Published online before print February 21, 2005, doi: 10.1161/01.CIR.0000156334.24955.B2
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(Circulation. 2005;111:1040-1044.)
© 2005 American Heart Association, Inc.
Interventional Cardiology |
Maintenance of Long-Term Clinical Benefit With Sirolimus-Eluting Coronary Stents
Three-Year Results of the RAVEL Trial
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.).
Correspondence to Jean Fajadet, MD, Clinique Pasteur, 45, Avenue du Lombez, 31300 Toulouse, France. E-mail fajadet{at}interv-cardiol-toul.com
Received June 8, 2004; revision received October 19, 2004; accepted October 22, 2004.
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.
Key Words: stents • sirolimus • restenosis • coronary disease • follow-up studies
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