Background The long-term effects of treatment with sirolimus-elutingstents, as compared with bare-metal stents, have not been established.
Methods We performed an analysis of individual data on 4958patients enrolled in 14 randomized trials comparing sirolimus-elutingstents with bare-metal stents (mean follow-up interval, 12.1to 58.9 months). The primary end point was death from any cause.Other outcomes were stent thrombosis, the composite end pointof death or myocardial infarction, and the composite of death,myocardial infarction, or reintervention.
Results The overall risk of death (hazard ratio, 1.03; 95% confidenceinterval [CI], 0.80 to 1.30) and the combined risk of deathor myocardial infarction (hazard ratio, 0.97; 95% CI, 0.81 to1.16) were not significantly different for patients receivingsirolimus-eluting stents versus bare-metal stents. There wasa significant reduction in the combined risk of death, myocardialinfarction, or reintervention (hazard ratio, 0.43; 95% CI, 0.34to 0.54) associated with the use of sirolimus-eluting stents.There was no significant difference in the overall risk of stentthrombosis with sirolimus-eluting stents versus bare-metal stents(hazard ratio, 1.09; 95% CI, 0.64 to 1.86). However, there wasevidence of a slight increase in the risk of stent thrombosisassociated with sirolimus-eluting stents after the first year.
Conclusions The use of sirolimus-eluting stents does not havea significant effect on overall long-term survival and survivalfree of myocardial infarction, as compared with bare-metal stents.There is a sustained reduction in the need for reinterventionafter the use of sirolimus-eluting stents. The risk of stentthrombosis is at least as great as that seen with bare-metalstents.
Restenosis after percutaneous coronary intervention (PCI) reducesthe quality of life and increases the morbidity of patientswith this complication1; it may even increase the risk of death.2Drug-eluting stents are highly effective in preventing restenosisafter PCI.3 It has been anticipated that by reducing the rateof restenosis, drug-eluting stents may have the potential toimprove the long-term prognosis of patients treated with thesedevices. However, initial randomized studies focused on restenosisitself and had insufficient power and duration to assess theincidence of less frequent adverse events, such as death.
Recent reports have identified pathologic responses of the vesselwall to drug-eluting stents that may serve as precursors toadverse clinical events.4 Such studies have raised concern thatdrug-eluting stents might actually worsen, rather than improve,long-term prognosis. However, efforts to examine this issueby combining data from previous randomized trials have beenlimited to published trial-level data and have not includedall the relevant studies.5,6,7 The aim of this study was toassess the long-term outcome after implantation of sirolimus-elutingstents on the basis of data from individual patients from randomizedclinical trials comparing this device with bare-metal stents.
Methods
Inclusion Criteria
We included in our analysis the results of randomized clinicaltrials that compared sirolimus-eluting stents (Cypher or CypherSelect, Cordis) with bare-metal stents for management of coronaryartery disease if results for a mean follow-up period of atleast 1 year were reported or made available by the trials'investigators or sponsors.
Data Sources
We searched the National Library of Medicine (PubMed, at www.pubmed.gov),the National Institutes of Health clinical trials registry (www.clinicaltrials.gov),and the Cochrane Central Register of Controlled Trials (www.mrw.interscience.wiley.com/cochrane/cochrane_clcentral_articles_fs.html)for randomized trials comparing sirolimus-eluting stents withbare-metal stents in patients with coronary artery disease.We also searched Internet-based sources of information on theresults of clinical trials in cardiology (www.cardiosource.com/clinicaltrials,www.theheart.org, www.clinicaltrialresults.com. and www.tctmd.com),as well as conference proceedings from meetings of the AmericanCollege of Cardiology, the American Heart Association, and theEuropean Society of Cardiology. Relevant reviews and editorialspublished within the past year in major medical journals wereidentified and assessed for possible information on trials ofinterest. Searches were restricted to the period from January2002 through September 2006.
We found and screened 16 randomized trials,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23the main characteristics of which are shown in Table 1. Tworandomized trials, Reduction of Restenosis in Saphenous VeinGrafts with Cypher Sirolimus-Eluting Stent (RRISC)16 and Sirolimus-ElutingStent in the Prevention of Restenosis in Small Coronary Arteries(SES-SMART),19 were not included in this analysis because eachhad a mean follow-up of less than 1 year; the findings of thesetrials are displayed in Table 1 of the Supplementary Appendix(available with the full text of this article at www.nejm.org).
An electronic form containing the data fields to be completedfor individual patients was sent to all principal investigatorsor sponsors of the trials. Data from nine randomized trials8,11,13,14,17,18,20,22,23were provided by the principal investigators; data from theremaining five trials9,10,12,15,21 were provided by the sponsor,who had no role in the study design or analysis or in the writingof or decision to publish the manuscript.
The data requested for each patient included the date of randomization,treatment allocation, diabetes status, event status (includingdeath, myocardial infarction, coronary reintervention [percutaneousor surgical], and stent thrombosis and the respective datesof occurrence), and the date of the last follow-up visit. Alldata were thoroughly checked for consistency (logical checkingand checking against the original publications). Any querieswere resolved and the final database entries verified by theresponsible trial investigator.
We also evaluated each trial for the adequacy of allocationconcealment, performance of the analysis according to the intention-to-treatprinciple, and blind assessment of the outcomes of interest.We used the criteria recommended by Altman and Schulz24 andby Jüni et al.25 to decide whether the treatment allocationwas adequately concealed. Some trials used a modified intention-to-treatprinciple (i.e., excluding patients who did not receive thestudy stent) (see Table 2 of the Supplementary Appendix).
Study Outcomes
The primary end point of this analysis was death from any cause.Secondary end points were the composite of death or myocardialinfarction and the composite of death, myocardial infarction,or reintervention (major adverse cardiac events). We also assessedthe occurrence of stent thrombosis (see Table 2 of the Supplementary Appendixfor the end-point definitions used in individual trials). Itis important to note that in eight trials, data for patientswho underwent target-lesion revascularization were censoredwith respect to the subsequent assessment of stent thrombosis.The adjudication of events in each trial was performed by thesame event committee over the entire follow-up period.
Statistical Analysis
We performed survival analyses with the use of the Mantel–Coxtest stratified according to trial. Survival was defined asthe interval from randomization until the event of interest.Data for patients who did not have the event of interest werecensored at the date of the last follow-up visit. The log-ranktest was used to calculate hazard ratios and their 95% confidenceintervals (CIs).
Trials in which the event of interest was not observed in eitherstudy group were omitted from the analysis of that event. Fortrials in which only one of the groups had no event of interest,the estimate of treatment effect and its standard error werecalculated after adding 0.5 to each cell of the 2x2 table forthe trial.26
We assessed the heterogeneity across trials by the Cochran testand by calculating the I2 statistic (describing the percentageof total variation across trials that was due to heterogeneityrather than chance), as proposed by Higgins et al.27 We pooledhazard ratios from individual trials according to the methodof DerSimonian and Laird for random effects.28
Sensitivity analyses were performed by comparing the treatmenteffects obtained with each trial removed consecutively fromthe analysis with the overall treatment effects. In addition,we used a random-effects meta-regression analysis to estimatethe extent to which including four covariates — the natureof the study with respect to blinding (double blinding or nodouble blinding), the length of follow-up, the protocol-mandatedduration of dual antiplatelet therapy, and the presence of acutemyocardial infarction — as inclusion criteria for thetrial might have influenced the treatment effect. Using theMantel–Cox model, we checked for statistically significantinteraction between the treatment effect (sirolimus-elutingstent vs. bare-metal stent) and the presence of diabetes mellitus(the only prespecified subgroup that was analyzed).
