Original Article
Safety and Efficacy of Sirolimus- and Paclitaxel-Eluting Coronary Stents
N Engl J Med 2007; 356:998-1008February 12, 2007
- Abstract
Background
The safety of drug-eluting stents has been called into question by recent reports of increased stent thrombosis, myocardial infarction, and death. Such studies have been inconclusive because of their insufficient size, the use of historical controls, a limited duration of follow-up, and a lack of access to original source data.
Methods
We performed a pooled analysis of data from four double-blind trials in which 1748 patients were randomly assigned to receive either sirolimus-eluting stents or bare-metal stents and five double-blind trials in which 3513 patients were randomly assigned to receive either paclitaxel-eluting stents or bare-metal stents; we then analyzed the major clinical end points of the trials.
Results
The 4-year rates of stent thrombosis were 1.2% in the sirolimus-stent group versus 0.6% in the bare-metal–stent group (P=0.20) and 1.3% in the paclitaxel-stent group versus 0.9% in the bare-metal–stent group (P=0.30). However, after 1 year, there were five episodes of stent thrombosis in patients with sirolimus-eluting stents versus none in patients with bare-metal stents (P=0.025) and nine episodes in patients with paclitaxel-eluting stents versus two in patients with bare-metal stents (P=0.028). The 4-year rates of target-lesion revascularization were markedly reduced in both the sirolimus-stent group and the paclitaxel-stent group, as compared with the bare-metal–stent groups. The rates of death or myocardial infarction did not differ significantly between the groups with drug-eluting stents and those with bare-metal stents.
Conclusions
Stent thrombosis after 1 year was more common with both sirolimus-eluting stents and paclitaxel-eluting stents than with bare-metal stents. Both drug-eluting stents were associated with a marked reduction in target-lesion revascularization. There were no significant differences in the cumulative rates of death or myocardial infarction at 4 years.
Media in This Article
Figure 1
Kaplan–Meier Curves Representing the Estimated 4-Year Cumulative Incidence Rates of Stent Thrombosis, Death, Myocardial Infarction, and Target-Lesion Revascularization for the Pooled Randomized Trials of Sirolimus-Eluting Stents and Bare-Metal Stents.Figure 2
Kaplan–Meier Curves Representing the Estimated 4-Year Cumulative Incidence Rates of Stent Thrombosis, Death, Myocardial Infarction, and Target-Lesion Revascularization for the Pooled Randomized Trials of Paclitaxel-Eluting Stents and Bare-Metal Stents.Article Activity
- Article
By reducing neointimal hyperplasia after vascular injury, drug-eluting coronary-artery stents decrease late luminal loss (the difference between the minimal luminal diameter immediately after the procedure and the diameter at 6 months) and angiographic restenosis, as compared with bare-metal stents. This decrease, in turn, reduces the need for subsequent revascularization procedures.1-9 Despite these benefits, drug-eluting stents may engender adverse arterial responses, including delayed endothelialization and hypersensitivity to the polymeric coating that regulates drug dose and release kinetics.10-13 Recent reports from randomized trials and observational studies using historical controls have suggested that drug-eluting stents may be associated with increased rates of late stent thrombosis and death, as compared with bare-metal stents.14-17 These studies have been inconclusive, however, because of an insufficient number of patients, the absence of concurrent controls, a limited duration of follow-up, and a lack of access to original source data. Since more than 1 million of these permanent bioactive devices are implanted in patients annually, understanding the relative safety and efficacy of drug-eluting stents represents a major public health imperative.
To address the limitations of previous studies, we performed a pooled analysis of data from four double-blind trials in which patients were randomly assigned to receive polymer-based sirolimus-eluting stents or bare-metal stents and five double-blind trials in which patients were randomly assigned to receive polymer-based paclitaxel-eluting stents or bare-metal stents. We report on the safety and efficacy of drug-eluting stents with 4-year follow-up after device implantation.
Methods
Study Description
The databases from four prospective, multicenter, double-blind, placebo-controlled randomized trials of sirolimus-eluting stents versus bare-metal stents were obtained from Cordis. These trials were the Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with De Novo Native Coronary-Artery Lesions (RAVEL), the Sirolimus-Eluting Balloon-Expandable Stent in the Treatment of Patients with De Novo Native Coronary-Artery Lesions (SIRIUS), and the smaller European and Latin American (E-SIRIUS) and Canadian (C-SIRIUS) trials.1-4 Similarly, the databases from five prospective, multicenter, double-blind, placebo-controlled, randomized trials of paclitaxel-eluting stents versus bare-metal stents were obtained from Boston Scientific. These trials consisted of the studies TAXUS-I, TAXUS-II, TAXUS-IV, TAXUS-V, and TAXUS-VI.5-9 These specific trials were selected because they are the only double-blind trials that compared each of the drug-eluting stents with bare-metal controls and that also served as the basis for the approval of the drug-eluting stents in the United States and Europe. In both cases, permission was obtained for the performance of an unrestricted, patient-level pooled analysis.
Details of the design and conduct of each of the trials included in these analyses have been reported previously.1-9 In each trial, patients with a single previously untreated native coronary-artery lesion were prospectively and randomly assigned in equal proportion to receive either a drug-eluting stent or an otherwise equivalent bare-metal stent. Entry criteria, device specifications, and geographic location varied somewhat, as outlined in Table 1Table 1
Characteristics of the Study Trials.. At the time of this report, the patients, investigators, study personnel, and sponsors were still unaware of assignments to study groups, with follow-up continuing to 5 years. Data regarding the use of aspirin and a thienopyridine were not consistently captured during follow-up. However, data on the use of antiplatelet drugs at the time of late thrombosis associated with drug-eluting stents were obtained from the manufacturers of both drug-eluting stents. No agreements with the sponsors regarding data confidentiality exist.End Points and Definitions
The goals of our study were to determine the short-term and long-term safety and efficacy of drug-eluting stents as compared with bare-metal stents. Before receiving the study databases, we specified that we would examine the following end points: stent thrombosis, as defined in the study protocols (see the Supplementary Appendix, available with the full text of this article at www.nejm.org)1-9; revascularization of the target lesion or target vessel; any myocardial infarction and Q-wave and non–Q-wave myocardial infarction; death from any cause and from cardiac and noncardiac causes; composite death or myocardial infarction; composite death or Q-wave myocardial infarction; and composite death from cardiac causes or myocardial infarction. The following time periods were prespecified for analysis of event rates: the time from stent implantation until 30 days after implantation, from 30 days after implantation until the latest follow-up, from 30 days after implantation until 1 year, from 1 year after implantation until the latest follow-up, and from the time of stent implantation until the latest follow-up.
We used data from the original databases, as defined and adjudicated by the clinical events committees for each study, in our analysis.1-9 Since the individual adverse-event narratives and original source documents were not available to us, readjudication of individual events to accommodate common definitions was not possible.
Statistical Analysis
We compared categorical variables by the chi-square test or Fisher's exact test. Continuous variables are described as means (±SD) and were compared by means of unpaired t-tests. At the time of this report, we had access to 5-year data from RAVEL and TAXUS-I; 4-year data from SIRIUS, E-SIRIUS, C-SIRIUS, TAXUS-II, and TAXUS-IV; 3-year data from TAXUS-VI; and 2-year data from TAXUS-V. We used Kaplan–Meier time-to-event estimates for the primary analyses, which were compared with the log-rank or exact log-rank test. Analyses were truncated at 4 years of follow-up owing to the small number of patients with data thereafter. We included data from all patients that were analyzed in each of the original study reports in our analysis, with follow-up data censored at the time of first event (for each specific event curve) or latest known follow-up. The Breslow–Day test for heterogeneity demonstrated that trials involving sirolimus-eluting stents and paclitaxel-eluting stents were sufficiently homogeneous to justify the pooled analyses performed. All P values are two-sided.
Results
Patients
A total of 1748 patients were randomly assigned to study groups and underwent percutaneous coronary intervention in the RAVEL and three SIRIUS trials comparing sirolimus-eluting stents with bare-metal stents (the sirolimus-stent trials). Another 3513 patients were randomly assigned to study groups and underwent percutaneous coronary intervention in the five TAXUS trials comparing paclitaxel-eluting stents with bare-metal stents (the paclitaxel-stent trials). The baseline demographic, procedural, and angiographic characteristics of the patients were well matched in both sets of trials (Table 2Table 2
Baseline Characteristics of the Patients.), except that in the sirolimus-stent trials, diabetes was slightly more prevalent among patients who received bare-metal stents than among those who received sirolimus-eluting stents. The lengths of lesions and total implanted stents were both greater in the paclitaxel-stent trials than in the sirolimus-stent trials (reflecting varying criteria for trial entry), although more stents per patient were used in the sirolimus-stent trials. Baseline reference measures of vessel diameter and lesion severity were similar for stenoses treated with both types of drug-eluting stents and for those treated with bare-metal stents.Stent Thrombosis
From stent implantation through 4-year follow-up, the rates of stent thrombosis among patients with sirolimus-eluting stents did not differ significantly from those with bare-metal stents (1.2% and 0.6%, respectively; P=0.20) (Table 3Table 3
Clinical Outcomes at 4 Years, According to Kaplan–Meier Estimates. and Figure 1Figure 1Kaplan–Meier Curves Representing the Estimated 4-Year Cumulative Incidence Rates of Stent Thrombosis, Death, Myocardial Infarction, and Target-Lesion Revascularization for the Pooled Randomized Trials of Sirolimus-Eluting Stents and Bare-Metal Stents. and Figure 2Figure 2Kaplan–Meier Curves Representing the Estimated 4-Year Cumulative Incidence Rates of Stent Thrombosis, Death, Myocardial Infarction, and Target-Lesion Revascularization for the Pooled Randomized Trials of Paclitaxel-Eluting Stents and Bare-Metal Stents.). Similarly, there were no significant differences in the 4-year cumulative rates of stent thrombosis between patients with paclitaxel-eluting stents and those with bare-metal stents (1.3% and 0.9%, respectively; P=0.30). However, between 1 and 4 years, the rates of stent thrombosis in the sirolimus-stent group and the bare-metal–stent group were 0.6% versus none (P=0.025, consistent with one extra event per 489 patient-years); during the same period, the rates in the paclitaxel-stent group and the bare-metal–stent group were 0.7% versus 0.2% (P=0.028, consistent with one extra event per 557 patient-years). After 1 year, of the five patients who had late thrombosis associated with sirolimus-eluting stents, two patients were taking aspirin and clopidogrel, two were taking only aspirin, and one was taking no antiplatelet agent. Of the nine patients with late thrombosis associated with paclitaxel-eluting stents, three were taking only aspirin, and five were taking no antiplatelet agent; the status of one patient is unknown.Revascularization
Both drug-eluting stents markedly reduced the rates of target-lesion revascularization and target-vessel revascularization at 4 years (Table 3). The difference in the rates of clinical restenosis peaked at approximately 1 year and then remained stable through 4 years of follow-up (Figure 1 and Figure 2). In the cohort of patients undergoing routine angiographic follow-up, both drug-eluting stents greatly reduced late luminal loss and binary restenosis, as compared with bare-metal stents, both in-stent (within the stent margins) and in-segment (in-stent plus 5 mm proximal and distal margins) (see the Supplementary Appendix for details).
Death and Myocardial Infarction
The cumulative 4-year rate of death from any cause in the sirolimus-stent group did not differ significantly from that in the bare-metal–stent group (6.7% vs. 5.3%, P=0.23); the difference in rates between the paclitaxel-stent group and the bare-metal–stent group was also not significant (6.1% vs. 6.6%, P=0.68) (Table 3 and Figure 1 and Figure 2). Cumulative rates of death from any cause and from cardiac and noncardiac causes were also similar in both drug-eluting–stent groups and the bare-metal–stent group at 4 years (Table 3) and during each prespecified interval (Supplementary Appendix).
The cumulative 4-year rates of myocardial infarction were similar in the sirolimus-stent group and the bare-metal–stent group (6.4% vs. 6.2%, P=0.86) and in the paclitaxel-stent group and the bare-metal–stent group (7.0% vs. 6.3%, P=0.66), with no significant differences in the rates of Q-wave or non–Q-wave myocardial infarction (Table 3 and Figure 1 and Figure 2). The rates of myocardial infarction were also similar in both drug-eluting–stent groups and bare-metal–stent group at all prespecified time periods, except that there were significantly fewer myocardial infarctions in the paclitaxel-stent group than in the bare-metal–stent group between 30 days after implantation and 1 year (0.8% vs. 1.8%, P=0.01).
