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Previous Volume 356:1030-1039 March 8, 2007 Number 10 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Perspective by Maisel, W. H. Perspective by Farb, A. Editorial by Curfman, G. D. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article by Maisel, W. H. Related Article by Farb, A. PubMed Citation

ABSTRACT

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 follow-up 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 receiving sirolimus-eluting stents versus bare-metal stents. There was a significant reduction in the combined risk of death, myocardial infarction, or reintervention (hazard ratio, 0.43; 95% CI, 0.34 to 0.54) associated with the use of sirolimus-eluting stents. There was no significant difference in the overall risk of stent thrombosis with sirolimus-eluting stents versus bare-metal stents (hazard ratio, 1.09; 95% CI, 0.64 to 1.86). However, there was evidence of a slight increase in the risk of stent thrombosis associated with sirolimus-eluting stents after the first year.

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

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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