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

The long-term effects of treatment with sirolimus-eluting stents, as compared with bare-metal stents, have not been established. Methods We performed an analysis of individual data on 4958 patients enrolled in 14 randomized trials comparing sirolimus-eluting stents with bare-metal stents (mean followup interval, 12.1 to 58.9 months). The primary end point was death from any cause. Other outcomes were stent thrombosis, the composite end point of death or myocardial infarction, and the composite of death, myocardial infarction, or reintervention | Analysis of 14 Trials Comparing Sirolimus-Eluting Stents with Bare-Metal Stents Analysis of 14 Trials Comparing Sirolimus-Eluting Stents with Bare-Metal Stents Adnan Kastrati M.D. Julinda Mehilli M.D. Jurgen Pache M.D. Christoph Kaiser M.D. Marco Valgimigli M.D. Ph.D. Henning Kelb k 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 Schốmig M.D. abstract From Deutsches Herzzentrum Technische Universitat 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. Rigs-hospitalet 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 fur Diagnostik Essen Germany D.B. . Address reprint requests to Dr. Kastrati at Deutsches Herzzentrum Laza-rettstr. 36 80636 Munich Germany or at kastrati@dhm.mhn.de. This article 10.1056 NEJ Moa067484 was published at www.nejm.org on February 12 2007. N Engl J Med 2007 356 1030-9. Copyright 2007 Massachusetts Medical Society. background The long-term effects of treatment with sirolimus-eluting stents as compared with bare-metal stents have not been established. methods We performed an analysis of individual data on 4958 patients enrolled in 14 randomized trials comparing sirolimus-eluting stents with bare-metal stents mean followup interval 12.1 to 58.9 months . The primary end point was death from any cause. Other outcomes were stent thrombosis the composite end point of death or myocardial infarction and the composite of death myocardial infarction or reintervention. results The overall risk 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 significantly different for patients .