex™ Please stent resulted in similar angiographic and clinical outcomes as the Taxus™ Liberte stent in patients with coronary artery lesions.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Republic of Korea; Single-Blind Method; Time Factors; Treatment Outcome

The SPIRIT Small Vessel (SV) was designed to evaluate the safety and effectiveness of the 2.25-mm XIENCE V everolimus eluting coronary stent system (EECSS), known as the XIENCE nano EECSS, in subjects with SVs and ischemic heart disease.. The core sizes of XIENCE V EECSS are associated with low rates of restenosis and thrombosis in the general population, but the XIENCE nano EECSS has not been tested in the United States.. This prospective, single-arm, open-label study was conducted at 33 centers and in 150 patients in the United States. The primary endpoint was the target lesion failure (TLF) rate at 1 year, required to meet the prespecified performance goal (PG) of 20.4%, derived from historical data.. The mean patient age was 63 years, 38% were women, 39.2% were diabetic, 49.3% had multivessel disease, and the reference vessel diameter was 2.13 ± 0.23 mm. The 1-year TLF rate was 8.1% in with an upper limit of the one-sided 95% confidence interval of 13.0%, which met the PG of 20.4% (P < 0.0001). At 1 year, the rate of cardiac death was 1.5%, the target vessel myocardial infarction rate was 1.5%, and clinically indicated target lesion revascularization rate was 5.1%. The 8-month angiographic in-stent late loss was 0.2 ± 0.4 mm, respectively. The 1-year academic research consortium defined definite/probable stent thrombosis rate was 1.5%.. Based on the 1-year clinical and 8-month angiographic SPIRIT SV data, the XIENCE nano EECSS is considered safe and effective in the treatment of SVs.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Nanomedicine; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; United States

Limited data are available regarding the direct comparison of angiographic and clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) for chronic total occlusion (CTO).. A prospective, randomized, multicenter trial was conducted to evaluate the non-inferiority of a zotarolimus-eluting stent (ZES; Endeavor Sprint®, n=80) to a sirolimus-eluting stent (SES; Cypher®, n=80) in patients with CTO lesion with a reference vessel diameter ≥ 2.5mm. The primary endpoint was in-segment binary restenosis rate at 9-month angiographic follow-up. Key secondary endpoints included target vessel failure (TVF; including cardiac death, myocardial infarction, and target vessel revascularization) and Academic Research Consortium-defined definite/probable stent thrombosis (ST) within 12 months. The ZES was non-inferior to the SES with respect to the primary endpoint, which occurred in 14.1% (95% confidence interval [CI]: 6.0-22.2) and in 13.7% (95%CI: 5.8-21.6) of patients, respectively (non-inferiority margin, 15.0%; P for non-inferiority <0.001). There were no significant between-group differences in the rate of TVF (10.0% vs. 17.5%; P=0.168) nor in the rate of ST (0.0% vs. 1.3%; P=0.316) during the 12-month clinical follow-up.. The effectiveness and safety of ZES are similar to those of SES and therefore it is a good treatment option in patients undergoing PCI for CTO with DESs.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Republic of Korea; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Drug-eluting stents (DES) have reduced the rate of restenosis but recent studies have raised concern over the risk of late stent thrombosis (LST). Incomplete stent endothelialization and delayed vascular healing have been associated with LST. The titanium-nitride-oxide coated bio-active stent (BAS) has shown promising results in patients with acute coronary syndromes, but there is little long-term optical coherence tomography (OCT) data comparing BAS with DES. The TITAX-AMI trial is a prospective, randomized, multicenter trial comparing BAS to paclitaxel-eluting stent (PES) in 425 patients with acute myocardial infarction. A total of 18 patients (9 per group) with no major cardiac events during follow-up, were enrolled in this substudy >36 months (mean 47 months) after stent implantation. Quantitative coronary angiography was performed and stent strut endothelialization and vascular healing were assessed with OCT. The binary stent strut coverage was significantly higher in the BAS group compared with the PES group (99.6 vs. 89.2%, p < 0.001) and there were less malapposed struts in the BAS group (0.2 vs. 13.8%, respectively, p < 0.001). The neointimal hyperplasia (NIH) thickness (266 ± 166 vs. 126 μm ± 126 μm, p < 0.001) and percentage of NIH area (26.2 vs. 7.6%, p < 0.001) were greater in the BAS group than in the PES group. Late incomplete endothelialization was not uncommon after PES implantation. Stents in the BAS group were completely endothelialized. This difference may contribute to the more common LST after PES implantation in the TITAX-AMI trial.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Endothelial Cells; Female; Humans; Hyperplasia; Male; Middle Aged; Myocardial Infarction; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Stents; Time Factors; Titanium; Tomography, Optical Coherence; Treatment Outcome

Percutaneous treatment of coronary bifurcation lesions remains hampered by suboptimal results, mainly in the side branch (SB), even with the use of drug-eluting stents (DES). Paclitaxel drug-eluting balloons (DEB) could provide an attractive alternative to treat bifurcations in combination with a provisional T-stenting technique in order to minimize SB restenosis. We compared angiographic and clinical outcomes of a provisional T-stenting technique with a DEB plus bare-metal stent (BMS) versus BMS versus paclitaxel DES.. In this randomized, international, multicenter, single-blinded 3-arm study, 117 patients with coronary bifurcation lesions underwent treatment with: (A) DEB in both main branch (MB) and SB and BMS in MB; (B) BMS in MB and regular balloon angioplasty in SB; or (C) paclitaxel DES in MB and regular balloon in SB. All patients underwent provisional T-stenting with an identical stent platform in the MB. Paclitaxel was the drug for elution in groups A and C. The primary endpoint was 6-month angiographic late luminal loss. Secondary end points were 6-month binary restenosis and 12-month major adverse cardiac events (MACE: death, myocardial infarction, target vessel revascularization).. The procedure was successful in all cases. Late luminal loss, measured respectively in the proximal MB, distal MB and SB was 0.58 ± 0.65, 0.41 ± 0.60, and 0.19 ± 0.66 mm in group A; 0.60 ± 0.65, 0.49 ± 0.85, and 0.21 ± 0.57 mm in group B; and 0.13 ± 0.45, 0.19 ± 0.64, and 0.11 ± 0.43 mm in group C (P = 0.001). Binary restenosis rates per bifurcation and MACE rates were 24.2%, 28.6%, and 15% (P = 0.45) and 20%, 29.7%, and 17.5% (P = 0.40) in groups A, B, and C, respectively.. Pretreatment of both MB and SB with DEB failed to show angiographic and clinical superiority over conventional BMS, using a provisional T-stenting technique. Moreover DES showed superior angiographic results than DEB and BMS.

Topics: Aged; Analysis of Variance; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Europe; Feasibility Studies; Female; Humans; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Risk Factors; Single-Blind Method; Stents; Time Factors; Treatment Outcome

This study presents long-term clinical follow-up, including binary restenosis rate and major adverse cardiovascular events, of the PACCOCATH-ISR (Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons) I and II trial.. The PACCOCATH-ISR trial was a first-in-human study with a drug-coated balloon catheter and the first study for the treatment of coronary ISR with a drug-coated balloon. So, far no long-term follow-up data have been presented.. This study enrolled 108 patients in a randomized, double-blinded multicenter trial on the efficacy and safety of a paclitaxel-coated balloon (3 μg/mm(2) balloon surface; PACCOCATH [Bayer AG, Germany]) compared with an uncoated balloon. The main inclusion criteria were a diameter stenosis of ≥ 70% and <30-mm length with a vessel diameter of 2.5 to 3.5 mm. The primary endpoint was angiographic late lumen loss in-segment after 6 months. Combined antiplatelet therapy was continued only for 1 month followed by treatment with aspirin alone.. During a follow-up of 5.4 ± 1.2 years, the clinical event rate was significantly reduced in patients treated with the drug-coated balloon (major adverse cardiovascular events: 59.3% vs. 27.8%, p = 0.009), which was mainly driven by the reduction of target lesion revascularization from 38.9% to 9.3% (p = 0.004).. Treatment of coronary ISR with paclitaxel-coated balloon catheters is safe and persistently reduces repeat revascularization during long-term follow-up. The initial results were sustained over the 5-year period. (Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons [PACCOCATH ISR I]; NCT00106587. Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons [PACCOCATH ISR II]; NCT00409981).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Catheters; Chi-Square Distribution; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Disease-Free Survival; Double-Blind Method; Drug Therapy, Combination; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Platelet Aggregation Inhibitors; Risk Assessment; Risk Factors; Severity of Illness Index; Time Factors; Treatment Outcome

Neointimal hyperplasia plays a pivotal role in the pathogenesis of in-stent restenosis in patients undergoing percutaneous coronary interventions. Drug-eluting balloons are a promising tool to prevent restenosis after coronary angioplasty. Moreover, an increased knowledge of the pathophysiology of restenosis my help improve therapeutic strategies.. We present the design of an open-label, randomized three-arm clinical trial aimed to assess whether a strategy of bare-metal stent implantation with additional use of drug-eluting balloons, either before (pre-dilation) or after stenting (post-dilation), reduces the primary endpoint of in-stent neointimal hyperplasia area as compared with a strategy of bare-metal stent implantation alone. This primary endpoint will be assessed by optical coherence tomography at follow-up. Secondary endpoints will be the percentage of uncovered struts, and the percentage of struts with incomplete apposition. An ancillary study investigating the relation between systemic levels of endothelial progenitors cells and neointimal hyperplasia, and the interaction between endothelial progenitors cell levels and drug-eluting balloons has been planned. Thirty consecutive patients undergoing percutaneous coronary intervention will be randomized with a 1:1:1 design to bare-metal stent implantation alone (n = 10); bare-metal stent implantation after pre-dilation with a drug-eluting balloon (n = 10); or bare-metal stent implantation followed by post-dilation with a drug-eluting balloon (n = 10). Six-month follow-up coronary angiography with optical coherence tomography imaging of the stented segment will be performed in all patients. Blood samples for the assessment of endothelial progenitors cell levels will be collected on admission and at 6 months.. Experimental and early clinical data showed that inhibition of neointimal hyperplasia may be obtained by local administration of antiproliferative drugs loaded on the surface of angioplasty balloons. The INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO) trial was conceived to test the superiority of a strategy of bare-metal stent implantation with additional drug-eluting balloon use (either before or after stenting) versus a strategy of bare-metal stent implantation alone for the reduction of neointimal hyperplasia. We also planned an ancillary study to assess the role of endothelial progenitors cells in the pathophysiology of neointimal hyperplasia.. Clinicaltrials.gov NCT01057563.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Catheters; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Endothelial Cells; Equipment Design; Humans; Hyperplasia; Italy; Metals; Neointima; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Research Design; Stem Cells; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Non-stent-based immediate release formulations of paclitaxel have been shown to reduce in-stent restenosis in animal experiments and clinical trials. In the porcine overstretch model paclitaxel dissolved in the contrast medium iopromide inhibited neointimal proliferation in a dose-dependent manner after intracoronary injection and was well tolerated.. As a first step entering clinical development, a phase I trial was performed using four ascending paclitaxel dose/concentration levels: samples of up to 100 mL of the contrast medium (iopromide) containing 10, 50, 100 or 200 µM paclitaxel or iopromide (controls) were randomly administered to patients assigned to bare metal stent implantation for single de novo coronary artery lesions. Safety variables, tolerability and angiographic parameters were assessed.. Adverse events, ECG, systolic and diastolic blood pressure, left ventricular ejection fraction, leukocyte count, other hematological or clinical chemistry data did not reveal any trend which could be related to the study medication. Short-lasting serum paclitaxel concentrations remained significantly below those known from cancer therapy. Angiographic late lumen loss was 0.72±0.50 mm (N.=7) in controls versus 0.45±0.65 mm (N.=17) in all paclitaxel-treated patients; binary restenosis rate was 5/7(63%) versus 6/17 (35%) and target lesion revascularization rate was 4/8 (50%) versus 4/24 (17%).. Intracoronary infusion of paclitaxel dissolved in an X-ray contrast medium was well tolerated. The results show restenosis inhibition, but the number of patients examined was too small to demonstrate a statistically significant inhibition.

Topics: Aged; Algorithms; Cardiac Catheterization; Cardiovascular Agents; Contrast Media; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Double-Blind Method; Female; Germany; Humans; Injections, Intra-Arterial; Iohexol; Male; Middle Aged; Paclitaxel; Pilot Projects; Recurrence; Stents; Treatment Outcome

 We compared the efficacy of the Cypher Select (Cordis Corporation, Bridgewater, NJ, USA) sirolimus-eluting stent (SES) versus balloon angioplasty (BA) in in-stent restenosis (ISR) of Taxus or Taxus Liberté paclitaxel-eluting stents (PES; Boston Scientific, Natick, MA, USA) or Cypher/Cypher Select SES.. Optimal treatment strategies have not been identified for drug-eluting stent (DES) ISR.. Patients with a native coronary artery SES or PES ISR were randomized to SES or BA. In addition, a control group included BMS ISR treated with SES. Angiographic control was performed at 12 months.. 281 patients were enrolled. Significant differences favoring SES over BA were noted in immediate and net gain (1.39 ± 0.51 vs. 0.97 ± 0.54 mm, P < 0.0001 and 1.07 ± 0.69 vs. 0.49 ± 0.67 mm, P < 0.0001), 12-month mean luminal diameter (MLD; 2.14 ± 0.62 vs. 1.71 ± 0.55 mm, P < 0.0001) and percent diameter stenosis (%DS; 21 ± 19.24 vs. 29.82 ± 18.47, P = 0.001). There was no significant difference at 12 months between SES and BA in the primary end-point late lumen loss (LLL; 0.37 ± 0.57 vs.0.41 ± 0.63, P = 0.73) and in in-stent binary restenosis (11.1% vs. 14%, P = 0.59). Target-lesion revascularization (TLR) was numerically lower in patients treated with SES (5.9% vs. 13.1%, P = 0.097). There was no difference according to the initial DES. In contrast, significantly higher immediate and net gains and MLD were noted in the BMS control group treated by SES.. In this angiographic randomized trial comparing SES and BA in SES or PES restenosis, 12 month MLD, immediate and net gain, and %DS favored SES whereas no difference was noted in LLL. Condensed abstract optimal treatment strategies have not been identified for sirolimus-(SES) or paclitaxel-eluting stent (PES) in-stent restenosis (ISR). We randomized patients with a native coronary artery SES or PES ISR to SES or BA. In addition, a control group included BMS ISR treated with SES. There was no difference in the primary end-point, late lumen loss (LLL) at 12 months between the SES and BA groups. However, follow-up MLD and immediate and net gain favored SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Paclitaxel; Sirolimus

Procedural and clinical outcomes still remain unfavorable for patients with long coronary lesions who undergo stent-based coronary interventions. Therefore, we compared the relative efficacy and safety of resolute zotarolimus-eluting stents (R-ZES) and sirolimus-eluting stents (SES) for patients with de novo long coronary lesions.. This randomized, multicenter, prospective trial, called the Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV (LONG-DES IV) trial, compared long R-ZES and SES in 500 patients with long (≥25 mm) native coronary lesions. The primary end point of the trial was in-segment late luminal loss at 9-month angiographic follow-up. The baseline characteristics were not different between R-ZES and SES groups, including lesion lengths (32.4±13.5 mm versus 31.0±13.5 mm, P=0.27). At 9-month angiographic follow-up, the R-ZES was noninferior to the SES with respect to in-segment late luminal loss, the primary study end point (0.14±0.38 mm versus 0.12±0.43 mm, P for noninferiority=0.03, P for superiority=0.68). In addition, in-stent late luminal loss (0.26±0.36 mm versus 0.24±0.42 mm, P=0.78) and the rates of in-segment (5.2% versus 7.2%, P=0.44) and in-stent (4.0% versus 6.0%, P=0.41) binary restenosis were not significantly different between the 2 groups. There were no significant between-group differences in the rate of adverse clinical events (death, myocardial infarction, stent thrombosis, target-lesion revascularization, and composite outcomes).. For patients with de novo long coronary artery disease, R-ZES implantation showed noninferior angiographic outcomes as compared with SES implantation.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186094.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Nonserial observations have shown this bioresorbable scaffold to have no signs of area reduction at 6 months and recovery of vasomotion at 1 year. Serial observations at 6 months and 2 years have to confirm the absence of late restenosis or unfavorable imaging outcomes.. The ABSORB trial is a multicenter single-arm trial assessing the safety and performance of an everolimus-eluting bioresorbable vascular scaffold. Forty-five patients underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography at 6 and 24 months of follow-up. From 6 to 24 months, late luminal loss increased from 0.16±0.18 to 0.27±0.20 mm on quantitative coronary angiography, with an increase in neointima of 0.68±0.43 mm(2) on optical coherence tomography and 0.17±0.26 mm(2) on intravascular ultrasound. Struts still recognizable on optical coherence tomography at 2 years showed 99% of neointimal coverage with optical and ultrasonic signs of bioresorption accompanied by increase in mean scaffold area compared with baseline (0.54±1.09 mm(2) on intravascular ultrasound, P=0.003 and 0.77±1.33 m(2) on optical coherence tomography, P=0.016). Two-year major adverse cardiac event rate was 6.8% without any scaffold thrombosis.. This serial analysis of the second generation of the everolimus-eluting bioresorbable vascular scaffold confirmed, at medium term, the safety and efficacy of the new device.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Diagnostic Imaging; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Male; Middle Aged; Neointima; New Zealand; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Tissue Scaffolds; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

The purpose of this study was to investigate the vascular response of the everolimus-eluting stent (EES) compared with the paclitaxel-eluting stent (PES) using serial intravascular ultrasound (IVUS).. Data were obtained from the SPIRIT III trial, a multicentre, 2:1 randomised, controlled study comparing EES and PES in de novo native coronary artery lesions. IVUS images were eligible for volumetric analysis at eight-month follow-up in 158 lesions (EES: 113, PES: 45). At eight months, EES had a smaller neointimal volume index (VI: mm3/mm) (EES: 0.4±0.4 vs. PES: 0.8±0.8 mm3/mm, p=0.002) and also a smaller % neointimal obstruction (EES: 7.1±6.7% vs. PES: 11.1±10.5%, p=0.005) compared with PES. While there was no significant change in vessel VI with EES, there was a significant increase in vessel VI in PES during eight-month follow-up (EES: 0.1±1.2 vs. PES: 1.2±0.8 mm3/mm, p=0.001). There were no statistical differences in the frequency of edge dissection or incomplete stent apposition between the two groups.. Detailed IVUS analysis confirmed significantly less neointimal hyperplasia with EES compared with PES. While there was no increase in vessel volume with EES during the eight-month follow-up period, vessel enlargement was seen at the stented segment in PES.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Hyperplasia; Japan; Male; Middle Aged; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Registries; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional; United States

This study sought to evaluate the safety and efficacy of the NOYA stent which is a cobalt chromium-based sirolimus-eluting stent (SES) with DL-polylactide biodegradable polymer (Medfavour Medical, Beijing, China) in treating de novo coronary artery lesions.. The NOYA I trial was designed to compare the NOYA stent with the FIREBIRD2™ stent, a durable polymer SES widely used in China (MicroPort Medical, Shanghai, China); the trial was a non-inferiority trial with a primary angiographic endpoint of the in-stent late lumen loss (LLL) at nine-month follow-up. The secondary endpoints were binary restenosis rates within nine months, major adverse cardiac events (MACE) defined as the composite of cardiac death, myocardial infarction (MI) or target lesion revascularisation (TLR), and definite/probable stent thrombosis (ST) at 24-month follow-up. A total of 300 patients (n=150 in each group) were enrolled in the study from 16 Chinese centres. The LLL in the NOYA group at nine-month follow-up was similar to the FIREBIRD2 group (0.11±0.18 mm vs. 0.14±0.23 mm, p=0.16; non-inferiority p<0.001). The rates of MACE, death, MI and TLR at 24-month follow-up were comparable between these two devices (p>0.05, respectively).. The biodegradable polymer NOYA stent was non-inferior to the FIREBIRD2 durable polymer stent with respect to the primary non-inferiority endpoint of in-stent LLL at nine-month follow-up. Clinical outcomes at 24-month follow-up were comparable between the two stents. (ClinicalTrials.gov number, NCT01226355).

Topics: Absorbable Implants; Aged; Analysis of Variance; Cardiovascular Agents; Chi-Square Distribution; China; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Polyesters; Predictive Value of Tests; Prosthesis Design; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

Percutaneous recanalization of total coronary occlusion (TCO) was historically hampered by high rates of restenosis and reocclusions. The PRISON II trial demonstrated a significant restenosis reduction in patients treated with sirolimus-eluting stents compared with bare metal stents for TCO. Similar reductions in restenosis were observed with the second-generation zotarolimus-eluting stent and everolimus-eluting stent. Despite favorable anti-restenotic efficacy, safety concerns evolved after identifying an increased rate of very late stent thrombosis (VLST) with drug-eluting stents (DES) for the treatment of TCO. Late malapposition caused by hypersensitivity reactions and chronic inflammation was suggested as a probable cause of these VLST. New DES with bioresorbable polymer coatings were developed to address these safety concerns. No randomized trials have evaluated the efficacy and safety of the new-generation DES with bioresorbable polymers in patients treated for TCO.. The prospective, randomized, single-blinded, multicenter, non-inferiority PRISON IV trial was designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (Orsiro; Biotronik, Berlin, Germany) compared with everolimus-eluting stents with durable polymers (Xience Prime/Xpedition; Abbott Vascular, Santa Clara, CA, USA) in patients with successfully recanalized TCOs. In total, 330 patients have been randomly allocated to each treatment arm. Patients are eligible with estimated duration of TCO ≥4 weeks with evidence of ischemia in the supply area of the TCO. The primary endpoint is in-segment late luminal loss at 9-month follow-up angiography. Secondary angiographic endpoints include in-stent late luminal loss, minimal luminal diameter, percentage of diameter stenosis, in-stent and in-segment binary restenosis and reocclusions at 9-month follow-up. Additionally, optical coherence tomography is performed in the first 60 randomized patients at 9 months to assess neointima thickness, percentage of neointima coverage, and stent strut malapposition and coverage. Personnel blinded to the allocated treatment will review all angiographic and optical coherence assessments. Secondary clinical endpoints include major adverse cardiac events, clinically driven target vessel revascularization, target vessel failure and stent thrombosis to 5-year clinical follow-up. An independent clinical event committee blinded to the allocated treatment will review all clinical events.. Clinical Trials.gov: NCT01516723. Patient recruitment started in February 2012.

Topics: Angioplasty, Balloon, Coronary; Belgium; Cardiovascular Agents; Clinical Protocols; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Humans; Neointima; Netherlands; Polymers; Prospective Studies; Prosthesis Design; Research Design; Single-Blind Method; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The aim of this study was the comparison of a new double-coated paclitaxel-eluting coronary stent with bare-metal stent (BMS) in patients undergoing percutaneous coronary intervention.. Stent coating with biodegradable polymers as a platform for elution of drugs has the potential for complete elution of drugs and for decreasing the risk of late complications.. Multicenter randomized trial comparing a paclitaxel-eluting stent (PES) coated with a biodegradable polymer and glycocalyx with the equivalent BMS. We randomly assigned 422 patients with de novo coronary lesions to PES (211 patients) or to BMS (211 patients). Primary end point was target vessel failure (TVF) defined as cardiac death, myocardial infarction, and target vessel revascularization. Clinical secondary end points were target vessel revascularization, target lesion revascularization, stent thrombosis (ST), and major adverse cardiovascular events (MACE). Angiographic secondary end points were late loss and binary restenosis.. At 1 year of follow-up, TVF rate was 9.5% in the PES group and 17.1% in the BMS group (P=0.02), and MACE rate was 10% in PES and 19% in BMS arm (P=0.009). All other secondary end points were reached but ST. ST rate was low and similar in both study arms.. The study shows that patients treated with PES with dual coating technology had significantly lower incidence of TVF and MACE than those treated with BMS design; however, longer follow-up should be necessary to assess true advantages of this technology compared with the previous one.

Topics: Aged; Angioplasty, Balloon, Coronary; Argentina; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Glycocalyx; Humans; Kaplan-Meier Estimate; Lactic Acid; Logistic Models; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Polyglycolic Acid; Polylactic Acid-Polyglycolic Acid Copolymer; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Stents; Thrombosis; Time Factors; Treatment Outcome

The aims of this study were to identify the efficacy of optimal stent expansion (OSE) according to the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study) criteria in drug-eluting stent (DES) and compare paclitaxel-eluting stent (PES) to sirolimus-eluting stent (SES).. Although poststent high-pressure balloon dilatation is proposed after bare metal stent implantation according to OSE, defined by the criteria of the MUSIC Study, very little data are available in DES.. Two hundred fifty patients (M:F = 149:101; age, 61.5 ± 9.2 years) who underwent 9-month follow-up angiography in the Poststent Optimal Stent Expansion Trial (POET) were included in this study. We assessed angiographic in-stent restenosis (ISR) and neointima volume (NV) using IVUS at 9 months.. At 9-month follow up, there were no significant differences in ISR and NV index (NV/stent length, mm(2) ) between patients with and without OSE. However, the rate of ISR and NV index were higher in PES [ISR: 18 (13.7%) and 4 (3.4%), P = 0.004; NV index: 1.02 ± 0.99 mm(2) and 0.21 ± 0.37, P < 0.001 in PES and SES].. OSE according to the MUSIC Study criteria was not related to ISR and NV in the DES era but PES had a significantly higher ISR rate and NV than SES after poststent high-pressure balloon dilatation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Odds Ratio; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Recent trials with different designs indicated that drug-eluting stents may be superior to vascular brachytherapy (VBT) for the treatment of in-stent restenosis (ISR). We performed a randomised, double-centre, clinical, quantitative coronary angiographic (QCA) and intravascular ultrasound (IVUS) acute and 3-years comparison of 90Sr/90Y-VBT and sirolimus-eluting stent implantation (SES) for ISR.. Ninety-one (91) consecutive patients were included. By QCA, SES led to a higher acute gain (2.08 ± 0.41 mm vs. 1.54 ± 0.70 mm, p < 0.0001), higher postprocedural minimum lumen diameter (2.76 ± 0.39 mm vs. 2.39 ± 0.52 mm; p < 0.0001), lower late lumen loss at follow-up (0.09 ± 0.29 vs. 0.39 ± 0.79 mm, p = 0.042), and a higher net lumen gain of the target lesion (2.05 ± 0.51 vs 1.18 ± 1.08 mm, p < 0.0001). By IVUS, the smaller acute gain following VBT was the result of residual intima hyperplasia, the intima hyperplasia formation following SES was extremely low, and the edge-effect was virtually absent after SES, respectively. At 6-month follow-up, both the angiographic restenosis rate (4.7 vs. 22.7%; p < 0.0001) and target lesion revascularisation rate (2.3 vs. 10.4%; p = 0.025) were lower in SES. Importantly, SES showed a stable clinical course at 3-year follow-up while VBT was associated with a sustained incidence of target vessel failure (11.6 vs. 46.7%; p < 0.0001).. SES for ISR is associated with superior QCA, IVUS and clinical results at 6-month and 3-year of follow-up when compared with VBT.

Topics: Aged; Angioplasty, Balloon, Coronary; Brachytherapy; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Strontium Radioisotopes; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Yttrium Radioisotopes

The aim of this study was to investigate the efficacy of a paclitaxel-eluting balloon (PEB) for the treatment of sirolimus-eluting stent (SES) restenosis.. Because drug-eluting stents (DES) are being used in increasingly complicated settings, DES restenosis is no longer an uncommon phenomenon, and its optimal treatment is unknown.. This study was a prospective single-blind randomized trial conducted in 50 patients with SES restenosis. Patients were randomly assigned to a PEB group (n = 25) or a conventional balloon angioplasty (BA) group (n = 25). The primary end point was late lumen loss at 6-month follow-up. Secondary end points included the rate of binary restenosis (in-segment analysis) and major adverse cardiac events (MACE) at 6-month follow-up.. At 6-month angiographic follow-up (follow-up rate: 94%), in-segment late lumen loss was lower in the PEB group than in the BA group (0.18 ± 0.45 mm vs. 0.72 ± 0.55 mm; p = 0.001). The incidence of recurrent restenosis (8.7% vs. 62.5%; p = 0.0001) and target lesion revascularization (4.3% vs. 41.7%; p = 0.003) was also lower in the PEB group than in the BA group. The cumulative MACE-free survival was significantly better in the PEB group than in the BA group (96% vs. 60%; p = 0.005).. In patients with SES restenosis, PEB provided much better clinical, angiographic outcomes than conventional BA.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Prospective Studies; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome

In the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) trial, we demonstrated the noninferiority of biodegradable polymer (BP) sirolimus-eluting stent to permanent polymer (PP) sirolimus/everolimus-eluting stent (Cypher/Xience-V) on the basis of clinical outcomes. In this study, we compare the antirestenotic efficacy of these stents in ISAR-TEST-4 patients with paired angiographic studies.. Patients with de novo coronary lesions in native vessels (excluding left main lesions) were randomly assigned to receive a BP stent or a PP stent. Endpoints of interest of this study were in-stent late lumen loss, in-segment binary restenosis, and restenosis morphology at 6-8-month follow-up angiogram.. Of the 2,603 patients (3,372 lesions) enrolled in ISAR TEST-4 trial, 2,016 patients (2,637 lesions) underwent repeat angiographic examination 6-8 months after randomization: 1,006 patients (1,323 lesions) treated with BP stents and 1,010 patients (1,314 lesions) treated with PP stents. No difference was observed between BP and PP stents in in-stent late lumen loss (0.24 ± 0.6 vs. 0.26 ± 0.5 mm, respectively, P = 0.49) or in in-segment binary restenosis (11.6% [153 lesions] vs. 11.8% [155 lesions], P = 0.85). Focal pattern of restenosis was observed in the majority of patients receiving either BP or PP stents. The diffuse pattern of restenosis was observed in 26.8% of patients treated with BP stent and 26.5% of patients treated with PP stent (P = 0.79).. Angiographic characteristics of restenosis after BP-based limus-eluting stents are similar to those of PP-based limus-eluting stents.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Polymers; Predictive Value of Tests; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Drug eluting stent (DES) use has improved clinical outcome after percutaneous coronary interventions. However, DES-treated patients may have a higher risk of stent thrombosis, mainly due to uncorrect stent deployment or lack of reendothelialization. Thus, the availabilily of different approaches with comparable efficacy to DES, but higher safety, especially in bleeding-prone patients, have to be investigated.. The EREMUS is a multicenter open-label prospective randomized three-arm clinical trial that will investigate the efficacy of a paclitaxel coated balloon + an endothelial progenitor capture stent for the treatment of native coronary lesions, and compare it to a DES strategy, or the sole endothelial progenitor capture stent. An angiographic follow-up with optical coherence tomography analysis will be scheduled 9 months after index procedure. Noninferiority regarding the primary endpoint (late luminal loss) between study group and DES is hypothesized. All patients will undergo clinical follow-up until 24 months from index hospitalization.. The EREMUS trial will determine whether a composite approach with a paclitaxel coated balloon + an endothelial progenitor capture stent in coronary lesions at medium-to-high risk of restenosis will achieve similar results compared to DES regarding inhibition of intrastent proliferation; complete stent strut reendothelialization, a safety issue, will also be investigated.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Endothelial Cells; Humans; Italy; Paclitaxel; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Research Design; Risk Assessment; Stem Cells; Time Factors; Tomography, Optical Coherence; Treatment Outcome

This study assessed the ability of the SYNTAX score (SXscore) to stratify risk in patients treated with percutaneous coronary intervention (PCI) using zotarolimus-eluting or everolimus-eluting stents.. The SXscore can identify patients treated with PCI who are at highest risk of adverse events.. The SXscore was calculated prospectively in 2,033 of the 2,292 patients enrolled in the RESOLUTE All Comers study (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention). Clinical outcomes in terms of a patient-oriented composite endpoint (POCE) of all-cause death, myocardial infarction (MI), and repeat revascularization; the individual components of POCE; target lesion failure (TLF) (a composite of cardiac death, target-vessel MI, and clinically driven target lesion revascularization); and stent thrombosis were subsequently stratified according to SXscore tertiles: SXscore(LOW) ≤ 9 (n = 698), 9 17 (n = 659).. At 12-month follow-up, rates of POCE, MI, repeat revascularization, TLF, and the composite of death/MI were all significantly higher in patients in the highest SXscore tercile. Rates of stent thrombosis were all highest in the SXscore(HIGH) tertile (p > 0.05). After multivariate adjustment, the SXscore was identified as an independent predictor of POCE, MI, repeat revascularization, and TLF (p < 0.05 for all). At 12-month follow-up, the SXscore, ACEF score, and Clinical SXscore had C-statistics of 0.57, 0.78, and 0.67, respectively, for mortality and of 0.62, 0.56, 0.63, respectively, for POCE. No significant between-stent differences were observed for TLF or POCE in any of the SXscore tertiles.. The SYNTAX score is able to stratify risk amongst an all-comers population treated with PCI with second-generation drug-eluting stents (DES); however, improvements can be made with the inclusion of clinical variables. (RESOLUTE III All Comers Trial: A Randomized Comparison of a Zotarolimus-Eluting Stent With an Everolimus-Eluting Stent for Percutaneous Coronary Intervention; NCT00617084).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Health Status Indicators; Humans; Israel; Kaplan-Meier Estimate; Linear Models; Male; Middle Aged; Myocardial Infarction; Predictive Value of Tests; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Survival Rate; Time Factors; Treatment Outcome

The objective of the study was to assess noninferiority of the polymer-free sirolimus-eluting Yukon Choice stent (Translumina GmbH, Hechingen, Germany) compared with the polymer-based Taxus Liberté stent (Boston Scientific, Natick, Massachusetts) with regard to the primary endpoint, in-stent late lumen loss, at 9 months in patients with diabetes mellitus.. The Yukon Choice stent has been evaluated in several randomized controlled trials before, albeit to date, there has been no trial that exclusively enrolled patients with diabetes mellitus.. Patients with diabetes mellitus undergoing percutaneous coronary intervention for clinically significant de novo coronary artery stenosis were randomized 1:1 to receive either the polymer-free sirolimus-eluting Yukon Choice stent or the polymer-based paclitaxel-eluting Taxus Liberté stent.. A total of 240 patients were randomized. Quantitative coronary angiography was available for 79% of patients. Mean in-stent late lumen loss was 0.63 ± 0.62 mm for the Yukon Choice stent and 0.45 ± 0.60 mm for the Taxus Liberté stent. Based on the pre-specified margin, the Yukon Choice stent failed to show noninferiority for the primary endpoint. During follow-up, there were no significant differences between groups regarding death, myocardial infarction, stent thrombosis, target lesion revascularization, target vessel revascularization, or nontarget vessel revascularization.. Compared with the Taxus Liberté stent, the polymer-free sirolimus-eluting Yukon Choice stent failed to show noninferiority with regard to the primary endpoint, in-stent late lumen loss, in patients with diabetes mellitus after 9-month follow-up. Both stents showed comparable clinical efficacy and safety. (Yukon Choice Versus Taxus Liberté in Diabetes Mellitus; NCT00368953).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Germany; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Polymers; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

In the prospective randomized TRIAS pilot study, the bio-engineered Genous™ endothelial progenitor cell capturing stent was compared with the Taxus Liberté™ SR paclitaxel-eluting stent. At 1 yr, a statistically nonsignificant difference in the rates of target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) was observed. We have evaluated the safety and efficacy up to 2 yr.. A total of 193 patients with de novo coronary artery lesions carrying a high risk of restenosis were randomized to a Genous stent versus a Taxus stent. Dual antiplatelet therapy was prescribed for ≥1 month after Genous stent implantation and for ≥6 months after a Taxus stent.. Between 1 and 2 yr, patients treated with the Genous stent tended to have fewer episodes of target lesion revascularization (2.0% versus 5.3%), but nearly similar rates of cardiac death (1.0% versus 0%), myocardial infarction (0% versus 1.1%), and stent thrombosis (0% versus 1.1%) when compared with the Taxus stent. As a result, at 2-yr follow-up treatment with the Genous stent compared with the Taxus stent resulted in a nonsignificant difference in target vessel failure (TVR) (20.4% versus 15.8%; risk difference 4.6%, 95% CI -6.2-15.5%). No stent thrombosis was observed in the Genous group compared to five cases (in four patients) in the Taxus group, resulting in a difference as compared with the Taxus stent (risk difference -4.2%; 95%CI -8.2% to -0.2%).. In the TRIAS pilot study, treatment of coronary artery lesions carrying a high risk of restenosis with the Genous compared with the Taxus stent resulted in a nonsignificant difference of TVR at 2-yr follow-up, with convergence of the Kaplan-Meier curves between 1 and 2 yr. Stent thrombosis was only observed after Taxus stent implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug Therapy, Combination; Drug-Eluting Stents; Endothelial Cells; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Netherlands; Paclitaxel; Pilot Projects; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Stem Cells; Stents; Thrombosis; Time Factors; Treatment Outcome

These studies sought to evaluate the clinical outcomes of the slow-release Taxus paclitaxel-eluting stent (PES) versus an otherwise identical bare-metal stent (BMS).. Prior studies were not individually powered to generate reliable estimates of low-frequency safety endpoints or to characterize the long-term safety and efficacy profile of PES.. The completed 5-year databases from the prospective, randomized, double-blind TAXUS I, II, IV, and V trials were pooled for a patient-level analysis.. The study population comprised 2,797 randomized patients (1,400 PES and 1,397 BMS). At the end of the 5-year study period, PES compared with BMS significantly reduced the rate of ischemia-driven target lesion revascularization (12.3% vs. 21.0%, p < 0.0001), with consistent reductions across high-risk subgroups and in patients with and without routine angiographic follow-up. There were no significant differences between the stent types in the 1-year or cumulative 5-year rates of death or myocardial infarction (MI). However, cardiac death or MI between 1 and 5 years was increased with PES (6.7% vs. 4.5%, p = 0.01), as was stent thrombosis (protocol definition: 0.9% vs. 0.2%, p = 0.007; ARC definition: 1.4% vs. 0.9%, p = 0.18).. In this pooled patient-level analysis from the prospective, randomized, double-blind TAXUS trials, PES compared with BMS resulted in a durable 47% reduction in the 5-year rate of ischemia-driven target lesion revascularization in simple and complex lesions, with nonsignificant differences in the cumulative 5-year rates of death or MI. Between 1 and 5 years, however, the rates of cardiac death or MI and protocol-defined stent thrombosis were increased with PES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Double-Blind Method; Drug-Eluting Stents; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Stents; Thrombosis; Time Factors; Treatment Outcome; United States

This study sought to compare late safety and efficacy outcomes following percutaneous coronary revascularization with zotarolimus-eluting stents (ZES) and sirolimus-eluting stents (SES).. Despite higher late lumen loss and binary restenosis with ZES compared with SES, it is uncertain whether differences in early angiographic measures translate into more disparate late clinical events.. Clinical outcomes were prospectively evaluated through 5 years in the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) that randomized 436 patients of relatively low anatomic and clinical risk to treatment with ZES (n = 323) or SES (n = 113) and evaluated a primary endpoint of 8-month angiographic late lumen loss.. At 5 years (completeness of follow-up: 95.2%), pre-specified endpoints of all-cause mortality (5.2% vs. 13.0%, p = 0.02), myocardial infarction (1.0% vs. 4.6%, p = 0.03), and the composite event rates of cardiac death/myocardial infarction (1.3% vs. 6.5%, p = 0.009) and major adverse cardiac events (14.0% vs. 22.2%, p = 0.05) were significantly lower among patients treated with ZES. Rates of target lesion (8.1% ZES vs. 6.5% SES, p = 0.68) and target vessel revascularization were similar between treatment groups. Stent thrombosis was infrequent and similar in both groups (0.7% ZES vs. 0.9% SES, p = 1.0). Between 9 months and 5 years, progression of major adverse cardiac events was significantly more common with SES than with ZES (16.7% vs. 7.8%, p = 0.015).. Despite initially higher angiographic late lumen loss, rates of clinical restenosis beyond the protocol-specified angiographic follow-up period remain stable with ZES compared with the rates for SES, resulting in similar late-term efficacy. Over 5 years, significant differences in death, myocardial infarction, and composite endpoints favored treatment with ZES. (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The SYNTAX score (SXscore) has been shown to be an effective predictor of clinical outcomes in patients undergoing percutaneous coronary intervention (PCI).. The SXscore was prospectively collected in 1,397 of the 1,707 patients enrolled in the "all-comers" LEADERS trial (patients post-surgical revascularisation were excluded). Post hoc analysis was performed by stratifying clinical outcomes at two-year follow-up, according to one of three SXscore tertiles: SXlow ≤8 (n=464), 816 (n=461). At two-year follow-up the rate of major adverse cardiovascular events was 18.4%, 12.0% and 9.4% in the SXhigh, SXmid, and SXlow tertile, respectively (HR 1.45; CI 1.21-1.74; p<0.01). There was a significantly higher rate of cardiac death in patients in the highest SXscore tertile (7% SXhigh versus 2.4% SXmid versus 1.8% SXlow; HR 2.22; CI 1.5-3.27; p<0.001). Within the SXhigh tertile the rate of cardiac death was significantly lower in patients treated with the biolimus-eluting stent compared with the sirolimus-eluting stent (4.7% versus 9.6%, HR 0.48; CI 0.23-0.99; p=0.046).. The SXscore when applied to an "all-comers" patient population allows for prospective risk stratification of patients undergoing PCI up to two years follow-up. In addition, the SXscore appears to separate the performance of devices in high risk patient groups.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Heart Diseases; Humans; Male; Middle Aged; Polymers; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The SYNTAX-LE MANS substudy prospectively evaluated 15-month angiographic and clinical outcomes in patients with treated left main (LM) disease.. In the SYNTAX trial, 1,800 patients with three-vessel and/or LM disease were randomised to either CABG or PCI; of these, 271 LM patients were prospectively assigned to receive a 15-month angiogram. The primary endpoint for the CABG arm was the ratio of ≥50% to <100% obstructed/occluded grafts bypassing LM lesions to the number placed. The primary endpoint for the PCI arm was the proportion of patients with ≤50% diameter stenosis ('patent' stents) of treated LM lesions. Per protocol, no formal comparison between CABG and PCI arms was intended based on the differing primary endpoints. Available 15-month angiograms were analysed for 114 CABG and 149 PCI patients. At 15 months, 9.9% (26/263) of CABG grafts were 100% occluded and an additional 5.7% (15/263) were ≥50% to <100% occluded. Overall, 27.2% (31/114) of patients had ≥1 obstructed/occluded graft. The 15-month CABG MACCE rate was 8.8% (10/114) and MACCE at 15 months was not significantly associated with graft obstruction/occlusion (p=0.85). In the PCI arm, 92.4% (134/145) of patients had ≤50% diameter LM stenosis at 15 months (89.7% [87/97] distal LM lesions and 97.9% [47/48] non-distal LM lesions). The 15-month PCI MACCE rate was 12.8% (20/156) and this was significantly associated with lack of stent patency at 15 months (p<0.001), mainly due to repeat revascularisation.. At 15 months, 15.6% (41/263) of grafts were at least 50% obstructed but this was not significantly associated with MACCE; 92.4% (134/145) of patients had stents that remained patent at 15 months, and stent restenosis was significantly associated with MACCE, predominantly due to revascularisation.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Europe; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Registries; Regression Analysis; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; United States; Vascular Patency

To test the efficacy of sequential application of drug-coated balloon (DCB) and bare metal stent (BMS) for treatment of de novo coronary lesions, comparing the sequence of application (DCB first vs. BMS first).. In a multicentre pilot trial, 26 patients with de novo coronary lesions were randomised to receive a paclitaxel-coated balloon application followed by BMS implantation (DCB first) or vice versa (BMS first). Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) were performed post-procedure and at six months, with OCT % neointimal volume obstruction as primary endpoint. Longitudinal geographical miss was only observed in DCB first (23.1 vs. 0.0%, p=0.220). Implantation of BMS first resulted in fewer malapposed struts (p=0.013) but similar coverage at six months. No significant difference was found regarding the primary endpoint (25.5 vs. 24.9%, p=0.922), mean thickness of coverage (261 vs. 225 µm, p=0.763), late loss (0.53 vs. 0.45 mm, p=0.833), binary restenosis (27.3 vs. 16.7% in-segment, p=0.640) or clinical endpoints.. Sequential application of DCB and not pre-mounted BMS for treatment of de novo coronary lesions results in efficient inhibition of neointimal hyperplasia. The sequence of application (DCB first vs. BMS first) does not seem to influence the outcome, except for better apposition in BMS first.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Equipment Design; Female; Humans; Logistic Models; Male; Metals; Middle Aged; Netherlands; Paclitaxel; Pilot Projects; Predictive Value of Tests; Proportional Hazards Models; Prosthesis Design; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The optimal treatment of bare metal stent restenosis is still not defined. The most employed contemporary option is the implantation of a drug-eluting stent (DES). However, this procedure implies the addition of a second metal layer in the vessel wall, which is linked to delayed healing. Furthermore, there may be a increased risk of malapposition of both struts of the bare metal and the newly implanted drug-eluting stent. These phenomena may give rise to an increased risk of stent thrombosis in this patient population. Recently, drug-eluting balloons (DEB) have been proposed as a new treatment strategy for bare metal stent restenosis. The initial results of this technique look promising.. To compare healing processes after treatment of bare metal stent (BMS) in-stent restenosis (ISR) with balloon dilatation using DEB versus implantation of DES.. This is a prospective, multicentre (University Hospitals Leuven and ZOL Hospital Genk, Belgium) randomised clinical trial with clinical, angiographic and OCT follow-up at nine months. Patients with bare metal stent restenosis and an indication for repeat PCI are randomised to treatment with a paclitaxel-eluting balloon (SeQuent Please, B-Braun, Melsungen, Germany) versus a Xience V/ Xience Prime everolimus-eluting stent (Abbott Vascular, Santa Clara, CA, USA). The primary objective of this study is to evaluate the vascular healing response of the vessel wall after balloon angioplasty with a paclitaxel-eluting balloon versus implantation of a drug-eluting stent in patients with in-stent restenosis in a coronary artery. The primary endpoint of the study is stent strut coverage and stent strut apposition at nine months, as assessed with OCT.. Currently no prospectively collected data on vessel wall healing after treatment of in-stent restenosis, whether with DES or with DEB, are available. Therefore, the SEDUCE trial will yield pivotal insights on this important topic and guide further optimisation of the interventional treatment for this condition.

Topics: Angioplasty, Balloon, Coronary; Belgium; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Drug Delivery Systems; Drug-Eluting Stents; Equipment Design; Everolimus; Humans; Metals; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Research Design; Sirolimus; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Drug-eluting balloons (DEB) have recently emerged as a valuable treatment option for patients with coronary in-stent restenosis (ISR). However, little information exists on results of DEB therapy of in-stent restenosis from drug-eluting stents (DES).. The Pantera Lux balloon catheter, a novel DEB releasing paclitaxel with a BTHC matrix was studied in a prospective, multicentre first-in-man trial of patients with ISR either from bare metal stents (BMS) or drug-eluting stents (DES). Here we report on the clinical and angiographic follow-up of the first 45 Pantera Lux patients after six months. The mean age (± SD) of the studied ISR patients was 69 ± 9 years (82% males, 18% females). The distribution of BMS and DES in these patients was 53% and 47%, respectively. Success of deployment of the device was 100%. After six months, the major adverse cardiac event (MACE) rate was 7.7% including one post-procedural non-fatal myocardial infarction, one target lesion- and one target vessel- revascularisation (each clinically driven). Angiographic in-stent late lumen loss was 0.03 ± 0.35 mm (BMS: -0.08 ± 0.37 mm, DES: 0.15 ± 0.28 mm) as assessed by an independent angiographic core laboratory.. Treatment of coronary in-stent restenosis with the Pantera Lux paclitaxel-releasing balloon catheter shows very promising preliminary 6-month results, irrespective of whether the initially implanted stent was a bare metal- or a drug-eluting stent.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Drug Delivery Systems; Drug-Eluting Stents; Equipment Design; Female; Germany; Humans; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Stents; Time Factors; Treatment Outcome

After the excellent results of the PACCOCATH ISR and PEPCAD II trials in in-stent restenosis, paclitaxel-coated balloon (PCB) still has to prove its efficacy in native coronary disease.. In the PICCOLETO randomised trial, patients with stable or unstable angina undergoing PCI of small coronary vessels (≤ 2.75 mm) were randomised to the Dior PCB (28 patients) or the Taxus DES (29 patients). The primary study endpoint was percent diameter stenosis at 6-month angiographic follow-up (non-inferiority); secondary endpoints were angiographic binary restenosis and major adverse cardiac events (MACE: death, Q-wave myocardial infarction, TLR) at 9-month follow-up (non-inferiority). The two groups were not dissimilar for clinical and angiographic data. The study was interrupted after enrolment of two-thirds of the patients due to a clear superiority of one study group. The primary endpoint was not met: the PCB group had higher percent diameter stenosis (43.6% vs. 24.3%, p=0.029), angiographic restenosis (32.1 vs. 10.3%, p=0.043), and higher occurrence of MACE (35.7% vs. 13.8%, p=0.054).. Dior PCB failed to show equivalence to Taxus DES regarding angiographic endpoints during PCI of small coronary arteries. We hypothesise that it concerned the lack of efficacy of the device used (which has since been replaced by its second generation) rather than a class-effect in native coronary vessels.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Drug-Eluting Stents; Equipment Design; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Time Factors; Treatment Outcome

Percutaneous coronary interventions for bifurcation lesions are often complex and associated with an unsatisfactory result. The aim of this first-in-man, observational study was to investigate the efficacy and safety of a paclitaxel-eluting balloon in these lesions.. Twenty-eight patients presenting significant coronary bifurcational lesions of the left coronary artery were studied. The main branch (MB) and the side branch (SB) were dilated with a drug-eluting balloon (DEB; SeQuent Please balloon catheter , 3 µg paclitaxel/mm2 balloon surface). An open-cell bare-metal stent (BMS; Coroflex) was then deployed in the MB. Only if the SB had a TIMI flow

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Catheters; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Equipment Design; Female; Germany; Humans; Male; Metals; Middle Aged; Paclitaxel; Pilot Projects; Prospective Studies; Prosthesis Design; Stents; Thrombosis; Time Factors; Treatment Outcome

Coronary bifurcation lesions, which account for 15-20% of all lesions treated percutaneously, remain hampered by procedural difficulties, post-procedural complications and suboptimal long-term results, even with the introduction of the drug-eluting stent (DES). Side branch (SB) restenosis rates remain a drawback even in the provisional T-stenting technique with final kissing balloons. The introduction of drug-eluting balloons (DEB) creates a new hope for this technique by maintaining the relatively easy provisional T-technique but promising better long term outcomes for the SB treated with DEB. The DEB delivers locally a high concentration of an anti-restenotic drug, paclitaxel, thereby potentially reducing restenosis rates as compared to a regular balloon. However little is still known on the optimal use and long-term outcomes of DEB in bifurcations. First results of the DEBIUT study will help to understand future directions in development of this new and promising device.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Catheters; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Equipment Design; Humans; Paclitaxel; Single-Blind Method; Time Factors; Treatment Outcome

Coronary lesions in diabetics (DM) are associated with a high recurrence following percutaneous coronary intervention (PCI), even after drug-eluting stent (DES) deployment. Encouraging clinical data of the drug-eluting balloon catheter (DEB) SeQuent Please warrant its investigation in these patients.. Eighty-four diabetic patients (60.8 ± 9.1 years, 76.2% male) were randomised to either the DEB SeQuent Please or the DES Taxus Liberté to compare the 9-month clinical and angiographic outcome of PCI in native coronary arteries. Comparing the DEB vs. the DES the 9-month results (follow-up DEB 39/45 [86.7%], DES 36/39 [92.3%]) are statistically not different at the 0.05 level for the primary endpoint of in-segment (0.37 ± 0.59 mm vs. 0.35 ± 0.63 mm) and in-stent (0.51 ± 0.61 mm vs. 0.53 ± 0.67 mm) late lumen loss, overall and cardiac deaths (2/45 [4.4%] and 3/45 [6.7%] vs. 0), target lesion revascularisation (3/45 [8.9%] vs. 4/39 [10.3%]), the total MACE rate (6/45 [13.3%] vs. 6/39 [15.4%]), and the event free survival after 10.2 ± 3.8 months (Kaplan-Meier analysis, p<0.80, log rank test).. The clinical and angiographic outcome of the combination of the drug-eluting balloon SeQuent Please with a cobalt chromium stent compared to the drug eluting Taxus stent are similar.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chromium Alloys; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Disease-Free Survival; Drug Delivery Systems; Drug-Eluting Stents; Equipment Design; Female; Humans; Kaplan-Meier Estimate; Malaysia; Male; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Stents; Thailand; Time Factors; Treatment Outcome

Safety concerns regarding use of drug-eluting stent systems (DES) are related mostly to late stent thrombosis, which is facilitated by incomplete stent endothelial coverage. Specific information about time course and amount of endothelial strut coverage of different DES is required, in order to further refine the concept of antiplatelet therapy after DES implantation. Optical coherence tomography (OCT) is emerging as a new gold standard for endovascular imaging of stents, atherosclerosis progression, vulnerable plaque, and neointimal proliferation. The aim of this study is a comparative evaluation using OCT of the XIENCE V everolimus-eluting stent (Abbot Vascular, Santa Clara, CA, USA) on one hand, and the bare metal stent Coroflex Blue postdilated with the paclitaxel-eluting balloon Sequent Please (both from B Braun Melsungen AG, Melsungen, Germany) on the other hand, with respect to endothelial coverage and neointimal proliferation.. Eighty patients scheduled for elective percutaneous coronary intervention (PCI) of a native coronary stenosis suitable for DES implantation and OCT imaging are scheduled to be openly randomised 1:1 to either XIENCE or Coroflex Blue/Sequent Please. The study is conducted prospectively at a university high-volume PCI centre with OCT expertise. Angiographic follow-up and time-domain OCT imaging with motorised pull-back at 1 mm/s are planned six months after study stent implantation in all patients. OCT endpoints are: (1) endothelial coverage, expressed as % of struts without coverage and % of stent length containing non-covered struts, and respectively (2) neointimal proliferation, given as % neointimal volumetric proliferation within the whole stent and also as peak focal % neointimal area proliferation. The study is not powered for clinical endpoints, which are: subacute or late stent thrombosis and need for revascularisation of the stent segment. Given the high number of measurements (15 cross-section images / 1 mm stent length), OCT endpoints are likely to reach significance at the level p <0.05, if the drop-out rate in follow-up does not exceed 20%.. The study is currently on-going and its termination is scheduled for February 2010. (ClinicalTrials.gov identifier: NCT01056744).

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Drug-Eluting Stents; Endothelial Cells; Everolimus; Germany; Humans; Metals; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Research Design; Sirolimus; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima

Drug-eluting stents (DES) have been designed to prevent restenosis, but long-term clinical outcome may be offset by an increased risk of stent thrombosis, which is associated with suboptimal stent implantation or delayed re-endothelialization. DES implantation has also been associated with local persistent endothelial dysfunction. Conversely, Trapidil is a potent anti-inflammatory, vasodilatator and antiproliferative drug and several studies have shown anti-restenotic effects, suggesting substantial clinical benefits through the use of Trapidil-eluting DES.. This is a longitudinal, single-blind, double-arm, randomized multicenter study. Forty patients with non-ST-elevation acute coronary syndromes who present at the index procedure with multivessel coronary disease in the major epicardial coronary arteries will be enrolled. Patients should present a culprit lesion with stenosis 70% or more associated with another stenosis 70% or more in another coronary artery. Patients will be randomized in a 1: 1 fashion to receive either an Intrepide trapidil-eluting stent or a Taxus paclitaxel-eluting stent on the culprit lesion. After 90 days, the nonculprit lesion will be treated with the stent of the opposite randomization arm and optical coherence tomography (OCT) analysis of the index stented segment will be performed. Follow-up angiography, combined with vasomotor analysis of endothelial function by rapid atrial pacing, will be done at 12 months after the index procedure on both stents. To further characterize the status of the endothelium, serum measurement of vascular endothelial growth factor gradient between the aorta and 15 mm distal to the implanted stent will be performed at 12 months. The primary endpoint of the study is to compare stent struts re-endothelialization at 90 days by OCT. The secondary endpoint is to compare angiographic outcome and coronary endothelial function 12 months after the index procedure and to compare clinical outcome at 1 and 2 years between trapidil-eluting DES versus paclitaxel-eluting DES.. We hypothesize that the utilization of trapidil-eluting DES in the setting of acute coronary syndromes will be characterized by a greater early re-endothelialization associated with an antiproliferative effect offering a similar efficacy with a better safety profile compared with first-generation DES.

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Biomarkers; Cardiac Catheterization; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Endothelium, Vascular; Humans; Italy; Longitudinal Studies; Paclitaxel; Prosthesis Design; Research Design; Single-Blind Method; Thrombosis; Time Factors; Tomography, Optical Coherence; Trapidil; Treatment Outcome; Vascular Endothelial Growth Factor A

The JACTAX HD trial ("JACTAX" Trial Drug Eluting Stent Trial) evaluated the safety and clinical performance of a novel JACTAX HD (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent (PES) in de novo coronary lesions.. The JACTAX HD (Boston Scientific) stent consists of a pre-crimped bare-metal Liberté (Boston Scientific) stent coated on its abluminal aspect with an ultrathin (<1 microm) 1/1 mixture of biodegradable polylactide polymer and paclitaxel applied as discrete microdots (nominal totals of 9.2 microg each of polymer and paclitaxel per 16-mm stent).. In this prospective, single-arm, multicenter, first-human-use study (n = 103), the primary end point of 9-month major adverse cardiac events (MACE) (cardiac death, myocardial infarction, ischemia-related target vessel revascularization) was compared with an objective performance criterion (OPC) of 17% (11% MACE based on TAXUS ATLAS [TAXUS Liberté-SR Stent for the Treatment of de Novo Coronary Artery Lesions] trial results plus a pre-specified noninferiority margin of 6%).. The composite primary end point occurred in 7.8% of JACTAX HD patients with an upper 1-sided 95% confidence limit of 13.6%, thus meeting the pre-specified criteria for noninferiority. There was no death, Q-wave myocardial infarction, or stent thrombosis through 9 months. In-stent late loss was 0.33 +/- 0.45 mm, with an in-stent binary restenosis of 5.2% and net volume obstruction by intravascular ultrasound of 11.4 +/- 11.2%.. The JACTAX HD stent with an abluminal biodegradable polymer showed 9-month MACE, in-stent late loss, restenosis, and net volume obstruction comparable to that observed with the TAXUS Liberté (Boston Scientific) stent coated with a conformal durable polymer. Further studies are underway to better evaluate the potential of this new PES design, which might allow for more rapid endothelialization and improved vessel healing. ("JACTAX" Trial Drug Eluting Stent Trial; NCT00754728).

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; England; Female; Germany; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Polymers; Prospective Studies; Prosthesis Design; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

We sought to determine the 2-year impact of early and late-acquired incomplete stent apposition (ISA) on clinical events.. The late clinical impact of early or late-acquired ISA in bare-metal stents (BMS) and TAXUS stents (Boston Scientific, Natick, Massachusetts) is debatable.. We evaluated 1,580 patients enrolled in the intravascular ultrasound (IVUS) substudies of TAXUS IV, V, VI and TAXUS-ATLAS WH, LL, and DS trials.. There were 96 cases of early ISA in 26 (7.2%) BMS patients, 35 (9.7%) TAXUS Express patients (p = 0.28 vs. BMS), and 35 (7.3%) TAXUS Liberté patients (p = 0.21 vs. TAXUS Express, and p = 1.00 vs. BMS). Major adverse cardiovascular events were similar at 9 months in patients with early ISA versus control subjects with no ISA for BMS (3.8% vs. 15.2%, p = 0.13) and for TAXUS (11.6% vs. 8.8%, p = 0.45). There was no impact of early ISA on stent thrombosis. At 9-month follow-up, there were 36 cases of late-acquired ISA in 7 (2.7%) BMS patients, 17 (3.1%) patients with TAXUS slow-release (TAXUS Express or TAXUS Liberté), and 12 (15.4%) patients receiving TAXUS moderate-release. Over 2 ensuing years, major adverse cardiovascular events were similar in patients with late-acquired ISA versus control subjects with no ISA for BMS (14.3% vs. 7.9%, p = 0.54), TAXUS (overall, 8.3% vs. 8.1% p = 0.87), or TAXUS slow-release formulation (0% vs. 7.9%, p = 0.28). There was no impact of late-acquired ISA on stent thrombosis.. Neither routinely detected acute ISA nor routinely detected late-acquired ISA in BMS or TAXUS patients was associated with adverse clinical events over long-term follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Double-Blind Method; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Drug-eluting stents have shown to be superior over bare metal stents in clinical and angiographic outcomes after percutaneous treatment of coronary artery stenosis. However, long-term follow-up data are scarce and only available for sirolimus- and paclitaxel-eluting stents.. To assess the feasibility and performance of the XIENCE V everolimus-eluting stent (EES) versus an identical bare metal stent after a 5-year follow-up period.. SPIRIT FIRST was a First in Man, multicentre, prospective, single-blind, clinical trial, randomizing 60 patients with a single de novo coronary artery lesion in a ratio of 1:1 to either an everolimus eluting or a bare metal control stent.. At 5-year clinical follow-up, data were available in 89% and 86% of patients in the everolimus and control arm, respectively. In the everolimus arm, no additional death, myocardial infarction, clinically driven target lesion revascularization (TLR), or clinically driven target vessel revascularization (TVR) events were observed between 1- and 5-year follow-up. The 5-year hierarchical major adverse cardiac events (MACE) and target vessel failure (TVF) rates for the everolimus arm were 16.7% (4/24) for both endpoints. In the control group, no additional cardiac death, myocardial infarction, or clinically driven TLR events were observed between 2- and 5-year follow-up. No additional clinically driven TVR events were observed between 3- and 5-year follow-up. The 5-year hierarchical MACE and TVF rates for the control arm were 28.0% (7/25) and 36.0% (9/25), respectively. No stent thromboses were observed in either the everolimus arm or the control arm up to 5 years.. The favorable 5-year long term clinical outcome of the EES is consistent with the results from other studies of the EES with shorter follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Risk Assessment; Severity of Illness Index; Single-Blind Method; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Chronic total coronary occlusions constitute a sub-group of lesions at very high risk of restenosis after successful percutaneous coronary intervention. The sirolimus-eluting coronary stent is the only drugeluting stent that has demonstrated to reduce angiographic restenosis and the need for new revascularisation procedures in comparison with bare-metal stents in randomised clinical trials focusing on these lesions. Everolimus-eluting stents have shown to offer optimal angiographic and clinical outcomes in comparison with bare-metal stents and paclitaxel-eluting stents, but no randomised trials have tested the device in chronic total occlusions. The CIBELES (non-acute Coronary occlusIon treated By EveroLimus- Eluting Stent) will randomise 208 patients with chronic total coronary occlusions in 13 centres from Portugal and Spain to receive everolimus- or sirolimus-eluting coronary stents. The primary endpoint will be angiographic in-stent late loss.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Portugal; Prosthesis Design; Research Design; Single-Blind Method; Sirolimus; Spain; Time Factors; Treatment Outcome

The optimal stenting strategy in true coronary artery bifurcation lesions has not been determined. In this study, a strategy of always stenting both the main vessel and the side branch (MV plus SB) was compared with a strategy of stenting the MV only with optional stenting of the SB. Stents used were sirolimus-eluting stents and paclitaxel-eluting stents.. A total of 108 patients with true coronary bifurcation lesions were randomly assigned to either routine stenting with drug-eluting stents (DES) in both the branches (group MV plus SB) or provisional stenting with DES placement in the main branch and DES placement in the SB only if MV stenting alone provided inadequate results (group MV). The primary end points were major adverse cardiac events (MACE) at 8 months, including myocardial infarction, cardiac death, and stent thrombosis or target vessel revascularization by either percutaneous coronary intervention or coronary artery bypass grafting.. Angiographic follow-up revealed 28.91+/-20.43% stenosis of the SB after provisional stenting and 18.93+/-15.34% (P<0.01) after routine stenting. The corresponding binary restenosis rates were 35.2 and 14.8% (P=0.015). SB stents were implanted in 16.7% of patients in the provisional stenting group and 94.4% of patients in the routine stenting group. In the main branch, binary restenosis rates prebifurcation were 11.1% after provisional and 7.4% after routine stenting (P=0.51), whereas binary restenosis rates postbifurcation were 14.8 and 9.3% (P=0.38), respectively. The overall 8-month incidence of target lesion reintervention was 31.5% after provisional and 7.4% after routine stenting (P<0.01), and cumulative MACE were 38.9 and 11.1% (P<0.01), respectively.. Routine stenting significantly improved the MACE outcome of percutaneous coronary intervention in true coronary bifurcation and bifurcation angle of 60 or less lesions as compared with provisional stenting.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; China; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Percutaneous coronary intervention (PCI) of small vessels is limited by an increased risk of restenosis and adverse outcome, even when drug-eluting stents (DES) are employed. In recent years, the paclitaxel-coated balloon (PCB) has been shown to reduce neointimal proliferation and the need for target lesion revascularization (TLR) in an in-stent restenosis setting. The impact of a PCB during PCI of small coronary vessels was evaluated and compared to one of the most widely used DES.. In the PICCOLETO randomised clinical trial, patients with stable or unstable angina undergoing PCI of small coronary vessels (< or = 2.75 mm) were randomised to Dior PCB (28 patients) or Taxus DES (29 patients). The primary study end point was per cent diameter stenosis at 6-month angiographic follow-up (non-inferiority), secondary end points were angiographic binary restenosis and occurrence of major adverse cardiac events (MACE: death, Q-wave myocardial infarction, TLR) at 9 month follow-up.. The two groups were not dissimilar regarding clinical and angiographic characteristics. Study was interrupted after enrolment of two-thirds of patients due to a clear superiority of one study group. The primary end point was not met, because the PCB group showed higher per cent diameter stenosis (43.6% vs 24.3%, p=0.029); angiographic restenosis was higher as well (32.1 vs 10.3%, p=0.043), whereas MACE were 35.7% in the PCB group and 13.8% in the DES group (p=0.054).. Dior PCB failed to show equivalence to Taxus DES regarding angiographic end points during PCI of small coronary arteries. CLINICAL TRIAL REGISTRATION NUMBER (EUDRACT CODE): 2009-012268-15.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Drug-Eluting Stents; Equipment Design; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Prospective Studies; Radiography; Treatment Outcome

Little is known about the impact of treatment with drug-eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus-eluting stent (EES) in patients with calcified or noncalcified culprit lesions.. The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six-month and 2-year angiographic follow-up and clinical follow-up up to 3 years were completed.. The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6-month in-stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia-driven target lesion revascularization (ID-TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in-stent ABR (7.4% vs. 0%, P = 0.08) and ID-TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID-TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12).. The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. © 2010 Wiley-Liss, Inc.

Topics: Aged; Angioplasty, Balloon, Coronary; Calcinosis; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; India; Kaplan-Meier Estimate; Male; Middle Aged; New Zealand; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

Erythropoietin (EPO) enhances re-endothelialization and anti-apoptotic action. Larger clinical studies to examine the effects of high-dose EPO are in progress in patients with acute myocardial infarction (AMI).. The aim of this multi-center pilot study was to investigate the effect of `low-dose EPO' (6,000 IU during percutaneous coronary intervention (PCI), 24 h and 48 h) in 35 patients with a first ST-elevated AMI undergoing PCI who was randomly assigned to EPO or placebo (saline) treatment. Neointimal volume, cardiac function and infarct size were examined in the acute phase and 6 months later (ClinicalTrials.gov identifier: NCT00423020). No significant regression in in-stent neointimal volume was observed, whereas left ventricular (LV) ejection fraction was significantly improved (49.2% to 55.7%, P=0.003) and LV end-systolic volume was decreased in the EPO group (47.7 ml to 39.0 ml, P=0.036). LV end-diastolic volume tended to be reduced from 90.2% to 84.5% (P=0.159), whereas in the control group it was inversely increased (91.7% to 93.7%, P=0.385). Infarction sizes were significantly reduced by 38.5% (P=0.003) but not in the control group (23.7%, P=0.051). Hemoglobin, peak creatine kinase values, and CD34(+)/CD133(+)/CD45(dim) endothelial progenitors showed no significant changes. No adverse events were observed during study periods.. This is a first study demonstrating that short-term `low-dose' EPO to PCI-treated AMI patients did not prevent neointimal hyperplasia but rather improved cardiac function and infarct size without any clinical adverse effects.

