7-Year Outcomes of a Randomized Trial Comparing the First-Generation Sirolimus-Eluting Stent Versus the New-Generation Everolimus-Eluting Stent: The RESET Trial
Hiroki Shiomi, Ken Kozuma, Takeshi Morimoto, Kazushige Kadota, Kengo Tanabe, Yoshihiro Morino, Takashi Akasaka, Mitsuru Abe, Yasuaki Takeji, Satoru Suwa, Yoshiaki Ito, Masakazu Kobayashi, Kazuoki Dai, Koichi Nakao, Yasuhiro Tarutani, Ryoji Taniguchi, Hideo Nishikawa, Yoshito Yamamoto, Yoshihisa Nakagawa, Kenji Ando, Koichi Kobayashi, Kazuya Kawai, Kiyoshi Hibi, Takeshi Kimura, RESET Investigators, Hiroki Shiomi, Ken Kozuma, Takeshi Morimoto, Kazushige Kadota, Kengo Tanabe, Yoshihiro Morino, Takashi Akasaka, Mitsuru Abe, Yasuaki Takeji, Satoru Suwa, Yoshiaki Ito, Masakazu Kobayashi, Kazuoki Dai, Koichi Nakao, Yasuhiro Tarutani, Ryoji Taniguchi, Hideo Nishikawa, Yoshito Yamamoto, Yoshihisa Nakagawa, Kenji Ando, Koichi Kobayashi, Kazuya Kawai, Kiyoshi Hibi, Takeshi Kimura, RESET Investigators
Abstract
Objectives: The aim of this study was to compare 7-year outcomes between the first-generation sirolimus-eluting stent (SES) and the new-generation everolimus-eluting stent (EES) in a randomized clinical trial.
Background: There is a scarcity of very long-term (beyond 5 years) data from clinical trials investigating whether new-generation drug-eluting stents have clear clinical advantages over first-generation drug-eluting stents.
Methods: RESET (Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial) is the largest randomized trial comparing EES with SES (NCT01035450). Among a total of 3,197 patients in the original RESET population from 100 centers, the present extended 7-year follow-up study was conducted in 2,667 patients from 75 centers after excluding those patients enrolled from centers that denied participation. Complete 7-year follow-up was achieved in 91.5% of patients.
Results: The cumulative 7-year incidence of the primary efficacy endpoint of target lesion revascularization was not significantly different between EES and SES (10.2% vs. 11.7%; hazard ratio: 0.87; 95% confidence interval: 0.68 to 1.10; p = 0.24). The risk for the primary safety endpoint of death or myocardial infarction trended lower with EES than with SES (20.6% vs. 23.6%; hazard ratio: 0.85; 95% confidence interval: 0.72 to 1.005; p = 0.06). The cumulative 7-year incidence of definite stent thrombosis was very low and similar between EES and SES (0.9% vs. 1.0%; p = 0.82). The lower risk of EES relative to SES was significant for the composite secondary endpoint of target lesion failure (13.3% vs. 18.1%; hazard ratio: 0.72; 95% confidence interval: 0.59 to 0.88; p = 0.001).
Conclusions: During 7 years of follow-up, the risk for target lesion revascularization was not significantly different between the new-generation EES and the first-generation SES.
Keywords: drug-eluting stent(s); everolimus-eluting stent(s); long-term outcome; sirolimus-eluting stent(s).
Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed