A Randomized Comparison of a Sirolimus-Eluting Stent with a Standard Stent for Coronary Revascularization
Marie-Claude Morice, M.D., Patrick W. Serruys, M.D., Ph.D., J. Eduardo Sousa, M.D., Jean Fajadet, M.D., Ernesto Ban Hayashi, M.D., Marco Perin, M.D., Antonio Colombo, M.D., G. Schuler, M.D., Paul Barragan, M.D., Giulio Guagliumi, M.D., Ferenc Molnàr, M.D., Robert Falotico, Ph.D., for the RAVEL Study Group
Background The need for repeated treatment of restenosis ofa treated vessel remains the main limitation of percutaneouscoronary revascularization. Because sirolimus (rapamycin) inhibitsthe proliferation of lymphocytes and smooth-muscle cells, wecompared a sirolimus-eluting stent with a standard uncoatedstent in patients with angina pectoris.
Methods We performed a randomized, double-blind trial to comparethe two types of stents for revascularization of single, primarylesions in native coronary arteries. The trial included 238patients at 19 medical centers. The primary end point was in-stentlate luminal loss (the difference between the minimal luminaldiameter immediately after the procedure and the diameter atsix months). Secondary end points included the percentage ofin-stent stenosis of the luminal diameter and the rate of restenosis(luminal narrowing of 50 percent or more). We also analyzeda composite clinical end point consisting of death, myocardialinfarction, and percutaneous or surgical revascularization at1, 6, and 12 months.
Results At six months, the degree of neointimal proliferation,manifested as the mean (±SD) late luminal loss, was significantlylower in the sirolimus-stent group (0.01±0.33mm) than in the standard-stent group (0.80±0.53 mm, P<0.001).None of the patients in the sirolimus-stent group, as comparedwith 26.6 percent of those in the standard-stent group, hadrestenosis of 50 percent or more of the luminal diameter (P<0.001).There were no episodes of stent thrombosis. During a follow-upperiod of up to one year, the overall rate of major cardiacevents was 5.8 percent in the sirolimus-stent group and 28.8percent in the standard-stent group (P<0.001). The differencewas due entirely to a higher rate of revascularization of thetarget vessel in the standard-stent group.
Conclusions As compared with a standard coronary stent, a sirolimus-elutingstent shows considerable promise for the prevention of neointimalproliferation, restenosis, and associated clinical events.
Source Information
From Institut Cardiovasculaire Paris Sud, Massy, France (M.-C.M.); Thoraxcentrum, Rotterdam, the Netherlands (P.W.S.); Institute Dante Pazzanese de Cardiologia, São Paulo, Brazil (J.E.S.); Clinique Pasteur, Toulouse, France (J.F.); Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City, Mexico (E.B.H.); the Heart Institute of the University of São Paulo, São Paulo, Brazil (M.P.); Centro Cuore Columbus, Milan, Italy (A.C.); Herzzentrum, Leipzig, Germany (G.S.); Centre Hospitalier Privé Beauregard, Marseilles, France (P.B.); Azienda Ospedaliera Ospedali Riuniti di Bergamo, Bergamo, Italy (G.G.); Semmelweis Egyetem Egészégtudomanyi Kar, Budapest, Hungary (F.M.); and Cordis, Johnson & Johnson, Warren, N.J. (R.F.).
Address reprint requests to Dr. Morice at the Institut Hospitalier Jacques Cartier, Ave. du Noyer Lambert, 91300 Massy, France.
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