There were no differences in the 4-year composite rates of death or myocardial infarction, death or Q-wave myocardial infarction, or myocardial infarction or death from cardiac causes between either drug-eluting stent and its control (Table 3) or at any interval time period (Supplementary Appendix), except that between 30 days after implantation and 1 year, the composite rate of myocardial infarction or death from cardiac causes was lower in the paclitaxel-stent group than in the bare-metal–stent group (1.4% vs. 2.5%, P=0.03). This reduction in rate was driven by a lower rate of non–Q-wave myocardial infarction in the paclitaxel-stent group than in the bare-metal–stent group (0.4% vs. 1.6%, P<0.001).
Discussion
We performed a patient-level pooled meta-analysis of four randomized, double-blind trials of sirolimus-eluting stents versus bare-metal stents and five randomized, double-blind trials of paclitaxel-eluting stents versus bare-metal stents in single, previously untreated coronary lesions through 4 years of follow-up. The principal findings were that although the overall rates of stent thrombosis were not significantly increased with drug-eluting stents, both sirolimus-eluting stents and paclitaxel-eluting stents were associated with a small but significant increase in the incidence of late stent thrombosis between 1 and 4 years after implantation. In addition, both drug-eluting stents were associated with marked reductions in ischemic target-lesion revascularization and target-vessel revascularization, an advantage that was maintained through 4 years of follow-up. The rates of death or myocardial infarction were not significantly different between the groups with drug-eluting stents and the control groups, either at 4 years of follow-up or between 1 and 4 years.
The number of episodes of stent thrombosis within the first year were identical among patients with sirolimus-eluting stents and those with bare-metal stents (5 patients with episodes in each group) and among patients with paclitaxel-eluting stents and those with bare-metal stents (12 patients in each group). Between 1 and 4 years, however, there were modest increases in stent thrombosis in both groups with drug-eluting stents, as compared with the control groups (14 patients with episodes in the groups with drug-eluting stents vs. 2 patients in the bare-metal–stent groups — a finding that is consistent with approximately one extra stent thrombosis per 500 patient-years of treatment with drug-eluting stents). Although our study does not identify the potential causes of late stent thrombosis, possible causes include delayed or incomplete endothelialization, late polymer reactions, strut fractures, positive remodeling with stent malapposition with or without aneurysm formation, and new plaque rupture either adjacent to or within the stented site, among others.10-13,18,19
Our study also demonstrates a marked and persistent reduction in target-lesion revascularization and target-vessel revascularization with both drug-eluting stents, as compared with bare-metal stents. The maximal difference between drug-eluting stents and bare-metal stents in clinical restenosis occurred by 1 year, with the hazard curves remaining parallel between 1 and 4 years. In this regard, the durability of clinical efficacy for drug-eluting stents during late follow-up stands in contradistinction to the “catch-up” phenomenon of late restenosis noted after coronary brachytherapy.20,21 Although the performance of routine angiographic follow-up may have increased the absolute difference in the rates of clinical restenosis between drug-eluting stents and bare-metal stents, the relative benefit is unlikely to have been affected.22
No significant differences in the cumulative 4-year rates of death or myocardial infarction were observed between patients receiving either drug-eluting stents or bare-metal stents. It is possible that reductions in the rates of death or myocardial infarction that otherwise might result from prevention of restenosis by drug-eluting stents may be offset by adverse events resulting from late stent thrombosis. In-stent restenosis presents as acute myocardial infarction in 3.5 to 19.4% of patients23-26 and as such is not always a benign process. However, the majority of episodes of stent thrombosis present as death or myocardial infarction.27,28 Thus, a large reduction in a phenomenon with moderate clinical risk (restenosis) may be offset by a small increase in a phenomenon with high clinical risk (stent thrombosis).
It is important to note that stent thromboses occurring subsequent to any target-lesion revascularization were excluded from the counts of episodes of stent thrombosis in most of the trials (see the definitions of stent thrombosis in the Supplementary Appendix).29 The purpose of this exclusion was to ensure that only episodes of stent thrombosis related to the original stent were included. However, the procedures to treat restenosis (balloon angioplasty, brachytherapy, or additional stenting) may result in “secondary” episodes of stent thrombosis. Such secondary stent thromboses would be expected to be more common with bare-metal stents, since revascularization procedures are much more common with these stents. Indeed, in an unpublished analysis, when such secondary episodes were considered, no overall or late differences in the patient-level rates of stent thrombosis between drug-eluting stents and bare-metal stents were present.29 Since data regarding death and myocardial infarction were not censored after target-lesion revascularization, greater rates of restenosis and secondary thrombosis with bare-metal stents than with drug-eluting stents probably contributed to the similar observed overall rates of death and myocardial infarction between the stent types in our analysis. Given the difficulties in defining stent thrombosis in the absence of angiographic confirmation or results on autopsy, greater emphasis should be placed on the occurrence of death and myocardial infarction, in our opinion, rather than on stent thrombosis, as indicative of the overall safety profile of a coronary intervention. Moreover, given the observation that the directional effect of drug-eluting stents on subsequent stent thrombosis, revascularization, death, and myocardial infarction may vary, we believe that composite measures combining safety and efficacy end points should be avoided in future trials of antirestenotic devices.