All P values are two-sided. Results were considered to be statisticallysignificant at a P value of less than 0.05. Statistical analysiswas performed with the use of Stata software, version 9.2 (Stata).Survival curves are presented as simple, nonstratified Kaplan–Meiercurves across all trials and constructed with the use of S-Plussoftware, version 4.5 (Insightful).
Results
Our analysis included 14 trials and 4958 patients, 1411 of whomhad diabetes mellitus.8,9,10,11,12,13,14,15,17,18,20,21,22,23Table 1 displays the main characteristics of these trials. Theage of the patients in the trials ranged from 59.3 to 66.6 years,and the length of follow-up ranged from 12.1 to 58.9 months.
Figure 1A shows the absolute numbers of deaths in each trialaccording to treatment group, with the hazard ratio for eachtrial. There was no statistical evidence of heterogeneity acrossthe 14 trials. In total, there were 146 deaths (83 from cardiaccauses) in patients with sirolimus-eluting stents and 147 deaths(79 from cardiac causes) in patients with bare-metal stents.Overall, the use of sirolimus-eluting stents was associatedwith a hazard ratio for death of 1.03 (95% CI, 0.80 to 1.30;P=0.80), as compared with that of bare-metal stents.
Figure 1. Hazard Ratios for Individual Trials and for the Pooled Population and Kaplan–Meier Estimates for 5-Year Survival.
In Panel A, hazard ratios are shown on a logarithmic scale. The size of each square is proportional to the weight of the individual study, measured as the inverse of the estimated variance of the log hazard ratio. In Panel B, Kaplan–Meier curves are shown for survival for the pooled population during a 5-year period in each of the stent groups.
Sequential exclusion of each individual trial from the analysisof death yielded hazard ratios that ranged from 0.96 (95% CI,0.74 to 1.25) to 1.06 (95% CI, 0.84 to 1.34) and were not significantlydifferent from the overall hazard ratio (P0.71). No significantinfluence of prespecified covariates on the treatment effectwas observed, including the length of follow-up (P=0.44), theprotocol-mandated duration of dual antiplatelet therapy (P=0.69),the presence of patients with acute myocardial infarction inthe trial (P=0.56), or the presence of double blinding in thetrial design (P=0.70). Figure 1B shows the overall 5-year survivalcurves for the two treatment groups.
Figure 2A shows the absolute numbers of patients who died orhad a myocardial infarction in each trial according to treatmentgroup, with the hazard ratio for each trial. There was no statisticalevidence of heterogeneity across the 14 trials. In total, 241patients with sirolimus-eluting stents either died or had amyocardial infarction, as compared with 252 patients with bare-metalstents. Overall, use of sirolimus-eluting stents was associatedwith a hazard ratio for death or myocardial infarction of 0.97(95% CI, 0.81 to 1.16; P=0.76), as compared with use of bare-metalstents. Figure 2B shows the overall 5-year curves for survivalfree of myocardial infarction in the two study groups.
Figure 2. Hazard Ratios for Death or Myocardial Infarction and Kaplan–Meier Estimates for Survival Free of Myocardial Infarction.
In Panel A, hazard ratios are shown on a logarithmic scale. The size of each square is proportional to the weight of the individual study, measured as the inverse of the estimated variance of the log hazard ratio. In Panel B, Kaplan–Meier curves are shown for survival free of myocardial infarction for the pooled population during a 5-year period in each of the stent groups.
Figure 3A shows the absolute numbers of patients who died, hada myocardial infarction, or required reintervention in eachtrial according to treatment group, with the hazard ratio foreach trial. In total, 331 patients with sirolimus-eluting stentsdied, had a myocardial infarction, or required reintervention,as compared with 649 patients with bare-metal stents. Overall,the use of sirolimus-eluting stents was associated with a hazardratio for death, myocardial infarction, or reintervention of0.43 (95% CI, 0.34 to 0.54; P<0.001), as compared with theuse of bare-metal stents. Although the point estimates for individualtrials all favored sirolimus-eluting stents, there was a significantheterogeneity across trials with a high I2 value. Figure 3Bshows the overall 5-year curves for survival free of myocardialinfarction and reintervention in the two study groups.
Figure 3. Hazard Ratios for Death, Myocardial Infarction, or Reintervention and Kaplan–Meier Curves for Survival Free of Myocardial Infarction and Reintervention.
Panel A shows significant heterogeneity in the effect of treatment resulting from the differing magnitude of risk reduction observed in patients with sirolimus-eluting stents among the 14 trials. Hazard ratios are shown on a logarithmic scale. The size of each square is proportional to the weight of the individual study, measured as the inverse of the estimated variance of the log hazard ratio. In Panel B, Kaplan–Meier curves are shown for survival free of myocardial infarction and reintervention for the pooled population during a 5-year period in each of the stent groups.
No significant interaction between treatment groups and thediagnosis of diabetes was observed for any of the three endpoints of the study, including death (P=0.19), death or myocardialinfarction (P=0.39), and death, myocardial infarction, or reintervention(P=0.49). We nonetheless performed a separate analysis of therate of death in the subgroup of patients with diabetes. Figure 4Ashows the absolute numbers of deaths in each trial by treatmentgroup, with the hazard ratio for the subgroup of patients withdiabetes in each trial. There was no significant heterogeneityacross trials. In total, 59 patients with diabetes and sirolimus-elutingstents died, as compared with 56 patients with diabetes andbare-metal stents. The overall hazard ratio associated withsirolimus-eluting stents was 1.27 (95% CI, 0.83 to 1.95; P=0.26).Figure 4B shows the overall 5-year survival curves in the subgroupof patients with diabetes.
Figure 4. Hazard Ratios for Death in a Subgroup of Patients with Diabetes and Kaplan–Meier Curves for Overall Survival.
In Panel A, hazard ratios are shown on a logarithmic scale. The size of each square is proportional to the weight of the individual study, measured as the inverse of the estimated variance of the log hazard ratio. In Panel B, Kaplan–Meier curves are shown for survival for the pooled subgroup of patients with diabetes during a 5-year period in each of the stent groups.
Stent thrombosis (as defined by the individual trials) was observedin 65 patients (34 with sirolimus-eluting stents and 31 withbare-metal stents). The hazard ratio for stent thrombosis was1.09 (95% CI, 0.64 to 1.86; P=0.75). After the first year, stentthrombosis occurred in nine patients, eight of whom had sirolimus-elutingstents (Figure 5A). Over the 4-year period after the first yearfollowing the procedure, the overall risk of stent thrombosiswas 0.6% (95% CI, 0.3 to 1.2) in the sirolimus-stent group and0.05% (95% CI, 0.01 to 0.4) in the bare-metal–stent group(P=0.02). Figure 5B shows the curves of probability of stentthrombosis in the two study groups after the trial-defined minimumduration of recommended use of dual antiplatelet therapy (Table 1).The overall risk of stent thrombosis during 4 years after thistime was 0.8% (95% CI, 0.5 to 1.5) in the sirolimus-stent groupand 0.3% (95% CI, 0.1 to 0.6) in the bare-metal–stentgroup (P=0.16).
Figure 5. Kaplan–Meier Curves for Stent Thrombosis in the Pooled Population According to Stent Type and the Duration of Dual Antiplatelet Therapy.
Panel A shows that after the first year following the index procedure, stent thrombosis occurred in eight patients in the sirolimus-stent group and in only one patient in the bare-metal–stent group. Panel B shows the probability of stent thrombosis after the use of a trial-defined minimum duration of recommended dual antiplatelet therapy, according to stent type.
In 8 of the 14 trials, data for patients undergoing target-lesionrevascularization were censored with respect to the subsequentassessment of stent thrombosis. This censoring resulted in theexclusion of five additional cases of stent thrombosis, allin the bare-metal–stent group. In contrast, in the othersix trials, such censoring did not occur, which resulted inthe inclusion of one case of stent thrombosis that occurredafter target-lesion revascularization in the sirolimus-stentgroup.
Discussion
In our study, we analyzed individual data for patients withcoronary heart disease from 14 randomized trials comparing sirolimus-elutingstents with bare-metal stents. We found that the use of sirolimus-elutingstents was associated with rates of death alone or combinedwith myocardial infarction that were similar to those observedwith the use of bare-metal stents. Sirolimus-eluting stentswere also associated with a sustained reduction in the needfor reintervention but with an overall risk of stent thrombosisthat was at least as high as that seen with bare-metal stents.
Several previous analyses of trials comparing drug-eluting stentsand bare-metal stents in patients with coronary artery diseasehave been reported.5,6,7,29,30,31,32,33,34 In these previousstudies, aggregate data from published reports, rather thandata from individual patients, were examined. The superiorityof analysis of data from individual patients over meta-analysisof lumped study outcomes has been emphasized.35,36,37,38 Inparticular for survival data, the lack of adjustment for censoringleads to an imprecise estimate of the overall treatment effectand interstudy heterogeneity.39 Access to data for individualpatients also makes it possible to analyze the timing of events.We made an extensive effort to identify and incorporate alltrials comparing sirolimus-eluting stents with bare-metal stents.As a result, we believe that we have reduced the likelihoodof study-selection bias, the major risk of any meta-analysis,which may have been present in previous reports.
The effect of the use of sirolimus-eluting stents on long-termmortality has not previously been established. Contrary to theexpectation that prevention of restenosis by sirolimus-elutingstents might lead to improved survival, recent reports suggestedthat sirolimus-eluting stents were associated with an increasedrate of death as early as 2 years after the procedure.5,6 Althoughthis finding was not statistically significant, it generatedmuch concern among the medical community.40 Our study showsno difference in mortality between patients with sirolimus-elutingstents and those with bare-metal stents during a 5-year period.The same finding was true for the combined end point of deathor myocardial infarction.
No significant increase in the overall rate of stent thrombosiswas seen with sirolimus-eluting stents. However, this complicationwas significantly more frequent in patients with sirolimus-elutingstents after the first year following the procedure, a findingthat was consistent with another recent report.41 This differenceis chronologically associated with the end of the protocol-specifiedinterval of dual antiplatelet therapy with thienopyridines andaspirin. Although an accurate assessment of this issue cannotbe made without knowledge of the actual timing of discontinuationof thienopyridine therapy in individual patients, our findings,as well as other recently published observations,42 may suggestthe need for a longer duration of dual antiplatelet therapyin patients receiving sirolimus-eluting stents.
As noted, there were another five cases of stent thrombosisthat were censored from the analysis of the original trialsbecause they occurred after target-lesion revascularization.One case of stent thrombosis that was included in our countwould have been excluded if such censoring had been appliedto all the trials. Whether such cases of stent thrombosis shouldbe included in comparisons of this kind is open to question.Proponents of inclusion would argue that post-revascularizationepisodes of stent thrombosis are an inseparable part of theexperience of receiving a stent and that such episodes are morecommon with bare-metal stents because target-lesion revascularizationis required more often in patients with such stents. The argumentfor excluding such episodes is that they may have occurred notas a result of the original stent choice, but as a result ofthe subsequent revascularization procedure, and thus that theydo not reflect the biologic effects of the specific stent type.
