Background Definitions of stent thrombosis that have been usedin clinical trials of drug-eluting stents have been restrictiveand have not been used in a uniform manner.
Methods We applied a hierarchical classification of stent thrombosisset by the Academic Research Consortium (ARC) across randomizedtrials involving 878 patients treated with sirolimus-elutingstents, 1400 treated with paclitaxel-eluting stents, and 2267treated with bare-metal stents. We then pooled 4 years of follow-updata. All events were adjudicated by an independent clinical-eventscommittee.
Results The cumulative incidence of stent thrombosis accordingto the original protocol definitions was 1.2% in the sirolimus-stentgroup versus 0.6% in the bare-metal–stent group (P=0.20;95% confidence interval [CI], –0.4 to 1.5) and 1.3% inthe paclitaxel-stent group versus 0.8% in the bare-metal–stentgroup (P=0.24; 95% CI, –0.3 to 1.4). The incidence ofdefinite or probable stent thrombosis as defined by the ARCwas 1.5% in the sirolimus-stent group versus 1.7% in the bare-metal–stentgroup (P=0.70; 95% CI, –1.5 to 1.0) and 1.8% in the paclitaxel-stentgroup versus 1.4% in the bare-metal–stent group (P=0.52;95% CI, –0.7 to 1.4). The incidence of definite or probableevents occurring 1 to 4 years after implantation was 0.9% inthe sirolimus-stent group versus 0.4% in the bare-metal–stentgroup and 0.9% in the paclitaxel-stent group versus 0.6% inthe bare-metal–stent group.
Conclusions The incidence of stent thrombosis did not differsignificantly between patients with drug-eluting stents andthose with bare-metal stents in randomized clinical trials,although the power to detect small differences in rates waslimited.
Source Information
From Brigham and Women's Hospital (L.M.), Harvard Clinical Research Institute (L.M., W.H., J.M.M., K.K.L.H., R.D., D.E.C.), Beth Israel Deaconess Medical Center (K.K.L.H., D.E.C.), Harvard Medical School (L.M., K.K.L.H., D.E.C.), and Boston University (J.M.M., R.D.) — all in Boston. This article (10.1056/NEJMoa067731) was published at www.nejm.org on February 12, 2007.
Address reprint requests to Dr. Cutlip at Beth Israel Deaconess Medical Center, Baker 4, 185 Pilgrim Rd., Boston, MA 02215, or at don.cutlip{at}hcri.harvard.edu.
American College of Cardiology Foundation, , American Heart Association Task Force on Practice, , American Society of Echocardiography, , American Society of Nuclear Cardiology, , Heart Rhythm Society, , Society of Cardiovascular Anesthesiologists, , Society for Cardiovascular Angiography and Interve, , Society for Vascular Medicine, , Society for Vascular Surgery, , Fleisher, L. A., Beckman, J. A., Brown, K. A., Calkins, H., Chaikof, E. L., Fleischmann, K. E., Freeman, W. K., Froehlich, J. B., Kasper, E. K., Kersten, J. R., Riegel, B., Robb, J. F.
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