Safety of Coronary Sirolimus-Eluting Stents in Daily Clinical Practice

Background—The expanding indications for sirolimus-eluting stents (SES) include increasingly complex coronary lesions and populations with clinical profiles markedly different from those of early pivotal controlled studies. The e-Cypher registry monitored the safety and efficacy of SES currently implanted worldwide in daily practice. Methods and Results—Between April 2002 and September 2005, data were collected on 15 157 patients who underwent implantation of 1 SES at 279 medical centers from 41 countries. An independent endpoint review committee adjudicated all reported major adverse cardiovascular events, stent thromboses, and target-vessel revascularizations. Data were managed and analyzed by independent organizations. Predictors of adverse clinical events were identified by regression analysis. The mean age of the sample was 61.7 11.4 years; 77.7% were men, and 28.6% were diabetics. A total of 18 295 lesions were treated (20 503 SES) during the index procedure. The cumulative rates of major adverse cardiovascular events were 1.36% at 30 days, 3.38% at 6 months, and 5.80% at 1 year. The rates of acute, subacute, and late stent thrombosis were 0.13%, 0.56%, and 0.19% of patients, respectively, representing a 12-month actuarial incidence of 0.87%. Insulin-dependent diabetes, acute coronary syndrome at presentation, and advanced age were clinical predictors, whereas TIMI flow grade 3 after the index procedure, treatment of multiple lesions, a prominently calcified or totally occluded target lesion, and multivessel disease were the angiographic or procedural predictors of stent thrombosis at 12 months. Conclusions—This analysis of 1-year data collected by the e-Cypher registry suggests a high degree of safety of SES, with a rate of stent thrombosis similar to that observed in randomized trials.