Topics: Aged; Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Creatine Kinase; Endothelial Cells; Erythropoietin; Female; Hemoglobins; Humans; Hyperplasia; Japan; Male; Middle Aged; Myocardial Infarction; Myocardium; Pilot Projects; Placebo Effect; Prospective Studies; Recombinant Proteins; Stem Cells; Stroke Volume; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Ventricular Function, Left; Ventricular Remodeling

The increased frequency of very late (>1 year) stent thrombosis (VLST) has raised concerns with regard to the safety of sirolimus-eluting stents and paclitaxel-eluting stents (PES).. Experimental and preliminary clinical findings with the zotarolimus-eluting stent (ZES) have suggested a favorable safety profile.. The ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease) trial is a single-blind randomized ZES versus PES clinical trial in 1,548 patients with de novo native coronary lesions; the primary end point-9-month target vessel failure-was previously reported, annual clinical follow-up is planned for 5 years, and this report describes the 3-year outcomes.. The ZES compared with PES reduced target vessel failure (12.3% vs. 15.9%, hazard ratio [HR]: 0.76, 95% confidence interval [CI]: 0.58 to 1.00, p = 0.049), myocardial infarctions (MI) (2.1% vs. 4.9%, HR: 0.44, 95% CI: 0.25 to 0.80, p = 0.005), and cardiac death plus MI (3.6% vs. 7.1%, HR: 0.52, 95% CI 0.32 to 0.82, p = 0.004). Although the overall 3-year rate of Academic Research Consortium definite/probable stent thrombosis did not differ significantly (1.1% vs. 1.7%, HR: 0.67, 95% CI 0.28 to 1.64, p = 0.380), VLST (between 1 and 3 years) was significantly reduced in ZES patients (1 event vs. 11 events; 0.1% vs. 1.6%, HR: 0.09, 95% CI: 0.01 to 0.71, p = 0.004). Ischemia-driven target lesion revascularization at 3 years was similar with ZES versus PES (6.5% vs. 6.1%, HR: 1.10, 95% CI: 0.73 to 1.65, p = 0.662).. Three-year follow-up results from the ENDEAVOR IV trial indicate similar antirestenosis efficacy but improved clinical safety associated with ZES compared with PES, due to significantly fewer peri-procedural and remote MIs associated with fewer VLST events. (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions; NCT00217269).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

To investigate the mechanistic basis underlying antirestenosis and the antiatherogenic effect of pioglitazone in patients with type 2 diabetes mellitus who were undergoing zotarolimus-eluting stent implantation.. Recent studies highlight the beneficial effect of pioglitazone in attenuating neointimal growth after stent implantation. Patients with coronary artery diseases were randomly assigned to pioglitazone (n=47) or placebo (n=47) after stent implantation. Pioglitazone significantly reduced neointimal hyperplasia within the stented lesion and attenuated total plaque burden in the in-segment regions of the stent, as assessed by intravascular ultrasonography at the 8-month follow-up. These changes were preceded by reduced circulating natural killer (NK) cells, diminished interleukin 6 and monocyte chemoattractant protein-1 levels, and downregulation of chemokine receptor 2 at 2 days after stent implantation; and an elevated interleukin 10 level at 10 days after implantation. Furthermore, the proliferation and migration of vascular smooth muscle cells were inhibited in the presence of pioglitazone-treated patient serum, demonstrating that the antiproliferative effects of pioglitazone occurred concurrently with its antiinflammatory action.. Our data present early cellular and immunologic changes by pioglitazone that might have been associated with antirestenotic and antiatherogenic effects in diabetic patients. Inhibiting proinflammatory responses while promoting antiinflammatory circuits, together with an antiproliferative action, may, in part, account for the antirestenotic effect of pioglitazone by altering vascular remodeling processes in the early phase.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Biomarkers; Blood Glucose; Cardiovascular Agents; Cell Movement; Cell Proliferation; Cells, Cultured; Chemokine CCL2; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Drug-Eluting Stents; Female; Glycated Hemoglobin; Humans; Hyperplasia; Hypoglycemic Agents; Inflammation Mediators; Insulin; Interleukin-6; Killer Cells, Natural; Lipids; Male; Middle Aged; Myocytes, Smooth Muscle; Pioglitazone; Prospective Studies; Prosthesis Design; Receptors, CCR2; Republic of Korea; Single-Blind Method; Sirolimus; Thiazolidinediones; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

The rates of side branch occlusion and subsequent periprocedural MI during everolimus-eluting stent (EES) and paclitaxel-eluting stent (PES) placement were examined in the randomised SPIRIT III trial. Periprocedural myocardial infarction (MI) following drug-eluting stent placement is associated with long-term adverse outcomes. Occlusion of side branches may be an important factor contributing to periprocedural MIs. Consecutive procedural angiograms of patients randomly assigned to EES (n=669) or PES (n=333) were analysed by an independent angiographic core laboratory. Side branch occlusion was defined as Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 or 1. Clinical outcomes through three years were compared by stent type and presence of side branch occlusion.. A total of 2,048 side branches were evaluated (EES N=1,345 side branches in 688 stented lesions, PES N=703 side branches in 346 stented lesions). Patients with compared to those without transient or final side branch occlusion had significantly higher non-Q-wave MI (NQMI) rates in-hospital (9.0% vs. 0.5%, p<0.0001). By multivariable analysis side branch occlusion was an independent predictor of NQMI (OR 4.45; 95% CI [1.82, 10.85]). Transient or final side branch occlusion occurred less frequently in patients receiving EES compared to PES (2.8% vs. 5.2%, p=0.009), contributing to the numerically lower rates of in-hospital NQMI with EES arm compared to PES (0.7% vs. 2.3%, p=0.05). Patients treated with EES rather than PES were less likely to develop side branch occlusion during stent placement, contributing to lower rates of periprocedural MI with EES compared to PES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; United States

To assess the efficacy of the AXXESS stent on the treatment of left main coronary artery (LMCA) bifurcation lesions using IVUS.. The treatment of LMCA bifurcation lesions remains challenging even with the use of drug-eluting stents. The AXXESS system is a biolimus A9-eluting self-expanding stent, dedicated to the treatment of bifurcation lesions.. Data were obtained from the AXXENT trial, a prospective, single-arm, multicenter study designed to evaluate the efficacy of the AXXESS stent on the treatment of LMCA bifurcation lesions. IVUS was available in 26 cases at 6-months follow-up. Volumetric and cross-sectional analyses within the AXXESS stent, and cross-sectional analyses at the ostia of left anterior descending (LAD) and left circumflex coronary arteries (LCX) were performed.. Within the AXXESS stent, percent neointimal volume obstruction was (3.0 +/- 4.1)% with a minimal lumen area of 10.3 +/- 2.6 mm(2). AXXESS stent volume showed an 12.4% increase at follow-up compared with postprocedure (P = 0.04). Lumen area was significantly smaller in the LCX ostium compared with the LAD ostium at follow-up (3.6 +/- 1.3 mm(2) vs. 5.5 +/- 2.0 mm(2), P = 0.0112). There was greater neointimal formation in the LCX ostium compared with the LAD ostium (1.37 +/- 1.20 mm(2) vs. 0.30 +/- 0.36 mm(2), P = 0.0003).. The AXXESS stent in the LMCA showed enlargement through 6-months follow-up and significant neointimal suppression. Greater neointimal formation and relatively inadequate stent expansion may contribute to luminal narrowing in the LCX ostium.

Topics: Aged; Alloys; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional; United States

Angiographic parameters (such as late luminal loss) are common endpoints in drug-eluting stent trials, but their correlation with the neointimal process and their reliability in predicting restenosis are debated.. Using quantitative coronary angiography (QCA) data (49 bare metal stent and 44 sirolimus-eluting stent lesions) and intravascular ultrasound (IVUS) data (39 bare metal stent and 34 sirolimus-eluting stent lesions) from the randomised Reduction of Restenosis In Saphenous vein grafts with Cypher stent (RRISC) trial, we analysed the "relocation phenomenon" of QCA-based in-stent minimal luminal diameter (MLD) between post-procedure and follow-up and we correlated QCA-based and IVUS-based restenotic parameters in stented saphenous vein grafts. We expected the presence of MLD relocation for low late loss values, as MLD can "migrate" along the stent if minimal re-narrowing occurs, while we anticipated follow-up MLD to be located close to post-procedural MLD position for higher late loss. QCA-based MLD relocation occurred frequently: the site of MLD shifted from post-procedure to follow-up an "absolute" distance of 5.8 mm [2.5-10.2] and a "relative" value of 29% [10-46]. MLD relocation failed to correlate with in-stent late loss (rho = 0.14 for "absolute" MLD relocation [p = 0.17], and rho=0.03 for "relative" relocation [p = 0.811). Follow-up QCA-based and IVUS-based MLD values well correlated in the overall population (rho = 0.76, p < 0.001), but QCA underestimated MLD on average 0.55 +/- 0.49 mm, and this was mainly evident for lower MLD values. Conversely, the location of QCA-based MLD failed to correlate with the location of IVUS-based MLD (rho = 0.01 for "absolute" values--in mm [p = 0.911, rho = 0.19 for "relative" values--in % [p = 0.111). Overall, the ability of late loss to "predict" IVUS parameters of restenosis (maximum neointimal hyperplasia diameter, neointimal hyperplasia index and maximum neointimal hyperplasia area) was moderate (rho between 0.46 and 0.54 for the 3 IVUS parameters).. These findings suggest the need for a critical re-evaluation of angiographic parameters (such as late loss) as endpoints for drug-eluting stent trials and the use of more precise techniques to describe accurately and properly the restenotic process.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Double-Blind Method; Drug-Eluting Stents; Graft Occlusion, Vascular; Humans; Metals; Predictive Value of Tests; Prosthesis Design; Reproducibility of Results; Saphenous Vein; Sirolimus; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

This study sought to evaluate the safety and efficacy of a biodegradable polymer-coated sirolimus-eluting stent (Excel, JW Medical System, Weihai, China) with 6-month dual antiplatelet therapy in daily practice.. It has been hypothesized that persistent presence of polymer may compromise the safety of drug-eluting stents, and that therefore biodegradable polymer coatings might reduce late adverse events.. Between June and November 2006, 2,077 patients, exclusively treated with Excel stents at 59 centers from 4 countries, were enrolled in this prospective, multicenter registry. Recommended antiplatelet regimen included clopidogrel and aspirin for 6 months followed by chronic aspirin therapy.. The average duration of clopidogrel treatment was 199.8 +/- 52.7 days and 80.5% of discharged patients discontinued clopidogrel at 6 months. The cumulative rates of major adverse cardiac events were 0.9% at 30 days, 2.7% at 1 year, and 3.1% at 18 months. Overall rate of stent thrombosis was 0.87% at 18 months. The rates of acute, subacute, late, and very late stent thrombosis were 0.1%, 0.38%, 0.34%, and 0.05%, respectively. Angiographic follow-up, performed in 974 (31.6%) lesions from 653 patients (31.7%), revealed a mean in-stent late lumen loss of 0.21 +/- 0.39 mm. Binary restenosis rates were 3.8% in-stent and 6.7% in-segment.. This multicenter registry documents satisfactory safety and efficacy profiles, as evidenced by low rates of major adverse cardiac events and stent thrombosis up to 18 months, for the Excel biodegradable polymer-based sirolimus-eluting stent when used with 6 months of dual antiplatelet therapy in a "real-world" setting. (Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent [CREATE]; NCT00331578).

Topics: Aged; Angioplasty, Balloon, Coronary; Asia; Aspirin; Cardiovascular Agents; Clopidogrel; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Platelet Aggregation Inhibitors; Polymers; Product Surveillance, Postmarketing; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Sirolimus; Thrombosis; Ticlopidine; Time Factors; Treatment Outcome

Stent length is a major predictor of restenosis in stable patients undergoing percutaneous coronary intervention (PCI) with bare metal stents (BMS). The effect of stent length is decreased by using drug eluting stents, however, this association had not been previously determined in patients with acute myocardial infarction (AMI). We sought to determine the impact of stent length on restenosis in patients who undergo primary PCI for AMI.. Three-hundred and fifty-seven and 355 patients with AMI were included respectively in the BMS and SES (sirolimus eluting stents) arms of the Trial to Assess the Use of the Cypher Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty (TYPHOON). Patients were divided into four subgroups based on the total length of the culprit lesion stented segment (in mm) : <18, >or=18 and <23, >or=23 and < 28, and >or=28 (groups 1 - 4 respectively). Target lesion revascularisation (TLR) and angiographic late loss were used to assess the restenotic process. Despite similar lesion length, average stent length was longer in patients treated with SES as compared to BMS 22.1+/-8.6 and 20.3+/-8.2 mm respectively, p=0.005. The rate of 12m death and AMI was similar in SES and BMS. There was no significance influence of stent length on % TLR neither in BMS (12.6, 10.1, 17.4 and 12.3 - subgroups 1-4 respectively) nor in SES (3.9, 5, 2.2 and 2.7 respectively). There was also no significant impact of stent length on angiographic late loss (mm) neither in BMS (0.7, 0.87, 0.84 and 0.92 respectively) nor in SES (0.32, 0.0, 0.11 and 0.3 respectively).. Physicians tend to choose longer SES than BMS for a similar lesion length during primary PCI for AMI. Interestingly, stent length did not affect clinical or angiographic restenosis neither in BMS nor in SES in this group of patients who underwent primary PCI for acute MI. This data challenges current practice concerning the chosen stent length in patients with AMI.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Female; Humans; Israel; Male; Metals; Middle Aged; Myocardial Infarction; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Single-Blind Method; Sirolimus; Stents; Time Factors; Treatment Outcome

The aim of this multicentre, non-randomised trial was to evaluate the safety and efficacy at 180+/-14 days of a pimecrolimus eluting coronary stent based on a cobalt-chromium platform and a poly-L-lactic acid (PLLA) bioresorbable polymer.. Sixty-one patients, with single de novo coronary lesions <14 mm in length and a reference vessel diameter of 3.0 to 3.5 mm, were enrolled in five centres (Germany and Belgium). Angiography and IVUS were performed at baseline, post-procedure and 180+/-14 days later. The primary endpoint was a composite of major adverse cardiac events (MACE) at 180+/-14 days and expected to be below 20%. Patients had single vessel disease in 59%, 2-vessel disease in 28% and 3-vessel disease in 13% of cases. MACE rate at 180+/-14 days was 18.0%. Binary in-stent restenosis was 32.7% due to in-stent late lumen loss of 1.11+/-0.65 mm by QCA. Stent thrombosis rate at 30+/-7 and 180+/-14 days was 1.6% and 3.3%, respectively. Overall TLR rate at 30+/-7, 180+/-14 days and 12+/-1 months was 1.6%, 27.9% and 32.8% respectively.. The primary endpoint was met at 180+/-14 days. However, the anti-restenotic effect of the pimecrolimus eluting stent did not reach levels similar to clinically established DES.

Topics: Aged; Angioplasty, Balloon, Coronary; Belgium; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Germany; Humans; Lactic Acid; Male; Middle Aged; Myocardial Infarction; Polyesters; Polymers; Prospective Studies; Prosthesis Design; Severity of Illness Index; Tacrolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

We evaluated the role of gender on clinical and angiographic results of the everolimus-eluting stent in the SPIRIT III trial.. The SPIRIT III trial demonstrated superior efficacy of the XIENCE V everolimus-eluting stent compared with the TAXUS paclitaxel-eluting stent. Whether these results are applicable to women is unknown.. A total of 1,002 patients with coronary artery lesions of 28 mm or less long in 2.5-3.75 mm diameter vessels were prospectively randomized to receive percutaneous coronary intervention with either XIENCE V stent or TAXUS stent placement. Post hoc gender subset analysis was performed.. A total of 669 patients (200 women) received the XIENCE V stent, and 332 patients (114 women) were assigned to the TAXUS stent. Women were older and had more hypertension and diabetes than men. At 1 year, rates of MACE (11.1% vs. 5.7%, P = 0.004), TVF (13.7% vs. 7.5%, P = 0.003), TVR (10.8% vs. 4.6%, P = 0.0007), and TLR (7.2% vs. 2.7%, P = 0.002) were higher in women compared with men. The difference in 1 year MACE and TVF rates between men and women remained after adjusting for baseline covariates. Although the angiographic characteristics at baseline were similar among the female cohort, women assigned to XIENCE V had lower in-stent late loss (0.19 vs. 0.42 mm, P = 0.01) compared with women treated with the TAXUS stent. Although 30-day clinical outcomes were similar for women treated with XIENCE V and TAXUS stents, at 1 year, women with XIENCE V stents had significantly lower MACE (8.2% vs. 16.1 %, P = 0.04) and TVR (3.1% vs. 8.9%, P = 0.03) compared with those treated with TAXUS stents. Stent thrombosis rates were similar between women receiving either XIENCE V or TAXUS stents.. Women in the SPIRIT III trial had inherently higher MACE and TVF rates than men. However, the angiographic and clinical benefits of using XIENCE V stents are generalizable to women.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Linear Models; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Sex Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Women's Health

We sought to compare patient-oriented outcomes related to target vessel or nontarget vessel events for sirolimus-eluting stents (SES) versus bare-metal stents.. SES significantly reduce restenosis but the influence of reduced restenosis on overall patient-oriented outcome has not been reported.. The study population included 1,057 patients randomized in the SIRIUS (Sirolimus-Eluting Stent in De Novo Native Coronary Lesions) study and followed clinically for 5 years. The primary end point was a composite of all-cause mortality, any myocardial infarction, or any repeat revascularization. In secondary analyses, myocardial infarction and repeat revascularization events attributed to the target vessel or a nontarget vessel were compared by stent type.. Patients with an SES were more likely to be free from the primary composite end point at 5 years (60.4% vs. 47.8%, p < 0.001) chiefly due to a sustained reduction in target lesion revascularization for SES (cumulative incidence: 12.5% vs. 28.8%, p < 0.001). There was no difference in the cumulative incidence of myocardial infarction or revascularization attributed to remote segments of the target vessel. Events attributed to the nontarget vessel were frequent and not different for SES versus bare-metal stents (25.7% vs. 25.8%).. The benefit of SES over bare-metal stents for reduced target lesion revascularization is maintained for 5 years. Remote coronary segments of the target vessel and nontarget vessel remain an important cause of future adverse events despite sustained restenosis benefit.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Disease Progression; Double-Blind Method; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

We evaluated the relative contributions of drug-eluting stent-specific and background natural history-driven causes for adverse clinical events between 1 and 5 years, in the paclitaxel-eluting stent (PES) and bare-metal stent (BMS) cohorts of the TAXUS randomized clinical trial program.. Prior studies have demonstrated that clinical events in the first year after BMS are predominantly stent-related but thereafter tend to be driven more by atherosclerotic activity outside the stented segment. It is not known whether the same is true for PES.. Annualized hazard rates (HRs) were calculated for major adverse events in 1,400 TAXUS and 1,397 BMS patients from the randomized and blinded TAXUS I, II, IV, and V trials (median 4.8-year follow-up).. Although target vessel revascularization (TVR) during the first year was driven by target lesion revascularization (TLR), TVR after 1 year involved similar numbers of TLR and non-TLR events. Moreover, the annualized HR for non-target lesion TVR and other major adverse events (including death, myocardial infarction, and stent thrombosis) were relatively constant beyond 1 year and not significantly different between PES and BMS.. The low and similar late HR for many of the observed late events after BMS and PES suggests that many of the late events after PES reflect background disease activity outside the stented segment rather than stent-related events per se. Analyses of long-term drug-eluting stent outcomes should recognize and attempt to correct for this background event rate by using suitable BMS control subjects.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Disease Progression; Double-Blind Method; Drug-Eluting Stents; Humans; Metals; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Stents; Thrombosis; Time Factors; Treatment Outcome

We report 2-year outcomes in a large unselected drug-eluting stent population (N=7,492) in the TAXUS Express2 ARRIVE post-market surveillance programme (101 U.S. sites).. No specific inclusion/exclusion criteria were mandated; patients enrolled at procedure initiation. Two-year follow-up was 94%, with independent adjudication of major cardiac events, monitoring of patients with cardiac events and an additional 10-20% sample by site. Most ARRIVE cases (64%, n=4,794) typified expanded use based on patient/lesion characteristics outside the simple use (single vessel/stent) pivotal trial populations. These expanded use patients had higher 2-year rates than simple use patients for mortality (7.8% vs. 4.2%, P<0.001), myocardial infarction (MI, 3.9% vs. 2.2%, P<0.001), target lesion revascularisation (TLR, 9.2% vs. 5.4%, P<0.001), and stent thrombosis (3.3% vs. 1.4%, P<0.001). Among subgroups with renal disease, chronic total occlusion (CTO), lesion >28 mm, reference vessel diameter (RVD) <2.5 mm, multivessel stenting, acute MI, bifurcation, vein graft, or in-stent restenosis, TLR ranged from 3.8% to 8.9% in year one, and from 1.3% to 6.0% during year two.. Mortality and stent-related events were higher in expanded use than simple use patients in the pivotal trials. ARRIVE provides a detailed estimate of procedural and 2-year outcomes in such real-world patients.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Heart Diseases; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Product Surveillance, Postmarketing; Proportional Hazards Models; Prosthesis Design; Registries; Risk Assessment; Time Factors; Treatment Outcome; United States

We tested two novel drug-eluting stents (DES), covered with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). The DES differed by the drug, but were identical otherwise, allowing to compare the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective).. The efficacy of novel DES with biodegradable polymers should be tested in the context of randomized trials, even when using drugs known to be effective, such as sirolimus and paclitaxel.. Overall, 274 patients with de novo coronary lesions in native vessels scheduled for stent implantation were randomly assigned (2:2:1 ratio) for the paclitaxel (n = 111), sirolimus (n = 106), or bare metal stent (n = 57) groups. Angiographic follow-up was obtained at 9 months and major cardiac adverse events up to 12 months.. Both paclitaxel and sirolimus stents reduced the 9-month in-stent late loss (0.54-0.44 mm, 0.32-0.43 mm, vs. 0.90-0.45 mm respectively), and 1-year risk of target vessel revascularization and combined major adverse cardiac events (P < 0.05 for both, in all comparisons), compared with controls. Sirolimus stents had lower late loss than paclitaxel stents (P < 0.01), but similar 1-year clinical outcomes. There were no differences in the risk of death, infarction, or stent thrombosis among the study groups.. Both novel DES were effective in reducing neointimal hyperplasia and 1-year re-intervention, compared to bare metal stents. Our findings also suggest that sirolimus is more effective than paclitaxel in reducing angiographic neointima, although this effect was not associated with better clinical outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Brazil; Cardiovascular Agents; Cardiovascular Diseases; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Hyperplasia; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to compare the vessel response between zotarolimus-eluting stents (ZES) and paclitaxel-eluting stents (PES) using intravascular ultrasound.. The ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease) trial was a randomized controlled study of zotarolimus-eluting, phosphorylcholine-coated, cobalt-alloy stents for the treatment of de novo coronary lesions compared with using PES for the same treatment.. Data were obtained from patients with serial (baseline and 8-months follow-up) intravascular ultrasound analysis available (n = 198). Volumetric analysis was performed for vessel, lumen, plaque, stent, and neointima. Cross-sectional narrowing (given as percentage) was defined as neointimal area divided by stent area. Neointima-free frame ratio was calculated as the number of frames without intravascular ultrasound-detectable neointima divided by the total number of frames within the stent. Subsegment analysis was performed at every matched 1-mm subsegment throughout the stent.. At follow-up, the ZES group showed significantly greater percentage of neointimal obstruction (16.6 +/- 12.0% vs. 9.9 +/- 8.9%, p < 0.01) and maximum cross-sectional narrowing (31.8 +/- 16.1% vs. 25.2 +/- 14.9%, p < 0.01) with smaller minimum lumen area than the PES group did. However, the incidence of maximum cross-sectional narrowing >50% was similar in the 2 groups. Neointima-free frame ratio was significantly lower in the ZES group. In overall analysis, whereas the PES group showed positive remodeling during follow-up (13.7 +/- 4.2 mm(3)/mm to 14.3 +/- 4.3 mm(3)/mm), the ZES group showed no significant difference (12.7 +/- 3.6 mm(3)/mm to 12.9 +/- 3.5 mm(3)/mm). In subsegment analysis, significant focal positive vessel remodeling was observed in 5% of ZES and 25% of PES cases (p < 0.05).. There were different global and focal vessel responses for ZES and PES. Both drug-eluting stents showed a similar incidence of lesions with severe narrowing despite ZES having a moderate increase in neointimal hyperplasia compared with neointimal hyperplasia in PES. There was a relatively lower neointima-free frame ratio in ZES, suggesting a greater extent of neointimal coverage. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

Topics: Aged; Alloys; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Cobalt; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Hyperplasia; Male; Middle Aged; Paclitaxel; Phosphorylcholine; Prosthesis Design; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional; United States

Lesion length remains a predictor of target lesion revascularisation and results of long lesion stenting remain poor. Sirolimus-eluting stents have been shown to perform better than paclitaxel eluting stents in long lesions. In this substudy of the LEADERS trial, we compared the performance of biolimus biodegradable polymer (BES) and sirolimus permanent polymer stents (SES) in long lesions.. A total of 1,707 'all-comer' patients were randomly allocated to treatment with BES and SES. A stratified analysis of angiographic and clinical outcomes at nine months and one year, respectively was performed for vessels with lesion length <20 mm versus >20 mm (as measured by quantitative angiography).Of 1,707 patients, 592 BES patients with 831 lesions and 619 SES patients with 876 lesions had only short lesions treated. One hundred and fifty-three BES patients with 166 lesions and 151 SES patients with 162 lesions had long lesions. There were no significant differences in baseline clinical characteristics, except for higher number of patients with long lesions presenting with acute myocardial infarction in both stent groups. Long lesions tended to have lower MLD and greater percent diameter stenosis at baseline than short lesions. Late loss was greater for long lesions than short lesions. There was no statistically significant difference in late loss between BES and SES stents (0.32+/-0.69 vs 0.24+/-0.57, p=0.59). Binary in-segment restenosis was present in 23.2% versus 13.1% of long lesions treated with BES and SES, respectively (p=0.042). In patients with long lesions, the overall MACE rate was similar for BES and SES (17% vs 14.6%; p=0.62). There was a trend towards higher overall TLR rate with BES (12.4 % vs 6.0%; HR=2.06; p=0.07) and clinically driven TLR (10.5% vs 5.3%: HR 1.94; p=0.13). Rates of definite stent thrombosis were 3.3% in the long lesion group and 1.3-1.7 % in the short lesion group.. BES and SES appear similar with respect to MACE in long lesions in this "all-comer" patient population. However, long lesions tended to have a higher rate of binary in-segment restenosis and TLR following BES than SES treatment.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Myocardial Infarction; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

We sought to compare the clinical presentation and angiographic patterns of saphenous vein graft (SVG) failure after stenting with a paclitaxel-eluting stent (PES) versus a similar bare-metal stent (BMS).. The mode of SVG failure after stenting has been poorly characterized.. The SOS (Stenting Of Saphenous Vein Grafts) trial enrolled 80 patients with 112 lesions in 88 SVGs who were randomized to a BMS or PES. Angiographic follow-up at 12 months was available in 83% of the patients.. Binary angiographic restenosis occurred in 51% (24 of 47) of BMS-treated lesions versus 9% (4 of 43) of PES-treated lesions (p < 0.0001). Graft occlusion occurred in 9 of the 21 SVGs (43%) that failed in the BMS group and in 2 of 4 SVGs (50%) that failed in the PES group. SVG failure after stenting presented as an acute coronary syndrome in 10 of the 24 patients (42%) (7 of those 10 patients presented with non-ST-segment elevation acute myocardial infarction), stable angina in 9 (37%) patients, and without symptoms in 5 (21%) patients. Of the 19 patients (with 20 grafts) who developed symptomatic graft failure, repeat SVG revascularization was successfully performed in all 13 (100%) subtotally obstructed SVGs but was attempted (and successful) in only 1 of 7 (14%) occluded SVGs. Revascularization of a native coronary artery was performed in an additional 4 of 7 (57%) symptomatic patients with an occluded SVG.. SVG failure after stenting often presents as acute myocardial infarction and with SVG occlusion. Compared with BMS, PES reduce SVG failure.

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Drug-Eluting Stents; Graft Occlusion, Vascular; Greece; Humans; Metals; Myocardial Infarction; Paclitaxel; Prosthesis Design; Recurrence; Saphenous Vein; Single-Blind Method; Stents; Thrombosis; Time Factors; Treatment Outcome; United States

We assessed the impact of vessel size on outcomes of stenting with biolimus-eluting degradable polymer stent (BES) and sirolimus-eluting permanent polymer stent (SES) within a randomized multicenter trial (LEADERS).. Stenting of small vessels might be associated with higher rates of adverse events.. "All-comer" patients (n = 1,707) were randomized to BES and SES. Post-hoc-stratified analysis of angiographic and clinical outcomes at 9 months and 1 year, respectively, was performed for vessels with reference diameter 2.75 mm.. Of 1,707 patients, 429 patients in the BES group with 576 lesions and 434 patients in the SES group with 557 lesions had only small vessels treated (50.6% of the patient cohort). In patients with small vessels there was no significant difference in overall major adverse cardiac events (MACE) rate (12.1% vs. 11.8%; p = 0.89) or target lesion revascularization (TLR) rate (9.6% vs. 7.4%; p = 0.26) between BES and SES. The MACE and TLR rates in the small-vessel patient population were higher than in the large-vessel population. The TLR rate was 9.6% versus 2.6%, and MACE rate was 12.1% versus 7.1% for small versus large vessels in the BES arm (TLR: hazard ratio [HR] = 3.724, p = 0.0013; MACE: HR = 1.720, p = 0.0412). In the SES arm, TLR was 7.4% versus 5.1%, and MACE was 11.8% versus 10.3% in small versus large vessels (TLR: HR = 1.435, p = 0.2594; MACE: HR = 1.149, p = 0.5546).. Prevalence of small vessel disease is high in an "all-comer" population with higher TLR and MACE rates. The BES and SES seem equivalent in treatment outcomes of small vessels in this "all-comer" patient population.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Polymers; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to examine outcomes related to the use of the Endeavor zotarolimus-eluting stent (ZES) (Medtronic CardioVascular, Santa Rosa, California) compared with the TAXUS paclitaxel-eluting stent (PES) (Boston Scientific Corp., Natick, Massachusetts) in the 477 patients with diabetes mellitus (DM) enrolled in the randomized ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial.. Percutaneous coronary intervention (PCI) in diabetic patients is associated with increased rates of restenosis-related end points compared with PCI in nondiabetic patients. Although ZES has been associated with similar clinical efficacy compared with PES in the overall trial population of the ENDEAVOR IV trial, whether these results are maintained in the higher-risk restenosis subgroup of patients with DM has not been determined.. Clinical and angiographic outcomes were compared according to randomized treatment assignment to either ZES or PES.. Baseline characteristics were similar among ZES (n = 241) and PES (n = 236) diabetic patients, with slightly longer lesion lengths in PES-treated patients (12.9 mm vs. 14.0 mm, p = 0.041). Among the 86 DM patients assigned to routine angiographic follow-up (18% of the overall DM cohort), in-stent percent diameter stenosis at 8 months was greater among ZES-treated patients (32.9 vs. 21.1, p = 0.023), with a trend toward higher in-stent late loss. One-year clinical outcomes were similar among DM patients treated with either ZES or PES (target vessel failure: 8.6% vs. 10.8%, p = 0.53; target lesion revascularization: 6.9% vs. 5.8%, p = 0.70; target vessel revascularization: 8.6% vs. 9.4%, p = 0.87). There were no significant interactions between DM status and stent type with respect to the outcomes measured, and the relative efficacy/safety of ZES and PES were similar among insulin- and noninsulin-requiring subgroups.. One-year clinical outcomes were similar among DM patients treated with ZES and PES in the ENDEAVOR IV trial. These findings parallel the overall trial results, which demonstrated similar efficacy and safety of ZES and PES for single de novo coronary lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetic Angiopathies; Drug-Eluting Stents; Female; Humans; Hypoglycemic Agents; Insulin; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Severity of Illness Index; Single-Blind Method; Sirolimus; Time Factors; Treatment Outcome; United States

The RESOLUTE trial examined the safety and efficacy of a next-generation zotarolimus-eluting coronary stent, Resolute (Medtronic CardioVascular Inc., Santa Rosa, California).. Revascularization benefits associated with current drug-eluting stents are often diminished in the presence of complex coronary lesions and in certain patient cohorts. Resolute uses a new proprietary polymer coating that extends the duration of drug delivery to match the longer healing duration often experienced in more complex cases.. The RESOLUTE trial was a prospective, nonrandomized, multicenter study of the Resolute stent in 139 patients with de novo coronary lesions with reference vessel diameters > or =2.5 and < or =3.5 mm and lesion length > or =14 and < or =27 mm. The primary end point was 9-month in-stent late lumen loss by quantitative coronary angiography. Secondary end points included major adverse cardiac events (MACE) at 30 days, 6, 9, and 12 months; acute device, lesion, and procedure success; and 9-month target vessel failure (TVF), target lesion revascularization (TLR), stent thrombosis, neointimal hyperplastic (NIH) volume, and percent NIH volume obstruction.. The 9-month in-stent late lumen loss was 0.22 +/- 0.27 mm. Cumulative MACE were 4.3%, 4.3%, 7.2%, and 8.7% at 30 days, 6, 9, and 12 months, respectively. Acute lesion, procedure, and device success rates were 100.0%, 95.7%, and 99.3%, respectively. At 9 months, TLR was 0.0%, TVF was 6.5%, stent thrombosis was 0.0%, NIH volume was 6.55 +/- 7.83 mm(3), and percent NIH volume obstruction was 3.73 +/- 4.05%.. In this feasibility study, the Resolute stent demonstrated low in-stent late lumen loss, minimal neointimal hyperplastic ingrowth, low TLR, no stent thrombosis, and acceptable TVF and MACE. (The RESOLUTE Clinical Trial; NCT00248079).

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Hyperplasia; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; New Zealand; Prospective Studies; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional; United States

The aim of this study was to determine the safety and efficacy of a novel pimecrolimus-eluting stent in a porcine coronary model and in a phase I clinical trial.. Rapamycin- and paclitaxel-eluting stents reduce the need for repeat intervention by limiting neointimal hyperplasia but might cause delayed healing, pre-disposing patients to late stent thrombosis. Because inflammation plays a key role in restenosis, pimecrolimus, an anti-inflammatory drug, might reduce restenosis without adversely affecting re-endothelialization.. We evaluated a novel polymeric pimecrolimus-eluting stent covered with a thin parylene C diffusion barrier in a porcine coronary model and in a phase I human clinical trial. The clinical study was a prospective, nonrandomized, first-in-human hypothesis-generating study that enrolled 15 patients who had a single de novo native coronary stenosis.. At 28 days and 3 months in the porcine model, histopathologic indicators predicted safety and biocompatibility when stents coated with polymer only, drug only, and 2 drug-polymer formulations were compared with bare-metal stents (BMS). In the phase I clinical trial, 15 patients had successful implantation of pimecrolimus-eluting stents. By 6 months, no patient suffered death, myocardial infarction, or stent thrombosis. However, the angiographic restenosis (61%), mean late loss (1.44 mm), and repeat target lesion revascularization (53%) were significantly higher than historical BMS controls. Whereas the primary end point was percent volume obstruction, restenosis was so severe that operators performed intravascular ultrasound examination in only 6 patients.. Pimecrolimus-eluting stents induced an exaggerated neointimal hyperplasia at 6 months in comparison with historical controls.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Disease Models, Animal; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Hyperplasia; Male; Middle Aged; New Zealand; Polymers; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Severity of Illness Index; Swine; Tacrolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Xylenes

Drug-eluting stents (DESs) are increasingly used for treatment of acute ST-segment elevation myocardial infarction (STEMI), but there are few comparisons of outcomes of various types of DES. We compared the efficacy and safety of zotarolimus-eluting stents (ZESs), sirolimus-eluting stents (SESs), and paclitaxel-eluting stents (PESs) in primary intervention for STEMI. This multicenter, prospectively randomized ZEST-AMI trial included 328 patients at 12 medical centers who were randomly assigned to ZES (n = 108), SES (n = 110), or PES (n = 110) deployment. The primary end point was major adverse cardiac events (death, MI, and ischemia-driven target vessel revascularization) at 12 months. Secondary end points included the individual components of the primary end point, late loss, angiographic restenosis, and stent thrombosis. Baseline clinical and angiographic characteristics were well matched. In-segment late loss (0.28 +/- 0.42 vs 0.46 +/- 0.48 vs 0.47 +/- 0.50 mm, respectively, p = 0.029) and restenosis rate (2.7% vs 15.9% vs 12.3%, respectively, p = 0.027) at 8 months were lowest in the SES group compared to the ZES and PES groups. At 12 months, cumulative incidence rates of primary end points in the ZES, SES, and PES groups were 11.3%, 8.2%, and 8.2%, respectively (p = 0.834). There were 2 acute (in the SES group) and 5 subacute (2 in the SES group and 3 in the PES group) stent thromboses. Incidence of death, recurrent MI, or ischemia-driven target vessel revascularization did not differ among the 3 groups. In conclusion, despite the difference in restenosis rate, the efficacy and safety of the 3 different DESs showed similar, acceptable results in the treatment of STEMI.

Topics: Angioplasty, Balloon, Coronary; Aspirin; Cardiovascular Agents; Clopidogrel; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Myocardial Revascularization; Paclitaxel; Platelet Aggregation Inhibitors; Prospective Studies; Recurrence; Sirolimus; Ticlopidine

We sought to investigate the long-term efficacy of oral sirolimus therapy and its impact on the incidence of de novo malignancies in the OSIRIS (Oral Sirolimus to Inhibit Recurrent In-Stent Stenosis) trial population.. The OSIRIS trial showed a significant reduction of angiographic restenosis with an oral adjunctive sirolimus treatment for in-stent restenosis. The long-term efficacy of oral sirolimus therapy is unknown.. Three hundred patients with in-stent restenosis were randomly assigned to receive placebo, a cumulative loading dose of 8 mg (usual-dose), or 24 mg (high-dose) of sirolimus over 3 days (2 days before and the day of intervention) followed by maintenance therapy of 2 mg/day for 7 days. The primary outcome of this analysis was the incidence of composite of death, myocardial infarction, and target vessel revascularization at 4-year follow-up. Secondary outcome was the incidence of newly diagnosed malignancies.. No significant differences were observed between placebo, usual-, and high-dose sirolimus treatment groups regarding primary outcome (33.3%, 39.4%, and 31.3%, respectively; p = 0.46), death (5.9%, 9.1%, and 11.1%, respectively; p = 0.41), target vessel revascularization (30.4%, 30.3%, and 22.2%, respectively; p = 0.33), and rate of newly diagnosed malignancies (7.8%, 3.0%, and 11.1%, respectively; p = 0.09).. The benefit in the reduced need for repeat intervention observed at 1 year with high-dose oral sirolimus therapy was attenuated over 4 years. Moreover, this regimen was associated with numerical yet not a significant increase in newly diagnosed malignancies without augmenting the malignancy-induced risk of death. (Oral Sirolimus for In-Stent Restenosis [OSIRUS] trial; NCT00859183).

Topics: Administration, Oral; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Double-Blind Method; Humans; Immunosuppressive Agents; Kaplan-Meier Estimate; Middle Aged; Myocardial Infarction; Neoplasms; Risk Assessment; Sirolimus; Time Factors

In a number of coronary bifurcation lesions, both the main vessel and the side branch need stent coverage. Using sirolimus eluting stents, we compared 2 dedicated bifurcation stent techniques, the crush and the culotte techniques in a randomized trial with separate clinical and angiographic end-points.. A total of 424 patients with a bifurcation lesion were randomized to crush (n=209) and culotte (n=215) stenting. The primary end point was major adverse cardiac events; cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis after 6 months. At 6 months there were no significant differences in major adverse cardiac event rates between the groups; crush 4.3%, culotte 3.7% (P=0.87). Procedure and fluoroscopy times and contrast volumes were similar in the 2 groups. The rates of procedure-related increase in biomarkers of myocardial injury were 15.5% in crush versus 8.8% in culotte group (P=0.08). A total of 324 patients had a quantitative coronary assessment at the index procedure and after 8 months. The angiographic end-points of in-segment and in-stent restenosis of main vessel and/or side branch after 8 months were found in 12.1% versus 6.6% (P=0.10) and in 10.5% versus 4.5% (P=0.046) in the crush and culotte groups, respectively.. Both the crush and the culotte bifurcation stenting techniques were associated with similar and excellent clinical and angiographic results. Angiographically, there was a trend toward less in-segment restenosis and significantly reduced in-stent restenosis following culotte stenting.

Topics: Aged; Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Denmark; Drug-Eluting Stents; Female; Finland; Humans; Kaplan-Meier Estimate; Latvia; Male; Middle Aged; Myocardial Infarction; Norway; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The newly developed Nobori coronary stent coated with a bioresorbable polymer, polylactic acid, and the antiproliferative agent Biolimus A9 has the potential to reduce restenosis by suppressing neointima formation.. We conducted a randomized (2:1), controlled trial comparing the Biolimus A9-eluting stent Nobori and the paclitaxel-eluting stent Taxus Liberté, in 243 patients (153 Nobori and 90 Taxus) at 29 centers in Europe, Asia, and Australia. Patients with previously untreated lesions in up to 2 native coronary arteries were considered for enrollment. The primary end point was in-stent late loss at 9 months, whereas secondary end points included other quantitative coronary angiography parameters, such as in-segment late loss and the rate of restenosis as well as key intravascular ultrasound parameters. Clinical secondary end points were stent thrombosis and composite of major adverse cardiac events comprising death, myocardial infarction, and target vessel revascularization. At 9 months, the in-stent late loss was significantly lower in the Nobori group compared with the Taxus group (0.11+/-0.30 mm versus 0.32+/-0.50 mm) reaching both the primary hypothesis of noninferiority of Nobori stent versus Taxus Liberté stent (P<0.001) and the secondary hypothesis of superiority (P=0.001). This finding was confirmed by a significant reduction in binary restenosis from 6.2% in Taxus to 0.7% in Nobori (P=0.02) and neointimal volume obstruction, detected by intravascular ultrasound, from 5.5+/-7.2% in Taxus to 1.8+/-5.2% in Nobori (P=0.01). The major adverse cardiac events rate was 4.6% in the Nobori and 5.6% in the Taxus cohort of patients. The stent thrombosis rate was 0% in the Nobori arm and 4.4% in the Taxus arm.. The NOBORI 1 clinical trial confirmed its primary hypothesis--noninferiority of the Nobori Biolimus A9-eluting stent versus the Taxus Liberté stent in reducing neointimal proliferation. Both stents showed a low major adverse cardiac events rate in the studied population.

Topics: Angioplasty, Balloon, Coronary; Asia; Australia; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Europe; Female; Humans; Hyperplasia; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Stents eluting antiproliferative drugs reduce the incidence of restenosis but delay healing of the vascular wall. We assessed the safety and efficacy of catheter-based local delivery of fluid paclitaxel in patients with coronary de novo stenoses after implantation of a bare metal stent.. We conducted a prospective, randomized trial comparing the local delivery of fluid paclitaxel after bare metal stent implantation (group I) with the implantation of a bare metal stent (group II) and the implantation of a paclitaxel-eluting stent (group III) in 204 patients. The primary end point was in-stent late lumen loss. Secondary end points included binary restenosis rate >50%, minimal lumen diameter, diameter stenosis, and a composite clinical end point (major adverse cardiac events and revascularization of the target lesion) 6 months after intervention. At 6 months, angiography showed an in-stent late lumen loss of 0.61+/-0.44 mm in group I versus 0.99+/-0.72 mm in group II (I versus II, P=0.0006) and 0.44+/-0.48 mm in group III (noninferiority of I versus III, P=0.023). The 1-sided 95% CI for the true difference of the means of in-stent late lumen loss in groups I and III was -infinity to 0.3174188. The cumulative overall rate of major cardiac events was 13.4% in group I, 26.8% in group II, and 14.9% in group III. Target lesion revascularization rate was 13.4% (group I), 22.1% (group II), and 13.4% (group III).. Additional antiproliferative treatment of de novo lesions in native coronary arteries with catheter-based delivery of fluid paclitaxel after bare metal stenting was safe and significantly reduced neointimal proliferation, restenosis, and clinical events compared with bare metal stent implantation alone.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheterization; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Single-Blind Method; Stents; Time Factors; Treatment Outcome; Tunica Intima

Treatment of bifurcations is a complex problem. The clinical value of treating side branches is an unsolved problem in the field of interventional cardiology.. We initiated a prospective randomized controlled trial. One hundred and ten patients with bifurcations were randomly assigned to 2 arms: Stenting of the main branch (MB, Taxus-stent, paclitaxel-eluting stents) and mandatory side branch (SB) percutaneous coronary intervention (PCI; kissing balloons) with provisional SB stenting (therapy A), or stenting of the MB (paclitaxel-eluting stents) with provisional SB-PCI only when the SB had a thrombolysis in myocardial infarction flow <2 (therapy B). The primary end point was target lesion revascularization. The mean ages were 66.8 years (A) versus 65.1 years (B, P=0.4), 71.4% (A) versus 77.8% were men (P=0.4), patients with diabetes were present in 25.0% versus 25.9% (P=0.9). The MB was left anterior descending artery in 80.4% versus 81.5% (A versus B, P=0.9). The SB-PCI and kissing balloon-PCI were performed according to the study protocol in 82.1%/73.2% versus 16.7%/13.0% (P<0.05 for both), while changing of the intended therapy was necessary in 17.9% versus 16.7% (A versus B, P=0.9). A final thrombolysis in myocardial infarction flow 3 (MB) was reached in all patients (groups A and B), final thrombolysis in myocardial infarction flow 3 (SB) was observed in 96.4% versus 88.9% (A versus B, P=0.3). Radiation time (min) and contrast medium (mL) were 14.2/210 (group A) versus 7.8/151.6 (group B; P for both <0.05). Six month - follow up: major adverse cardiac events was 23.2% (A) versus 24.1% (B, P=0.9), target lesion revascularization was 17.9% (A) versus 14.8% (B, P=0.7), and late lumen loss (MB) was 0.2 mm (A) versus 0.3 mm (B, P=0.5). In group B, no PCI of the SB was done during follow up.. A simple strategy using paclitaxel-eluting stents with only provisional SB-PCI may be of equal value to a more complex strategy with mandatory SB-PCI. Clinical Trial Registration- URL: http://www.controlled.trials.com. Unique identifier: ISRCTN22637771.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Circulation; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Pilot Projects; Prospective Studies; Single-Blind Method; Thrombosis; Time Factors; Treatment Outcome

This paper reports the 3-year clinical outcomes of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) compared with the TAXUS (Boston Scientific, Natick, Massachusetts) paclitaxel-eluting stent (PES) in the randomized SPIRIT II (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions) study.. The Xience V EES is a new-generation drug-eluting stent (DES) that might offer advantages over the first-generation DES in terms of improved clinical outcomes and a better safety profile.. The SPIRIT II trial was a multicenter, prospective, randomized, single-blind, clinical trial, randomizing 300 patients with de novo coronary artery lesions in a ratio of 3:1 to either EES or PES. The primary end point was in-stent late loss at 180 days.. At 3-year clinical follow-up cardiac death was numerically lower with EES than PES (0.5% vs. 4.3%, p = 0.056). The observed rate of myocardial infarction was 3.6% for EES and 7.2% for PES (p = 0.31). The rate of ischemia-driven target lesion revascularization was 4.6% and 10.1% for EES and PES, respectively (p = 0.14). Overall, there was a trend for lower major adverse cardiovascular events in the EES group compared with PES (7.2% vs. 15.9%, p = 0.053). The rate of stent thrombosis was low and comparable in both groups (EES 1.0% vs. PES 2.9%).. The present study reports the favorable 3-year clinical outcomes of the EES, which are consistent with the results from other studies of the EES with shorter follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Europe; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Single-Blind Method; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; United States

We describe the rationale and design for the 'PercutAneous INTervention with biodegradable-polymer based paclitaxel-eluting or sirolimus-eluting versus bare stents for de novo coronary lesions - PAINT trial'.. To evaluate two novel formulations of paclitaxel-eluting stent and the sirolimus-eluting stent against a stent with the same metallic structure but without polymer coating or drug elution.. The PAINT is a multicenter 3-arm randomized trial, conducted in Brazilian tertiary institutions, which included 275 patients allocated for the InfinniumR paclitaxel-eluting stent, the SupralimusR sirolimus-eluting stent or the Milennium MatrixR bare metal stent in a 2:2:1 ratio. Patients had de novo coronary lesions in native vessels with a diameter between 2.5 and 3.5 mm, amenable for treatment with a single stent of 29 mm or less in length. The primary objective was to compare the in-stent late loss at 9 months of both paclitaxel- and sirolimus-eluting versus the late loss of control bare metal stents. Important secondary objectives included the comparison in outcomes between sirolimus and paclitaxel stents, as well as the analysis of the incidence of major adverse cardiac events.. The PAINT trial had a unique design that allowed for the evaluation of the safety and efficacy profiles of two novel drug-eluting stent formulations, with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). As the drug-eluting stents differed by the drug, but were identical otherwise, the trial also allowed the comparison of the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective).

Topics: Absorbable Implants; Adolescent; Angioplasty, Balloon, Coronary; Brazil; Cardiovascular Agents; Coronary Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Epidemiologic Methods; Humans; Paclitaxel; Polymers; Prosthesis Design; Sirolimus; Treatment Outcome; Young Adult

Previous randomised studies have shown a significant reduction in restenosis when oral rapamycin (OR) is administered to patients undergoing bare metal stent (BMS) implantation. How this regimen compares to drug eluting stents (DES) is unknown.. Two-hundred patients with de novo coronary lesions were randomised to treatment with OR plus BMS (100 pts) or with DES (100 pts). OR was given as a bolus of 10 mg per day before PCI followed by daily doses of 3 mg during following 13 days. Primary endpoints were to compare hospital, follow-up and overall cost at one, two, three and five years of follow-up. The secondary endpoints included death, myocardial infarction (MI) and stroke and were analysed as major adverse cardiovascular events (MACCE). Target vessel (TVR) and target lesion revascularisation (TLR) were independently analysed. Costs included procedural resources, hospitalisation, medications, repeat revascularisation procedures and professional fees. Baseline demographic, clinical and angiographic characteristics were similar. At 18.3 +/- 7 months of follow-up, the initial strategy of OR plus BMS resulted in significant cost saving when compared to DES (p=0.0001). TLR rate was 8.2% with DES and 7.0% with OR plus BMS (p=0.84), similarly no differences in TVR rate in both groups was seen (10.6% and 10.5% in OR and DES group respectively, p=0.86). Non-inferiority testing, determined that DES therapy failed to be cost saving compared to OR in all possible cost scenarios.. A strategy of OR plus BMS is cost saving compared to DES in patients undergoing PCI for de novo coronary lesions.

Topics: Administration, Oral; Aged; Angioplasty, Balloon, Coronary; Argentina; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Cost Savings; Drug-Eluting Stents; Female; Health Care Costs; Hospital Mortality; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Metals; Middle Aged; Myocardial Infarction; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Sirolimus; Stents; Stroke; Time Factors; Treatment Outcome

To compare the effects of sirolimus-eluting (SES) versus bare metal stents (BMS) on 6-month in-stent late luminal loss (LLL) and 1-year major adverse cardiac events (MACE) in diabetics undergoing percutaneous coronary interventions.. In studies of unselected patients, coronary restenosis rates have been lower with SES than with BMS. Comparisons of SES versus BMS in diabetics with more than one stenosis or more than one vessel disease are few.. This open-label trial randomly assigned 200 diabetics with de novo coronary artery stenoses to receive up to three SES versus BMS in a 2:1 ratio. The patients underwent repeat coronary angiography at 6 months after the index procedure and were followed-up for 1 year. The primary study endpoint was in-stent LLL at 6 months.. Between August 2002 and May 2004, 83 patients (mean age = 60 years) with 128 lesions (mean = 1.5 per patient) were enrolled at four U.S. and seven Asian medical centers. Enrollment was terminated early by the Safety Monitoring Board because of a statistically significant difference in rates of clinical endpoints. The mean in-stent LLL at 6 months was 0.23 mm in SES versus 1.10 mm in BMS recipients (P < 0.001). At 12 months, 8 patients (15%) assigned to SES had experienced MACE versus 12 patients (41%) assigned to BMS (P = 0.006).. In diabetics, the mean 6-month in-stent LLL was significantly smaller, and 12-month MACE rate significantly lower, after myocardial revascularization with SES than with BMS.

Topics: Aged; Angioplasty, Balloon, Coronary; Asia; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Female; Fibrinolytic Agents; Humans; Male; Metals; Middle Aged; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome; United States

This study was conducted to determine whether direct stenting with TAXUS Liberté is noninferior to stenting after pre-dilation.. Direct stenting is performed in approximately 30% of patients, but data on clinical and angiographic outcomes with drug-eluting stents are limited.. The TAXUS ATLAS DIRECT STENT is a single-arm, multicenter study that enrolled patients with de novo coronary lesions visually estimated to be 10 to 28 mm in length in vessels 2.5 to 4.0 mm in diameter. The control group is the quantitative coronary angiography (QCA) subset of the TAXUS ATLAS trial, which used identical inclusion and exclusion criteria but mandated pre-dilation. The primary end point is 9-month analysis-segment percent diameter stenosis (%DS).. Baseline patient characteristics were similar between the groups. On QCA analysis, significantly shorter lesions with larger lumen diameter and less calcification were observed in the direct stent group. Direct stenting was successful in 97.6% of patients and was associated with a shorter procedure time and fewer complications. Follow-up %DS was noninferior for direct stent (26.41%) versus pre-dilation (29.14%) with a 1-sided 95% confidence interval of the difference between the groups (-0.34%) well below the pre-specified noninferiority margin (6.75%). Additionally, significantly lower restenosis (5.9% vs. 11.4%, p = 0.0229) and target lesion revascularization (TLR) 2.9% vs. 7.8%, p = 0.0087) rates were seen for direct stent versus pre-dilation.. Direct stenting of TAXUS Liberté is feasible and highly successful in carefully selected lesions. Direct stenting is noninferior to stenting after pre-dilation on the basis of %DS and can significantly reduce procedural time, procedural complications, and possibly angiographic restenosis and TLR.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Male; Middle Aged; New Zealand; Paclitaxel; Prospective Studies; Prosthesis Design; Severity of Illness Index; Singapore; Thrombosis; Time Factors; Treatment Outcome; United States

The aim of this study was to evaluate long-term outcome of patients treated for in-stent restenosis of bare-metal stents (BMS).. Treatment of restenosis of BMS is characterized by high recurrence rates. Vascular brachytherapy (VBT) improved outcome although late catch-up events were documented. Drug-eluting stents tested against VBT in this setting were found superior for at least the first year; superiority at longer follow-up is uncertain.. We evaluated 3-year outcome of the multicenter SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) trial, which randomized patients with restenosis of BMS to either a sirolimus-eluting stents (SES) or VBT.. Target vessel failure (cardiac death, infarction, or target vessel revascularization [TVR]) at 9 months as previously reported was significantly improved with SES. Kaplan-Meier analysis at 3 years documented that survival free from target lesion revascularization (TLR) and TVR continues to be significantly improved with SES: freedom from TLR 81.0% versus 71.6% (log-rank p = 0.018), and TVR 78.2% versus 68.8% (log-rank p = 0.022), SES versus VBT. At 3 years, target vessel failure and major adverse cardiac events (death, infarction, emergency coronary artery bypass grafting, or repeat TLR) remained improved with SES, but did not reach statistical significance. There was no statistically significant difference in definite or probable stent thrombosis (3.5% for SES, 2.4% for VBT; p = 0.758).. At 3 years of follow-up, after treatment of in-stent restenosis of BMS, patients treated with SES have improved survival free of TLR and TVR compared with patients treated with VBT. Stent thrombosis rates are not different between the 2 groups but are higher than reported in trials of treatment of de novo lesions.

Topics: Angioplasty, Balloon, Coronary; Brachytherapy; Cardiovascular Agents; Coronary Artery Bypass; Coronary Restenosis; Drug-Eluting Stents; Humans; Kaplan-Meier Estimate; Metals; Myocardial Infarction; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Recurrence; Risk Assessment; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome; United States

A novel zotarolimus-eluting coronary stent system (ZoMaxx, Abbott Laboratories, Abbott Park, Illinois) was compared with a paclitaxel-eluting coronary stent (Taxus Express2) in a randomized trial of percutaneous intervention for de novo coronary artery stenosis. The primary end point was defined as noninferiority of in-segment late lumen loss after 9 months.. The ZoMaxx stent system elutes 10 microg/mm zotarolimus using a phosphorylcholine polymer loaded onto a novel stainless steel stent platform containing a 0.0007-inch inner layer of tantalum.. Twenty-nine investigative sites in Europe, Australia, and New Zealand enrolled 401 patients, 396 of whom received a study stent.. After 9 months, late lumen loss was significantly greater in the ZoMaxx group (in-stent 0.67 +/- 0.57 mm vs. 0.45 +/- 0.48 mm; p < 0.001; in-segment 0.43 +/- 0.60 mm vs. 0.25 +/- 0. 45 mm; p = 0.003), resulting in significantly higher rates of >50% angiographic restenosis (in-stent 12.9% vs. 5.7%; p = 0.03; in-segment 16.5% vs. 6.9%; p = 0.007). The upper bound of the 95% confidence interval on the difference in in-segment late lumen loss between the 2 treatment groups (0.27 mm) exceeded the 0.25 mm value pre-specified for noninferiority. There were no significant differences between ZoMaxx and Taxus-treated groups with respect to target lesion revascularization (8.0% vs. 4.1%; p = 0.14), major adverse cardiac events (12.6% vs. 9.6%; p = 0.43), or stent thrombosis (0.5% in both groups).. After 9 months, the ZoMaxx stent showed less neointimal inhibition than the Taxus stent, as shown by higher in-stent late loss and restenosis by qualitative coronary angiography.

Topics: Aged; Angioplasty, Balloon, Coronary; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Europe; Female; Humans; Logistic Models; Male; Middle Aged; New Zealand; Paclitaxel; Prospective Studies; Prosthesis Design; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The TAXUS ATLAS Small Vessel (SV) and Long Lesion (LL) multicenter studies compared the performance of the thin-strut (0.0038 inch) TAXUS Liberté 2.25-mm stent (Boston Scientific; Natick, Massachusetts) and the TAXUS Liberté 38-mm long stent (Boston Scientific; Natick, Massachusetts) with the earlier paclitaxel-eluting TAXUS Express (Boston Scientific) stent that has identical polymer, drug dosage, and release kinetics but different stent geometry and thicker struts (0.0052 inch).. The TAXUS Liberté stent was designed with thinner and more even strut spacing to provide more uniform drug distribution, as well as increased flexibility and conformability. Clinical benefits of the new stent design have not been evaluated.. The TAXUS ATLAS SV and LL studies are nonrandomized studies comparing outcomes of the TAXUS Liberté 2.25 mm (N = 261) and TAXUS Liberté 38 mm (N = 150) stents to TAXUS Express historical control groups derived from the TAXUS IV and V trials. Inclusion/exclusion criteria for TAXUS Express and Liberté groups were similar in both studies.. Each study met its primary end point of noninferiority of 9-month in-segment diameter stenosis. Furthermore, TAXUS Liberté 2.25 mm, when compared with TAXUS Express, significantly reduced the rate of both 9-month angiographic restenosis (18.5% vs. 32.7%, p = 0.0219) and 12-month target lesion revascularization (6.1% vs. 16.9%, p = 0.0039). In addition, TAXUS Liberté 38 mm significantly reduced the risk of 12-month myocardial infarction compared with TAXUS Express (1.4% vs. 6.5%, p = 0.0246).. The thinner-strut TAXUS Liberté stent improved outcomes compared with the earlier TAXUS Express stent in both SVs and LLs (A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748; A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475).

Topics: Aged; Angioplasty, Balloon, Coronary; Asia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Linear Models; Logistic Models; Male; Middle Aged; Myocardial Infarction; North America; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Time Factors; Treatment Outcome

Wall shear stress (WSS) has been associated with neointimal hyperplasia (NIH) following bare metal stent (BMS) implantation. Drug-eluting stents (DES) almost abolish NIH. Conversely, diabetes mellitus amplifies NIH response. The association between WSS and arterial wall response following DES and BMS implantation in diabetic patients remains to be evaluated.. The study involved 20 diabetic patients randomized to BMS (n = 9) or sirolimus-eluting stent (SES; n = 11) implantation in native coronary arteries. A computational fluid dynamic model applied 3D intravascular ultrasound (IVUS) and two-plane angiographic to measure WSS (Pa). IVUS assessments were performed post-procedure and at 9-months follow-up. The target segment encompassed the stent plus 5 mm distal and proximal edges. A total of 93 subsegments were evaluated: in-stent segments divided in three subsegments (proximal, mid and distal; n = 60) and proximal and distal edges (n = 33).. Stent length was similar between BMS (17.4 +/- 7.3 mm) and SES (19.8 +/- 6.8 mm) groups. NIH was observed in all BMS subsegments (n = 27) versus one subsegment in the SES group (n = 33). WSS ranged from 0.52 to 4.20 Pa in the BMS and from 0.42 to 3.06 Pa in the SES group. There was no correlation between WSS and NIH in either stent group. In addition, there were no correlation between the change of external elastic membrane (EEM) or plaque growth at the edges and WSS.. WSS was not associated with NIH after implantation of SES or BMS in diabetic patients. Plaque growth or the change of EEM at the edges were not associated with WSS either.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Computer Simulation; Coronary Angiography; Coronary Circulation; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Diabetic Angiopathies; Drug-Eluting Stents; Female; Hemorheology; Humans; Hyperplasia; Image Interpretation, Computer-Assisted; Imaging, Three-Dimensional; Male; Metals; Middle Aged; Models, Cardiovascular; Pulsatile Flow; Sirolimus; Stents; Stress, Mechanical; Time Factors; Treatment Outcome; Ultrasonography, Interventional

To evaluate outcomes after percutaneous coronary intervention (PCI) with a drug-eluting balloon catheter (paclitaxel-coated) in patients with coronary artery bifurcation lesions.. The current practice of provisional stenting of the main branch (MB) is reasonable; however, long-term results of side-branch (SB) treatment are suboptimal. The use of drug-eluting stents has not improved these results, regardless of the implantation technique, and could potentially lead to a significant increase in (late) thrombotic events. To evaluate short-term safety and efficacy of a drug-eluting balloon (DEB) in patients with bifurcation lesions followed by provisional stenting of the main branch, we set up the DEBIUT Registry.. This registry enrolled 20 eligible patients with coronary artery bifurcation lesions. Patients received a PCI with a paclitaxel-coated balloon catheter, followed by provisional stenting of the MB with a bare-metal stent. Acute angiographic and clinical follow-up were performed after 1 and 4 months.. The procedure was successful in all patients. The use of sequential predilatation with DEB was safe and well tolerated. No acute or subacute closure of side branches occurred after treating with DEB. All patients were treated according to the provisional stenting technique; no stents were placed in the SB. At 4-month follow-up no major acute coronary events and no subacute vessel closure were reported.. The use of a drug-eluting balloon in patients with bifurcation lesions was effective and safe up to 4 months following PCI in patients with coronary artery bifurcation lesions.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Catheterization; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Equipment Design; Female; Humans; Male; Metals; Middle Aged; Netherlands; Paclitaxel; Prosthesis Design; Registries; Severity of Illness Index; Stents; Time Factors; Treatment Outcome

After coronary stenting with drug eluting stents, long-term clinical outcome of unprotected left main coronary artery disease is unknown, even large scale registries or randomised trials with coronary artery bypass graft are ongoing.. To report clinical and angiographic results of paclitaxel-eluting stent implantation for left main coronary artery stenosis (a series of 101 consecutive patients).. This report is a prospective study performed to evaluate the immediate and mid-term clinical and angiographic outcomes of patients undergoing paclitaxel-eluting stent (PES) implantation for unprotected left main coronary artery (LMCA) stenosis. From January 2004 to December 2005, 101 consecutive patients were stented with paclitaxel-eluting stents (the provisional T stenting technique followed by Kissing balloon for distal left main vessel disease).. Mean age was 68.9+/-11.07 years. 73.3% of patients were male. Acute coronary syndrome was present in 65% of patients, of whom 22.8% had ST elevation. Distal left main trunk lesions were present in 87.1% of cases. Three-vessel disease represented 7% of cases. Angiographic success was obtained in 97.03% of patients with an acute gain of 2.18+/-0.53mm. GpIIbIIIa inhibitors were used in only 8.9% of cases. Hospital stay was 7.6 +/- 3.7 days. In-hospital complications were present in 7.9%, with a hospital mortality rate of 2%. At six month follow-up, the rate of target lesion revascularization (TLR) was 3%, and the rate for major adverse cardiac events (MACE) was 8.9%. Angiographic control was performed in 88.1% and a late loss of 0.1mm (0.04-0.2mm) was noted. Re-stenosis occurred in 4 patients (4.5% of cases). 4 patients (4%) died, including 2 from cardiac causes.. Paclitaxel-eluting stent implantation for unprotected left main coronary disease appears to be safe with high procedural success rate and a low re-stenosis rate at six month-follow-up.

Topics: Acute Coronary Syndrome; Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Feasibility Studies; Female; Hospital Mortality; Humans; Length of Stay; Male; Middle Aged; Paclitaxel; Platelet Aggregation Inhibitors; Prospective Studies; Time Factors; Treatment Outcome

The use of the Endeavor stent might reduce restenosis and stent thrombosis at 9 months.. Patients (n =1,197) treated for single coronary artery stenosis were enrolled in a prospective, randomized, double-blind study and randomly assigned to receive the Endeavor zotarolimus-eluting phosphorylcholine polymer-coated stent (n= 598) or the same bare metal stent but without the drug or the polymer coating (n=599).. The 2 groups were well matched in baseline characteristics. Diabetes was present in 20.1% of patients; the mean reference vessel diameter was 2.75 mm; and the mean lesion length was 14.2 mm. The primary end point of target vessel failure at 9 months was reduced from 15.1% with the bare metal stent to 7.9% with the Endeavor (P=0.0001), and the rate of major adverse cardiac events was reduced from 14.4% with the bare metal stent to 7.3% with the Endeavor (P=0.0001). Target lesion revascularization was 4.6% with Endeavor compared with 11.8% with the bare metal stent (P=0.0001). The rate of stent thrombosis was 0.5% with the Endeavor, which was not significantly different from 1.2% with the bare metal stent. In 531 patients submitted to angiographic follow-up, late loss was reduced from 1.03+/-0.58 to 0.61+/-0.46 (P<0.001) in stent and from 0.72+/-0.61 to 0.36+/-0.46 (P<0.001) in segment. The rate of in-segment restenosis was reduced from 35% to 13.2% with Endeavor (P<0.0001). There was no excessive edge stenosis, aneurysm formation, or late acquired malposition by intravascular ultrasound imaging. Differences in clinical outcome were maintained at 12 and 24 months (P<0.0001).. Compared with bare metal stents, the Endeavor stent is safe and reduces the rates of clinical and angiographic restenosis at 9, 12, and 24 months.

Topics: Aged; Australia; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Double-Blind Method; Drug Delivery Systems; Equipment Design; Europe; Female; Humans; Israel; Male; Middle Aged; New Zealand; Pacific Islands; Phosphorylcholine; Prospective Studies; Sirolimus; Stents; Treatment Outcome

To see whether use of a sirolimus-eluting stent (SES) is superior to a third-generation thin-strut, cobalt-chromium stent (CCS) in terms of in-segment late loss at 9 months in patients with symptomatic coronary artery disease.. Stent-strut thickness has been shown to be strictly related with risk of in-stent restenosis, but available demonstrations of the angiographic efficacy of SES have been based on comparisons with thick-strut bare metal control stents.. The primary outcome measure of this single-center, single-blind randomized comparative trial was 9-month in-segment late loss. Eligibility criteria were symptomatic coronary artery disease and target vessel diameter appropriate for implantation a 3-mm stent. Based on a power calculation, 104 patients were randomly assigned to receive a SES (Cypher) or a CCS (Vision).. In-segment late loss was significantly lower in the SES group (0.18 +/- 0.40 mm vs 0.58 +/- 0.51 mm, P < 0.001). Regarding subsidiary outcome measures, in-segment restenosis (at 9 months) was recorded in 10% (5/50) patients treated with SES and 23% (11/48) receiving CCS (P = 0.14). No clinical difference between the two groups was apparent at 12 months. Freedom from target vessel failure at 12 months was 72% for SES patients and 68% for CCS patients (P = 0.65).. In patients with de-novo coronary lesions at medium risk of restenosis the anti-proliferative effect of SES is greater than that of a thin-strut CCS. Nevertheless, the angiographic results of the CCS were rather good. It remains to be seen whether the angiographic superiority of SES can translate into clinical superiority.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Prosthesis Design; Research Design; Risk Factors; Single-Blind Method; Sirolimus; Stents; Time Factors; Treatment Outcome

Despite routine use of coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI), no conclusive evidence exists that either modality is superior to medical therapy (MT) alone for treating multivessel coronary artery disease with stable angina and preserved ventricular function.. The primary end points were total mortality, Q-wave myocardial infarction, or refractory angina requiring revascularization. The study comprised 611 patients randomly assigned to undergo CABG (n=203), PCI (n=205), or MT (n=203). At the 5-year follow-up, the primary end points occurred in 21.2% of patients who underwent CABG compared with 32.7% treated with PCI and 36% receiving MT alone (P=0.0026). No statistical differences were observed in overall mortality among the 3 groups. In addition, 9.4% of MT and 11.2% of PCI patients underwent repeat revascularization procedures compared with 3.9% of CABG patients (P=0.021). Moreover, 15.3%, 11.2%, and 8.3% of patients experienced nonfatal myocardial infarction in the MT, PCI, and CABG groups, respectively (P<0.001). The pairwise treatment comparisons of the primary end points showed no difference between PCI and MT (relative risk, 0.93; 95% confidence interval, 0.67 to 1.30) and a significant protective effect of CABG compared with MT (relative risk, 0.53; 95% confidence interval, 0.36 to 0.77).. All 3 treatment regimens yielded comparable, relatively low rates of death. MT was associated with an incidence of long-term events and rate of additional revascularization similar to those for PCI. CABG was superior to MT in terms of the primary end points, reaching a significant 44% reduction in primary end points at the 5-year follow-up of patients with stable multivessel coronary artery disease.

Topics: Adrenergic beta-Antagonists; Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Angiotensin-Converting Enzyme Inhibitors; Calcium Channel Blockers; Cardiovascular Agents; Coronary Artery Bypass; Coronary Disease; Coronary Restenosis; Diet, Fat-Restricted; Disease-Free Survival; Drug Therapy, Combination; Electrocardiography; Endpoint Determination; Female; Follow-Up Studies; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Male; Middle Aged; Myocardial Infarction; Nitrates; Prognosis; Reoperation; Stents; Survival Analysis; Treatment Outcome

Paclitaxel-eluting stents inhibit restenosis; however, this technology has drawbacks (e.g., stent thrombosis, requirement for long-term antiplatelet therapy, and cost--particularly for patients with multivessel disease). Systemic treatment with a novel 130-nm, albumin-bound particle form of paclitaxel (nab-paclitaxel) has been shown to reduce restenosis in animals.. This study was designed to establish the safety and optimal dose of systemic nab-paclitaxel for reducing in-stent restenosis in humans. If well tolerated, systemic nab-paclitaxel may be used with any available bare-metal stent and at potentially lower cost than drug-eluting stents.. Patients received nab-paclitaxel 10, 30, 70, or 100 mg/m(2) intravenously after stenting of a single de novo lesion >or= 3 mm in diameter. Study endpoints included safety and major adverse cardiac events (MACE) at 2 and 6 months.. Data were obtained for all 23 enrolled patients (mean age 66 +/- 10 years, 74% men, 26% with diabetes). No significant adverse events (AE) were attributable to nab-paclitaxel at 10 or 30 mg/m(2). Moderate neutropenia, moderate sensory neuropathy, and mild to moderate, reversible alopecia occurred only at doses of 70 and 100 mg/m(2); therefore, doses of 70 mg/m(2) or higher were considered unacceptable in this patient population. No MACE were reported at 2 months. At 6 months, 4 target lesion revascularizations (TLR) for restenoses were reported (2 each in the 10- and 100-mg/m(2)-dose groups).. Systemic nab-paclitaxel was well tolerated at doses below 70 mg/m(2) in this group of patients; no unexpected AE were noted. Additional studies are under way to explore intravenous and intracoronary administration of nab-paclitaxel.

Topics: Adult; Aged; Aged, 80 and over; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Humans; Infusions, Intravenous; Male; Middle Aged; Nanoparticles; Paclitaxel; Prospective Studies; Stents; Time Factors; Treatment Outcome

The ZoMaxx Coronary Stent System elutes the antiproliferative agent zotarolimus via a biocompatible phosphorylcholine polymer loaded onto a novel, thin, stainless steel stent platform containing an 0.0007-inch inner layer of tantalum that enhances fluoroscopic radiopacity. The objective of this single-arm prospective clinical trial was to assess the safety and performance of the ZoMaxx stent for the treatment of coronary artery stenosis. Forty consecutive patients with ischemic coronary occlusive disease due to single de novo obstructive lesions of native coronary arteries were treated with 3 x 18 mm ZoMaxx stents at the Dante Pazzanese de Cardiologie in Saõ Paulo, Brazil, between April and July 2005. Independent core laboratories analyzed quantitative coronary angiography and intravascular ultrasound results immediately after stent implantation, and after 4 months. The lesion, procedure, and device-deployment success rates were all 100% (40 of 40). There were no major adverse cardiac events during the study. Follow-up quantitative coronary angiography at 4 months revealed in-stent and in-segment late lumen losses of 0.20 +/- 0.35 and 0.17 +/- 0.35 mm, respectively. Follow-up intravascular ultrasound at 4 months revealed 6.5 +/- 6.2% neointimal volume obstruction. There were no instances of late acquired stent incomplete apposition or stent thrombosis. In conclusion, the ZoMaxx Coronary Stent can be safely implanted for the treatment of de novo coronary artery stenosis. The inhibition of neointima formation as measured by follow-up angiography and IVUS after 4 months suggests therapeutic potential for the reduction of restenosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coronary Angiography; Coronary Circulation; Coronary Restenosis; Coronary Stenosis; Female; Follow-Up Studies; Humans; Male; Middle Aged; Phosphorylcholine; Prospective Studies; Prosthesis Design; Research Design; Sirolimus; Stents; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

Elderly patients are increasingly referred for revascularisation yet have been underrepresented in some large clinical trials. Although the advent of drug-eluting stents has dramatically reduced clinical events related to restenosis, older age remains one of the most important correlates of adverse outcome, even after an elective percutaneous coronary intervention (PCI). We sought to evaluate the impact of paclitaxel-eluting stents on coronary restenosis in elderly patients undergoing elective PCI.. Patients undergoing successful elective PCI with stenting of de novo coronary artery lesions were identified and screened for participation in this study. All patients included in our analysis were divided into two cohort groups: patients aged <75 years (younger cohort) and patients aged >or=75 years (elderly cohort). We evaluated the six-month incidence of target lesion revascularisation (TLR) and major adverse cardiac events, which included TLR, death and myocardial infarction.. A total of 171 (58 aged >or=75 years) consecutive patients were enrolled in the study. At six months, TLR rate was similar in both groups [1.77 vs. 1.72%, odds ratio (OR) 0.97, 95% confidence interval (CI) 0.08-10.9, P = 0.98, in the younger and elderly group, respectively]. Even the rate of major adverse cardiac events was comparable between the two groups (7.96 vs. 8.62%, OR 1.09, 95% CI 0.34-3.41, P = 0.88, in the younger and elderly group, respectively). Also the angiographic restenosis rates were comparable between patients <75 or >or=75 years (4.42 vs. 3.46%, P = 0.76).. After elective paclitaxel-eluting stent implantation, there is no difference in coronary restenosis in younger and elderly patients, suggesting an age-independent efficacy.

Topics: Aged; Cardiovascular Agents; Cohort Studies; Coronary Angiography; Coronary Restenosis; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Revascularization; Paclitaxel; Stents; Treatment Outcome

Using serial intravascular ultrasound (IVUS), the efficacy of reduced-dose sirolimus-eluting stents (SESs) in the prevention of neointimal hyperplasia (NH) and maintenance of luminal patency in human coronary arteries was evaluated.. In the animal model, a broad therapeutic window regarding sirolimus doses in suppressing NH has been reported.. Serial cross-sectional and volumetric IVUS analyses were performed in 44 patients treated with SES that contained lower sirolimus doses (either 45% or 70%) than standard SES. For cross-sectional analysis, minimum lumen area (MLA) was measured. Percent (%) NH volumetric obstruction was calculated as 100 x NH volume/stent volume.. IVUS measurements were similar between the two drug-dose groups. At 12 months follow-up, only one case developed late incomplete stent apposition. Between 4 and 12 months, a slight increase of in-stent % area loss and % NH obstruction was noted (3.5% +/- 10.4% to 6.7% +/- 10.7% and 1.9% +/- 5.0% to 4.4% +/- 8.0%, respectively). The majority of studied cases, however, sustained less than a 10% volumetric (93% of studied cases) and area loss (75% of studied cases) in the stented segment up to 12 months. At 12 months, % area loss within the stented segments and 5-mm reference segments were comparable (7.0% +/- 19.6% versus 6.7% +/- 10.7%).. Although slight increases of NH were noted, SESs, delivering two reduced drug doses, appeared to be effective for maintaining luminal patency during 12 months follow-up.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Dose-Response Relationship, Drug; Drug-Eluting Stents; Humans; Hyperplasia; Sirolimus; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional; Vascular Patency

To assess the safety and efficacy of direct stenting using the sirolimus-eluting BX Velocitytrade mark stent in patients with coronary lesions.. Although direct coronary stenting has become a widespread practice, there have been no systematic assessments of direct stenting with drug-eluting stents.. Total of 225 patients with identical inclusion and exclusion criteria as the original SIRIUS trial were enrolled in this prospective single-arm study. They were compared in a no-inferiority design with 412 similar patients from the SIRIUS trial who had sirolimus-eluting stents deployed after predilatation and were preassigned to angiographic follow-up evaluation.. Direct stenting was successful in 85.8% of the patients. Compared with the predilatation group, direct stenting was associated with shorter median procedure duration (33 min vs. 45 min, P < 0.001). Angiographic follow-up at 8 months revealed similar late loss (in-stent-0.19 +/- 0.47 mm vs. 0.17 +/- 0.44 mm, and in-lesion-0.23 +/- 0.41 mm vs. 0.24 +/- 0.47 mm) and similar frequency of binary restenosis (in-stent-4.6% vs. 3.2% and in-lesion-6.1% vs. 8.9%) between the two treatment strategies. However, stent-edge restenosis was lower with direct stenting than in the predilatation control group (2.1% vs. 6.9%, P = 0.02). At 12-months, there were no significant differences in target lesion revascularization (3.7% vs. 5.1%, P = ns) or composite major adverse cardiac events (7.0% vs. 8.3%, P = ns).. In patients similar to those treated in the SIRIUS trial, direct stenting using sirolimus-eluting stents achieves excellent short- and long-term clinical and angiographic results with shorter procedure time and less frequent stent edge restenosis compared with predilation stent implantation techniques.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Male; Middle Aged; Prospective Studies; Research Design; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional; United States

The aim of this intravascular ultrasound (IVUS) study was to assess the efficacy of the AXXESS Plus stent system for the treatment of bifurcation coronary lesions.. The AXXESS Plus is a novel bifurcation drug-eluting stent, comprised of a self-expanding flare-shaped stent platform and bioabsorbable polymer coating that releases Biolimus A9.. Data were obtained from the AXXESS PLUS trial, a prospective, multicenter, nonrandomized, single-arm study to evaluate safety and efficacy. Six-month follow-up IVUS analysis was available in 49 cases. Volumetric analysis using Simpson's method within the AXXESS stent, and cross-sectional analysis at the ostium of main branch and/or side branch was performed. Impact of bifurcation angle on stent expansion at the carina was also evaluated.. Within the AXXESS stent, neointimal volume obstruction percentage was 2.3% +/- 2.2%, with a minimum lumen area of 7.9 +/- 2.6 mm(2). Lumen area was 5.2 +/- 1.7 mm(2) at main branch ostium, and 4.0 +/- 1.5 mm(2) at side branch ostium. In two cases, incomplete stent apposition was observed at the proximal edge of the AXXESS stent. In one case, a gap between the AXXESS stent and an additional stent was observed. Greater bifurcation angle inversely correlated with smaller stent area at side branch ostium (r = -0.54, P = 0.03) but not at main branch ostium (r = -0.2, P = 0.29).. This novel self-expanding, drug-eluting bifurcation stent demonstrated effective lesion coverage along with significant neointimal suppression equivalent to current generation balloon-expandable drug-eluting stent technology.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Hyperplasia; Male; Middle Aged; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

Coronary stents dramatically improve acute outcomes of percutaneous coronary interventions but also induce abundant intraluminal neointimal growth. Drug-eluting stents reduce intimal hyperplasia, the main cause of in-stent restenosis. The safety and beneficial effects of paclitaxel-eluting stents (Taxus) in patients treated in daily practice remains to be defined. The aim of this study was to report the late outcomes of Taxus implantation in patients with coronary artery disease. The study population consisted of 151 patients (202 stents) who had undergone coronary Taxus stent implantation between March 2003 and May 2005. Patients were eligible for enrollment if there was symptomatic coronary artery disease or positive functional testing, and angiographic evidence of single or multivessel disease with a target lesion stenosis of 70% in a 2.0 mm vessel. The control coronary angiographies were performed after stent deployment at 12 +/- 2.8 months, and approximately 2 years of follow-up was completed. The polymer-based paclitaxel-eluting stent has been shown to be effective in reducing restenosis. Patients were followed-up for 16.7 +/- 7.4 months. All patients survived after stent implantation, but 2 (1.3%) patients experienced acute myocardial infarction after 3 and 9 months following angioplasty. Recurrent angina pectoris was observed in 3 patients. Angiographic evidence of restenosis was observed in these 5 patients. Three patients underwent angioplasty because of re- stenosis, and coronary artery bypass grafting was conducted in the other 2 patients. The results indicate that Taxus stents can be implanted with a very high success rate and have encouraging long-term angiographic and clinical results.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Treatment Outcome

Compared with bare metal stents, sirolimus-eluting and paclitaxel-eluting stents have been shown to markedly improve angiographic and clinical outcomes after percutaneous coronary revascularization, but their performance in the treatment of de novo coronary lesions has not been compared in a prospective multicenter study.. To compare the safety and efficacy of sirolimus-eluting vs paclitaxel-eluting coronary stents.. Prospective, randomized comparative trial (the REALITY trial) conducted between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months.. Ninety hospitals in Europe, Latin America, and Asia.. A total of 1386 patients (mean age, 62.6 years; 73.1% men; 28.0% with diabetes) with angina pectoris and 1 or 2 de novo lesions (2.25-3.00 mm in diameter) in native coronary arteries.. Patients were randomly assigned in a 1:1 ratio to receive a sirolimus-eluting stent (n = 701) or a paclitaxel-eluting stent (n = 685).. The primary end point was in-lesion binary restenosis (presence of a more than 50% luminal-diameter stenosis) at 8 months. Secondary end points included 1-year rates of target lesion and vessel revascularization and a composite end point of cardiac death, Q-wave or non-Q-wave myocardial infarction, coronary artery bypass graft surgery, or repeat target lesion revascularization.. In-lesion binary restenosis at 8 months occurred in 86 patients (9.6%) with a sirolimus-eluting stent vs 95 (11.1%) with a paclitaxel-eluting stent (relative risk [RR], 0.84; 95% confidence interval [CI], 0.61-1.17; P = .31). For sirolimus- vs paclitaxel-eluting stents, respectively, the mean (SD) in-stent late loss was 0.09 (0.43) mm vs 0.31 (0.44) mm (difference, -0.22 mm; 95% CI, -0.26 to -0.18 mm; P<.001), mean (SD) in-stent diameter stenosis was 23.1% (16.6%) vs 26.7% (15.8%) (difference, -3.60%; 95% CI, -5.12% to -2.08%; P<.001), and the number of major adverse cardiac events at 1 year was 73 (10.7%) vs 76 (11.4%) (RR, 0.94; 95% CI, 0.69-1.27; P = .73).. In this trial comparing sirolimus- and paclitaxel-eluting coronary stents, there were no differences in the rates of binary restenosis or major adverse cardiac events.. ClinicalTrials.gov Identifier: NCT00235092.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Implants; Female; Humans; Immunosuppressive Agents; Male; Middle Aged; Paclitaxel; Sirolimus; Stents; Survival Analysis; Treatment Outcome

To study the 5-year outcome of patients treated with gold-coated stent placement.. We have previously shown in the setting of a randomized trial that gold-coated stents are associated with worse mid-term outcome, mainly because of an increased risk of restenosis, compared to uncoated stents. The long-term outcome and, in particular, mortality risk after implantation of gold-coated stents are not known.. A total of 731 patients with symptoms or signs of ischemia received randomly either a gold-coated (n = 367) or an uncoated steel stent (n = 364) of identical design. Patients were clinically followed-up at 1 and 5 years. The primary endpoint of the study was the composite of major cardiac events (death, myocardial infarction, or target vessel revascularization (TVR)). The incidence of death was a secondary endpoint.. Five-year follow-up was available in 97.5% of the patients. The composite of death, myocardial infarction, or TVR occurred in 51% of the patients treated with gold-coated stents and 40% of the patients treated with uncoated stents (P = 0.005). Of note, there was a marked increase in the absolute difference in mortality between patients in the gold-coated and uncoated stent groups, from 1.6% at 1 year to 4.9% after 5-year follow-up (P = 0.09). A multivariate analysis showed that gold-coated stent implantation was independently associated with 5-year mortality (hazard ratio, 1.46; 95% confidence interval, 1.02-2.09; P = 0.04).. Gold-coated stents are associated with a sustained increased overall risk for major cardiac events, and notably, they may increase the long-term mortality risk.

Topics: Aged; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Female; Follow-Up Studies; Germany; Gold; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Predictive Value of Tests; Risk Factors; Stents; Survival Analysis; Time Factors; Treatment Outcome

To compare the effect of sirolimus-eluting stents to paclitaxel-eluting stents in complex and diffuse coronary lesions.. 138 consecutive patients with complex and diffuse coronary lesions were enrolled from April 2004 to August 2005; they were implanted with more than 25 mm long sirolimus-eluting stents or paclitaxel-eluting stents. Unsuccessful cases were excluded. All patients received medical treatment according to guideline. Aspirin 300 mg and clopidogrel 75 mg once daily were continually administered for 6 months after the procedure. The patients were followed up after 6 months.. The study population consisted of 138 patients, including 124 men and 14 women. There were 129 (87.8%) C ACC/AHA type lesions. The average reference vessel diameter was (2.91 +/- 0.43) mm. The average lesion length was (36.36 +/- 12.27) mm. The average stent length per lesion was (40.25 +/- 12.79) mm. There was no difference of patient and lesion baseline characteristics between the groups of sirolimus-eluting and paclitaxel-eluting stents. At the end of follow up, in-stent restenosis rate (5.9% vs 17.7%, P = 0.023) and in-segment restenosis rate (9.4% vs 21.0%, P = 0.048) in the group of sirolimus-eluting stents were less than that in the group of paclitaxel-eluting stents. The difference was also seen in in-stent late luminal loss [(0.26 +/- 0.46) mm vs (0.60 +/- 0.66) mm, P = 0.001)] and in-segment late lumens loss [(0.16 +/- 0.52) mm vs (0.45 +/- 0.65) mm, P = 0.003)]. There was no difference between the sirolimus-eluting stents group and paclitaxel-eluting stents group in the incidence of target lesion revascularization (7.1% vs 12.9%, P = 0.223).. In patients with complex and diffuse coronary lesions, the use of the sirolimus-eluting stent was associated with a decrease in the extent of late luminal loss, as compared with use of paclitaxel-eluting stents, suggesting that sirolimus-eluting stent might be more suitable to be used in small vessel.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Disease; Coronary Restenosis; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Sirolimus; Stents; Treatment Outcome

Thiazolidinediones have been shown to have an antiproliferative vascular effect in experimental models. We sought to study the effect of rosiglitazone on in-stent restenosis in patients with established type 2 diabetes.. Patients with treated type 2 diabetes (mean duration 5.5 +/- 7.5 years) referred for coronary stenting were randomized in a double-blind fashion to receive oral rosiglitazone or placebo for 6 months. Quantitative coronary angiography and intravascular ultrasound data were obtained at baseline and follow-up. Plasma plasminogen activator inhibitor-1 levels were prospectively measured.. Sixteen patients were enrolled. There were no significant differences in follow-up in-stent luminal diameter stenosis measured by quantitative coronary angiography or in-stent luminal area stenosis and neointimal volume index obtained by intravascular ultrasound, nor were there any differences in plasma plasminogen activator inhibitor-1 levels after long-term use despite improvement in diabetes control and insulin sensitivity.. Rosiglitazone, given at the time of stent implantation in treated diabetics, did not reduce in-stent restenosis in this small series. The vascular biological effects of this agent await further clarification in humans and evaluation in larger clinical trials.

Topics: Administration, Oral; Adult; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Double-Blind Method; Female; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Male; Middle Aged; Plasminogen Activator Inhibitor 1; Rosiglitazone; Stents; Thiazolidinediones

Restenosis after percutaneous coronary intervention (PCI) is a major problem affecting 15% to 30% of patients after stent placement. No oral agent has shown a beneficial effect on restenosis or on associated major adverse cardiovascular events. In limited trials, the oral agent tranilast has been shown to decrease the frequency of angiographic restenosis after PCI.. In this double-blind, randomized, placebo-controlled trial of tranilast (300 and 450 mg BID for 1 or 3 months), 11 484 patients were enrolled. Enrollment and drug were initiated within 4 hours after successful PCI of at least 1 vessel. The primary end point was the first occurrence of death, myocardial infarction, or ischemia-driven target vessel revascularization within 9 months and was 15.8% in the placebo group and 15.5% to 16.1% in the tranilast groups (P=0.77 to 0.81). Myocardial infarction was the only component of major adverse cardiovascular events to show some evidence of a reduction with tranilast (450 mg BID for 3 months): 1.1% versus 1.8% with placebo (P=0.061 for intent-to-treat population). The primary reason for not completing treatment was > or =1 hepatic laboratory test abnormality (11.4% versus 0.2% with placebo, P<0.01). In the angiographic substudy composed of 2018 patients, minimal lumen diameter (MLD) was measured by quantitative coronary angiography. At follow-up, MLD was 1.76+/-0.77 mm in the placebo group, which was not different from MLD in the tranilast groups (1.72 to 1.78+/-0.76 to 80 mm, P=0.49 to 0.89). In a subset of these patients (n=1107), intravascular ultrasound was performed at follow-up. Plaque volume was not different between the placebo and tranilast groups (39.3 versus 37.5 to 46.1 mm(3), respectively; P=0.16 to 0.72).. Tranilast does not improve the quantitative measures of restenosis (angiographic and intravascular ultrasound) or its clinical sequelae.

Topics: Administration, Oral; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; ortho-Aminobenzoates; Treatment Outcome; Ultrasonography

Drug-eluting stents (DES) are mostly used in percutaneous coronary intervention, which is the main treatment for coronary artery occlusion. This procedure aims to restore the natural lumen, while minimizing the risk of restenosis. However, stent insertion increases the risk for infections, due to contamination of the device or insertion hub with normal skin flora. While coronary stent infection is a rare complication, it can be fatal. Currently, there is little information on biofilm formation on everolimus-eluting stents. Although everolimus is not designed as an antimicrobial agent, its antimicrobial activity should be investigated. In this study, biofilm formation on everolimus-eluting and bare metal stents (BMS) is characterized through biochemical and electrochemical methods. DES and BMS are inoculated with Pseudomonas aeruginosa and Staphylococcus epidermidis, both independently and in co-culture. Biofilms formed on DES were 49.6 %, 12.9 % and 47.5 % higher than on BMS for P. aeruginosa, S. epidermidis and their co-culture, respectively. Further, the charge output for DES was 18.9 % and 59.7 % higher than BMS for P. aeruginosa and its co-culture with S. epidermidis, respectively. This observation is most likely due to higher surface roughness of DES, which favors biofilm formation. This work shows that bioelectrochemical methods can be used for rapid detection of biofilms on drug-eluting and bare metal stents, which may find application in quality assessment of stents and in characterization of stents removed after polymicrobial infections.

Topics: Biofilms; Cardiovascular Agents; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Metals; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

Topics: Angioplasty, Balloon; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Humans; Paclitaxel; Treatment Outcome; Ultrasonography, Interventional

A decade ago, the iopromide-paclitaxel coated balloon (iPCB) was added to the cardiologist's toolbox to initially treat in-stent restenosis followed by the treatment of de novo coronary lesions. In the meantime, DES technologies have been substantially improved to address in-stent restenosis and thrombosis, and shortened anti-platelet therapy. Recently, sirolimus-coated balloon catheters (SCB) have emerged to provide an alternative drug to combat restenosis.. The objective of this study is to determine the safety and efficacy of a novel crystalline sirolimus-coated balloon (cSCB) technology in an unselective, international, large-scale patient population. Percutaneous coronary interventions of native stenosis, in-stent stenosis, and chronic total occlusions with the SCB in patients with stable coronary artery disease or acute coronary syndrome were included. The primary outcome variable is the target lesion failure (TLF) rate at 12 months, defined as the composite rate of target vessel myocardial infarction (TV-MI), cardiac death or ischemia-driven target lesion revascularization (TLR). The secondary outcome variables include TLF at 24 months, ischemia driven TLR at 12 and 24 months and all-cause death, cardiac death at 12 and 24 months.. Since there is a wealth of patient-based all-comers data for iPCB available for this study, a propensity-score matched analysis is planned to compare cSCB and iPCB for the treatment of de novo and different types of ISR. In addition, pre-specified analyses in challenging lesion subsets such as chronic total occlusions will provide evidence whether the two balloon coating technologies differ in their clinical benefit for the patient.. ClinicalTrials.gov Identifier: NCT04470934.

Topics: Angioplasty; Cardiovascular Agents; Clinical Trials as Topic; Constriction, Pathologic; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Paclitaxel; Sirolimus; Treatment Outcome

Drug-coated balloons (DCBs) have emerged for percutaneous coronary interventions (PCI) of in-stent restenosis or particular anatomical subsets. We provide a real-world analysis of the prognostic determinants and long-term outcomes of patients treated with DCB for any lesion in a comprehensive multicenter registry. The primary study endpoint was the occurrence of major cardiovascular events (MACE: composite of all-cause death, myocardial infarction, and target vessel revascularization) at the longest available follow-up. We included 267 patients (196 treated for in-stent restenosis and 71 for de novo lesions), with a median follow-up of 616 [368-1025] days. MACE occurred in 70 (26.2%) of the patients and related with higher rates of in-stent restenosis (P = .04), longer and more type C lesions (

Topics: Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Percutaneous Coronary Intervention; Registries; Risk Factors; Treatment Outcome

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

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Humans; Paclitaxel; Sirolimus; Stents; 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

To evaluate the long-term efficacy of three currently available drug coated balloons (DCB) for the treatment of de-novo coronary lesions.. This was a retrospective analysis of prospectively collected data from the Swedish Coronary Angiography and Angioplasty Registry. Between 2009 and 2017, three currently available DCB brands used in the treatment of de novo lesions were included. Outcomes were clinically driven restenosis and target lesion thrombosis (TLT) (per device) and major adverse cardiac events (MACE) including death, myocardial infarction or target vessel revascularization (per patient) at 4 years. Multivariable Cox regression models were used to adjust for differences.. We included 6715 lesions treated with DCBs, 4483 SeQuent® Please (S-DCB), 1071 IN.PACT Falcon (I-DCB) and 1161 Pantera® Lux (P-DCB), in 5670 patients. The mean DCB diameter was 2.4 mm. Bailout stenting occurred in 6.7% of lesions. Angiographic success was 98.5%. The overall cumulative rate of restenosis was 5.5% (299 events). The risk for reported restenosis did not significantly differ between I-DCB vs S-DCB, adjusted hazard ratio (aHR) 0.96; 95% confidence interval (CI) 0.69-1.34, P-DCB vs S-DCB aHR 0.88; 95% CI 0.63-1.23 and I-DCB vs P-DCB aHR 1.10; 95% CI 0.72-1.68. The cumulative risk for TLT was 0.8% in all three DCBs. The risk for MACE or individual components of MACE did not differ between the three patient-groups.. In de novo coronary lesions, we found comparable long-term efficacy with three currently available DCB brands. DCB angioplasty was feasible with low risk for long-term restenosis and TLT.

Topics: Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Pharmaceutical Preparations; Retrospective Studies; Treatment Outcome

Interventional therapies such as drug-eluting stents (DES) and drug-coated balloons (DCB) have significantly improved the clinical outcomes of patients with coronary occlusions in recent years. Despite this marked improvement, ischemic cardiovascular disease remains the most common cause of death worldwide. To address this, research efforts are focused on improving the safety and efficacy of the next generation of these devices. However, current experimental methods are unable to account for the influence of atherosclerotic lesions on drug uptake and retention. Therefore, in this study, we used an integrated approach utilizing both in vitro and in silico methods to assess the performance of DCB therapy. This approach was validated against existing in vivo results before being used to numerically estimate the effect of the atheroma. A bolus release of sirolimus was observed with our coating matrix. This, coupled with the rapid saturation of specific and non-specific binding sites observed in our study, indicated that increasing the therapeutic dose coated onto the balloons might not necessarily result in greater uptake and/or retention. Additionally, our findings alluded to an optimal exposure time, dependent on the coating matrix, for the DCBs to be expanded against the vessel. Moreover, our findings suggest that a biphasic drug release profile might be beneficial for establishing and maintaining the saturation of bindings sites within severely occluded vessels. Ultimately, we have demonstrated that computational methods may be capable of assessing the efficacy of DCB therapy as well as predict the influence of atherosclerotic lesions on said efficacy.

Topics: Angioplasty, Balloon, Coronary; Atherosclerosis; Cardiovascular Agents; Computer Simulation; Coronary Occlusion; Coronary Restenosis; Coronary Vessels; Dose-Response Relationship, Drug; Drug Liberation; Drug-Eluting Stents; Humans; Models, Cardiovascular; Sirolimus; Treatment Outcome

Drug-eluting balloons currently constitute a therapeutic tool used in percutaneous coronary interventions (PCI). Long-term results remain unknown. We evaluated the prognosis of PCI using a second generation paclitaxel-eluting balloon (PEB) in real-world patients. We included all PCI with PEB in de novo or in-stent restenosis coronary lesions performed in our unit from March 2009 to March 2019. We assessed the composite of major adverse cardiovascular events (MACE) rate after a median follow-up of 42 months. Consecutive patients (n = 320) with 386 lesions were included; 46.9% presented with stable angina and 53.1% acute coronary syndromes; 52.6% of the lesions were in-stent restenosis and 47.3% de novo lesions with a mean diameter of 2.4 ± 0.5 mm. A bare metal stent was implanted in 6.7% and a drug-eluting stent in 8.5% of patients. The MACE rate was 8%: 10 (2.6%) cardiovascular deaths, 13 (3.4%) myocardial infarctions, and 16 (4.1%) target lesion revascularization. The all-cause death rate was 5.2%. No cases of thrombosis were recorded. In conclusion, PEB was a safe and effective tool to treat in-stent restenosis and de novo coronary lesions, especially small vessel disease, during long-term follow-up.

Topics: Acute Coronary Syndrome; Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Equipment Design; Female; Humans; Male; Middle Aged; Paclitaxel; Prospective Studies; Time Factors; Treatment Outcome

Local administration of growth-inhibiting substances such as paclitaxel or sirolimus could reduce the risk of restenosis. In the drug coated balloon (DCB) technology the coating and the applied dose seem to play a major role. The aim of the present preclinical studies was to investigate the efficacy and safety of a specific DCB with paclitaxel as active ingredient and magnesium stearate as excipient.. Evaluation of the coating, drug release and transfer was done ex vivo and in vivo on peripheral arteries. A porcine coronary stent model was chosen to provoke intimal thickening. Conventional uncoated balloons were compared with paclitaxel urea and paclitaxel magnesium stearate coated balloons. QCA and histomorphometry was performed on treated vessels. Three areas of the heart were histologically examined for pathological changes.. QCA and histomorphometry revealed no differences in baseline data between treatment groups. All DCB groups showed a significant reduction of angiographic and histologic parameters describing neointimal formation 4 weeks after treatment (e.g. mean angiographic late lumen loss all coated 0.31 ± 0.18 mm versus 0.91 ± 0.37 mm in the uncoated balloon group). There were no device-related animal deaths or clinical abnormalities. In spite of very slight-to-slight microscopic findings limited to small arterial vessels in downstream tissue there was no change in left ventricular ejection fraction or angiographic presentation of small side branches of treated arteries.. Paclitaxel DCB using stearate as excipient show a high efficacy in reducing neointima formation after experimental coronary intervention. No evidence of myocardial damage resulting from distal embolization was found.

Topics: Animals; Cardiovascular Agents; Catheters; Coated Materials, Biocompatible; Coronary Restenosis; Paclitaxel; Stearic Acids; Stroke Volume; Swine; Treatment Outcome; Ventricular Function, Left

We evaluated the angiographic parameter and clinical outcomes of drug-coated balloon (DCB) to assess the optimal angiographic criteria in de novo small vessel disease (SVD). Patients (n = 424, mean age: 64.4 ± 11.2 years, men: 69.8%) at 20 sites in Korea were prospectively enrolled. The primary end point was late luminal loss (LLL) at 9-month follow-up angiography. Secondary end points included restenosis rates, target lesion failure (TLF), and DCB-related thrombosis during the 12-month follow-up period. We included 403 patients for analysis excluding 21 patients who required bailout stenting. Baseline mean reference vessel .diameter was 2.52 ± 0.39 mm and mean minimal luminal diameter (MLD) was 0.71 ± 0.40 mm. The mean MLD was 1.54 ± 0.37 mm after DCB. Late luminal loss was -0.01 ± 0.43 mm and restenosis was noted in 26 patients (12.2%). Minimal luminal diameter >1.6 mm and %

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Equipment Design; Female; Humans; Male; Middle Aged; Paclitaxel; Predictive Value of Tests; Prospective Studies; Registries; Republic of Korea; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

The everolimus-eluting stent (EES), one of the effective stents for in-stent restenosis (ISR), has a lower incidence of stent thrombosis; however, the underlying mechanism remains unknown. This study aimed to identify the effects of everolimus on vascular metabolism and thrombogenicity and examine their mechanistic link.. EESs and bare-metal stents were implanted in rabbit iliac arteries with smooth muscle cell (SMC)-rich neointima induced by endothelial denudation. Four weeks after stent implantation, the stented arteries were examined for histological analysis and metabolomics. Additionally, everolimus effects in coronary artery SMCs metabolism, tissue factor (TF) expression, and procoagulant activity were assessed in vitro.. EES-implanted arteries showed decreased neointima formation, less SMCs infiltration, and reduced TF expression. Concomitantly, they were metabolically characterized by increased levels of metabolites in amino acids, such as glutamine. Similarly, everolimus increased intracellular glutamine levels, decreased TF expression, and reduced procoagulant activity in SMCs in vitro. On the contrary, exogenous glutamine administration also increased intracellular glutamine level, decreased TF expression, and reduced procoagulant activity despite enhanced mammalian target of rapamycin (mTOR) activity.. Intracellular glutamine level is likely to determine vascular SMC-related thrombogenicity regardless of mTOR pathway activity. Therefore, increased intracellular glutamine level might contribute partially to the beneficial effect of EES use on stent thrombosis.

Topics: Animals; Cardiovascular Agents; Coronary Restenosis; Drug-Eluting Stents; Glutamine; Muscle, Smooth, Vascular; Myocytes, Smooth Muscle; Percutaneous Coronary Intervention; Prosthesis Design; Rabbits

Percutaneous coronary intervention (PCI) for coronary bifurcation lesions using the 2-stent strategy remains a challenging procedure for interventionalists because of the higher incidence of in-stent restenosis (ISR) and adverse events. ISR predictors in patients treated with newer-generation everolimus-eluting stents (EES) and the 2-stent strategy remain unknown. Hence, we aimed to evaluate the 1-year clinical and angiographic outcomes of non-left main trunk (LMT) bifurcation lesions treated with the 2-stent strategy using newer-generation EES.Methods and Results:The study sample consisted of 262 non-LMT bifurcation lesions treated using culotte or T-stenting with EES between 2010 and 2018. One-year post-procedural angiographic and clinical examinations were conducted in 208 (79.4%) and 260 (99.2%) lesions, respectively. The primary outcome measure was the 1-year post-procedural ISR rate, which was found to be 15.9%. Independent predictors of 1-year post-procedural ISR were long side branch lesions (adjusted odds ratio [aOR] 2.31; 95% confidence interval [CI] 1.02-5.23; P=0.04) and 3-link EES implantation (aOR 2.45; 95% CI 1.07-5.61; P=0.03). The 1-year cumulative incidence of target lesion revascularization was 3.5%.. The 1-year clinical outcomes of non-LMT bifurcation lesions treated with the 2-stent strategy using EES were acceptable. Long side branch lesions and lesions treated with 3-link EES were independent predictors of 1-year post-procedural ISR.

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

The PREVAIL study evaluated the safety and effectiveness of a paclitaxel-coated percutaneous transluminal coronary angioplasty balloon catheter for the treatment of coronary de novo and in-stent restenosis (ISR) lesions in patients with symptomatic ischemic heart disease.. PREVAIL was a prospective, multicenter, single-arm study that enrolled patients with clinical evidence of ischemia who had coronary lesions (de novo or first ISR) amenable to treatment with a drug-coated balloon (DCB). The study included 50 subjects (53 target lesions) who were treated with a Prevail DCB (Medtronic) during the index procedure and followed for 12 months. Mean lesion length was 14.5 ± 7.6 mm. The primary endpoint was in-stent (in-balloon) late lumen loss (LLL) by quantitative coronary angiography at 6 months post procedure. If the mean in-stent (in-balloon) LLL was less than the maximum acceptance rate of 0.50 mm at 6 months, then the study was considered successful.. Mean in-stent (in-balloon) LLL was 0.05 ± 0.44 mm at 6 months post procedure. There were no deaths, myocardial infarctions, or stent (lesion) thrombosis events within 12 months. The incidence of clinically driven target-lesion revascularization was 6.0% at 12 months and clinically driven target-vessel revascularization was 10.0%.. Paclitaxel DCB treatment of coronary de novo and first ISR lesions led to low LLL at 6 months and low rates of revascularization and safety events through 12 months.

Topics: Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Humans; Paclitaxel; Pharmaceutical Preparations; Prospective Studies; Treatment Outcome

This study sought to assess the efficacy of the drug-coated balloon (DCB) ESSENTIAL for the treatment of in-stent restenosis (ISR).. DCBs have proven a valid therapeutic option for the management of ISR in several clinical trials, yet no class effect can be claimed. Accordingly, every new DCB model has to be individually evaluated through clinical studies.. This is a prospective, multicenter study including consecutive patients undergoing percutaneous coronary intervention for ISR with the ESSENTIAL DCB. A 6-month quantitative coronary angiography (QCA)/optical coherence tomography (OCT) follow-up was scheduled. The primary endpoint was OCT-derived in-segment maximal area stenosis. Secondary endpoints included QCA-derived in-segment late lumen loss (LLL) and target lesion failure (TLF) rates at 6, 12, and 24 months. TLF was defined as the composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization.. A total of 31 patients were successfully treated with DCB, with 67% of ISR corresponding to drug-eluting stents (DES). At 6 months, 26 patients underwent the scheduled angiographic follow-up. The mean value for in-segment maximal area stenosis was 51.4 ± 13% and the median value was 53% (IQR 46.4-59.5). In the DES-ISR subgroup, these parameters were 52.6 ± 10% and 55.2% (IQR 49.3-58.5), respectively. In-segment LLL was 0.25 ± 0.43 mm with only 2 (7.7%) patients showing binary restenosis (>50%). The incidence of TLF was 10% at 6 months, 13.3% at 12 months, and 13.3% at 24 months.. In this study, the ESSENTIAL DCB showed sustained efficacy in the prevention of recurrent restenosis after treatment of ISR.. We sought to assess the efficacy of the drug-coated balloon ESSENTIAL for the treatment of in-stent restenosis through a prospective, multicenter study including QCA and OCT assessment at 6-month follow-up. The primary endpoint was in-segment maximal area stenosis. Among the 31 patients successfully treated with the ESSENTIAL DCB, an angiographic follow-up was conducted in 26. Mean in-segment maximal area stenosis was 51.4 ± 13% and the median value was 53% (IQR 46.4-59.5). In the DES-ISR subgroup, corresponding values were 52.6 ± 10% and 55.2% (IQR 49.3-58.5), respectively. The observed in-segment LLL was 0.25 ± 0.43 mm and binary restenosis rate was 7.7%. TLF was 10% at 6 months and 13.3% at 12 and 24 months.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Equipment Design; Female; Humans; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Risk Factors; Spain; Stents; Tomography, Optical Coherence; Treatment Outcome

Paclitaxel-coated balloon (PCB) treatment guided by fractional flow reserve (FFR) is safe and effective for de novo coronary lesions. It is unknown whether the instantaneous wave-free ratio (iFR), an alternative measure that does not require the administration of adenosine, will offer benefits similar to those of FFR in de novo lesion treatment with PCB. Baseline, post-balloon and 9-month angiographical parameters were obtained from 116 lesions of 104 patients. The cutoff value of iFR after balloon angioplasty used to define functionally nonsignificant residual stenotic lesions was 0.86 and they were subdivided into PCB or Stent group according to the treated device. The primary endpoint was late lumen loss at 9 months and the secondary endpoint was target vessel failure (TVF) at 3 years. Fifty-eight lesions were treated with PCB only and 58 lesions were treated with metal stent implantation. There were no differences in iFR between PCB and Stent groups at baseline (0.76 ± 0.19 vs. 0.73 ± 0.23, p = 0.630) and after procedure (0.93 ± 0.04 vs. 0.94 ± 0.05, p = 0.574). At 9 months, late lumen loss was significantly lower in PCB group compared with Stent group (0.04 ± 0.32 mm vs. 0.59 ± 0.77 mm, p = 0.001). At 3-year follow-up, TVF were not different between the treatment groups (5.2% vs. 8.6%, p = 0.453). PCB treatment guided by iFR measured right after balloon angioplasty is safe and effective for de novo coronary lesions with good angiographic results at 9 months and similar clinical outcomes at 3 years compared to stent group.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheterization; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Equipment Design; Female; Fractional Flow Reserve, Myocardial; Humans; Male; Middle Aged; Paclitaxel; Predictive Value of Tests; Registries; Severity of Illness Index; Stents; Time Factors; Treatment Outcome

To test the long-term efficacy of a sirolimus-coated balloon (SCB).. Nanoluté was a prospective registry to evaluate the clinical performance of a novel SCB (Concept Medical Research Private Limited, India) for the treatment of de novo coronary lesions and in-stent restenosis (ISR). We here present the 24 months clinical data.. All patients treated with SCB for any type of coronary indication between July 2012 and September 2015 were enrolled at Indian centers and clinically followed up to 24 months. Primary endpoints were major adverse cardiovascular events (MACE) defined as a composite of cardiac death, target lesion revascularization (TLR), and target vessel-myocardial infarction (MI).. A total of 484 SCBs were used in 408 patients to treat 435 lesions. In detail, the SCB was used for 183 patients with ISR, 185 with de novo small vessel disease, and 40 with de novo large vessel disease. Mean balloon length and diameter (average ± SD) were 22.3 ± 7.1 mm and 2.7 ± 0.40 mm, respectively. All patients with 24 months follow-up were included. Overall MACE rate was 4.2% (n = 17) with three cardiac deaths (0.7%), 13 TLR (3.2%), and one MI (0.2%).. The Nanoluté prospective registry is the first long-term clinical evidence of the safety and feasibility of this type of SCB, both in patients with ISR or de novo lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Equipment Design; Female; Humans; India; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

RENASCENT is a prospective, multi-center first-in-human clinical study to evaluate the clinical performance of the novel sirolimus-eluting 150-μm strut thickness FORTITUDE® BRS for percutaneous coronary intervention of single de novo coronary lesions.. FORTITUDE® BRS was tested in a prospective study in Italy and Colombia. Study objectives were in-scaffold angiographic late lumen loss (LLL) measured by quantitative coronary angiography and target vessel failure (TVF) defined as the composite rate of cardiac death, target vessel myocardial infarction or ischemia driven target lesion revascularization (TLR) at 9- and 24-months with clinical results up to 36-months.. A total of 63 patients were enrolled. All patients underwent lesion pre-dilatation and 22 patients (34.9%) underwent post-dilatation. Clinical device and procedural success was 98.4% (62/63 patients) and 96.8% (61/63 patients) respectively. At 9-months, TVF occurred in 3/61 (4.9%) of the patients including 2 peri-procedural MI and one ischemia-driven TLR. Between 9- to 24-months, ischemia-driven TLR occurred in 3 additional patients (4.9%) including 1 patient who presented with very late ST after stopping all medications. There were no further TVF between 24- and 36-months.. In this multi-center prospective study, the FORTITUDE® BRS was shown to be safe and effective in the treatment of single coronary lesions with low levels of TVF and LLL at 9- and 24-months. It was shown to be clinically safe upto 36-months follow-up.

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

Topics: Cardiovascular Agents; Cardiovascular Diseases; Coronary Restenosis; Drug-Eluting Stents; Extracorporeal Membrane Oxygenation; Humans; Pharmaceutical Preparations; Prosthesis Design; Stem Cells; Stents; Treatment Outcome

To assess the performance of the commercially available Magmaris sirolimus-eluting bioresorbable scaffold (BRS) with invasive imaging at different time points.. Coronary BRS with a magnesium backbone have been recently studied as an alternative to polymeric scaffolds, providing enhanced vessel support and a faster resorption rate. We aimed to assess the performance of the commercially available Magmaris sirolimus-eluting BRS at different time points.. A prospective, single-center, nonrandomized study was performed at the Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. Six patients with stable de novo coronary artery lesions underwent single-vessel revascularization with the Magmaris sirolimus-eluting BRS. Invasive follow-up including intravascular imaging using optical coherence tomography (OCT) was performed at different time points.. At a median of 8 months (range 4-12 months) target lesion failure occurred in one patient. Angiography revealed a late lumen loss of 0.59 ± 0.39 mm, a percentage diameter stenosis of 39.65 ± 15.81%, and a binary restenosis rate of 33.3%. OCT showed a significant reduction in both minimal lumen area (MLA) and scaffold area at the site of the MLA by 43.44 ± 28.62 and 38.20 ± 25.74%, respectively. A fast and heterogeneous scaffold degradation process was found with a significant reduction of patent struts at 4-5 months.. Our findings show that the latest iteration of magnesium BRS suffers from premature dismantling, resulting in a higher than expected decrease in MLA.

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Female; Humans; Magnesium; Male; Middle Aged; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Approximately, 10-20% of patients with drug eluting stent (DES) in-stent restenosis (ISR) will develop recurrent ISR; yet, the optimal management of recurrent DES-ISR is unknown. We sought to compare the outcomes of recurrent DES-ISR treated with drug eluting balloons (DEB) to those with repeated implantation of new-generation DES.. A total of 172 patients with recurrent DES-ISR were enrolled and stratified into two cohorts: the repeated DES implantation (Re-DES) group and the DEB group. The primary endpoint was the 1-year incidence of major adverse cardiovascular events (MACE).. Ninety-three patients treated with DEB and 79 patients with Re-DES implantation were analyzed. Both groups had comparable baseline characteristics. Lesser residual stenosis was achieved in the Re-DES group (11.3 ± 3.2% vs. 22.4 ± 4.3%; P = 0.00) than in the DEB group. However, the incidence of MACE and target lesion revascularization (TLR) were less in the DEB group (17.2% vs. 32.9%; P = 0.02 and 15.1% vs. 27.8%; P = 0.04, respectively). For the ≥3 metal-layered DES-ISR subgroup, DEB drastically reduced the incidences of MACE and TLR compared with Re-DES (20.0% vs. 57.9%; P = 0.02 and 16.0% vs. 47.4%; P = 0.04, respectively). Survival analysis demonstrated that MACE-free survival was significantly higher in the DEB group compared with the Re-DES group, whether the metal layers were ≥3 or 2. Multivariate analysis revealed that the risk factors of MACE were diabetes mellitus, ≥3 metal-layered DES ISR, and repeat DES deployment.. For recurrent DES-ISR, DEB may improve clinical outcomes compared with Re-DES implantation, especially for ≥3 metal-layered DES-ISR.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Progression-Free Survival; Recurrence; Retreatment; Retrospective Studies; Risk Factors; Time Factors

Managing patients with in-stent restenosis (ISR) remains an important clinical challenge. In particular, large, randomized trials assessing the effect of drug-eluting balloons (DEB) in patients with de novo lesions are warranted. We investigated the effect of DEB on procedural complications, target lesion revascularization (TLR), and major adverse cardiac and cerebrovascular events in patients with drug-eluting stent ISR and de novo lesions. The clinical profiles of 238 consecutive patients treated for coronary ISR (n = 174) and de novo lesions (n = 64) using SeQuent Please paclitaxel-coated balloon were analyzed. Study end points were major adverse cardiac events (MACEs). At 1-year follow-up, TLR and MACEs occurred with acceptably low rates (5.0% and 6.3%, respectively). At 2.00 (0.74) years of follow-up, there was a significant difference in the rates of TLR between the ISR and the de novo lesions groups (14.4% [ISR] vs 3.1% [de novo], P = .028), and the occurrence of MACEs distinctly increased in the ISR group compared to the de novo lesions group (21.8% vs 6.2%, P = .009). The long-term outcomes of the ISR group were inferior to those of the de novo group (TLR, log-rank P = .019; MACEs, log-rank P = .010). Drug-eluting balloon for ISR and de novo lesions of small coronary vessels is effective and safe.

Topics: Aged; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Postoperative Complications; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome

The use of vascular endothelial growth factor inhibitors such as sorafenib is limited by a risk of severe cardiovascular toxicity. A 28-year-old man with acute myeloid leukemia treated with prednisone, tacrolimus, and sorafenib following stem cell transplantation presented with severe bilateral lower extremity claudication. The patient was discharged against medical advice prior to finalizing a cardiovascular evaluation, but returned 1 week later with signs suggestive of septic shock. Laboratory tests revealed troponin I of 12.63 ng/mL, BNP of 1690 pg/mL, and negative infectious workup. Electrocardiogram showed sinus tachycardia and new pathologic Q waves in the anterior leads. Coronary angiography revealed severe multivessel coronary artery disease. Peripheral angiography revealed severely diseased left anterior and posterior tibial arteries, tibioperoneal trunk, and peroneal artery, and subtotal occlusion of the right posterior tibial artery. Multiple coronary and peripheral drug-eluting stents were implanted. An intra-aortic balloon pump was placed. Cardiac magnetic resonance imaging revealed chronic left ventricular infarction with some viability, 17% ejection fraction, and left ventricular mural thrombi. The patient opted for medical management. Persistent symptoms 9 months later led to repeat angiography, showing total occlusion of the second obtuse marginal artery due to in-stent restenosis with proximal stent fracture, and chronic total occlusion of the right internal iliac artery extending to the pudendal branch. Cardiac positron emission tomography/computed tomography viability study demonstrated viable myocardium, deeming revascularization appropriate. Symptom resolution was obtained with no recurrences. Sorafenib-associated vasculopathy may follow a fulminant course. Multimodality cardiovascular imaging is essential for optimal management.

Topics: Adult; Antineoplastic Agents; Cardiotoxicity; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Defibrillators; Defibrillators, Implantable; Drug-Eluting Stents; Electric Countershock; Endovascular Procedures; Humans; Intra-Aortic Balloon Pumping; Leukemia, Myeloid, Acute; Male; Myocardial Infarction; Peripheral Arterial Disease; Protein Kinase Inhibitors; Sorafenib; Treatment Outcome

Percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) usually involves multiple overlapping stents implantation to cover long coronary segments. A higher rate of restenosis has been described with stent overlapping. Recently, new long tapered stents emerged as a potential tool for treating long coronary lesions. Feasibility of using these new devices for the CTO PCI has not been described. The aim of this work was to describe our initial experience with 50 and 60 mm-long tapered sirolimus-eluting stents (SES) in CTO PCI.. We included 54 consecutive patients who underwent a CTO PCI and in whom an attempt to implant a 50 or 60 mm-long tapered SES was performed. Baseline clinical, angiographic, and procedural characteristics were recorded.. The median (IQR) age was 64 (58-73) years, and 45 (83.3%) patients were male. The tapered SES 50 and 60 mm-long was successfully implanted in 51 (94.4%) patients. In three patients, a 60 mm-long stent could not be implanted, and two or three overlapped shorter drug-eluting stents were deployed instead. An average of 1.4 ± 0.6 stents per patient was implanted. A single stent was deployed in 32 (59.3%) patients. During a median follow-up of 330 (149-551) days, repeat PCI in the target vessel was performed in two patients.. The use of the new BioMime Morph™ tapered SES for the treatment of CTO appears to be feasible in a high proportion of procedures. Further studies confirming the feasibility of this approach and its potential clinical advantages are needed.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome; Vascular Patency

Everolimus-eluting stent (EES) is effective for treating in-stent restenosis (ISR). However, the long-term incidence of target lesion revascularization (TLR) is unknown. Further, the role of post-intervention minimal stent area (MSA) measured by intravascular ultrasound (IVUS) in TLR is unknown in this setting.. Overall, 223 ISR lesions (192 patients) that were treated with EES between 2010 and 2016 were analyzed retrospectively. Lesions were divided into two groups according to the post-intervention MSA [ ≤ 5.3 mm: 72 lesions (67 patients), and > 5.3 mm: 151 lesions (138 patients)]. The cut-off point was determined on the basis of receiver operating characteristic curve analysis.. The cumulative 5-year incidence of TLR was significantly higher in the group with MSA of 5.3 mm or less than in the group with MSA more than 5.3 mm (15.8 and 7.2%, P = 0.01). After adjusting for confounders, the excess risk of the group with MSA of 5.3 mm or less relative to the group with MSA more than 5.3 mm for TLR remained significant [hazard ratio: 3.07, 95% confidence interval (CI): 1.17-8.51, P = 0.02]. Using multivariate logistic regression analysis, we identified female sex (odds ratio: 2.39, 95% CI: 1.06-5.49, P = 0.04) and stent size of 3.0 mm or less (odds ratio: 13.43, 95% CI: 6.23-32.38, P < 0.0001) as independent predictors of MSA of 5.3 mm or less.. EES implantation for ISR was associated with an acceptable rate of TLR through long-term follow-up. Postintervention MSA of 5.3 mm or less was associated independently with a higher risk for TLR.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vascular Patency

Drug-coated balloon (DCB) angioplasty has been shown to be a promising option for the treatment of coronary in-stent restenosis (ISR). We compared the clinical outcomes of patients with ISR who were treated with two commonly used paclitaxel-containing DCBs, the Pantera Lux (PL) and SeQuent Please (SP). A total of 491 patients with 507 ISR lesions [PL-DCB in 127 (26%) patients and SP-DCB in 364 (74%) patients] underwent DCB angioplasty for ISR lesions. The major adverse cardiac events (MACEs), including cardiac death, target lesion-related myocardial infarction, and target lesion revascularization, were assessed. There were no significant differences in each occurrence of MACE and cardiac death: 16 MACEs (61 per 1000 person-years) in the PL-DCB group and 55 (60 per 1000 person-years) MACEs in the SP-DCB group, log-rank p = 0.895, and three cardiac deaths (11 per 1000 person-years) in the PL-DCB group and ten cardiac deaths (11 per 1000 person-years) in the SP-DCB group, log-rank p = 0.849. Diabetes mellitus under insulin treatment [hazard ratio (HR) 2.71; 95% confidence interval (CI) 1.31-5.60; p = 0.007], chronic kidney disease (HR 1.99; 95% CI 1.01-3.92; p = 0.045), early-onset ISR (HR 1.99; 95% CI 1.18-3.36; p = 0.010), and recurrent ISR (HR 1.89; 95% CI 1.08-3.32; p = 0.026) were associated with the occurrence of MACE after DCB angioplasty. There was no significant difference of MACE between PL-DCB and SP-DCB treatment in patients with ISR. Patients with insulin-treated diabetes, chronic kidney disease, early-onset ISR, and recurrent ISR were at a higher risk of MACE after DCB angioplasty.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Republic of Korea; Retrospective Studies; Time Factors; Treatment Outcome

We aimed to compare the angiographic outcomes between repeat drug-eluting stent (DES) implantation and drug-coated balloon (DCB) treatment for restenotic lesion caused by stent fracture (SF). The treatment of restenotic lesion caused by SF after DES implantation has not been well evaluated. From April 2007 to April 2015, 9320 lesions were implanted with a DES during percutaneous coronary intervention in our hospital; of those, 815 lesions (8.7%) showed restenosis on the follow-up angiogram. The study subjects were 47 consecutive patients with 69 restenotic lesions caused by SF and treated by target lesion revascularization (TLR); of those, 27 patients with 45 lesions were treated with repeat DES during TLR (either a cobalt-chromium or platinum-chromium everolimus-eluting stent or zotarolimus-eluting stent; DES group), and 20 patients with 24 lesions were treated with DCB (DCB group) during TLR. The 12-month cumulative incidence of repeat TLR and predictors of repeat TLR was evaluated. Restenosis and re-restenosis were defined as % diameter stenosis > 50% on the follow-up angiogram. SF was defined as complete or partial separation of the stent strut as assessed by plain fluoroscopy. Baseline characteristics were similar between the groups. The 12-month binary re-restenosis rate and cumulative incidence of repeat TLR between the DES group and DCB group were 44.4% and 37.5% (p = 0.58) and 43.9% and 31.9% (p = 0.31), respectively. On multivariate analysis, a lesion with vessel hinge movement was an independent predictor of repeat TLR (p = 0.02, hazard ratio: 6.54, 95% confidence interval 1.30-32.8). The 12-month repeat TLR rate was high in both groups. After treating restenosis lesions caused by SF after DES implantation, mechanical stress leads to further interventional treatment, regardless of the type of device used.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Percutaneous Coronary Intervention; Proportional Hazards Models; Treatment Outcome

To evaluate the angiographic performance of a novel sirolimus-coated balloon (SCB) in de novo coronary lesions.. Out of an all-comer prospective registry of patients treated with the SCB at our center from April 2016 to September 2017, we selected those treated for a de novo stenosis on a native vessel, with a scheduled angiographic control at at least 4 months after the index procedure. We performed a centralized, blinded core-lab adjudicated quantitative coronary angiography analysis. Primary endpoint was late lumen loss. Secondary endpoints were binary restenosis and target-lesion revascularization.. A total of 27 patients with native coronary arteries treated with SCB and with angiographic follow-up entered the study; seven patients were excluded because a stent was implanted at the lesion site during the index procedure. The degree of calcification (assessed with coronary angiography) was high in six patients (30%) and the average lesion length was 20.52 ± 6.88 mm. The reference vessel diameter was 2.32 ± 0.44 mm and the percentage diameter stenosis was 67 ± 12. Procedural success was obtained in all patients. After a median of 6.6 ± 2.5 months, late lumen loss was 0.09 ± 0.34 mm and the percentage diameter stenosis was 31 ± 18. We observed two cases (10%) of binary restenosis which underwent subsequent target-lesion revascularization: in one a drug-eluting stent was implanted, whereas the other patient was treated with paclitaxel-coated balloon. No myocardial infarction or death was observed during follow-up.. The use of a novel SCB in native coronary arteries was associated with good angiographic outcome at 6-month follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Female; Humans; Italy; Male; Middle Aged; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Background A novel bioresorbable scaffold, the sirolimus-eluting Fantom, incorporates a radiopaque polymer, struts with a thickness of 125 µm, and a crossing profile of 1.35 mm. The purpose of this study was to evaluate the 9-month angiographic and 12-month clinical outcomes of the FANTOM scaffold in a larger patient population. Methods and Results The FANTOM II study (Safety & Performance Study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold - First Report on Initial 24 Month Outcomes) was a prospective, multicenter trial which enrolled 240 patients with single de novo coronary stenosis with reference vessel diameter 2.5 to 3.5 mm diameter and lesion length ≤20 mm. Major adverse cardiac events through 12-month follow-up were assessed. Angiographic follow-up was performed in consecutive patient cohorts at 6 months (n=117) and 9 months (n=123). Acute delivery success, acute technical success, acute procedural success, and clinical procedural success rates as defined in the clinical protocol were 97.9% (235/240), 95.8% (230/240), 99.1% (228/230), and 99.6% (227/228), respectively. The mean in-stent late lumen loss at 6 months and 9 months were 0.25±0.40 mm and 0.33±0.36 mm, respectively, and in-segment binary restenosis occurred in 2.0% and 7.6% of patients, respectively. Major adverse cardiac events and target lesion failure through 12 months occurred in 4.2% of 240 patients; scaffold thrombosis developed in only one patient (0.4%). Conclusions The Fantom sirolimus-eluting bioresorbable coronary scaffold demonstrated favorable safety and effectiveness performance at 12-month follow-up. Longer-term follow-up is ongoing to examine the late outcomes with this novel device. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02539966.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Female; Humans; Male; Middle Aged; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

Patients with diabetes mellitus (DM) remain at higher risk of restenosis after percutaneous coronary intervention despite the use of contemporary drug-eluting stents. The Cre8 amphilimus-eluting stent (AES) has shown promising results in DM patients. Whether this holds true irrespective of patient's clinical and angiographic complexity is unknown.. Five hundred and ninety five consecutive patients (738 lesions) undergoing AES implantation were included in the INVESTIG8 multicenter registry. Patients were stratified according to DM status and further stratified according to patients' complexity. The prespecified primary endpoint was target lesion failure (TLF)-defined as the composite of cardiac death, target-vessel myocardial infarction, and target lesion revascularization (TLR).. DM patients were more often complex as compared to non-DM patients (70% vs. 61%, P = 0.015). At 18-month follow-up, there was a trend to a higher TLF rate in DM than in non-DM patients (6.9% vs. 3.5%, P = 0.063). This was largely driven by a markedly higher risk of TLF among complex DM patients as compared to simple DM patients (8.9% vs. 2.4%, P = 0.053). A multivariate analysis identified complexity (HR 6.11, 95% CI: 1.42-26.2) but not DM (HR 1.59; 95% CI 0.71-3.56) as an independent predictor of TLF. Of note, TLR rates were similar between DM and non-DM patients (3.3% vs. 1.9%, P = 0.228).. In this real-world, multicenter registry the Cre8 AES showed favorable clinical outcomes in DM patients. Increased risk of TLF appears to be driven by patients' complexity rather than DM status. These findings will need to be confirmed in a large-scale randomized trial.

Topics: Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Diabetes Mellitus; Drug-Eluting Stents; Europe; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Recurrence; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

We report a case of percutaneous coronary intervention with drug coated balloon (DCB) for the in-stent restenosis of polytetrafluoroethylene-covered stent. One year follow-up angiography was excellent and in-stent lumen enlargement compared with the postprocedure and 6-months follow-up was demonstrated by optical coherent tomography. This case suggested the utility of DCB as a therapeutic option for covered-stent restenosis.

Topics: Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Fractional Flow Reserve, Myocardial; Humans; Male; Paclitaxel; Percutaneous Coronary Intervention; Polytetrafluoroethylene; Prosthesis Design; Stents; Tomography, Optical Coherence; Treatment Outcome

Coronary calcification (CCA) is one of the independent predictors for major adverse cardiac events (MACEs) in coronary intervention. Post-marketing surveillance study Japan is a prospective registry designed to evaluate the safety and efficacy of the everolimus-eluting stent (EES, XIENCE V/PROMUS Stent) in routine clinical practice at 47 centers. In this study, 1848 lesions (1546 patients) were assessed using quantitative coronary angiography. In these 1546 patients, renal function data were unknown in 26 patients. Three patients in 70 patients with dialysis and 56 patients in 1450 patients with no dialysis were excluded, because they had multiple lesions with mixed calcification lesions. We evaluated the effects of CCA on 8-month angiographic and 3-year clinical outcomes in dialysis and non-dialysis patients. Moderate-to-severe (Ca group) and none-to-mild CCA (non-Ca group) were observed in 33 lesions (30 patients) and 48 lesions (37 patients) in dialysis patients, and these were observed in 306 lesions (286 patients) and 1303 lesions (1108 patients) in non-dialysis patients, respectively. In non-dialysis patients, the ischemic-driven target lesion revascularization (ID-TLR) and MACE rate over the 3 years were significantly higher in the Ca group than in the non-Ca group (5.8 vs. 3.1%, p = 0.025 and 10.0 vs. 5.0%, p = 0.0011). In dialysis patients, ID-TLR and MACE rates were high in both groups (14.3 vs. 17.9%, p = 0.85 and 17.5 vs. 36.1%, p = 0.16). In non-dialysis patients, 8-month angiographic and 3-year clinical outcomes were worse in the Ca group. However, in dialysis patients, both outcomes were worse regardless of CCA.Clinical Trial registration https://clinicaltrials.gov/ct2/show/NCT01086228 .

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Product Surveillance, Postmarketing; Prospective Studies; Registries; Renal Dialysis; Treatment Outcome; Vascular Calcification

This study aimed at assessing the performance of a new generation polymer-free biolimus-eluting stent (BES) in real-world patients with ST-segment elevation myocardial infarction (STEMI).. Polymers components of early-generation drug-eluting stents have been implicated in the pathogenesis of delayed arterial healing, vessel remodeling, and delayed stent thrombosis. Recently, a novel polymer-free BES has shown excellent clinical performance in clinical trial setting.. Overall, 175 consecutive patients (64 ± 14 years, 141 men) treated with the BioFreedom (Biosensors Europe, Morges, Switzerland) polymer-free BES because of STEMI were included in this study. The primary endpoint was the rate of major adverse cardiac events (MACE), a composite of cardiac death, recurrent myocardial infarction, and ischemia-driven target vessel revascularization at 1 year follow-up. A subgroup of patients underwent 6-month angiographic follow-up. Dual antiplatelet therapy was prescribed for 12 months after STEMI.. At 1 year, the cumulative rate of MACE was 4.6%. One patient (0.6%) had an arrhythmic cardiac death and five (2.9%) had ischemia-driven target vessel revascularization, although only three (1.7%) had target lesion revascularization. Two (1.1%) patients had acute stent thrombosis yielding nonfatal myocardial infarction. In 70 patients (63 ± 14 years, 61 men), quantitative coronary angiography at 6-month follow-up revealed diameter stenosis of 24.1 ± 13.7% and minimal lumen diameter of 2.29 ± 0.56 mm, yielding a late lumen loss of 0.13 ± 0.14 mm.. In real-world setting, implantation of a new-generation polymer-free BES during STEMI is associated with favorable clinical and angiographic results, pointing toward the overall efficacy and safety of the device in complex clinical scenarios.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Hospitals, Public; Hospitals, Urban; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Recurrence; Registries; Risk Factors; Rome; Sirolimus; ST Elevation Myocardial Infarction; Time Factors; Treatment Outcome

To assess the safety and efficacy of everolimus-eluting bioresorbable scaffolds (BRS) in the treatment of chronic total occlusions (CTO) using noninvasive multislice computed tomography (MSCT) angiography at one-year follow-up.. Current evidence regarding the safety and efficacy of BRS for the percutaneous treatment of CTO is limited.. Between September 2013 and January 2016, patients who received one or more ABSORB BRSs were included at three centers. MSCT (including quantitative analysis) and clinical follow-up were performed at one year.. The low number of events and high patency rate at 1 year are encouraging the further use of the ABSORB scaffold for CTOs with low J-CTO score. Noninvasive MSCT angiography is a valid tool to assess scaffold patency, although its image resolution limits the use for quantitative measurements.

Topics: Absorbable Implants; Aged; Cardiovascular Agents; Chronic Disease; Coated Materials, Biocompatible; Computed Tomography Angiography; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Coronary Vessels; Europe; Everolimus; Female; Humans; Male; Middle Aged; Multidetector Computed Tomography; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Reproducibility of Results; Time Factors; Treatment Outcome; Vascular Patency

To assess clinical outcomes of Amphilimus Sirolimus-Eluting Stents (A-SES) as compared to Zotarolimus-Eluting Stents (ZES) in complex real-world diabetic patients.. Patients with diabetes mellitus represent one of the most challenging scenarios with high rates of restenosis and stent thrombosis in the current era of drug-eluting stents. Hence, we assessed the safety of A-SES versus ZES in complex diabetic patients.. In this observational study, we analyzed all consecutive patients with diabetes mellitus referred to our center from November 2012 to November 2014. The primary outcome was target-lesion failure at 1-year follow-up.. A total of 165 consecutive diabetic patients underwent percutaneous coronary intervention with A-SES or ZES for stable coronary artery disease in our tertiary center. Using the Kaplan Meier method the cumulative incidence of target-lesion failure was 6.7% (5.9% A-SES versus 7.5% ZES, p=0.19) at 1-year follow-up. Event-free survival at 1year follow-up was similar (89.4% A-SES vs. 83.3% ZES, p=0.29). Interestingly, we did not find any cases of definite-, and only one case of probable stent thrombosis in this high risk cohort.. In this real-world registry, A-SES and ZES seems to be associated with promising 1-year clinical safety outcomes following PCI in a contemporary cohort of high-risk diabetic patients. Our results should be considered hypothesis generating, as the clinical safety of A-SES has to be confirmed in a large trial.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Diabetes Mellitus; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Netherlands; Percutaneous Coronary Intervention; Progression-Free Survival; Prosthesis Design; Registries; Retrospective Studies; Risk Factors; Sirolimus; Time Factors

Polymeric component is associated with the increased risk of delayed vessel healing and stent endothelialization. We aimed to clarify neointimal coverage within 1 month after implantation of the new-generation abluminal biodegradable polymer (BP) drug-eluting stent (DES) compared with the second-generation durable polymer (DP) everolimus-eluting stent (EES). Between November 2015 and October 2016, 32 BP-DES and 25 DP-EES were evaluated by optical frequency domain imaging (OFDI) within 1 month after the procedure. The average interval to follow-up OFDI was not significantly different between the groups (16.3 ± 7.7 days in BP-DES vs. 15.4 ± 7.4 days in DP-EES, P = 0.75). Neointimal coverage was significantly superior in BP-DES in both apposed and malapposed strut (apposed: 53.9% in BP-DES vs. 28.0% in DP-EES, P < 0.001; malapposed: 22.9% in BP-DES vs. 7.5% in DP-EES, P = 0.001). When the follow-up period was divided into < 2 and > 2 weeks, neointimal coverage was also significantly superior in BP-DES (< 2 weeks: 47.7% in BP-DES vs. 19.2% in DP-EES, P < 0.001; > 2 weeks: 60.1% in BP-DES vs. 37.4% in DP-EES, P = 0.001). The new-generation BP-DES showed excellent early neointimal coverage compared with the second-generation DP-EES in both apposed and malapposed struts.

Topics: Absorbable Implants; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Polymers; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

The main drawback of current available drug coated balloons (DCB) is that a certain percentage of the coated drug is lost in the bloodstream during its delivery to the target lesion. We integrated the nanoparticle-mediated drug delivery technology and polydimethylsiloxane (PDMS) as a new excipient to facilitate an efficient drug delivery and uptake by endothelial cells. The present study aimed to evaluate the efficacy of the new DCB.. The novel DCB were coated with 5.6mg of paclitaxel-incorporated nanoparticles using PDMS. The efficacy of the new DCB was examined in rabbit iliac stent model (n=12) and in the swine in-stent restenosis model (n=8) by quantitative coronary angiography (QCA) and optical coherence tomography (OCT). At 28days follow-up in the swine in-stent restenosis model, the area stenosis was significantly lower in DCB group as compared with that of the control group in OCT analysis (0.31±0.05 vs 0.49±0.06, p=0.04) though there was no significant differences observed in the rabbit iliac stent model in QCA and OCT analysis.. The study results indicated that the paclitaxel-incorporated nanoparticle-coated balloon using PDMS has an inhibitory effect for the proliferation of smooth muscle cell in a swine coronary in-stent restenosis model.

Topics: Animals; Cardiac Catheterization; Cardiac Catheters; Cardiovascular Agents; Cell Proliferation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Dimethylpolysiloxanes; Disease Models, Animal; Drug Carriers; Endothelial Cells; Female; Iliac Artery; Male; Materials Testing; Myocytes, Smooth Muscle; Nanoparticles; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Rabbits; Sus scrofa; Time Factors; Tomography, Optical Coherence

to compare the 1-year outcome between bioresorbable vascular scaffold (BVS), everolimus-eluting stent (EES), and drug-eluting balloon (DEB) for in-stent restenosis (ISR) treatment.. BVS has been proposed as alternative for ISR treatment. To date a direct comparison between BVS and DES or DEB for ISR treatment is lacking.. We retrospectively analyzed all ISR lesions treated with BVS, DEB, and EES from January 2012 to December 2014. A total of 548 lesions (498 patients) were included. By applying two propensity-score matching, 93 lesions treated with BVS were compared with 93 lesions treated with DEB, and 100 lesions treated with BVS were compared to 100 lesions treated with EES.. At 1-year follow-up the incidence of device-oriented cardiovascular events (DOCE) and its components did not significantly differ between BVS and DEB (DOCE: 10.9 vs. 11.8%, HR, 0.91; 95% CI, 0.33-2.52; P = 0.86; Cardiac death: 2.2 vs. 1.2%, HR, 1.74, 95% CI 0.16-18.80, P = 0.65; ID-TLR: 8.9 vs. 10.7%, HR, 0.81, 95% CI 0.27-2.48, P = 0.71; TV-MI: 3.3 vs. 1.2%, HR, 2.39, 95% CI 0.27-21.32, P = 0.43) and BVS vs. EES (DOCE: 10.1 vs. 5.2% HR, 1.81, 95% CI, 0.63-5.25; P = 0.27; Cardiac death: 3.0 vs. 1.1%; HR, 2.83, 95% CI 0.29-27.4, P = 0.37; ID-TLR: 7.2 vs. 4.2%, HR, 1.57, 95% CI 0.47-5.23, P = 0.46; TV-MI: 3.1 vs. 0%).. At 1-year follow-up the use of BVS as ISR treatment is associated with a higher, even if not significant, DOCE rate compared with EES while a similar rate compared to DEB.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Italy; Male; Middle Aged; Percutaneous Coronary Intervention; Propensity Score; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome

Studies comparing drug coated balloons (DCB) with new generation drug-eluting stents (nDES) for the treatment of de novo coronary artery lesions are lacking.. From 2009 to 2016, DCB or nDES used for treatment of de novo coronary lesions at our institution were included, in total 1,197 DEB and 6,458 nDES. We evaluated target lesions restenosis (TLR) and definite target lesion thrombosis (TLT). Propensity score modeling were utilized to study adjusted associations between treatment and outcomes.. Median follow-up was 901days. DCB patients were older, with higher cardiovascular risk profile. Bailout stenting after DCB was performed in 8% of lesions. The cumulative rate of TLR and TLT was 7.0 vs. 4.9% and 0.2 vs. 0.8% for DCB vs. nDES, respectively. Before adjustment, DCB was associated with a higher risk of TLR [hazard ratio (HR) 1.44; 95% confidence interval (CI) 1.07-1.94] and a non-significantly lower risk of TLT (HR 0.30; 95% CI 0.07-1.24), compared to nDES. In the propensity matched population consisted of 1,197 DCB and 1,197 nDES, treatment with DCB was associated with similar risk for TLR (adjusted HR 1.05; 95% CI 0.72-1.53) but significantly lower risk for TLT (adjusted HR 0.18; 95% CI 0.04-0.82) compared to nDES.. Treatment with DCB was associated with a similar risk of TLR and a lower risk of definite TLT compared with nDES. In selected cases, DCB appears as a good alternative to nDES for the treatment of de novo coronary lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prosthesis Design; Registries; Retrospective Studies; Time Factors; Treatment Outcome

The aim of this study was to investigate the impact of optimizing procedure-related factors during drug-eluting balloon (DEB) angioplasty on clinical outcomes of drug-eluting stent in-stent restenosis (ISR).. Although DEB angioplasty is recommended as a reasonable option for ISR, recurrent target lesion failure (TLF) still occurs in many patients after DEB angioplasty.. Consecutive patients with drug-eluting stent ISR treated with DEB (SeQuent Please) were collected from 4 centers in Korea. The primary outcome was 2-year TLF. Procedure-related modifiable independent predictors for TLF and their best cutoff values were determined.. In a total of 256 patients (309 lesions), TLF occurred in 52 patients (20.3%). Modifiable independent predictors of TLF among procedure-related factors were residual diameter stenosis after lesion preparation (residual percentage diameter stenosis [%DS]), DEB-to-stent ratio (BSR), and DEB inflation time (T. Residual %DS after lesion preparation, BSR, and T

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Registries; Republic of Korea; Retreatment; Risk Factors; Time Factors; Treatment Outcome

Treatment of in-stent restenosis (ISR) is still a clinical challenge in interventional cardiology. Paclitaxel-coated balloons (PCBs) are an attractive therapeutic option for ISR. There are several different types of PCBs available for percutaneous coronary intervention, but to date, comparative data between different types of PCBs for the treatment of ISR are scarce.. This single centre, nonrandomized, retrospective study under real-world condition included 194 patients with 194 ISR treated by repeat percutaneous coronary intervention with PCBs. The primary end point was major adverse cardiac events (MACEs), defined as cardiac death, myocardial infarction and need for target lesion revascularization (TLR) at 1 year. Secondary end points were MACE and TLR at long-term follow-up.. Baseline clinical and angiographic parameters were comparable between the two groups. Patients in the iopromide-based PCB and butyryl-tri-hexyl citrate (BTHC)-PCB groups were followed up for 32.2±20.5 and 24.2±13.3 months, respectively (P=0.001). MACEs at 1-year follow-up were 15.0 and 15.8% (P=0.879) for the BTHC-PCB and iopromide-based PCB groups, respectively. TLR, myocardial infarction and cardiac death for BTHC-PCB versus iopromide-based PCB at 1-year follow-up were 9.6 versus 11.8%, P=0.622; 5.3 versus 3.9%, P=0.640; and 5.3 versus 3.9%, P=0.640, respectively. If complete follow-up periods were included in the analysis, BTHC-PCB and iopromide-based PCB had comparable rates of MACE (P=0.835) and TLR (P=0.792).. BTHC-PCB and iopromide-based PCB had comparable rates of MACE and TLR for the treatment of ISR at 1-year and long-term follow-up.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Butyrates; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Equipment Design; Excipients; Female; Humans; Iohexol; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome

This study assesses clinical outcomes after drug-eluting balloon treatment for recurrent in-stent restenosis lesions based on the number of metallic layers.. We enrolled 304 consecutive patients (333 lesions) treated with percutaneous coronary intervention using drug-eluting balloon for in-stent restenosis lesions between March 2014 and June 2015. Per the number of stent layers previously implanted to the lesion, the patients were categorized into 3 groups, 1 stent layer (1L), 166 patients; 2 stent layers (2L), 87 patients; and ≥3 stent layers (≥3L), 51 patients. The end points were major adverse cardiovascular events (MACE), including cardiac death, target lesion revascularization, myocardial infarction, and definite or probable stent thrombosis. No significant differences were observed in patients' baseline characteristics among the groups. The 1-year MACE and target lesion revascularization rates were significantly higher in the ≥3L group than those in the 1L and 2L groups (MACE: 1L, 16.9%; 2L, 16.1%; and ≥3L, 43.1%, P<0.01; target lesion revascularization: 1L, 14.5%; 2L, 14.9%; and ≥3L, 41.2%, P<0.01). The multivariable Cox regression analysis revealed that the number of metallic layers (≥3L compared with 1L; hazard ratio, 3.17; [95% CI, 1.75-5.76]; P<0.01 and hemodialysis [hazard ratio, 2.21; (95% CI, 1.12-4.36); P=0.02]) were independent predictors for MACE. No significant differences were observed in the occurrence of cardiac death among the groups ( P=0.34).. Seemingly, drug-eluting balloon is less effective for ≥3L in-stent restenosis lesions. Hemodialysis and in-stent restenosis with the number of metallic layers are independent predictors for MACE.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Female; Humans; Male; Metals; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Tokyo; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Drug-Eluting Stents; Humans; Paclitaxel; Treatment Outcome

A 79-year-old male who had a history of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) received coronary angiography (CAG), because of angina pectoris. CAG showed in-stent restenosis of the paclitaxel-eluting stent (PES). Since the devices could not pass the lesion, we performed rotational atherectomy. Although we could not identify the calcified lesion by the optical frequency domain imaging (OFDI) findings because of strong attenuation, the intravascular ultrasound (IVUS) image showed the superficial calcification. On the other hand, strong attenuation in OFDI suggested the presence of foamy macrophage, which was essential for the diagnosis of neoatherosclerosis. We could obtain a favorable result by deploying another drug-eluting stent. While an earlier report showed the calcified neoatherosclerosis following bare-metal stent implantation, we clearly showed the calcified neoatherosclerosis following PES implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Male; Paclitaxel; Treatment Outcome; Vascular Calcification

Long coronary artery lesions are increasingly treated with new technologies including current generation drug eluting stents (DES) despite a lack of robust data on outcomes. In the current study, patients receiving Xience V DES for very long lesions (>35 mm) compared to lesions 25-35 mm had similar outcomes. Future research should address late outcomes, stent thrombosis rates, as well as investigation of lesions greater than 60 mm.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome

The aim of this study was to assess clinical restenosis and its predictors after implantation of bioresorbable vascular scaffolds (BVS) in everyday practice in the large-scale German-Austrian ABSORB Registry (GABI-R).. Between November 2013 and January 2016, 3,264 patients underwent BVS implantation in the 93 centres of GABI-R. At six-month follow-up, 24 patients experienced clinically indicated target lesion revascularisation (cTLR) unrelated to BVS thrombosis (cumulative incidence 0.76%; angiographically, 58.3% of in-BVS restenosis of focal pattern). Compared to patients without cTLR, patients with cTLR had more lesions per patient (1.83±1.0 vs. 1.36±0.7), complex (52.3% vs. 36.2%) and mild-to-moderately calcified lesions (65.9% vs. 60.5%) treated, and more frequently had overlapping BVS (22.2% vs. 10.8%), all p<0.05. Implanted BVS length was 40.0 mm (28.0, 46.9) vs. 23.0 mm (18.0, 30.0), p<0.001, remaining in the multivariable analysis the only independent predictor of cTLR (hazard ratio 1.02, 95% CI: 1.01-1.04, p<0.001). The myocardial infarction rate was also significantly higher among patients with cTLR, 29.2% vs. 1.7%, p<0.0001.. cTLR related to BVS restenosis at six months after BVS implantation is a rare event depending on implanted BVS length. Whether cTLR increases the myocardial infarction risk needs to be evaluated at longer-term follow-up and within the setting of adequately powered randomised trials.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Austria; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Everolimus; Female; Germany; Humans; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Time Factors; Treatment Outcome

Our study aimed to compare the efficacy of seal-wing paclitaxel-eluting balloon catheters (PEB) with iopromide-coated PEB and everolimus-eluting stents (EES) for treating bare metal stent restenosis (BMS-ISR).. We enrolled 64 patients with 69 BMS-ISR. The control group comprised patients from the iopromide-PEB and EES arms of a previous TIS study. The primary end-point was 12-month in-segment late lumen loss (LLL). Secondary end-points included incidence of binary in-stent restenosis and 12-month major adverse cardiac events (MACE).. Compared to iopromide-coated PEB, seal-wing PEB was associated with significantly higher 12-month LLL (0.30 vs. 0.02 mm; p < 0.0001), repeated binary restenosis (28.12% vs. 8.7%; p = 0.012), 12-month MACE (26.98% vs. 10.29%; p = 0.003), and target vessel revascularization (TVR; 20.63% vs. 7.35%; p = 0.009). Compared to EES, no significant differences were found in the 12-month LLL (0.30 vs. 0.19 mm; p = 1.000), repeated binary restenosis (28.12% vs. 19.12%; p = 0.666), 12-month MACE (26.98% vs. 19.12%; p = 0.102) or TVR (20.63% vs. 16.18%; p = 0.360).. BMS-ISR treatment using seal-wing PEB led to significantly higher 12-month LLL, repeated binary restenosis, MACE, and TVR compared to iopromide-coated PEB. However, no significant differences were found in comparison with EES.. ClinicalTrials.gov; NCT01735825.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Case-Control Studies; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Metals; Middle Aged; Odds Ratio; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome

The third generation drug eluting Orsiro stent had shown already promising results in non-complex lesions.. We evaluated angiographic and 24 month clinical results of the sirolimus eluting Orsiro stents (O-SES) after recanalization of coronary chronic total occlusions (CTO). Results were compared with the zotarolimus eluting Resolute Integrity (R-ZES).. In a prospective series 57 patients were treated with a R-ZES followed by 74 patients treated with a O-SES stent. Angiographic follow up after 9 months and clinical follow-up after 12 and 24 months was performed.. In-stent late lumen loss was 0.24±0.53 mm for the O-SES compared with 0.59±0.72 (P=0.01) for R-ZES. Rates for TLR were similar (O-SES 10.0% versus R-ZES 11.1%, P=0.84). There was no definite stent thrombosis.. The O-SES resulted in a significant lower late lumen loss but with similar clinical results up to 24 month compared to the R-ZES after treatment of CTO lesions.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Obiectives: Angiographic and clinical outcomes after crushing of everolimus-eluting stent (EES) for distal unprotected left main disease (ULMD).. Few data exist about crushing of EES for distal ULMD.. From the Florence ULMD Percutaneous Coronary Interevention Registry consecutive patients with distal ULMD treated with EES were included in the analysis. Patients treated with provisional stenting were compared with patients treated with crush stenting.. angiographic in-segment restenosis rate, and 1-year clinical outcome.. From 2008 to 2015, 405 patients with distal ULMD were treated with EES: 278 (69%) were treated with provisional stenting while 127 (31%) with crush stenting. Provisional stenting group compared to crush stenting group had higher incidence of acute coronary syndrome on admission (63% vs. 52%; P = 0.033) and of left ventricular ejection fraction ≤ 40% (36% vs. 23%; p= 0.008), while patients treated with crush stenting had more frequently diabetes mellitus (35% vs. 21%; P = 0.003) and 3-vessel coronary artery disease (46% vs. 29%; P < 0.001). Angiographic follow rate was 95%. Restenosis rates were similar: 7.1% in the crush stenting group and 5.8% in the provisional stenting group. There were no differences in 1-year clinical outcome between crush stenting group and provisional stenting group: major adverse cardiac events 11.1% and 11.2%, stent thrombosis 0.8% and 1.4%, respectively.. Crush stenting using EES in patients with complex distal ULMD is associated with low rates of restenosis and adverse clinical events and could be considered as a valid double stenting technique in all patients with complex ULMD bifurcation lesions. © 2017 Wiley Periodicals, Inc.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Disease-Free Survival; Drug-Eluting Stents; Everolimus; Female; Humans; Italy; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Predictive Value of Tests; Proportional Hazards Models; Prosthesis Design; Registries; Risk Factors; Time Factors; Treatment Outcome

The purpose of this study was to evaluate the outcomes of the novel Fantom coronary bioresorbable scaffold at 6 months.. The Fantom sirolimus-eluting bioresorbable scaffold incorporates a unique proprietary iodinated, polycarbonate copolymer of tyrosine analogs that is radiopaque, with thin struts (125 μm) that facilitate device delivery and precise target lesion treatment.. The 6-month outcomes and performance of the Fantom scaffold were evaluated in 117 patients with single de novo native coronary artery lesions of length ≤20 mm and reference vessel diameter 2.5 to 3.5 mm. The primary angiographic endpoint was mean late lumen loss at 6 months measured by quantitative coronary angiography. Procedural outcomes were categorized as short-term technical success, short-term procedural success, and clinical procedural success. The primary clinical endpoint was major adverse cardiac events at 6 months, the composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).. Short-term technical success, short-term procedural success, and clinical procedural success were achieved in 96.6%, 99.1%, and 99.1% of patients, respectively. Mean 6-month in-stent late lumen loss was 0.25 ± 0.40 mm (n = 100). Binary restenosis was present in 2 patients (2.0%). Major adverse cardiac events within 6 months occurred in 3 patients (2.6%), including no deaths, 2 MIs, and 2 TLRs (1 patient had both an MI and TLR). Scaffold thrombosis occurred in 1 patient (0.9%).. The clinical results from 117 patients enrolled in cohort A of the multicenter FANTOM II (Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold) study demonstrate favorable 6-month outcomes of this novel device in the treatment of noncomplex coronary artery disease.

Topics: Absorbable Implants; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Stenosis; Female; Humans; Male; Middle Aged; Myocardial Infarction; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

To compare and analyze the effect and the safety of the paclitaxel-eluting stents and paclitaxel-eluting balloon in the treatment for in-stent rest enosis. 120 cases, who had been undergone percutaneous coronary intervention (PCI) in the Department of Cardiology of Henan Provincial People's Hospital from January 2012 to January 2014 were selected. All the patients were randomly treated with paclitaxel-eluting balloon or paclitaxel-eluting stents. The former were divided into different groups that named group A and the later group B. All the selected patients signed the informed consent on interventional therapy and be given anti-platelet drugs before operating. At the same time, they had routine examination, like chest X-ray, ultrasound, biochemical detection, Myocardial injury markers. (1) The two groups had no significant difference in the general information (P>0.05); (2) The success rate in the two groups reached 100% and (3) All the patients were visited in the 9th, 12th and 24th month to see if any of them was dead. The reexamination results in the 9th month showed that both drug-eluting balloon and drug-eluting stents were safe and effective in treating coronary artery in-stent restenosis. In addition, drug-eluting balloon was more effective than drug-eluting stents to prevent from the in-stent restenosis.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; China; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome

The aims of this study were to evaluate clinical outcomes following PCI using SeQuent Please paclitaxel-coated balloons (PCB) of ISR and denovo lesions (DNL), in all-comer patients at Liverpool Hospital, Sydney, Australia.. There have been promising results for PCI using drug-coated balloons; however, long-term data for clinical outcomes are lacking.. Baseline patient demographics, PCI procedural details, and clinical outcomes were collected. The primary endpoint was the incidence of MACE, a composite of cardiac death, myocardial infarction (MI), and clinical-driven target lesion restenosis (TLR). The median follow-up for clinical events was 1.3 [0.6-1.9] years.. A total of 188 lesions (n = 147 patients) were treated with PCB, comprising 118 (63%) ISR lesions and 70 (38%) DNL. Patient mean age was 67 ± 11years, 79% were male, and 54% had type 2 diabetes mellitus (DM). MACE was recorded in 17 patients (12%), with cardiac death confirmed in 1 patient (0.7%). MACE was significantly lower for DNL than ISR (1% vs. 15%, P = 0.03), and PCB had favourable TLR for DNL. Cox regression demonstrated that DM (HR 7.17, 0.92-55.6, P = 0.05) and prior CABG (HR 3.22, 1.17-8.83, P = 0.02) were independent predictors of MACE for ISR lesions.. MACE rates were acceptable, with overall low incidence of cardiac death, MI, and TLR, for PCB treatment of ISR and DNL. Independent predictors of poor outcome in the ISR group were DM and prior CABG. The particularly low MACE for the DNL group supports direct PCB as a viable stent-sparing PCI strategy in challenging patients and lesion subsets. © 2016 Wiley Periodicals, Inc.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; New South Wales; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Registries; Retreatment; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome

Topics: Cardiac Pacing, Artificial; Cardiovascular Agents; Combined Modality Therapy; Coronary Restenosis; Heart Arrest; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Recurrence; ST Elevation Myocardial Infarction; Stents; Ventricular Dysfunction, Left; Ventricular Fibrillation; Ventricular Premature Complexes

Lesion length has been an important factor in predicting a worse outcome after percutaneous coronary interventions (PCI); however, the safety and efficacy of second-generation drug eluting stents in very long coronary lesions has not been validated in large scale randomized controlled trials.. We performed a patient level pooled analysis of 13,266 patients undergoing planned overlapping stent treatment of very long coronary lesions with the XIENCE V everolimus eluting coronary stent system from 6 trials evaluating the XIENCE V stent (Spirit II, III, IV, V, Spirit Small Vessel and XIENCE V USA). Patients were divided into two cohorts, a very long lesion (VLL) group (lesions ≥35 mm) and a control group (lesions >24 to <35 mm). The primary outcome measures were Target Lesion Failure (TLF), Major Adverse Cardiac Events (MACE), and Academic Research Consortium (ARC) defined definite and probable stent thrombosis at 1 year.. A total of 13,266 patients were included in the pooled analysis of which 2.4% (323 patients with 328 total lesions) had a mean lesion length of 47.1 ± 13.7 mm in the VLL group which were compared to controls comprised of 3.6% of the cohort (482 patients with 500 total lesions) with mean lesion length of 28.1 ± 2.4 mm.There was no significant difference in the rates of TLF between the VVL and control groups (8.9 vs. 10%, P = 0.63), MACE (9.2 vs. 10%, P = 0.74) or stent thrombosis (1.6 vs. 1.5%, P = 0.92) at 1 year.. In the treatment of very long coronary lesions, the XIENCE V stent appears as safe and effective as percutaneous coronary interventions for long lesions. © 2016 Wiley Periodicals, Inc.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Time Factors; Treatment Outcome

Percutaneous coronary intervention (PCI) with bare-metal and first-generation drug-eluting stents (DES) for cardiac allograft vasculopathy (CAV) is associated with unexpectedly high restenosis rates and target lesion revascularization (TLR). Long-term outcomes of stenting for CAV using second-generation everolimus-eluting stents (EES) are not established.. To evaluate clinical and angiographic outcomes of CAV stenting with EES.. Patients who underwent PCI with EES for CAV were studied. Surveillance angiography was performed at 6-12 months post-PCI and as indicated. Patient survival, freedom from MACE, binary restenosis, TLR, target vessel revascularization (TVR), and non-TVR are reported.. One-hundred and thirty two EES were placed in 113 discrete lesions in 48 patients. Pre-PCI stenosis was 82.1 ± 12.4%, and average stent length and diameter were 16.9 ± 5.7 and 3.0 ± 0.6 mm, respectively. Mean follow-up was 30.7 ± 18.8 months. Time from transplantation to PCI was 9.9 ± 5.1 years. Post-PCI survival at 1 (93.5 ± 3.6%), 2 (91.0 ± 4.3%), and 3 years (83.8 ± 6.3%), and freedom from MACE (87.2 ± 4.9%, 82.3 ± 5.7%, 75.8 ± 6.9%) were high. Binary restenosis at 1 (3.0 ± 1.7%), 2 (6.9 ± 3.2%), and 3 years (10.0 ± 4.3%) mirrored expected rates with EES use in native CAD. One-, two-, and three-year rates of TLR (5.1 ± 2.5%, 14.3 ± 4.6%, and 21.2 ± 6.3%), TVR (17.1 ± 4.5%, 39.0 ± 6.9%, and 46.2 ± 7.8%), and NTVR (26.3 ± 5.4%, 55.4 ± 7.0%, and 58.0 ± 7.0%) remain high. Diabetes was associated with an increased hazard ratio for binary restenosis 6.084 (95% CI 1.271-29.133, P = 0.024).. PCI strategy using EES in the treatment of CAV was associated with a low binary restenosis rate, a high survival rate, and a high rate of freedom from MACE. However, at 3 years, TLR and TVR rates appeared similar to rates observed with first-generation DES. © 2016 Wiley Periodicals, Inc.

Topics: Adolescent; Adult; Aged; Allografts; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Disease-Free Survival; Drug-Eluting Stents; Everolimus; Female; Heart Transplantation; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Young Adult

To develop an ameliorated sirolimus (SIR) liposome for intramural delivery, the effects of various carrier physicochemical parameters on the antirestenosis efficacy were evaluated.. Different liposomes were prepared, characterized and administered to balloon injured rats (12 animal groups). Their efficacies were investigated using morphometric, immunohistochemical and in vivo computed tomography imaging analyses.. The antirestenosis efficacy of SIR liposomes decreased in the following order: cationic 100 nm vesicles ≥ cationic 60 nm vesicles > neutral 100 nm vesicles ≥ stealth 100 nm vesicles > anionic 100 nm vesicles. The 100 µg SIR loaded in cationic liposomes showed almost no artery stenosis.. Appropriate modulation of physicochemical characteristics makes it possible to optimize the liposomes for local delivery.

Topics: Animals; Cardiovascular Agents; Carotid Arteries; Carotid Artery Injuries; Coronary Restenosis; Ki-67 Antigen; Liposomes; Male; Neointima; Plasma; Polysorbates; Rats; Rats, Sprague-Dawley; Sirolimus

The success of drug-coated balloon therapy might be compromised by intraprocedural particulate embolisation of matrix coating, which may cause downstream microvascular obstruction. We aimed to investigate whether drug-coated balloon therapy was associated with an increase in markers of myocardial necrosis compared with drug-eluting stents or plain balloon angioplasty.. In the ISAR-DESIRE-3 trial, patients with limus-eluting stent restenosis were randomised to treatment with a paclitaxel-coated balloon (PCB), paclitaxel-eluting stent (PES) or balloon angioplasty. We included enrolled patients who had pre- and post-intervention high-sensitivity troponin (hs-TnT) levels available. The delta (peak post-procedure minus baseline) troponin was compared between treatment arms. The association between delta troponin tertiles and three-year mortality was also evaluated. Three hundred and forty-three (343) patients were included, comprising patients treated with PCB (n=115), PES (n=112) and balloon angioplasty (n=116). Groups were well matched in terms of baseline characteristics. There was no difference in delta troponin in patients treated with PCB, PES and balloon angioplasty (36±65, 70±183, and 51±124 ng/L, respectively, p=0.16). Three-year mortality was 7.7%, 8.8% and 14.3% for the 1st, 2nd and 3rd tertiles of delta troponin, respectively, p=0.23.. In patients with drug-eluting stent restenosis, there was no difference in subclinical myocardial necrosis among patients treated with PCB, PES, and balloon angioplasty.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Treatment Outcome

The objective of this study was to clarify the incidence and predictors of early and late target lesion revascularization (TLR) after everolimus-eluting stent (EES) implantation in actual clinical practice.. Several clinical studies have reported the incidence and predictors of TLR after EES implantation. However, detailed features of early and late TLR are unknown.. We analyzed the clinical data of patients who underwent EES implantation between January 2010 and December 2011 at 22 institutions in Japan (Tokyo-MD PCI study). Patients who underwent ischemia-driven TLR (ID-TLR) were grouped according to the number of years elapsed since stent placement, and incidence and correlations between clinical factors were analyzed.. Statistical analysis was performed for 1,899 patients and 2,305 lesions. The mean age was 70.0 ± 9.9 years, and the median follow-up period was 1,281 days (IQR: 762-1,440 days). The incidence of ID-TLR was 2.7% at 1 year and 5.4% at 4 years. After 2 years, the ID-TLR rates plateaued. The independent predictors of ID-TLR occurring within 2 years were hemodialysis, triple vessel disease, restenotic lesion, and ostial lesions. The independent predictors of ID-TLR between 2 and 4 years were diabetes mellitus and peripheral artery disease.. The ID-TLR rates leveled off after 2 years. Furthermore, the predictors of ID-TLR that occurred within 2 years of EES implantation differed from those that occurred later than 2 years. © 2017 Wiley Periodicals, Inc.

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

This case report describes a patient who underwent implantation of a bare-metal stent (BMS) for the treatment of everolimus-eluting stent (EES) restenosis caused by chronic stent recoil, and the BMS successfully escaped from duplicate restenosis and target lesion revascularization (TLR).

Topics: Aged; Angina, Unstable; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Metals; Percutaneous Coronary Intervention; Stents; Treatment Outcome

To report clinical outcomes in patients treated with drug-eluting balloon (DEB) versus second-generation drug-eluting stent (DES) for in-stent restenosis (ISR) involving a bifurcation lesion.. Between February 2007 and November 2012, 167 bifurcation restenoses in 158 patients were treated with either DEB (n=73) or second-generation DES (n=85). The EuroSCORE was significantly higher in the DEB group (4.2±3.8 vs. 2.8±2.1, p=0.004). Regarding restenosed stent type, second-generation DES was more frequently seen in the DEB group (26.9% vs. 6.7%, p<0.001). In this group, there was also a trend towards more frequent stenting for a previous ISR (stent-in-stent) as compared with the DES group (25.6% vs. 15.6%, p=0.074). Over a median follow-up period of 701 days, there was no significant difference in major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction including periprocedural myocardial infarction, target vessel revascularisation, between the two groups (p=0.585). Independent predictors of MACE on multivariate Cox regression analysis included stent-in-stent (HR: 2.16; 95% CI: 1.11 to 4.20; p=0.023) and true bifurcation lesions (HR: 2.98; 95% CI: 1.45 to 6.14; p=0.001).. DEB for bifurcation restenosis may be an acceptable treatment option, especially in cases where repeat stenting has not already been performed for the treatment of a previous restenosis.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Retreatment; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome; Vascular Access Devices

The aim of this study was to compare the efficacy between paclitaxel-coated balloon (PCB) and drug-eluting stent (DES) implantation for the treatment of DES restenosis in complex situations.. Data of patients who received revascularisation for DES restenosis between 2004 and 2011 were collected. A total of 683 patients with 777 lesions were analysed in this study (306 lesions treated by PCB, 471 lesions by DES). The use of PCB or DES was at the discretion of the operator. Angiographic outcomes at six to eight months and clinical outcomes at 12-month follow-up were compared between groups. The primary outcome was binary restenosis. Cox regression analysis with propensity score adjustment suggested that there were no significant differences between the two groups with respect to binary restenosis, target lesion revascularisation (TLR), and major adverse cardiac events. As for the angiographic endpoints, subgroup analysis was performed for several parameters. There was a significant trend favouring PCB with respect to binary restenosis and TLR in non-focal type lesions and bifurcation lesions.. Angiographic and clinical outcomes in the PCB group were similar to those in the repeat DES group. PCB seemed to offer more favourable results in non-focal type lesions and bifurcation lesions.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Prosthesis Design; Treatment Outcome

Although drug-eluting stents (DES) for percutaneous coronary intervention (PCI) have dramatically reduced the incidence of in-stent restenosis, their deployment for large-size coronary lesions is still controversial because of problems such as late in-stent thrombosis and late catch-up in DES. We aimed to evaluate the long-term outcome beyond 2 years of bare metal stents (BMS) as compared with DES in large vessels. Consecutive 228 patients who underwent PCI with large-size stents (>3.5 mm in diameter) in our hospital were enrolled in this study. The end points of this study are target lesion revascularization (TLR) and occurrence of major adverse cardiac events (MACE) for subject patients. We analyzed 183 patients (152 men, mean age 65.8 ± 10.5 years) whose outcome could be followed up for at least 2 years. At the first 8-month follow-up, clinically driven TLR rate was significantly higher in patients who received BMS than those who received DES (17.2 vs. 2.2 %, p < 0.05), although the rate of TLR was not different between the 2 groups beyond 8 months. Thus, overall rate of TLR was higher in BMS than in DES (22.7 vs. 5.4 %, p < 0.05). Under these conditions, the higher rate of TLR for BMS was observed in simple as well as complex lesions with or without diabetes, although there were no significant differences in MACE between BMS and DES. Multivariate analysis showed that BMS was an only independent factor of TLR at the 8 month follow-up period [p = 0.004, odds ratio 9.58, 95 % confidence interval (2.10-43.8)]. These results demonstrate that the rate of in-stent restenosis in large-size coronary lesions was transiently higher in the first 8 months for patients implanted with BMS compared with DES in which no in-stent thrombosis and TLR beyond 2 years were observed. We suggest using the DES even in large-size coronary lesions in terms of short- and long-term outcomes.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Japan; Kaplan-Meier Estimate; Logistic Models; Male; Metals; Middle Aged; Multivariate Analysis; Odds Ratio; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome

A 70-year-old man underwent stent implantation for right coronary artery (RCA) lesions with a bare metal stent (BMS) and two sirolimus-eluting stents (SES). However, as both the BMS and SES stented sites developed restenosis after 13 months, he underwent target lesion revascularization using directional coronary atherectomy (DCA). On histopathology, the restenosis lesion at the SES-deployed site showed greater inflammation and less re-endothelialization than that at the BMS-deployed site. Three months later, the SES-deployed site developed a second restenosis, in which paclitaxel-eluting stents (PES) were implanted (PES-in-SES), while the BMS-deployed site was restenosis free. Five years later, restenosis was absent in these RCA lesions. However, by optical coherence tomography and/or coronary angioscopy, the PES-in-SES site in the RCA showed poor neointimal coverage over the stent struts and yellowish neointima, suggesting lipid-rich neoatheroma formation, whereas at the BMS site appropriate white neointima formation was observed. Drug-eluting stents still have problems of persistent inflammation, inappropriate neointima formation, and neoatherosclerosis. Although we are now in the era of second generation DESs in which better stent performance would be promising, we should remember that we are obliged to continue to follow-up all patients in whom first generation DESs such as SES or PES have been placed.

Topics: Aged; Angioscopy; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Immunohistochemistry; Male; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Retreatment; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

We aimed to comprehensively evaluate poly-lactide polymer degradation and sirolimus release kinetics from a drug-eluting stent matrix in the in vivo setting using a nuclear magnetic resonance (NMR) method.. In 22 domestic swine, 18 biodegradable polymer-only coated stents (BPSs) and 36 biodegradable polymer-coated sirolimus-eluting stents (BP-SES) were implanted in coronary arteries with 115% overstretch. The animals were sacrificed at 1, 3, 7, 14, 28, and 56 days following baseline procedures. Vessel segments with BPS were harvested to evaluate polymer degradation with a NMR method, whereas BP-SES to analyze sirolimus tissue uptake and retention. Additionally, 8 BP-SES were implanted for histological analysis for 90 days of follow-up.. The NMR showed a gradual absorption of the polymer over the 6 consecutive time points, from 5.48 µg of the polymer on the stent at 1-day follow-up, through 4.33 µg at 3 days, 3.16 µg at 7 days, 2.42 µg at 14 days, 1.92 µg at 28 days to 1.24 µg in the last day of the study. The curve of polymer degradation corresponds well with the pharmacokinetic profile of sirolimus eluted from its surface and measured at identical time points. In histopathology, at 90 days, complete healing and biocompatibility were reported.. The utilization of NMR method for BP absorption kinetics evaluation is a useful tool, which may be widely adopted to test other biodegradable implants. Further, it may substantially improve their safety and efficacy by facilitating programmed polymer and drugs elution.

Topics: Absorbable Implants; Animals; Cardiovascular Agents; Coronary Restenosis; Disease Models, Animal; Drug-Eluting Stents; Female; Magnetic Resonance Spectroscopy; Male; Percutaneous Coronary Intervention; Polyesters; Prosthesis Design; Sirolimus; Sus scrofa

A 54-year-old woman treated with cobalt-chromium everolimus eluting stents (CoCr-EES) for her left distal circumflex and diagonal branch lesions suffered from repeated in-stent restenosis in both lesions. Neointimal proliferation occurred rapidly and almost simultaneously in the two lesions. The cause was established to be metal allergy, as determined by patch tests which were strongly positive for bare metal stents and weakly positive for CoCr-EES. Following the third successive angioplasty, we initiated treatment with prednisolone (30 mg daily) and the anti-allergic and anti-proliferative drug tranilast (300 mg daily). An elective angiogram performed 3 months later showed no evidence of in-stent restenosis in any of the stented lesions. Furthermore, the patient has remained angina-free for 15 months. The unique features of this case include: (1) near-simultaneous repeated multivessel in-stent restenosis in a patient with skin test-documented metal allergy to cobalt-chromium stents; (2) adjunctive systemic medical therapy with prednisolone and tranilast appeared to terminate the malignant restenotic cycle.

Topics: Anti-Allergic Agents; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Therapy, Combination; Drug-Eluting Stents; Everolimus; Female; Glucocorticoids; Humans; Hypersensitivity; Middle Aged; Neointima; ortho-Aminobenzoates; Patch Tests; Percutaneous Coronary Intervention; Predictive Value of Tests; Prednisolone; Prosthesis Design; Recurrence; Risk Factors; Tomography, Optical Coherence; Treatment Outcome

There is increasing evidence that various types of drug-eluting stents (DES) may differ regarding the long-term safety and efficacy, particularly in complex lesion subsets.. In a cohort of consecutive patients undergoing bifurcation stenting, we sought to compare the 1-year efficacy and safety of the first-generation paclitaxel-eluting stents (PES), the first-generation sirolimus-eluting (SES) and the second-generation everolimus- or zotarolimus-eluting stents (EES/ZES).. We treated 2197 patients (mean age 67.5 years, 75.4 % male) with provisional T-stenting for de novo coronary bifurcation lesions using PES, SES or EES/ZES. Primary endpoint (MACE) was the composite of death from any cause, myocardial infarction (MI) and target lesion revascularisation (TLR).. Side branch stenting was found to be clinically indicated in 793 patients (36.1 %). The cumulative 1-year incidence of MACE was 18.8 % after PES, 13.1 % after PCI with SES and 12.2 % after EES/ZES (p = 0.003), the combined endpoint death and MI occurred in 6.6, 5.6 and 8.3 % (p = 0.253) and death in 4.3, 5.2 and 5.3 % (p = 0.581), respectively. After adjustment for co-variables the type of DES was a significant (p = 0.008) predictor of MACE [HR (95 % confidence interval) PES vs SES 1.34 (1.04-1.71), PES vs. EES/ZES 1.75 (1.19-2.57), EES/ZES vs. SES 0.762 (0.531-1.095)], but not of death (p = 0.581), death and MI (p = 0.077) or stent thrombosis (ST) (p = 0.925).. In de novo coronary bifurcation lesions treated with provisional T-stenting, SES and EES/ZES achieved better outcomes than PES by reducing the need for reintervention.

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

Even though drug-coated balloon (DCB) angioplasty has emerged as a treatment option for drug-eluting stent in-stent restenosis (DES-ISR), the most effective treatment strategy for DES-ISR is still under debate. Therefore, we compared long-term clinical outcomes following DCB treatment of DES-ISR with those following 2nd-generation drug-eluting stent (DES) treatment. We identified 248 DES-ISR lesions in 238 patients that were treated with either 2nd-generation DES implantation (n = 56) or DCB angioplasty (n = 192). We compared the incidences of major adverse cardiac events (MACEs) in the two groups during the 2-year period following treatment. MACE was defined as cardiac death, non-fatal myocardial infarction, or target-vessel revascularization. The percentage of patients with diabetes and the mean age of patients in the DCB group were greater than in the DES group. The DCB group also had a smaller reference vessel diameter. The DES group had a larger post-intervention minimal luminal diameter. We found no significant difference in the MACE rate between the two groups during the 2 years following treatment (11.0 % in the DCB group vs. 8.9 % in the DES group, p = 0.660). Reference segment diameter was the only independent predictive factor for MACE in the post-treatment period (hazard ratio 0.35, 95 % confidence interval: 0.15-0.82, p = 0.016). Clinical efficacy of DCB angioplasty for treatment of DES-ISR was comparable to that of 2nd-generation DES implantation as measured by the rate of MACEs in the two groups. Reference segment diameter was the only statistically significant independent predictor for MACE in the 2-year period following treatment.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Republic of Korea; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome

To assess the safety and efficacy of fractional flow reserve (FFR) guided paclitaxel-coated balloon (PCB) treatment for de novo coronary artery lesions.. There is limited data on PCB treatment for de novo lesions especially of major epicardial coronary arteries.. Sixty-six patients with 67 de novo lesions who underwent successful plain old balloon angioplasty (POBA) were included. If POBA-FFR was favorable (≥ 0.85), PCB was applied and if POBA-FFR was <0.85, stent implantation was preferred over PCB.. Forty-five lesions were treated with PCB (67.2%) and 22 lesions with stents (32.8%). Dual antiplatelet therapy duration was 6 weeks. Late luminal loss with PCB was significantly less than stent (0.05 ± 0.27 mm vs. 0.40 ± 0.54 mm, P = 0.022). The baseline FFR of target lesions was 0.69 ± 0.16 in PCB and 0.60 ± 0.11 in stent group (P = 0.015), however, the FFR at 9 months was not different between groups (0.85 ± 0.08 in PCB vs. 0.85 ± 0.05 in stent group, P = 0.973). At 1 year, one myocardial infarction and one target lesion revascularization related to in-stent restenosis were detected, both in the stent group.. POBA-FFR-guided PCB treatment is safe and effective for de novo coronary lesions with good anatomical and physiological patency at mid-term follow-up. © 2015 Wiley Periodicals, Inc.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug Therapy, Combination; Drug-Eluting Stents; Equipment Design; Female; Fractional Flow Reserve, Myocardial; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prospective Studies; Registries; Republic of Korea; Time Factors; Treatment Outcome; Vascular Patency

To compare the long-term clinical outcomes between Resolute zotarolimus-eluting stent (R-ZES) and paclitaxel-eluting stent (PES) in patients with small coronary artery disease.. Patients with a small vessel diameter are independently associated with increased risk of adverse cardiac events after drug-eluting stent implantation.. A cohort of 265 patients treated with R-ZES (185 patients with 211 lesions) or PES (80 patients with 100 lesions) in small vessel (≤2.5 mm) lesions were retrospectively analyzed. The primary end point of the study was the composite of major adverse cardiac events. The secondary end points included target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis at 3 years.. The baseline characteristics were similar between the 2 groups. In the R-ZES group, the mean stent diameter was smaller and the total stent length per lesion was longer. Major adverse cardiac events occurred in 8 (10%) patients who had received PES and in 7 (3.8%) patients who had received R-ZES (P = .07). The rates of 3-year TLR (2.2% vs 2.5%; P = 1.00) and TVR (5.4% vs 10.0%; P = .17) showed no statistically significant difference between the R-ZES and PES groups. The rate of stent thrombosis was 0.5% in the R-ZES group and 2.5% in the PES group (P = .21).. The rates of major adverse cardiac events and cardiac death were similar in the R-ZES-treated group compared with the PES-treated group.

Topics: Adult; Aged; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Retrospective Studies; Risk Factors; Sirolimus; Treatment Outcome

Preclinical investigations have suggested that coating technology is crucial for the efficacy of drug-eluting balloons (DEB). Aim of this study is to compare the antirestenotic efficacy of two paclitaxel DEB with different coatings in the treatment of in-stent restenosis (ISR) by means of a morphological and functional assessment.. In a single center, prospective, non-randomized study, the shellac-paclitaxel coated DIOR, and the urea-paclitaxel coated IN.PACT Falcon were compared in the setting of ISR. Quantitative angiography, fractional flow reserve (FFR), and optical coherence tomography (OCT) were performed at baseline, postprocedure and 6-month follow-up. Main endpoints were QCA, FFR and OCT-based parameters of restenosis.. Forty-five patients were included, 20 (44 %) received treatment with the DIOR and 25 (56 %) with the IN.PACT Falcon. Angiographic and device success were 100 and 90 % for the DIOR, and 100 and 92 % for the IN.PACT Falcon, respectively. After 6-months, in-segment late lumen loss (-0.03 ± 0.43 vs. 0.36 ± 0.48 mm, p = 0.014) and diameter stenosis (30.7 ± 16.2 vs. 41.3 ± 22.6 %, p = 0.083) were lower for the IN.PACT Falcon. FFR distal of the stent was significantly higher in the IN.PACT Falcon group (0.92 ± 0.07 vs. 0.84 ± 0.13, p = 0.029) and in-stent FFR gradient was lower (0.05 ± 0.05 vs. 0.13 ± 0.12, p = 0.002). Between postprocedure and follow-up, a 16 % decrease in neointimal volume was observed for the IN.PACT Falcon, while a 30 % increase was observed for the DIOR (p = 0.006).. The IN.PACT Falcon DEB showed higher antirestenotic efficacy than the DIOR in the treatment of ISR, demonstrating that DEB with an excipient-based coating is not equally effective.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Female; Fractional Flow Reserve, Myocardial; Humans; Male; Middle Aged; Netherlands; Paclitaxel; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Risk Factors; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome

To evaluate the biological effect of a paclitaxel-coated balloon (PCB) technology on vascular drug distribution and healing in drug eluting stent restenosis (DES-ISR) swine model.. The mechanism of action and healing response via PCB technology in DES-ISR is not completely understood.. A total of 27 bare metal stents were implanted in coronary arteries and 30 days later the in-stent restenosis was treated with PCB. Treated segments were harvested at 1 hr, 14 days and 30 days post treatment for the pharmacokinetic analysis. In addition, 24 DES were implanted in coronary arteries for 30 days, then all DES-ISRs were treated with either PCB (n = 12) or uncoated balloon (n = 12). At day 60, vessels were harvested for histology following angiography and optical coherence tomography (OCT).. The paclitaxel level in neointimal tissue was about 18 times higher (P = 0.0004) at 1 hr Cmax , and retained about five times higher (P = 0.008) at day 60 than that in vessel wall. A homogenous distribution of paclitaxel in ISR was demonstrated by using fluorescently labeled paclitaxel. Notably, in DES-ISR, both termination OCT and quantitative coronary angioplasty showed a significant neointimal reduction and less late lumen loss (P = 0.05 and P = 0.03, respectively) post PCB versus post uncoated balloon. The PES-ISR + PCB group displayed higher levels of peri-strut inflammation and fibrin scores compared to the -limus DES-ISR + PCB group.. In ISR, paclitaxel is primarily deposited in neointimal tissue and effectively retained over time following PCB use. Despite the presence of metallic struts, a uniform distribution was characterized. PCB demonstrated an equivalent biological effect in DES-ISR without significantly increasing inflammation. © 2015 Wiley Periodicals, Inc.

Topics: Animals; Cardiac Catheterization; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Disease Models, Animal; Equipment and Supplies; Fibrin; Metals; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Stents; Swine; Tissue Distribution; Tomography, Optical Coherence; Wound Healing

The internal mammary artery (IMA) is the preferred conduit for bypassing the left anterior descending (LAD) artery in patients undergoing coronary artery bypass grafting. Systematic evaluation of the frequency and predictors of IMA failure and long-term outcomes is lacking.. The Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV trial participants who underwent IMA-LAD revascularization and had 12- to 18-month angiographic follow-up (n=1539) were included. Logistic regression with fast false selection rate methods was used to identify characteristics associated with IMA failure (≥75% stenosis). The relationship between IMA failure and long-term outcomes, including death, myocardial infarction, and repeat revascularization, was assessed with Cox regression. IMA failure occurred in 132 participants (8.6%). Predictors of IMA graft failure were LAD stenosis <75% (odds ratio, 1.76; 95% confidence interval, 1.19-2.59), additional bypass graft to diagonal branch (odds ratio, 1.92; 95% confidence interval, 1.33-2.76), and not having diabetes mellitus (odds ratio, 1.82; 95% confidence interval, 1.20-2.78). LAD stenosis and additional diagonal graft remained predictive of IMA failure in an alternative model that included angiographic failure or death before angiography as the outcome. IMA failure was associated with a significantly higher incidence of subsequent acute (<14 days of angiography) clinical events, mostly as a result of a higher rate of repeat revascularization.. IMA failure was common and associated with higher rates of repeat revascularization, and patients with intermediate LAD stenosis or with an additional bypass graft to the diagonal branch had increased risk for IMA failure. These findings raise concerns about competitive flow and the benefit of coronary artery bypass grafting in intermediate LAD stenosis without functional evidence of ischemia.. URL: http:/www.clinicaltrials.gov. Unique identifier: NCT00042081.

Topics: Aged; Cardiac Catheterization; Cardiovascular Agents; Combined Modality Therapy; Comorbidity; Coronary Angiography; Coronary Disease; Coronary Restenosis; Diabetes Complications; Double-Blind Method; Female; Graft Occlusion, Vascular; Humans; Internal Mammary-Coronary Artery Anastomosis; Kaplan-Meier Estimate; Male; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; Postoperative Complications; Proportional Hazards Models; Randomized Controlled Trials as Topic; Reoperation; Treatment Failure

We aimed to analyze angiographic and clinical results of patients undergoing BRS implantation in a real-world setting.. Angiographic and clinical outcome data from patients undergoing implantation of drug-eluting bioresorbable stents (BRS) in routine clinical practice is scant.. Consecutive patients undergoing implantation of everolimus-eluting BRS at two high-volume centers in Munich, Germany were enrolled. Data were collected prospectively. All patients were scheduled for angiographic surveillance 6-8 months after stent implantation. Quantitative coronary angiographic analysis was performed in a core laboratory. Clinical follow-up was performed to 12 months and events were adjudicated by independent assessors.. A total of 419 patients were studied. Mean age was 66.6 ± 10.9 years, 31.5% had diabetes mellitus, 76.1% had multivessel disease, and 39.0% presented with acute coronary syndrome; 49.0% of lesions were AHA/ACC type B2/C, 13.1% had treatment of bifurcation lesions. Mean reference vessel diameter was 2.89 ± 0.46 mm. At angiographic follow-up in-stent late loss was 0.26 ± 0.51 mm, in-segment diameter stenosis was 27.5 ± 16.1, and binary angiographic restenosis was 7.5%. At 12 months, the rate of death, myocardial infarction, or target lesion revascularization was 13.1%. Definite stent thrombosis occurred in 2.6%.. The use of everolimus-eluting BRS in routine clinical practice is associated with high antirestenotic efficacy in patients undergoing angiographic surveillance. Overall clinical outcomes at 12 months are satisfactory though stent thrombosis rates are not insignificant. Further study with longer term follow-up and larger numbers of treated patients is required before we can be sure of the role of these devices in clinical practice.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Germany; Hospitals, High-Volume; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Registries; Risk Factors; Time Factors; Treatment Outcome

To compare drug-eluting balloons (DEBs) versus second-generation DES in the treatment of drug-eluting stent restenosis (DES-ISR).. The optimal treatment of DES-ISR remains unclear. Several modes of treatment ranging from plain-old balloon angioplasty to repeated use of DES have yielded disappointing results. DEBs are increasingly been used in restenotic lesions; however, their use in DES-ISR is less established.. We evaluated all procedures between 2009 and 2011, involving DES-ISR that were treated either with DEB or second-generation DES. The measured end-points during the follow-up period were cardiac-death, target-vessel MI, TLR, TVR, and MACE defined as composite of cardiac-death, TV-MI, and TVR.. Two hundred and forty-seven patients (302 lesions) with DES-ISR were treated with either DEB (81 patients; 104 lesions) or second-generation DES (166 patients; 198 lesions). The mean age of patients was 66.1 ± 9.4 years. There were higher numbers of patients with diabetes in the DEB group (DEB 47% vs DES 33%; p = 0.03). The mean length of DEB was significantly longer than the DES (35.4 vs 19.8 mm; p < 0.001). During the 12-month follow-up, there were no significant differences in the MACE rates (12.3% vs 8.4%; p = 0.3) and TLR rates (9.9% vs 7.8%; p = 0.6) between DEB and DES, respectively. On the multivariate analysis, use of DEB or DES was not the predictor of MACE (hazard ratio: 0.84, 95% CI: 0.46-1.85; p = 0.6). There were no cases of definite or probable stent thrombosis in either group.. There were no significant differences in the clinical outcomes between DEB and second-generation DES in the treatment of DES-ISR. These results should encourage operators to consider DEB in the treatment of DES-ISR, which offers certain advantages over DES. © 2015 Wiley Periodicals, Inc.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Italy; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Retreatment; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome

This work aims to demonstrate the possibility to fabricate ultra-thin polymeric films loaded with an anti-restenotic drug and capable of tunable drug release kinetics for the local treatment of restenosis. Vascular nanopatches are composed of a poly(lactic acid) supporting membrane (thickness: ~250 nm) on which 20 polyelectrolyte bilayers (overall thickness: ~70 nm) are alternatively deposited. The anti-restenotic drug is embedded in the middle of the polyelectrolyte structure, and released by diffusion mechanisms. Nanofilm fabrication procedure and detailed morphological characterization are reported here. Barium titanate nanoparticles (showing piezoelectric properties) are included in the polymeric support and their role is investigated in terms of influence on nanofilm morphology, drug release kinetics, and cell response. Results show an efficient drug release from the polyelectrolyte structure in phosphate-buffered saline, and a clear antiproliferative effect on human smooth muscle cells, which are responsible for restenosis. In addition, preliminary evidences of ultrasound-mediated modulation of drug release kinetics are reported, thus evaluating the influence of barium titanate nanoparticles on the release mechanism. Such data were integrated with quantitative piezoelectric and thermal measurements. These results open new avenues for a fine control of local therapies based on smart responsive materials.

Topics: Barium Compounds; Cardiovascular Agents; Cell Adhesion; Cells, Cultured; Coronary Restenosis; Drug Carriers; Drug Delivery Systems; Humans; Lactic Acid; Muscle, Smooth, Vascular; Nanoparticles; Nanostructures; Polyesters; Polymers; Pyridines; Pyrimidinones; Titanium; Ultrasonics

To evaluate angiographic and clinical results of ZES compared with EES after recanalization of CTOs.. ZES and EES showed similar clinical results in non-CTO lesions. Whether ZES and EES are also comparable in true CTO lesions (TIMI 0 flow, duration of occlusion of more than 3 months) with a higher risk of restenosis has not been addressed so far.. 125 patients with successful CTO recanalization via antegrade or retrograde approach were included. EES were implanted in 68 patients and ZES in 57 patients. Dual antiplatelet therapy was prescribed for 12 months. Follow-up angiography was scheduled at 9 months and clinical follow-up at 12 months. The primary angiographic outcome measure was in-stent late lumen loss. Primary clinical outcome measures were target lesion revascularization rate (TLR) and major adverse cardiac events (MACE) as a composite of cardiac death, TLR and myocardial infarction not clearly attributable to a non-target vessel.. Baseline characteristics were similar in both groups. Mean stent length was 72.8 ± 33.0mm with EES and 70.8 ± 31.5 mm with ZES (P = 0.72). In-stent late lumen loss was 0.50 ± 0.71 mm for EES compared with 0.59 ± 0.72 (P = 0.52) for ZES. There were similar rates for TLR (EES 10.3% versus ZES 10.5%, P = 0.97) and MACE (EES 10.3% versus ZES 12.3%). No definite or probable stent thrombosis occurred. Stent length but not type of stent was predictive for in-stent late loss and TLR.. ZES and EES showed similar angiographic and clinical outcomes for treatment of CTOs. © 2016 Wiley Periodicals, Inc.

Topics: Aged; Cardiovascular Agents; Chronic Disease; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug Therapy, Combination; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Predictive Value of Tests; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Treatment of coronary in-stent restenosis (ISR) is still associated with a high incidence of recurrence. We aimed to compare the efficacy and safety of drug-eluting balloons (DEB) for the treatment of ISR as compared with conventional balloon angioplasty (BA) and drug-eluting stents (DES).. Between January 2006 and May 2012 a total of 177 patients (188 lesions, 64.1 ± 11.7 years old) who underwent percutaneous coronary intervention for ISR were retrospectively enrolled. Clinical outcomes were compared between patients treated with DEB (n = 58, 32.8%), conventional BA (n = 65, 36.7%), or DES (n = 54, 30.5%). The primary end point was a major adverse cardiac event (MACE), defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization(TLR).. Baseline characteristics were not different except for a history of previous MI, which was more frequent in patients treated by conventional BA or DES than in patients treated by DEB (40.0% vs. 48.1% vs. 17.2%, respectively, p = 0.002). The total incidences of MACEs were 10.7%, 7.4%, and 15.4% in patients treated by DEB, DES, or conventional BA, respectively (p > 0.05). TLR was more frequent in patients treated by conventional BA than in patients treated by DEB or DES, but this was not statistically significant (10.8% vs. 6.9% vs. 3.7%, p > 0.05 between all group pairs, respectively).. This study showed that percutaneous coronary intervention using DEB might be a feasible alternative to conventional BA or DES implantation for treatment of coronary ISR. Further large-scaled, randomized study assessing long-term clinical and angiographic outcomes will be needed.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Cause of Death; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Retreatment; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome

The treatment of in-stent restenosis (ISR) remains challenging. Small case series have described successful utilisation of bioresorbable vascular scaffolds (BVS) (Absorb; Abbott Vascular, Santa Clara, CA, USA) to treat ISR. We report our experience with this novel approach.. Patients with ISR in native coronary arteries undergoing percutaneous coronary intervention (PCI) for ISR were treated using BVS. A total of 84 ISR lesions were treated in 65 patients. The mean age was 66±11 years, 28% had acute coronary syndrome (ACS) and 28% were diabetic. PCI was successful in all patients and all scaffolds were delivered and deployed successfully in the target lesion. All 65 patients had six-month follow-up and 49 patients had 12-month clinical follow-up. The target lesion revascularisation (TLR) rate was 3.1% at six months and 12.2% at 12 months. The mean duration from PCI to TLR was 301±148 days. No scaffold thrombosis occurred during the study period.. This proof of concept study demonstrates that ISR treatment utilising BVS is feasible and appears to have acceptable target lesion failure rates. Prospective randomised trials are necessary to assess whether BVS are more effective than drug-eluting stents or drug-eluting balloons to treat ISR.

Topics: Absorbable Implants; Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prospective Studies; Time Factors

This study determined angiographic and clinical outcomes after everolimus-eluting stent (EES)-supported percutaneous coronary intervention for unprotected left main disease (ULMD) and high SYNTAX (SYNergy between PCI with TAXus and Cardiac Surgery) trial score (≥33).. The SYNTAX trial has shown the superiority of coronary surgery over percutaneous coronary intervention (PCI) in patients with ULMD and complex coronary anatomy. It has been hypothesized that, if newer generation drug-eluting stents had been used in the SYNTAX trial, there would have been a significant reduction in clinical events.. Patients had angiograms scored according to the SYNTAX score algorithm and were divided into 2 groups: those with SYNTAX score of ≥33 and those with <33. The main endpoints were ULMD restenosis and 3-year cardiac mortality.. From May 2008 to July 2014, 393 patients underwent EES implantation for ULMD (181 patients had a SYNTAX score ≥33, whereas 212 patients had a SYNTAX score <33). Overall, the restenosis rate was 4.9% (6% in SYNTAX patients scoring ≥33 and 4.1% in SYNTAX patients scoring <33; p = 0.399). On multivariate analysis, the only variable related to restenosis was stent length (odds ratio [OR]: 1.06; 95% confidence interval [CI]: 1.02 to 1.09; p = 0.002). Three-year cardiac survival rates were 99 ± 1% and 98 ± 2% in patients with European system for cardiac operative risk evaluation (EuroSCORE) <6 and SYNTAX <33 and ≥33, respectively, and 90 ± 3% and 87 ± 3% in patients with a EuroSCORE >6 and SYNTAX score <33 and ≥33, respectively. EuroSCORE was strongly related to cardiac mortality, while the SYNTAX score ≥33 was not both in patients with a EuroSCORE <6 or ≥6, and there were no interactions between EuroSCORE and SYNTAX score ≥33.. For ULMD patients, high anatomical complexity as defined by a SYNTAX score ≥33 is not predictive of clinical outcome after PCI. (TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972).

Topics: Aged; Aged, 80 and over; Algorithms; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Italy; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Percutaneous Coronary Intervention; Predictive Value of Tests; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Time Factors; Treatment Outcome

We report a case of bioresorbable vascular scaffold restenosis which could be caused by abnormal resorption 17months after implantation.

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Male; Middle Aged; Non-ST Elevated Myocardial Infarction; Prosthesis Design; Retreatment; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is more challenging than that of patients with bare-metal stent ISR. However, the results of everolimus-eluting stents (EES) in these distinct scenarios remain unsettled.. A pooled analysis of the RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) and RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) randomized trials was performed using patient-level data to compare the efficacy of EES in bare-metal stent ISR and DES-ISR. Inclusion and exclusion criteria were identical in both trials. Results of 94 patients treated with EES for bare-metal stent ISR were compared with those of 155 patients treated with EES for DES-ISR. Baseline characteristics were more adverse in patients with DES-ISR, although they presented later and more frequently with a focal pattern. After intervention, minimal lumen diameter (2.22±0.5 versus 2.38±0.5 mm, P=0.01) was smaller in the DES-ISR group. Late angiographic findings (89.3% of eligible patients), including minimal lumen diameter (2.03±0.7 versus 2.36±0.6 mm, P<0.001) and diameter stenosis (23±22 versus 13±17%, P<0.001) were poorer in patients with DES-ISR. Results were consistent in the in-segment and in-lesion analyses. On multiple linear regression analysis, minimal lumen diameter at follow-up remained significantly smaller in patients with DES-ISR. Finally, at 1-year clinical follow-up (100% of patients), mortality (2.6 versus 0%, P<0.01) and need for target vessel revascularization (8 versus 2%, P=0.03) were higher in the DES-ISR group.. This patient-level pooled analysis of the RIBS IV and RIBS V randomized clinical trials suggests that EES provide favorable outcomes in patients with ISR. However, the results of EES are less satisfactory in patients with DES-ISR than in those with bare-metal stent ISR.. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01239953 and NCT01239940.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Linear Models; Male; Metals; Middle Aged; Multivariate Analysis; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Stents; Time Factors; Treatment Outcome

The unique physical properties of optical coherence tomography (OCT) make it a useful technique in the study of restenosis mechanisms. In fact, OCT is able to differentiate between neointimal proliferation and neoatherosclerosis within the stent. We report a rare case of occlusive neoatherosclerosis presenting beyond one year after a successful drug-eluting stent implantation. The impact of OCT findings in the clinical decision making process is emphasized.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Occlusion; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Hypolipidemic Agents; Male; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Retreatment; Sirolimus; Stents; Time Factors; Tomography, Optical Coherence; Treatment Outcome

We assessed long-term outcomes in patients with extra-small (XS) (≤2.25 mm) and small vessels (SV) (>2.25-2.75 mm) treated with the Resolute zotarolimus-eluting stent (R-ZES).. Data from eight studies including patients with XS or SV were pooled for this analysis. Among 2,141 patients (837 XS, 1,304 SV), three-year cumulative major adverse cardiac events (15.4% vs. 11.5%; adj. HR [95% CI]: 1.3 [1.0, 1.7], p=0.12), target lesion failure (12.4% vs. 9.3%, adj. HR: 1.1 [0.8, 1.5], p=0.56), and target lesion revascularisation (TLR: 6.9% vs. 4.5%, adj. HR 1.4 [0.9, 2.1], p=0.17) were greater in the XS cohort but were not significantly different after propensity adjustment. Target vessel revascularisation occurred more frequently in XS patients in both unadjusted and adjusted analyses (11.2% vs. 7.6%, adj. HR: 1.5 [1.1, 2.1], p=0.02). Stent thrombosis was low in both cohorts (1.2% vs. 0.6%, p=0.09). In the XS cohort, insulin-dependent diabetics had over twofold higher rates of TLR than non-diabetics (13.6% vs. 6.0%, p=0.02).. Long-term lesion-specific results among patients with XS vessels treated with the R-ZES were not significantly different from those among patients with SV, but specific patients with XS vessels (e.g., insulin-dependent diabetics) may remain at high risk for TLR.

Topics: Adult; Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Sirolimus; Treatment Outcome

A 78-year-old man with unstable angina showed 90% stenosis in the proximal left anterior descending artery. Pre-procedural intravascular ultrasound revealed ruptured plaque and attenuated plaque in the lesion. Under these conditions, two overlapping sirolimus-eluting stent (SES) implantation in this lesion resulted in slow flow which was recovered by intracoronary nitrates, nicorandil, and nitroprusside without further complications. When the patient showed up again 5 years later with recurrence of angina pectoris, angiography revealed a hazy ulcerated in-stent restenosis (ISR) at the site of the SES. Pre-procedural optical coherence tomography (OCT) imaging revealed multiple intimal ruptures, cavity formation behind the stent struts, a thin-cap fibroatheroma containing neointima surrounded by signal-poor, lipid-rich area in the proximal SES, suggesting the progression of neoatherosclerosis within SES. Importantly, there occurred slow flow again after balloon angioplasty for this lesion. We would suggest careful OCT examination is warranted to confirm development of neoatherosclerosis within the stent, and distal protection device should be considered to prevent slow flow phenomenon even in a patient with very late ISR.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Circulation; Coronary Restenosis; Coronary Stenosis; Denture, Partial, Temporary; Drug-Eluting Stents; Humans; Male; No-Reflow Phenomenon; Recurrence; Retreatment; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

This study investigated p aclitaxel-induced luminal changes following drug-coated balloon (DCB) angioplasty to treat coronary de novo lesions without additional stenting. DCB-mediated local drug delivery reduces late lumen loss in de novo coronary artery lesions. We performed a retrospective clinical assessment based on a pre-specified quantitative coronary angiography (QCA) protocol.. QCA was performed for each centre to assess the primary endpoint late lumen changes, i.e. the difference between in-lesion minimal lumen diameter (MLD) at the routine angiographic follow-up as compared to post-procedural in-lesion MLDs. These MLD changes were compared to corresponding reference vessel diameter changes as an intra-patient control.. We evaluated 58 consecutive native coronary artery lesions directly after DCB angioplasty and at a routine target follow-up angiography of 4 months by QCA. Target lesion MLD increased significantly within the 4.1 ± 2.1 month observation period (1.75 ± 0.55 vs. 1.91 ± 0.55 mm, p < 0.001, diameter stenosis 33.8 ± 12.3 vs. 26.9 ± 13.8 %, p < 0.001), while there were no changes in non-target reference vessel diameters (2.33 ± 0.60 vs. 2.34 ± 0.61 mm, p = ns). A total of 69 % of patients showed luminal enlargement whereas 29 % had minor luminal loss.. Local application of paclitaxel by DCB angioplasty to native coronary arteries after pre-dilatation without major dissection and recoil leads to late lumen increase.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Female; Humans; Hyperplasia; Male; Middle Aged; Neointima; Paclitaxel; Retrospective Studies; Time Factors; Treatment Outcome; Vascular Remodeling

The purpose of this study was to describe the multimodal outcome 12 months after implantation of coronary bioresorbable scaffolds (BVS) for the treatment of patients with acute coronary syndromes (ACS).. Functional and imaging data on the use of BVS are limited to simple, stable lesions; in the setting of ACS, only short-term clinical follow-up data are available, and no information from intracoronary imaging and vasomotion tests has been reported.. A total of 133 patients (age 62 ± 12 years, 74% males, 15% diabetic) underwent BVS (n = 166) implantation for the treatment of thrombotic lesions in the setting of ACS (43% non-ST-segment elevation myocardial infarction, 38% ST-segment elevation myocardial infarction, 20% unstable angina). Clinical, angiographic, intracoronary imaging, and vasomotor endpoints were evaluated at 12 months.. During the 374 days (interquartile range: 359 to 411 days) of follow-up, there were 4 deaths; 3 definite and 1 probable in-BVS thromboses (all in the first 6 months). At 12-month angiography (75 patients, 83 BVS), in-segment late lumen loss was 0.19 ± 0.45 mm, and 3 (4%) patients showed binary restenosis. Optical coherence tomography (80 BVS, n = 70) showed a mean lumen area of 6.3 ± 2.3 mm(2). Malapposition was evidenced in 21 (26%) BVS. Endothelium-dependent and -independent vasodilation were observed in 48% and 49% of the BVS.. Twelve months after BVS implantation, clinical, intracoronary imaging, and vasomotion data appear to provide a rationale for the use of BVS in the setting of ACS and the basis for a randomized study.

Topics: Absorbable Implants; Acute Coronary Syndrome; Aged; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Recovery of Function; Registries; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vasodilation

Topics: Absorbable Implants; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Middle Aged; Neointima; Percutaneous Coronary Intervention; Prosthesis Design; Prosthesis Failure; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Aged, 80 and over; Autopsy; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Fatal Outcome; Female; Humans; Neointima; Percutaneous Coronary Intervention; Polycythemia Vera; Predictive Value of Tests; Prosthesis Design; Risk Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheterization; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Paclitaxel; Percutaneous Coronary Intervention

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Guidelines as Topic; Hospitalization; Humans; Male; Myocardial Infarction; Sirolimus; Tomography, Optical Coherence

This study sought to assess the incidence and clinical impact of stent fracture (SF) after the PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES).. SF remains an unresolved, clinically relevant issue, even in the newer-generation drug-eluting stent era.. From March 2012 to August 2013, 816 patients with 1,094 lesions were treated only with PtCr-EES and 700 patients (85.7%) with 898 lesions undergoing follow-up angiography within 9 months after the index procedure were analyzed. SF was defined as complete or partial separation of the stent, as assessed by plain fluoroscopy, intravascular ultrasound, or optical coherence tomography during the follow-up. We assessed the rate of SF and the cumulative incidence of clinically driven target lesion revascularization and definite stent thrombosis within 9 months after the index procedure.. SF was observed in 16 of 898 lesions (1.7%) and 16 of 700 patients (2.2%). Lesions with in-stent restenosis at baseline (odds ratio [OR]: 14.2, 95% confidence intervals [CI]: 5.09 to 39.7; p < 0.001) or hinge motion (OR: 4.31, 95% CI: 1.12 to 16.5; p = 0.03), and total stent length (per 10-mm increase; OR: 1.32, 95% CI: 1.12 to 1.57; p = 0.001) were predictors of SF. Cumulative incidence of clinically driven target lesion revascularization within 9-months was numerically higher in the SF group than that in the non-SF group (18.7% vs. 2.3%). Cumulative incidence of definite stent thrombosis within 9 months after the index procedure was similar between the SF and non-SF groups (0.0% vs. 0.23%).. SF after PtCr-EES occurs in 1.7% of lesions and appears to be associated with clinically driven target lesion revascularization.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Chromium; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; Japan; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Percutaneous Coronary Intervention; Platinum; Prosthesis Design; Prosthesis Failure; Risk Factors; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Topics: Angioplasty, Balloon; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Humans; Male; Paclitaxel; Percutaneous Coronary Intervention; Plaque, Atherosclerotic; Prosthesis Design; Prosthesis Failure; Retreatment; Thrombectomy; Tomography, Optical Coherence; Treatment Outcome

The authors sought to understand the clinical and angiographic outcomes of dissections left after drug-coated balloon (DCB) angioplasty.. Second-generation DCB may be an alternative to stents in selected populations for the treatment of native coronary lesions. However, the use of these devices may be hampered by a certain risk of acute vessel recoil or residual coronary dissection. Moreover, stenting after DCB has shown limited efficacy. Little is known about when a non-flow-limiting dissection is left after DCB angioplasty.. This was a prospective observational study whose aim was to investigate the outcome of a consecutive series of patients with native coronary artery disease treated with second-generation DCB and residual coronary dissection at 2 Italian centers. We evaluated patient clinical conditions at 1 and 9 months, and angiographic follow up was undertaken at 6 months.. Between July 2012 and July 2014, 156 patients were treated with DCB for native coronary artery disease. Fifty-two patients had a final dissection, 4 of which underwent prosthesis implantation and 48 were left untreated and underwent angiographic follow-up after 201 days (interquartile range: 161 to 250 days). The dissections were all type A to C, and none determined an impaired distal flow. Complete vessel healing at angiography was observed in 45 patients (93.8%), whereas 3 patients had persistent but uncomplicated dissections, and 3 had binary restenosis (6.2%). Late lumen loss was 0.14 mm (-0.14 to 0.42). Major adverse cardiovascular events occurred in 11 patients in the entire cohort and in 4 of the dissection cohort (7.2% vs. 8.1%; p = 0.48). We observed 8 and 3 target lesion revascularizations, respectively (5.3% vs. 6.2%; p = 0.37).. In this cohort of consecutive patients treated with new-generation DCB and left with a final dissection, this strategy of revascularization seemed associated with the sealing of most of dissections and without significant neointimal hyperplasia.

Topics: Aged; Angioplasty, Balloon, Coronary; Aortic Dissection; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Aneurysm; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Female; Humans; Italy; Male; Middle Aged; Prospective Studies; Risk Factors; Time Factors; Treatment Outcome

The role of the second-generation zotarolimus-eluting stent RESOLUTE in small-vessel coronary artery disease is unclear. The aim of this study was examine the angiographic results of RESOLUTE in de novo coronary lesions of ≥50 % diameter stenosis in target vessels ≤2.5 mm. From August 2008 to April 2010, 142 symptomatic patients with 159 lesions who fitted the inclusion criteria were treated with RESOLUTE. The mean age of patients was 66 ± 10 years, with male predominance (66 %). Diabetes mellitus was found in 62 (43.7 %) patients, whereas multivessel disease was observed in 105 (73.9 %). The mean stent size and length used were 2.33 ± 0.13 and 22 ± 8 mm, respectively. Follow-up angiography was performed on 143 (89.9 %) lesions in 127 (89.4 %) patients at a mean of 10.3 ± 3.6 months. Angiographic restenosis was found in 9 (6.3 %) lesions; the late loss was 0.26 ± 0.34 mm. At 1-year follow-up there were four cardiovascular deaths, two nonfatal myocardial infarctions, and six repeated revascularizations. The resultant major adverse cardiac event rate was 8.5 %. The use of RESOLUTE to treat small-vessel disease is associated with good clinical and angiographic outcomes at 1 year.

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Percutaneous Coronary Intervention; Prosthesis Design; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

A 60-year-old man who had received repeated angioplasty for silent ischemia was suspected to have restenosis based on radioisotope imaging (exercise-RI) findings 6 months after everolimus-eluting stent (EES) implantation (3.5 × 28, 3.5 × 28, 3.0 × 18 mm). The stents had been implanted for chronic total occlusion of the right coronary artery (RCA), and the patient was on continuous dual antiplatelet therapy. Diagnostic angiography demonstrated in-stent restenosis in the proximal RCA, which was treated by optical coherence tomography (OCT)-guided cutting balloon angioplasty with distal protection. OCT findings of the stenotic segment before angioplasty showed that the lesion had complex features. The lesion was successfully dilated, and whitish material obtained by a distal protection device was composed of fibrin thrombi with neutrophils and small pieces of mature fibrocellular neointima. The mechanisms and patterns of restenosis after EES placement have not been well clarified. This case may reflect a restenosis pattern (i.e., asymptomatic, focal, and thrombi-related) in the era of the newer generation of drug-eluting stents.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prosthesis Design; Severity of Illness Index; Sirolimus; Tomography, Optical Coherence; Treatment Outcome

Drug-eluting stent (DES) implantation is a very effective treatment of bare-metal stent-in-stent restenosis (BMS-ISR). Therapeutic options for drug-eluting stent-in-stent restenosis (DES-ISR) are less well defined, as there are only few data on safety and effectiveness of interventional modalities. This study compared the 1-year clinical outcome after the use of drug-eluting balloon (DEB) to second-generation everolimus-eluting stent (EES) for treatment of DES-ISR.. This observational study included 86 patients with 86 DES-ISR. Forty patients were treated by repeat percutaneous coronary intervention (PCI) using an EES. Forty-six patients were treated by repeat PCI using a DEB. Follow-up periods were 22 ± 11 and 25 ± 19 months, respectively. The primary endpoint of the study was survival free of major adverse cardiac events (MACEs) at 1 year. Secondary endpoints were needed for target lesion revascularization (TLR), definite stent thrombosis (ST) at 1 year, and MACE rate during total follow-up period.. Baseline clinical and angiographic parameters were comparable between the two groups. EES were associated with a higher MACE rate at 1 year compared to DEB (27.5 vs. 8.6%, respectively; P = 0.046). TLR rates for EES and DEB were 22.5% versus 4.3%, respectively, P = 0.029, while rates of definite ST at 1 year follow-up were comparable (2.5% vs. 0%, respectively; P = 0.945). There were no differences in myocardial infarction rates between the two groups (5% vs. 2%, respectively; P = 0.595) and in mortality. Considering the complete follow-up periods, DEB were associated with significantly less MACE compared to EES (log-rank test, P = 0.045). Furthermore, comparison of TLR rates showed a strong trend in favor of DEB compared to EES (P = 0.074).. Treatment of DES-ISR using a DEB is associated with favorable rates of MACE and TLR at 1-year follow-up compared to the implantation of an EES.

Topics: Aged; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Compared with the bare metal stent (BMS), suppression of neointimal growth in the sirolimus-eluting stent (SES) reduced restenosis at the cost of more exposed struts that could impose the risk of stent thrombosis. The present study was conducted to analyze neointimal coverage patterns of stents at a strut-level after implantation of BMS or SES with the use of optical coherence tomography (OCT). We enrolled 35 patients and analyzed neointimal coverage of every strut from 41 stents (BMS: n = 8, SES: n = 33) by using OCT at follow-up of the stent implantation. All of the 371 struts from eight BMSs were covered with ≥100 μm of neointima, while 19.8 and 3.5% of 3,478 struts from 33 SESs were uncovered (neointimal thickness of <10 μm) and malapposed, respectively. The histogram of neointimal thickness showed basically normal distribution in BMS but skewed in SES. No regional difference in neointimal thickness was observed in BMS (proximal, 535.7 ± 25.2 μm; body, 532.4 ± 17.0 μm; distal, 485.8 ± 27.0 μm). In SES, however, the body segment showed thinner neointima [median 40 μm (interquartile range (IQR) 10-90 μm)] than proximal [60 μm (IQR 10-140 μm), p < 0.001] or distal [50 μm (IQR 10-110 μm), p < 0.001] segment, while uncovered and malapposed struts were more frequent in the proximal and body segments. In conclusion, SES, compared with BMS, showed more suppressed neointimal growth with regional variation: neointimal thickness was the least in the body part while the ratio of exposed and malapposed struts was minimal in the distal segment. OCT was useful for a strut-level analysis of neointimal coverage over the whole stent.

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

Treatment of coronary in-stent restenosis (ISR) remains a challenge in interventional cardiology, especially after drug eluting stent (DES)-ISR. Drug coated balloons (DCB) provide a new therapeutic option in the treatment of ISR. In patients with multiple layers of stents due to refractory ISR and exclusion criteria for revascularization by coronary artery bypass grafting, DCB may be a last therapy option. This paper presents DCB therapy as compassionate use treatment before the balloons were available in Europe.. Compassionate use of DCB was approved by the local ethical committee. Fifteen patients with refractory ISR in 28 lesions were prospectively enrolled between 12/2006 and 04/2009. The frequency of prior ISR was 3.0 ± 1.1. Nine patients presented with coronary three-vessel disease and six patients with one- or two-vessel disease. Thirteen patients had DES-ISR, two patients with contraindication for prolonged dual anti-platelet therapy repeated BMS-ISR. Two or three layers of metal were present in eleven patients. Four patients had prior coronary artery bypass grafting.. All lesions were treated with DCB (SeQuent™ Please, B.Braun, Germany). Angiographic follow-up was obtained in 14 patients. Clinical follow-up was available in all patients after 3.2 ± 0.8 years (maximum 4.8 years). Target lesion revascularization was done in 2 of 28 lesions (7.1 %), one patient with ischemic cardiomyopathy died after 1.5 years. No further MACE occurred.. DCB appear to be safe and clinically useful in the treatment of ISR. DCB is a new promising option for high-risk patients with refractory ISR.

Topics: Aged; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Compassionate Use Trials; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome

To analyze the effect of paclitaxel-coated balloon (PCB) treatment on patients with drug-eluting stent (DES) restenosis.. In the Valentines I trial, treatment of coronary in-stent restenosis was effective and safe with the second-generation DIOR® PCB.. Valentines I prospectively enrolled 250 patients with in-stent restenosis (ISR); 76 patients (30.4%) had restenosis of a previous paclitaxel or limus DES. Patients underwent balloon angioplasty followed by PCB treatment. Clinical outcomes of patients with paclitaxel-eluting DES restenosis (n=34; 41 lesions) and limus-eluting (sirolimus, everolimus and zotarolimus) DES restenosis (n=42; 43 lesions) treated with DIOR® PCB were compared.. Baseline characteristics were similar. There were more diffuse lesions >20mm treated in paclitaxel- compared to limus-eluting DES restenosis (50% vs. 26.8%, p=0.032). Number of PCB used per patient (1.08±0.31 overall), mean PCB diameter (2.99±0.42mm overall), mean PCB length (24.4±11.9mm overall), and bailout stenting (2.4% vs. 4.7%) were similar (p=NS). At mean follow-up of 231±43days, major adverse cardiac events was 0% vs. 23.8% in paclitaxel- vs. limus-eluting DES restenosis (p=0.002), driven mainly by less target vessel revascularization (0% vs. 21.4%, p=0.004). Target lesion revascularization was 0% vs. 16.7% for paclitaxel- vs. limus-eluting DES restenosis (p=0.015).. In Valentines I, PCB use was more effective in patients with paclitaxel DES restenosis compared to limus DES restenosis, achieving better mid-term clinical outcomes. This suggests the efficacy of localized paclitaxel delivery to overcome paclitaxel resistance but not limus resistance due to different mechanisms of DES failure.

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

The growing interest in the bioresorbable polymers contributed to developing a number of commercially available controlled drug delivery systems. Due to a variety of drugs and their physicochemical properties, there is a necessity of choosing an appropriate drug carrier. Terpolymer with shape memory properties was used to obtain double layer matrices composed of drug free matrix and paclitaxel containing layer. The in vitro degradation and drug release study were conducted at 37 °C in PBS (pH 7.4). The investigated materials were characterized by GPC (gel permeation chromatography) and DSC (differential scanning calorimetry). HPLC (high-pressure liquid chromatography) was applied to analyze the amount of released paclitaxel. The main purpose of this work was to determine the usefulness of the studied terpolymer as an anti-restenotic drug vehicle. Based on the obtained results it was established that polymer's degradation proceeded regularly and provided even paclitaxel release profiles. Double layer systems allowed to modify the amount of released drug which may be considered while developing the self-expanding drug-eluting stents tailoring different clinical indications.

Topics: Absorbable Implants; Calorimetry, Differential Scanning; Cardiovascular Agents; Chemistry, Pharmaceutical; Chromatography, Gel; Chromatography, High Pressure Liquid; Coronary Restenosis; Delayed-Action Preparations; Dioxanes; Drug Carriers; Drug-Eluting Stents; Humans; Hydrogen-Ion Concentration; Hydrolysis; Kinetics; Paclitaxel; Polyesters; Polyglycolic Acid; Polymers; Solubility; Technology, Pharmaceutical; Temperature

Stent fracture (SF) after drug-eluting stent implantation has become an important concern. The aim of this study was to assess the incidence, predictors, and clinical impact of SF after biolimus-eluting stent.. A total of 1026 patients with 1407 lesions undergoing the Nobori biolimus-eluting stent implantation and follow-up angiography within 9 months after index procedure were analyzed. SF was defined as complete or partial separation of the stent, as assessed by using plain fluoroscopy, intravascular ultrasound, or optical coherence tomography during the follow-up. We assessed the rate of SF and the cumulative incidence of clinically driven target lesion revascularization and definite stent thrombosis within 9 months. SF was observed in 58 (4.1%) of 1407 lesions and 57 (5.5%) of 1026 patients. Lesions with hinge motion (OR 8.90, 95% CI 3.84 to 20.6, P<0.001), tortuosity (OR 4.16, 95% CI 1.75 to 9.88, P=0.001), and overlapping stents (OR 2.41, 95% CI 0.95 to 6.10, P=0.06) were predictors of SF. Cumulative incidence of clinically driven target lesion revascularization within 9 months was numerically higher in the SF group than that in the non-SF group (12.0% versus 1.0%). Cumulative incidence of definite stent thrombosis within 9 months tended to be higher in the SF group than that in the non-SF group (1.7% versus 0.5%).. SF after biolimus-eluting stent occurs in 4.1% of lesions and appears to be associated with clinically driven target lesion revascularization.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Incidence; Japan; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Percutaneous Coronary Intervention; Prosthesis Design; Prosthesis Failure; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Topics: Angioscopy; Autopsy; Biopsy; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Fatal Outcome; Fibrosis; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Tomography, Optical Coherence

Patients requiring chronic hemodialysis (HD) are at high risk for restenosis after percutaneous coronary intervention (PCI) with bare metal stents. Outcome data on drug-eluting stent (DES) implantation in HD patients are limited and suggest superiority of paclitaxel-eluting stents (PES) over limus-eluting stents (LES).. In total, 218 consecutive patients were prospectively enrolled. A comparison of post-PCI outcomes up to 2 years was carried out between patients receiving PES (n=62) and LES (n=156; SES n=112, EES n=44). The primary end point was 2-year major adverse cardiac events [MACE; death, Q-wave myocardial infarction and target lesion revascularization (TLR)].. Baseline characteristics were comparable. The overall prevalence of diabetes mellitus was 71%. On clinical follow-up to 2 years, MACE rates were similar [PES 32/51 (62.7%) vs. LES 77/132 (58.3%), p=0.59]; however, clinically-driven revascularization occurred more than twice as frequently in LES patients: TLR [PES 4/36 (11.1%) vs. LES 24/93 (25.8%), p=0.07] and target vessel revascularization [5/37 (13.5%) vs. 33/96 (34.4%), p=0.02]. Given that overall mortality was nominally higher for PES patients [31/50 (62.0%) vs. 61/127 (48.0%), p=0.09], a competing outcome analysis was implemented for TLR against mortality, which demonstrated that the trend for increased TLR with LES was no longer apparent (p=0.282). On multivariable adjustment, only diabetes mellitus was independently associated with TLR (use of PES was not).. Patients on chronic HD experience high rates of clinically driven TLR despite DES implantation. Use of PES does not demonstrate a significant advantage over LES in this population.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Restenosis; Diabetes Mellitus; District of Columbia; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Prevalence; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Renal Dialysis; Renal Insufficiency, Chronic; Risk Factors; Time Factors; Treatment Outcome

The low-density lipoprotein cholesterol (LDL-C)/high-density lipoprotein cholesterol (HDL-C) ratio is considered to be a sensitive marker of the risk of atherosclerotic cardiovascular disease; however, in patients with a previous history of percutaneous coronary intervention (PCI), there is little information regarding the predictive value of this parameter beyond the period of early restenosis. The aim of this study was to investigate contributing factors to newly developed coronary artery disease in patients with a previous history of PCI after stabilization.. The clinical characteristics of 238 patients with a previous history of PCI who underwent coronary angiography following recurrent cardiac ischemia beyond the period of early restenosis were examined.. Overall, 64% of the patients underwent late revascularization, while 31% and 50% underwent late target lesion revascularization and new lesion revascularization, respectively. A multivariate analysis identified the LDL-C/HDL-C ratio to be an independent contributor to late revascularization (hazard ratio (HR), 1.37; p<0.001). Similarly, the independent contributors to late target lesion revascularization and new lesion revascularization were the non-HDL-C level and LDL-C/HDL-C ratio, respectively. Based on the median value of the LDL-C/HDL-C ratio, the patients were classified into high and low LDL-C/HDL-C ratio groups. The log-rank test revealed a significantly higher incidence of late revascularization in the high-LDL-C/HDL-C ratio group than in the low-LDL-C/HDL-C ratio group among the patients with an LDL-C level of ≥ 100 mg/dL (p=0.011). However, the difference between the two groups was diminished among the patients with an LDL-C level of <100 mg/dL (p=0.047), and only diabetes mellitus (HR, 2.239; p=0.009) was found to be an independent contributor to late coronary revascularization in these patients.. The LDL-C/HDL-C ratio is an important contributor to the development of new coronary artery disease in patients with a previous history of PCI beyond the period of early restenosis, particularly among patients with an LDL-C level of ≥ 100 mg/dL.

Topics: Aged; Aged, 80 and over; Biomarkers; Cardiovascular Agents; Cholesterol, HDL; Cholesterol, LDL; Comorbidity; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Female; Health Behavior; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Risk Factors

Topics: Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Everolimus; Female; Humans; Male; Percutaneous Coronary Intervention; Sirolimus; Ultrasonography, Interventional

Topics: Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Paclitaxel; Percutaneous Coronary Intervention; Sirolimus

To report a single-center experience of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) and de novo coronary artery disease.. DEB are emerging as an alternative treatment for coronary stenosis especially when metal scaffolding is undesirable (in-stent restenosis and small-vessel de novo disease). Although there are various randomized trials and registry studies, the data from real-world cohorts are lacking.. Consecutive patients treated with the In.Pact Falcon™ (Medtronic Inc., Minneapolis, MN, USA) paclitaxel-eluting balloon between January 2009 and December 2011 were retrospectively studied. The measured end-points were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE) defined as combination of cardiac death, MI, and TVR.. A total of 275 lesions were successfully treated in 184 patients. The mean age was 66.2 ± 9.6 years, and 87% were males. The predominant indication for DEB use was ISR (62%), with de novo lesions accounting for the remainder (38%). A mean of 1.48 ± 0.9 DEB were used per patient. Bailout stenting was required in 24% of lesions. The median clinical follow-up was 14.6 months (IQR 12-23). The overall rates of cardiac death, MI, TLR, TVR, and MACE were 3.8%, 1.6%, 16.8%, 17.9%, and 21.7%, respectively. The overall rate of stent thrombosis was 0.5% (n = 1).. Our results suggests that DEB can be considered in lesions where the use of stents is not desirable, especially restenotic lesions. Further long-term follow-up of these patients will provide us more insights on the long-term outcomes.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Patient Outcome Assessment; Registries; Retrospective Studies; Stents

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Endothelium, Vascular; Female; Humans; Male; Metals; Paclitaxel; Sirolimus; Stents

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Paclitaxel; Sirolimus

Despite the success that drug-eluting stents (DESs) have achieved for minimizing in-stent restenosis (ISR), the antirestenotic agents used in DES have been implicated in delayed endothelial healing and impairment of endothelial functions. Cenderitide (CD-NP) is a novel antiproliferation chimeric peptide of semiendothelial origin; thus, this paper aims to demonstrate the selectivity aspect of this new peptide via in vitro evaluation on key players in ISR-smooth muscle cells (SMCs) and endothelial cells. The microbicinchoninic acid protein assay was used to investigate the CD-NP release from films and stents. Cenderitide-containing films blended with poly(ethylene glycol) and its copolymer exhibited higher release kinetics compared with neat poly(ε-caprolactone) (PCL) formulation. Cenderitide-eluting stents (CES) was produced by coating bare metallic stents with CD-NP entrapped PCL using an ultrasonic spray coater. The investigation of CD-NP on in vitro cells revealed that CD-NP inhibits human coronary smooth muscle cells (HCaSMCs) proliferation but exhibits no effects on human umbilical vein endothelial cells (HUVECs) proliferation. Moreover, CD-NP released up to 7 days displayed inhibitory effects on SMCs proliferation. The CES produced in this work shows that the released CD-NP inhibits HCaSMCs proliferation but did not hamper HUVECs proliferation in vitro, suggesting that it has potential to reduce ISR without retarding the endothelialization healing in vivo.

Topics: Cardiovascular Agents; Cell Proliferation; Coronary Restenosis; Coronary Vessels; Delayed-Action Preparations; Drug Carriers; Drug Stability; Drug-Eluting Stents; Human Umbilical Vein Endothelial Cells; Humans; Kinetics; Materials Testing; Metals; Muscle, Smooth, Vascular; Myocytes, Smooth Muscle; Natriuretic Peptides; Polyesters; Polyethylene Glycols; Prosthesis Design; Snake Venoms; Solubility

Limited data exist on contemporary sex-related differences in long-term outcomes of coronary patients receiving drug-eluting stents. In this study we evaluate differences for males (M) and females (F) in 2-year target lesion failure (TLF) in an unselected consecutive series of patients treated with everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) at a tertiary medical center.. Data on 348 consecutive patients (M 221, F 127) stented with EES and PES were retrospectively analyzed. The primary end point of the study was to compare sex-related outcomes in TLF, defined as the combined end point of cardiac death, nonfatal myocardial infarction, and target lesion revascularization (TLR). Secondary end points included TLR, target vessel failure, target vessel revascularization, acute stent thrombosis as defined by the Academic Research Consortium, and cardiac death. The cineangiograms of the first consecutive 162 patients (M 105, F 57) were independently reviewed by a cardiologist blinded to clinical outcome, and SYNTAX scoring was performed. Follow-up was achieved using medical records and/or phone calls and was censored at 2 years. Descriptive analysis was performed on all variables. Univariate analysis compared the M and F cohorts. Multivariate analysis using Cox regression was performed to determine independent predictors of TLF with time, including sex as an independent variable in the model.. M had more prior percutaneous coronary interventions and restenotic lesions and a higher prevalence of smoking. They also had longer length of disease and received more stents than F. F were older and had a higher prevalence of prior stroke. Angiographic complexity was not statistically different between the two groups, as judged by SYNTAX scoring (M 20.8±13.8, F 19.7±13.9, P=0.650). At 2-year follow-up, TLF was 27.4% and 24.8% (P=0.614) with no statistical difference between TLR (23.3% versus [vs] 21.6%), cardiac death (2.8% vs 3.2%), and definite and probable stent thrombosis (2.3% vs 0.0%) in M and F, respectively. Cox regression analysis using backward elimination showed that the number of stents per patient was the only independent predictor of TLF with time (hazard ratio 1.201, 95% confidence interval 1.126-1.280, P=0.001).. In this cohort of patients receiving EES and PES, M and F did not have statistically different outcomes at 2-year follow-up, consistent with recent reports in the current era of percutaneous coronary interventions.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Iowa; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Paclitaxel; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Factors; Sex Factors; Sirolimus; Tertiary Care Centers; Time Factors; Treatment Outcome

The impact of underexpansion and minimal stent area (MSA) criteria in the second generation drug-eluting stents (DES) has not been addressed yet.. Using intravascular ultrasound (IVUS), we assessed the optimal cut-off values of post-stenting MSA to prevent in-stent restenosis (ISR). Poststenting IVUS data and 9-month follow-up angiography were available in 912 patients with 990 lesions: 541 sirolimus-eluting stents (SES), 220 zotarolimus-eluting stents (ZES) and 229 everolimus-eluting stents (EES).. For the prediction of angiographic ISR, the MSA of each DES was measured. The poststenting MSA was 6.4 ± 1.8 mm(2) in SES, 6.2 ± 2.1 mm(2) in ZES and 6.2 ± 2.1 mm(2) in EES. At the 9-months follow-up, the incidence of angiographic ISR was similar between SES (3.3%) vs. ZES (4.5%) vs. EES. (4.4%), (P = 0.53). Multivariable logistic regression analysis identified the post-stenting MSA as the only independent predictor of angiographic ISR in ZES (Odds ratio 0.722, 95% confidence interval 0.581-0.897, P = 0.001) and in EES (Odds ratio 0.595, 95% confidence interval 0.392-0.904, P = 0.015). The best MSA cut-off value was 5.5 mm(2) for the prediction of SES restenosis (sensitivity 72.2% and specificity 66.3%). For ZES, the optimal MSA predicting ISR was 5.3 mm(2) (sensitivity 56.7% and specificity 61.8%). For EES, the MSA <5.4 mm(2) predicted ISR (sensitivity 60.0% and specificity 60.0%).. As a preventable mechanism of ISR, smaller stent area predicted angiographic restenosis of the second generation DES as well as the first generation. The optimal cut-off values of post-stenting MSA for preventing restenosis were similar between ZES vs. EES vs. SES.

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

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Paclitaxel; Percutaneous Coronary Intervention; Sirolimus

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheterization; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Female; Fractional Flow Reserve, Myocardial; Humans; Male; Paclitaxel

First generation drug-eluting stents (DES) are associated with reduced in-stent restenosis but significant increased risk of very late stent thrombosis (VLST). The absence of polymer in DES systems may reduce the occurrence of VLST. Optic coherence tomography (OCT) has been used for stent analysis as a surrogate safety endpoint. This study aimed to assess the long-term follow up of strut apposition and tissue coverage of BioMatrix DES by OCT. 20 patients undergoing BioMatrix DES (n = 15) or S-Stent BMS (n = 5) implantation were followed for at least 5 years and evaluated by quantitative coronary angiography, intravascular ultrasound, and OCT. The difference between the stent types was evaluated by nonparametric Mann-Whitney U test while categorical variables were evaluated by Fisher exact test. Rates of in-stent late loss were similar between groups [0.40 (0.21;0.77) vs. 0.68 (0.66; 0.82) mm, p = 0.205, for BioMatrix and S-Stent, respectively]. The vessel, stent and lumen volumes did not differ between groups. Patients treated with BioMatrix had significantly less stent obstruction [5.6 (4.4;9.7) vs. 28.6 (24.7;29.0) %, p = 0.001]. OCT analysis of 12 stents (Biomatrix = 9 and S-Stent = 3) demonstrated 126 (8.7 %) uncovered struts in the BioMatrix group compared to 23 (4.0 %) in the S-Stent group (p = 0.297), being the majority of them well apposed (117/126 and 21/23, respectively, p = 0.292). Only 9 (0.6 %) struts in the DES and 2 (0.4 %) struts in the BMS groups were simultaneously uncovered and malapposed (p = 0.924). BioMatrix DES was associated with lower rates of in-stent obstruction, and similar percentage of neointimal coverage on struts and of complete strut apposition.

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

To evaluate the incidence, time course and predictors of late target lesion revascularisation (TLR) (between one and two years) as compared to early TLR (<1 year) following everolimus-eluting stent implantation in patients enrolled in the SPIRIT V study.. The SPIRIT V single-arm study enrolled a total of 2,700 patients (n=2,663 intent-to-treat) with de novo coronary artery lesions undergoing EES implantation. Patients were evaluated at 30 days, one year and two years following the index procedure. All patients who had a clinically driven TLR (not associated with stent thrombosis) were allocated to either the early or the late group. Clinical, angiographic and procedural data were recorded and predictors of early vs. late TLR were assessed by logistic regression analysis. There were no significant differences in baseline demographics and risk factors between the two groups with the exception that patients in the late TLR group were significantly older (68.5 ± 8.5 years vs. 63.5 ± 8.9 years, p=0.022). At two years, only 2.7% (70/2,562) experienced a TLR unrelated to a stent thrombosis event with 1.6% (43/2,627) occurring within one year of the index procedure and 1.1% (27/2,562) occurring between one and two years. There were no differences between the groups in terms of clinical outcomes. Age ≥70 years was the only variable which independently predicted late TLR (OR=4.80 [1.69-13.63], p=0.0032).. In this large registry without angiographic follow-up, early (<1 year) and late (>1 year) TLR rates were exceedingly low and thereby confirm the previous findings of randomised controlled studies. Age (>70 years) emerged as the only predictor of late TLR.

Topics: Age Factors; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Everolimus; Female; Humans; Incidence; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

The optimal therapy for in-stent restenosis (ISR) is controversial. We evaluated three different strategies for the treatment of in-stent restenosis: cutting balloon angioplasty (CBA), paclitaxel-eluting balloon angioplasty (PEBA) and cutting balloon followed by paclitaxel-eluting balloon angioplasty (CB+PEBA).. Forty-five coronary arteries in 45 mini-pigs underwent oversized bare-metal stent (stent-to-artery ratio, 1.2:1) implantation to induce in-stent restenosis. After 28 days, vessels with in-stent restenosis (≥50% diameter stenosis) were randomly divided into three groups: CBA, PEBA and CB+PEBA. In vivo angiography was performed before intervention, immediately after intervention and at 28-day follow-up. Stented arteries were harvested for pathological analyses. The proliferation and apoptosis of vascular smooth muscle cells were evaluated by immunohistochemical staining and the terminal deoxynucleotidyl transferase dUTP nick end labelling (TUNEL) assay, respectively.. Acute lumen gain was not different between the three groups. Late lumen loss and neointimal area at follow-up were lower for CB+PEBA compared with CBA but similar for CB+PEBA compared with PEBA. There were no significant differences in proliferating cell nuclear antigen-positive vascular smooth muscle cells and TUNEL-positive vascular smooth muscle cells between the CB+PEBA and PEBA groups.. PEBA with or without cutting balloon was superior to CBA alone for in-stent restenosis. The underlying mechanism was probably related to inhibition of smooth muscle cell proliferation and increased apoptosis. In this porcine coronary artery restenosis model, PEBA with or without cutting balloon was superior.

Topics: Angioplasty, Balloon, Coronary; Animals; Apoptosis; Cardiac Catheters; Cardiovascular Agents; Cell Proliferation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Disease Models, Animal; Equipment Design; Immunohistochemistry; In Situ Nick-End Labeling; Metals; Muscle, Smooth, Vascular; Neointima; Paclitaxel; Prosthesis Design; Stents; Swine; Swine, Miniature; Time Factors

The aim of this study is to evaluate the acute and long-term outcomes of ostial stentings among bare-metal stents (BMS), sirolimus-eluting stents, and paclitaxel-eluting stents.. According to the CAPTAIN (Cardiovascular Atherosclerosis and Percutaneous TrAnsluminal INterventions) registry, from November 1995 to June 2011, 420 patients with ostial lesions were treated using BMS implantations (243 patients with 247 lesions), CYPHER implantations (77 patients with 77 lesions), or TAXUS implantations (100 patients with 104 lesions).. Compared with the CYPHER and TAXUS groups, the BMS group had larger late loss (0.29±0.53, 0.64±0.78, and 1.30±0.79 mm, respectively, P=0.006) and restenosis rate (6, 8, and 33%, respectively, P<0.001). During the long-term follow-up, the BMS group had higher target lesion revascularization than the CYPHER and TAXUS groups (17, 4, and 6%, respectively, P=0.002). The cardiac event-free survival rate, as determined by the Kaplan-Meier analysis, was also lower in the BMS group than in the CYPHER and TAXUS groups (55, 86, and 76%, respectively, P<0.001).. Intracoronary stenting with drug-eluting stent for ostial lesions was associated with lower angiographic restenosis and late loss, and a more favorable long-term clinical outcome than BMS.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Registries; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

The economic impact of drug-eluting stent (DES) in-stent restenosis (ISR) is substantial, highlighting the need for cost-effective treatment strategies.. Compared to plain old balloon angioplasty (POBA) or repeat DES implantation, drug-coated balloon (DCB) angioplasty is a cost-effective therapy for DES-ISR.. A Markov state-transition model was used to compare DCB angioplasty with POBA and repeat DES implantation. Model input parameters were obtained from the literature, and the cost analysis was conducted from a German healthcare payer's perspective. Extensive sensitivity analyses were performed.. Initial procedure costs amounted to €3488 for DCB angioplasty and to €2782 for POBA. Over a 6-month time horizon, the DCB strategy was less costly (€4028 vs €4169) and more effective in terms of life-years (LYs) gained (0.497 versus 0.489) than POBA. The DES strategy incurred initial costs of €3167 and resulted in 0.494 LYs gained, at total costs of €4101 after a 6-month follow-up. Thus, DCB angioplasty was the least costly and most effective strategy. Base-case results were influenced mostly by initial procedure costs, target lesion revascularization rates, and the costs of dual antiplatelet therapy.. DCB angioplasty is a cost-effective treatment option for coronary DES-ISR. The higher initial costs of the DCB strategy compared to POBA or repeat DES implantation are offset by later cost savings.

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Cost Savings; Cost-Benefit Analysis; Drug Carriers; Drug Costs; Drug-Eluting Stents; Germany; Health Care Costs; Humans; Markov Chains; Models, Economic; Monte Carlo Method; Paclitaxel; Platelet Aggregation Inhibitors; Quality-Adjusted Life Years; Time Factors; Treatment Outcome

This study sought to elucidate the underlying mechanism through which drug-eluting balloons (DEB) restore coronary blood flow, by assessing the coronary vessel before, immediately after, and at 6-month follow-up with angiography, optical coherence tomography (OCT), and fractional flow reserve (FFR).. In-stent restenosis (ISR) treatment remains challenging. Drug-eluting balloons have been shown to be a valid treatment option in several studies. These studies focused on efficiency of the device, whereas the mechanisms of action of DEB in ISR treatment have not been investigated.. In this prospective, single-center observational study, patients with ISR were treated with a second-generation DEB. Serial angiographic, OCT, and FFR measurements were performed before and after the procedure, as well as at 6-month follow-up.. Twenty-five patients were assigned to DEB treatment, with an angiographic and device success of 100% and 92%, respectively. Late luminal loss was 0.01 ± 0.43 mm. Median percent changes [interquartile range] between pre-and post-procedure, and post-procedure and follow-up were, respectively: lumen volume 75.1% increase [43.7 to 115.0], and 8% increase [-14.0 to 25.8]; stent volume 23.7% increase [15.5 to 40.0], and -1.2% decrease [-6.9 to 5.9]; and neointimal volume -14.4% decrease [-29.2 to -9.5], and -15.8% decrease [-38.1 to 28.3]. The FFR gradient along the treated stent (difference in FFR between the distal and the proximal stent edge) was 0.37 ± 0.18 pre-procedure, 0.06 ± 0.04 post-procedure, and 0.05 ± 0.05 at follow-up. In all post-procedural OCT images, intrastent dissections were seen, which were sealed at follow-up OCT.. DEB restore coronary blood flow by means of a short-term mechanical effect, causing an increase in lumen and stent volumes and compression of neointimal hyperplasia (with intra-stent dissections). Due to the local drug effect, patency persists and may even improve at follow-up, with further increase in lumen volume, decrease in neointimal volume, and complete sealing of neointimal dissections.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheterization; Cardiac Catheters; Cardiovascular Agents; Chi-Square Distribution; Coronary Restenosis; Coronary Vessels; Drug Carriers; Equipment Design; Female; Fractional Flow Reserve, Myocardial; Humans; Male; Middle Aged; Neointima; Netherlands; Percutaneous Coronary Intervention; Predictive Value of Tests; Prospective Studies; Stents; Time Factors; Tomography, Optical Coherence; Tomography, X-Ray Computed; Treatment Outcome; Vascular Patency

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheterization; Cardiac Catheters; Cardiovascular Agents; Coronary Restenosis; Coronary Vessels; Drug Carriers; Female; Fractional Flow Reserve, Myocardial; Humans; Male; Percutaneous Coronary Intervention; Stents; Tomography, Optical Coherence; Tomography, X-Ray Computed

This study sought to assess the clinical safety and effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in patients with in-stent restenosis (ISR) from 2 large trials.. ISR treatment is associated with higher rates of subsequent cardiac events compared with treatment of de novo lesions. Although drug-eluting stents (DES) are an option, second-generation DES are largely untested in the treatment of ISR.. A total of 3,489 patients were pooled from the RAC (RESOLUTE All Comers) trial and the RESOLUTE International (RINT) registry. Two-year clinical endpoints included clinically driven target lesion revascularization (TLR), target lesion failure (TLF), cardiac death (CD), target vessel myocardial infarction (TVMI), combined CD or TVMI (CD/TVMI), and Academic Research Consortium definite and probable stent thrombosis (ST).. Overall, 281 patients (8.1%) received an R-ZES for ISR. Two-year TLR and TLF rates were significantly higher in ISR patients than in non-ISR patients (TLR: 12.7% vs. 4.3%, p = 0.003; TLF: 17.4% vs. 9.4%, p = 0.007); however, the CD/TVMI rate was not (6.9% vs. 6.1%, p = 0.711). Seven ISR patients had ST. Two-year outcomes by ISR stent type were similar: bare-metal stent (BMS)-ISR TLR was 12.5% and TLF was 17.2%; DES-ISR TLR was 13.0% and TLF was 18.8%. CD/TVMI was 7.3% and 7.2% for BMS-ISR and DES-ISR, respectively.. Using R-ZES to treat ISR appears equally safe in BMS-ISR and DES-ISR, with CD/TVMI rates comparable to 2-year outcomes in other clinical trials. Although revascularization rates are still higher in ISR lesions, the R-ZES offers an effective alternative for treatment of BMS-ISR and DES-ISR. (Randomized, Two-Arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; and RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population [RINT]; NCT00752128).

Topics: Aged; Cardiovascular Agents; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Propensity Score; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Angina Pectoris; Blood Flow Velocity; Cardiovascular Agents; Combined Modality Therapy; Coronary Circulation; Coronary Restenosis; Coronary Stenosis; Hemodynamics; Humans; Multicenter Studies as Topic; Myocardial Infarction; Patient Selection; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome

Topics: Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Wound Healing

This study sought to investigate the role of drug-eluting balloons (DEB) alone or in combination with drug-eluting stents (DES) in the treatment of diffuse de novo coronary artery disease (CAD) (>25 mm).. The use of DEB in diffuse CAD, either alone or in combination with DES, offers an alternative to stenting alone. Data regarding DEB in this context are limited.. We retrospectively evaluated all patients treated with DEB for diffuse CAD between June 2009 and October 2012. Endpoints analyzed were major adverse cardiac events, defined as all-cause death, myocardial infarction, and target vessel revascularization (TVR), as well as TVR and target lesion revascularization separately. Results were compared with those obtained from a cohort of patients with similar characteristics treated with DES alone.. A total of 69 patients (93 lesions) were treated with DEB ± DES, and 93 patients with DES alone (93 lesions). A high proportion of patients were diabetic (46.4% vs. 44.1%, p = 0.77). Of the DEB-treated lesions, 56.0% were treated with DEB alone, 7.4% with DEB and DES as bail out, and 36.6% with DES and DEB as part of a hybrid approach for very long disease. Outcome rates with DEB ± DES were comparable to those with DES alone at 2-year follow-up (major adverse cardiac events = 20.8% vs. 22.7%, p = 0.74; TVR = 14.8% vs. 11.5%, p = 0.44; target lesion revascularization = 9.6% vs. 9.3%, p = 0.84).. DEB may have a role in the treatment of diffuse de novo CAD, either alone in smaller vessels or in combination with DES in very long disease.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiac Catheters; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Hospitals, High-Volume; Humans; Italy; Kaplan-Meier Estimate; Male; Middle Aged; Prosthesis Design; Retrospective Studies; Risk Factors; Time Factors; Treatment Outcome

Because systemic inflammation after coronary intervention places patients at increased risk of subsequent cardiac events, we aimed to compare clinical outcomes and chronic serum inflammation markers of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) in hemodialysis patients. Paclitaxel-eluting stents and SES were implanted in 36 patients with 46 lesions, and 32 patients with 40 lesions, respectively. In addition to 1-year major adverse cardiac event (MACE) rates, high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), neopterin, intercellular adhesion molecule 1 (ICAM-1) and vascular cell adhesion molecule 1 (VCAM-1) were also compared before and 9 months after percutaneous coronary intervention (PCI). The incidence of MACE was significantly lower in the PES group than in the SES group (11.1 vs. 25.0 %, respectively, P = 0.042), mainly due to the reduction of target lesion revascularization in the PES group (6.5 vs. 17.5 %, P = 0.003). The logarithm of hs-CRP as well as IL-6 decreased significantly 9 months post-PCI compared with pre-PCI in the PES group (hs-CRP: 3.65 ± 0.35 vs. 2.91 ± 0.48, P = 0.007; IL-6: 6.73 ± 3.66 vs. 2.61 ± 2.29, P = 0.017) but not in the SES group (hs-CRP: 3.33 ± 0.29 vs. 3.42 ± 0.27, P not significant; IL-6: 6.08 ± 4.97 vs. 5.66 ± 4.29, P not significant). However, neopterin, ICAM-1, and VCAM-1 remained unchanged both pre-PCI and 9 months post-PCI in both groups. Moreover, MACE were less frequent in patients with decreased hs-CRP levels 9 months post-PCI compared with patients without decreased hs-CRP levels (P = 0.002) in all patients. Paclitaxel-eluting stents appear to be more effective than SES in reducing MACE rates, especially target lesion revascularization, and may be able to stabilize local inflammatory changes of target lesions specifically in patients on hemodialysis. Thus PES, which inhibit in-stent restenosis and cardiac events in hemodialysis patients, may play an important role in suppression of chronic inflammatory response in target lesions as compared with SES. Chronic continuous inflammation plays an important role after implantation of both types of stent with regard to in-stent restenosis in patients on hemodialysis.

Topics: Aged; Biomarkers; C-Reactive Protein; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Inflammation; Inflammation Mediators; Intercellular Adhesion Molecule-1; Interleukin-6; Male; Middle Aged; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Renal Dialysis; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Vascular Cell Adhesion Molecule-1

To test the local delivery of sirolimus nanoparticles following percutaneous transluminal coronary angioplasty (PTCA) to treat in-stent restenosis (ISR) in a swine model.. Coronary bare-metal stent (BMS) implantation reduces major adverse cardiac events when compared with PTCA; however, ISR rates remain high.. Eighteen swine underwent BMS deployment guided by intravascular ultrasound (IVUS). Of these, 16 developed ISR (1 stent/swine) and underwent angioplasty with a noncompliant balloon (PTCA-NC). The animals were then randomized into four groups for local infusion of sirolimus nanoparticles through a porous balloon catheter, as follows: (1) PTCA-NC alone (control); (2) PTCA-NC + (polylactic acid)-based nanoparticle formulation (anionic 1); (3) PTCA-NC + (polylactic-co-glycolic acid)-based nanoparticle formulation (anionic 2); and (4) PTCA-NC + Eudragit RS nanoparticle formulation (cationic). Coronary angiography and IVUS follow-up were performed 28 days after ISR treatment.. There was one episode of acute coronary occlusion with the cationic formulation. Late area loss was similar in all groups at 28 days according to IVUS. However, luminal volume loss (control = 20.7%, anionic 1 = 4.0%, anionic 2 = 6.7%, cationic = 9.6%; P = 0.01) and neointimal volume gain (control = 68.7%, anionic 1 = 17.4%, anionic 2 = 29.5%, cationic = 31.2%; P = 0.019) were significantly reduced in all treatment groups, especially in anionic 1.. PTCA-NC followed by local infusion of sirolimus nanoparticles was safe and efficacious to reduce neointima in this model, and this strategy may be a promising treatment for BMS ISR. Further studies are required to validate this method in humans.

Topics: Acrylic Resins; Animals; Cardiac Catheters; Cardiovascular Agents; Chemistry, Pharmaceutical; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Disease Models, Animal; Drug Carriers; Drug Delivery Systems; Equipment Design; Infusions, Parenteral; Lactic Acid; Nanoparticles; Neointima; Percutaneous Coronary Intervention; Polyesters; Polyglycolic Acid; Polylactic Acid-Polyglycolic Acid Copolymer; Polymers; Porosity; Sirolimus; Swine; Time Factors; Ultrasonography, Interventional

The Taxus Liberte stent (Boston Scientific Co.) evolved from the Taxus Express stent, with enhanced stent deliverability and uniform drug delivery. This study was designed to compare angiographic and clinical outcomes in real-world practice between the Taxus Liberte and Taxus Express stents.. Between 2006 and 2008, 240 patients receiving the Taxus Liberte stent at three centers were registered and compared to historical control patients who had received the Taxus Express stent (n = 272). After propensity score matching, 173 patients treated with the Taxus Liberte stent and the same number of patients treated with the Taxus Express stent were selected. The primary outcome was a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), ischemia driven target vessel revascularization (TVR), and stent thrombosis (ST) at 1 year. An additional angiographic assessment was conducted at 9 to 12 months.. The study showed no significant difference between the Taxus Express and Taxus Liberte stents (death, 1.73% vs. 2.31%, p = 1.000; MI, 0% vs. 1.73%, p = 0.2478; TVR, 2.31% vs. 1.16%, p = 0.6848; and ST, 0% vs. 1.16%, p = 0.4986). The total MACE rate at 1 year did not differ between the groups (4.05% in Taxus Express vs. 4.05% in Taxus Liberte, p = 1.000). In addition, the binary restenosis rate did not differ (2.25% in Taxus Express vs. 1.80% in Taxus Liberte, p = 0.6848).. In real-world experience with the two Taxus stent designs, both stents showed similarly good clinical and angiographic outcomes at 1 year. A long-term follow-up study is warranted.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Propensity Score; Prosthesis Design; Registries; Republic of Korea; Retrospective Studies; Risk Factors; Stainless Steel; Time Factors; Treatment Outcome

Drug-coated balloons (DCB) are being increasingly used in interventional cardiology. The effect of DCB on acute changes of coronary flow reserve (CFR) has never been reported.. Patients with in-stent restenosis or with contraindication for use of clopidogrel were included in this study. The FloWire was used to assess CFR before and immediately after conventional balloon angioplasty and after the use of In.Pact, a paclitaxel-coated balloon. In a sub-selection of patients, CFR was measured immediately and then 2, 5, and 10 min post-DCB.. Thirty patients (18 males, 60%) with a total of 32 lesions were studied. Comparison of CFR pre- and post-conventional balloon angioplasty was not statistically significant (P = 0.95). CFR dropped significantly after the use of In.Pact (n = 32, 1.59 ± 0.49 vs. 1.22 ± 0.28, P < 0.0001) and showed a statistically significant improvement over 10 min in a subset of patients (n = 6, P = 0.01). Implantation of a coronary stent after the use of In.Pact rapidly improved CFR (n = 10, P = 0.0004).. We describe a novel phenomenon of acute decrease in CFR after the use of DCB. This phenomenon is temporary and spontaneously improves after approximately 10 min. The exact pathophysiological mechanism remains unclear and further studies are warranted to study the long-term effects of acute CFR drop after use of DCB.

Topics: Aged; Analysis of Variance; Angioplasty, Balloon, Coronary; Cardiac Catheterization; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Equipment Design; Female; Fractional Flow Reserve, Myocardial; Humans; Male; Middle Aged; Paclitaxel; Pilot Projects; Stents; Switzerland; Time Factors; Treatment Outcome

We aimed to uncover the protein changes of coronary artery in-stent restenosis (ISR) tissue in minipigs with and without streptozotocin-induced diabetes mellitus by quantitative 2-dimensional fluorescence in-gel electrophoresis (2D-DIGE), and to investigate the influences of crucial proteins identified, particularly adipocyte fatty acid binding protein (AFABP), in human arterial smooth muscle cells.. Sirolimus-eluting stents were implanted in the coronary arteries of 15 diabetic and 26 nondiabetic minipigs, and angiography was repeated after 6 months. The intima tissue of significant ISR and non-ISR segments in both diabetic and nondiabetic minipigs was analyzed by 2D-DIGE and MALDI-TOF/TOF mass spectrometry. AFABP level was significantly increased in ISR tissue than in non-ISR tissue in both diabetic and nondiabetic minipigs, with level being higher in diabetic ISR than in nondiabetic ISR tissue. In human arterial smooth muscle cells, overexpression of AFABP significantly altered phenotype and promoted growth and migration, with effects more prominent in high-glucose than in low-glucose medium, whereas AFABP knockdown inhibited these effects. AFABP overexpression increased reactive oxygen species production by upregulating the expression of NADPH oxidase subunits Nox1, Nox4, and P22 through multiple pathways, with elevation of downstream gene cyclin D1, matrix metalloproteinase-2, and monocyte chemoattractant protein-1. However, AFABP-induced effects were inhibited by diphenyleneiodonium, pathway inhibitors, and small interfering RNA. In addition, the supernatant from AFABP-expressing human arterial smooth muscle cells and recombinant AFABP also promoted cellular growth and migration.. This study has demonstrated that AFABP is significantly increased in coronary artery ISR segments of both diabetic and nondiabetic minipigs. Increased AFABP expression and secretory AFABP of human arterial smooth muscle cells promote growth and migration via reactive oxygen species-mediated activation.

Topics: Animals; Cardiovascular Agents; Cell Movement; Cell Proliferation; Cells, Cultured; Coronary Restenosis; Coronary Vessels; Diabetes Mellitus, Experimental; Drug-Eluting Stents; Electrophoresis, Gel, Two-Dimensional; Enzyme Inhibitors; Fatty Acid-Binding Proteins; Fluorescence; Glucose; Humans; Male; Muscle, Smooth, Vascular; Myocytes, Smooth Muscle; NADPH Oxidases; Neointima; NF-kappa B; Oxidative Stress; Percutaneous Coronary Intervention; Phenotype; Reactive Oxygen Species; RNA Interference; RNA, Messenger; Signal Transduction; Sirolimus; Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization; STAT3 Transcription Factor; Swine; Swine, Miniature; Time Factors; Transcription Factor AP-1; Transfection; Up-Regulation

This study examined whether sirolimus-eluting stent (SES) implantation exerts an antiproliferative action on a bare metal stent (BMS) placed distally in the same coronary artery.. Diffusion of sirolimus into flowing coronary blood may cause accumulation of this drug in the coronary bed beyond the distal edge of an SES.. We analyzed data from 115 consecutive patients with ischemic heart disease who were treated with two overlapping stents without a gap in the same coronary artery for a long de novo lesion. The distal stent was a 2.25 mm BMS in all patients, and the proximal stent was an SES in 73 patients (SES-BMS group) and a BMS in 42 patients (BMS-BMS group). Quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) were performed at stent implantation and 8 months later.. Clinical and procedural variables were comparable between the two groups. QCA and IVUS showed that the SES-BMS group had less luminal late loss and a lower percent of in-stent volume obstruction in the distal BMS compared with the BMS-BMS group. Furthermore, compared with the BMS-BMS group, the SES-BMS group had less in-stent restenosis (23.3 vs. 54.8%, P < 0.0005) and target lesion revascularization (21.9 vs. 50.0%, P < 0.005).. SES implantation just proximal to a BMS inhibits neointimal proliferation in the BMS, when both stents are implanted in the same coronary artery to treat a de novo lesion.

Topics: Aged; Aged, 80 and over; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Metals; Neointima; Percutaneous Coronary Intervention; Prospective Studies; Prosthesis Design; Severity of Illness Index; Sirolimus; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional

In recent years there has been a debate about the functional severity of restenosis of drug-eluting stents. The aim of the present study was to assess the functional severity of stenosis in patients with moderate angiographic restenosis after paclitaxel-eluting stents (PES) deployment.. Forty-two patients with moderate angiographic restenosis at the in-stent segment and/or approximately 5mm from the stent edge were enrolled. For comparison, furthermore, 42 patients with de novo stenosis lesions matched for angiographic severity were assigned to the control group. Quantitative coronary angiography and functional assessment using fractional flow reserve (FFR) were performed. Although percent diameter stenosis was not significantly different between the 2 groups (PES group, 40.6±11.2%; de novo group, 40.6±9.0%, P=0.981), the functional severity of stenosis was significantly less in the PES group than in the de novo group (FFR: PES group, 0.86±0.07; de novo group, 0.79±0.10, P=0.002).. FFR was preserved in patients with moderate angiographic restenosis after PES deployment, and the functional severity of restenosis is often limited. Therefore, revascularization should be performed with caution for patients with moderate angiographic restenosis after PES deployment. 

Topics: Aged; Cardiac Catheterization; Cardiovascular Agents; Case-Control Studies; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Fractional Flow Reserve, Myocardial; Humans; Japan; Male; Middle Aged; Paclitaxel; Patient Selection; Percutaneous Coronary Intervention; Predictive Value of Tests; Prosthesis Design; Risk Factors; Severity of Illness Index; Treatment Outcome

The purpose of this article is to investigate the prevalence of plaque prolapse (PP) after Xience V and Taxus Liberte stent implantation. During the study period 2006-2007, 200 consecutive patients underwent coronary revascularization for de novo lesions and received an intravascular ultrasound (IVUS) post-stenting evaluation, (n = 124 patients with Taxus Liberte and n = 76 with Xience V) (227 stent segments). Cross-sectional and longitudinal 3D IVUS images were analyzed in a blind fashion, evaluating the prevalence of PP and calculating its depth and angle. The angulation degree of the coronary artery at the lesion site pre-stent implantation was also evaluated by angiography. The prevalence of PP was 23.9% in Xience V versus 38.1% in Taxus Liberte (P = 0.025). The depth and angle of PP were greater in Taxus Liberte stent than Xience V stent (0.4 ± 0.1 mm versus 0.5 ± 0.2 mm, P = 0.004; and 32.0 ± 8.9° versus 44.6 ± 27.6°, P = 0.044, respectively). The angulation degree of the coronary artery at the lesion site was higher in presence of plaque prolapse than in its absence (48.2 ± 29.3° vs. 38.2 ± 28.1°, P = 0.013). By multivariate analysis, stent type was independently associated with incidence of plaque prolapse. Xience V stent has less plaque prolapse than Taxus Liberte stent. Stent design may play a role in the prevalence of plaque prolapse.

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Cross-Sectional Studies; Drug-Eluting Stents; Female; Humans; Imaging, Three-Dimensional; Longitudinal Studies; Male; Middle Aged; Plaque, Atherosclerotic; Prevalence; Single-Blind Method; Treatment Outcome; Ultrasonography, Interventional

Recent studies reported favorable angiographic and clinical outcomes after everolimus-eluting stent (EES) implantation. However, there were no studies to assess vascular responses after EES implantation using optical coherence tomography (OCT). Therefore, the OCT findings in EES were investigated and compared with those in sirolimus-eluting stent (SES). Follow-up OCT studies were performed in 110 lesions (40 EES and 70 SES) of 104 patients at 9 months after stent implantation. The strut apposition, neointimal hyperplasia (NIH) thickness and stent coverage on each stent struts were evaluated. The mean NIH thickness was significantly greater in EES-treated lesions than in SES-treated lesions (115 ± 52 μm vs. 89 ± 58 μm, P = 0.001, respectively). The percentage of uncovered strut was significantly smaller in EES-treated lesions than in SES-treated lesions (4.4 ± 4.7% vs. 10.5 ± 12.7%, P = 0.016, respectively). There was no significant difference in the percentage of malapposed strut between the two groups (0.4 ± 0.8% in EES vs. 1.7 ± 4.5% in SES, P = 0.344). The incidence of intracoronary thrombus was significantly lower in EES-treated lesions than in SES-treated lesions (5.0% vs. 34.3%, P < 0.001, respectively). EES showed a significantly lower incidence of uncovered stent struts and intracoronary thrombus than SES in 9-month follow-up OCT examination. Compared to SES, EES might have more favorable vascular responses after stent implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Hyperplasia; Male; Middle Aged; Neointima; Predictive Value of Tests; Registries; Republic of Korea; Retrospective Studies; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

We evaluated the predictive factors for recurrent restenosis lesions treated on two previous occasions with sirolimus-eluting stents (SES).. Angiography data related to recurrent SES restenosis have not been reported.. Binary restenosis was observed in 66 patients with 78 lesions from a total of 1,393 patients with 1,965 lesions who received follow-up angiography after SES implantation. We enrolled 55 patients with 67 lesions who underwent revascularization using another SES with a second follow-up coronary angiography. These restenotic lesions were divided into two groups based on the presence or absence of recurrent restenosis: no recurrent restenosis group (n = 56) and recurrent restenosis group (n = 11). The coronary angiography data during first and second SES implantation were compared between the groups.. Minimal lumen diameter (MLD) was smaller before first and second percutaneous coronary interventions (PCI) with SES implantation in the recurrent restenotic group compared with no recurrent restenosis group (first PCI, 0.28 ± 0.19 mm vs. 0.54 ± 0.42 mm, P = 0.040; second PCI, 0.44 ± 0.36 mm vs. 0.69 ± 0.39 mm, P = 0.036, respectively). Acute stent recoil after second SES implantation was significantly greater in the recurrent restenosis group compared with no recurrent restenosis group (0.08 ± 0.17 mm vs. 0.20 ± 0.22 mm, P = 0.049, respectively). Multivariate analysis showed preprocedural MLD at first PCI and acute stent recoil at second PCI as independent predictors of recurrent restenosis.. Preprocedural smaller MLD at first PCI and acute stent recoil at second PCI are predictors of recurrent restenosis treated on two previous occasions with SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Japan; Logistic Models; Male; Middle Aged; Multivariate Analysis; Prosthesis Design; Recurrence; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

There have been little data regarding major determinants for the uncovered stent struts after drug-eluting stent (DES) implantation on optical coherence tomography (OCT). We investigated the major determinants of incomplete neointimal coverage of DES struts on OCT after implantation in a large cohort of patients. A total of 261 patients with 279 lesions who were treated with various DESs were selected from the OCT registry database. The lesions were divided into two groups based on the ratio of uncovered struts to total struts in all OCT cross-sections; an uncovered group (highest quartile with % uncovered struts ≥5.4%, n = 70), and covered group (the remaining lower quartiles with % uncovered struts <5.4%, n = 209). The uncovered group was more likely to have complex lesions, smaller reference vessel and stent diameter, and longer stent, more use of sirolimus-eluting stents, and less use of zotarolimus-eluting stents compared with the covered group. Of these variables, the most significant determinant of uncovered stent struts was DES type (odds ratio [OR] = 2.75, 95% confidence interval [CI] = 1.94-3.89, P < 0.001). The use of sirolimus-eluting stents (OR = 2.44, 95% CI, 1.15-5.47, P = 0.023) and zotarolimus-eluting stents (OR = 0.02, 95% CI = 0.01-0.25, P = 0.002) were the only significant risk and protective factors for uncovered stent struts, respectively. This study demonstrated that DES type might be associated with the most important determinants of uncovered struts compared to any other clinical or angiographic factor.

Topics: Aged; Analysis of Variance; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Everolimus; Female; Humans; Logistic Models; Male; Middle Aged; Odds Ratio; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Registries; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

To report the safety and efficacy of zotarolimus eluting stents for treatment of unprotected left main coronary artery disease.. Percutaneous stent insertion is an increasingly popular alternative to bypass surgery for the management of left main (LM) coronary artery disease. While data support the use of sirolimus- and paclitaxel-coated stents in the LM coronary artery, there are no published series reporting results with Endeavor (zotarolimus) stents, particularly in the context of unprotected left main (ULM) lesions.. We retrospectively identified 40 consecutive patients who had ULM disease treated with Endeavor stents (ZES) and who had follow-up angiography. The primary endpoint was the prevalence of major adverse cardiac events (MACE), including cardiac/unexplained death, nonfatal myocardial infarction (MI), and in-stent restenosis (ISR)/target lesion revascularization (TLR).. Angiographic and procedural success was achieved in all cases. Follow-up angiography occurred on average 5.6 ± 0.9 months after the index procedure. There were three incidences of ISR requiring TLR and another patient who had a NSTEMI in the follow-up period. At late follow-up (12.4 ± 1.8 months) three patients underwent CABG (one for RCA stenosis) and four patients died without knowledge of the status of the ULM stent (two cardiovascular and two deaths related to cancer progression).. In conclusion, our experience with Endeavor stents for the treatment of ULM disease demonstrates excellent angiographic and clinical outcomes, with a 7.5% ISR/TLR rate and a 15% MACE rate, respectively, at an average clinical follow-up of 12.4 months.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cause of Death; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Ontario; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The management of in-stent restenosis (ISR) complicating bifurcation lesions is technically challenging and implant of further stents may not be feasible. The use of drug-eluting balloons provides an attractive option for treatment of such lesions allowing a technically simple procedure without the need for further complex stenting. The SeQuent Please paclitaxel-eluting balloon (B. Braun, Berlin, Germany) has been shown to be superior to a paclitaxel eluting stent or balloon angioplasty for ISR complicating a bare-metal stent. However, there is no data on the efficacy of the SeQuent Please in ISR complicating drug-eluting stents or bifurcation lesions. We report two cases where the SeQuent Please was used in this setting with angiographic success and freedom from target vessel failure and angina at 24 months. In both cases the Sheathless Eau Cath guide (Asahi Intecc, Japan) was employed to perform a kissing-balloon dilatation with the SeQuent Please, so allowing treatment via radial access.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Paclitaxel; Prosthesis Design; Treatment Outcome; Ultrasonography, Interventional

Stent fracture has emerged as a complication of drug-eluting stent and is now recognized as contributing to in-stent restenosis and possibly stent thrombosis. Although optical coherence tomography (OCT) can detect stent fractures in the absence of circumference struts, it is challenging to visualize stent fractures with only cross-sectional OCT images. We describe two cases of restenosis with stent fracture detected by a novel three-dimensional OCT image reconstruction technique. This technique allows identification of a single stent fracture even in the absence of angiographic signs.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Imaging, Three-Dimensional; Male; Prosthesis Design; Prosthesis Failure; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome

This study aimed to compare the neointimal coverage (NIC), subclinical thrombus, color of plaque underneath the stent at 9-month after implantation of sirolimus-eluting stent (SES) either with durable or with biodegradable polymer (BDPM).. A total of 175 patients were assigned as Cypher (n = 81, 97 stents with durable polymer) and Excel (n = 94, 112 stents with BDPM) stent at 9-month after indexed procedure. NIC was classified from grade 0-3. Color of plaque was divided into white, light-yellow, yellow, and dark yellow. Thrombus was diagnosed as white or red material with cotton-like or ragged appearance. Incomplete NIC (grade 0/1) circled by a blush was termed by "inflaming.". There were significant differences in unstable angina (90.5 vs. 52.4%, P = 0.015), previous myocardial infarction (33.3 vs. 4.0%, P = 0.045) and left ventricular eject fraction (55.2 ± 7.8 vs. 62.6 ± 6.3%, P = 0.021) between the Excel and Cypher groups. The minimal- and maximal-NIC grades in the Cypher group were 0.67 ± 0.58 and 2.29 ± 0.46, respectively, when compared with 1.45 ± 0.67 (P < 0.001) and 2.64 ± 0.49 (P = 0.023) in the Excel group. The percentage of yellow plaque, thrombus, "inflaming" and NIC grade of 0 in the Excel and Cypher groups, respectively, were as follows: 8.0 vs. 26.8% (P = 0.031), 9.8 vs. 32.9% (P = 0.024), 8.0 vs. 38.1% (P = 0.017), and 38.1 vs. 0% (P < 0.001). Of the stents with "inflaming," 63.6% had thrombus when compared with 20.1% of the non-erosion stents (P < 0.001). Overlapping segments had the lowest NIC grades and more "inflaming" demonstrating a significant difference between Cypher vs. Excel stents. NIC grade was positively correlated with thrombus.. SES with BDPM has improved NIC resulting in less yellow plaque, thrombus, and "inflaming." Overlapping segments had the lowest NIC grade and more "inflaming."

