Masahiro Natsuaki1, Ken Kozuma1, Takeshi Morimoto1, Kazushige Kadota1, Toshiya Muramatsu1, Yoshihisa Nakagawa1, Takashi Akasaka1, Keiichi Igarashi1, Kengo Tanabe1, Yoshihiro Morino1, Tetsuya Ishikawa1, Hideo Nishikawa1, Masaki Awata1, Mitsuru Abe1, Hisayuki Okada1, Yoshiki Takatsu1, Nobuhiko Ogata1, Kazuo Kimura1, Kazushi Urasawa1, Yasuhiro Tarutani1, Nobuo Shiode1, Takeshi Kimura2. 1. Division of Cardiology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan (M.N.); Division of Cardiology, Teikyo University Hospital, Tokyo, Japan (K. Kozuma); Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan (T. Morimoto); Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan (K. Kadota); Division of Cardiology, Saiseikai Yokohama-city Eastern Hospital, Yokohama, Japan (T. Muramatsu); Division of Cardiology, Tenri Hospital, Tenri, Japan (Y.N.); Department of Cardiovascular Medicine, Wakayama Medical University Hospital, Wakayama, Japan (T.A.); Division of Cardiology, Japan Community Health Care Organization Hokkaido Social Hospital, Sapporo, Japan (K.I.); Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan (K.T.); Division of Cardiology, Iwate Medical University Hospital, Morioka, Japan (Y.M.); Division of Cardiology, Saitama Cardiovascular and Respiratory Center, Kumagaya, Japan (T.I.); Division of Cardiology, Mie Heart Center, Mie, Japan (H.N.); Division of Cardiology, Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan (M. Awata); Division of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan (M. Abe); Division of Cardiology, Seirei Hamamatsu General Hospital, Hamamatsu, Japan (H.O.); Division of Cardiology, Hyogo Prefectural Amagasaki Hospital, Amagasaki, Japan (Y. Takatsu); Division of Cardiology, Jichi Medical University Hospital, Shimotsuke, Japan (N.O.); Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan (K. Kimura); Division of Cardiology, Caress Sapporo Tokeidai Memorial Hospital, Sapporo, Japan (K.U.); Division of Cardiology, Okamura Memorial Hospital, Shizuoka, Japan (Y. Tarutani); Division of Cardiology, Tsuchiya General Hospital, Hiroshima, Japan (N.S.); and Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan (T.K.). 2. Division of Cardiology, Saiseikai Fukuoka General Hospital, Fukuoka, Japan (M.N.); Division of Cardiology, Teikyo University Hospital, Tokyo, Japan (K. Kozuma); Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan (T. Morimoto); Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan (K. Kadota); Division of Cardiology, Saiseikai Yokohama-city Eastern Hospital, Yokohama, Japan (T. Muramatsu); Division of Cardiology, Tenri Hospital, Tenri, Japan (Y.N.); Department of Cardiovascular Medicine, Wakayama Medical University Hospital, Wakayama, Japan (T.A.); Division of Cardiology, Japan Community Health Care Organization Hokkaido Social Hospital, Sapporo, Japan (K.I.); Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan (K.T.); Division of Cardiology, Iwate Medical University Hospital, Morioka, Japan (Y.M.); Division of Cardiology, Saitama Cardiovascular and Respiratory Center, Kumagaya, Japan (T.I.); Division of Cardiology, Mie Heart Center, Mie, Japan (H.N.); Division of Cardiology, Kansai Rosai Hospital Cardiovascular Center, Amagasaki, Japan (M. Awata); Division of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan (M. Abe); Division of Cardiology, Seirei Hamamatsu General Hospital, Hamamatsu, Japan (H.O.); Division of Cardiology, Hyogo Prefectural Amagasaki Hospital, Amagasaki, Japan (Y. Takatsu); Division of Cardiology, Jichi Medical University Hospital, Shimotsuke, Japan (N.O.); Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan (K. Kimura); Division of Cardiology, Caress Sapporo Tokeidai Memorial Hospital, Sapporo, Japan (K.U.); Division of Cardiology, Okamura Memorial Hospital, Shizuoka, Japan (Y. Tarutani); Division of Cardiology, Tsuchiya General Hospital, Hiroshima, Japan (N.S.); and Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan (T.K.). taketaka@kuhp.kyoto-u.ac.jp.
