Interventional Cardiology Comparison of Everolimus-Eluting and Sirolimus-Eluting Coronary Stents 1-Year Outcomes from the Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial (RESET)

Background—Several recent randomized trials comparing everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) reported similar outcomes. However, only 1 trial was powered for a clinical end point, and no trial was powered for evaluating target-lesion revascularization. Methods and Results—Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized open-label trial comparing EES with SES in Japan. The trial was powered for evaluating noninferiority of EES relative to SES in terms of target-lesion revascularization. From February and July 2010, 3197 patients were randomly assigned to receive either EES (1597 patients) or SES (1600 patients). At 1 year, the primary efficacy end point of target-lesion revascularization occurred in 65 patients (4.3%) in the EES group and in 76 patients (5.0%) in the SES group, demonstrating noninferiority of EES to SES (P noninferiority Ͻ0.0001, and P superiority ϭ0.34). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%, Pϭ0.77). An angiographic substudy enrolling 571 patients (EES, 285 patients and SES, 286 patients) demonstrated noninferiority of EES relative to SES regarding the primary angiographic end point of in-segment late loss (0.06Ϯ0.37 mm versus 0.02Ϯ0.46 mm, P noninferiority Ͻ0.0001, and P superiority ϭ0.24) at 278Ϯ63 days after index stent implantation. Conclusions—One-year clinical and angiographic outcome after EES implantation was noninferior to and not different from that after SES implantation in a stable coronary artery disease population with relatively less complex coronary anatomy. One-year clinical outcome after both EES and SES use was excellent with a low rate of target-lesion revascularization and a very low rate of stent thrombosis. S irolimus-eluting stent (SES) was the first-generation drug-eluting stent (DES) that had been most widely used and most extensively studied in the past decade. 1 Although SES has substantially reduced restenosis after coronary stent implantation, late adverse events such as very late stent thrombosis (ST) and late target-lesion revascularization (TLR) occurring beyond 1 year emerged as new problems associated with use of SES. 2,3 Everolimus-eluting stent (EES), a second-generation DES, is a cobalt chromium alloy stent with thin (81 ␮m) strut thickness, which is coated with a thin nonadhesive, durable, biocompatible fluorinated copo-lymer releasing a reduced dose of everolimus in comparison with the dose used in SES. 4 In a pooled analysis of the 4 randomized controlled trials comparing EES with paclitaxel-eluting stent (PES), EES demonstrated consistent clinical benefit over PES in terms of myocardial infarction (MI), ST, …