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Previous Volume 356:1020-1029 March 8, 2007 Number 10 Next

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ABSTRACT

Background Definitions of stent thrombosis that have been used in clinical trials of drug-eluting stents have been restrictive and have not been used in a uniform manner.

Methods We applied a hierarchical classification of stent thrombosis set by the Academic Research Consortium (ARC) across randomized trials involving 878 patients treated with sirolimus-eluting stents, 1400 treated with paclitaxel-eluting stents, and 2267 treated with bare-metal stents. We then pooled 4 years of follow-up data. All events were adjudicated by an independent clinical-events committee.

Results The cumulative incidence of stent thrombosis according to the original protocol definitions was 1.2% in the sirolimus-stent group versus 0.6% in the bare-metal–stent group (P=0.20; 95% confidence interval [CI], –0.4 to 1.5) and 1.3% in the paclitaxel-stent group versus 0.8% in the bare-metal–stent group (P=0.24; 95% CI, –0.3 to 1.4). The incidence of definite or probable stent thrombosis as defined by the ARC was 1.5% in the sirolimus-stent group versus 1.7% in the bare-metal–stent group (P=0.70; 95% CI, –1.5 to 1.0) and 1.8% in the paclitaxel-stent group versus 1.4% in the bare-metal–stent group (P=0.52; 95% CI, –0.7 to 1.4). The incidence of definite or probable events occurring 1 to 4 years after implantation was 0.9% in the sirolimus-stent group versus 0.4% in the bare-metal–stent group and 0.9% in the paclitaxel-stent group versus 0.6% in the bare-metal–stent group.

Conclusions The incidence of stent thrombosis did not differ significantly between patients with drug-eluting stents and those with bare-metal stents in randomized clinical trials, although the power to detect small differences in rates was limited.

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.

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