Sirolimus-Eluting and Paclitaxel-Eluting Stents for Coronary Revascularization
Stephan Windecker, M.D., Andrea Remondino, M.D., Franz R. Eberli, M.D., Peter Jüni, M.D., Lorenz Räber, M.D., Peter Wenaweser, M.D., Mario Togni, M.D., Michael Billinger, M.D., David Tüller, M.D., Christian Seiler, M.D., Marco Roffi, M.D., Roberto Corti, M.D., Gabor Sütsch, M.D., Willibald Maier, M.D., Thomas Lüscher, M.D., Otto M. Hess, M.D., Matthias Egger, M.D., and Bernhard Meier, M.D.
Background Sirolimus-eluting stents and paclitaxel-eluting stents,as compared with bare-metal stents, reduce the risk of restenosis.It is unclear whether there are differences in safety and efficacybetween the two types of drug-eluting stents.
Methods We conducted a randomized, controlled, single-blindtrial comparing sirolimus-eluting stents with paclitaxel-elutingstents in 1012 patients undergoing percutaneous coronary intervention.The primary end point was a composite of major adverse cardiacevents (death from cardiac causes, myocardial infarction, andischemia-driven revascularization of the target lesion) by ninemonths. Follow-up angiography was completed in 540 of 1012 patients(53.4 percent).
Results The two groups had similar baseline clinical and angiographiccharacteristics. The rate of major adverse cardiac events atnine months was 6.2 percent in the sirolimus-stent group and10.8 percent in the paclitaxel-stent group (hazard ratio, 0.56;95 percent confidence interval, 0.36 to 0.86; P=0.009). Thedifference was driven by a lower rate of target-lesion revascularizationin the sirolimus-stent group than in the paclitaxel-stent group(4.8 percent vs. 8.3 percent; hazard ratio, 0.56; 95 percentconfidence interval, 0.34 to 0.93; P=0.03). Rates of death fromcardiac causes were 0.6 percent in the sirolimus-stent groupand 1.6 percent in the paclitaxel-stent group (P=0.15); therates of myocardial infarction were 2.8 percent and 3.5 percent,respectively (P=0.49); and the rates of angiographic restenosiswere 6.6 percent and 11.7 percent, respectively (P=0.02).
Conclusions As compared with paclitaxel-eluting stents, theuse of sirolimus-eluting stents results in fewer major adversecardiac events, primarily by decreasing the rates of clinicaland angiographic restenosis.
Source Information
From the Departments of Cardiology (S.W., A.R., L.R., P.W., M.T., M.B., D.T., C.S., O.M.H., B.M.) and Social and Preventive Medicine (P.J.), University Hospital Bern, Bern, Switzerland; the Department of Cardiology, University Hospital Zurich, Zurich, Switzerland (F.R.E., M.R., R.C., G.S., W.M., T.L.); and the Medical Research Council Health Services Research Collaboration, University of Bristol, Bristol, United Kingdom (M.E.).
Address reprint requests to Dr. Windecker at the Department of Cardiology, University Hospital Bern, 3010 Bern, Switzerland, or at stephan.windecker{at}insel.ch.
Drug-Eluting Coronary Stents
Alarcón J. A., Arribas J. M., Ruiz V., Czupryniak L., Pawlowski M., Loba J., Bonvini R. F., Verin V., Waksman R., Wolfram R. M., Jneid H., Jang I.-K., Palacios I., Kastrati A., Dibra A., Schömig A., Windecker S., Jüni P., Meier B., Moliterno D. J.
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N Engl J Med 2005;
353:2404-2408, Dec 1, 2005.
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