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European Heart Journal Advance Access originally published online on November 15, 2006
European Heart Journal 2006 27(23):2815-2822; doi:10.1093/eurheartj/ehl385
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© The European Society of Cardiology 2006. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

Cause of death with bare metal and sirolimus-eluting stents{dagger}

David R. Holmes, Jr1,*, Jeffrey W. Moses2, Joachim Schofer3, Marie-Claude Morice4, Erick Schampaert5 and Martin B. Leon2

1 Division of Cardiovascular Diseases, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA
2 Center for Interventional Vascular Therapy, Columbia University Medical Center, New York, NY, USA
3 Hamburg University Cardiovascular Center, Hamburg, Germany
4 Institut Cardiovasculaire Paris Sud, Institute Hospitalier Jacques Cartier, Massy, France
5 Cardiac Catheterization Laboratories, Division of Cardiology, Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada

Received 27 July 2006; revised 9 October 2006; accepted 31 October 2006; online publish-ahead-of-print 15 November 2006.

* Corresponding author. Consultant, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA.

See page 2737 for the editorial comment on this article (doi:10.1093/eurheartj/ehl378)

Aims Although drug-eluting stents have assumed a dominant role in interventional cardiology, concern has been raised about the potential for long-term adverse outcomes, including death. The aim of the present study was to compare the incidence and cause of death between patients who received sirolimus-eluting or bare metal stents.

Methods and results An integrated analysis was performed on 1748 patients enrolled in four prospective double-blind trials that randomly assigned patients to receive either a sirolimus-eluting or a bare metal stent for treatment of a single de novo coronary stenosis. During a mean follow-up of 2.6±0.6 years, 64 patients (3.7%) died. Total mortality was 3.2% among 870 bare metal stent patients and 4.1% among 878 sirolimus-eluting stent patients (P=0.37); there was no difference in cardiac mortality (1.4 vs. 1.3%; P=0.55) or causes of death between these two groups. The predominant cause of death was non-cardiac. Cardiac death was most frequently assigned owing to unwitnessed death. Death due to acute myocardial infarction, congestive heart failure, and stent thrombosis occurred infrequently.

Conclusion At a mean follow-up of 2.6 years in percutaneous coronary intervention patients, the predominant cause of death was non-cardiac. There was no significant difference in either the frequency or the cause of death with implantation of either sirolimus-eluting or bare metal stents.

Key Words: Cardiac death • Drug-eluting stents • Follow-up mortality


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