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Stent thrombosis in randomized clinical trials of drug-eluting stents Mauri L; Hsieh WH; Massaro JM; Ho KK; D'Agostino R; Cutlip DEN Engl J Med 2007[Mar]; 356 (10): 1020-9BACKGROUND: 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.|Angioplasty, Balloon, Coronary[MESH]|Brachytherapy[MESH]|Combined Modality Therapy[MESH]|Coronary Disease/mortality/*therapy[MESH]|Coronary Restenosis/epidemiology/therapy[MESH]|Coronary Thrombosis/epidemiology/*etiology[MESH]|Drug Delivery Systems[MESH]|Female[MESH]|Follow-Up Studies[MESH]|Humans[MESH]|Immunosuppressive Agents/*administration & dosage[MESH]|Incidence[MESH]|Kaplan-Meier Estimate[MESH]|Male[MESH]|Middle Aged[MESH]|Paclitaxel/*administration & dosage[MESH]|Platelet Aggregation Inhibitors/therapeutic use[MESH]|Prosthesis Design[MESH]|Prosthesis Failure[MESH]|Randomized Controlled Trials as Topic[MESH]|Sirolimus/*administration & dosage[MESH]|Stents/*adverse effects[MESH] |
