Author + information
- Received November 4, 2008
- Revision received April 6, 2009
- Accepted April 7, 2009
- Published online September 1, 2009.
- Adriano Caixeta, MD, PhD⁎,
- Martin B. Leon, MD⁎,
- Alexandra J. Lansky, MD⁎,
- Eugenia Nikolsky, MD, PhD⁎,
- Jiro Aoki, MD, PhD⁎,
- Jeffrey W. Moses, MD⁎,
- Joachim Schofer, MD†,
- Marie-Claude Morice, MD‡,
- Erick Schampaert, MD§,
- Ajay J. Kirtane, MD, SM⁎,
- Jeffrey J. Popma, MD∥,
- Helen Parise, DSc⁎,
- Martin Fahy, MSc⁎ and
- Roxana Mehran, MD⁎,⁎ ()
- ↵⁎Reprint requests and correspondence:
Dr. Roxana Mehran, 161 Fort Washington Avenue, 5th Floor, New York, New York 10032
Objectives Five-year clinical follow-up has been scheduled per protocol by the 4 Cypher (Cordis/Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) versus bare-metal stent (BMS) randomized trials.
Background A delayed arterial healing response after drug-eluting stent implantation has raised concerns about the long-term safety of drug-eluting stents.
Methods In a pooled analysis of 4 randomized trials, 1,748 patients were assigned to receive either an SES (n = 878) or BMS (n = 870).
Results At 5 years, there was no significant difference in the rate of death, myocardial infarction (MI), or the composite of death/MI between the 2 groups (15.1% in the SES group vs. 13.6% in the BMS group; p = 0.36). The 5-year incidence of stent thrombosis by the Academic Research Consortium definition did not differ between SES and BMS (definite/probable stent thrombosis, 2.1% vs. 2.0%; p = 0.99). The incidence of very late stent thrombosis was also similar between the SES and BMS groups (1.4% vs. 0.7%; p = 0.22). The annualized rates of definite/probable stent thrombosis after 1 year were 0.4% for SES and 0.2% for BMS. The 5-year incidence of target vessel revascularization was significantly lower in the SES group (15.2% vs. 30.1%; p < 0.0001).
Conclusions In this patient-level pooled analysis, overall use of SES compared with BMS demonstrated persistent superior efficacy at 5 years in terms of a reduction in target vessel revascularization, without an increase in rates of death, MI, or stent thrombosis. (The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study, NCT00233805; The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions, NCT00381420; Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions [SIRIUS], NCT00232765; The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions, NCT00235144)
Dr. Leon, within the last 12 months, was a member of Cordis/Johnson & Johnson Science Advisory Board. Dr. Lansky received a research grant from Cordis/Johnson & Johnson. Dr. Moses has served as a speaker for Cordis/Johnson & Johnson (minor). Dr. Schampaert has served as a speaker (honoraria <$10,000) with Cordis Canada/Johnson & Johnson and Boston Scientific, and was on the Advisory Board of Cordis/Johnson & Johnson, Boston Scientific, Eli Lilly, Sanofi-Aventis, and GlaxoSmithKline. Dr. Kirtane was a consultant (advisory board/lecture fees) for Abbott Vascular and Medtronic Cardiovascular. Dr. Mehran received research grants (significant) from Abbott Vascular, Cordis/Johnson & Johnson, Boston Scientific, and The Medicines Company, and has served as a speaker/consultant (modest) for Abbott Vascular, Cordis/Johnson & Johnson, Medtronic, Lilly/Daiichi Sankyo, and The Medicines Company.
- Received November 4, 2008.
- Revision received April 6, 2009.
- Accepted April 7, 2009.
- American College of Cardiology Foundation