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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Long-Term Clinical Outcomes With Sirolimus-Eluting Coronary Stents

Five-Year Results of the RAVEL Trial

Marie-Claude Morice, MD, FACC, FESC^_*,_*, Patrick W. Serruys, MD, PhD, FACC, Paul Barragan, MD, Christoph Bode, MD, Gerrit-Anne Van Es, PhD^||, Hans-Peter Stoll, MD^¶, David Snead, PhD^#, Laura Mauri, MD, MSc, FACC^_**, Donald E. Cutlip, MD, FACC^_** and Eduardo Sousa, MD, PhD, FACC

^_* Institut Cardiovasculaire Paris Sud, Massy, France
Erasmus Medical Center, Rotterdam, the Netherlands
Clinique Beauregard, Marseille, France
Albert-Ludwigs-Universitätskliniken, Kardiologie, Freiburg, Germany
^|| Cardialysis, Rotterdam, the Netherlands
^¶ Cordis Clinical Research, Waterloo, Belgium
^# Cordis Clinical Research, Warren, New Jersey
^_** Harvard Clinical Research Institute, Boston, Massachusetts
Instituto Dante Pazzanese, Sao Paulo, Brazil.

Manuscript received April 5, 2007; revised manuscript received June 11, 2007, accepted June 18, 2007.

^_* Reprint requests and correspondence: Dr. Marie-Claude Morice, Institut Hospitalier Jacques Cartier, Avenue du Noyer Lambert, 91300 Massy, France. (Email: mc.morice{at}icps.com.fr).

Objectives: This study examined the clinical outcomes at 5 years in RAVEL (A Randomized Comparison of a Sirolimus-Eluting Stent With a Standard Stent for Coronary Revascularization), the first controlled trial of drug-eluting stents.

Background: The 6-month rate of angiographic coronary restenosis has been markedly lowered by sirolimus-eluting stents (SES). The long-term performance of drug-eluting stents, however, is under close scrutiny.

Methods: The trial included 238 patients (mean age 60.7 ± 10.4 years, 76% men) with a single, de novo native coronary artery lesion, randomly assigned to treatment with SES versus bare-metal stents (BMS). Rates of major adverse cardiac events (MACE), defined as all-cause mortality, myocardial infarction, and percutaneous or surgical revascularization up to 5 years of follow-up, and rates of stent thrombosis were compared between the 2 treatment groups.

Results: Complete datasets were available in 92.5% of patients treated with SES and 89.1% of patients assigned to BMS. The 1-, 3-, and 5-year rates of survival free from target lesion revascularization (TLR) were, respectively, 99.2%, 93.8%, and 89.7% in the SES group versus 75.9%, 75.0%, and 74.0% in the control group (p < 0.001; log-rank). Rates of all MACE at 5 years were 25.8% in patients treated with SES versus 35.2% in patients assigned to BMS (p = 0.03; log-rank). Rates of stent thrombosis, per protocol or by the Academic Research Consortium definitions, were similar in both groups.

Conclusions: The 5-year rate of TLR associated with SES was significantly lower than that with BMS. There was no apparent adverse effect associated with the use of SES, although the trial was not powered to examine uncommon complications.

Abbreviations and Acronyms   ARC = Academic Research Consortium   BMS = bare-metal stent(s)   MACE = major adverse cardiac events   MI = myocardial infarction   QCA = quantitative coronary angiography   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization   TVR = target vessel revascularization

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