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

Abstract

Randomised studies have demonstrated the beneficial effect of drug-eluting stents in reducing repeat revascularisation at one year. However, they were individually underpowered to assess long-term safety endpoints such as death and myocardial infarction. The long-term safety of drug-eluting stents has been recently questioned. We performed a pooled analysis of 2,797 patients included in four randomised trials to assess the safety of slow-release paclitaxel-eluting stents as compared with bare metal stents. Patient level data were obtained and analysed by two independent academic statistical institutions. The primary safety endpoint was survival at four years. Secondary endpoints were myocardial infarction and stent thrombosis. Heterogeneities in treatment effect were tested in subgroups.Survival at four years was 93.4% in the paclitaxel-eluting stent group versus 93.0% in the bare-metal stent group (Hazard ratio for survival 0.95; 95% confidence interval [CI] 0.96 - 1.30; P=0.75). Myocardial infarction occurred at a similar rate between both treatment groups. Whereas the total rates of stent thrombosis were equal between the two groups, there was a trend towards a higher rate of stent thrombosis occurring after repeat target lesion revascularisation in the bare-metal stent group. No heterogeneity of treatment effect was found in the subgroups, including diabetic patients and complex lesions. In a pooled analysis of four trials comparing paclitaxel-eluting stents with bare metal stents, no significant differences were found in the rates of death, myocardial infarction or stent thrombosis.