Our findings differ from those of some other investigators, who have suggested, on the basis of trial-level meta-analyses, that overall rates of stent thrombosis and death are higher with drug-eluting stents than with bare-metal stents.16,17 These discrepancies may be partially explained by the fact that we had access to the complete patient-level data from the trials we examined and did not have to rely on an estimation of event rates from limited published results, abstracts, and online summaries. We also confined our analysis to a precisely defined subgroup of clinical trials involving drug-eluting stents, whereas some previous analyses have also included later studies that were not double-blind.16
Several limitations of our analysis deserve comment. First, given the relatively infrequent occurrence of death, myocardial infarction, and stent thrombosis, larger studies with longer-term follow-up are required to detect small differences in event rates. Moreover, we made no adjustments for the multiple end points examined. The interval data analyses in particular should be considered hypothesis-generating. Second, our analysis is most applicable for patients with single, previously untreated coronary lesions, as reflected in the labels for sirolimus-eluting stents (lesions as long as 30 mm in vessels of 2.5 to 3.5 mm in diameter) and paclitaxel-eluting stents (lesions as long as 28 mm in vessels of 2.5 to 3.75 mm in diameter) that were approved by the Food and Drug Administration. The rates of stent thrombosis and the relative risk–benefit ratio of drug-eluting stents versus bare-metal stents may vary in the “real world,” in which stents are implanted in more complex scenarios (i.e., “off-label” use).27,28 Third, the nine studies we analyzed used different clinical sites, adjudication committees, and core laboratories, with possible differences in definitions and processes. Fourth, the paclitaxel-stent trials included both the commercial slow rate–release formulation and the noncommercialized moderate rate–release formulation. However, the results were directionally similar with both devices, and no major differences have been described between the two versions of this stent.6 Fifth, in five of the trials, the protocol-specified definitions of stent thrombosis after 30 days required angiographic confirmation and may therefore underestimate the true event rate. Sixth, pooling of the data from sirolimus-stent trials and paclitaxel-stent trials was avoided, since the mechanisms underlying the safety and efficacy of these two types of stents may differ. Given the different entry criteria for types of lesions in the two groups of trials, as well as the different bare-metal stents used as controls, comparisons across the two pooled meta-analyses may not be valid. Finally, detailed data regarding the use of antiplatelet medication throughout the follow-up period were not available, precluding firm recommendations regarding the optimal duration of thienopyridine administration.
In conclusion, our study examined the relative safety and efficacy of drug-eluting stents, as compared with bare-metal stents, in a pooled, patient-level analysis of double-blind, randomized trial data. The use of both sirolimus-eluting stents and paclitaxel-eluting stents was associated with a small but significant increase in the incidence of late stent thrombosis between 1 and 4 years after implantation, as compared with that of bare-metal stents. We also reconfirmed the marked benefit of both types of drug-eluting stents in reducing the need for subsequent revascularization procedures, with persistence of this benefit through 4 years of follow-up. We found no significant differences between drug-eluting stents and bare-metal stents in the rates of death or myocardial infarction.
Supported by the Cardiovascular Research Foundation.
Dr. Stone reports receiving consulting fees from Boston Scientific, Abbott, Guidant, Xtent, and BMS Imaging, receiving lecture fees from Boston Scientific, Abbott, and Medtronic, having equity interests in Devax and Xtent, and being a member of the board of directors of Devax; Dr. Moses, receiving consulting fees from Cordis; Dr. Ellis, receiving consulting fees from Boston Scientific and Cordis; Dr. Dawkins, receiving consulting fees from Boston Scientific, Abbott, Conor, and Nycomed, receiving lecture fees from Eli Lilly, and receiving research grant support from Boston Scientific; Dr. Schampaert, receiving consulting fees, lectures fees, and research grant support from Boston Scientific and Cordis and receiving lecture fees from Sanofi-Aventis; Dr. Pocock, receiving consulting fees from Boston Scientific and Conor and receiving research grant support from Boston Scientific; Dr. Mehran, receiving research grant support from Boston Scientific, the Medicines Co., Cordis, and Conor; and Dr. Leon, receiving consulting fees from Cordis, Medtronic, Boston Scientific, and OrbusNeich and having equity interests in Conor, Medinol, and OrbusNeich. Drs. Stone, Moses, Kirtane, Mehran, and Leon report that they are directors of the Cardiovascular Research Foundation, a public charity affiliated with Columbia University Medical Center, from which they receive no compensation. The Cardiovascular Research Foundation receives research or educational funding from Boston Scientific, Cordis, Sanofi-Aventis, and Bristol-Myers Squibb. Dr. Fahy is a paid employee of the Cardiovascular Research Foundation, and Dr. Pocock is a paid consultant of the Cardiovascular Research Foundation. No other potential conflict of interest relevant to this article was reported.
This article (10.1056/NEJMoa067193) was published at www.nejm.org on February 12, 2007.
Source Information
From Columbia University Medical Center and the Cardiovascular Research Foundation, New York (G.W.S., J.W.M., A.J.K., M.F., R.M., M.B.L.); Cleveland Clinic, Cleveland (S.G.E.); Hamburg University Cardiovascular Center, Hamburg, Germany (J.S.); Southampton University Hospital, Southampton, United Kingdom (K.D.D.); Institut Cardiovasculaire Paris Sud, Massy, France (M.-C.M.); San Raffaele Hospital, Milan (A.C.); Hôpital du Sacre-Coeur de Montréal, Montreal (E.S.); Heart Center Siegburg, Siegburg, Germany (E.G.); Harvard Clinical Research Institute, Boston (D.E.C.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).
Address reprint requests to Dr. Stone at Columbia University Medical Center, Cardiovascular Research Foundation, 111 E. 59th St., 11th Fl., New York, NY 10022, or at gs2184@columbia.edu.
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Citing Articles
1
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Boris Bigalke, Stephan Lindemann, Tanja Schönberger, Ilka Pohlmeyer, Amedeo Chiribiri, Andreas Schuster, Rene M. Botnar, Christoph M. Griessinger, Bernd J. Pichler, Meinrad Gawaz. (2012) Ex vivo imaging of injured arteries in rabbits using fluorescence-labelled glycoprotein VI-Fc. Platelets 23:1, 1-6
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Raban Jeger, Matthias Pfisterer, Hannes Alber, Franz Eberli, Søren Galatius, Christoph Naber, Giovanni Pedrazzini, Hans Rickli, Jan Skov Jensen, André Vuilliomenet, Nicole Gilgen, Christoph Kaiser. (2012) Newest-generation drug-eluting and bare-metal stents combined with prasugrel-based antiplatelet therapy in large coronary arteries: The BAsel Stent Kosten Effektivitäts Trial PROspective Validation Examination part II (BASKET-PROVE II) trial design. American Heart Journal 163:2, 136-141.e1
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Vivian G. Ng, Alexandra J. Lansky. (2012) The Generations of Drug-Eluting Stents and Outcomes in Women. Interventional Cardiology Clinics
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Helèn Boden, Bas L. van der Hoeven, Su-San Liem, Jael Z. Atary, Suzanne C. Cannegieter, Douwe E. Atsma, Marianne Bootsma, J. Wouter Jukema, Katja Zeppenfeld, Pranobe V. Oemrawsingh, Ernst E. van der Wall, Martin J. Schalij. (2012) Five-year clinical follow-up from the MISSION! Intervention Study: sirolimus-eluting stent versus bare metal stent implantation in patients with ST-segment elevation myocardial infarction, a randomised controlled trial. EuroIntervention 7:9, 1021-1029
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Wail Nammas. (2012) Drug-eluting stents at a crossroads: the good, the bad and the ugly. Future Cardiology 8:1, 1-3
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Gail D. Baura. 2012. Drug-Eluting Stents. , 405-421.
