title: 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).
abstract: 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.
  
  
  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)<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). 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 (0.06±0.37 mm versus 0.02±0.46 mm, P(noninferiority)<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 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.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035450.
authors: Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, 54 Shogoin Kawahara-cho, Kyoto, Japan 606-8507. taketaka@kuhp.kyoto-u.ac.jp
authors: Takeshi
authors: T
authors: Kimura
authors: Takeshi
authors: T
authors: Morimoto
authors: Masahiro
authors: M
authors: Natsuaki
authors: Hiroki
authors: H
authors: Shiomi
authors: Keiichi
authors: K
authors: Igarashi
authors: Kazushige
authors: K
authors: Kadota
authors: Kengo
authors: K
authors: Tanabe
authors: Yoshihiro
authors: Y
authors: Morino
authors: Takashi
authors: T
authors: Akasaka
authors: Yoshiki
authors: Y
authors: Takatsu
authors: Hideo
authors: H
authors: Nishikawa
authors: Yoshito
authors: Y
authors: Yamamoto
authors: Yoshihisa
authors: Y
authors: Nakagawa
authors: Yasuhiko
authors: Y
authors: Hayashi
authors: Masashi
authors: M
authors: Iwabuchi
authors: Hisashi
authors: H
authors: Umeda
authors: Kazuya
authors: K
authors: Kawai
authors: Hisayuki
authors: H
authors: Okada
authors: Kazuo
authors: K
authors: Kimura
authors: Charles A
authors: CA
authors: Simonton
authors: Ken
authors: K
authors: Kozuma
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis / Q000517:prevention & control; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D007564:Japan; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus