Masahiro Natsuaki1, Ken Kozuma2, Takeshi Morimoto3, Kazushige Kadota4, Toshiya Muramatsu5, Yoshihisa Nakagawa6, Takashi Akasaka7, Keiichi Igarashi8, Kengo Tanabe9, Yoshihiro Morino10, Tetsuya Ishikawa11, Hideo Nishikawa12, Masaki Awata13, Mitsuru Abe14, Hisayuki Okada15, Yoshiki Takatsu16, Nobuhiko Ogata17, Kazuo Kimura18, Kazushi Urasawa19, Yasuhiro Tarutani20, Nobuo Shiode21, Takeshi Kimura22. 1. Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan. 2. Division of Cardiology, Teikyo University Hospital, Tokyo, Japan. 3. Center for General Internal Medicine and Emergency Care, Kinki University School of Medicine, Osaka-Sayama, Japan. 4. Department of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan. 5. Division of Cardiology, Saiseikai Yokohama-City Eastern Hospital, Yokohama, Japan. 6. Division of Cardiology, Tenri Hospital, Tenri, Japan. 7. Department of Cardiovascular Medicine, Wakayama Medical University Hospital, Wakayama, Japan. 8. Division of Cardiology, Hokkaido Social Insurance Hospital, Sapporo, Japan. 9. Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan. 10. Division of Cardiology, Iwate Medical University Hospital, Morioka, Japan. 11. Division of Cardiology, Saitama Cardiovascular and Respiratory Center, Kumagaya, Japan. 12. Division of Cardiology, Mie Heart Center, Mie, Japan. 13. Division of Cardiology, Kansai Rosai Hospital, Amagasaki, Japan. 14. Division of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan. 15. Division of Cardiology, Seirei Hamamatsu General Hospital, Hamamatsu, Japan. 16. Division of Cardiology, Hyogo Prefectural Amagasaki Hospital, Amagasaki, Japan. 17. Division of Cardiology, Tokai University Hospital, Isehara, Japan. 18. Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan. 19. Division of Cardiology, Caress Sapporo Tokeidai Memorial Hospital, Sapporo, Japan. 20. Division of Cardiology, Okamura Memorial Hospital, Shizuoka, Japan. 21. Division of Cardiology, Tsuchiya General Hospital, Hiroshima, Japan. 22. Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan. Electronic address: taketaka@kuhp.kyoto-u.ac.jp.
Abstract
OBJECTIVES: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.
RCT Entities:
OBJECTIVES: 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-chromiumEES 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: Tomohisa Tada; Adnan Kastrati; Robert A Byrne; Tibor Schuster; Rezarta Cuni; Lamin A King; Salvatore Cassese; Michael Joner; Jürgen Pache; Steffen Massberg; Albert Schömig; Julinda Mehilli Journal: Int J Cardiovasc Imaging Date: 2014-01-23 Impact factor: 2.357