Masahiro Natsuaki1, MD; Hirotoshi Watanabe2, MD; Takeshi Morimoto3, MD; Ken Kozuma4, MD; Kazushige Kadota5, MD; Toshiya Muramatsu6, MD; Yoshihisa Nakagawa7, MD; Takashi Akasaka8, MD; Keiichi Igarashi Hanaoka9, MD; Kengo Tanabe10, MD; Yoshihiro Morino11, MD; Tetsuya Ishikawa12, MD; Harumi Katoh5, MD; Hideo Nishikawa13, MD; Toshihiro Tamura14, MD; Koh Ono15, MD; Ko Yamamoto15, MD; Takayuki Ishihara16, MD; Mitsuru Abe17, MD; Ryoji Taniguchi18, MD; Yuji Ikari19, MD; Kozo Okada20, MD; Takeshi Kimura2, MD
1. Department of Cardiovascular Medicine, Saga University, Saga, Japan; 2. Division of Cardiology, Hirakata Kohsai Hospital, Hirakata, Japan; 3. Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan; 4. Department of Cardiology, Teikyo University Hospital, Tokyo, Japan; 5. Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Japan; 6. Division of Cardiology, Tokyo Kamata Hospital, Tokyo, Japan; 7. Department of Cardiology, Shiga University of Medical Science Hospital, Otsu, Japan; 8. Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan; 9. Division of Cardiology, Hanaoka Seishu Memorial Hospital, Sapporo, Japan; 10. Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan; 11. Division of Cardiology, Iwate Medical University Hospital, Morioka, Japan; 12. Division of Cardiology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan; 13. Division of Cardiology, Mie Heart Center, Mie, Japan; 14. Division of Cardiology, Tenri Hospital, Tenri, Japan; 15. Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan; 16. Division of Cardiology, Kansai Rosai Hospital, Amagasaki, Japan; 17. Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan; 18. Division of Cardiology, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan; 19. Division of Cardiology, Tokai University Hospital, Isehara, Japan; 20. Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan
Background: There are no randomised trials reporting clinical outcomes of biodegradable polymer biolimus-eluting stents (BP-BES) and durable polymer everolimus-eluting stents (DP-EES) at 10 years.
Aims: We aimed to compare the 10-year clinical outcomes between BP-BES and DP-EES.
Methods: The randomised NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial (NEXT) was originally designed to evaluate the non-inferiority of BP-BES relative to DP-EES with the primary efficacy endpoint of target lesion revascularisation (TLR) at 1 year and the primary safety endpoint of death or myocardial infarction (MI) at 3 years. In this extended follow-up study, clinical outcomes were compared from 1 year after stent implantation up to 10 years between patients with BP-BES and DP-EES.
Results: From May to October 2011, NEXT enrolled a total of 3,241 patients from 98 centres in Japan. The current study population consisted of 2,417 patients (1,204 patients with BP-BES and 1,213 with DP-EES) from 66 centres that agreed to participate in the extended study. Complete 10-year follow-up was achieved in 87.5% of patients. The cumulative 10-year incidence of death or MI was 34.0% in the BP-BES group and 33.1% in the DP-EES group (hazard ratio [HR] 1.04, 95% confidence interval [CI]: 0.90-1.20; p=0.58). TLR occurred in 15.9% of patients in the BP-BES group and in 14.1% of the DP-EES group (HR 1.12, 95% CI: 0.90-1.40; p=0.32). In a landmark analysis at 1 year, the cumulative incidences of death or MI and TLR were not significantly different between the 2 groups.
Conclusions: The safety and efficacy outcomes for BP-BES were not significantly different from those for DP-EES at 1 year and up to 10 years after stent implantation.
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