Analysis of 14 Trials Comparing Sirolimus-Eluting Stents with Bare-Metal Stents

doi:10.1056/NEJMoa067484

Published at www.nejm.org February 12, 2007 (10.1056/NEJMoa067484)

Analysis of 14 Trials Comparing Sirolimus-Eluting Stents with Bare-Metal Stents

Adnan Kastrati, M.D., Julinda Mehilli, M.D., Jürgen Pache, M.D., Christoph Kaiser, M.D., Marco Valgimigli, M.D., Ph.D., Henning Kelbæk, M.D., Maurizio Menichelli, M.D., Manel Sabaté, M.D., Maarten J. Suttorp, M.D., Ph.D., Dietrich Baumgart, M.D., Melchior Seyfarth, M.D., Matthias E. Pfisterer, M.D., and Albert Schömig, M.D.

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ABSTRACT

Background The long-term effects of treatment with sirolimus-elutingstents, as compared with bare-metal stents, have not been established.

MethodsWe performed an analysis of individual data on 4958 patientsenrolled 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 overallrisk of death (hazard ratio, 1.03; 95% confidence interval [CI],0.80 to 1.30) and the combined risk of death or myocardial infarction(hazard ratio, 0.97; 95% CI, 0.81 to 1.16) were not significantlydifferent for patients receiving sirolimus-eluting stents versusbare-metal stents. There was a significant reduction in thecombined risk of death, myocardial infarction, or reintervention(hazard ratio, 0.43; 95% CI, 0.34 to 0.54) associated with theuse of sirolimus-eluting stents. There was no significant differencein the overall risk of stent thrombosis with sirolimus-elutingstents versus bare-metal stents (hazard ratio, 1.09; 95% CI,0.64 to 1.86). However, there was evidence of a slight increasein the risk of stent thrombosis associated with sirolimus-elutingstents after the first year.

Conclusions The use of sirolimus-elutingstents does not have a significant effect on overall long-termsurvival and survival free of myocardial infarction, as comparedwith bare-metal stents. There is a sustained reduction in theneed for reintervention after the use of sirolimus-eluting stents.The risk of stent thrombosis is at least as great as that seenwith bare-metal stents.

Notice: This article was published atwww.nejm.org on February 12, 2007. It will appear in the March8 issue of the Journal.

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