Safety and Efficacy of Sirolimus- and Paclitaxel-Eluting Coronary Stents
Gregg W. Stone, M.D., Jeffrey W. Moses, M.D., Stephen G. Ellis, M.D., Joachim Schofer, M.D., Keith D. Dawkins, M.D., Marie-Claude Morice, M.D., Antonio Colombo, M.D., Erick Schampaert, M.D., Eberhard Grube, M.D., Ajay J. Kirtane, M.D., Donald E. Cutlip, M.D., Martin Fahy, M.Sc., Stuart J. Pocock, Ph.D., Roxana Mehran, M.D., and Martin B. Leon, M.D.
Background The safety of drug-eluting stents has been calledinto question by recent reports of increased stent thrombosis,myocardial infarction, and death. Such studies have been inconclusivebecause of their insufficient size, the use of historical controls,a limited duration of follow-up, and a lack of access to originalsource data.
Methods We performed a pooled analysis of data from four double-blindtrials in which 1748 patients were randomly assigned to receiveeither sirolimus-eluting stents or bare-metal stents and fivedouble-blind trials in which 3513 patients were randomly assignedto 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 thesirolimus-stent group versus 0.6% in the bare-metal–stentgroup (P=0.20) and 1.3% in the paclitaxel-stent group versus0.9% in the bare-metal–stent group (P=0.30). However,after 1 year, there were five episodes of stent thrombosis inpatients with sirolimus-eluting stents versus none in patientswith bare-metal stents (P=0.025) and nine episodes in patientswith paclitaxel-eluting stents versus two in patients with bare-metalstents (P=0.028). The 4-year rates of target-lesion revascularizationwere markedly reduced in both the sirolimus-stent group andthe paclitaxel-stent group, as compared with the bare-metal–stentgroups. The rates of death or myocardial infarction did notdiffer significantly between the groups with drug-eluting stentsand those with bare-metal stents.
Conclusions Stent thrombosis after 1 year was more common withboth sirolimus-eluting stents and paclitaxel-eluting stentsthan with bare-metal stents. Both drug-eluting stents were associatedwith a marked reduction in target-lesion revascularization.There were no significant differences in the cumulative ratesof death or myocardial infarction at 4 years.
By reducing neointimal hyperplasia after vascular injury, drug-elutingcoronary-artery stents decrease late luminal loss (the differencebetween the minimal luminal diameter immediately after the procedureand the diameter at 6 months) and angiographic restenosis, ascompared with bare-metal stents. This decrease, in turn, reducesthe need for subsequent revascularization procedures.1,2,3,4,5,6,7,8,9Despite these benefits, drug-eluting stents may engender adversearterial responses, including delayed endothelialization andhypersensitivity to the polymeric coating that regulates drugdose and release kinetics.10,11,12,13 Recent reports from randomizedtrials and observational studies using historical controls havesuggested that drug-eluting stents may be associated with increasedrates of late stent thrombosis and death, as compared with bare-metalstents.14,15,16,17 These studies have been inconclusive, however,because of an insufficient number of patients, the absence ofconcurrent controls, a limited duration of follow-up, and alack of access to original source data. Since more than 1 millionof these permanent bioactive devices are implanted in patientsannually, understanding the relative safety and efficacy ofdrug-eluting stents represents a major public health imperative.
To address the limitations of previous studies, we performeda pooled analysis of data from four double-blind trials in whichpatients were randomly assigned to receive polymer-based sirolimus-elutingstents or bare-metal stents and five double-blind trials inwhich patients were randomly assigned to receive polymer-basedpaclitaxel-eluting stents or bare-metal stents. We report onthe safety and efficacy of drug-eluting stents with 4-year follow-upafter device implantation.