Abstract
BACKGROUND: There is a paucity of data reporting the clinical outcomes of biodegradable polymer biolimus-eluting stent (BP-BES) compared with durable polymer everolimus-eluting stent (DP-EES) beyond 1 year after stent implantation when the polymer is fully degraded. METHODS AND RESULTS: The NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial (NEXT) is a prospective, multicenter, randomized, open-label, noninferiority trial comparing BP-BES with DP-EES in patients scheduled for percutaneous coronary intervention using drug-eluting stent (DES) without any exclusion criteria among 98 participating centers in Japan. The trial was designed to evaluate noninferiority of BP-BES relative to DP-EES in terms of any target-lesion revascularization at 1 year and death or myocardial infarction at 3 years. Between May and October 2011, 3235 patients were randomly assigned to receive either BP-BES (1617 patients) or DP-EES (1618 patients). Complete 3-year follow-up was achieved in 97.6% of patients. At 3 years, the primary safety end point of death or myocardial infarction occurred in 159 patients (9.9%) in the BP-BES group and in 166 patients (10.3%) in the DP-EES group, demonstrating noninferiority of BP-BES relative to DP-EES (P noninferiority<0.0001 and P superiority=0.7). Cumulative incidence of target-lesion revascularization was not significantly different between the 2 groups (7.4% versus 7.1%; P=0.8). By a landmark analysis at 1 year, the cumulative incidences of death or myocardial infarction and target-lesion revascularization were also not significantly different between the 2 groups (4.6% versus 5.2%; P=0.46 and 3.3% versus 2.7%; P=0.39, respectively). CONCLUSIONS: Safety and efficacy outcomes of BP-BES were non inferior to those of DP-EES 3 years after stent implantation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01303640.
RCT Entities:
BACKGROUND: There is a paucity of data reporting the clinical outcomes of biodegradable polymer biolimus-eluting stent (BP-BES) compared with durable polymereverolimus-eluting stent (DP-EES) beyond 1 year after stent implantation when the polymer is fully degraded. METHODS AND RESULTS: The NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial (NEXT) is a prospective, multicenter, randomized, open-label, noninferiority trial comparing BP-BES with DP-EES in patients scheduled for percutaneous coronary intervention using drug-eluting stent (DES) without any exclusion criteria among 98 participating centers in Japan. The trial was designed to evaluate noninferiority of BP-BES relative to DP-EES in terms of any target-lesion revascularization at 1 year and death or myocardial infarction at 3 years. Between May and October 2011, 3235 patients were randomly assigned to receive either BP-BES (1617 patients) or DP-EES (1618 patients). Complete 3-year follow-up was achieved in 97.6% of patients. At 3 years, the primary safety end point of death or myocardial infarction occurred in 159 patients (9.9%) in the BP-BES group and in 166 patients (10.3%) in the DP-EES group, demonstrating noninferiority of BP-BES relative to DP-EES (P noninferiority<0.0001 and P superiority=0.7). Cumulative incidence of target-lesion revascularization was not significantly different between the 2 groups (7.4% versus 7.1%; P=0.8). By a landmark analysis at 1 year, the cumulative incidences of death or myocardial infarction and target-lesion revascularization were also not significantly different between the 2 groups (4.6% versus 5.2%; P=0.46 and 3.3% versus 2.7%; P=0.39, respectively). CONCLUSIONS: Safety and efficacy outcomes of BP-BES were non inferior to those of DP-EES 3 years after stent implantation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01303640.
Authors: Rainer Zbinden; Raffaele Piccolo; Dik Heg; Marco Roffi; David J Kurz; Olivier Muller; André Vuilliomenet; Stéphane Cook; Daniel Weilenmann; Christoph Kaiser; Peiman Jamshidi; Anna Franzone; Franz Eberli; Peter Jüni; Stephan Windecker; Thomas Pilgrim Journal: J Am Heart Assoc Date: 2016-03-15 Impact factor: 5.501
Authors: Marta Francesca Brancati; Francesco Burzotta; Carlo Trani; Ornella Leonzi; Claudio Cuccia; Filippo Crea Journal: Pragmat Obs Res Date: 2017-07-13