Hiroki Shiomi1, Ken Kozuma2, Takeshi Morimoto3, Kazushige Kadota4, Kengo Tanabe5, Yoshihiro Morino6, Takashi Akasaka7, Mitsuru Abe8, Yasuaki Takeji1, Satoru Suwa9, Yoshiaki Ito10, Masakazu Kobayashi11, Kazuoki Dai12, Koichi Nakao13, Yasuhiro Tarutani14, Ryoji Taniguchi15, Hideo Nishikawa16, Yoshito Yamamoto17, Yoshihisa Nakagawa18, Kenji Ando19, Koichi Kobayashi20, Kazuya Kawai21, Kiyoshi Hibi22, Takeshi Kimura23. 1. Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan. 2. Division of Cardiology, Teikyo University Hospital, Tokyo, Japan. 3. Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan. 4. Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan. 5. Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan. 6. Division of Cardiology, Iwate Medical University Hospital, Morioka, Japan. 7. Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan. 8. Division of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan. 9. Division of Cardiology, Juntendo University Shizuoka Hospital, Izonokuni, Japan. 10. Division of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan. 11. Division of Cardiology, Hamamatsu Medical Center, Hamamatsu, Japan. 12. Division of Cardiology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan. 13. Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan. 14. Division of Cardiology, Okamura Memorial Hospital, Shimizu, Japan. 15. Division of Cardiology, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan. 16. Division of Cardiology, Mie Heart Center, Mie, Japan. 17. Division of Cardiology, Iwaki Kyoritsu General Hospital, Iwaki, Japan. 18. Division of Cardiology, Tenri Hospital, Tenri, Japan. 19. Division of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan. 20. Division of Cardiology, Toyota Memorial Hospital, Toyota, Japan. 21. Division of Cardiology, Chikamori Hospital, Kochi, Japan. 22. Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan. 23. Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan. Electronic address: taketaka@kuhp.kyoto-u.ac.jp.
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.
RCT Entities:
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.