title: Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent: a randomized, controlled, noninferiority trial.
abstract: OBJECTIVE
  NEXT (NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial) was designed for evaluating the noninferiority of a biolimus-eluting stent (BES) relative to an everolimus-eluting stent (EES) in terms of target lesion revascularization (TLR) at 1 year.
  
  
  BACKGROUND
  Efficacy and safety data comparing biodegradable polymer BES with durable polymer cobalt-chromium EES are currently limited.
  
  
  METHODS
  The NEXT trial is a prospective, multicenter, randomized, open-label, noninferiority trial comparing BES with EES. Between May and October 2011, 3,235 patients were randomly assigned to receive either BES (n = 1,617) or EES (n = 1,618).
  
  
  RESULTS
  At 1 year, the primary efficacy endpoint of TLR occurred in 67 patients (4.2%) in the BES group, and in 66 patients (4.2%) in the EES group, demonstrating noninferiority of BES relative to EES (p for noninferiority <0.0001, and p for superiority = 0.93). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.25% vs. 0.06%, p = 0.18). An angiographic substudy enrolling 528 patients (BES: n = 263, and EES: n = 265) demonstrated noninferiority of BES relative to EES regarding the primary angiographic endpoint of in-segment late loss (0.03 ± 0.39 mm vs. 0.06 ± 0.45 mm, p for noninferiority <0.0001, and p for superiority = 0.52) at 266 ± 43 days after stent implantation.
  
  
  CONCLUSIONS
  One-year clinical and angiographic outcome after BES implantation was noninferior to and not different from that after EES implantation in a mostly stable coronary artery disease population. One-year clinical outcome after both BES and EES use was excellent, with a low rate of TLR and extremely low rate of stent thrombosis.
authors.affiliation: Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Natsuaki
authors.affiliation: Division of Cardiology, Teikyo University Hospital, Tokyo, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Kozuma
authors.affiliation: Center for General Internal Medicine and Emergency Care, Kinki University School of Medicine, Osaka-Sayama, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Morimoto
authors.affiliation: Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan.
authors.forename: Kazushige
authors.initials: K
authors.lastname: Kadota
authors.affiliation: Division of Cardiology, Saiseikai Yokohama-City Eastern Hospital, Yokohama, Japan.
authors.forename: Toshiya
authors.initials: T
authors.lastname: Muramatsu
authors.affiliation: Division of Cardiology, Tenri Hospital, Tenri, Japan.
authors.forename: Yoshihisa
authors.initials: Y
authors.lastname: Nakagawa
authors.affiliation: Department of Cardiovascular Medicine, Wakayama Medical University Hospital, Wakayama, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Akasaka
authors.affiliation: Division of Cardiology, Hokkaido Social Insurance Hospital, Sapporo, Japan.
authors.forename: Keiichi
authors.initials: K
authors.lastname: Igarashi
authors.affiliation: Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan.
authors.forename: Kengo
authors.initials: K
authors.lastname: Tanabe
authors.affiliation: Division of Cardiology, Iwate Medical University Hospital, Morioka, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Morino
authors.affiliation: Division of Cardiology, Saitama Cardiovascular and Respiratory Center, Kumagaya, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Ishikawa
authors.affiliation: Division of Cardiology, Mie Heart Center, Mie, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Nishikawa
authors.affiliation: Division of Cardiology, Kansai Rosai Hospital, Amagasaki, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Awata
authors.affiliation: Division of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Abe
authors.affiliation: Division of Cardiology, Seirei Hamamatsu General Hospital, Hamamatsu, Japan.
authors.forename: Hisayuki
authors.initials: H
authors.lastname: Okada
authors.affiliation: Division of Cardiology, Hyogo Prefectural Amagasaki Hospital, Amagasaki, Japan.
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Takatsu
authors.affiliation: Division of Cardiology, Tokai University Hospital, Isehara, Japan.
authors.forename: Nobuhiko
authors.initials: N
authors.lastname: Ogata
authors.affiliation: Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Kimura
authors.affiliation: Division of Cardiology, Caress Sapporo Tokeidai Memorial Hospital, Sapporo, Japan.
authors.forename: Kazushi
authors.initials: K
authors.lastname: Urasawa
authors.affiliation: Division of Cardiology, Okamura Memorial Hospital, Shizuoka, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Tarutani
authors.affiliation: Division of Cardiology, Tsuchiya General Hospital, Hiroshima, Japan.
authors.forename: Nobuo
authors.initials: N
authors.lastname: Shiode
authors.affiliation: Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan. Electronic address: taketaka@kuhp.kyoto-u.ac.jp.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
mesh_terms: D020341:Absorbable Implants / Q000592:standards; D000368:Aged; D000369:Aged, 80 and over; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000601:surgery*; D054855:Drug-Eluting Stents / Q000592:standards; D000068338:Everolimus; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011108:Polymers / Q000008:administration & dosage*; D011446:Prospective Studies; D011859:Radiography; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D011108:Polymers; D000068338:Everolimus; C518022:umirolimus; D020123:Sirolimus