Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents.

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.

• Authors: Adnan Kastrati, Julinda Mehilli, Jürgen Pache, Christoph Kaiser, Marco Valgimigli, Henning Kelbaek, Maurizio Menichelli, Manel Sabaté, Maarten J Suttorp, Dietrich Baumgart, Melchior Seyfarth, Matthias E Pfisterer, Albert Schömig
• Journal: The New England journal of medicine (N Engl J Med) Vol. 356 Issue 10 Pg. 1030-9 (Mar 08 2007) ISSN: 1533-4406 [Electronic] United States
• PMID: 17296823 (Publication Type: Comparative Study, Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2007 Massachusetts Medical Society.

Chemical References

• Immunosuppressive Agents
• Sirolimus

Topics

• Angioplasty, Balloon, Coronary
• Coronary Disease (mortality, therapy)
• Coronary Restenosis (epidemiology, therapy)
• Coronary Thrombosis (epidemiology, etiology)
• Drug Delivery Systems
• Follow-Up Studies
• Humans
• Immunosuppressive Agents (administration & dosage)
• Myocardial Infarction (epidemiology, etiology)
• Prosthesis Design
• Prosthesis Failure
• Randomized Controlled Trials as Topic
• Regression Analysis
• Risk
• Sirolimus (administration & dosage)
• Stents (adverse effects)
• Survival Analysis