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Corrado Tamburino, Davide Capodanno, Maria Elena Di Salvo, Alessandra Sanfilippo, Irene Cascone, Valentina Incardona, Giovanni Longo, Daniele Giacoppo, Piera Capranzano, Carmelo Sgroi, Gianpaolo Ussia, Alfio Monaco, Alessio La Manna. (2012) Safety and effectiveness of the Catania Polyzene-F coated stent in real world clinical practice: 12-month results from the ATLANTA 2 registry. EuroIntervention 7:9, 1062-1068
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GENNARO SARDELLA, MASSIMO MANCONE, GIUSEPPE BIONDI-ZOCCAI, GIULIA CONTI, EMANUELE CANALI, ROCCO STIO, LUIGI LUCISANO, SIMONE CALCAGNO, CARLOTTA DE CARLO, FRANCESCO FEDELE. (2012) Beneficial Impact of Prolonged Dual Antiplatelet Therapy after Drug-Eluting Stent Implantation. Journal of Interventional Cardiologyno-no
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Mahn-Won Park, Sung-Ho Her, Jong Bum Kwon, Jae Beom Lee, Min-Seok Choi, Jung Sun Cho, Dong-Bin Kim, Wook-Sung Chung, Ki-Bae Seung, Keon-Yeop Kim. (2012) Safety of Dental Extractions in Coronary Drug-Eluting Stenting Patients Without Stopping Multiple Antiplatelet Agents. Clinical Cardiologyn/a-n/a
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Takenori Domei, Hiroyoshi Yokoi, Shoichi Kuramitsu, Yoshimitsu Soga, Takeshi Arita, Kenji Ando, Shinichi Shirai, Katsuhiro Kondo, Koyu Sakai, Masahiko Goya, Masashi Iwabuchi, Masayuki Ueeda, Masakiyo Nobuyoshi. (2012) Ratio of Serum n-3 to n-6 Polyunsaturated Fatty Acids and the Incidence of Major Adverse Cardiac Events in Patients Undergoing Percutaneous Coronary Intervention. Circulation Journal 76:2, 423-429
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Stuart J Head, Ad JJC Bogers, A Pieter Kappetein. (2012) Drug-eluting stent implantation for coronary artery disease: current stents and a comparison with bypass surgery. Current Opinion in Pharmacology
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K. Hamesch, P. Subramanian, X. Li, K. Dembowsky, E. Chevalier, C. Weber, A. Schober. (2012) The CXCR4 antagonist POL5551 is equally effective as sirolimus in reducing neointima formation without impairing re-endothelialisation. Thrombosis and Haemostasis 107:2,
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Jiyeon Choi, Seong Bae Cho, Bong Soo Lee, Yoon Ki Joung, Kwideok Park, Dong Keun Han. (2011) Improvement of Interfacial Adhesion of Biodegradable Polymers Coated on Metal Surface by Nanocoupling. Langmuir 27:23, 14232-14239
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Jithendra B Somaratne, Robert J Whitbourn. (2011) TAXUS ® Element™ stent system. Interventional Cardiology 3:6, 641-648
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Zachary M. Gertz, Robert L. Wilensky. (2011) Local Drug Delivery for Treatment of Coronary and Peripheral Artery Disease. Cardiovascular Therapeutics 29:6, e54-e66
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Glenn N. Levine, Eric R. Bates, James C. Blankenship, Steven R. Bailey, John A. Bittl, Bojan Cercek, Charles E. Chambers, Stephen G. Ellis, Robert A. Guyton, Steven M. Hollenberg, Umesh N. Khot, Richard A. Lange, Laura Mauri, Roxana Mehran, Issam D. Moussa, Debabrata Mukherjee, Brahmajee K. Nallamothu, Henry H. Ting. (2011) 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. Journal of the American College of Cardiology 58:24, e44-e122
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G. Lemesle, C. Delhaye. (2011) La thrombose de stent, de plus en plus rare !. Annales de Cardiologie et d'Angéiologie 60:6, 338-346
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Gennaro Sardella, Giulia Conti, Teodoro Bisceglia, Emanuele Canali, Massimo Mancone, Carlotta De Carlo, Leonardo Spedicato, Giorgio Morocutti, Francesco Fedele, Guglielmo Bernardi. (2011) Long-term outcome after drug-eluting stent implantation in unselected population: ROME and UDINE Experience (The RUDI Registry). Catheterization and Cardiovascular Interventions 78:7, 1068-1075
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Olivier Barthelemy, Gérard Helft, Johanne Silvain, Anne Bellemain-Appaix, Farzin Beygui, Rémi Choussat, Emmanuel Berman, Jean-Philippe Collet, Gilles Montalescot, Jean-Philippe Metzger, Claude Le Feuvre. (2011) One-year clinical outcomes in patients with chronic renal failure treated by percutaneous coronary intervention with drug-eluting stent. Archives of Cardiovascular Diseases 104:12, 604-610
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Herbert D. Aronow, Robert L. Strawderman, Mauro Moscucci, Mark E. Cowen. (2011) Duration of evidence-based medical therapy and the hazard for atherothrombotic events following percutaneous coronary intervention. International Journal of Cardiology 153:3, 262-266
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Giulio G Stefanini, Bindu Kalesan, Patrick W Serruys, Dik Heg, Pawel Buszman, Axel Linke, Thomas Ischinger, Volker Klauss, Franz Eberli, William Wijns, Marie-Claude Morice, Carlo Di Mario, Roberto Corti, Diethmar Antoni, Hae Y Sohn, Pedro Eerdmans, Gerrit-Anne van Es, Bernhard Meier, Stephan Windecker, Peter Jüni. (2011) Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial. The Lancet 378:9807, 1940-1948
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Giuseppe Musumeci, Emilio Di Lorenzo, Marco Valgimigli. (2011) Dual antiplatelet therapy duration. Current Opinion in Cardiology 26, S4-S14
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J. M. Chan, J.-W. Rhee, C. L. Drum, R. T. Bronson, G. Golomb, R. Langer, O. C. Farokhzad. (2011) In vivo prevention of arterial restenosis with paclitaxel-encapsulated targeted lipid-polymeric nanoparticles. Proceedings of the National Academy of Sciences 108:48, 19347-19352
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Manrico Balbi, Massimiliano Fedele, Gian P. Bezante, Claudio Brunelli, Antonio Barsotti. (2011) Acute myocardial infarction related to very late sirolimus-eluting stent thrombosis 6 months after discontinuation of dual antiplatelet therapy. Journal of Cardiovascular Medicine 12:11, 839-842
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Israel M Barbash, Ron Waksman. (2011) Current status, challenges and future directions of drug-eluting balloons. Future Cardiology 7:6, 765-774
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Dimitrios Alexopoulos. (2011) Acute myocardial infarction late following stent implantation: Incidence, mechanisms and clinical presentation. International Journal of Cardiology 152:3, 295-301
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Gilles Barone-Rochette, Alison Foote, Pascal Motreff, Gerald Vanzetto, Jean-Louis Quesada, Nicolas Danchin, Jacques Machecourt. (2011) Stent-Related Cardiac Events Beyond Three Years After Implantation of the Sirolimus-Eluting Stent (from the EVASTENT Patients). The American Journal of Cardiology 108:10, 1401-1407
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Ramesh de Silva, Christian J. Mussap, Harvey S. Hecht, Nicolas M. van Mieghem, Thomas J. Matarazzo, Gary S. Roubin, Georgia Panagopoulos. (2011) Stent sizing by coronary computed tomographic angiography: Comparison with conventional coronary angiography in an experienced setting. Catheterization and Cardiovascular Interventions 78:5, 755-763
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Kyung Woo Park, Woo-Hyun Lim, Ji-Hyun Kim, Si-Hyuck Kang, Jung-Won Seo, Young Bin Song, Joo-Yong Hahn, Hae-Young Lee, Hyun-Jae Kang, Young-Seok Cho, Tae-Jin Youn, Bon-Kwon Koo, Seung-Hyuk Choi, In-ho Chae, Hyeon-Cheol Gwon, Dong-Ju Choi, Hyo-Soo Kim. (2011) Comparison between zotarolimus-eluting stents and first generation drug-eluting stents in the treatment of patients with acute ST-segment elevation myocardial infarction. International Journal of Cardiology
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Soon Yong Suh, Kyoung Hoon Lee, Jeonggeun Moon, Woong Chol Kang, Seung Hwan Han, Tae Hoon Ahn, Eak Kyun Shin. (2011) Comparison of efficacy between paclitaxel-eluting stents with different polymers in terms of major adverse cardiac events and stent thrombosis up to 12months of clinical follow-up. International Journal of Cardiology 152:3, 392-395
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John Fani Srour, Gerald W. Smetana. (2011) Triple therapy in hospitalized patients: Facts and controversies. Journal of Hospital Medicine 6:9, 537-545
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Tomoaki Higo, Yasunori Ueda, Koshi Matsuo, Mayu Nishio, Akio Hirata, Mitsutoshi Asai, Takayoshi Nemoto, Ayaka Murakami, Kazunori Kashiwase, Kazuhisa Kodama. (2011) Risk of in-stent thrombus formation at one year after drug-eluting stent implantation. Thrombosis Research 128:5, 431-434
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Michael A. Kutcher. (2011) Second-Generation Everolimus-Eluting Stents. JACC: Cardiovascular Interventions 4:11, 1216-1217
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Michael Mahmoudi, Cedric Delhaye, Ron Waksman. (2011) Safety and efficacy of drug-eluting stents and bare metal stents in acute coronary syndrome. Cardiovascular Revascularization Medicine 12:6, 385-390
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Etienne Puymirat, Fabio Mangiacapra, Aaron Peace, Faisal Sharif, Micaela Conte, Jozef Bartunek, Marc Vanderheyden, William Wijns, Bernard de Bruyne, Emanuele Barbato. (2011) Long-term clinical outcome in patients with small vessel disease treated with drug-eluting versus bare-metal stenting. American Heart Journal 162:5, 907-913
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Bimmer E. Claessen, Pieter C. Smits, Dean J. Kereiakes, Helen Parise, Martin Fahy, Elvin Kedhi, Patrick W. Serruys, Alexandra J. Lansky, Ecaterina Cristea, Krishnankutty Sudhir, Poornima Sood, Charles A. Simonton, Gregg. W. Stone. (2011) Impact of Lesion Length and Vessel Size on Clinical Outcomes After Percutaneous Coronary Intervention With Everolimus- Versus Paclitaxel-Eluting Stents. JACC: Cardiovascular Interventions 4:11, 1209-1215
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Johannes Lammer, Dierk Scheinert, Frank Vermassen, Renate Koppensteiner, Klaus A. Hausegger, Herman Schroë, Rajeev M. Menon, Lewis B. Schwartz. (2011) Pharmacokinetic analysis after implantation of everolimus-eluting self-expanding stents in the peripheral vasculature. Journal of Vascular Surgery
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Makoto Sasaki, Motoki Inoue, Yasuyuki Katada, Tetsushi Taguchi. (2011) The effect of VEGF-immobilized nickel-free high-nitrogen stainless steel on viability and proliferation of vascular endothelial cells. Colloids and Surfaces B: Biointerfaces
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Pasi Karjalainen, Wail Nammas. (2011) Bioactive stents for percutaneous coronary intervention: a new forerunner on the track. Interventional Cardiology 3:5, 527-529
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David E. Kandzari, Colin S. Barker, Martin B. Leon, Laura Mauri, William Wijns, Jean Fajadet, Roxana Mehran. (2011) Dual Antiplatelet Therapy Duration and Clinical Outcomes Following Treatment With Zotarolimus-Eluting Stents. JACC: Cardiovascular Interventions 4:10, 1119-1128
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Usman Baber, Roxana Mehran, Samin K. Sharma, Somjot Brar, Jennifer Yu, Jung-Won Suh, Hyo-Soo Kim, Seung-Jung Park, Adnan Kastrati, Antoinette de Waha, Prakash Krishnan, Pedro Moreno, Joseph Sweeny, Michael C. Kim, Javed Suleman, Robert Pyo, Jose Wiley, Jason Kovacic, Annapoorna S. Kini, George D. Dangas. (2011) Impact of the Everolimus-Eluting Stent on Stent Thrombosis. Journal of the American College of Cardiology 58:15, 1569-1577
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MARGO KLOMP, MARCEL A.M. BEIJK, PETER DAMMAN, PIER WOUDSTRA, KAREL T. KOCH, JAN G.P. TIJSSEN, ROBBERT J. DE WINTER. (2011) Three-Year Clinical Follow-Up of an Unselected Patient Population Treated with the Genous Endothelial Progenitor Cell Capturing Stent. Journal of Interventional Cardiology 24:5, 442-449
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Emilio Lorenzo, Giannignazio Carbone, Luigi Sauro, Alfredo Casafina, Michele Capasso, Rosario Sauro. (2011) Bare-Metal Stents Versus Drug-Eluting Stents for Primary Angioplasty: Long-Term Outcome. Current Cardiology Reports 13:5, 459-464
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Didier Carrié, Hélène Eltchaninoff, Thierry Lefèvre, Marc Silvestri, Philippe Brunel, Jean Fajadet, Anouska Moynagh, Martine Gilard, René Koning, Alain Dibie, Olivier Darremont, Jean Marc Lablanche, Didier Blanchard. (2011) Early and long-term results of unprotected left main coronary artery stenosis with paclitaxel-eluting stents: the FRIEND (French multicentre registry for stenting of unprotected LMCA stenosis) registry. EuroIntervention 7:6, 680-688
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PEDRO BERALDO DE ANDRADE, MARDEN ANDRÉ TEBET, FELIPE SOUZA MAIA DA SILVA, MÔNICA VIEIRA ATHANAZIO DE ANDRADE, ANDRÉ LABRUNIE, LUIZ ALBERTO PIVA E MATTOS. (2011) Drug-Eluting Stents during ST-Segment Elevation Acute Myocardial Infarction: A Critical Analysis. Journal of Interventional Cardiology 24:5, 416-423
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David Planer, Pieter C. Smits, Dean J. Kereiakes, Elvin Kedhi, Martin Fahy, Ke Xu, Patrick W. Serruys, Gregg W. Stone. (2011) Comparison of Everolimus- and Paclitaxel-Eluting Stents in Patients With Acute and Stable Coronary Syndromes. JACC: Cardiovascular Interventions 4:10, 1104-1115
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Amir Lotfi, Jiang Cui, Siddharth Wartak, Jesse Columbo, Scott Mulvey, Mary Davis, Marc Schweiger, Gregory R. Giugliano. (2011) Influence of Low-Dose Aspirin (81 mg) on the Incidence of Definite Stent Thrombosis in Patients Receiving Bare-Metal and Drug-Eluting Stents. Clinical Cardiology 34:9, 567-571
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Kazuhiko Yumoto, Tagayasu Anzai, Hajime Aoki, Akira Inoue, Shuhei Funada, Hiroki Nishiyama, Shingo Tanaka, Shinya Kowase, Yasuhiro Shirai, Kenji Kurosaki, Akihiko Nogami, Hiroyuki Daida, Kenichi Kato. (2011) Calcified plaque rupture and very late stent thrombosis after bare-metal stent implantation. Cardiovascular Intervention and Therapeutics 26:3, 252-259
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Ali H. Al-Fiadh, Nick Andrianopoulos, Omar Farouque, Bryan P. Yan, Stephen J. Duffy, Kerrie Charter, Surat Tongyoo, Gishel New, Thomas Yip, Angela Brennan, George Proimos, Christopher M. Reid, Andrew E. Ajani, David J. Clark. (2011) Contemporary outcomes in women undergoing percutaneous coronary intervention for acute coronary syndromes. International Journal of Cardiology 151:2, 195-199
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Yoshihiro Yamamoto, Hajime Otani, Junji Iwasaka, Haengnam Park, Takao Sakuma, Hiroshi Kamihata, Toshiji Iwasaka. (2011) Comparison of neointimal morphology of in-stent restenosis with sirolimus-eluting stents versus bare metal stents: virtual histology-intravascular ultrasound analysis. Cardiovascular Intervention and Therapeutics 26:3, 186-192
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Takahide Arai, Akio Kawamura, Yumiko Matsubara, Kenji Yokoyama, Yasuo Ikeda, Keiichi Fukuda, Mitsuru Murata. (2011) Effect of chronic kidney disease on platelet reactivity to dual-antiplatelet therapy in patients treated with drug-eluting stents. Heart and Vessels
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Volker Klauss, Patrick W. Serruys, Thomas Pilgrim, Pawel Buszman, Axel Linke, Thomas Ischinger, Franz Eberli, Roberto Corti, William Wijns, Marie-Claude Morice, Carlo di Mario, Robert Jan van Geuns, Gerrit-Anne van Es, Bindu Kalesan, Peter Wenaweser, Peter Jüni, Stephan Windecker. (2011) 2-Year Clinical Follow-Up From the Randomized Comparison of Biolimus-Eluting Stents With Biodegradable Polymer and Sirolimus-Eluting Stents With Durable Polymer in Routine Clinical Practice. JACC: Cardiovascular Interventions 4:8, 887-895
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Marcel A.M. Beijk, Margo Klomp, Nan van Geloven, Karel T. Koch, José P.S. Henriques, Jan Baan, Marije M. Vis, Jan G.P. Tijssen, Jan J. Piek, Robbert J. de Winter. (2011) Two-year follow-up of the genous™ endothelial progenitor cell capturing stent versus the taxus liberté stent in patients with De Novo coronary artery lesions with a high-risk of restenosis. Catheterization and Cardiovascular Interventions 78:2, 189-195
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Christine K Kissel, Christoph Kaiser. (2011) The BASKET study program: continued evaluation of the efficacy and safety of drug-eluting stents. Interventional Cardiology 3:4, 461-466
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Corrado Tamburino, Daniele Giacoppo, Davide Capodanno. (2011) The Rapid Evaluation of Vessel Healing after Angioplasty (REVEAL) trial. Interventional Cardiology 3:4, 451-460
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Kyung Woo Park, Si-Hyuck Kang, Keun-Ho Park, Dong-Hyun Choi, Hae-Young Lee, Hyun-Jae Kang, Young-Seok Cho, Tae-Jin Yeon, Woo-Young Chung, Bon-Kwon Koo, In-Ho Chae, Dong-Ju Choi, Byung-Hee Oh, Young-Bae Park, Hyo-Soo Kim. (2011) Sirolimus- vs. paclitaxel-eluting stents for the treatment of unprotected left main coronary artery stenosis: Complete 2-year follow-up of a two-center registry. International Journal of Cardiology 151:1, 89-95
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LOIC BELLE, MICHAEL MAHMOUDI, CEDRIC DELHAYE, ITSIK BEN-DOR, GABRIEL MALUENDA, MICHAEL A. GAGLIA Jr., REBECCA TORGUSON, LOWELL F. SATLER, AUGUSTO D. PICHARD, RON WAKSMAN. (2011) Do Patients with Drug-Eluting Stent Thrombosis Have a Similar Prognosis to Patients Presenting with ST-Elevation Myocardial Infarction of de novo Lesions?. Journal of Interventional Cardiology 24:4, 320-325
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C-L. Poh, M. Y. Chan, C. Lau, S-G. Teo, A. F. Low, H-C. Tan, C-H. Lee. (2011) Prevalence and predictors of premature discontinuation of dual antiplatelet therapy after drug-eluting stent implantation: importance of social factors in Asian patients. Internal Medicine Journal 41:8, 623-629
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Salvatore Cassese, Raffaele Piccolo, Gennaro Galasso, Roberta De Rosa, Federico Piscione. (2011) Twelve-month clinical outcomes of everolimus-eluting stent as compared to paclitaxel- and sirolimus-eluting stent in patients undergoing percutaneous coronary interventions. A meta-analysis of randomized clinical trials. International Journal of Cardiology 150:1, 84-89
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Brendan Bell, Jamie Layland, Karl Poon, Christian Spaulding, Darren Walters. (2011) Focused Clinical Review: Periprocedural Management of Antiplatelet Therapy in Patients with Coronary Stents. Heart, Lung and Circulation 20:7, 438-445
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Aida Ribera, Ignacio Ferreira-González, Bruno García del Blanco, Josep R. Marsal, Purificación Cascant, Gerard Martí, Ángel R. Cequier, Joan Antoni Gómez-Hospital, Eduard Fernandez-Nofrerías, Xavier Carrillo, M. Carmen López-Pérez, Josep Navarro, Rafael Raso, David García-Dorado, Gaietà Permanyer-Miralda. (2011) Drug-eluting stents for off-label indications in real clinical world: Evidence based or ‘intuition’ based clinical practice?. International Journal of Cardiology
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Young-Guk Ko, Dong-Min Kim, Jin Man Cho, So Yeon Choi, Jung Han Yoon, Jung-Sun Kim, Byeong-Keuk Kim, Donghoon Choi, Yangsoo Jang, Myeong-Ki Hong. (2011) Optical coherence tomography findings of very late stent thrombosis after drug-eluting stent implantation. The International Journal of Cardiovascular Imaging
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Lorenz Räber, Stephan Windecker. (2011) Current Status of Drug-Eluting Stents. Cardiovascular Therapeutics 29:3, 176-189
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Michael Mahmoudi, Cedric Delhaye, Kohei Wakabayashi, Itsik Ben-Dor, Manuel A. Gonzalez, Gabriel Maluenda, Michael A. Gaglia, Rebecca Torguson, Zhenyi Xue, William O. Suddath, Lowell F. Satler, Kenneth M. Kent, Augusto D. Pichard, Ron Waksman. (2011) Outcomes After Unrestricted Use of Everolimus-Eluting Stent Compared to Paclitaxel- and Sirolimus-Eluting Stents. The American Journal of Cardiology 107:12, 1757-1762
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Masato Nakamura. (2011) Review of the everolimus-eluting coronary stent system. Interventional Cardiology 3:3, 299-307
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Paolo Ortolani, Emilia Solinas, Paolo Guastaroba, Gianni Casella, Antonio Manari, Giancarlo Piovaccari, Marco Balducelli, Stefano Tondi, Gianfranco Percoco, Fabio Tarantino, Francesco Passerini, Rosario Rossi, Luigi Vignali, Rossana De Palma, Roberto Grilli, Antonio Marzocchi. (2011) Long-term clinical outcomes after drug eluting stent implantation in women with de novo coronary lesions. International Journal of Cardiology 149:1, 55-62
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R. Scott Wright, Jeffrey L. Anderson, Cynthia D. Adams, Charles R. Bridges, Donald E. Casey, Steven M. Ettinger, Francis M. Fesmire, Theodore G. Ganiats, Hani Jneid, A. Michael Lincoff, Eric D. Peterson, George J. Philippides, Pierre Theroux, Nanette K. Wenger, James Patrick Zidar. (2011) 2011 ACCF/AHA Focused Update Incorporated Into the ACC/AHA 2007 Guidelines for the Management of Patients With Unstable Angina/Non–ST-Elevation Myocardial Infarction. Journal of the American College of Cardiology 57:19, e215-e367
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Editorials published in JACC: Cardiovascular Interventions reflect the views of the authors and do not necessarily represent the views of JACC: Cardiovascular Interventions or the American College of Cardiology.. JACC: Cardiovascular Interventions 2:6, 513-514
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