Topics: Absorbable Implants; Aged; Angioscopy; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Neointima; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Polymers; Predictive Value of Tests; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

The authors investigate whether the combination of anti-CD34 antibody with DES is win-win cooperation.. DES may reduce the risk of restenosis compared to bare-metal stents (BMS), but they were found to inhibit the healing process of intima.. Fifteen BMS, 17 DES, and 16 combined anti-CD34 antibody and DES were randomly implanted in the coronary arteries of 22 minipigs. Ten minipigs were followed up to 2 weeks. The stenting coronary segments were examined by histological examination and scanning electron microscopy after in vivo coronary angiography and intracoronary optical coherence tomography (OCT) examinations. The other 12 minipigs were followed up to 3 months. Coronary angiography and intracoronary OCT examination were performed in vivo and histological examination was performed on the stenting coronary segments.. After 2 weeks, the neointimal covering level of the DES was lower than that in BMS, but the covering level of the combined stents was even better than the BMS. After 3 months, neointimal hyperplasia was significant in the BMS, but not in the other two types of stents. The in-stent late lumen loss of the combined stents even showed a decreasing tendency when compared with the DES.. The combination of anti-CD34 antibody and DES can not only well offset the short-term inhibitory effect on re-endothelialization but also slightly enhance the long-term antiproliferative effect.

Topics: Angioplasty, Balloon, Coronary; Animals; Antibodies; Antigens, CD34; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Hyperplasia; Metals; Microscopy, Electron, Scanning; Neointima; Prosthesis Design; Sirolimus; Stents; Swine; Swine, Miniature; Time Factors; Tomography, Optical Coherence

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Paclitaxel

Recent studies have demonstrated the safety and efficacy of drug-coated balloon (DCB) angioplasty for the treatment of coronary in-stent restenosis (ISR). The cost-effectiveness of this practice is unknown.. A Markov state-transition decision analytic model accounting for varying procedural efficacy rates, complication rates, and cost estimates was developed to compare DCB angioplasty with drug-eluting stent (DES) placement in patients with bare-metal stent (BMS)-ISR. Data on procedural outcomes associated with both treatment strategies were derived from the literature, and the cost analysis was conducted from a health care payer perspective. Effectiveness was expressed as life-years gained.. In the base-case analysis, initial procedure costs amounted to €3,604.14 for DCB angioplasty and to €3,309.66 for DES implantation. Over a 12-month time horizon, the DCB strategy was found to be less costly (€4,130.38 vs. €5,305.30) and slightly more effective in terms of life expectancy (0.983 vs. 0.976 years) than the DES strategy. Extensive sensitivity analyses indicated that, in comparison with DES implantation, the cost advantage of the DCB strategy was robust to clinically plausible variations in the values of key model input parameters. The variables with the greatest impact on base-case results were the duration of dual antiplatelet therapy with acetylsalicylic acid and clopidogrel after DCB angioplasty, the use of generic clopidogrel, and variations in the costs associated with the DCB device.. DCB angioplasty is a cost-effective treatment option for coronary BMS-ISR. The higher initial costs of DCB are more than offset by later cost-savings, predominantly as a result of reduced medication costs.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Catheters; Coated Materials, Biocompatible; Computer Simulation; Coronary Artery Disease; Coronary Restenosis; Cost Savings; Cost-Benefit Analysis; Drug Costs; Drug-Eluting Stents; Equipment Design; Germany; Health Care Costs; Humans; Markov Chains; Metals; Models, Economic; Paclitaxel; Platelet Aggregation Inhibitors; Prosthesis Design; Stents; Time Factors; Treatment Outcome

A 55-year-old male underwent paclitaxel-eluting stent implantation in a bifurcation lesion of his left anterior descending artery (LAD) during an episode of unstable angina in 2008. A late in-stent restenosis developed 15 months after implantation of the drug-eluting stent (DES) and was treated with paclitaxel eluting balloon. Two months later, during angiography for functional assessment of the significance of lesions in the circumflex artery, an aneurysm at the place of drug-eluting balloon (DEB) inflation was observed. The patient was left on double antiplatelet therapy and scheduled for clinical observation after 3 months and control coronary angiography after 6 months for aneurysm progression follow-up.

Topics: Angina, Unstable; Angioplasty, Balloon, Coronary; Aspirin; Cardiac Catheters; Cardiovascular Agents; Clopidogrel; Coronary Aneurysm; Coronary Angiography; Coronary Restenosis; Drug Delivery Systems; Drug Therapy, Combination; Drug-Eluting Stents; Equipment Design; Humans; Male; Middle Aged; Paclitaxel; Platelet Aggregation Inhibitors; Ticlopidine; Time Factors

Clinical trials have consistently demonstrated benefits of paclitaxel-coated balloons (PCB) in particular clinical situations such as in-stent restenosis and peripheral vascular interventions. However, the long-term vascular effects of bare metal stents (BMS) delivered via PCB (PCB+BMS) are still unknown. The aim of this study was to assess the long-term effects of PCB+BMS on vascular healing and neointimal formation (NF).. A total of 208 stents: 56 BMS crimped on PCB, 50 BMS crimped on uncoated balloons (UCB+BMS), 52 Taxus and 50 Cypher stents were implanted in normal coronary arteries of 104 pigs using 1.2:1.0 stent-to-artery ratio. Follow-up occurred at 3, 7, 28, 90, and 180 days. Vascular effects were assessed based on angiographic and histological analysis. Endothelialization was evaluated using an anti von-Willebrand Factor stain.. At 28 days, delivery of a BMS using a PCB led to a significant reduction in NF compared to the UCB+BMS and the Taxus stent (P < 0.01). Between 28 and 180 days, the progression of NF tended to be lower in the PCB+BMS compared to all DES groups. At 90 days, the PCB+BMS (2.56 ± 0.43) and the Taxus stents (2.60 ± 0.59) had a trend toward higher inflammatory scores compared to the UCB+BMS group (1.85 ± 1.13, P = 0.09). By 180 days, inflammation and NF had completely normalized between the groups. Expression of peristrut vWF was comparable among all tested groups at 28 days.. The long-term pattern of vascular healing occurring following PCB+BMS deployment appears to be comparable to what has been reported with DES technologies.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiac Catheters; Cardiovascular Agents; Cell Proliferation; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Disease Models, Animal; Drug-Eluting Stents; Endothelial Cells; Equipment Design; Metals; Neointima; Paclitaxel; Prosthesis Design; Stents; Swine; Swine, Miniature; Time Factors; von Willebrand Factor

The current study sought to examine inflammation at the stented segments of Nobori (Terumo Corporation, Tokyo, Japan) and Cypher (Cordis, Miami, Florida) drug-eluting stents (DES), as well as free radical production and endothelial function of the adjacent nonstented segments in a pig coronary model.. Nobori is a novel DES, incorporating a biolimus A9-eluting biodegradable polymer coated only on the abluminal surface of the stent. These unique features may favorably affect inflammation and endothelial function, as compared to the currently marketed DES. Presently, pre-clinical data on direct comparison of the various generations of DES are not available.. A total of 18 DES were implanted in pig coronary arteries and subsequently explanted at 1 month. Stented segments were assessed by angiography and histology. Ex vivo vasomotor function and superoxide production in segments proximal and distal to the stent were determined. The vasoconstriction, endothelial-dependent relaxation, and endothelial-independent relaxation of proximal and distal nonstented segments were measured.. Histological evaluation revealed lower inflammatory response with Nobori than with Cypher DES. There is trend for lower angiographic percentage diameter stenosis in Nobori versus Cypher groups (p = 0.054). There was increased endothelium-dependent relaxation, decreased endothelin-1-mediated contraction, and less superoxide production in the vessel segments proximal and distal to Nobori versus Cypher stents.. Our data show significantly lower inflammatory response in the stented segments, and rapid recovery of endothelial function of peristent segments in the Nobori group compared with Cypher DES group at 1 month in porcine coronary artery model.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Dose-Response Relationship, Drug; Drug-Eluting Stents; Endothelium, Vascular; Inflammation; Japan; Models, Animal; Prosthesis Design; Recovery of Function; Sirolimus; Superoxides; Sus scrofa; Time Factors; Vasoconstriction; Vasoconstrictor Agents; Vasodilation; Vasodilator Agents

Biodegradable stent coatings were recently introduced as a potential solution to overcome sustained inflammatory responses observed with permanent polymer-based drug-eluting stents. In a preliminary study, selected biodegradable or permanent polymer-based sirolimus-eluting stent (SES) formulations were screened for effectiveness in comparison to bare metal stents (BMS) at 28 days. Subsequently, the most favourable SES formulation was compared to commercially available SES (Cypher™) at 28, 90 and 180 days to investigate the histopathologic response as well as tissue, blood and organ pharmacokinetics. Overlapping SES implantation was conducted to evaluate vascular healing at 28 days in this particular setting. SES with biodegradable poly (L-lactide) polymer (PLLA) or poly(lactide-co-glycolide) showed the most favourable outcome with regards to reductions in neointimal area in comparison to BMS at 28 days. The PLLA SES showed a similar reduction in neointimal area compared to Cypher™ at 28 days, with significant greater reductions at 90 and 180 days (1.7 ± 0.7 mm² vs. 3.1 ± 1.5 mm², p=0.03 and 1.8 ± 1.2 mm² vs. 3.0 ± 1.5 mm², p=0.01, respectively). Sirolimus vascular tissue concentrations were detectable up to 90 days following implantation. Overlapping stented segments showed favourable histopathologic results with respect to fibrin deposition and endothelialisation at 28 days. In conclusion, the use of PLLA as drug-eluting matrix resulted in mild inflammatory responses in the presence of effective sirolimus tissue concentrations. The greater efficacy observed at long-term follow-up in PLLA SES compared to Cypher™ may be a multifactorial result of stent design, polymer biocompatibility and improved release kinetics.

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Lactic Acid; Models, Animal; Neointima; Polyesters; Polyglactin 910; Polymers; Prosthesis Design; Sirolimus; Sus scrofa; Time Factors; Tissue Distribution

In this study we compared the outcomes of the everolimus-eluting stent (EES) versus the zotarolimus-eluting stent (ZES) in patients treated at a tertiary medical center, with up to one year of follow-up.. Unselected consecutive patients were retrospectively recruited following stenting with the ZES (n = 197) or EES (n = 190). The first 100 consecutive patients in each cohort underwent syntax scoring. The primary endpoint of the study was target vessel failure, defined as the combined endpoint of cardiac death, non-fatal myocardial infarction, or target vessel revascularization. Secondary endpoints included target lesion revascularization, target lesion failure, acute stent thrombosis, total death, cardiac death, and non-fatal myocardial infarction.. The two groups were similar, including for Syntax scores (19.6 ± 12.8 versus 20.6 ± 13.6), number of stents per patient (2.9 ± 1.9 versus 2.9 ± 2.1), and cardiovascular risk factors. By one year, the primary outcome occurred in 20.8% EES versus 26.7% ZES (P = 0.19) patients. The secondary endpoints were as follows: target lesion revascularization (8.9% versus 20.6%, P = 0.003), target vessel revascularization (18.9% versus 25.6%, P = 0.142), definite and probable stent thrombosis (0% versus 2.5%), non-fatal myocardial infarction (2.7% versus 3.6%), and mortality (3.2% versus 5.1%) for the EES versus the ZES, respectively.. EES had similar target vessel failure to ZES, but superior target lesion revascularization and target lesion failure at one year of follow-up in an unselected cohort of patients.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Iowa; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Retrospective Studies; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The purpose of this study was to investigate the elimination of paclitaxel from the arterial wall after a single short administration with a coated balloon.. Slightly oversized paclitaxel-coated balloons (dose 3 or 9 μg/mm(2)) without or with premounted stents were inflated in nonatherosclerotic coronary arteries of either young domestic pigs or adult Goettingen minipigs. The paclitaxel content of plasma, arterial segments, and residual hearts (without treated arteries) was measured for up to 180 days using high-performance liquid chromatography/ultraviolet detection or mass spectrometry. Angiograms were evaluated for lumen narrowing. The paclitaxel concentration in plasma remained <10 ng/mL. In arteries of domestic pigs and minipigs treated with paclitaxel-coated balloons with premounted stents, 10%±5% or 21%±8% of dose, respectively, was initially detected and decreased to 3.5%±3.1% of dose (domestic pig) by Day 7. Within 6 months it fell with a half-life of 1.9 months to 0.40%±0.35%. After 3 months the concentration in the arterial wall was 17±11 μmol/L. Without a stent, drug transfer to the vessel wall was somewhat reduced and elimination faster. Immediately after treatment up to 26%±4% of dose was detected in the residual whole hearts. It dropped with a half-life of 45 days to 1.5%±0.6% of dose (0.3 μmol/L) within 6 months.. After a single local administration with coated balloons, paclitaxel stays in the vessel wall of pigs long enough to explain persistent inhibition of neointimal proliferation. The pharmacokinetics of paclitaxel does, however, not exclude other reasons for sustained efficacy such as early blocking of processes initiating excessive and prolonged neointimal proliferation.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Catheters; Chromatography, High Pressure Liquid; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Half-Life; Mass Spectrometry; Myocardium; Neointima; Paclitaxel; Spectrophotometry, Ultraviolet; Stents; Sus scrofa; Swine; Swine, Miniature; Tissue Distribution

Delayed endothelialization contributes to stent thrombosis of current drug-eluting stents. The asymmetrical coating technique provides an anti-proliferative effect abluminally without affecting luminal endothelialization. Layer-by-layer self-assembled chitosan/heparin (C/H LBL) has been proved to promote re-endothelialization. A novel stent system, C/H LBL coated luminally and sirolimus released abluminally (C/H LBL-SES), was fabricated.. Bare metal stents (BMS), traditionally circumferential sirolimus-eluting stents (SES), and C/H LBL-SES were implanted into porcine coronary arteries. At the 7, 14 and 28 days follow-up (FU), angiography, intravascular ultrasound (IVUS), vasomotor function induced by acetylcholine (Ach), scanning-electron microscopy and histopathology were performed. Remodeling index (RI) was based on IVUS and defined as cross-sectional area (CSA) of vessel at in-stent segment divided by CSA of reference vessel and expressed as a percentage with a normal range from 0.95 to 1.05.. Thirty-eight mini pigs were enrolled and 74 stents (BMS = 23, C/H LBL = 28, SES = 23) were implanted in this study. At 28 days after implantation, the diameter stenosis of C/H LBL-SES by quantitative coronary angiography was 18.8 ± 2.5 %, the area stenosis by histomorphometry was 24.2 ± 2.9 %, which were comparable to that of SES and superior to BMS. At 14 days, re-endothelialization of C/H LBL-SES was almost completed, while only about 50 % of surface of SES was covered by endothelium. At 7, 14 and 28 days FU, although C/H LBL-SES suffered a greater vasoconstriction induced by Ach infusion than BMS (P < 0.05), it behaved better than SES (P < 0.01). No sign of stent malapposition was detected, while RI was within the normal range by IVUS. No acute or subacute thrombotic events occurred in all three groups.. The asymmetrically designed C/H LBL-SES successfully inhibited neointima hyperplasia, while diminishing vasoconstriction after Ach-stress. Endothelialization of C/H LBL-SES was less affected compared with traditionally circumferentially coated SES.

Topics: Acetylcholine; Animals; Cardiovascular Agents; Chitosan; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Disease Models, Animal; Drug-Eluting Stents; Endothelial Cells; Heparin; Hyperplasia; Metals; Microscopy, Electron, Scanning; Neointima; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Swine; Swine, Miniature; Time Factors; Ultrasonography, Interventional; Vasoconstriction

Diabetes remains a significant risk factor for restenosis/thrombosis following stenting. Although vascular healing responses following drug-eluting stent (DES) treatment have been characterized previously in healthy animals, comparative assessments of different DES in a large animal model with isolated features of diabetes remains limited. We aimed to comparatively assess the vascular response to paclitaxel-eluting (PES) and everolimus-eluting (EES) stents in a porcine coronary model of streptozotocin (STZ)-induced type I diabetes.. Twelve Yucatan swine were induced hyperglycemic with a single STZ dose intravenously to ablate pancreatic β-cells. After two months, each animal received one XIENCE V® (EES) and one Taxus Liberte (PES) stent, respectively, in each coronary artery. After three months, vascular healing was assessed by angiography and histomorphometry. Comparative in vitro effects of everolimus and paclitaxel (10-5 M-10-12 M) after 24 hours on carotid endothelial (EC) and smooth muscle (SMC) cell viability under hyperglycemic (42 mM) conditions were assayed by ELISA. Caspase-3 fluorescent assay was used to quantify caspase-3 activity of EC treated with everolimus or paclitaxel (10-5 M, 10-7 M) for 24 hours.. After 3 months, EES reduced neointimal area (1.60 ± 0.41 mm, p < 0.001) with trends toward reduced % diameter stenosis (11.2 ± 9.8%, p = 0.12) and angiographic late-loss (0.28 ± 0.30 mm, p = 0.058) compared to PES (neointimal area: 2.74 ± 0.58 mm, % diameter stenosis: 19.3 ± 14.7%, late loss: 0.55 ± 0.53 mm). Histopathology revealed increased inflammation scores (0.54 ± 0.21 vs. 0.08 ± 0.05), greater medial necrosis grade (0.52 ± 0.26 vs. 0.0 ± 0.0), and persistently elevated fibrin scores (1.60 ± 0.60 vs. 0.63 ± 0.41) with PES compared to EES (p < 0.05). In vitro, paclitaxel significantly increased (p < 0.05) EC/SMC apoptosis/necrosis at high concentrations (≥ 10-7 M), while everolimus did not affect EC/SMC apoptosis/necrosis within the dose range tested. In ECs, paclitaxel (10-5 M) significantly increased caspase-3 activity (p < 0.05) while everolimus had no effect.. After 3 months, both DES exhibited signs of delayed healing in a STZ-induced diabetic swine model. PES exhibited greater neointimal area, increased inflammation, greater medial necrosis, and persistent fibrin compared to EES. Differential effects of everolimus and paclitaxel on vascular cell viability may potentially be a factor in regulating delayed healing observed with PES. Further investigation of molecular mechanisms may aid future development of stent-based therapies in treating coronary artery disease in diabetic patients.

Topics: Animals; Apoptosis; Cardiovascular Agents; Cells, Cultured; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Diabetes Mellitus, Experimental; Diabetes Mellitus, Type 1; Diabetic Angiopathies; Disease Models, Animal; Dose-Response Relationship, Drug; Drug-Eluting Stents; Endothelial Cells; Everolimus; Muscle, Smooth, Vascular; Myocytes, Smooth Muscle; Necrosis; Neointima; Paclitaxel; Percutaneous Coronary Intervention; Prosthesis Design; Sirolimus; Swine; Time Factors; Wound Healing

The efficacy of drug-eluting stents (DES) for the treatment of in-stent restenosis (ISR) after DES implantation is not well defined. This study compared the clinical outcome after the use of everolimus-eluting stents (EES) for the treatment of bare-metal stent (BMS) versus DES restenosis.. Ninety-four patients with 94 ISR were included in this study. Sixty-four patients had BMS-ISR and 30 patients had DES-ISR. Patients were treated by repeat PCI using an EES. The primary endpoint of the study was survival free of target lesion revascularization (TLR) at 12 months or DES-ISR versus BMS-ISR patients. The secondary endpoints were survival free of major adverse cardiac events (MACE) and definite stent thrombosis.. The baseline clinical and angiographic parameters were comparable between the two groups. Treatment of DES-ISR was associated with higher rates of recurrent TLR, myocardial infarction (MI), and MACE at the 12-month follow-up compared with the treatment of BMS-ISR (23.3 versus 1.6%, P=0.002 for TLR; 13.3 versus 0%, P=0.017 for MI; and 30 versus 4.6%, P=0.003 for MACE). There were no differences in mortality and definite stent thrombosis between both groups (P=0.5686 and 0.6927, respectively). Initial stent number (odds ratio=1.13, 95% confidence interval 1.02-1.25; P=0.024) and initial stent type being a DES (odds ratio=8.11, 95% confidence interval 5.99-10.45; P<0.001) were independent predictors of recurrent TLR after the treatment of ISR using an EES.. EES used for the treatment of DES-ISR is associated with higher rates of recurrent revascularization, MI, and MACE compared with EES for the treatment of BMS-ISR.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Disease-Free Survival; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Multivariate Analysis; Myocardial Infarction; Odds Ratio; Percutaneous Coronary Intervention; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

We have sometimes noted abnormal angiographic coronary dilatation, <50% of the reference vessel, at the site of sirolimus-eluting stent implantation, suggesting contrast staining outside the stent struts and named this finding peri-stent contrast staining (PSS). Little was known about optical coherence tomography findings of lesions with PSS.. Between May 2008 and March 2010, we performed optical coherence tomography for 90 in-stent restenosis lesions after sirolimus-eluting stent implantation. We found PSS in 20 of the 90 lesions by coronary angiography. The differences in optical coherence tomography findings, including incomplete stent apposition, multiple interstrut hollows (MIH), strut coverage, and thrombus, were compared between lesions with PSS and those without PSS. PSS is defined as contrast staining outside the stent contour extending to >20% of the stent diameter measured by quantitative coronary angiography. MIH is defined as multiple hollows (the maximum depth >0.5 mm) existing between and outside well-apposed stent struts. Both incomplete stent apposition (60.0% versus 10%; P<0.001) and MIH (85.0% versus 25.7%; P<0.001) were frequently observed in lesions with PSS than in lesions without PSS. Among the 20 lesions with PSS, there was only 1 lesion in which we found neither MIH nor incomplete stent apposition, but only minor dissection. Uncovered struts (11.6% versus 3.9%; P=0.001), malapposed struts (2.0% versus 0.0%; P<0.001), and red thrombus (35% versus 10%; P=0.012) were frequently observed in lesions with PSS than in lesions without PSS.. PSS might be closely associated with 2 different optical coherence tomography findings, MIH and incomplete stent apposition, in lesions after sirolimus-eluting stent implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Observer Variation; Predictive Value of Tests; Prosthesis Design; Reproducibility of Results; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

At present, percutaneous coronary intervention with drug-eluting stent (DES) implantation represents the default strategy to treat coronary artery disease in many institutions around the world. However, concerns regarding long-term safety of first-generation DES have prompted the development of novel DES systems such as the NEVO (Cordis Corporation, Johnson & Johnson, Warren, NJ) sirolimus-eluting stent with biodegradable polymer and reservoir technology. In the current report, we present, for the first time, a complete midterm invasive assessment of a patient treated with this novel device in the Res-Elution I study.

Topics: Angioplasty, Balloon, Coronary; Biocompatible Materials; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Male; Middle Aged; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Drug-eluting stents (DES) have revolutionized the treatment of coronary bifurcation lesions. Among different DES types, sirolimus-eluting stents (SES) showed better outcomes than paclitaxel-eluting stents. Because novel sirolimus analogues have been implemented in DES, a prospective observational comparison was undertaken to compare major mammalian target of rapamycin inhibitor-eluting stents in the treatment of bifurcation lesions according to the provisional T-stenting and small protrusion (TAP) technique. Overall, 187 patients (165 men, 65 ± 10 years) were enrolled in the study: 80 patients received a SES, whereas zotarolimus-eluting stents (ZES) were implanted in 53 patients and everolimus-eluting stents (EvES) in 62 patients. Primary end-point of the study was the 12-month incidence of target bifurcation failure (TBF) defined as occurrence of cardiovascular death, nonfatal myocardial infarction (MI), and target vessel revascularization (TVR) or angiographic documentation of > 50% restenosis on the main vessel or TIMI flow < 3 on the side branch. Groups were homogeneous according to main clinical and angiographic characteristics. Overall, 17 (9.1%) patients had TBF: 4 (2.1%) patients had nonfatal non-ST-segment elevation MI, 9 (4.8%) patients underwent TVR, and 6 (3.2%) patients had an angiographic restenosis. The rate of TBF was statistically different among the three groups (7.9% in SES group, 18% in ZES group, and 3.3% in EvES group, P = 0.024). Previous MI was associated with a worse outcome (P = 0.025), whereas final kissing balloon was associated with a better outcome (P = 0.045). In conclusion, in this prospective registry, significant differences between DES were found in the outcome of patients treated for coronary bifurcation lesions according to provisional TAP technique. Thus, prospective randomized trials in this field are needed.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Italy; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Time Factors; TOR Serine-Threonine Kinases; Treatment Outcome

Topics: Administration, Oral; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Humans; Metals; Prosthesis Design; Sirolimus; Stents; Treatment Outcome

Though restenosis after drug-eluting stent implantation is still observed, the factors affecting post-sirolimus-eluting stent restenosis (re-restenosis) have not been fully determined. We evaluated the long-term angiographic outcomes and examined background factors affecting re-restenosis. We enrolled 51 patients with 68 sirolimus-eluting stent (SES) restenosis lesions who underwent target lesion revascularization (TLR) and angiographic follow-up studies. Re-restenosis was observed in 29 of 68 restenosis lesions, and the rate was 42.6%. Study subjects were divided into two groups: a re-restenosis (Re-R) group (20 patients) with 29 lesions and a restenosis (R) group (31 patients) with 39 lesions with no re-restenosis. There were no differences in age, sex, coronary risk factors, past history, or medications between the two groups. Re-restenosis was observed more frequently in the right coronary artery (Re-R group vs. R group; 65.5 vs. 33.3%, P = 0.009). The incidence of stent fracture was higher in the Re-R group (Re-R group vs. R group; 48.3 vs. 12.8%, P = 0.003). QCA results showed that the initial lesion length at the time of first coronary intervention was significantly longer in the Re-R group (Re-R group vs. R group; 21.6 ± 3.37 vs. 12.6 ± 4.98 mm, P = 0.049). The rate of re-restenosis was 47.1% when treated with POBA alone, while it was 36.7% with SES treatment. In multivariate analysis, the initial lesion length at the time of first coronary intervention (odds ratio = 1.64, 95% CI 1.29-2.06, P < 0.001) and stent fracture (odds ratio = 12.42, 95% CI 1.89-81.4, P = 0.009) were independent predictors of re-restenosis. This study demonstrates that recurrent restenosis with SES treatment is associated with lesion length and stent fracture, a finding that is beneficial in the management of restenosis after SES implantation.

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

Despite the expressive reduction in the intimal hyperplasia (IH) formation after DES implantation at the mid-term, late restenosis has been recently noticed. Our objective was to determine, by means of serial angiography (QCA) and intravascular ultrasound (IVUS) at two different time points, whether the occurrence of the "late catch-up" phenomenon occurs after sirolimus-eluting stent (SES) implantation. Thirty-eight non-complex patients treated with a single 18-mm SES who had systematic serial QCA and IVUS analyses at mean 8 and 20 months were enrolled. Primary endpoint is to evaluate the temporal course of IH formation after SES implantation, by comparing QCA in-stent late loss and IVUS percent IH obstruction between the invasive follow-ups. Mean cohort age was 59.3 years and 31.6% were diabetics. Baseline reference vessel diameter was 2.8 ± 0.4 mm and lesion length was 11.5 ± 3.5 mm. Left anterior descending artery was the most frequent target vessel (55.3%). Between 8 and 20 months, a non-significant increase in in-stent late loss from 0.10 ± 0.18 to 0.15 ± 0.30 mm (P = 0.38) was observed. By IVUS, a slight increase in the percent IH obstruction (1.03 ± 2.13 to 1.76 ± 1.87%, P = 0.12) was detected between the two evaluations. Interestingly, all the neoformed tissue accrued from 8 to 20 months accumulated in the distal portion of the stent. In the non-complex scenario, SES implantation was associated with a minimal, non-significant increase in the IH volume between 8 and 20 months.

Topics: Aged; Analysis of Variance; Angioplasty, Balloon, Coronary; Brazil; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Hyperplasia; Male; Middle Aged; Predictive Value of Tests; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Biocompatible Materials; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Ultrasonography, Interventional

Drug eluting stents (DES) have had a great impact in reducing in-stent restenosis (ISR) in de novo lesions. However, long-term data regarding effectiveness and safety of these stents in treating bare metal stent (BMS) ISR are limited. We report long-term clinical outcomes in a cohort of patients with BMS-ISR treated with DES between April 2002 and December 2003 at our institution.. Sixty-nine consecutive patients with significant BMS-ISR were treated with DES implantation. Sirolimus DES were used in 43 patients and paclitaxel DES in 26. All patients were followed up to determine the incidence of major adverse cardiac event (MACE) rates (all-cause death, myocardial infarction, or target vessel revascularisation [TVR]), angina class and the need for clinically driven angiography. The mean age of the cohort was 58.6 ± 10.8 years; 68% were male, 33% were diabetic, 50% had hypertension, 78% were on statin therapy and 59% were current (19%) or previous (41%) smokers. The clinical presentation of ISR was with chronic stable angina in 54 patients, 12 had a non-ST elevation acute coronary syndrome and three presented with ST-elevation myocardial infarction. Multivessel stenting was performed in 21 patients and bifurcation stenting in seven patients. Over a mean follow period of 4.9 years, the first event MACE rate was 20% (17 events in 14 patients - eight deaths of which three were cardiac, two non-fatal myocardial infarctions and seven TVR). Excluding non-cardiac death, the adjusted MACE rate was 14.5% (12 events in 10 patients). At long-term follow-up, mean Canadian angina class decreased from 2.3 ± 0.7 pre-procedure to 1.2 ± 0.4, 65% of patients were angina free and 80% were free of MACE. No differences in long-term outcomes were observed between patients receiving paclitaxel and sirolimus DES.. The use of DES for the treatment of BMS-ISR is safe and effective over a mean follow-up period of nearly five years. To our knowledge, this represents the longest follow-up data of real world patients treated in a single interventional centre.

Topics: Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Disease-Free Survival; Drug-Eluting Stents; England; Female; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

To investigate the clinical outcomes of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) in patients on dialysis.. Between May 2004 and December 2008, 95 patients on dialysis with 124 lesions were treated with PES alone, and were compared to 184 patients on dialysis with 244 lesions treated with SES alone, retrospectively. One-year major adverse cardiac event (MACE) including stent thrombosis, target lesion revascularisation (TLR), myocardial infarction (MI) and cardiac death were compared. Baseline characteristics were similar except for previous CABG (p = 0.02) and reference vessel diameter (p = 0.04). During hospitalisation, all cause death was more frequently observed in the PES group (p = 0.004). In-hospital MACE was not significantly different (p = 0.8). The incidence of 1-year MACE in the PES group was lower than that in the SES group (14.7%, 28.3%, p = 0.04), mainly due to the reduction of TLR (11.6%, 25.0%, p = 0.03). Rates of stent thrombosis (0%, 2.7%, p = 0.1), MI (1.1%, 3.8%, p = 0.2), and cardiac death (3.2%, 4.4%, p = 0.6) were not significantly different.. PES appears to be more efficient in reducing angiographic and clinical restenosis in dialysis patients compared with SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Hospital Mortality; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Renal Dialysis; Renal Insufficiency; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Stent fracture (SF) has been implicated as a risk factor for in-stent restenosis, but its incidence and clinical characteristics are not well established. Therefore we investigated the conditions associated with stent fracture and its clinical presentation and outcome. Between 2004 and 2007, consecutive cases of SF were collected from the Seoul National University Hospital. Clinical characteristics and outcome of patients with fractured stents were compared with a ten-fold cohort of age and gender matched controls (n = 236). A total of 4,845 patients received percutaneous coronary intervention and 3,315 patients (68.4%) underwent angiographic follow-up. Twenty-eight fractured stents were observed in 24 patients. The incidence of SF was 0.89% for sirolimus-eluting stents (SES) and 0.09% for paclitaxel-eluting stents. Chronic kidney disease, stent implantation in the right coronary artery (RCA), and SES use were independent predictors of drug-eluting stent fracture by multivariate analysis. SF was significantly associated with binary restenosis (11.4% vs 41.7%, P < 0.001) and increased risk of target lesion revascularization (8.1% vs 33.3%, P = 0.001). Patients with SF but without significant restenosis showed excellent outcome despite only medical treatment. In conclusion, SF is associated with increased rates of restenosis and repeat revascularization. Significant risk factors include chronic kidney disease, RCA intervention, and SES use.

Topics: Age Factors; Aged; Cardiovascular Agents; Cohort Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Prosthesis Failure; Registries; Risk Factors; Sex Factors; Sirolimus

This serial angiographic study evaluated the incidence and predictors of late restenosis after sirolimus-eluting stent (SES) implantation.. Previous studies showed late restenosis (i.e., late catch-up phenomenon) after implantation of 7-hexanoyltaxol-eluting stents and nonpolymeric, paclitaxel-eluting stents.. Between August 2004 and December 2006, SES implantation was performed in 1,393 patients with 2,008 lesions, in whom 8-month and 2-year follow-up coronary angiography were planned.. Of 2,008 lesions, 1,659 (83%) underwent 8-month follow-up angiography (8.3 ± 2.2 months). Restenosis was observed in 122 lesions (7.4%). Coronary angiography 2 years (1.9 ± 0.4 years) after SES deployment was performed in 1,168 lesions (74% of lesions without restenosis at 8-month follow-up angiography). Late restenosis was observed in 83 lesions (7.1%). There was significant decrease in minimum luminal diameter (MLD) between 8-month and 2-year follow-up (2.56 ± 0.56 mm vs. 2.35 ± 0.71 mm, p < 0.001). Multivariate analysis showed in-stent restenosis before SES implantation and MLD at 8-month follow-up as independent predictors of late restenosis.. Between 8-month and 2-year follow-up after SES implantation, MLD decreases, which results in late restenosis in some lesions. In-stent restenosis before SES implantation and MLD at 8-month follow-up are independent predictors of late restenosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Incidence; Japan; Logistic Models; Male; Middle Aged; Myocardial Infarction; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Hemodialysis patients were recognized as a high-risk group for restenosis after percutaneous coronary intervention in the era of the bare-metal stent. Recently, sirolimus-eluting stents (SES) have reduced restenosis and target lesion revascularization (TLR); however, it has been reported that their efficacy in hemodialysis patients is limited. The purpose of this study was to investigate whether paclitaxel-eluting stents (PES) improved angiographic outcomes of hemodialysis patients compared with SES. This study is a retrospective cohort study. We analyzed 54 hemodialysis patients with 87 lesions implanted with PES from February 2007 to September 2008, and 49 hemodialysis patients with 68 lesions implanted with SES from August 2004 to January 2007. Angiographic follow-up after 8-10 months was obtained for 59 lesions (67.8%) in the PES group and 43 lesions (63.2%) in the SES group. At baseline, the PES patients had more peripheral artery disease compared with the SES group (66.7 vs. 34.7%; p = 0.0012). There were no significant differences in the angiographic characteristics or procedural index. The binary restenosis rate was lower in lesions implanted with PES than in those with SES (13.6 vs. 39.5%; p = 0.034). Accordingly, the TLR rate was lower in lesions implanted with PES than with SES (9.3 vs. 26.5%; p = 0.041). Our results suggest that PES is more effective than SES in reducing restenosis and TLR in hemodialysis patients.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Renal Dialysis; Renal Insufficiency; Retrospective Studies; Sirolimus; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Disease Models, Animal; Dose-Response Relationship, Drug; Drug-Eluting Stents; Female; Inflammation; Prosthesis Design; Prosthesis Failure; Swine; Swine, Miniature

Although edge stenosis (ES) is a main limitation of drug-eluting stents, the predictors for ES are not well known. We evaluated the predictors for ES after paclitaxel-eluting stent implantation.. One hundred and eleven angina patients (64 men; 62.2±8.4 years of age) were divided into ES (n=9) and non-ES groups (n=102). The clinical findings, procedural factors, and intravascular ultrasound (IVUS) parameters were analyzed.. Although clinical characteristics were not different between groups, diabetes mellitus (DM) was more common in the ES group (P=0.002). The vessel, plaque, and lumen areas of the lesions were not different between groups; however, the vessel area of the proximal and distal reference artery was smaller in the ES group. Lesions with positive remodeling were more common in the ES group (P=0.015). On the basis of univariate analysis, predictors of ES included DM, lesions with positive remodeling, IVUS parameters, and procedural factors. After adjusting for clinical findings, angiographic factors, and IVUS parameters, the presence of DM [odds ratio (OR): 9.20; 95% confidence interval (CI): 1.40-60.62, P=0.021] and lesions with positive remodeling (OR: 5.93; 95% CI: 1.13-31.02, P=0.035) were independent predictors of ES. The lumen area in the distal 1 mm reference segment was a protective factor for ES (OR: 0.05; 95% CI: 0.00-0.74, P=0.029).. The risk of ES after paclitaxel-eluting stent implantation was higher in patients who had DM and lesions with positive remodeling. Of the IVUS parameters, the lumen area in the distal 1 mm reference segment was a protective factor against ES.

Topics: Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Odds Ratio; Paclitaxel; Republic of Korea; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Evidence-Based Medicine; Humans; Myocardial Infarction; Paclitaxel; Patient Selection; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Information relating the outcome of percutaneous coronary intervention to diabetes mellitus or hypertension is limited. The study objective was to describe the outcome in patients undergoing percutaneous coronary intervention in relation to diabetes and hypertension.. Data were extracted from 5 national registers: the Swedish Coronary Angiography and Angioplasty Register (all percutaneous coronary interventions), the Prescribed Drug Registry (all prescribed pharmaceuticals purchased in Swedish pharmacies), the Swedish Hospital Discharge Register (data on myocardial infarction, revascularization, stroke, and congestive heart failure from in-hospital and specialist health care), and the National Population Register and Cause of Death Register (data on death). We included all "first percutaneous coronary interventions" between January 1, 2006, and December 31, 2008 (n=44,268; followed an average of 1.9 [± 0.9] years).. Mortality was 6.4% and highest in patients with diabetes plus hypertension. Hypertension per se did not increase mortality or the risk for repeat intervention, but carried a 10% increased risk for subsequent myocardial infarction, increasing to a 4-fold increase when combined with diabetes. Stroke occurred in 2%; the importance of hypertension was evident in nondiabetic patients, but even stronger in diabetic patients. Congestive heart failure caused hospital admission in 8%, with a negative influence from hypertension with and without diabetes.. After percutaneous coronary intervention and with modern pharmacotherapy, diabetes had a negative effect on the outcome, especially when combined with hypertension. Hypertension per se was not associated with increased mortality but with an increased risk for myocardial infarction, stroke, and congestive heart failure, probably related to widespread coronary artery disease. Improved diabetes care might improve the prognosis.

Topics: Adult; Aged; Angina, Unstable; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Confounding Factors, Epidemiologic; Coronary Disease; Coronary Restenosis; Diabetes Complications; Diabetes Mellitus, Type 2; Female; Follow-Up Studies; Heart Failure; Humans; Hypertension; Hypoglycemic Agents; Male; Middle Aged; Myocardial Infarction; Prognosis; Registries; Retreatment; Stroke; Sweden; Treatment Outcome

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Humans; Male; Myocardial Infarction; Prosthesis Design; Sirolimus; Tomography, Optical Coherence

Optical coherence tomography is a high-resolution imaging technology that allows in vivo assessment of neointimal hyperplasia and strut coverage after coronary stenting.. Assessment of spatial distribution of healing, 6 months after zotarolimus-eluting stent implantation.. Forty-two zotarolimus-eluting stents were monitored by optical coherence tomography 6 months after implantation. Mean neointimal strut coverage thickness and percentage of neointimal hyperplasia were measured every millimetre. Non-covered strut ratios were assessed on each slice. In addition, the spatial distribution of neointimal hyperplasia and strut coverage were analysed longitudinally on five stent segments and axially on each slice.. There were no clinical events at 6 months under dual antiplatelet therapy. The optical coherence tomography analysis showed a mean neointimal hyperplasia thickness of 333±147μm and neointimal hyperplasia obstruction of 36.1±12.3%. The percentage of covered struts at 6 months was very high (98.9%). Only 6/745 slices analysed (0.8%) had non-covered strut ratios exceeding 30%. There was no significant heterogeneity in either longitudinal or axial neointimal hyperplasia distribution. No thrombi were observed.. This optical coherence tomography study found relatively constant neointimal hyperplasia thickness, regardless of the zotarolimus-eluting stent length or diameter. This spatially homogeneous neointimal hyperplasia was associated with near-total coverage of all struts, 6 months after implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug Therapy, Combination; Drug-Eluting Stents; Female; France; Humans; Hyperplasia; Male; Middle Aged; Platelet Aggregation Inhibitors; Prospective Studies; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Tunica Intima

The treatment of unprotected left main coronary artery (uLMCA) bifurcation lesions remains challenging.. We hypothesized that the type of drug-eluting stent would correlate with clinical outcomes for the treatment of uLMCA bifurcation lesions.. One hundred fifteen patients who underwent stent implantation using a provisional T-stenting technique with sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) for uLMCA bifurcation lesions were enrolled. A major adverse cardiac event (MACE) was defined as a composite of cardiac death, myocardial infarction, or target lesion revascularization.. Ninety-four patients were treated with SES and 21 patients with PES. Baseline characteristics were similar between the 2 groups. Angiographic follow-up was performed in 99 (86%) patients. Late loss in the LMCA to the left anterior descending coronary artery was significantly lower in the SES group than in the PES group (0.28 ± 0.54 mm vs 1.03 ± 0.45 mm, P<0.001). One case of stent thrombosis occurred in the SES group. During follow-up with a median of 712 days, the SES group had a lower MACE compared with the PES group (10.6% vs. 28.6%, P = 0.032). Cox proportional hazards models including age, sex, diabetes, acute coronary syndrome, true bifurcation, stenting strategy, and type of drug-eluting stent used (SES vs. PES) demonstrated that stent type was the only predictor of MACE (hazard ratio of PES vs SES: 3.88, 95% confidence interval: 1.29-11.67, P = 0.016).. According to the results of the present study, SES may be associated with more favorable outcomes than PES for stenting of uLMCA bifurcation, which should be further studied by larger trials.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Republic of Korea; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

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

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Paclitaxel; Sirolimus

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

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Male; Polymers; Sirolimus

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Endothelial Cells; Female; Humans; Male; Paclitaxel; Stem Cells; Stents

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

To explore optimal management strategies for bifurcation lesions with sirolimus-eluting stents (SES).. Among 12,824 patients enrolled in the j-Cypher Registry, we identified 2,122 patients with 2,250 non-left main bifurcation lesions (average age: 69 years; diabetes: 39%; acute coronary syndrome: 24%; lesion length ≥30 mm: 17%; true bifurcation: 53%) treated exclusively with SES. The majority of lesions (1,978 lesions, 88%) were treated by provisional side branch stenting approach with a 4.5% crossover rate, while the elective two-stent approach (stenting both main and side branches) was adopted in 272 lesions. The 3-year incidence of target-lesion revascularisation (TLR) was significantly higher in the elective two-stent group than in the provisional group (18.5% vs. 9.8%, p<0.0001). The incidence of definite stent thrombosis was not different between the two groups (1.3% vs. 0.61%, p=0.21). Among 1,871 lesions with main branch stenting alone, final kissing balloon dilatation (FKB) was performed in 938 lesions (50%). The incidence of TLR was not different between the two groups with or without FKB (9.9% vs. 9.2%, p=0.98).. The provisional approach provided a good long-term outcome in the majority of lesions with low crossover rate to the two-stent approach. Lesions treated with FKB had similar TLR outcome to those without FKB after main branch stenting alone.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Japan; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Odds Ratio; Proportional Hazards Models; Registries; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The optimal treatment strategy for coronary bifurcation lesions is still unknown. The BiOSS Lim stents (Bifurcation Optimisation Stent System) is a novel dedicated bifurcation stent introduced over a single wire in to the main vessel, covered with biodegradable polymer and sirolimus. It has wider proximal and narrower distal parts. The aim of the study was to assess applicability of the the BiOSS Lim stent in a porcine coronary model.. A total of 14 BiOSS Lims were implanted in normal non-atherosclerotic porcine coronary bifurcations of 14 animals (six stents for 28 days, eight stents for 90 days) using 1.1:1.0 stent-to-artery ratio. Stent geometry and morphology were evaluated by Faxitron imagery (Faxitron Bioptics, LLC, IL, USA). Vascular effects were assessed based on angiographic and histological analysis. Analysis of Faxitron images revealed no major abnormalities except two struts fractures at the place of connection between the mid-portion and proximal wider part of the stent. Histomorphometry showed decreased area stenosis and intimal thickness at 90 days compared with the 28 days cohort. The inflammatory scores were low (<1) at both time points and struts endothelialisation was completed at 28 days.. The novel BiOSS Lim stent demonstrates good short- and mid-term vascular effects in a porcine coronary bifurcation model.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Feasibility Studies; Materials Testing; Models, Animal; Prosthesis Design; Sirolimus; Swine; Time Factors

To assess the safety and efficacy of the second generation DIOR paclitaxel drug-eluting balloon (DEB) for in-stent restenosis in a real world setting in a prospective single-arm registry with 8-month clinical outcomes.. In this "real world", international prospective registry, patients with in-stent restenosis (bare-metal stent and drug-eluting stent) were enrolled- in a unique study design- with a one week enrolment period, spread over 104 centres worldwide. Patients underwent predilatation with a regular balloon, with subsequent DEB inflation in the target lesion. Additional stenting of the target lesion was left to the operators discretion in case of suboptimal angiographic success (TIMI flow <3 and/or residual stenosis >30%). The primary endpoint was 6-9-month major adverse cardiac events (MACE: all cause death, myocardial infarction, and target vessel revascularisation). A total of 250 evaluable patients were enrolled in a large web-based clinical research form and treated with the second generation DIOR DEB. Of these, 244 had 6-9 month clinical follow-up, with a mean follow-up time of 7.5 months. The cumulative MACE rate at follow-up was 11.1%, with 3 (1.2%) cardiac deaths, 1 (0.4%) non-cardiac death, 5 (2.0%) myocardial infarctions of which 2 (0.8%) periprocedural, 21 (8.6%) target vessel revascularisations, of which 18 (7.4%) target lesion revascularisations.. In-stent restenosis treatment with the second generation DIOR DEB is safe and feasible, with high angiographic success and low target lesion revascularisation and overall MACE rates. Moreover this new and unique method of high speed and short duration multicentre study enrolment was very successful.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Patient Selection; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Thrombosis; Time Factors; Treatment Outcome

To evaluate the angiographic and clinical outcome of patients undergoing paclitaxel-eluting stent (PES) implantation for unprotected left main coronary artery (ULMCA) stenosis in a "real-world" multicentre, prospective registry. Percutaneous coronary intervention (PCI) is an increasingly utilised method of revascularisation in patients with ULMCA.. A prospective registry including all patients with a significant (>50%) ULMCA stenosis. Of 151 such patients, the target lesion involved the distal bifurcation in 100 patients (66%), which was treated predominantly by a "provisional T-stenting" strategy. In the distal ULMCA disease group, 72% had only one stent implantation while 28% had multiple (either two or three) stents implanted. At a median follow-up of 1,123±80 days, cardiac death occurred in five patients (3.3%) and major adverse cardiac and cerebrovascular events (MACCE) in 32 patients (21.2%). The three-year survival rate was 93.3%.. In the drug-eluting stent era, paclitaxel-eluting stent implantation of ULMCA stenosis provided excellent immediate and long-term results in this selected population, suggesting that this approach may be considered as a safe and effective alternative to CABG for selected patients with ULMCA who are treated in experienced institutions performing large numbers of PCI procedures.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cerebrovascular Disorders; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Disease-Free Survival; Drug-Eluting Stents; Female; France; Hospital Mortality; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Severity of Illness Index; Survival Analysis; Survival Rate; Time Factors; Treatment Outcome

We sought to assess the efficacy and safety of everolimus-eluting stents for unprotected left main disease.. A total of 173 consecutive patients with de novo significant unprotected left main stenosis received an everolimus-eluting stent in four French centres. Among them, 140 (81 %) had involvement of the distal portion of left main, and 129/140 (92%) were treated with provisional side branch T-stenting, with a side branch stenting rate of 20%. Angiographic success was achieved in all cases. At 12 months, the cumulative rate of major adverse cardiac or cerebrovascular events (MACCE) was 26/173 (15%) including death from any cause (N=5, 2.9%), stroke (N=4, 2.3%), Q-wave myocardial infarction (MI) (N=2, 1.2%), non-Q-wave MI (N=6, 3.5%) and any repeat revascularisation (N=16, 9.3%). At one year, the rate of target-lesion revascularisation (TLR) was 5/173 (2.9%), target-vessel revascularisation was 12/173 (7 %) and the rate of definite or probable left main stent thrombosis 1/173 (0.6 %).. Unprotected left main stenting using everolimus-eluting stents and a strategy of provisional side branch T-stenting for distal lesions, is safe and effective in the midterm, with a relatively low rate of events and reintervention at one year.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Female; Hospital Mortality; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Pilot Projects; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Stroke; Thrombosis; Time Factors; Treatment Outcome

Topics: Aged; Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Catheters; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Equipment Design; Germany; Humans; Middle Aged; Paclitaxel; Prosthesis Design; Radiography; Stents; Treatment Outcome

Our initial investigations into restenosis inhibition by local drug delivery were prompted by reports on an improved outcome of coronary interventions, including a lower rate of target lesion revascularisation, when the intervention was performed with an ionic instead of non-ionic contrast medium. Although this was not confirmed in an animal study, the short exposure of the vessel wall to paclitaxel dissolved in contrast agent or coated on balloons proved to be efficacious. A study comparing three methods of local drug delivery to the coronary artery in pigs indicated the following order of efficacy in inhibiting neointimal proliferation: paclitaxel-coated balloons > sirolimus-eluting stents, sustained drug release > paclitaxel in contrast medium. Cell culture experiments confirmed that cell proliferation can be inhibited by very short exposure to the drug. Shorter exposure times require higher drug concentrations. Effective paclitaxel concentrations in porcine arteries are achieved when the drug is dissolved in contrast medium or coated on balloons. Paclitaxel is an exceptional drug in that it stays in the treated tissue for a long time. This may explain the long-lasting efficacy of paclitaxel-coated balloons, but does not disprove the hypothesis that the agent blocks a process initiating long-lasting excessive neointimal proliferation, which occurs early after vessel injury.

Topics: Angioplasty, Balloon, Coronary; Animals; Berlin; Cardiovascular Agents; Catheters; Cell Proliferation; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Delayed-Action Preparations; Dose-Response Relationship, Drug; Drug Delivery Systems; Drug-Eluting Stents; Equipment Design; Humans; Models, Animal; Paclitaxel; Sirolimus; Swine; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Catheters; Cell Proliferation; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Vessels; Dose-Response Relationship, Drug; Drug Delivery Systems; Drug-Eluting Stents; Equipment Design; History, 20th Century; History, 21st Century; Humans; Time Factors

EPC and hCASMC play an important role in the pathogenesis of restenosis and stent thrombosis. Drug-coated balloon catheters exert a local, short-term application of antiproliferative agents. This study investigates the time-dependent influence on growth and motility of paclitaxel and sirolimus alone and combined with the coating additive iopromide on EPC and hCASMC.. Treatment of cultured human EPC and hCASMC with paclitaxel and sirolimus 1.5 and 15 µM for three seconds, three minutes and 24 hours, alone or combined with iopromide 0.197 M, resulted in a concentration- and time- dependent inhibition of proliferation and of migration. Paclitaxel and sirolimus increase apoptosis in either cell type. However, the effects of paclitaxel and sirolimus differed between the cell types: short-term exposure with paclitaxel leads to stronger inhibition of cell-density and apoptosis of hCASMC compared to EPC. In comparison to paclitaxel, short-term incubation with sirolimus showed a more effective inhibition of cell-density and migration as well as increased apoptosis in EPC in contrast to hCASMC. The effects of paclitaxel and sirolimus were increased in combination with iopromide. Interestingly, the antiproliferative effect of the paclitaxel-iopromide formulation on hCASMC was more potent compared to its effect on EPC. Endothelialisation in a porcine coronary stent model was similar with drug-coated balloons and uncoated controls, whereas it was delayed with drug-eluting stents.. After short-term application, paclitaxel and sirolimus show differential, cell-specific effects on EPC and hCASMC. Iopromide used as a coating agent intensifies these effects.

Topics: Angioplasty, Balloon, Coronary; Animals; Apoptosis; Cardiovascular Agents; Cell Movement; Cell Proliferation; Cells, Cultured; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Vessels; Dose-Response Relationship, Drug; Drug Delivery Systems; Drug-Eluting Stents; Endothelial Cells; Equipment Design; Humans; Iohexol; Models, Animal; Muscle, Smooth, Vascular; Myocytes, Smooth Muscle; Paclitaxel; Sirolimus; Stem Cells; Sus scrofa; Time Factors

Lesions in small coronary vessels comprise a challenging disease subset in contemporary interventional practice. Due to the limitations of mechanical methods for preventing restenosis in small vessels, such lesions have been considered the Achilles' heel of bare metal stenting, with little marginal antirestenotic efficacy in comparison with balloon angioplasty. In contrast, modalities employing biological or pharmaceutical methods for restenosis prevention - in particular drug-eluting stents (DES) - have demonstrated greatest antirestenotic advantage in vessels with reference diameter under 2.8 mm. Moreover, lesions in small vessels served as in important stress test in uncovering efficacy differences between comparator DES platforms. Drug-coated balloon therapy has shown encouraging results in certain subgroups - most notably in restenosis within bare metal stents. However, what limited data exists to date does not suggest a clear role for this modality in lesions in small coronary vessels. On the basis of sound scientific principle and accumulated trial data, DES therapy represents the treatment of choice for this condition, simultaneously combining high acute gain with low late loss. While concerns related to late adverse events after DES implantation focus attention on the need for interventional modalities delivering high antirestenotic efficacy with a minimum of vascular wall toxicity, it may well transpire that in this disease subset novel stent platforms - such as fully bioabsorbable DES - represent a more promising way forward than drug-coated balloons.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Drug-Eluting Stents; Equipment Design; Evidence-Based Medicine; Humans; Patient Selection; Prosthesis Design; Risk Assessment; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Drug-Eluting Stents; Equipment Design; Evidence-Based Medicine; Humans; Metals; Patient Selection; Practice Guidelines as Topic; Prosthesis Design; Stents; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug Carriers; Equipment Design; Humans; Practice Guidelines as Topic; Stents; Treatment Outcome

We aimed to investigate the effects of brachytherapy, drug-eluting stent (DES) and bare metal stent (BMS) applications in the treatment of coronary artery disease, on five-year clinical outcomes and mortality.. Two hundred and seventeen patients who were treated in our clinics between January 2000 and December 2003 with brachytherapy, DES, or BMS for both de novo and in-stent restenosis lesions were included in this cohort study. Of these 217 patients, 69 received brachytherapy, 80 were given BMS and 68 were given DES. The clinical outcomes of the patients during hospitalization and over a long-term follow-up were evaluated. Cardiovascular events, revascularizations and mortality rates were compared among the three groups over a five-year follow-up.. The mean age was 60.1 ± 9.5 years in the brachytherapy group, 55.7 ± 9.2 years in the BMS group, and 58.9 ± 9.8 years in the DES group (p = 0.44). All-cause mortality rates were 20 (29%) brachytherapy patients, 22 (27.5%) BMS patients, and four (5.9%) DES patients (p = 0.01). Cardiovascular event was the cause of death for 14 (20.3%) brachytherapy patients, 16 (20%) BMS patients and four (5.9%) DES patients (p = 0.001). All-cause mortality rates were 20 (29%) brachytherapy patients, 22 (27.5%) BMS patients and four (5.9%) DES patients. All-cause and cardiovascular mortality rates were significantly lower in the DES group compared to both the BMS and the brachytherapy groups (p = 0.01 and p = 0.001, respectively).. DES application for in-stent restenosis and de novo lesions was superior to brachytherapy and BMS application with respect to all-cause and cardiovascular mortalities.

Topics: Aged; Analysis of Variance; Angioplasty, Balloon, Coronary; Brachytherapy; Cardiovascular Agents; Cause of Death; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Stents; Time Factors; Treatment Outcome

Calcified coronary lesions have commonly been considered as a challenge for interventional cardiologists, and few previous studies of sirolimus-eluting stent (SES) for calcified lesion have been limited by small sample size. Therefore, we evaluated the effectiveness of SES implantation for the treatment of calcified lesions in a large Chinese cohort of real world practice.. A total of 956 consecutive patients who successfully received SES placement were enrolled in this study, and were divided into the two groups according to whether the mild-moderate calcified lesion treated with SES exists or not: noncalcified group (n = 637) and calcified group (n = 319). Lesions treated with SES were subjected to quantitative coronary angiography immediately and 8 months after stenting.. Baseline characteristics including clinical, demographic or angiographic data were well balanced between the noncalcified and calcified groups. In the angiographic follow-up at 8 months, the in-stent restenosis and in-segment restenosis rates were similar in both the groups (in-stent restenosis: 3.8 vs. 4.0%, P>0.05; in-segment restenosis: 8.5 vs. 9.7%, P>0.05). The target lesion revascularization was not different between the two groups (5.2 vs. 6.8%; P>0.05). In addition, the in-stent late loss and overall thrombosis rate were also similar in both the groups (0.17+/-0.41 vs. 0.18+/-0.35 mm and 1.8 vs. 1.8%, P>0.05, respectively).. Although stenting of the calcified lesion was hard, successful treatment with SES for mild-moderate calcified lesions was conferred to similar favorable results compared with noncalcified lesions in patients with coronary artery disease.

Topics: Aged; Angioplasty, Balloon, Coronary; Calcinosis; Cardiovascular Agents; China; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Prospective Studies; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Our aim was to access the incidence of late major adverse cardiac events (MACE) and stent thrombosis (ST) in nonselected, complex patients followed for a period >/=4 years.. Despite the efficacy of drug-eluting stents (DES) in reducing repeated target lesion revascularization, concerns regarding the occurrence of late and very late ST have partially obscured the benefits of this novel technology.. All consecutive patients treated solely with DES between May 2002 and January 2005 were enrolled into this prospective, nonrandomized, single-center registry. The primary end point was long-term occurrence of MACE up to 7 years. Independent predictors of MACE, cardiac death, target lesion revascularization, and ST were obtained by a multivariate Cox proportional hazards regression model.. A total of 1,010 patients were enrolled. Most of them were men (77%) with a mean age of 63.7 years. Stent/patient rate was 1.4. Patients were kept in dual antiplatelet therapy for 3 and 6 months after Cypher (Cordis, Johnson & Johnson, Miami Lakes, Florida) and Taxus (Boston Scientific Corp., Natick, Massachusetts) stent implantation, respectively. Follow-up was obtained in 98.2% of the cohort (median 5.01 years). Survival free of MACE and cumulative incidence of definite/probable ST were 84.6% and 1.7%, respectively. Independent predictors of ST were percutaneous coronary intervention in the setting of acute myocardial infarction, DES overlapping, treatment of multivessel disease, presence of moderate-to-severe calcification at lesion site, and in-stent residual stenosis.. The deployment of DES in complex, real-world patients resulted in a low rate of very long-term MACE and ST. However, ST still occurs very long after the index procedure.

Topics: Aged; Angioplasty, Balloon, Coronary; Brazil; Calcinosis; Cardiovascular Agents; Coronary Restenosis; Disease-Free Survival; Drug Therapy, Combination; Drug-Eluting Stents; Female; Heart Diseases; Humans; Incidence; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Platelet Aggregation Inhibitors; Proportional Hazards Models; Prospective Studies; Registries; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

We sought to report the results of both bench-testing and our first clinical experience with this novel technique.. The optimal stenting technique for bifurcation lesions has yet to be defined.. This technique works by flaring the proximal side of the stent in side branch out like a flower petal. We tested it in vitro and the resultant stent structure and stent polymer damage was observed in both main branch and side branch with an optical microscopy, multislice computer tomography, intravascular ultrasound, endoscopy, and by electron microscopy. We also applied this technique in 33 patients and assessed patient outcomes up to 9 months prospectively. Drug-eluting stents were used for the bench tests and for all patients.. Bench-testing showed complete coverage of the bifurcation with minimal stent-layer overlapping. There was little polymer damage by electron microscopy. Procedural success was achieved in all cases and restenosis occurred in 2 cases. In both restenosis cases, "petal" stenting technique was done reluctantly after another stent had already been deployed in the main branch before any stenting of the side branch. There were no incidences of restenosis when this technique was used electively.. In terms of damage to the polymer and ostial strut coverage, this new "flower petal stenting" technique is effective for treatment of bifurcation lesion and it may well be superior to other available techniques.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Endoscopy; Female; Humans; Male; Materials Testing; Middle Aged; Paclitaxel; Prospective Studies; Prosthesis Design; Severity of Illness Index; Sirolimus; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Paclitaxel; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome

In this study, we hypothesized that an antihuman-CD34 antibody immobilized on the surface of commercially available sirolimus-eluting stents (SES) could enhance re-endothelialization compared with SES alone.. Previous experience with antihuman-CD34 antibody surface modified Genous stents (GS) (OrbusNeich Medical, Fort Lauderdale, Florida) has shown enhanced stent endothelialization in vivo.. In the phase 1 study, stents were deployed in 21 pig coronary arteries for single stenting (9 vessels: 3 GS, 3 SES, and 3 bare-metal stents) and overlapping stenting with various combinations (12 vessels: 4 GS+GS, 4 SES+SES, and 4 GS+SES) and harvested at 14 days for scanning electron and confocal microscopy. In phase 2, immobilized anti-CD34 antibody coating was applied on commercially available SES (SES-anti-CD34, n = 7) and compared with GS (n = 8) and SES (n = 7) and examined at 3 and 14 days by scanning electron/confocal microscopy analysis.. In phase 1, single stent implantation showed greatest endothelialization in GS (99%) and in bare-metal stent (99%) compared with SES (55%, p = 0.048). In overlapping stents, endothelialization at the overlapping zone was significantly greater in GS+GS (95 +/- 6%) and GS+SES (79 +/- 5%) compared with the SES+SES (36 +/- 14%) group (p = 0.007). In phase 2, SES-anti-CD34 resulted in increased endothelialization compared with SES alone at 3 days (SES-anti-CD34 36 +/- 26%; SES 7 +/- 3%; and GS 76 +/- 8%; p = 0.01), and 14 days (SES-anti-CD34 82 +/- 8%; SES 53 +/- 20%; and GS 98 +/- 2%; p = 0.009).. Immobilization of anti-CD34 antibody on SES enhances endothelialization and may potentially be an effective therapeutic alternative to improve currently available drug-eluting stents.

Topics: Angioplasty, Balloon, Coronary; Animals; Antibodies; Antigens, CD34; Cardiovascular Agents; Cell Proliferation; Cells, Cultured; Coronary Restenosis; Dose-Response Relationship, Drug; Drug-Eluting Stents; Endothelial Cells; Humans; Metals; Microscopy, Confocal; Microscopy, Electron, Scanning; Models, Animal; Prosthesis Design; Sirolimus; Stents; Swine; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Animals; Antibodies; Antigens, CD34; Cardiovascular Agents; Cell Proliferation; Coronary Restenosis; Drug-Eluting Stents; Endothelium, Vascular; Humans; Prosthesis Design; Sirolimus; Stents; Swine; Treatment Outcome

Our aim was to test whether serum levels of matrix metalloproteinase (MMP)-2 and -9 are associated with the development of in-stent restenosis (ISR) after implantation of drug-eluting stents (DES).. With the introduction of DES coronary ISR could be reduced dramatically. However, it still plays a significant role, particularly after treatment of multiple, complex lesions.. We studied 85 patients who were treated with 159 DES. Blood samples for measurement of MMP-2 and -9 antigen and activity were taken directly before and 24 h after percutaneous coronary intervention (PCI). Restenosis was evaluated at 6 to 8 months by coronary angiography.. During the follow-up period, 2 patients (2.4%) died of cardiovascular causes, and 12 patients developed angiographic ISR. Patients with ISR showed significantly higher serum activity of MMP-9 at baseline (p = 0.017) and of MMP-2 (p < 0.0001) and MMP-9 (p < 0.0001) after the procedure. The PCI increased serum activity of MMP-2 (p = 0.005) and MMP-9 (p = 0.008) only in patients with ISR. The restenosis rates of patients in the highest quartile of MMP-2 after and MMP-9 before and after PCI were 40.0%, 38.9%, and 42.9% compared with 6.3%, 7.7%, and 4.0% in the lower quartiles, respectively. This was independent of clinical and procedural characteristics.. Elevated serum activities of MMP-2 and -9 are associated with dramatically increased restenosis rates after PCI with implantation of DES. Determination of MMP levels might be useful for identification of patients who are at high risk for ISR despite implantation of DES.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Logistic Models; Matrix Metalloproteinase 2; Matrix Metalloproteinase 9; Odds Ratio; Paclitaxel; Prospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Up-Regulation

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

Two months after left anterior descending (LAD) artery and left circumflex (LCx) artery bare metal stent implantation, a proliferative subocclusive in-stent restenosis in LCx coronary with severe LM coronary (LM) involvement developed. The present clinical case describes a simplified strategy for unprotected LM percutaneous coronary intervention using two bioabsorbable biolimus-eluting stents without involvement of the LAD coronary using an "L" technique.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Male; Metals; Middle Aged; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome

The aim of this study was to evaluate the long-term clinical outcome of the efficacy and safety of sirolimus-eluting stents (SES) for in-stent restenosis (ISR) in the TRUE (Tuscany Registry of Unselected In-Stent Restenosis) database.. The TRUE registry demonstrated that SES in the treatment of bare-metal stent ISR is efficacious (5% of target lesion revascularization [TLR]) and safe (stent thrombosis <1%) at 9 months. Clinical outcome at 4 years is reported.. A total of 244 patients with ISR who were treated with SES implantation represent the study population. The incidence of major adverse cardiac events was collected at 4 years.. At 4-year follow-up, overall mortality was 9.8% (24 patients). Cardiac death occurred in 11 (4.5%), nonfatal myocardial infarction in 8 (3.2%), and TLR in 27 (11.1%) patients for a cumulative event-free survival rate of 80.3%. Definite stent thrombosis occurred in 5 (2%) patients and possible stent thrombosis in 2 (0.8%). Diabetes remained an independent negative predictor of freedom from TLR (odds ratio [OR]: 0.38; 95% confidence interval [CI]: 0.20 to 0.71, p = 0.002) and major adverse cardiac events (OR: 0.38; 95% CI: 0.20 to 0.71, p = 0.002).. The clinical benefit of SES implantation for bare-metal stent ISR is maintained at 4 years with a low TLR rate and an overall incidence of stent thrombosis of 0.7% per year.

Topics: Aged; Aged, 80 and over; Aspirin; Cardiovascular Agents; Clopidogrel; Coronary Restenosis; Coronary Thrombosis; Creatinine; Diabetes Mellitus; Drug-Eluting Stents; Follow-Up Studies; Humans; Myocardial Infarction; Myocardial Revascularization; Platelet Aggregation Inhibitors; Prospective Studies; Registries; Sirolimus; Stroke Volume; Ticlopidine

This study aimed to evaluate the impact of angiographic and intravascular ultrasound (IVUS) features on clinical outcome in nondiabetic and type 2 diabetic patients after percutaneous coronary intervention (PCI) with sirolimus-eluting stent (SES) implantation.. Repeat coronary angiography with IVUS imaging was performed after SES-based PCI for de-novo lesions in 128 diabetic and 327 nondiabetic patients (189 lesions and 504 lesions, respectively). The rate of major adverse cardiac events including cardiac death, non fatal myocardial infarction (MI), and target lesion revascularization during clinical follow-up was recorded.. In-stent and in-segment late loss, intimal hyperplasia volume, and percentage volumetric obstruction were similar, but stented external elastic membrane cross-sectional area and reference/stented segment ratio were lower in diabetic than in nondiabetic patients. Incomplete stent apposition (ISA) was less frequent, but occurrence of new coronary lesions was higher in diabetic than in nondiabetic patients. Despite similar target lesion revascularization, cumulative survival rates freedom from composite cardiac death and nonfatal MI or major adverse cardiac events were reduced in diabetic patients. Cox proportional hazards model identified diabetes, left ventricular ejection fraction, minimal stent CSA, maximal ISA area, atherosclerotic progression and lesion length as independent predictors of non fatal MI or mortality at follow-up.. In diabetic patients, PCI with SES implantation neutralizes the excess risk of intimal hyperplasia and decreases occurrence of ISA, but could not modify the propensity of increased adverse clinical outcomes at follow-up.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Diabetes Mellitus, Type 2; Drug-Eluting Stents; Female; Heart Diseases; Humans; Hyperplasia; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Predictive Value of Tests; Proportional Hazards Models; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The aim of this study was to compare outcomes after percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in the treatment of cardiac allograft vasculopathy (CAV).. PCI in patients with CAV is associated with increased rates of restenosis compared with PCI in patients without CAV. There are no dedicated studies on the influence of different drug-eluting stents (DES) on the outcomes of patients with CAV.. This is a retrospective observational study of 108 consecutive patients with CAV who underwent PCI with SES and PES at UCLA Medical Center and University of Padova Medical Center between 2002 and 2008.. Baseline characteristics were similar among SES (n = 68) and PES (n = 40) patients with the exception of older patients, larger minimal lumen diameter, and smaller diameter stenosis in the SES-treated patients. Angiographic follow-up at 1 year was high in the SES and PES groups (74% vs. 76%, p = 0.8). The SES and PES groups had similar binary restenosis rates (10% vs. 9%, p = 0.7), percent diameter stenosis (24 +/- 24% vs. 24 +/- 18%, p = 0.94), and late lumen loss (0.67 +/- 1.03 mm vs. 0.68 +/- 1.11 mm, p > 0.9). One-year clinical outcomes were not significantly different among CAV patients treated with either SES or PES (major adverse cardiac events: 10% vs. 15%, p = 0.5; death: 3% vs. 5%, p = 0.4; myocardial infarction: 3% vs. 5%, p = 0.4; target vessel revascularization: 4% vs. 8%, p = 0.3).. In patients who underwent PCI for CAV, both SES and PES were safe and effective with no significant differences in clinical and angiographic outcomes. Randomized clinical trials comparing different DES with longer follow-up are necessary to identify the optimal treatment strategy for patients with CAV.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Heart Transplantation; Humans; Italy; Los Angeles; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Retrospective Studies; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Transplantation, Homologous; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Humans; Metals; Paclitaxel; Prosthesis Design; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Everolimus; Humans; Metals; Myocardial Infarction; Patient Selection; Prosthesis Design; Risk Assessment; Severity of Illness Index; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Metals; Prosthesis Design; Sirolimus; Stents; Time Factors; Treatment Outcome

Limited data are available on the long-term outcome following PCI with paclitaxel-eluting stent (PES) implantation in patients with unprotected left main coronary artery (LMCA). The objective of this study was to evaluate "real world" long-term outcome following paclitaxel-eluting stent (PES) implantation for unprotected LMCA disease in patients enrolled in the TRUE registry.. From March 2003 to October 2004, 93 consecutive patients (81.7% male) underwent PCI for unprotected LMCA disease. Surveillance angiography was performed at 6.8+/-3.3 months follow-up. The target lesion involved the distal LMCA in 68 (73.1%) patients. Double stenting techniques were performed in 46 (67.6%) distal LMCA, of these 50% were stented using the Crush technique. Clinical follow-up was complete in all patients with 85.8% angiographic follow-up rate. In-segment restenosis occurred in 16 (20.3%) patients and was focal in 72.4% of cases and significantly higher in patients with distal LMCA (36.8% vs. 13.6%, p<0.04). At a median follow-up of 1,450 days (IQR 1281-1595), the overall incidence of MACE was 35.5% and the TLR rate was 25.8% and significantly higher in patients with bifurcation stenting (32.3% vs. 8%, p<0.02). The estimated cardiac survival rate at one and four years was 96.7% and 93.3%, respectively. Total mortality rate was 14.1% and cardiac was 6.5%. There was one (1.1%) definite stent thrombosis (ST) and one (1.1%) probable ST.. Treatment of unprotected LMCA disease with PES, after four years follow-up, appears to be safe and effective with a low rate of cardiac mortality and overall risk of ST. The need for target lesion revascularisation in 25.8% of patients highlights the need for more effective PCI especially in patients with distal LMCA disease.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Disease-Free Survival; Drug-Eluting Stents; Europe; Female; Follow-Up Studies; Hospital Mortality; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Severity of Illness Index; Thrombosis; Time Factors; Treatment Outcome

The aim of this study was to evaluate and compare the clinical and angiographic outcomes of 3 drug-eluting stents (DES) in patients with large vessel diameter and single coronary artery lesions.. The efficacy of 3 DESs may be similar.. A total of 411 consecutive patients who visited 3 university hospitals from June 2004 to December 2007 and had a single coronary lesion which was treated with the use of a DES that was 3.5 mm in diameter were enrolled in this study. Patients were divided into 3 stent groups: Paclitaxel-eluting stent (PES, n = 105), Sirolimus-eluting stent (SES, n = 259), and Zotarolimus-eluting stent (ZES, n = 47). The study end point was a composite of major adverse cardiac events (MACE) including cardiac death, myocardial infarction (MI), and ischemia-driven target-vessel revascularization (TVR) for 12 months.. Baseline characteristics were not different. Late loss was higher in the ZES group than the other stents (0.5 +/- 0.4 mm in SES vs 0.3 +/- 0.5 mm in PES, 0.7 +/- 0.5 mm in ZES, P = 0.001). The total MACE-free survival rate was not significantly different between the SES group and the PES group (98.8% in SES vs 97.1% in PES, P = 0.252) or the PES group and the ZES group (97.1% in PES vs 93.6% in ZES, P = 0.301). However, the SES group showed a significantly better MACE-free survival rate compared with the ZES group (98.8% in SES vs 93.6% in ZES, P = 0.018).. Clinical and angiographic outcomes of DES in a large vessel diameter and single coronary artery is excellent and SES appears to show better angiographic and clinical outcomes than ZES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Hospital Mortality; Hospitals, University; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Prosthesis Design; Republic of Korea; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

To evaluate the safety and efficacy of the XIENCE V everolimus-eluting stent compared to the TAXUS paclitaxel-eluting stent in small vessels.. The XIENCE V everolimus-eluting stent (EES) has been shown to improve angiographic and clinical outcomes after percutaneous myocardial revascularization, but its performance in small coronary arteries has not been investigated.. In this pooled analysis, we studied a cohort of 541 patients with small coronary vessels (reference diameter <2.765 mm) by using patient and lesion level data from the SPIRIT II and SPIRIT III studies. TAXUS Express (73% of lesions) and TAXUS Liberté (27% of lesions) paclitaxel-eluting stents (PES) were used as controls in SPIRIT II. In SPIRIT III, Taxus Express(2) PES was the control.. Mean angiographic in-stent and in-segment late loss was significantly less in the EES group compared with the PES group, (0.15 +/- 0.37 mm vs. 0.30 +/- 0.44 mm; P = 0.011 for in-stent; 0.10 +/- 0.38 mm vs. 0.21 +/- 0.34 mm; P = 0.034 for in-segment). EES also resulted in a significant reduction in composite major adverse cardiac events at 1 year (19/366 [5.2%] vs. 17/159 [10.7%]; P = 0.037), due to fewer non-Q-wave myocardial infarctions and target lesion revascularizations. At 1 year, the rate of non-Q-wave myocardial infarction was significantly lower in the EES group compared with that of the PES group (6/366 [1.6%] vs. 8/159 [5.0%]; P = 0.037).. In patients with small vessel coronary arteries, the XIENCE V EES was superior to the TAXUS PES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multicenter Studies as Topic; Myocardial Infarction; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Myocardial Infarction; Paclitaxel; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

Stent fracture (SF) of sirolimus-eluting stents (SES) has emerged recently in the literature and shown to be associated with an increased risk of restenosis; however, little is known regarding SF after bare-metal stent implantation. We sought to assess whether the use of SES was associated with an increased risk of SF compared with its bare-metal platform, the Bx-velocity stent (BX-BMS).. A total of 478 lesions in 416 patients undergoing SES implantation and subsequent angiography 6-9 months after the index procedure were compared with 152 lesions in 142 consecutive patients treated with BX-BMS. Stented lesions with total stent-length greater than 40 mm were excluded.. There were no significant differences in overall baseline clinical and anatomic features between the SES and BX-BMS groups, or in SF frequencies at 6-9 month follow-up (4.4% for SES and 1.3% for BX-BMS, P= 0.078). In-stent restenosis was observed more often in SF lesions versus non-SF lesions (34.8 vs. 7.7%, P< 0.001) in association with a higher 3-year adverse events rate (27.3 vs. 13.6%, P = 0.076). The risk of SF at 6-9 months was independently associated with total stent length [odds ratio (OR), 2.13; 95% confidence interval (CI), 1.18-3.83; P = 0.012], angulated lesions (OR, 4.25; 95% CI, 1.80-10.00; P = 0.001), and right coronary artery lesions (OR, 3.55; 95% CI, 1.46-8.62; P = 0.005) but not with SES use.. Stent implantation in right coronary artery lesions, tortuous lesions, and/or longer lesions covered with longer stents, and not SES versus BX-BMS use, may be associated with increased likelihood of SF.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Metals; Middle Aged; Odds Ratio; Prosthesis Design; Prosthesis Failure; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Failure

The aim of this study was to examine the incidence of clinical events after implantation of the TAXUS Express (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent in saphenous vein graft (SVG) lesions in an unselected patient population.. Saphenous vein grafts have 1-year occlusion rates of 12% to 20%, with >50% failure by 7 to 10 years. Many diseased SVGs are treated by percutaneous coronary intervention to avoid higher-risk reoperation, but bare-metal stents have 35% to 40% historical SVG restenosis rates by 18 months. Reported outcomes of drug-eluting stents in SVG lesions are limited and mainly retrospective.. The ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) program compiled data on 7,492 patients receiving > or =1 TAXUS Express (Boston Scientific) stent, including 474 patients with SVG. All cardiac events were monitored with independent adjudication of end points. Patients enrolled at procedure start with no mandated inclusion/exclusion criteria.. The ARRIVE SVG patient 2-year follow-up was 96% complete (457 of 474). The SVG patients had significantly more baseline comorbidities/complex disease than simple-use patients (n = 2,698) undergoing native coronary intervention or other expanded-use patients (n = 4,320 without SVG patients). They had higher 2-year rates of mortality (10.9% vs. 4.2%, p < 0.001), myocardial infarction (5.3% vs. 2.2%, p < 0.001), and Academic Research Consortium definite/probable stent thrombosis (4.7% vs. 1.4%, p < 0.001) than the simple-use group. They also had higher 2-year adverse event rates, including significantly more mortality (10.9% vs. 7.5%, p = 0.008) than other expanded-use patients.. The ARRIVE SVG patients have significantly different baseline risk and higher clinical risk through 2 years than simple-use and other expanded-use patients. Nonetheless, compared with historical SVG revascularization rates, treatment with paclitaxel-eluting stent seems to offer a reasonable therapeutic option in this high-risk group. (TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance Program; NCT00569491) and (TAXUS ARRIVE 2: A Multicenter Safety Surveillance Program; NCT00569751).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Artery Bypass; Coronary Restenosis; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Proportional Hazards Models; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Saphenous Vein; Thrombosis; Time Factors; Treatment Outcome; United States

We examined angiographic and late-term clinical outcomes according to sex in recent percutaneous coronary intervention (PCI) trials involving zotarolimus-eluting stents (ZES).. Differences in outcome between men and women undergoing PCI have been inconsistently described with bare metal and first-generation drug-eluting stents.. Clinical and angiographic outcomes among ZES-treated patients were evaluated by sex using propensity score modeling in a patient-level systematic overview of six trials and were also compared to patients receiving bare metal stents (BMS).. Among 2,132 patients, 608 were female (28.5%). Compared to men, women were older and more frequently had diabetes, hypertension, and a smaller reference vessel diameter (P < 0.05 for all). For both sexes, the relative reductions in 8-month angiographic binary restenosis and late lumen loss were statistically significant and of similar extent with ZES compared to BMS. By 2 years, treatment with ZES resulted in significantly lower target vessel revascularization (TVR) and target vessel failure (TVF; 10.0% vs. 21.5%, P = 0.0003) among women that paralleled risk reductions for men. However, among ZES-treated patients, 2-year rates of TVR (8.2% vs. 10.4%, P = 0.005) and TVF (9.9% vs. 12.8%, P = 0.004) were significantly lower among women, although rates of death and myocardial infarction were similar.. Despite greater baseline clinical and angiographic risk than men, women undergoing PCI with ZES compared to BMS experienced significant reductions in angiographic restenosis and repeat revascularization yet similar safety. Among all patients treated with ZES, late-term safety and efficacy outcomes are similar, if not lower, among women compared to men.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Predictive Value of Tests; Propensity Score; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Sex Factors; Sirolimus; Time Factors; Treatment Outcome

Data on the relevance of the location of coronary bifurcation lesions treated by crush stenting with outcomes were limited.. We hypothesized that the location of the bifurcation lesion correlated with clinical outcome.. A total of 212 patients with 230 true bifurcation lesions treated by crush stenting with drug-eluting stents (DES) were assessed prospectively. Surveillance quantitative angiographies were indexed at 8 months after procedure. Primary endpoint was major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, and target lesion revascularization (TLR).. Patients in the distal right coronary artery (RCAd) group were characterized by higher proportions of prior myocardial infarction and very tortuous lesions. However, lesions in the RCAd group, compared to those of other groups, had the lowest late lumen loss, with resultant lowest incidence of MACE at a mean follow-up of 268±35 days. Independent predictors of MACE included unsatisfied kissing (KUS; hazard ratio [HR]: 12.14, 95% confidence interval [CI]: 4.01-12.10, P = .001) and non-RCA lesion (HR: 20.69, 95% CI: 5.05-22.38, P = .001), while those of TLR were KUS (HR: 10.21, 95% CI: 0.01-0.34, P = .002), bifurcation angle (HR: 4.728, 95% CI: 2.541-4.109, P = .001), and non-RCA lesion (HR: 16.05, 95%CI: 1.01-4.83, P = .001).. Classical crush stenting with drug-eluting stents is associated with significantly better outcomes in RCAd. Quality of kissing inflation is mandatory to improve outcome.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; China; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Myocardial Infarction; Paclitaxel; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

Coronary stent fracture has been postulated as an important mechanism for in-stent restenosis and late-stent thrombosis. We have developed a nondestructive microcomputed tomography (micro-CT) technique to image en bloc stented arterial segments.. A 43-year-old man died of sepsis 5 months following placement of a paclitaxel-eluting stent (PES) in the left circumflex coronary artery to treat in-stent restenosis of a sirolimus-eluting stent (SES). Micro-CT three-dimensional images of the overlapping stents were notable for numerous connecting element fractures along the length of the SES. No fractures were observed in the PES. The greatest area of luminal narrowing is related to the region of most extensive stent fracture. Micro-CT of en bloc specimens provides high resolution (16 μm), three-dimensional images allowing for visualization of the stented arterial segment in a nondestructive manner.

Topics: Adult; Angioplasty, Balloon, Coronary; Autopsy; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Fatal Outcome; Humans; Imaging, Three-Dimensional; Male; Paclitaxel; Prosthesis Design; Prosthesis Failure; Radiographic Image Interpretation, Computer-Assisted; Treatment Outcome; X-Ray Microtomography

In-stent restenosis (ISR) remains a persistent, unresolved issue even in the era of percutaneous coronary intervention (PCI) using drug-eluting stents. The present study compares the clinical and angiographic outcomes of using sirolimus-eluting stents (SES) for re-intervention against ISR that was originally treated with sirolimus-eluting or bare-metal (BMS) stents.. This prospective single-center registry investigated 179 ISR lesions in 158 consecutive patients (53 lesions in 49, and 126 in 109 patients originally treated with SES and BMS, respectively), who had undergone re-intervention with SES. The patients were clinically and angiographically followed up at 8 months after re-PCI. The incidence of re-restenosis (29 vs 12%, P<0.01), ischemia-driven target lesion revascularization (TLR; 21 vs 8%, P<0.05) and major adverse cardiac events (MACE; 21 vs 9%, P<0.05) were significantly greater in ISR lesions originally treated with SES than in those originally treated with BMS at 8 months after re-PCI. Moreover, late luminal loss was significantly greater in the group with post-SES restenosis (P<0.05). Even after adjustment, post-SES restenosis was the only independent predictor of re-restenosis and MACE (P<0.05, each).. Although the re-restenosis rate is acceptable, the incidence rates of late restenosis, ischemia-driven TLR and MACE are higher after repeated SES implantation to treat SES, than BMS restenosis. These results might affect the mid-term clinical outcomes of re-intervention with SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Japan; Logistic Models; Male; Metals; Middle Aged; Myocardial Infarction; Odds Ratio; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

The ZoMaxx I and II trials were randomized controlled studies of the zotarolimus-eluting, phosphorylcholine-coated, TriMaxx stent for the treatment of de novo coronary lesions. The aim of this study was to compare the vessel response between zotarolimus- (ZES) and paclitaxel-eluting stents (PES) using intravascular ultrasound (IVUS).. Data were obtained from the ZoMaxx I and II trials, in which a standard IVUS parameter was available in 263 cases (baseline and 9-months follow up). Neointima-free frame ratio was calculated as the number of frames without IVUS-detectable neointima divided by the total number of frames within the stent. While an increase in vessel and plaque was observed in PES from baseline to follow up, there was no significant change in ZES. At follow up, % neointimal obstruction was significantly higher (15.4 ± 8.8% vs 11.3 ± 9.7%), and minimum lumen area at follow up was significantly smaller in ZES compared to PES. However, the incidence of IVUS-defined restenosis (maximum cross-sectional narrowing >60%) was similar in the 2 groups (3.2% vs 6.7%). Neointima-free frame ratio was significantly lower in ZES. There were 5 cases of late incomplete stent apposition in PES and none in ZES.. These IVUS results demonstrate a similar incidence of severe narrowing between these 2 DES. There was a moderate increase in neointimal hyperplasia that was associated with a greater extent of neointimal coverage in ZES compared with PES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Hyperplasia; Male; Middle Aged; Multicenter Studies as Topic; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Endothelial Cells; Erythropoietin; Humans; Hyperplasia; Myocardial Infarction; Myocardium; Recombinant Proteins; Stroke Volume; Time Factors; Treatment Outcome; Ventricular Function, Left; Ventricular Remodeling

Topics: Angioplasty, Balloon, Coronary; Calcinosis; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Everolimus; Humans; Prosthesis Design; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cell Proliferation; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Drug-Eluting Stents; Humans; Male; Microvessels; Middle Aged; Prosthesis Design; Sirolimus; Time Factors; Tomography, Optical Coherence; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Predictive Value of Tests; Prosthesis Design; Risk Assessment; Risk Factors; Sex Factors; Sirolimus; Time Factors; Treatment Outcome

Drug-eluting stents become increasingly popular for the treatment of coronary artery disease. Consequently, side effects including hypersensitivity reactions have to be anticipated.. Here we report on a patient with an anaphylactic reaction 2 weeks after implantation of a polymer-based paclitaxel-eluting stent (Taxus, Boston Scientific). The patient presented with disseminated wheals, pruritus, bronchial asthma and acute synovitis. The reaction was successfully treated with initial intravenous injection followed by oral antihistamine treatment for 1 month until all stent-bound paclitaxel was assumed to be eluted. Thereafter no further anaphylactic reaction occurred.. This sequence of events points towards a causal relation of the stent implantation and hypersensitivity reaction with a central role of paclitaxel. The increasing use of this type of stent should therefore be carefully monitored for such adverse reactions.

Topics: Aged; Anaphylaxis; Anti-Allergic Agents; Cardiovascular Agents; Coronary Disease; Coronary Restenosis; Drug Hypersensitivity; Drug-Eluting Stents; Histamine H1 Antagonists; Humans; Male; Paclitaxel; Treatment Outcome

Several reports have suggested that stent fractures in sirolimus-eluting stents (SESs) might be related to in-stent restenosis (ISR). However, the role of stent strut fracture in ISR has not been clearly elucidated. Therefore, we investigated the association of the SES fracture and ISR.. From 2003 to 2006, SES implantations with follow-up coronary angiography (CAG) for 628 lesions in 557 patients were analyzed. We reviewed clinical and procedural factors that might affect SES fracture and ISR. The median time interval from stent implantation to follow-up CAG was 9 months (range: 2-30 months).. ISR occurred in 38 patients (5.7%), and 21 stent fractures (3.3%) were identified by follow-up CAG. Fourteen cases occurred in the left anterior descending artery, and seven occurred in the right coronary artery. The binary ISR rate in the stent fracture group was higher compared with that of the nonfracture group (38.1% vs. 4.6%, P<0.001). Predictors of ISR as estimated by multivariate analysis were a stent diameter less than 2.75 mm [odds ratio (OR)=2.76, P=0.012], a stent length over 28 mm (OR=3.30, P=0.024), and stent fracture (OR=11.03, P<0.001) after controlling for the angiographic and clinical risk factors of ISR.. Stent fracture was an independent predictor of ISR and may be one of the crucial mechanisms of ISR after implantation of an SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Equipment Failure Analysis; Female; Humans; Logistic Models; Male; Middle Aged; Odds Ratio; Prosthesis Failure; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome

Topics: Alloys; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Prosthesis Design; Sirolimus; Stents; Treatment Outcome; Ultrasonography, Interventional

Drug eluting stents have led to a substantial reduction of in-stent restenosis. Stent fracture (SF) is an important cause for the cases of restenosis which still occur. Sites of increased vessel movement, long stents, and overlapping stents have been observed to be more prone to fracture. We report the case of a patient with multiple drug eluting SFs at the site of coronary artery bypass insertion. The decision to implant stents at the site of bypass insertion should be made carefully. SF should be considered when gaps between previously implanted stents are observed.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Male; Middle Aged; Prosthesis Design; Prosthesis Failure; Risk Factors; Sirolimus; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Prosthesis Design; Prosthesis Failure; Risk Factors; Sirolimus; Thrombosis; Treatment Outcome

We sought to evaluate the safety and performance of the Janus Tacrolimus-Eluting stent (TES) in an unselected population of patients, without application of restrictive clinical or angiographic criteria.. Continued attention to the safety, efficacy, and deliverability of first-generation drug eluting stents has led to the development of new antiproliferative agents with alternative stent platforms and different drug carrier vehicles.. The TEST (Tacrolimus Eluting STent) registry is a prospective, nonrandomized single-center registry in which 140 consecutive patients who underwent single- or multi-vessel percutaneous coronary intervention between February 2005 and August 2005 were enrolled.. The composite rate of major adverse cardiac events (MACE) at 22 months clinical follow-up was 40.9%. The rate of mortality, myocardial infarction, and target lesion revascularization (TLR) were 5.5%, 11%, and 31.5%, respectively. Angiographic follow-up at 8 months was achieved in 74% of patients; binary restenosis occurred in 39.4% of lesions. Most restenosis lesions (94.6%) had a diffuse pattern, while focal restenosis was observed in 5.4% of cases. Definite or probable stent thrombosis was observed in 2.4% of patients.. The present prospective, nonrandomized, TEST registry indicated high MACE and restenosis rates, and thereby rather discouraging long-term outcomes with use of the Janus TES in an unselected "real world" population of patients who underwent single- or multi-vessel percutaneous coronary intervention.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Tacrolimus; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Prosthesis Design; Risk Assessment; Tacrolimus; Time Factors; Treatment Outcome

Restenosis still occurs, even with the sirolimus-eluting stent (SES), and the precise mechanisms have not yet been elucidated. In the present case, focal in-stent stenosis was discovered on angiography 16 months after SES implantation. Intravascular ultrasound revealed an echolucent homogeneous zone, which has been termed "black hole". A sample of stenotic tissue retrieved by aspiration revealed neointimal hyperplasia, composed of proteoglycans and smooth muscle cells with scanty cellularity. Furthermore, infiltration of many macrophages and T lymphocytes coexisted in the restenotic tissue. These findings suggest that delayed healing is 1 of the mechanisms of SES restenosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Biopsy, Needle; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Humans; Hyperplasia; Macrophages; Male; Sirolimus; T-Lymphocytes; Tunica Intima; Ultrasonography, Interventional

In percutaneous coronary intervention for chronic total occlusion (CTO), the retrograde approach is an advanced technique. To improve the long-term patency rate, stent implantation is necessary for CTO, however, antegrade stent delivery to the lesion is contraindicated in cases where there is an anomalous origin or deviation of the coronary artery, or the edge of a previously implanted stent extends into the aorta. We report a successful case of retrograde stent implantation via a septal perforator in a patient with marked deviation of the RCA origin. In this case, antegrade stent implantation was difficult because antegrade catheter insertion carried a risk of crush deformation of an ostial stent.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Occlusion; Coronary Restenosis; Coronary Stenosis; Coronary Vessel Anomalies; Drug-Eluting Stents; Equipment Design; Humans; Male; Metals; Middle Aged; Prosthesis Design; Prosthesis Failure; Radiography, Interventional; Sirolimus; Stents; Treatment Outcome

This study sought to assess predictive values of coronary flow velocity and an index of shear stress throughout the vessel for angiographic restenosis after sirolimus-eluting stent implantation.. The study patients underwent successful implantation of a sirolimus-eluting stent for de novo lesions located in native coronary vessels and underwent follow-up angiography 6-9 months later. The TIMI frame count method and quantitative digital angiographic analysis were performed based on the post-stenting angiogram. Coronary flow velocity and Reynolds number, an index of shear stress, were measured.. Post-stenting digital angiograms from 267 patients were analyzed. We divided the study patients into two groups: a Restenosis group with 21 patients and a Non-Restenosis group with 246 patients. The Restenosis group indicated significantly lower coronary flow velocity (137.7+/-35.6 mm/sec versus 241.1+/-72.9 mm/sec, p = 0.0001) and lower Reynolds number (107.0+/-35.8 versus 199.2+/-67.1, p = 0.0001) than did the Non-Restenosis group.. Lowered coronary flow velocity and shear stress after sirolimus-eluting stenting may predict the risk of restenosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Blood Flow Velocity; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Circulation; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Japan; Male; Middle Aged; Prosthesis Design; Regression Analysis; Risk Assessment; Risk Factors; Sirolimus; Stress, Mechanical; Time Factors; Treatment Outcome

Percutaneous coronary interventions for very small vessels are common in clinical practice despite an unavailability of the 2.25-mm sirolimus-eluting stent (SES) in some countries. We sought to evaluate the clinical and angiographic outcomes of 2.5-mm SES implantation at lower deployment pressures in very small coronary arteries.. Between June 2004 and March 2007, a total of 244 patients underwent percutaneous coronary interventions in vessels with reference diameters less than 2.5 mm at our centers: outcomes in 126 consecutive patients undergoing 2.5-mm SES implantation at lower deployment pressures (< or =10 atmospheres) with predilatation and postdilatation were compared with those in 118 patients who received bare-metal stents (BMS).. In the SES group, rates of predilatation and postdilatation were 73.8 and 81% respectively, and mean deployment pressure was 8.3+/-1.2 atmospheres. At follow-up, in-segment late loss was markedly lower in SES versus BMS (0.21+/-0.41 vs. 0.48+/-0.63 mm, P=0.001), resulting in significantly lower rates of restenosis (14.7 vs. 37.5%, P<0.001). At 1 year, SES versus BMS use was associated with similar rates of stent thrombosis (0.8 vs. 0.8%, P>0.999), but significantly lower rates of major adverse cardiac events (MACE) (11.9 vs. 27.1%, P=0.003), mainly driven by a significantly lower need for target-lesion revascularization (9.5 vs. 26.3%, P=0.001). Multivariable analysis identified the SES use as independently associated with a reduced 1-year MACE risk (hazard ratio: 0.32; 95% confidence interval: 0.15-0.66; P=0.002).. Implantation of 2.5-mm SES in vessels with reference diameters less than 2.5 mm using lower deployment pressures and predilatation and postdilatation may lead to reduced risks of restenosis and MACE without an increased risk of stent thrombosis up to 1 year.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Female; Humans; Japan; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Platelet Aggregation Inhibitors; Pressure; Proportional Hazards Models; Prosthesis Design; Risk Assessment; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome

We compared local vessel healing and inflammatory responses associated with nonoverlapping sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES).. Sirolimus and paclitaxel may have different effects on vascular healing. In the present study, we analyzed the local histologic effects of drug-eluting stents (DES).. We placed 43 stents (22 PES and 21 SES) in 16 Yucatan minipigs. Stents were randomly assigned and placed in the left anterior descending, circumflex, or right coronary arteries (one stent per artery), covering a region previously injured by balloon angioplasty.. Histopathologic analysis showed that the distribution of injury scores was similar between the two stent groups, reflecting the homogeneity of coronary injury secondary to balloon overstretch. Electron microscopy showed complete endothelialization in most cases. Incomplete endothelialization was present in 12.5% of PES and almost 20% of SES at 30 days. In the PES group, moderate to severe inflammation was found in eight arteries, whereas only one vessel had moderate inflammation in the SES group. Severe inflammation was observed significantly more often in the PES than in the sirolimus group (P = 0.006). With the PES group, stent struts overlying side branches had a significantly higher frequency of poor endothelialization scores than did stent struts that did not overlay side branches (P = 0.006).. In this preclinical study in a pig model of in-stent restenosis, implantation of nonoverlapping DES was associated with local inflammatory reactions and decreased endothelial repair. Impaired endothelialization was visualized in the struts overlying side branches.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Restenosis; Coronary Vessels; Disease Models, Animal; Drug-Eluting Stents; Inflammation; Paclitaxel; Platelet Endothelial Cell Adhesion Molecule-1; Platelet-Derived Growth Factor; Sirolimus; Swine; Swine, Miniature; Time Factors; Vascular Endothelial Growth Factor A; Wound Healing

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

Topics: Animals; Cardiovascular Agents; Carotid Stenosis; Cell Proliferation; Coronary Restenosis; Drug-Eluting Stents; Enzyme Activation; Enzyme Activators; Humans; Hyperplasia; Muscle, Smooth, Vascular; NAD(P)H Dehydrogenase (Quinone); Naphthoquinones; Secondary Prevention; Tunica Intima

There is limited information about optimal management of drug-eluting stent (DES) restenosis. This study evaluated the incidences of re-restenosis and re-target lesion revascularization (TLR) after the treatment of sirolimus-eluting stent (SES) restenosis.. A total of 102 lesions in 101 patients who underwent TLR for SES restenosis were classified according to: (1) focal (lesion length < or = 10 mm) or non-focal restenosis (>10 mm); and (2) use of DES for TLR: (1) focal restenosis treated with DES (focal-DES, n=40); (2) focal restenosis treated by balloon angioplasty (focal-balloon, n=31); (3) non-focal restenosis with DES (non-focal-DES, n=17); and (4) non-focal restenosis by balloon angioplasty (non-focal-balloon, n=14). Re-restenosis and re-TLR were observed in 6 (19.4%) and 5 lesions (12.5%) of the focal-DES group, in 13 (65.0%) and 11 (35.5%) of the focal-balloon group, in 7 (50.0%) and 6 (35.3%) of the non-focal-DES group, and in 8 (61.5%) and 7 (50.0%) of the non-focal-balloon group, respectively (P<0.05 for restenosis and TLR between the focal-DES group and other groups).. Re-DES implantation for focal DES restenosis results in lower re-restenosis and re-TLR rates compared to re-DES implantation for non-focal DES restenosis or conventional balloon angioplasty either for focal or non-focal DES restenosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Hospitals; Humans; Incidence; Japan; Logistic Models; Male; Middle Aged; Prosthesis Design; Retrospective Studies; Risk Assessment; Sirolimus; Treatment Outcome

We aimed to evaluate long-term outcomes of a modified mini-crush technique for treating bifurcation lesions.. Coronary bifurcation lesions continue to show a relatively high restenosis rate despite the use of a drug-eluting stent (DES).. We enrolled 52 consecutive patients treated with sirolimus-eluting stent implantation using the modified mini-crush technique for 56 coronary bifurcation lesions (MEDINA 1, 1, 1, 89.2%; left main lesion, 28.6%). To minimize crushing, the proximal marker of the side branch (SB) stent was located in contact with the main vessel (MV) stent. After SB stenting, we drew the SB balloon proximally and dilate the SB ostium at a rated burst pressure. After MV stenting, both vessels were redilated at a high pressure before final kissing balloon (FKB) inflation. Clinical and angiographic follow-ups were performed at 9 months.. Immediate procedural success was obtained in all cases including a FKB success rate of 98%. At 9 months, there was no death or myocardial infarction. The incidences of major adverse cardiac events and target lesion revascularization were 11.8 and 7.8%, respectively. The in-stent restenosis (ISR) rate was 14.9% (SB ostium, 10.6%) and most ISRs were of the focal type and the cause of ISR was intimal hyperplasia but not chronic stent recoil by an intravascular ultrasound study. There was one case (2.0%) of late stent thrombosis without any ischemic symptoms during the follow-up period of 9 months.. Modified mini-crush technique provides excellent technical and angiographic success immediately and it also provides acceptable long-term outcomes.

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

With the aim of reducing restenosis after percutaneous coronary intervention with bare-metal stents (BMSs) for the treatment of ischemic heart disease, drug-eluting stents (DESs) were introduced in the field of percutaneous coronary intervention in 2002. However, the higher cost of DES in comparison with BMS made it necessary to determine whether their use brings a real economic advantage.. In order to verify the clinical and economic benefit of DES in comparison with BMS and surgical treatment with coronary artery bypass graft (CABG), the Sicily Regional Government arranged for the creation of a directory where patients receiving at least one DES (with sirolimus or with paclitaxel) were enrolled from June 2004 to February 2005. The cost-effectiveness analysis for DES was carried out by means of two decisional models: one referring to patients treated with DES who, without such a device, would have undergone CABG, and the second one referring to patients treated with DES who, without such device, would have received BMS. Cost analysis was carried out from the point of view of the SSR (Servizio Sanitario Regionale, Regional Health Service).. The use of DES on patients destined to CABG generated average unitary differential savings of euro9003, after 9 months of follow-up, and average total differential savings of euro4 438 479. The use of DES on patients destined to BMS gave average unitary differential savings of euro1075, after 9 months of follow-up, and average total differential savings of euro1 052 425. The use of DES instead of BMS and CABG allowed SSR to make average differential savings of euro3760 per successful case. The refund threshold value of DES, setting to zero the SSR average differential savings for patients treated with DES who would otherwise have been treated with BMS, was euro2489.. The medium-term results of the proposed models, tested with sensitivity analysis, demonstrate the use of DES to be justified; moreover, these results could positively influence the attitude of the SSR toward these new therapeutic strategies, which are an improvement on standard therapies, both from a clinical and a financial standpoint.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Coronary Artery Disease; Coronary Restenosis; Cost Savings; Cost-Benefit Analysis; Drug Costs; Drug-Eluting Stents; Female; Hospital Costs; Humans; Male; Metals; Middle Aged; Models, Economic; Paclitaxel; Prosthesis Design; Registries; Sicily; Sirolimus; Stents; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Angioscopy; Autopsy; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Metals; Prosthesis Design; Registries; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Tunica Intima

The objective of this study was to formulate a nanoparticle (NP)-eluting drug delivery stent system by a cationic electrodeposition coating technology.. Nanoparticle-mediated drug delivery systems (DDS) are poised to transform the development of innovative therapeutic devices. Therefore, we hypothesized that a bioabsorbable polymeric NP-eluting stent provides an efficient DDS that shows better and more prolonged delivery compared with dip-coating stent.. We prepared cationic NP encapsulated with a fluorescence marker (FITC) by emulsion solvent diffusion method, succeeded to formulate an NP-eluting stent with a novel cation electrodeposition coating technology, and compared the in vitro and in vivo characteristics of the FITC-loaded NP-eluting stent with dip-coated FITC-eluting stent and bare metal stent.. The NP was taken up stably and efficiently by cultured vascular smooth muscle cells in vitro. In a porcine coronary artery model in vivo, substantial FITC fluorescence was observed in neointimal and medial layers of the stented segments that had received the FITC-NP-eluting stent until 4 weeks. In contrast, no substantial FITC fluorescence was observed in the segments from the polymer-based FITC-eluting stent or from bare metal stent. The magnitudes of stent-induced injury, inflammation, endothelial recovery, and neointima formation were comparable between bare metal stent and NP-eluting stent groups.. Therefore, this NP-eluting stent is an efficient NP-mediated DDS that holds as an innovative platform for the delivery of less invasive nano-devices targeting cardiovascular disease.

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Cations; Cells, Cultured; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Feasibility Studies; Fluorescein-5-isothiocyanate; Fluorescent Dyes; Humans; Kinetics; Lactic Acid; Male; Materials Testing; Models, Animal; Muscle, Smooth, Vascular; Nanoparticles; Polyglycolic Acid; Polylactic Acid-Polyglycolic Acid Copolymer; Prosthesis Design; Stainless Steel; Sus scrofa

The aim of this study was to compare efficacy of low- and high-dose sirolimus release (25, 40, or 100 microg) from hydroxyapatite (HAp) with Cypher (Cordis, Johnson & Johnson, Warren, New Jersey) (111 microg sirolimus) in porcine coronary arteries.. Polymer-based sirolimus-eluting stents such as Cypher interfere with vascular healing, probably due to the permanent presence of the polymer coating and the high sirolimus dose. The use of low-dose sirolimus and inert nonpolymeric but biodegradable coatings such as HAp might be more appropriate.. Stents (n = 68) were implanted, guided by quantitative coronary angiography. All swine received clopidogrel and acetylsalicylic acid during 28 days follow-up. Safety of the coating in absence of drugs was studied by comparing HAp with and without a lipid-based release regulating layer (HApR) with bare-metal stents. Efficacy was studied by comparing the release of 25, 40, and 100 microg sirolimus with Cypher.. The safety study (without drug) revealed no differences in neointimal thickening in response to HAp and HApR with complete healing in all groups. Dose response analysis showed that neointimal thickening was similar in all groups regardless of sirolimus dose, with a normal appearance of the endothelium. There was, however, a dose-dependent increase in fibrinoid (p = 0.028), considered to be a marker of delayed healing. The Cypher stent induced the highest amount of fibrinoid.. Reducing the dose of sirolimus eluting from a biocompatible HAp coated stent reduces signs of delayed vascular healing, without affecting neointimal hyperplasia.

Topics: Angioplasty, Balloon, Coronary; Animals; Aspirin; Cardiovascular Agents; Clopidogrel; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Durapatite; Hyperplasia; Lipids; Materials Testing; Models, Animal; Platelet Aggregation Inhibitors; Prosthesis Design; Sirolimus; Stainless Steel; Surface Properties; Sus scrofa; Ticlopidine; Wound Healing

We sought to assess changes in antirestenotic efficacy of drug-eluting stents (DES) by restudying subjects at 2 time points after coronary stenting (6 to 8 months and 2 years) and to compare differences in time courses of late luminal loss (LLL) between 3 different DES platforms in use at our institution.. DES therapy is associated with low levels of LLL at 6 to 8 months. The temporal course of neointimal formation after this time point remains unclear.. This prospective, observational, systematic angiographic follow-up study was conducted at 2 centers in Munich, Germany. Patients underwent stenting with permanent-polymer rapamycin-eluting stents (RES), polymer-free RES, or permanent-polymer paclitaxel-eluting stents (PES). The primary end point was delayed LLL (the difference in in-stent LLL between 6 to 8 months and 2 years).. Of 2,588 patients undergoing stenting, 2,030 patients (78.4%) had 6- to 8-month angiographic follow-up and were enrolled in the study. Target lesion revascularization was performed in 259 patients; these patients were not considered for further angiographic analysis. Of 1,771 remaining patients, 1,331 had available 2-year reangiographic data (75.2%). Overall mean (SD) delayed LLL was 0.12 +/- 0.49 mm (0.17 +/- 0.50 mm, 0.01 +/- 0.42 mm, and 0.13 +/- 0.50 mm in permanent-polymer RES, polymer-free RES, and permanent-polymer PES groups, respectively [p < 0.001]). In multivariate analysis, only stent type (in favor of polymer-free RES) predicted delayed LLL.. Ongoing erosion of luminal caliber beyond 6 to 8 months after the index procedure is observed following DES implantation. Absence of permanent polymer from the DES platform seems to militate against this effect.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Germany; Humans; Hyperplasia; Logistic Models; Male; Middle Aged; Paclitaxel; Polymers; Prospective Studies; Prosthesis Design; Risk Assessment; Sirolimus; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Humans; Hyperplasia; Paclitaxel; Polymers; Prosthesis Design; Risk Assessment; Sirolimus; Time Factors; Treatment Outcome; Tunica Intima

Topics: Angioplasty, Balloon, Coronary; Aspirin; Cardiovascular Agents; Clopidogrel; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Drug Administration Schedule; Drug Therapy, Combination; Drug-Eluting Stents; Humans; Platelet Aggregation Inhibitors; Polymers; Prosthesis Design; Risk Assessment; Sirolimus; Thrombosis; Ticlopidine; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Prosthesis Design; Risk Assessment; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

The data of long-term outcomes of sirolimus-eluting stent (SES) according to lesion location of unprotected left main coronary artery (LMCA) is scarce.. The purpose of this study was to evaluate the long-term outcomes after implantation of the SES in LMCA.. A total of 84 patients (51 males) who had undergone SES implantation for the treatment of native LMCA stenosis were enrolled. The patients were divided into 2 groups based on angiographic lesion location: those with significant stenosis in the ostium and/or body (group 1; n = 39) and those involving bifurcation (group 2; n = 45).. All of the group 1 patients were treated with simple lesion coverage while different stenting techniques were used in group 2 (cross-over: 44.8%, T: 6.7%, kissing: 37.8%, and crush techniques: 11.1%). The 8-month quantitative angiographic findings and in-hospital and 2 year rates of major adverse cardiac events (MACE) were compared between the 2 groups. Although angiographic success and in-hospital MACE rates were similar in both groups with 1 cardiac death due to acute stent thrombosis in group 2, at 2-year follow-up, the MACE rate was significantly higher in group 2 than in group 1 at 2 years (22.2% vs 2.6%, respectively, P = 0.008). Coronary angiography revealed a significantly higher binary restenosis rate in group 2 compared with group 1 (20% vs 0%, respectively, P = 0.003).. Interventional treatment using SES in left main lesions showed favorable short-term and long-term outcomes in selected patients with lesion location being an important determinant of clinical and angiographic outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Topics: Anticholesteremic Agents; Anticoagulants; Antihypertensive Agents; Cardiovascular Agents; Coronary Restenosis; Drug Design; Drug Industry; Drug-Eluting Stents; Humans; Platelet Aggregation Inhibitors; Thrombosis; United States; United States Food and Drug Administration

Topics: Alloys; Cardiovascular Agents; Clinical Trials as Topic; Coronary Restenosis; Drug-Eluting Stents; Humans; Hypersensitivity; Incidence; Paclitaxel; Platelet Aggregation Inhibitors; Risk Factors; Sirolimus; Thrombosis; Time Factors

Drug-eluting stents (DES) have become routine therapy in clinical practice because restenosis is significantly reduced in patients treated with these devices. New generations of DES bearing newer antiproliferative drugs have been developed. Sirolimus was the first antiproliferative drug eluted by a DES (SES) while zotarolimus represents a sirolimus-derived, newer antiproliferative drug borne by a different kind of DES (ZES). This report describes two cases of different vascular response to concurrent side by side implantation of SES and ZES in the same vessel and highlights significant early restenosis of ZES as compared with SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Therapy, Combination; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Platelet Aggregation Inhibitors; Prosthesis Design; Sirolimus; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Myocardial Infarction; Paclitaxel; Prosthesis Design; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; 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

Sirolimus-eluting stent (SES) has revolutionized interventional cardiology. Its application is spreading to complex, high-risk subsets of patients and lesions. Therefore, it is important to determine the factors associated with post-SES restenosis.. The study investigated 341 patients with angina pectoris, in whom SES was implanted. The coronary artery calcification (CAC) degree was assessed using the angiographic scoring system as follows: 0, none; 1, blocky or spotty calcification; 2, linear calcification compromising 1 side of the arterial lumen; 3, linear calcification found unidirectionally compromising both sides of the arterial lumen; 4, linear calcification found bidirectionally compromising both sides of the arterial lumen; and 5, blanket/circumferential and dense calcification. Restenosis was observed in 23 patients (7.3%). The target lesion (1.8 +/-1.7 vs 0.7 +/-1.1 [mean +/- SD]) and stent delivery route CAC scores (3.1 +/-2.5 vs 1.4 +/-2.0) were significantly higher in patients with restenosis than in those without it (P<0.0001). In multivariate analysis, the CAC score of the stent delivery route was independently associated with restenosis (odds ratio of 6.804, P<0.05), although CAC score of the target lesion was not.. CAC in the stent delivery route is an important determinant of post-SES restenosis.

Topics: Aged; Aged, 80 and over; Angina Pectoris; Angioplasty, Balloon, Coronary; Calcinosis; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Microscopy, Electron; Middle Aged; Odds Ratio; Prosthesis Failure; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Treatment Outcome

The aim of this study was to investigate the angiographic and intravascular ultrasound (IVUS) findings of the Endeavor zotarolimus-eluting stent (ZES) in patients from a "real-world" clinical practice.. From January to March 2006, 100 patients undergoing routine or emergency percutaneous intervention were prospectively enrolled at one institution. Overall, 39% of the patients were diabetics and 80.8% of lesions were type B2/C. A total of 140 lesions were successfully treated with 174 ZES, and procedural success was 98%. Mean vessel diameter was 2.69 mm and mean lesion length was 16.0 mm; at 6-month angiographic follow-up (completed in 96%), in-stent late lumen loss was 0.66 mm, and in-segment restenosis was 8.2%. Angiographic restenosis was increased among diabetics (15.5 vs. 2.6%, p=0.009), and diabetes was the only significant predictor of angiographic restenosis (OR=15.27 [95%CI 2.45-95.04], p=0.003). By IVUS (performed in 88% at 6-month), % volume obstruction was 14.4+/-13.4%, and there was no late acquired incomplete stent apposition (ISA). At 1-year, overall MACE rate was 6%, including 5 TLRs (4% of patients), with no occurrence of stent thrombosis.. In this prospective "real-world" experience, the ZES demonstrated favourable angiographic and IVUS results in complex patients, with overall in-stent late lumen loss of 0.66 mm, and absence of late acquired ISA. At 1-year, there were no safety concerns including absence of death and stent thrombosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Prospective Studies; Prosthesis Design; Registries; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

It is unclear if patients with intermediate coronary artery lesions (40-70% of diameter reduction) benefit from percutaneous coronary intervention (PCI) as compared with pharmacological treatment.. To investigate whether PCI of intermediate coronary artery lesions may improve the outcome in this group of patients.. We performed a retrospective analysis of data of 232 symptomatic patients with intermediate coronary lesions. Hundred sixty five patients received only pharmacological treatment (group A) while 67 were treated with PCI with or without stent implantation (group B). Primary study endpoints were defined as follows: death (cardiac and non-cardiac), myocardial infarction, unstable angina, recurrent angina and coronary reintervention. Demographic and clinical variables were evaluated to identify predictors of the composite endpoint (exacerbation of angina, hospitalisation because of severe angina, restenosis in the intermediate coronary lesion, acute coronary syndrome and cardiac death).. In group A, patients were treated with typical pharmacotherapy including beta-blockers, Ca-blockers, ACE-inhibitors, and antiplatelet drugs. In group B, 68 PCI procedures were performed in 67 patients and optimal pharmacotherapy was administered. The average age of patients in both groups was 58.0 +/- 9.1 years and the majority were males (76%). Preinterventional coronary angiography showed that the intermediate lesions were most frequently localised in the left anterior descending (LAD) coronary artery; the next most frequent localisation was the right coronary artery (RCA). During the 12-month follow-up in 9 (13%) patients from the group B repeated PCI due to restenosis was performed, while in group A intervention was necessary in 7 (4%) of patients due to aggravation of symptoms (p = 0.01). The cumulative probability of restenosis after PCI in intermediate coronary lesions was 14%. Recurrent angina was more frequent in group B as compared to group A (34 vs. 19%; p = 0.005). None of the patients in any group died during 12 months of follow-up. In patients with intermediate coronary lesions, the independent predictors of the composite study endpoint were: history of previous percutaneous coronary angioplasty, type 2 diabetes, persistent ST-segment elevation in 12-lead ECG, heart rhythm disturbances, presence of the intermediate lesion in the LAD, and left ventricular dysfunction.. Patients with intermediate coronary artery stenoses could safely undergo pharmacological treatment and PCI may be postponed until aggravation of symptoms occurs. In the presence of predictors of the composite study endpoint, the use of intracoronary diagnostic methods may be considered to obtain more reliable and precise measurements of coronary stenosis severity.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Combined Modality Therapy; Coronary Artery Disease; Coronary Restenosis; Female; Hematologic Agents; Humans; Male; Middle Aged; Poland; Retrospective Studies; Stents; Treatment Outcome

There is limited information regarding the angiographic and clinical outcomes among the different drug-eluting stents (DESs) in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI).. A total 355 consecutive AMI patients who underwent PCI with a sirolimus- (SES, n=116) or paclitaxel- (PES, n=153) or zotarolimus-eluting stent (ZES, n=86) were enrolled. The 6-month angiographic and 1-year clinical outcomes were compared among the 3 groups. At 6 months, there was a trend toward a higher incidence of binary restenosis in the PES group (SES: 8.6%, PES: 19.8%, ZES: 8.3%, P=0.052). Percentage of restenosis was higher in the PES group compared with SES, but was similar to ZES (SES: 18.75 +/-18.16%, PES: 29.32 +/-24.16%, ZES: 23.91 +/-17.03%, P=0.006). Late loss was lower in the SES group compared with PES and ZES (SES: 0.44 +/-0.52, PES: 0.83 +/-0.87, ZES: 0.75 +/-0.63, P<0.001). However, clinical outcomes, including mortality, MI, repeat PCI and major adverse cardiac events, were not different among the 3 groups.. The angiographic benefit of SES did not translate into a clinical benefit for up to 1 year in AMI patients.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Odds Ratio; Paclitaxel; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Sirolimus; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Hyperplasia; Myocardial Infarction; Prosthesis Design; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Hyperplasia; Polymers; Prosthesis Design; Risk Assessment; Severity of Illness Index; Tacrolimus; Time Factors; Treatment Outcome; Xylenes

After novel findings from genomewide association studies that sequence variation on chromosome 9p21.3 is a genetic factor for coronary heart disease, we investigated whether this locus influenced the clinical and angiographic outcomes after implantation of drug-eluting stents in coronary arteries.. Recently, genomewide association studies have identified a locus on chromosome 9 (approximately 100 kb in band p21.3) as the strongest genetic factor for coronary heart disease.. We studied the rs7865618, rs1537378, rs1333040, and rs1333049 polymorphisms located on chromosome 9p21.3 in a cohort of 2,028 patients who were treated with percutaneous coronary intervention and implantation of sirolimus- or paclitaxel-eluting stents. Records of 3-year adverse clinical outcomes were obtained from all stented patients. Follow-up angiography at 6 to 8 months after stenting was performed in 1,683 patients (83%).. The polymorphisms were not significantly related with clinical outcomes at 3 years, including death (p >or= 0.18), myocardial infarction (p >or= 0.19), repeat revascularization (p >or= 0.08), and the composite end point of adverse events (death, myocardial infarction, repeat revascularization) (p >or= 0.34). No association of the polymorphisms was found with angiographic measures at follow-up, including minimal lumen diameter (p >or= 0.51), diameter stenosis (p >or= 0.31), late lumen loss (p >or= 0.05), and binary restenosis (p >or= 0.31).. Specific polymorphisms in the chromosome 9p21.3 region that were shown to be associated with coronary heart disease in genomewide analyses were not related to the clinical and angiographic outcomes after the placement of drug-eluting stents in coronary arteries.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chromosomes, Human, Pair 9; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Gene Frequency; Genetic Predisposition to Disease; Humans; Logistic Models; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Phenotype; Polymorphism, Single Nucleotide; Proportional Hazards Models; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

Although previously reported studies on coronary calcification mainly focused on its presence or absence in discrete focal target lesions, calcified coronary lesions (CCL) angiographically present as diffuse long lesions in some patients. The aim of our study was to evaluate the long-term efficacy of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) on long CCL.. A total of 122 patients with 134 lesions (77 patients with 88 lesions for SES and 45 patients with 46 lesions for PES) were enrolled from 3 centers. Long CCL was defined visually as a culprit lesion with type B or C that was mainly due to coronary calcification with > 20 mm in total length by coronary angiography. Clinical follow-up was performed at 1 year and angiographic follow-up at 6 to 9 months after procedure. Major adverse coronary events (MACE) were defined as all-cause death, myocardial infarction (MI), and repeat target-lesion revascularization (TLR).. There were no statistically significant differences in baseline, procedural, or angiographic characteristics and in 1-year rates of all-cause death, MI, and TLR between the 2 groups (all P = NS [not significant]). Likewise, the cumulative incidence of MACE at 1 year was similar between the 2 groups (7.8% of patients in the SES group vs 4.4% of patients in the PES group, respectively, P = NS). In patients who underwent follow-up angiography, the angiographic binary restenosis rate was 6.2% in the SES group vs 12.1% in the PES group, respectively (P = NS).. In patients with long CCL, both SES and PES were comparably effective in either angiographic or clinical long-term outcomes.

Topics: Aged; Angioplasty, Balloon, Coronary; Calcinosis; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Disease-Free Survival; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Republic of Korea; Retrospective Studies; Severity of Illness Index; Sirolimus; Time Factors; Treatment Outcome

In part 1 of the present study, the authors demonstrated that coronary paclitaxel uptake from drug eluting stents (DESs) was not dependent on exposure time and dose. In this second part, the effect of the different paclitaxel dose densities on long-term biologic behavior was evaluated.. In 40 minipigs, (with 4- and 12-week follow-up), identical stents with the same three paclitaxel dose densities as in part 1 were implanted in the right coronary artery. Minipigs implanted with Polyzene-F nanocoated stents served as the control group. Quantitative angiography measuring average luminal diameter (from three in-stent reference points), minimal luminal diameter (from the point of maximum in-stent stenosis), average late loss, maximum late loss, and binary stenosis rate was performed, as was microscopy to determine neointimal thickening, injury score, and inflammation.. All three DESs were associated with a high average late loss, binary stenosis rate, and neointimal thickening, without significant differences. Drug-free stents had significantly less late in-stent stenosis: there was an average late loss of 0.3 mm +/- 0.3 in drug-free stents versus 0.8 mm +/- 0.2 in intermediate-dose stents and 1.5 mm +/- 0.6 in high-dose stents (P = .04). DES-associated inflammation was high in all DESs and six times higher as in the drug-free stents (Kornowski scores of 0.2 +/- 0.1 in drug-free stents, 1.3 +/- 0.9 in low-dose stents, 1.7 +/- 0.8 in intermediate-dose stents, and 1.3 +/- 1.0 in high-dose stents; P = .04). It worsened with time in all DESs, as did late in-stent stenosis.. The extensive and long-term retention of paclitaxel even in a low-dose formulation, at least according to the present labeling of DESs, might be associated with negative long-term results with regard to inflammation and late in-stent stenosis.

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Dose-Response Relationship, Drug; Drug-Eluting Stents; Female; Inflammation; Models, Animal; Paclitaxel; Prosthesis Design; Prosthesis Failure; Swine; Swine, Miniature; Time Factors

Percutaneous coronary intervention (PCI) using drug-eluting stents significantly reduces the risk of restenosis in the general population. However, in patients on hemodialysis, adverse cardiac events are frequently seen even if treated with drug-eluting stents. Recent studies suggest that C-reactive protein (CRP) reflects vascular wall inflammation and can predict adverse cardiac events. We evaluated possible prognostic values of CRP on outcomes in patients on hemodialysis undergoing PCI with drug-eluting stents.. A total of 167 patients undergoing PCI with sirolimus-eluting stents for stable angina (322 lesions) were enrolled. They were divided into tertiles according to serum CRP levels. We analyzed the incidence of major adverse cardiovascular events including cardiovascular death, nonfatal myocardial infarction, and target lesion revascularization after PCI as well as quantitative coronary angiographic data. The mean follow-up was 31 months (SD, 14). Major adverse cardiac events occurred in 11 patients (19.6%) of the lowest tertile, in 22 patients (39.3%) of the middle tertile, and in 28 patients (50.9%) of the highest tertile during follow-up period (P=0.0009). There was a progressive increase in neointimal growth after sirolimus-eluting stent implantation during follow-up because preprocedural CRP levels were higher, despite similar angiographic data just after PCI. Angiographic restenosis at 6 to 8 months after PCI was seen in 10.6% in the lowest tertile, 17.9% in the middle tertile, and 32.0% in the highest tertile (P=0.0007).. Increased preprocedural serum CRP levels would predict higher major adverse cardiac events and restenosis rates after sirolimus-eluting stents implantation in patients on hemodialysis.

Topics: Aged; Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Inflammation Mediators; Kaplan-Meier Estimate; Kidney Diseases; Male; Middle Aged; Myocardial Infarction; Proportional Hazards Models; Protein C; Renal Dialysis; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Up-Regulation

Drug-eluting stents were developed and approved for the reduction of in-stent restenosis. However, restenosis still occurs, and stent fracture is suggested as a cause of restenosis after implantation. Although sirolimus-eluting stents are considered to carry a high risk of fracture, the risk is also present with other drug-eluting stents. Herein, we report the case of a 78-year-old woman who received a zotarolimus-eluting stent for a bifurcation lesion of the left anterior descending coronary artery. Ten months later, she underwent coronary angiography due to angina. The angiogram revealed in-stent restenosis, with a grade IV stent fracture. After percutaneous coronary angioplasty, the patient's clinical symptoms improved.

Topics: Aged; Angina Pectoris; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Prosthesis Failure; Sirolimus; Treatment Outcome

We investigated the predictive value of the intravascular ultrasound (IVUS) measured post-intervention minimum stent area (MSA) on 9-month follow-up paclitaxel-eluting stent (PES) patency compared with bare-metal stents (BMS).. Stent underexpansion is a strong predictor for restenosis after sirolimus-eluting stent implantation, but the implication of underexpansion in PES is still unknown.. From the combined TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent trials, 1,580 patients (PES 1,098, BMS 482) in IVUS substudies were analyzed. The MSA that best predicted angiographic in-stent restenosis (ISR) (% diameter stenosis > or =50%) was determined.. The post-intervention IVUS MSA was similar in PES and BMS (6.6 +/- 2.5 mm(2) vs. 6.7 +/- 2.3 mm(2), p = 0.92). At 9-month follow-up, ISR was lower in the PES group versus the BMS group (10% vs. 31%, p < 0.0001). Using multivariable logistic regression analysis, post-intervention IVUS MSA was the independent predictor of subsequent ISR in both the PES and BMS groups (p = 0.0002 for PES and p = 0.0002 for BMS). The ability of the post-intervention IVUS MSA to predict ISR was further assessed using receiver operating characteristic analysis. The post-intervention IVUS MSA was found to be a faithful discriminator between patients with and without ISR in both PES (c = 0.6382) and BMS (c = 0.6373). Finally, the optimal thresholds of post-intervention IVUS MSA that best predicted stent patency at 9 months were 5.7 mm(2) for PES and 6.4 mm(2) for BMS.. Post-intervention MSA measured by IVUS can predict 9-month follow-up stent patency after both PES and BMS implantation. (Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions; NCT00301522) (Direct Stenting of TAXUS Liberté-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions; NCT00371423) (A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475) (A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748).

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Clinical Trials as Topic; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Double-Blind Method; Drug-Eluting Stents; Female; Humans; Logistic Models; Male; Metals; Middle Aged; Odds Ratio; Paclitaxel; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Risk Assessment; Risk Factors; ROC Curve; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

To report long-term outcome data on the V technique using drug-eluting stents.. From April 2002 to December 2006, 31 consecutive patients were successfully treated with V stenting of a de novo bifurcation lesion. The technique involves the deployment of two stents in the two branches of a bifurcation, the proximal edges of the stents just touching one another. Patients exclusively received either sirolimus- (10), paclitaxel- (20) or biolimus-eluting (one) stents. On average, 1.5 +/- 0.8 stents with a total length of 26.6 +/- 17.2 mm and 1.1 +/- 0.4 stents with a total length of 18.3 +/- 7.6 mm were deployed in the distal main vessel and side branch respectively. Mean duration of follow-up was 853 +/- 553 days. Within 30 days, three patients died; two other patients had definite stent thrombosis involving the V stents, both requiring re-PCI. Beyond 30 days and within one year, there was one death and three cases of target vessel revascularisation, including one target lesion revascularisation. There were a further three deaths (one cardiac) beyond one year. Eleven patients (35.5%) had angiographic follow-up, exhibiting a binary restenosis rate of 9.1% at 203 +/- 33 days.. In this real-world cohort, late clinical events stand in accord with studies on competitive techniques, but early outcome was less encouraging, probably due to the baseline risks.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Netherlands; Paclitaxel; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

The concept of fully biodegradable stents has emerged as an attractive alternative to current permanent metallic stents, mainly as a potential solution to avoid late stent thrombotic events. We sought to evaluate a novel, fully bioabsorbable sirolimus-eluting stent (SES) synthesised entirely from a unique salicylic-acid polymer, in a clinically relevant animal model.. Fully biodegradable balloon-expandable stents (n=45) were implanted in a porcine coronary arteries using quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) to optimise stent apposition. Dose density of sirolimus was 8.3 µg/mm of stent length with in vitro studies demonstrating elution over 30 days and complete stent degradation over 12 months. Animals were terminated at 7, 14, 30, 90, and 180 days for complete histological analysis. Optical coherence tomography (OCT) was also performed for the 90- and 180-days samples. All stents were deployed successfully without notable mechanical difficulties. Angiographic diameter stenosis (DS) was 20±16%, 24±4%, and 23±17%, at one, three, and six months, respectively. In parallel, IVUS showed good stent apposition with DS of 21±9%, 25±7%, and 18±3%; and area stenosis (AS) of 35±13%, 33±7%, and 32±4% at one, three, and six months,respectively. OCT further demonstrated good stent apposition with DS of 28±7% and 20±6%, and AS of 37±10% and 33±13% at three and six months, respectively. OCT showed reduction of stent thickness by 23% from three to six months. Histologic analysis confirmed these in vivo findings and revealed a favourable healing process of absorbable stent incorporation into the arterial wall, without excessive thrombotic or inflammatory reactions.. This study shows favourable vascular compatibility and efficacy for a novel fully bioabsorbable salicylate-based SES. This device has good mechanical performance during deployment and stays well-apposed to the vessel wall at long-term follow-up. These initial results are highly encouraging and support progress into more extensive preclinical studies as well as early clinical testing.

Topics: Absorbable Implants; Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Vessels; Drug-Eluting Stents; Materials Testing; Models, Animal; Prosthesis Design; Salicylic Acid; Sirolimus; Sus scrofa; Time Factors; Tomography, Optical Coherence; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Animals; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Humans; Prosthesis Design; Sirolimus; Treatment Outcome

Arterial drug concentrations determine local toxicity. As such the emergent safety concerns surrounding drug-eluting stents mandate an investigation of the factors contributing to fluctuations in arterial drug uptake. Drug-eluting stents were implanted into porcine coronary arteries, arterial drug uptake was followed and modeled using 2-dimensional computational drug transport. Arterial drug uptake in vivo occurred faster than predicted by free drug diffusion, thus an alternate, mechanism for rapid transport has been proposed involving carrier-mediated transport. Though there was minimal variation in vivo in release kinetics from stent to stent, arterial drug deposition varied by up to 114% two weeks after stent implantation. The extent of adherent mural thrombus also fluctuated by 113% within 3 days after implantation. The computational drug transport model predicted that focal and diffuse thrombi elevate arterial drug deposition in proportion to the thrombus size by reducing drug washout subsequently increasing local drug availability. Fluctuations in arterial drug uptake are commonly reported. We now explain that variable peristrut thrombus can explain such observations even in the face of a narrow range of drug release from the stent. The mural thrombus effects on arterial drug deposition may be circumvented by forcing slow, rate limiting arterial transport that cannot be further hindered by mural thrombus.

Topics: Animals; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coronary Restenosis; Coronary Vessels; Drug Delivery Systems; Drug-Eluting Stents; Sirolimus; Swine; Swine, Miniature; Thrombosis; Time Factors

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Restenosis; Drug-Eluting Stents; Humans; Metals; Prosthesis Design; Radiography; Risk Assessment; Sirolimus; Stents; Time Factors; Treatment Outcome

Treatment of ostial coronary lesions represents a challenge for interventional cardiologists. The efficacy of drug-eluting stents (DES) has been demonstrated as improving the outcomes of patients in a few studies. It is not known, however, which DES, sirolimus-eluting stent (SES) versus paclitaxel-eluting stent (PES), is superior for the treatment of ostial lesions.. In this retrospective study, 95 consecutive patients with de-novo ostial lesions underwent coronary SES (n=47, lesions=48) or PES implantation (n=45, lesions=47), and quantitative coronary analysis was performed at the time of stent implantation and subsequently at 8 months post stenting. Ostial lesion was defined as > or =50% diameter stenosis rising within 3 mm of either left anterior descending coronary artery or left circumflex artery or right coronary artery measured by quantitative coronary analysis. Major adverse cardiac events including death, thrombosis, nonfatal myocardial infarction, and target lesion revascularization were compared between the two groups.. Baseline clinical and angiographic characteristics were well balanced between the two groups. At 8 months clinical and angiographic follow-up, overall major adverse cardiac events and target lesion revascularization rates were similar in both groups (6.4 vs. 11.2%, P=0.184; 4.3 vs. 8.9%, P=0.170, respectively). The in-stent and in-segment restenosis were, however, significantly higher in PES group compared with SES group (15.5 vs. 0%, P=0.001; 22.2 vs. 4.3%, P=0.003). Similarly, the late loss in both in-stent and in-segment was significantly higher in the PES group than in SES group (0.65+ or -0.67 vs. 0.16+ or -0.18 mm; 0.68+ or -0.65 vs. 0.15+ or -0.12 mm; P<0.001, respectively).. In this small sample-size, nonrandomized, and nonprospective study, the data indicated that implantation of DES appears safe and effective for the treatment of patients with de-novo ostial coronary lesions, but SES implantation showed more favorable results in respect of restenosis compared with PES implantation.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Odds Ratio; Paclitaxel; Retrospective Studies; Risk Assessment; Sirolimus; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Patient Selection; Sirolimus; Time Factors; Treatment Outcome

Drug-eluting stent (DES) therapy reduces restenosis in patients with diabetes when compared with bare metal stent implantation. There are significant differences between commercially available DES platforms both in terms of design characteristics and clinical outcomes. Randomized active-comparator inter-DES trials powered for clinical endpoints are unlikely to be performed in patients with diabetes, however, direct comparison randomized trials utilizing surrogate endpoints support a superior anti-restenotic efficacy with sirolimus- versus paclitaxel-eluting stents. Thrombotic stent occlusion may be higher in patients with diabetes compared with nondiabetic patients, though there is no clear signal of a safety differential between the two platforms. Insufficient data on comparative performance in diabetics exist in relation to the approved zotarolimus-eluting and everolimus-eluting stent platforms. If all other factors are equal, then there seems to be no reason why the diabetic patient should not receive treatment with the sirolimus-eluting stent, which appears to have superior antirestenotic efficacy in this patient group.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Diabetes Complications; Drug-Eluting Stents; Everolimus; Evidence-Based Medicine; Humans; Hypoglycemic Agents; Insulin; Meta-Analysis as Topic; Metals; Paclitaxel; Patient Selection; Prosthesis Design; Randomized Controlled Trials as Topic; Registries; Risk Assessment; Sirolimus; Thrombosis; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Cost-Benefit Analysis; Drug-Eluting Stents; Humans; Paclitaxel; Prosthesis Design; Randomized Controlled Trials as Topic; Research Design; Risk Assessment; Severity of Illness Index; Sirolimus; Thrombosis; Time Factors; Treatment Outcome

We sought to investigate the performance and efficacy of the third-generation polymer-free Vestasync-eluting stent (VES).. Recent concerns regarding the long-term safety of drug-eluting stents have been raised. Synthetic polymers have been associated with intensive inflammatory response and late stent thrombosis. Newly developed, the VES combines a stainless steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free sirolimus formulation (55 mum).. In May 2007, 15 patients with single de novo lesion located in native coronary arteries 3.0 to 3.5 mm in diameter and < or =14 mm in length were consecutively enrolled. Primary end points included in-stent late lumen loss and in-stent percent of obstruction at 4 months. Serial angiography and intravascular ultrasound were obtained at the index procedure and repeated at 4-month follow-up.. Mean population age was 63.8 years; 33% of patients were diabetic. The left anterior descending artery was the prevalent target vessel (47%). Reference vessel diameter and lesion length were 2.67 +/- 0.32 mm and 9.98 +/- 1.98 mm, respectively. The VES was successfully implanted in all cases, and there were no procedure and in-hospital complications. Life-long aspirin and 6-month clopidogrel therapy were prescribed for all patients. At 4 months, in-stent late lumen loss was 0.30 +/- 0.25 mm and percent of stent obstruction was 2.8 +/- 2.2%. After up to 6 months of clinical follow-up, no major adverse cardiac event was registered.. The third-generation VES demonstrated excellent acute results in the treatment of de novo coronary lesions. Longer follow-up with a more complex subset of patients and lesions is required to confirm these preliminary results.

