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 one trial was powered for a clinical endpoint, and no trial was powered for evaluating target-lesion revascularization (TLR).
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 non-inferiority of EES relative to SES in terms of TLR. 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 endpoint of TLR occurred in 65 patients (4.3%) in the EES group, and in 76 patients (5.0%) in the SES group, demonstrating non-inferiority of EES to SES (P non-inferiority<0.0001, and P superiority=0.34). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%, P=0.77). Angiographic sub-study enrolling 571 patients (EES: 285 patients, and SES: 286 patients) demonstrated non-inferiority of EES relative to SES regarding the primary angiographic endpoint of in-segment late loss (0.06±0.37mm versus 0.02±0.46mm, P non-inferiority<0.0001, and P superiority=0.24) at 278±63 days after index stent implantation.
Conclusions—One-year clinical and angiographic outcome after EES implantation was non-inferior 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 low rate of TLR and very low rate of stent thrombosis.
Clinical Trial Registration Information—clinicaltrials.gov; Identifier: NCT01035450.
- Received March 7, 2012.
- Accepted July 13, 2012.
- Copyright © 2012, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited