on February 21, 2005
Published online before print February 21, 2005, doi: 10.1161/01.CIR.0000156334.24955.B2
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Submitted on June 8, 2004
From the Clinique Pasteur, Toulouse, France (F.J.); Institut Cardiovasculaire Paris Sud, Massy, France (M.-C.M.); Albert-Ludwigs-Universitätskliniken, Kardiologie, Freiburg, Germany (C.B.); Clinique Beauregard, Marseille, France (P.B.); Thoraxcentrum, Rotterdam, the Netherlands (P.W.S.); Onze Lieve Vrouw Ziekenhuis, Cardiologie Intervasculair, Aalst, Belgium (W.W.); Clinica Cardiológyca C. Constantini, Curitiba, Paraná, Brazil (C.R.C.); Hôpital Broussais, Paris, France (J.-L.G.); Centre Hospitalier Universitaire de Rouen, Service de Cardiologie, Rouen, France (H.E.); Clinique Saint-Gatien, Tours, France (D.B.); Centro Cardiologico Monzino, Servizio Emodinamica, Milano, Italy (A.B.); OLVG Hospital, Department of Cardiology, Amsterdam, the Netherlands (G.-J.L.); The Heart Institute-Incor of the University Hospital of Sao Paulo, Sao Paulo, Brazil (M.P.); Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil (J.E.S.); Herzzentrum, Leipzig, Germany (G.S.); Semmelweis Egyetem Egészégtudomanyi Kar, Budapest, Hungary (F.M.); Azienda Ospedali Riuniti di Bergamo, Bergamo, Italy (G.G.); Centre Cuore Columbus, Milano, Italy (A.C.); Instituto Nacional de Cardiologia, Mexico City, Mexico (E.B.H.); and Cordis Clinical Research Europe, Waterloo, Belgium (E.W.). * To whom correspondence should be addressed. E-mail: fajadet{at}interv-cardiol-toul.com.
Background--The use of sirolimus-eluting coronary stents has been associated with a nearly complete elimination of restenosis at 6 months and with a very low 1-year incidence of major adverse cardiac events (MACE). This analysis examined whether these beneficial effects persist over the longer term. Methods and Results--This multicenter trial randomly assigned 238 patients to revascularization of single, de novo, native coronary artery lesions with sirolimus-eluting versus conventional bare-metal stents. Survival free from target lesion revascularization (TLR), target vessel failure (TVF), and MACE up to 3 years of follow-up was compared between the 2 treatment groups. Complete data sets were available in 94.2% of patients treated with sirolimus-eluting stents and in 94.1% of patients randomized to the control group. The cumulative 1-, 2-, and 3-year event-free survival rates were 99.2%, 96.5%, and 93.7% for TLR and 95.8%, 92.3%, and 87.9% for TVF, respectively, in the sirolimus-eluting stent group, versus 75.9%, 75.9%, and 75.0% for TLR and 71.2%, 69.4%, and 67.3% for TVF in the control group (P<0.001 for both comparisons at 3 years). Rates of MACE at 3 years were 15.8% in patients randomly assigned to sirolimus-eluting stents versus 33.1% in patients assigned to bare-metal stents (P=0.002). One patient treated with a sirolimus-eluting stent died of a cardiac cause between 12 and 36 months. Conclusions--Treatment of de novo coronary stenosis with sirolimus-eluting stents was associated with a sustained clinical benefit and very low rates of TLR and of other MACE up to 3 years after device implantation.
Revised on October 19, 2004
Accepted on October 22, 2004
Maintenance of Long-Term Clinical Benefit With Sirolimus-Eluting Coronary Stents. Three-Year Results of the RAVEL Trial
Jean Fajadet MD*,
Key words: stents • sirolimus • restenosis • coronary disease • follow-up studies
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