A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents

BACKGROUND: Although randomized studies have shown a beneficial effect of drug-eluting stents in reducing the risk of repeated revascularization, these trials were underpowered to compare rates of death and myocardial infarction. The long-term safety of drug-eluting stents has been questioned recently. METHODS: We performed a pooled analysis of 1748 patients in four randomized trials evaluating the safety of sirolimus-eluting stents as compared with bare-metal stents. Patient-level data were obtained and analyzed by independent statisticians at two academic institutions. The primary safety end point was survival at 4 years. We tested for heterogeneities in treatment effect in patient subgroups. RESULTS: The survival rate at 4 years was 93.3% in the sirolimus-stent group, as compared with 94.6% in the bare-metal-stent group (hazard ratio for death, 1.24; 95% confidence interval [CI], 0.84 to 1.83; P=0.28). In the 428 patients with diabetes, a significant difference in the survival rate was observed in favor of the bare-metal-stent group over the sirolimus-stent group (95.6% vs. 87.8%; hazard ratio for death in the sirolimus-stent group, 2.9; 95% CI, 1.38 to 6.10; P=0.008). The lower survival rate among patients with diabetes who were treated wit