Topics: Aged; Angioplasty, Balloon, Coronary; Aspirin; Cardiovascular Agents; Clopidogrel; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Coronary Thrombosis; Drug-Eluting Stents; Durapatite; Female; Humans; Male; Middle Aged; Pilot Projects; Platelet Aggregation Inhibitors; Prosthesis Design; Registries; Sirolimus; Stainless Steel; Ticlopidine; Time Factors; Treatment Outcome; Ultrasonography, Interventional

We used intravascular ultrasound (IVUS) to compare restenotic sirolimus-eluting (SES) vs paclitaxel-eluting (PES) stents.. Little is known about the IVUS pattern and mechanisms of restenosis, in the two widely available drug-eluting stent (DES) platforms.. Volumetric IVUS analysis was performed in patients with clinical restenosis in DES (n=29 SES and 11 PES respectively).. Despite similar vessel volumes (347.5+/-155.6 vs 356.5+/-164.1 mm(3), p=0.84) and stent volumes (175.6+/-74.57 vs 179.7+/-84.24 mm(3), p=1.0), IVUS analysis showed that neointimal hyperplasia volume was significantly greater in PES restenoses than in SES restenoses (40.0+/-44.2 vs 19.3+/-11.4 mm(3), p=0.02) without any significant difference in distribution over the stent length. This leads to a higher percent of volume obstruction (intimal hyperplasia volume divided by stent volume: 18.5+/-13.7% vs 11.8+/-7.7%, p=0.045). Minimal stent area was smaller in SES than in PES (4.3+/-1.2 vs 5.6+/-1.2 mm(2), p=0.06) and stent underexpansion was more frequently observed in SES stents: minimal stent area <4.5 mm(2) (65% in SES vs 27% in PES, p=0.04). Stent edge restenosis occurred in 1/29 SES (3%) vs 3/11 PES (27%) stents, p=0.056.. The magnitude of neointimal hyperplasia was greater in PES than in SES while stent underexpansion appeared to be more common in SES.

Topics: Cardiovascular Agents; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Paclitaxel; Retrospective Studies; Risk Factors; Sirolimus; Treatment Outcome; Ultrasonography, Interventional

Higher rates of clinical and angiographic restenosis have been reported after coronary stenting in patients with significant chronic kidney disease (CKD). Whether drug-eluting stents (DES) can reduce long-term clinical events in CKD patients compared with bare metal stents (BMS) has not been established.. The study enrolled 104 consecutive significant CKD patients (estimated creatinine clearance <60 ml/min) treated with DES for 142 de novo coronary lesions, comprising 76 patients treated with sirolimus-eluting stents (SES) for 106 lesions and 28 patients treated with paclitaxel-eluting stents (PES) for 36 lesions. Data from these patients were compared to those from a control group comprising 50 patients treated with BMS during the preceding 1 year.. There were no differences in terms of baseline clinical characteristics except that the patients of the DES group were older, had a higher ratio of insulin treatment for diabetes mellitus, and had a more frequent history of previous percutaneous coronary intervention. The patients in the DES group had more unfavorable lesion characteristics with smaller reference vessel diameter (2.8 mm versus 3.3 mm; P<0.001) and longer lesion length (28.8 mm versus 20.5 mm; P<0.001) than those in the BMS group. Compared to BMS, DES implantation had a lower 1-year major adverse cardiac events rate (cardiac death, non-fatal myocardial infarction or target vessel revascularization) (12% versus 26%; P=0.042). There were no significant differences between the SES and PES groups in terms of clinical outcomes.. DES implantation for de novo coronary lesions in significant CKD patients reduces 1-year clinical events compared with BMS implantation.

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kidney Failure, Chronic; Male; Middle Aged; Paclitaxel; Renal Artery Obstruction; Retrospective Studies; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

Despite excellent clinical results for sirolimus (rapamycin)-eluting stents, the exact mechanisms of antirestenotic activity and affected cellular targets are incompletely understood. Therefore, we determined the presence and tem- porospatial expression pattern of FKBP12, the primary intracellular receptor of rapamycin, in rat carotid arteries after balloon injury, as well as in human in-stent restenosis and primary stable coronary atheroma. FKBP12 expression was assessed by immunohistochemistry. Rat carotid arteries revealed maximal expression in 57.7 +/- 4.0% of neointimal cells at day 7. A large proportion of these FKBP12+ cells showed luminally confined co-expression with dendritic cell markers. Despite a considerably thicker neointima at day 28, presence of FKBP12 decreased (8.5 +/- 1.9%, p = 0.02) with a scattered pattern in luminal and deep neointima. Likewise, human in-stent restenosis atherectomy specimens (time after stent implantation 2-12 months) revealed a comparable extent of cellular rapamycin receptor expression (9.3 +/- 1.0%) that significantly differed from that found in primary stable atheroma (1.3 +/- 0.4%, p < 0.001). In conclusion, the rapamycin receptor is predominantly present during early neointima formation, while mature neointimal atheromas show a relatively low expression without confinement to luminal areas. Co-expression of FKBP12 and dendritic cell markers suggests that dendritic cells may be another important target for early and long-term rapamycin effects.

Topics: Aged; Animals; Atherectomy, Coronary; Cardiovascular Agents; Carotid Artery Injuries; Catheterization; Coronary Restenosis; Coronary Stenosis; Disease Models, Animal; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Rats; Rats, Sprague-Dawley; Sirolimus; Tacrolimus Binding Protein 1A; Time Factors; Tunica Intima

Sirolimus-eluting stents have been increasingly used for treatment of restenosis after implantation of bare metal stents (BMSs) or drug-eluting stents (DESs), but little is known regarding their long-term outcomes.. We compared long-term clinical outcomes in 295 patients treated with sirolimus-eluting stents for post-BMS (n = 224) vs. post-DES (n = 71) restenosis. All follow-ups were at least 12 months, and the primary endpoint was major adverse cardiac events (MACE), defined as cardiac death, nonfatal myocardial infarction (MI) or target lesion revascularization (TLR).. Baseline characteristics were similar between the two groups, except that mean lesion length (28.0 +/- 16.2 vs. 19.5 +/- 13.6, P < 0.01) and mean stented length (35.4 +/- 19.2 vs. 25.7 +/- 14.7, P < 0.01) were significantly longer in the post-BMS group. Major in-hospital complications occurred in 2 patients. During a mean follow-up of 31.3 +/- 11.1 months, there were 9 deaths (4 cardiac, 5 noncardiac), 3 nonfatal MIs, and 25 TLRs. Late stent thrombosis was documented in 2 patients (1 in each group). There were no between group differences in cardiac or total deaths, but there were trends toward less frequent cardiac death/MI or TLR in the post-BMS group. The cumulative probability of MACE-free survival was significantly better for the post-BMS group (95.0% +/- 1.5% vs. 87.3% +/- 4.0% at 1 year; 93.0% +/- 1.7% vs. 81.0% +/- 5.2% at 2 years; Log Rank P = 0.016). In multivariate analysis, post-DES restenosis was the only significant predictor of MACE (OR 3.29, 95%CI 1.13-9.61, P = 0.029).. Sirolimus-eluting stents were effective for treatment of in-stent restenosis, but post-DES restenosis was associated with poorer outcomes than post-BMS restenosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Restenosis; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Odds Ratio; Prosthesis Design; Retrospective Studies; Risk Assessment; Sirolimus; Stents; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Restenosis; Drug-Eluting Stents; Humans; Metals; Patient Selection; Practice Guidelines as Topic; Prosthesis Design; Risk Assessment; Sirolimus; Stents; Time Factors; Treatment Outcome

The predictors and clinical significance for stent fracture (SF) in drug-eluting stents (DES) remain unknown. We identified procedural factors leading to SF and its clinical consequences in DES.. Percutaneous coronary interventions were performed on 3,920 patients with DES over 12 months. In-stent restenosis (ISR) of DES was observed in 188 cases with 121 cases (64.4%) receiving a sirolimus-eluting stent (SES) and 67 (35.6%) a paclitaxol-eluting stent (PES).. SF was identified in 35 (18.6%) of the 188 cases. The 35 cases were then compared with 153 cases of ISR without angiographic evidence of SF. SF was identified in 29 (23.9%) SES compared with 6 (9.0%) in PES (P < 0.05). With univariate analysis, additional factors associated with SF included longer mean stented segment length, male gender, overlapping stents, vessel segment angulation >75 degrees , and more stents (all P < 0.05). With multivariate adjustment, three factors, i.e., stenting on a bend >75 degrees (OR = 13.8, 95%CI 3.7 to 51; P < 0.001), SES (OR = 4.1, 95%CI 1.3 to 13.4; P < 0.018) and overlapping stented segments (OR = 3.9, 95%CI 1.1 to 14.1; P < 0.041) were statistically significant independent predictors of SF while larger stent diameter was protective (OR = 0.14, 95%CI 0.04 to 0.70; P < 0.017).. SF proved to be associated with angiographically-documented clinical ISR. Although the exact mechanism is unknown, factors that appear to play a negative role in SF include vessel tortuosity, use of SES and overlapping stents. Larger stent diameter was protective. Further studies are needed to better define the factors important in the mechanism of SF.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cineangiography; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Equipment Failure Analysis; Female; Humans; Incidental Findings; Male; Middle Aged; Odds Ratio; Paclitaxel; Prosthesis Design; Prosthesis Failure; Research Design; Retrospective Studies; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome; Wisconsin

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cineangiography; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Incidental Findings; Paclitaxel; Prosthesis Design; Prosthesis Failure; Risk Assessment; Risk Factors; Sirolimus; Stress, Mechanical; Time Factors; Treatment Outcome

Concerns have been raised regarding late mortality, particularly from late stent thrombosis, from drug-eluting stents (DES). Randomized clinical trials have shown that DES decrease restenosis but do not decrease mortality compared with bare metal stents (BMS). These studies utilized well-defined clinical and angiographic subsets. In the "real world" drug-eluting stents are used in a much broader crosssection of patients. We evaluated mortality in the first year after implantation of DES, specifically the sirolimus-eluting stent (SES), Cypher vs. BMS in "real world" older patients using the Medicare claims database.. Data for the years 2002 (n = 6,890; pre-DES) and 2003 (n = 7,566; first year of DES use) (May through December of each year) were analyzed. BMS and DES groups had similar baseline characteristics except for small but significant differences with BMS patients being somewhat older, having more males and African Americans, and a higher percentage of peripheral artery disease and heart failure while DES patients had a higher percentage of diabetics and patients with prior revascularization procedures. A significant improvement in mortality using both unadjusted and adjusted analyses was observed for DES (6.0% vs. 11.4%, P < 0.0001; hazard ratio 1.98, 95% CI 1.68-2.34). Controlling for comorbidity, extent of disease, and other characteristics by multivariable analysis or by propensity analysis had little impact on these results. On the other hand, there was no change in overall mortality in all stented patients in 2003 compared with all stented patients in 2002.. An observed mortality benefit for DES compared with BMS in 2003 was observed, demonstrating the safety of DES, and suggesting the possibility of superiority in outcome in older patients with DES vs. BMS. However, the lack of improved survival from 2002 to 2003 in all stented patients suggests that the mortality advantage with DES finding may be due to unidentified selection biases. Our data suggest that DES in the Medicare population is as safe as, and possibly superior, to BMS for survival over the first year after implantation.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Artery Disease; Coronary Restenosis; Drug-Eluting Stents; Female; Humans; Kaplan-Meier Estimate; Male; Medicare; Metals; Proportional Hazards Models; Prosthesis Design; Reproducibility of Results; Research Design; Risk Assessment; Selection Bias; Sirolimus; Stents; Time Factors; Treatment Outcome; United States

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Artery Disease; Coronary Restenosis; Cost-Benefit Analysis; Drug-Eluting Stents; Humans; Kaplan-Meier Estimate; Medicare; Metals; Practice Guidelines as Topic; Prosthesis Design; Reproducibility of Results; Research Design; Sirolimus; Stents; Treatment Outcome; United Kingdom; United States

Topics: Acute Coronary Syndrome; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Paclitaxel; Patient Selection; Platelet Aggregation Inhibitors; Practice Guidelines as Topic; Time Factors; Treatment Outcome

To evaluate the long-term clinical outcomes of patients undergoing percutaneous coronary intervention for saphenous vein graft (SVG) disease. Specifically, we compared clinical endpoints of patients who received sirolimus-eluting stents (SES) versus bare-metal stents (BMS) for SVG disease.. A recent small randomized-controlled trial (RCT) reported increased mortality with the use of SES in SVG disease.. We retrospectively identified patients who underwent SES placement for a SVG lesion(s) at our institutions over a 4-year period. The procedural and medical records were reviewed to identify predetermined clinical outcomes.. 318 patients who underwent SES placement for a SVG lesion were identified. 7 patients were lost to follow-up. 141/311 patients (45%) received SES, while 170/311 (55%) received BMS. At a mean follow-up of 34 months, there was a reduction in target lesion revascularization (TLR) (7% vs. 14%, P = 0.07) without an increased risk of mortality (6% vs. 12%, P = 0.06) in patients who received SES compared to patients who received BMS. When compared to the recent RCT's SES patients at long-term follow-up, our SES patients had significantly less mortality; rates of myocardial infarction, TLR, target vessel revascularization, and major adverse cardiac events; and were more likely to be taking dual antiplatelet and statin medications.. Our results support that SES used in SVG lesions result in a reduction in TLR without an increased risk of mortality, and therefore may be an equally safe and feasible technique for revascularization with excellent long-term clinical outcomes. These patients may benefit from prolonged dual antiplatelet and statin medication regimens.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Restenosis; Drug-Eluting Stents; Feasibility Studies; Female; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Kaplan-Meier Estimate; Male; Metals; Patient Selection; Platelet Aggregation Inhibitors; Prosthesis Design; Registries; Retrospective Studies; Risk Assessment; Saphenous Vein; Sirolimus; Stents; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Restenosis; Drug-Eluting Stents; Graft Occlusion, Vascular; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Metals; Patient Selection; Platelet Aggregation Inhibitors; Prosthesis Design; Risk Assessment; Saphenous Vein; Sirolimus; Stents; Time Factors; Treatment Outcome

Stent fracture is uncommon but may have consequences including restenosis. To date, stent fractures reported have been related to aggressive post dilation. We describe a case that involves fracture of a stent deployed to nominal pressure. Unlike most stent fractures reported that involve stent struts only our case demonstrated circumferential disruption with complete separation of the stent segments.

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Female; Humans; Middle Aged; Prosthesis Design; Prosthesis Failure; Radiography, Interventional; Sirolimus; Stents; Time Factors; Treatment Outcome

Predictors of cardiac events and restenosis after sirolimus-eluting stent (SES) implantation in small coronary arteries were evaluated.. Although SES implantation has markedly reduced the risk of restenosis, small vessel disease remains a major cause of SES failure.. We prospectively investigated the factors predictive of cardiac events and restenosis in 1,092 consecutive patients who received SES implantation for 1,269 lesions in small coronary arteries (< or = 2.8 mm). Follow-up angiography at 6 months was performed in 751 patients with 889 lesions (follow-up rate 70.3%).. Restenosis (diameter stenosis > or = 50%) was angiographically documented in 65 patients with 77 lesions (8.7%): 55 focal (71.4%), 8 diffuse (10.4%), 2 diffuse proliferative (2.6%), and 12 total (15.6%). Lesion length, stent length, reference artery size, and in-stent restenotic lesions were univariate predictors of restenosis. By multivariate analysis, lesion length (OR 1.04; 95% CI 1.02-1.05; P < 0.001) and in-stent restenotic lesions (OR 3.38; 95% CI 1.80-6.35; P < 0.001) were significant independent predictors of restenosis. During follow-up (23.2 +/- 7.9 months), there were 17 deaths (5 cardiac and 12 noncardiac), 5 nonfatal Q-wave myocardial infarctions, and 42 target lesion revascularizations. The cumulative probability of survival without major adverse cardiac events (MACE) was (96.6 +/- 0.6)% at 1 year and (95.1 +/- 0.7)% at 2 years. In multivariate analysis, lesion length (HR 1.04; 95% CI 1.01-1.07; P = 0.004) and in-stent restenotic lesions (HR 3.29; 95% CI 1.58-6.86; P = 0.001) were independently related to MACE.. SES implantation in small coronary arteries is safe and effective, with lesion length having a major impact on restenosis and MACE.

Topics: Adult; Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Disease; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Female; Follow-Up Studies; Humans; Male; Middle Aged; Odds Ratio; Predictive Value of Tests; Prospective Studies; Risk Assessment; Risk Factors; Sirolimus; Stents; Time Factors; Treatment Outcome

The goal of this study was to determine whether three-dimensional (3D) reconstruction of traditional coronary angiography could optimize the choice of drug-eluting stent (DES) length and number during percutaneous coronary intervention (PCI).. Coronary angiography is subject to significant foreshortening artifact that limits the ability of the operator to accurately determine lesion length.. The angiographic images of the target vessels of consecutive PCI procedures were postprocessed using a 3D reconstruction algorithm. The appropriate length and optimal number of DES to span each target lesion were calculated and compared with the number and length of DES actually chosen by the operator.. A total of 42 target vessels were analyzed, and 3D reconstruction was successful in 38/42 (90.5%) of cases. The results of 3D analysis would have changed operator decision making in six cases (16%): in four cases, the stent chosen by the operator was too short requiring an additional DES; in two cases, the chosen DES was too long and exchanged for a shorter one. In each of these six cases, 3D analysis would have determined the correct stent length prior to stent selection. The optimal stent number derived by 3D reconstruction was significantly less than the actual number of stents per lesion used by the operator (1.31 +/- 0.47 versus 1.54 +/- 0.68, P = 0.01), and the optimal stent length trended less than the actual stented length (27.5 +/- 12.8 mm versus 28.7 +/- 14.7 mm, P = 0.23).. 3D reconstruction algorithm of standard coronary angiography is a promising technique to improve DES utilization during PCI.

Topics: Algorithms; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Humans; Image Processing, Computer-Assisted; Immunosuppressive Agents; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Research Design; Sirolimus; Stents; Treatment Outcome

Coronary artery stent infection is a rare complication of percutaneous intervention. We report a case of fulminant coronary stent infection with Staphylococcus aureus presenting as a pseudoaneurysm of the left circumflex artery following repeated implantation of drug-eluting stents in the setting of multiple episodes of recurrent in-stent restenosis. We speculate that sirolimus- and paclitaxel-eluting stents may be more likely to predispose to infection than bare metal stents because of their immunomodulating and antiproliferative effects.

Topics: Aged; Aneurysm, False; Aneurysm, Infected; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Cell Proliferation; Coronary Restenosis; Fatal Outcome; Humans; Immunosuppressive Agents; Male; Paclitaxel; Prosthesis-Related Infections; Sirolimus; Staphylococcal Infections; Staphylococcus aureus; Stents

To evaluate clinical and angiographic long-term outcome of "the mini-crush" technique for treating bifurcation lesions.. Despite proven efficacy of drug-eluting stent (DES) within most lesions subsets, bifurcation lesions continue to exhibit high restenosis rate using current DES stenting technique.. We report a new stenting technique which was employed in 45 consecutive patients (52 lesions) between April 2004 and July 2005 to treat true bifurcation lesions using DES in both branches.. Using this technique procedural success was obtained in 100% of cases, without complications and with excellent angiographic result in 96.1% and 98.1% of main vessel and side branch. Preprocedure reference vessel diameter and minimal lumen diameter (MLD) were 2.68 +/- 0.48 and 0.90 +/- 0.55 mm for the main branch, respectively and 2.28 +/- 0.34 and 1.14 +/- 0.47 mm for the side branch, respectively. Postprocedure MLD was 2.56 +/- 0.39 mm for the main branch and 2.16 +/- 0.29 mm for the side branch. There were no in-hospital major adverse cardiac events (MACE). At 72 days after procedure there was one case of side branch stent thrombosis (2.2%), which resulted in non Q-wave MI. Angiographic follow up was obtained in 100% of patients at 7.5 +/- 1.3 months. Target lesion revascularization (TLR) was 12.2%; no death and Q-wave MI were observed; reference vessel diameter and MLD for the main branch were 2.79 +/- 0.51 and 1.99 +/- 0.65 mm respectively and for the side branch 2.28 +/- 0.40 and 1.63 +/- 0.48 mm respectively. Restenosis rate in the main branch was 12.2% while in the side branch was 2.0%.. In-hospital outcome indicates that the mini-crush technique for bifurcation lesions with DES can be easily performed. It provides very low total MACE rate and restenosis at 8-month follow-up. These results confirmed the advantage of this specific technique to give complete coverage of the ostium of the side branch using two stents technique.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Databases as Topic; Female; Follow-Up Studies; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Pilot Projects; Prospective Studies; Prosthesis Design; Sirolimus; Stents; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Topics: Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coronary Restenosis; Coronary Thrombosis; Humans; Metals; Risk Factors; Stents; United States; United States Food and Drug Administration

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Chromium Alloys; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Humans; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Stents; Treatment Outcome

Vascular response at edges of drug-eluting stents is still not well established, particularly in diabetic patients who are prone to aggressive atherosclerosis progression. Recently, Biolimus and Zotarolimus have demonstrated potent antiproliferative effects.. To compare the vascular responses at edges of sirolimus analogous-eluting stents in patients with and without diabetes, using intravascular ultrasound (IVUS).. 306 edges were analyzed in 153 patients treated with drug-eluting stents and divided in: diabetics (122 edges) and nondiabetics (166 edges). IVUS was performed postintervention and at 6-month follow-up and included 5 mm distal and proximal to the stented segment. Vessel, lumen, and plaque volumes were calculated. Volume variation (follow-up minus basal) was also calculated. Edge restenosis was defined as obstruction >50%.. Baseline characteristics were similar between groups. In both groups the entire lesion length was covered (stent length/lesion length ratio was 1.5 for both groups). There were no differences in edge volumes and restenosis rate between the groups. Among diabetics, there was no significant volume variation. However, in nondiabetic patients there was significant increase in vessel volume in proximal (from 67.1 +/- 22 mm(3) to 72.2 +/- 25 mm(3): P = 0.02) and distal (from 54.4 +/- 22 mm(3) to 59.8 +/- 22 mm(3): P = 0.001) edges.. Nondiabetic patients showed a significant positive vascular remodeling in proximal and distal edges of sirolimus analogous-eluting stent. This vascular mechanism was not observed in diabetic patients. Although different vascular responses were observed, restenosis rates were equivalent between the 2 groups at 6-month follow-up.

Topics: Aged; Cardiovascular Agents; Case-Control Studies; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetic Angiopathies; Drug-Eluting Stents; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Topics: Cardiovascular Agents; Clinical Trials as Topic; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Humans; Prosthesis Design; Stents

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Humans; Prosthesis Design; Prosthesis Failure; Sirolimus; Stents; Treatment Outcome

Pleiotropic anti-restenotic properties of drugs that are eluted from coated stents are critical for efficacy and safety. Little is known about comparative drug properties in appropriate human coronary target cell lines for the two compounds that are utilized on FDA-approved drug-eluting stent (DES) platforms, paclitaxel (PTX) and sirolimus (SRL). Target cell lines that play a pivotal role for the pathogenesis of restenosis and vascular healing include human coronary artery smooth muscle (CASMC) and endothelial cells (CAEC). PTX and SRL inhibited CASMC and CAEC proliferation and migration efficiently. However, there was a differential effect on proliferation and migration in CAEC with a more profound inhibition of both parameters by PTX, even at low dosages. Induction of cytotoxicity and apoptosis was pronounced in PTX- and very modest in SRL-treated CASMC and CAEC. PTX increased eNOS activity and nitric oxide (NO) release from CAEC. Neutrophilic leukocyte activation and transmigration, which should be avoided since it may precipitate adverse coronary events such as restenosis and stent thrombosis, was suppressed by SRL, whereas PTX tended to increase neutrophilic leucocyte activity. Therefore, although the primary drug target, inhibition of mitogen-mediated CASMC proliferation, is effectively accomplished by both drugs, auxiliary pharmacological properties that are crucial for the anti-restenotic drug effect and vascular healing are considerably different between PTX and SRL. In comparison with PTX, SRL shows minor interference with endothelial cell proliferation and migration, lower levels of cytotoxicity and apoptosis, a broader therapeutic range and distinctive immunosuppressive properties.

Topics: Apoptosis; Cardiovascular Agents; Cell Cycle Proteins; Cell Movement; Cell Proliferation; Cell Shape; Cell Survival; Cells, Cultured; Coronary Restenosis; Coronary Vessels; Dose-Response Relationship, Drug; Endothelial Cells; Enzyme Activation; Humans; Immunosuppressive Agents; Muscle, Smooth, Vascular; Myocytes, Smooth Muscle; Neutrophil Activation; Nitric Oxide; Nitric Oxide Synthase Type III; Paclitaxel; Prosthesis Design; Research Design; Sirolimus; Stents

The authors aimed to compare the clinical outcomes with repeat drug-eluting stent (DES) implantation utilizing the same type versus an alternate DES type for in-stent restenosis (ISR) of DES.. : DES are proven as an effective treatment for bare metal ISR.. A cohort of 116 patients previously treated with a sirolimus-eluting stent (SES) or a paclitaxel-eluting stent (PES) who presented with angiographic ISR were treated with repeat DES. Of these, 62 (53.4%) were treated with different DES and 54 (46.6%) were treated with the same DES. This cohort was followed for clinical events at 30 days, 6 months, and 1 year.. Baseline characteristics were similar except for more diabetes among patients receiving the different type of DES. Of the 116, overall 16.4% of the DES were implanted for previous ISR and 2.6% had previously received brachytherapy. At 6 months, the overall target vessel revascularization (TVR) rate was 12.2% for the entire cohort. The TVR-major adverse cardiac event (MACE) rate for the patients treated with different DES was 14.5% and 16.7% for the same DES (P = 0.750). Overall TVR rate at 1 year was 28.8%. The TVR-MACE was 32.6% for different DES and 35.0% for the same DES (P = 0.814).. Reimplantation of DES for the treatment of DES ISR (same or different) is safe but associated with a high rate of recurrences at 1 year regardless of the initial DES type. Other treatment modalities for ISR of DES should be considered to further improve the overall TVR-MACE.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Female; Follow-Up Studies; Heart Diseases; Humans; Kaplan-Meier Estimate; Male; Metals; Middle Aged; Paclitaxel; Prosthesis Design; Reoperation; Secondary Prevention; Sirolimus; Stents; Time Factors; Treatment Outcome

The performance of drug eluting stents (DES) and impact on every day practice in the USA, where complex, nonselective cases are the rule, remain unknown.. The Brigham and Women's Hospital interventional experience in the bare metal stents (BMS) (6/2002 to 2/2003) and after abrupt and near universal adoption of DES (4/2003 to 9/2004) were compared. Demographic, procedural and in-hospital outcomes for all consecutive cases where investigated. Predictors and angiographic characteristics of patients returning for clinically driven target lesion revascularization (TLR) in both eras were analyzed.. Of 2,555 DES cases (3,061 lesions, 87.9% Cypher, 12.1% Taxus), 47 underwent TLR during follow-up (68 lesions, 2.2%). Of the 1,731 BMS cases (1,798 lesions), 162 underwent clinically indicated TLR (209 lesions, 11.6%), representing an 81% DES era TLR risk reduction. Multivariate predictors of TLR in the DES era: left main lesion (LM) (odds ratio (OR) 7.65, 95% confidence interval (CI) 3.33-17.53, P<0.01, treatment of restenosis (OR 5.96, CI 3.21-11.08, P<0.01), and diabetes (OR 1.68, CI 0.92-3.04, P=0.07). Predictors of restenosis in the BMS era included additional clinical, lesion, and stent characteristics, while LM lesion was absent. Angiographic patterns of stent restenosis differed in the DES (focal) and BMS (diffuse) era.. The transition from BMS to DES in the setting of a large USA hospital practice is safe and associated with significant reduction in clinically driven TLR. Treatment of specific lesions types (repeat restenosis, distal LM) and diabetic patients remain suboptimal and warrant further investigation.

Topics: Aged; Angioplasty, Balloon, Coronary; Boston; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Diabetes Complications; Female; Follow-Up Studies; Humans; Incidence; Logistic Models; Male; Metals; Middle Aged; Myocardial Ischemia; Odds Ratio; Prospective Studies; Prosthesis Design; Registries; Research Design; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Restenosis; Diabetes Complications; Humans; Incidence; Metals; Myocardial Ischemia; Prosthesis Design; Risk Assessment; Risk Factors; Stents; Treatment Outcome

Drug eluting stents (DESs) reduce the incidence of restenosis after percutaneous coronary intervention (PCI) and have been predicted to decrease the number of patients referred for coronary artery bypass grafting (CABG). We studied about the impact of DESs on CABG. We compared our isolated CABG patients over two years (May 2002-April 2004) before the introduction of DESs (non DES term) with those over the two years (May 2004-April 2006) after the implementation of DESs (DES term). We studied a total of 136 CABG cases in the non DES term and 138 CABG cases in the DES term. In the non DES term, of 3650 coronary angiographies (CAGs), 794 (21.8%) underwent PCI, and 65 (1.9%) underwent CABG. In the DES term, of 4003 CAG, 1091 (27.3%) underwent PCI, and 70 (1.7%) underwent CABG. Among CABG patients, there was no significant difference in the age, sex, and ejection fraction. Patients in the DES term were more likely to have severe diabetes and severe renal failure. The clinical introduction of DESs was associated with a modest decrease in the percentage of CAG patients referred for CABG. Moreover, preoperative conditions have become more serious.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Angiography; Coronary Artery Bypass; Coronary Artery Disease; Coronary Restenosis; Female; Humans; Japan; Male; Middle Aged; Patient Selection; Prosthesis Design; Referral and Consultation; Retrospective Studies; Severity of Illness Index; Sirolimus; Stents; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Humans; Sirolimus; Thrombosis; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Diabetic Angiopathies; Drug-Eluting Stents; Humans; Prosthesis Design; Sirolimus; Time Factors; Treatment Outcome; Ultrasonography, Interventional

Sirolimus-eluting stents (SES) have been shown to significantly reduce restenosis in the treatment of lesions in large coronary arteries. We assessed and compared the in-hospital and long-term outcomes of patients treated with SES and bare-metal stents (BMS) for small coronary artery disease.. We compared 448 patients who underwent SES implantation in small coronary arteries (<2.5mm) with patients who received conventional BMS (n=124). In-hospital and nine-month events were evaluated.. The rate of angiographic restenosis at nine months was significantly lower in the SES group (1.6% vs 9.9%, P<0.001) than in the BMS group. The overall rate of MACE was 4.3% in SES and 13.9% in BMS groups (P<0.001).. As compared with BMS, SES placement in small coronary arteries is effective and associated with a marked reduction in restenosis rate and the subsequent need for target lesion revascularization at nine months.

Topics: Aged; Angioplasty, Balloon; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Female; Humans; Male; Middle Aged; Retrospective Studies; Sirolimus; Stents

The TriMaxx coronary stent system includes a novel trilayer metal stent having two outer layers of 316L stainless steel and with an inner 0.0007 inches layer of tantalum. This enables creation of a maximally flexible and thin device (0.0029 inches) while still maintaining the requisite strength and radiopacity for effective implantation.. The objective of this multi-center, single-arm prospective clinical trial was to assess the safety and performance of the TriMaxx stent for the treatment of single de novo coronary artery lesions.. One hundred patients with ischemic coronary occlusive disease because of single de novo obstructive lesions of native coronary arteries were treated with 3 x 15 or 3 x 18 mm TriMaxx stents in four hospitals in Brazil and Germany between May of 2004 and September of 2005. An independent core laboratory analyzed the quantitative coronary angiography (QCA) results immediately after stent implantation, and after six months.. The lesion, procedure, and device-deployment success rates were 100, 99, and 100%, respectively. Eighty-eight patients underwent follow-up angiography at 6 +/- 1 months. After six months, 13 (13%) of patients had sustained major adverse cardiac events, including 9.0% that required target lesion revascularization (TLR). The follow-up angiographic studies revealed a binary in-stent restenosis rate of 25% with in-stent late lumen loss of 0.94 +/- 0.57 mm.. These results demonstrate that the TriMaxx stent can be safely deployed for the treatment of single de novo coronary occlusive lesions with six-month clinical and angiographic results rates comparable to historical results using other bare metal stents.

Topics: Aged; Angioplasty, Balloon, Coronary; Brazil; Cardiovascular Agents; Cardiovascular Diseases; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Feasibility Studies; Female; Germany; Humans; Male; Middle Aged; Phosphorylcholine; Prospective Studies; Prosthesis Design; Severity of Illness Index; Stainless Steel; Tantalum; Time Factors; Treatment Outcome

The aim of the present study was the detection of asymptomatic coronary re-stenosis after percutaneous coronary intervention (PCI).. We studied 26 subjects who had been recently implanted with a paclitaxel-eluting coronary stent by both a conventional exercise test and the determination of plasma B-type natriuretic peptide (BNP) levels.. At control coronary angiography, nine months after initial PCI, six patients had re-stenosis and 20 were re-stenosis free. We found that re-stenosis was best predicted by the combination of a basal plasma BNP level > or = 50 pg/ml and a positive or uncertain conventional exercise test (positive likelihood ratio of the combination = 10). The best predictor of absence of re-stenosis was a low (< 50 pg/ml) plasma BNP level (negative likelihood ratio = 0.26).. Accordingly, basal BNP level testing can be recommended in the follow-up evaluation of coronary patients after PCI, to improve both the detection and the exclusion of asymptomatic re-stenosis.

Topics: Angioplasty, Balloon, Coronary; Biomarkers; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Drug-Eluting Stents; Exercise Test; Female; Follow-Up Studies; Humans; Male; Middle Aged; Natriuretic Peptide, Brain; Paclitaxel; Predictive Value of Tests; Sensitivity and Specificity; Time Factors; Treatment Outcome

This study compared the efficacy of the sirolimus-eluting stent (SES), the paclitaxel-eluting stent (PES), and the bare metal stent (BMS) for long coronary lesions.. The outcome of drug-eluting stent (DES) implantation in long coronary lesions remains unclear.. The study involved 527 patients with de novo long coronary lesions (> or = 24 mm), which were treated with long (> or = 28 mm) SESs (223 lesions), PESs (194 lesions), or BMSs (201 lesions).. Lesions in the SES (36.0 +/- 14.9 mm, P < 0.001) and PES (36.3 +/- 14.5 mm, P < 0.001) groups were longer than those in the BMS group (32.0 +/- 12.3 mm), meaning the two DES groups had longer stented segments than did the BMS group. Six-month angiographic follow-up showed the SES (9.3%, P < 0.001) and PES (21.3%, P < 0.001) groups had lower in-segment restenosis rates than that of the BMS group (42.5%). The rate of major adverse cardiac events (MACE) including death, myocardial infarction, and target lesion revascularization at 9 months was higher in the BMS group (26.6%) than that in the SES (13.0%, P < 0.001) and PES (15.7%, P < 0.001) groups. Posthoc analysis of the two DES groups showed that the in-segment restenosis rate was lower for the SES than that for the PES group (P = 0.002), while the MACE rate was similar.. The use of DESs for long coronary lesions appears to be safe and more effective than the use of BMSs in terms of restenosis and adverse clinical events. SES use was associated with lower late luminal loss and a lower angiographic restenosis rate compared with PES use.

Topics: Analysis of Variance; Cardiovascular Agents; Chi-Square Distribution; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Drug Delivery Systems; Female; Humans; Logistic Models; Male; Metals; Middle Aged; Paclitaxel; Prospective Studies; Sirolimus; Stents

This study was conducted to reevaluate the significance of angiographic late loss and to assess the agreement between new proposed neointimal volumetric measurements derived from quantitative coronary angiography (QCA) and standard intravascular ultrasound (IVUS)-based parameters. Neointimal volumetric measurements may better estimate the magnitude of neointimal growth after stenting than late loss. In 56 in-stent segments (27, everolimus; 29, bare metal) in the SPIRIT FIRST study, we compared QCA measures with the corresponding IVUS parameters. Two IVUS-late loss models were derived from minimal luminal diameter (MLD) using either a circular model or a so-called projected MLD. QCA-neointimal volume was calculated as follows: stent volume (mean area of the stented segment x stent length) at post procedure - lumen volume (mean area of the stented segment x stent length) at follow-up (the stent length either from nominal stent length or the length measured by QCA). Videodensitometric neointimal volume was also evaluated. Each of the three neointimal volume and percentage volume obstruction by QCA showed significant correlation with the corresponding IVUS parameters (r = 0.557-0.594, P < 0.0001), albeit with a broad range of limits of agreement. Late loss and volumetric measurements by QCA had a broader range of standard deviation than those by IVUS. QCA-volumetric measurements successfully confirmed the efficacy of everolimus-eluting stents over bare metal stents (P < 0.05). Our proposed QCA volumetric measurements may be a practical surrogate for IVUS measurements and a discriminant methodological approach for assessment of treatment effects of drug-eluting stents.

Topics: Cardiovascular Agents; Coronary Angiography; Coronary Disease; Coronary Restenosis; Drug Delivery Systems; Everolimus; Female; Humans; Linear Models; Male; Randomized Controlled Trials as Topic; Sirolimus; Stents; Tunica Intima; Ultrasonography, Interventional

Topics: Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Disease; Coronary Restenosis; Drug Implants; Humans; Immunosuppressive Agents; Paclitaxel; Sirolimus; Stents

Topics: Adult; Aged; Cardiovascular Agents; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Female; Humans; Male; Middle Aged; Stents; Time Factors; Tunica Intima

The purpose of this study was to evaluate predictors of an adverse outcome after "crush" bifurcation stenting.. The "crush" technique is a recently introduced strategy with limited data regarding long-term outcomes.. We identified 231 consecutive patients treated with drug-eluting stent implantation with the "crush" technique for 241 de novo bifurcation lesions. Clinical follow-up was obtained in 99.6%.. The in-hospital major adverse cardiac event (MACE) rate was 5.2%. At 9 months, 10 (4.3%) patients had an event consistent with possible post-procedural stent thrombosis. Survival free of target lesion revascularization (TLR) was 90.3%; the only independent predictor of TLR was left main stem (LMS) therapy (odds ratio [OR] 4.97; 95% confidence interval [CI] 2.00 to 12.37, p = 0.001). Survival free of MACE was 83.5% and independent predictors of MACE were LMS therapy (OR 3.79; 95% CI 1.76 to 8.14, p = 0.001) and treatment of patients with multivessel disease (OR 4.21; 95% CI 0.95 to 18.56, p = 0.058). Angiographic follow-up was obtained in 77% of lesions at 8.3 +/- 3.7 months. The mean late loss of the main vessel and side branch were 0.30 +/- 0.64 mm and 0.41 +/- 0.67 mm, respectively, with binary restenosis rates of 9.1% and 25.3%. Kissing balloon post-dilation significantly reduced the side branch late lumen loss (0.24 +/- 0.50 mm vs. 0.58 +/- 0.77 mm, p < 0.001).. The crush technique of bifurcation stenting with drug-eluting stents is associated with favorable outcomes for most lesions; however, efficacy appears significantly reduced in LMS bifurcations, and further research is needed before the technique can be routinely recommended in this group. Furthermore, the incidence of possible stent thrombosis is of concern and requires further investigation. Kissing balloon post-dilatation is mandatory to reduce side branch restenosis.

Topics: Angina Pectoris; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Delayed-Action Preparations; Female; Humans; Male; Middle Aged; Paclitaxel; Postoperative Complications; Prognosis; Sirolimus; Stents; Time Factors; Treatment Outcome

Topics: Blood Vessel Prosthesis; Cardiovascular Agents; Coronary Restenosis; Coronary Stenosis; Equipment Failure; Humans; Myocardial Revascularization; Randomized Controlled Trials as Topic; Risk Factors; Stents

Although drug-eluting stents (DES) significantly reduce restenosis, they require 3 to 6 months of thienopyridine therapy to prevent stent thrombosis. The rate and consequences of prematurely discontinuing thienopyridine therapy after DES placement for acute myocardial infarction (MI) are unknown.. We used prospectively collected data from a 19-center study of MI patients to examine the prevalence and predictors of thienopyridine discontinuation 30 days after DES treatment. We then compared the mortality and cardiac hospitalization rates for the next 11 months between those who stopped and those who continued thienopyridine therapy. Among 500 DES-treated MI patients who were discharged on thienopyridine therapy, 68 (13.6%) stopped therapy within 30 days. Those who stopped were older, less likely to have completed high school or be married, more likely to avoid health care because of cost, and more likely to have had preexisting cardiovascular disease or anemia at presentation. They were also less likely to have received discharge instructions about their medications or a cardiac rehabilitation referral. Patients who stopped thienopyridine therapy by 30 days were more likely to die during the next 11 months (7.5% versus 0.7%, P<0.0001; adjusted hazard ratio=9.0; 95% confidence interval=1.3 to 60.6) and to be rehospitalized (23% versus 14%, P=0.08; adjusted hazard ratio=1.5; 95% confidence interval=0.78 to 3.0).. Almost 1 in 7 MI patients who received a DES were no longer taking thienopyridines by 30 days. Prematurely stopping thienopyridine therapy was strongly associated with subsequent mortality. Strategies to improve the use of thienopyridines are needed to optimize the outcomes of MI patients treated with DES.

Topics: Aged; Aged, 80 and over; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Cause of Death; Clopidogrel; Combined Modality Therapy; Coronary Restenosis; Drug Administration Schedule; Drug Implants; Female; Follow-Up Studies; Hospitalization; Humans; Life Tables; Male; Middle Aged; Mortality; Myocardial Infarction; Patient Education as Topic; Platelet Aggregation Inhibitors; Prevalence; Proportional Hazards Models; Prospective Studies; Pyridines; Registries; Sirolimus; Stents; Survival Analysis; Thrombosis; Ticlopidine; Treatment Outcome; Treatment Refusal

This study sought to analyze the cost of percutaneous coronary interventions with use of sirolimus-eluting stents (SES) or paclitaxel-eluting stents (PES) in patients at high risk of restenosis.. Recent studies have shown different clinical efficacy with these drug-eluting stents. Whether this difference extends on cost estimates between the 2 stents is not known.. We included 450 patients with diabetes mellitus and in-stent restenosis from 2 randomized studies comparing SES with PES. Assigned costs for the economic evaluation were the initial hospitalization and all subsequent cardiac-related inpatient/outpatient health resources during 9 to 12 months of clinical follow-up. The economic evaluation was performed from the health insurance system's perspective.. There were no differences between the 2 study groups regarding mortality (p = 0.78) and myocardial infarction rates (p = 0.76). Target lesion revascularization was performed in 16 patients (7.1%) in the SES group and in 34 patients (15.1%) in the PES group (p = 0.01). Initial hospital costs were not significantly different between the 2 stents (p = 0.53). The follow-up costs were, however, different: 2,684 +/- 2,072 euros per patient treated with SES and 4,527 +/- 6,466 euros per patient treated with PES (p < 0.001). Total costs also differed at the end of the follow-up: 8,924 +/- 3,077 euros per patient treated with SES and 10,903 +/- 7,205 euros per patient treated with PES (p < 0.001).. In patients at high risk of restenosis, use of SES is associated with lower costs compared with PES. The cost savings are mainly due to the reduced need of repeat revascularization procedures with SES.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Disease; Coronary Restenosis; Cost Savings; Costs and Cost Analysis; Diabetic Angiopathies; Female; Germany; Health Services; Hospital Costs; Hospitalization; Humans; Male; Middle Aged; Paclitaxel; Randomized Controlled Trials as Topic; Sirolimus

To determine patterns and outcomes of drug-eluting stents (DES) use in clinical practice.. DES are technology associated with superior outcomes. The initial limited availability and high cost of DES had the potential to influence their use.. Data from the American College of Cardiology-National Cardiovascular Data Registry were examined to describe the patterns of DES use in 408,033 percutaneous coronary intervention (PCI) procedures at 383 sites. Predictors of DES use were determined, and inhospital outcomes were examined.. From April 2003 through December 2004, the proportion of procedures using DES increased from 19.7% to 78.2%. DES use increased across all patient groups and hospital types, but adoption was slower among older patients and those without health insurance. DES use varied among hospitals such that use was lower at rural and low-volume hospitals. Multivariable regression demonstrated a progressive decrease in the odds of DES use as age increased. White race, female sex, presence of insurance, diabetes mellitus, PCI of de novo lesion, PCI at a high volume center, and PCI at a suburban hospital were significant predictors of DES use. The availability of a second DES product did not influence the adoption patterns. Inhospital outcomes with DES were excellent.. Access to DES was influenced by demographic, socioeconomic, and hospital characteristics. Further study is needed to determine if the availability of another DES platform or increased overall availability of DES impacts favorably on PCI practice patterns.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Disease; Coronary Restenosis; Coronary Stenosis; Drug Delivery Systems; Female; Hospital Mortality; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Myocardial Infarction; Outcome Assessment, Health Care; Registries; Stents; Survival Analysis

We report the case of a 67-year-old man who presented with a [corrected] non-ST-elevation acute myocardial infarction 41 months after implantation of a sirolimus-eluting stent in his left circumflex coronary artery. Coronary angiography revealed stent thrombosis.

Topics: Aged; Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Thrombosis; Humans; Male; Myocardial Infarction; Paclitaxel; Reoperation; Sirolimus; Stents

Topics: Blood Vessel Prosthesis Implantation; Brachytherapy; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Equipment Safety; Humans; Paclitaxel; Polymers; Stents; Taxus

To evaluate the safety and efficacy of Taxus paclitaxel-eluting stents in a real world group of unselected patients with coronary in-stent restenosis (ISR) lesions.. This is a prospective single-center registry of a consecutive series of 94 patients with 104 ISR lesions, without previous brachytherapy, over a period of 1 year. Quantitative coronary angiographic analyses were performed at baseline and at 6-month angiographic follow-up. Clinical follow-up were obtained at 6 months.. Pre-intervention mean reference vessel diameter was 2.62 +/- 0.50 mm and mean lesion length was 13.95 +/- 6.78 mm. Baseline ISR patterns were mostly either Type I focal (32.7%) or Type II diffuse intrastent (48.1%). At 6-month angiographic follow-up, the in-stent and in-segment binary restenosis was 3.8% (4/105) and 7.6% (8/105) respectively, and the in-stent and in-segment late loss was 0.30 +/- 0.50 mm and 0.57 +/- 0.54 mm, respectively. Seven of these eight restenosed lesions had a diffuse or proliferative ISR pattern prior to intervention. Lesions that restenosed had longer mean stent length per lesion (37.3 mm vs. 22.5 mm in nonrestenosed group; P = 0.001) and more likely to have had a pattern of total occlusion pre-intervention (25.0% vs. 3.1% in nonrestenosed group; P = 0.046). At 6-month clinical follow-up, the MACE rate was 8.5% and target lesion revascularization rate was 7.4%. There was no death but subacute stent thrombosis occurred in 1 patient (1.1%) at 3 days after intervention.. Paclitaxel-eluting Taxus stent for the treatment of ISR effectively suppresses recurrent neointimal proliferation, and was safe and efficacious at 6-month follow-up.

Topics: Aged; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Equipment Safety; Female; Follow-Up Studies; Humans; Male; Middle Aged; Paclitaxel; Polymers; Prospective Studies; Stents; Survival Rate; Taxus; Treatment Outcome

We report the case of a 43-year-old patient with acute ST-segment elevation anterior myocardial infarction who underwent off-pump coronary artery bypass grafting. To reduce the duration of ongoing myocardial ischemia, acute reperfusion of the infarcted coronary artery was achieved using an aortocoronary shunt, thereby perfusing the occluded left anterior descending artery. Under the protection of the aortocoronary shunt, the left internal thoracic artery was harvested and was thereafter anastomosed to the left anterior descending artery. The patient had an uneventful postoperative recovery.

Topics: Adult; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Catheterization; Coronary Artery Bypass, Off-Pump; Coronary Restenosis; Drug Delivery Systems; Electrocardiography; Humans; Internal Mammary-Coronary Artery Anastomosis; Intra-Aortic Balloon Pumping; Male; Myocardial Infarction; Myocardial Revascularization; Stents; Time Factors

We present real world experience from a single center registry comparing the 6-month outcome of percutaneous coronary intervention (PCI) in unselected high-risk individuals using either sirolimus-eluting (SES) or paclitaxel-eluting stents (PES).. We compared clinical outcome at 6 months follow-up in two cohorts of 156 consecutive patients (total n = 312) who underwent SES (June 2002-February 2003) and PES (march 2003-July 2003) implantation. The primary endpoint was a composite of major adverse cardiac events (MACE). Baseline clinical characteristics were well matched. The 6-month target vessel revascularization (TVR) rates were 1.9% (SES) and 2.6% (PES) and MACE rates were similar in the two groups (SES 4.5% vs. PES 3.2%, P = NS). In the PES group, intervention for multivessel disease, bifurcation lesions and in small vessels was more common, and for in-stent restenosis less common, reflecting the impact of drug eluting stents on indications for PCI. The incidence of sub-acute stent thrombosis, related to inadequate antiplatelet therapy in 3 of the 6 cases, was 0.95% with no difference between the two groups.. This study confirms the safety and efficacy of SES and PES in unselected high risk patients undergoing PCI. Clinical outcomes of both stents are equivalent at 6 months with low rates of MACE and TVR. These data provide important complementary information to forthcoming randomized studies.

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Incidence; Male; Middle Aged; Paclitaxel; Postoperative Complications; Prospective Studies; Registries; Risk Factors; Sirolimus; Stents; Taxus; Treatment Outcome

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Artery Disease; Coronary Restenosis; Humans; Paclitaxel; Randomized Controlled Trials as Topic; Registries; Sirolimus; Stents

Four drug-eluting stents were deployed in the right coronary artery (RCA) of a symptomatic young woman who presented with a chronic total occlusion (CTO) of the RCA. The occlusion was successfully crossed using the recently described STAR technique. However, the patient died suddenly 15 hr later. Autopsy demonstrated a long segment of subintimal stenting in the proximal and mid RCA that was intraluminal in the distal vessel. Acute stent thrombosis in the subintimal stents was responsible for sudden death. This case highlights the potential risk of performing extensive subintimal stenting for CTO.

Topics: Angioplasty, Balloon, Coronary; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Chronic Disease; Coated Materials, Biocompatible; Coronary Angiography; Coronary Restenosis; Coronary Stenosis; Coronary Thrombosis; Fatal Outcome; Female; Humans; Middle Aged; Sirolimus; Stents; Tunica Intima

The optimal treatment for sirolimus-eluting stent (SES) restenosis is not known. This study evaluated the safety and clinical outcome of paclitaxel-eluting stent (PES) implantation for SES restenosis. From March 2004 to July 2005, PESs were implanted in 125 patients with 140 lesions with SES restenosis. Acute and 6-month clinical outcomes were determined through review of the medical record and/or telephone interview. In-hospital major adverse cardiac events (death, nonfatal myocardial infarction, or repeat revascularization) occurred in 14 patients (11.2%), driven entirely by postprocedure non-Q-wave myocardial infarction. At a mean clinical follow-up of 7.2 +/- 1.8 months, the incidence of target lesion revascularization (TLR) was 14.0%, and the rate of major adverse cardiac events was 17.2%. Subacute thrombosis occurred in 2 patients (1.6%). Length of PES implanted, postprocedure diameter stenosis, and total occlusion of the target lesion were independent predictors of TLR. In patients with de novo SES restenosis, TLR was only 8.7%. In conclusion, at medium-term follow-up, PES implantation for SES failure appears to be safe and effective, although efficacy is decreased in the setting of total occlusions, greater residual diameter stenosis, and longer PESs.

Topics: Aged; Cardiovascular Agents; Chi-Square Distribution; Comorbidity; Coronary Restenosis; Drug Delivery Systems; Female; Humans; Logistic Models; Male; Paclitaxel; Retrospective Studies; Sirolimus; Stents; Treatment Failure; Treatment Outcome

With the reduction in restenosis rates by drug-eluting stents, there is new controversy concerning the optimal management of incidental, nontarget lesions identified during percutaneous coronary intervention (PCI). Such lesions have been treated conservatively because of risk of restenosis but now are being considered for PCI to prevent plaque instability. However, the impact of incidental stenoses on future cardiac events remains unknown.. We performed a retrospective cohort study to determine the rate and features of clinical plaque progression using the National Heart, Lung, and Blood Institute Dynamic Registry of consecutive patients undergoing PCI at multiple centers in 1997 to 1998 and 1999. Of 3747 PCI patients, 216 (5.8%) required additional nontarget lesion PCI for clinical plaque progression at 1 year. Fifty-nine percent presented with new unstable angina, and 9.3% presented with nonfatal myocardial infarction. Patients with multivessel coronary artery disease during original PCI were more likely to require nontarget lesion PCI during follow-up (adjusted odds ratio, 1.72 [95% CI, 1.18 to 2.52] for 2 vessels; adjusted odds ratio, 3.37 [95% CI, 2.32 to 4.89] for 3 vessels). Angiographic review showed that the majority (86.9%) of lesions requiring subsequent PCI were < or =60% in severity during original PCI, with the mean lesion stenosis 41.8+/-20.8% at the time of the initial PCI and 83.9+/-13.9% during the recurrent event.. Approximately 6% of PCI patients will have clinical plaque progression requiring nontarget lesion PCI by 1 year. Greater coronary artery disease burden confers a significantly higher risk for clinical plaque progression.

Topics: Angioplasty, Balloon, Coronary; Cardiac Catheterization; Cardiovascular Agents; Cohort Studies; Combined Modality Therapy; Coronary Angiography; Coronary Artery Disease; Coronary Restenosis; Disease Progression; Follow-Up Studies; Humans; Incidental Findings; Life Tables; Myocardial Infarction; Myocardial Ischemia; Registries; Retrospective Studies; Risk; Stents

To compare clinical outcome of paclitaxel eluting stents (PES) versus sirolimus eluting stents (SES) for the treatment of acute ST elevation myocardial infarction.. The first 136 consecutive patients treated exclusively with PES in the setting of primary percutaneous coronary intervention for acute myocardial infarction in this single centre registry were prospectively clinically assessed at 30 days and one year. They were compared with 186 consecutive patients treated exclusively with SES in the preceding period.. Academic tertiary referral centre.. At 30 days, the rate of all cause mortality and reinfarction was similar between groups (6.5% v 6.6% for SES and PES, respectively, p = 1.0). A significant difference in target vessel revascularisation (TVR) was seen in favour of SES (1.1% v 5.1% for PES, p = 0.04). This was driven by stent thrombosis (n = 4), especially in the bifurcation stenting (n = 2). At one year, no significant differences were seen between groups, with no late thrombosis and 1.5% in-stent restenosis (needing TVR) in PES versus no reinterventions in SES (p = 0.2). One year survival free of major adverse cardiac events (MACE) was 90.2% for SES and 85% for PES (p = 0.16).. No significant differences were seen in MACE-free survival at one year between SES and PES for the treatment of acute myocardial infarction with very low rates of reintervention for restenosis. Bifurcation stenting in acute myocardial infarction should, if possible, be avoided because of the increased risk of stent thrombosis.

Topics: Adult; Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Drug Delivery Systems; Epidemiologic Methods; Female; Humans; Male; Middle Aged; Myocardial Infarction; Paclitaxel; Sirolimus; Stents; Treatment Outcome

The aim of this study was to assess technical feasibility, biocompatibility, and impact on coronary stenosis of a new biodegradable paclitaxel-loaded polylactide stent. Due to high rates of in-stent restenosis and permanent nature of metal stent implants, synthetic polymers have been proposed as surrogate materials for stents and local delivery systems for drugs. Paclitaxel was shown to inhibit vascular smooth muscle cell proliferation and migration.. A novel biodegradable double-helical stent was manufactured using controlled expansion of saturated polymers (CESP) for the moulding of a bioresorbable poly(D,L)-lactic acid (PDLLA). A modified balloon catheter for stent deployment was developed according to the mechanical stent properties. Twelve paclitaxel-loaded (170 microg) polylactide stents, 12 unloaded polylactide stents, and 12 316L bare metal stents were deployed in porcine coronary arteries of 36 animals. Six pigs of each group were sacrificed after 3 weeks and 3 months, respectively, for every setting. Drug release kinetics as well as histomorphometrical and histopathological analyses were performed. A slow paclitaxel release kinetic for more than 2 months and therapeutic tissue concentrations were demonstrated. Coronary stenosis after implantation of paclitaxel-loaded stents (30+/-5% or 49+/-4%) was significantly inhibited compared to unloaded PDLLA stents (65+/-10%, P=0.021 or 71+/-4%, P=0.004) and metal stents (53+/-6% or 68+/-8%, P=0.029 and P=0.020) after 3 weeks or 3 months. Early complete endothelialisation was shown. Nevertheless, a local inflammatory response to the polylactide as a result of the polymer resorption process was observed.. This novel polylactide stent showed sufficient mechanic stability, and by incorporation of paclitaxel, a significant potential to reduce restenosis development after vascular intervention was seen.

Topics: Animals; Biocompatible Materials; Cardiovascular Agents; Coronary Restenosis; Drug Implants; Feasibility Studies; Models, Animal; Paclitaxel; Polyesters; Random Allocation; Stents; Swine; Tunica Intima

Platelet-derived microparticles that are produced during platelet activation are capable of adhesion and aggregation. Endothelial trauma that occurs during percutaneous transluminal coronary angioplasty (PTCA) may support platelet-derived microparticle adhesion and contribute to development of restenosis. We have previously reported an increase in platelet-derived microparticles in peripheral arterial blood with angioplasty. This finding raised concerns regarding the role of platelet-derived microparticles in restenosis, and therefore the aim of this study was to monitor levels in the coronary circulation. The study population consisted of 19 angioplasty patients. Paired coronary artery and sinus samples were obtained following heparinization, following contrast administration, and subsequent to all vessel manipulation. Platelet-derived microparticles were identified with an anti-CD61 (glycoprotein IIIa) fluorescence-conjugated antibody using flow cytometry. There was a significant decrease in arterial platelet-derived microparticles from heparinization to contrast administration (P = 0.001), followed by a significant increase to the end of angioplasty (P = 0.004). However, there was no significant change throughout the venous samples. These results indicate that the higher level of platelet-derived microparticles after angioplasty in arterial blood remained in the coronary circulation. Interestingly, levels of thrombin-antithrombin complexes did not rise during PTCA. This may have implications for the development of coronary restenosis post-PTCA, although this remains to be determined.

Topics: Angioplasty, Balloon, Coronary; Antithrombin III; Blood Platelets; Cardiovascular Agents; Combined Modality Therapy; Coronary Circulation; Coronary Restenosis; Coronary Stenosis; Coronary Vessels; Female; Humans; Integrin beta3; L-Lactate Dehydrogenase; Leukocyte Count; Male; Middle Aged; Particle Size; Peptide Hydrolases; Platelet Adhesiveness; Platelet Count; Stents; Thromboxane B2

Diabetes mellitus has been recognized as a strong predictor of heart failure (HF) in patients with acute myocardial infarction (AMI). However, considerable controversy exists regarding the pathogenetic mechanisms of HF after AMI in diabetic patients. We hypothesized that the increased incidence of HF in diabetic patients was associated with a greater propensity for left ventricular (LV) remodeling.. A series of 325 patients (42 diabetics) with AMI successfully treated with primary angioplasty underwent serial 2D echocardiography from admission to 1 and 6 months and 6-month angiography. No significant difference was found between diabetics and nondiabetics regarding baseline clinical, angiographic, and echocardiographic characteristics, as well as 6-month restenosis and reocclusion rates. At 6 months, a similar incidence of LV remodeling was observed in diabetics and nondiabetics (33% versus 25%; P=0.234), with similar patterns of changes in LV volumes and LV global and regional systolic function. At 5 years, the incidence of HF was higher in the diabetics (43% versus 20%, P=0.001). Diabetes was found to be an independent predictor of HF at 5 years (hazard ratio, 1.8; P=0.0366). However, LV remodeling was predictive of HF in the nondiabetics (P=0.023) but not in the diabetics (P=0.123). In a subgroup of patients, higher LV chamber stiffness (as assessed by echocardiography) was detected in the diabetics with HF.. The more frequent progression to HF in the diabetics after AMI is not explained by a greater propensity for LV remodeling. Other factors, such as diastolic dysfunction, may play a role.

Topics: Aged; Angioplasty, Balloon; Cardiac Catheterization; Cardiovascular Agents; Combined Modality Therapy; Coronary Restenosis; Diabetes Complications; Disease Progression; Echocardiography; Female; Follow-Up Studies; Heart Failure; Heart Ventricles; Humans; Incidence; Italy; Male; Middle Aged; Myocardial Infarction; Proportional Hazards Models; Recurrence; Systole; Treatment Outcome; Ventricular Dysfunction, Left; Ventricular Remodeling

Current guidelines for non-ST elevation acute coronary syndromes (NSTACS) recommend tailoring the intensity of therapeutic management according to the baseline risk of the patient. Although the clinical characteristics, risk stratification and therapeutic management of contemporary patients with NSTACS have been reported for other geographical regions, this information has not been documented from a Canadian perspective.. To describe the baseline clinical characteristics, therapeutic management and clinical outcomes of contemporary patients with NSTACS at a Canadian, tertiary care, teaching hospital, and to retrospectively risk stratify the patients with NSTACS according to the American College of Cardiology (ACC)/American Heart Association (AHA) and Thrombolysis in Myocardial Infarction (TIMI) risk guidelines to characterize management and outcomes according to the various risk classifications.. Baseline demographics, procedural variables and clinical outcome data were retrospectively collected in 380 patients with a diagnosis of NSTACS from July 1999 to July 2000. Patients were retrospectively categorized into high, intermediate and low risk categories using two classification schemes.. According to the ACC/AHA guidelines, 10.3% and 89.7% of patients were intermediate and high risk, respectively. Applying the TIMI risk score, 20.0%, 52.4% and 27.6% of patients were low, intermediate and high risk, respectively. The use of antithrombotic, acetylsalicylic acid and beta-blocker therapy was very high both in hospital and at discharge. Glycoprotein IIb/IIIa inhibitors, angiotensin-converting enzyme inhibitors and lipid lowering agents were all underutilized. The use of pharmacological therapies and cardiovascular interventions did not appear to correlate with the level of risk of the patient, at least within these classification schemes. Adverse clinical events in hospital and length of hospital stay increased as the risk level of the patients increased.. According to the ACC/AHA guidelines, patients with a discharge diagnosis of NSTACS in a nontrial setting are a high risk population, requiring prompt recognition and aggressive management. This study serves as an integral part of clinical practice to continually evaluate the quality of medical care.

Topics: Aged; Angioplasty, Balloon, Coronary; Cardiovascular Agents; Coronary Artery Bypass; Coronary Restenosis; Drug Utilization; Electrocardiography; Evidence-Based Medicine; Female; Follow-Up Studies; Hospitals, Teaching; Humans; Male; Middle Aged; Myocardial Infarction; Practice Guidelines as Topic; Quebec; Retrospective Studies; Risk Assessment; Stents; Survival Rate; Thrombolytic Therapy; Treatment Outcome

Topics: Cardiovascular Agents; Coronary Restenosis; Device Approval; Humans; Sirolimus; Stents

Topics: Cardiovascular Agents; Coronary Restenosis; Drug Delivery Systems; Drug Therapy; Humans; Materials Management, Hospital; Medicare; Stents; United States

Strictly intravascular approaches for the treatment of postangioplasty restenosis are effective in the intima and the inner parts of the media but may be insufficient to control redundant pathways in the more outer parts of the media and the adventitia. An inverse situation may occur subsequently to a strictly extravascular approach, like the recently suggested pericardial approach in pigs. We hypothesized that simultaneous intra/extravascular administration of anti-restenotic agents inhibits restenosis by blocking all stimulatory pathways in the entire arterial wall.. Fresh hearts of 25 domestic pigs were obtained from a local slaughterhouse. Left anterior descending coronary arteries (LAD) were harvested, cut into cylindric 5 mm segments, and cultured as ex vivo porcine organ cultures (POCs). After 9 bar ballooning simultaneous intra/extravascular administration of high dose diltiazem (50 microg/mL) was carried out for a period of 1, 2, 3, 4, 5, 6, and 7 days. At day 7 and 28 proliferative activity (BrdU), neointimal thickening, and staining against smooth muscle alpha-actin and vWF was analysed.. 7 days after ballooning administration of diltiazem for 4, 5, 6, and 7 days inhibited reactive cell proliferation by more than 50% (n.s.) as compared to control, 28 days after ballooning administration for 6 and 7 days inhibited neointimal thickening by more than 75% (p < 0.05). Simultaneous intra/extravascular administration of high dose diltiazem did not affect the expression of vWF in endothelial cells or smooth muscle alpha-actin in smooth muscle cells.. Simultaneous intra/extravascular administration of high dose diltiazem (50 microg/mL) has to be maintained for at least 6 days to achieve a significant inhibition of neointimal thickening. The data demonstrate the importance of the maximal reactive cell proliferation (= day 7 in the POC-model) for the calculation of the duration of the treatment period.

Topics: Angioplasty, Balloon; Animals; Cardiovascular Agents; Cell Division; Coronary Restenosis; Coronary Vessels; Diltiazem; Endothelium, Vascular; Hyperplasia; Muscle, Smooth, Vascular; Organ Culture Techniques; Swine; Tunica Intima

Local drug delivery from polymer-coated coronary stents may reduce the incidence of in-stent restenosis. Angiopeptin, an inhibitor of smooth muscle cell proliferation, may reduce the clinical impact of restenosis. The objectives of this study were to characterize the release kinetics and distribution of angiopeptin-loaded phosphorylcholine (PC)-coated drug delivery (DD) BiodivYsio stents and assess their safety and efficacy at reducing neointima formation. I125-angiopeptin-loaded DD-PC-coated stents were implanted into human saphenous vein segments ex vivo, and I125 angiopeptin was detected in the medial layer at 1 hour. When implanted in pig coronary arteries, I125 angiopeptin was found adjacent to the stent at intervals up to 28 days. No significant amounts were found elsewhere. To assess efficacy, twelve angiopeptin-loaded DD-PC-coated stents, twelve non-loaded DD-PC stents, ten standard PC-coated stents and 8 uncoated stents were implanted into normal porcine coronary arteries. Stents were harvested at 28 days and neointima formation was assessed by computerized morphometry. No adverse tissue reactions were seen with any of the PC-coated stents. No significant differences were seen in neointimal or luminal cross-sectional areas between study groups. Local delivery of I125 angiopeptin into the vascular wall can be achieved using a PC-coated stent. Delivery of angiopeptin from drug delivery PC-coated stents is safe, but does not lead to a significant reduction in neointimal growth at 28 days within the parameters of this study.

Topics: Animals; Cardiovascular Agents; Coated Materials, Biocompatible; Coronary Restenosis; Coronary Vessels; Humans; In Vitro Techniques; Iodine Radioisotopes; Oligopeptides; Peptides, Cyclic; Phosphorylcholine; Saphenous Vein; Somatostatin; Stents; Swine; Tunica Intima