Our observation that there is no late difference in hard endpoints (death or myocardial infarction) despite an increasein late stent thrombosis associated with sirolimus-eluting stentsmay be explained by the small proportion of patients with thiscomplication in the trials. Also, the negative effect of latestent thrombosis on clinical outcome might have been offsetby the reduction in the need for reintervention with the sirolimus-elutingstent and, consequently, by the exposure of a lower number ofpatients to postprocedural complications, as suggested by recentanalyses.43
We paid special attention to patients with diabetes througha prespecified subgroup analysis. Patients with diabetes areat increased risk for adverse events after PCI,44,45 and aortocoronarybypass surgery is often considered to be a better treatmentoption for them. The effect of drug-eluting stents on the long-termoutcome of patients with diabetes is not known. In the Sirolimus-CoatedBx Velocity Balloon-Expandable Stent in the Treatment of DeNovo Native Coronary Artery Lesions (SIRIUS) trial, the largesttrial in our analysis, patients with diabetes continued to havea relatively high rate of restenosis even after receiving drug-elutingstents.21 In our study, there was no statistical interactionbetween the presence of diabetes and the effect of sirolimus-elutingstents on the outcome of patients, including the rate of death.However, when we analyzed mortality in the subgroup of patientswith diabetes, there was a trend toward a higher hazard ratioin patients with sirolimus-eluting stents. This observationsuggests that patients with diabetes should be observed andfollowed especially carefully after treatment with sirolimus-elutingstents. It also justifies further collection of data on thelong-term outcome of patients with diabetes who are treatedwith such stents. In addition, it will be important to evaluatewhether other available or new drug-eluting stents may offerbetter results to patients with diabetes.
In conclusion, the use of sirolimus-eluting stents did not havea significant effect on overall long-term survival or on survivalfree of myocardial infarction, as compared with bare-metal stents.There was a sustained reduction in the need for reinterventionafter the placement of sirolimus-eluting stents. The risk ofstent thrombosis was at least as great as that seen with bare-metalstents.
Supported by Deutsches Herzzentrum, Munich, Germany.
Dr. Kastrati reports receiving lecture fees from Bristol-MyersSquibb, Cordis, GlaxoSmithKline, Lilly, Medtronic, Novartis,and Sanofi-Aventis; Dr. Valgimigli, lecture fees from Guilfordand Merck and grant support from Merck; Dr. Kelbæk, unrestrictedgrant support from Cordis to fund part of the salary of a researchnurse; Dr. Pfisterer, lecture fees from Medtronic; and Dr. Schömig,unrestricted grant support for the Department of Cardiologyhe chairs from Amersham/General Electric, Bayerische Forschungsstiftung,Bristol-Myers Squibb, Cordis, Cryocath, Guidant, Medtronic,Nycomed, and Schering. No other potential conflict of interestrelevant to this article was reported.
Source Information
From Deutsches Herzzentrum, Technische Universität, Munich, Germany (A.K., J.M., J.P., M. Seyfarth, A.S.); University of Basel, Basel, Switzerland (C.K., M.E.P.); University of Ferrara, Ferrara, Italy (M.V.); Rigshospitalet, Copenhagen (H.K.); San Camillo Hospital, Rome (M.M.); Cardiovascular Institute, Hospital de la Santa Creu i Sant Pau, Barcelona (M. Sabaté); St. Antonius Hospital, Nieuwegein, the Netherlands (M.J.S.); and Preventicum–Klinik für Diagnostik, Essen, Germany (D.B.). This article (10.1056/NEJMoa067484) was published at www.nejm.org on February 12, 2007.
Address reprint requests to Dr. Kastrati at Deutsches Herzzentrum, Lazarettstr. 36, 80636 Munich, Germany, or at kastrati{at}dhm.mhn.de.
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0.71). No significant influence of prespecified covariates on the treatment effect was observed, including the length of follow-up (P=0.44), the protocol-mandated duration of dual antiplatelet therapy (P=0.69), the presence of patients with acute myocardial infarction in the trial (P=0.56), or the presence of double blinding in the trial design (P=0.70). Figure 1B shows the overall 5-year survival curves for the two treatment groups. 
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