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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

5-Year Clinical Outcomes After Sirolimus-Eluting Stent Implantation

Insights From a Patient-Level Pooled Analysis of 4 Randomized Trials Comparing Sirolimus-Eluting Stents With Bare-Metal Stents

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^_*,_*

^_* Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York
Hamburg University Cardiovascular Center, Hamburg, Germany
Institut Cardiovasculaire Paris Sud, Massy, France
Hôpital du Sacre-Coeur de Montréal, Montréal, Quebec, Canada
^|| St. Elisabeth Medical Center, Boston, Massachusetts

Manuscript received November 4, 2008; revised manuscript received April 6, 2009, accepted April 7, 2009.

^_* Reprint requests and correspondence: Dr. Roxana Mehran, 161 Fort Washington Avenue, 5th Floor, New York, New York 10032 (Email: rmehran{at}crf.org).

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 [ClinicalTrials.gov] ; The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions, NCT00381420 [ClinicalTrials.gov] ; Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions [SIRIUS], NCT00232765 [ClinicalTrials.gov] ; The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions, NCT00235144 [ClinicalTrials.gov] )

Key Words: drug-eluting stent • stent • restenosis • thrombosis • long term

Abbreviations and Acronyms   ARC = Academic Research Consortium   BMS = bare-metal stent(s)   DES = drug-eluting stent(s)   MI = myocardial infarction   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization   TVR = target vessel revascularization

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