Long-Term Safety and Efficacy of Drug-Eluting Stents

Background— The long-term safety and efficacy of drug-eluting stents (DES) have been questioned recently. Methods and Results— Between July 2002 and June 2005, 10 629 patients undergoing elective percutaneous coronary intervention with either DES (n=3064) or bare-metal stents (BMS, n=7565) were enrolled in a prospective registry comprising 13 hospitals. We assessed the cumulative incidence of major adverse cardiac events (death, acute myocardial infarction, and target-vessel revascularization) and angiographic stent thrombosis during 2-year follow-up. A propensity score analysis to adjust for different baseline clinical, angiographic, and procedural characteristics was performed. The 2-year unadjusted cumulative incidence of major adverse cardiac events was 17.8% in the DES group and 21.0% in the BMS group ( P =0.003 by log-rank test). Angiographic stent thrombosis was 1.0% in the DES group and 0.6% in the BMS group ( P =0.09). After adjustment, the 2-year cumulative incidence of death was 6.8% in the DES group and 7.4% in the BMS group ( P =0.35), whereas the rates were 5.3% in DES and 5.8% in BMS for acute myocardial infarction ( P =0.46), 9.1% in DES and 12.9% in BMS for target-vessel revascularization ( P P Conclusions— In this large real-world population, the beneficial effect of DES in reducing the need for new revascularization compared with BMS extends to 2 years without evidence of a worse safety profile.