Author + information
- Received September 17, 2018
- Revision received December 30, 2018
- Accepted January 11, 2019
- Published online April 1, 2019.
- Hiroki Shiomi, MDa,
- Ken Kozuma, MDb,
- Takeshi Morimoto, MDc,
- Kazushige Kadota, MDd,
- Kengo Tanabe, MDe,
- Yoshihiro Morino, MDf,
- Takashi Akasaka, MDg,
- Mitsuru Abe, MDh,
- Yasuaki Takeji, MDa,
- Satoru Suwa, MDi,
- Yoshiaki Ito, MDj,
- Masakazu Kobayashi, MDk,
- Kazuoki Dai, MDl,
- Koichi Nakao, MDm,
- Yasuhiro Tarutani, MDn,
- Ryoji Taniguchi, MDo,
- Hideo Nishikawa, MDp,
- Yoshito Yamamoto, MDq,
- Yoshihisa Nakagawa, MDr,
- Kenji Ando, MDs,
- Koichi Kobayashi, MDt,
- Kazuya Kawai, MDu,
- Kiyoshi Hibi, MDv,
- Takeshi Kimura, MDa,∗ (, )
- on behalf of the RESET Investigators
- aDepartment of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan
- bDivision of Cardiology, Teikyo University Hospital, Tokyo, Japan
- cDepartment of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan
- dDepartment of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan
- eDivision of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan
- fDivision of Cardiology, Iwate Medical University Hospital, Morioka, Japan
- gDepartment of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan
- hDivision of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan
- iDivision of Cardiology, Juntendo University Shizuoka Hospital, Izonokuni, Japan
- jDivision of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan
- kDivision of Cardiology, Hamamatsu Medical Center, Hamamatsu, Japan
- lDivision of Cardiology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan
- mDivision of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan
- nDivision of Cardiology, Okamura Memorial Hospital, Shimizu, Japan
- oDivision of Cardiology, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan
- pDivision of Cardiology, Mie Heart Center, Mie, Japan
- qDivision of Cardiology, Iwaki Kyoritsu General Hospital, Iwaki, Japan
- rDivision of Cardiology, Tenri Hospital, Tenri, Japan
- sDivision of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan
- tDivision of Cardiology, Toyota Memorial Hospital, Toyota, Japan
- uDivision of Cardiology, Chikamori Hospital, Kochi, Japan
- vDivision of Cardiology, Yokohama City University Medical Center, Yokohama, Japan
- ↵∗Address for correspondence:
Dr. Takeshi Kimura, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan.
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.
This research was supported by Abbott Vascular. Drs. Kimura, Morino, Tanabe, and Kozuma were advisory board members for Abbott Vascular and Terumo Japan. Dr. Nakagawa was an advisory board member for Abbott Vascular. Dr. Kimura has received a research grant from Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 17, 2018.
- Revision received December 30, 2018.
- Accepted January 11, 2019.
- 2019 American College of Cardiology Foundation
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