Methods
Study Description
The databases from four prospective, multicenter, double-blind,placebo-controlled randomized trials of sirolimus-eluting stentsversus bare-metal stents were obtained from Cordis. These trialswere the Randomized Study with the Sirolimus-Coated Bx VelocityBalloon-Expandable Stent in the Treatment of Patients with DeNovo Native Coronary-Artery Lesions (RAVEL), the Sirolimus-ElutingBalloon-Expandable Stent in the Treatment of Patients with DeNovo Native Coronary-Artery Lesions (SIRIUS), and the smallerEuropean and Latin American (E-SIRIUS) and Canadian (C-SIRIUS)trials.1,2,3,4 Similarly, the databases from five prospective,multicenter, double-blind, placebo-controlled, randomized trialsof paclitaxel-eluting stents versus bare-metal stents were obtainedfrom Boston Scientific. These trials consisted of the studiesTAXUS-I, TAXUS-II, TAXUS-IV, TAXUS-V, and TAXUS-VI.5,6,7,8,9These specific trials were selected because they are the onlydouble-blind trials that compared each of the drug-eluting stentswith bare-metal controls and that also served as the basis forthe approval of the drug-eluting stents in the United Statesand Europe. In both cases, permission was obtained for the performanceof an unrestricted, patient-level pooled analysis.
Details of the design and conduct of each of the trials includedin these analyses have been reported previously.1,2,3,4,5,6,7,8,9In each trial, patients with a single previously untreated nativecoronary-artery lesion were prospectively and randomly assignedin equal proportion to receive either a drug-eluting stent oran otherwise equivalent bare-metal stent. Entry criteria, devicespecifications, and geographic location varied somewhat, asoutlined in Table 1. At the time of this report, the patients,investigators, study personnel, and sponsors were still unawareof assignments to study groups, with follow-up continuing to5 years. Data regarding the use of aspirin and a thienopyridinewere not consistently captured during follow-up. However, dataon the use of antiplatelet drugs at the time of late thrombosisassociated with drug-eluting stents were obtained from the manufacturersof both drug-eluting stents. No agreements with the sponsorsregarding data confidentiality exist.
The goals of our study were to determine the short-term andlong-term safety and efficacy of drug-eluting stents as comparedwith 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 theSupplementary Appendix, available with the full text of thisarticle at www.nejm.org)1,2,3,4,5,6,7,8,9; revascularizationof the target lesion or target vessel; any myocardial infarctionand Q-wave and non–Q-wave myocardial infarction; deathfrom any cause and from cardiac and noncardiac causes; compositedeath or myocardial infarction; composite death or Q-wave myocardialinfarction; and composite death from cardiac causes or myocardialinfarction. The following time periods were prespecified foranalysis of event rates: the time from stent implantation until30 days after implantation, from 30 days after implantationuntil the latest follow-up, from 30 days after implantationuntil 1 year, from 1 year after implantation until the latestfollow-up, and from the time of stent implantation until thelatest follow-up.
We used data from the original databases, as defined and adjudicatedby the clinical events committees for each study, in our analysis.1,2,3,4,5,6,7,8,9Since the individual adverse-event narratives and original sourcedocuments were not available to us, readjudication of individualevents to accommodate common definitions was not possible.
Statistical Analysis
We compared categorical variables by the chi-square test orFisher'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 fromRAVEL 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-yeardata from TAXUS-V. We used Kaplan–Meier time-to-eventestimates for the primary analyses, which were compared withthe log-rank or exact log-rank test. Analyses were truncatedat 4 years of follow-up owing to the small number of patientswith data thereafter. We included data from all patients thatwere analyzed in each of the original study reports in our analysis,with follow-up data censored at the time of first event (foreach specific event curve) or latest known follow-up. The Breslow–Daytest for heterogeneity demonstrated that trials involving sirolimus-elutingstents and paclitaxel-eluting stents were sufficiently homogeneousto justify the pooled analyses performed. All P values are two-sided.
Results
Patients
A total of 1748 patients were randomly assigned to study groupsand underwent percutaneous coronary intervention in the RAVELand three SIRIUS trials comparing sirolimus-eluting stents withbare-metal stents (the sirolimus-stent trials). Another 3513patients were randomly assigned to study groups and underwentpercutaneous coronary intervention in the five TAXUS trialscomparing paclitaxel-eluting stents with bare-metal stents (thepaclitaxel-stent trials). The baseline demographic, procedural,and angiographic characteristics of the patients were well matchedin both sets of trials (Table 2), except that in the sirolimus-stenttrials, diabetes was slightly more prevalent among patientswho received bare-metal stents than among those who receivedsirolimus-eluting stents. The lengths of lesions and total implantedstents were both greater in the paclitaxel-stent trials thanin the sirolimus-stent trials (reflecting varying criteria fortrial entry), although more stents per patient were used inthe sirolimus-stent trials. Baseline reference measures of vesseldiameter and lesion severity were similar for stenoses treatedwith both types of drug-eluting stents and for those treatedwith bare-metal stents.
Table 2. Baseline Characteristics of the Patients.
Stent Thrombosis
From stent implantation through 4-year follow-up, the ratesof stent thrombosis among patients with sirolimus-eluting stentsdid not differ significantly from those with bare-metal stents(1.2% and 0.6%, respectively; P=0.20) (Table 3 and Figure 1and Figure 2). Similarly, there were no significant differencesin the 4-year cumulative rates of stent thrombosis between patientswith paclitaxel-eluting stents and those with bare-metal stents(1.3% and 0.9%, respectively; P=0.30). However, between 1 and4 years, the rates of stent thrombosis in the sirolimus-stentgroup and the bare-metal–stent group were 0.6% versusnone (P=0.025, consistent with one extra event per 489 patient-years);during the same period, the rates in the paclitaxel-stent groupand the bare-metal–stent group were 0.7% versus 0.2% (P=0.028,consistent with one extra event per 557 patient-years). After1 year, of the five patients who had late thrombosis associatedwith sirolimus-eluting stents, two patients were taking aspirinand clopidogrel, two were taking only aspirin, and one was takingno antiplatelet agent. Of the nine patients with late thrombosisassociated with paclitaxel-eluting stents, three were takingonly aspirin, and five were taking no antiplatelet agent; thestatus of one patient is unknown.
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.
The number of patients at risk each year is provided, equal to the number of patients for whom follow-up data were available at each time minus those with earlier events. The median duration of follow-up was 4.0 years.
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.
The number of patients at risk each year is provided, equal to the number of patients for whom follow-up data were available at each time minus those with earlier events. The median duration of follow-up was 3.2 years.
Revascularization
Both drug-eluting stents markedly reduced the rates of target-lesionrevascularization and target-vessel revascularization at 4 years(Table 3). The difference in the rates of clinical restenosispeaked at approximately 1 year and then remained stable through4 years of follow-up (Figure 1 and Figure 2). In the cohortof patients undergoing routine angiographic follow-up, bothdrug-eluting stents greatly reduced late luminal loss and binaryrestenosis, as compared with bare-metal stents, both in-stent(within the stent margins) and in-segment (in-stent plus 5 mmproximal and distal margins) (see the Supplementary Appendixfor details).
Death and Myocardial Infarction
The cumulative 4-year rate of death from any cause in the sirolimus-stentgroup did not differ significantly from that in the bare-metal–stentgroup (6.7% vs. 5.3%, P=0.23); the difference in rates betweenthe paclitaxel-stent group and the bare-metal–stent groupwas also not significant (6.1% vs. 6.6%, P=0.68) (Table 3 andFigure 1 and Figure 2). Cumulative rates of death from any causeand from cardiac and noncardiac causes were also similar inboth drug-eluting–stent groups and the bare-metal–stentgroup at 4 years (Table 3) and during each prespecified interval(Supplementary Appendix).
The cumulative 4-year rates of myocardial infarction were similarin the sirolimus-stent group and the bare-metal–stentgroup (6.4% vs. 6.2%, P=0.86) and in the paclitaxel-stent groupand 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-wavemyocardial infarction (Table 3 and Figure 1 and Figure 2). Therates of myocardial infarction were also similar in both drug-eluting–stentgroups and bare-metal–stent group at all prespecifiedtime periods, except that there were significantly fewer myocardialinfarctions in the paclitaxel-stent group than in the bare-metal–stentgroup 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 deathor myocardial infarction, death or Q-wave myocardial infarction,or myocardial infarction or death from cardiac causes betweeneither drug-eluting stent and its control (Table 3) or at anyinterval time period (Supplementary Appendix), except that between30 days after implantation and 1 year, the composite rate ofmyocardial infarction or death from cardiac causes was lowerin the paclitaxel-stent group than in the bare-metal–stentgroup (1.4% vs. 2.5%, P=0.03). This reduction in rate was drivenby a lower rate of non–Q-wave myocardial infarction inthe paclitaxel-stent group than in the bare-metal–stentgroup (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-metalstents and five randomized, double-blind trials of paclitaxel-elutingstents versus bare-metal stents in single, previously untreatedcoronary lesions through 4 years of follow-up. The principalfindings were that although the overall rates of stent thrombosiswere not significantly increased with drug-eluting stents, bothsirolimus-eluting stents and paclitaxel-eluting stents wereassociated with a small but significant increase in the incidenceof late stent thrombosis between 1 and 4 years after implantation.In addition, both drug-eluting stents were associated with markedreductions in ischemic target-lesion revascularization and target-vesselrevascularization, an advantage that was maintained through4 years of follow-up. The rates of death or myocardial infarctionwere not significantly different between the groups with drug-elutingstents and the control groups, either at 4 years of follow-upor between 1 and 4 years.
The number of episodes of stent thrombosis within the firstyear were identical among patients with sirolimus-eluting stentsand those with bare-metal stents (5 patients with episodes ineach group) and among patients with paclitaxel-eluting stentsand those with bare-metal stents (12 patients in each group).Between 1 and 4 years, however, there were modest increasesin stent thrombosis in both groups with drug-eluting stents,as compared with the control groups (14 patients with episodesin the groups with drug-eluting stents vs. 2 patients in thebare-metal–stent groups — a finding that is consistentwith approximately one extra stent thrombosis per 500 patient-yearsof treatment with drug-eluting stents). Although our study doesnot identify the potential causes of late stent thrombosis,possible causes include delayed or incomplete endothelialization,late polymer reactions, strut fractures, positive remodelingwith stent malapposition with or without aneurysm formation,and new plaque rupture either adjacent to or within the stentedsite, among others.10,11,12,13,18,19
Our study also demonstrates a marked and persistent reductionin target-lesion revascularization and target-vessel revascularizationwith both drug-eluting stents, as compared with bare-metal stents.The maximal difference between drug-eluting stents and bare-metalstents in clinical restenosis occurred by 1 year, with the hazardcurves remaining parallel between 1 and 4 years. In this regard,the durability of clinical efficacy for drug-eluting stentsduring late follow-up stands in contradistinction to the "catch-up"phenomenon of late restenosis noted after coronary brachytherapy.20,21Although the performance of routine angiographic follow-up mayhave increased the absolute difference in the rates of clinicalrestenosis 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 ofdeath or myocardial infarction were observed between patientsreceiving either drug-eluting stents or bare-metal stents. Itis possible that reductions in the rates of death or myocardialinfarction that otherwise might result from prevention of restenosisby drug-eluting stents may be offset by adverse events resultingfrom late stent thrombosis. In-stent restenosis presents asacute myocardial infarction in 3.5 to 19.4% of patients23,24,25,26and as such is not always a benign process. However, the majorityof episodes of stent thrombosis present as death or myocardialinfarction.27,28 Thus, a large reduction in a phenomenon withmoderate clinical risk (restenosis) may be offset by a smallincrease in a phenomenon with high clinical risk (stent thrombosis).
It is important to note that stent thromboses occurring subsequentto any target-lesion revascularization were excluded from thecounts of episodes of stent thrombosis in most of the trials(see the definitions of stent thrombosis in the Supplementary Appendix).29The purpose of this exclusion was to ensure that only episodesof 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 thromboseswould be expected to be more common with bare-metal stents,since revascularization procedures are much more common withthese stents. Indeed, in an unpublished analysis, when suchsecondary episodes were considered, no overall or late differencesin the patient-level rates of stent thrombosis between drug-elutingstents and bare-metal stents were present.29 Since data regardingdeath and myocardial infarction were not censored after target-lesionrevascularization, greater rates of restenosis and secondarythrombosis with bare-metal stents than with drug-eluting stentsprobably contributed to the similar observed overall rates ofdeath and myocardial infarction between the stent types in ouranalysis. Given the difficulties in defining stent thrombosisin the absence of angiographic confirmation or results on autopsy,greater emphasis should be placed on the occurrence of deathand myocardial infarction, in our opinion, rather than on stentthrombosis, as indicative of the overall safety profile of acoronary intervention. Moreover, given the observation thatthe directional effect of drug-eluting stents on subsequentstent thrombosis, revascularization, death, and myocardial infarctionmay vary, we believe that composite measures combining safetyand efficacy end points should be avoided in future trials ofantirestenotic 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 higherwith drug-eluting stents than with bare-metal stents.16,17 Thesediscrepancies may be partially explained by the fact that wehad access to the complete patient-level data from the trialswe examined and did not have to rely on an estimation of eventrates from limited published results, abstracts, and onlinesummaries. We also confined our analysis to a precisely definedsubgroup of clinical trials involving drug-eluting stents, whereassome previous analyses have also included later studies thatwere not double-blind.16
Several limitations of our analysis deserve comment. First,given the relatively infrequent occurrence of death, myocardialinfarction, and stent thrombosis, larger studies with longer-termfollow-up are required to detect small differences in eventrates. Moreover, we made no adjustments for the multiple endpoints examined. The interval data analyses in particular shouldbe considered hypothesis-generating. Second, our analysis ismost applicable for patients with single, previously untreatedcoronary lesions, as reflected in the labels for sirolimus-elutingstents (lesions as long as 30 mm in vessels of 2.5 to 3.5 mmin diameter) and paclitaxel-eluting stents (lesions as longas 28 mm in vessels of 2.5 to 3.75 mm in diameter) that wereapproved by the Food and Drug Administration. The rates of stentthrombosis and the relative risk–benefit ratio of drug-elutingstents 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 useddifferent clinical sites, adjudication committees, and corelaboratories, with possible differences in definitions and processes.Fourth, the paclitaxel-stent trials included both the commercialslow rate–release formulation and the noncommercializedmoderate rate–release formulation. However, the resultswere directionally similar with both devices, and no major differenceshave been described between the two versions of this stent.6Fifth, in five of the trials, the protocol-specified definitionsof stent thrombosis after 30 days required angiographic confirmationand may therefore underestimate the true event rate. Sixth,pooling of the data from sirolimus-stent trials and paclitaxel-stenttrials was avoided, since the mechanisms underlying the safetyand efficacy of these two types of stents may differ. Giventhe different entry criteria for types of lesions in the twogroups of trials, as well as the different bare-metal stentsused as controls, comparisons across the two pooled meta-analysesmay not be valid. Finally, detailed data regarding the use ofantiplatelet medication throughout the follow-up period werenot available, precluding firm recommendations regarding theoptimal duration of thienopyridine administration.
In conclusion, our study examined the relative safety and efficacyof drug-eluting stents, as compared with bare-metal stents,in a pooled, patient-level analysis of double-blind, randomizedtrial data. The use of both sirolimus-eluting stents and paclitaxel-elutingstents was associated with a small but significant increasein the incidence of late stent thrombosis between 1 and 4 yearsafter implantation, as compared with that of bare-metal stents.We also reconfirmed the marked benefit of both types of drug-elutingstents in reducing the need for subsequent revascularizationprocedures, with persistence of this benefit through 4 yearsof follow-up. We found no significant differences between drug-elutingstents and bare-metal stents in the rates of death or myocardialinfarction.
Supported by the Cardiovascular Research Foundation.
Dr. Stone reports receiving consulting fees from Boston Scientific,Abbott, Guidant, Xtent, and BMS Imaging, receiving lecture feesfrom Boston Scientific, Abbott, and Medtronic, having equityinterests in Devax and Xtent, and being a member of the boardof directors of Devax; Dr. Moses, receiving consulting feesfrom Cordis; Dr. Ellis, receiving consulting fees from BostonScientific and Cordis; Dr. Dawkins, receiving consulting feesfrom Boston Scientific, Abbott, Conor, and Nycomed, receivinglecture fees from Eli Lilly, and receiving research grant supportfrom Boston Scientific; Dr. Schampaert, receiving consultingfees, lectures fees, and research grant support from BostonScientific and Cordis and receiving lecture fees from Sanofi-Aventis;Dr. Pocock, receiving consulting fees from Boston Scientificand 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, receivingconsulting fees from Cordis, Medtronic, Boston Scientific, andOrbusNeich and having equity interests in Conor, Medinol, andOrbusNeich. Drs. Stone, Moses, Kirtane, Mehran, and Leon reportthat they are directors of the Cardiovascular Research Foundation,a public charity affiliated with Columbia University MedicalCenter, from which they receive no compensation. The CardiovascularResearch Foundation receives research or educational fundingfrom Boston Scientific, Cordis, Sanofi-Aventis, and Bristol-MyersSquibb. Dr. Fahy is a paid employee of the Cardiovascular ResearchFoundation, and Dr. Pocock is a paid consultant of the CardiovascularResearch Foundation. No other potential conflict of interestrelevant to this article was reported.
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.). This article (10.1056/NEJMoa067193) was published at www.nejm.org on February 12, 2007.
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{at}columbia.edu.
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