Masato Nakamura1, Raisuke Iijima2, Junya Ako3, Toshiro Shinke4, Hisayuki Okada5, Yoshiaki Ito6, Kenji Ando7, Hitoshi Anzai8, Hiroyuki Tanaka9, Yasunori Ueda10, Shin Takiuchi11, Yasunori Nishida12, Hiroshi Ohira13, Katsuhiro Kawaguchi14, Makoto Kadotani15, Hiroyuki Niinuma16, Kazuto Omiya17, Takashi Morita18, Kan Zen19, Yoshinori Yasaka20, Kenji Inoue21, Sugao Ishiwata22, Masahiko Ochiai23, Toshimitsu Hamasaki24, Hiroyoshi Yokoi25. 1. Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan. Electronic address: masato@oha.toho-u.ac.jp. 2. Division of Cardiovascular Medicine, Toho University Ohashi Medical Center, Tokyo, Japan. 3. Department of Cardiovascular Medicine, Kitasato University Hospital, Sagamihara, Japan. 4. Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine, Kobe, Japan. 5. Department of Cardiology, Seirei Hamamatsu General Hospital, Hamamatsu, Japan. 6. Division of Cardiology, Saiseikai Yokohama-City Eastern Hospital, Yokohama, Japan. 7. Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan. 8. Cardiology Department, Ota Memorial Hospital, Ota, Japan. 9. Department of Cardiology, Tokyo Metropolitan Tama Medical Center, Tokyo, Japan. 10. Cardiovascular Division, National Hospital Organization Osaka National Hospital, Osaka, Japan. 11. Department of Cardiology, Higashi Takarazuka Satoh Hospital, Takarazuka, Japan. 12. Department of Cardiovascular Medicine, Takai Hospital, Nara, Japan. 13. Department of Cardiology, Edogawa Hospital, Tokyo, Japan. 14. Department of Cardiology, Komaki City Hospital, Komaki, Japan. 15. Department of Cardiology, Kakogawa Central City Hospital, Kakogawa, Japan. 16. Department of Cardiology, St. Luke's International Hospital, Tokyo, Japan. 17. Division of Cardiology, St. Marianna University School of Medicine Yokohama City Seibu Hospital, Yokohama, Japan. 18. Division of Cardiology, Osaka General Medical Center, Osaka, Japan. 19. Department of Cardiovascular Medicine, Omihachiman Community Medical Center, Omihachiman, Japan. 20. Department of Cardiology, Hyogo Brain and Heart Center, Himeji, Japan. 21. Department of Cardiology, Juntendo University Nerima Hospital, Tokyo, Japan. 22. Cardiovascular Center, Toranomon Hospital, Tokyo, Japan. 23. Division of Cardiology and Cardiac Catheterization Laboratories, Showa University Northern Yokohama Hospital, Yokohama, Japan. 24. Department of Data Science, National Cerebral and Cardiovascular Center, Suita, Japan. 25. Department of Cardiovascular Medicine Center, Fukuoka Sanno Hospital, Fukuoka, Japan.
Abstract
OBJECTIVES: The NIPPON (Nobori Dual Antiplatelet Therapy as Appropriate Duration) study was a multicenter randomized investigation of the noninferiority of short-term versus long-term dual antiplatelet therapy (DAPT) in patients with implantation of the Nobori drug-eluting stent (DES) (Terumo, Tokyo, Japan), which has a biodegradable abluminal coating. BACKGROUND: The optimum duration of DAPT for patients with a biodegradable polymer-coated DES is unclear. METHODS: The subjects were 3,773 patients with stable or acute coronary syndromes undergoing Nobori stent implantation. They were randomized 1:1 to receive DAPT for 6 or 18 months. The primary endpoint was net adverse clinical and cerebrovascular events (NACCE) (all-cause mortality, myocardial infarction, stroke, and major bleeding) from 6 to 18 months after stenting. Intention-to-treat analysis was performed in 3,307 patients who were followed for at least 6 months. RESULTS:NACCE occurred in 34 patients (2.1%) receiving short-term DAPT and 24 patients (1.5%) receiving long-term DAPT (difference 0.6%, 95% confidence interval [CI]: 1.5 to 0.3). Because the lower limit of the 95% CI was inside the specified margin of -2%, noninferiority of short-term DAPT was confirmed. Mortality was 1.0% with short-term DAPT versus 0.4% with long-term DAPT, whereas myocardial infarction was 0.2% versus 0.1%, and major bleeding was 0.7% versus 0.7%, respectively. The estimated probability of NACCE was lower in the long-term DAPT group (hazard ratio: 1.44, 95% CI: 0.86 to 2.43). CONCLUSIONS: Six months of DAPT was not inferior to 18 months of DAPT following implantation of a DES with a biodegradable abluminal coating. However, this result needs to be interpreted with caution given the open-label design and wide noninferiority margin of the present study. (Nobori Dual Antiplatelet Therapy as Appropriate Duration [NIPPON]; NCT01514227).
RCT Entities:
OBJECTIVES: The NIPPON (Nobori Dual Antiplatelet Therapy as Appropriate Duration) study was a multicenter randomized investigation of the noninferiority of short-term versus long-term dual antiplatelet therapy (DAPT) in patients with implantation of the Nobori drug-eluting stent (DES) (Terumo, Tokyo, Japan), which has a biodegradable abluminal coating. BACKGROUND: The optimum duration of DAPT for patients with a biodegradable polymer-coated DES is unclear. METHODS: The subjects were 3,773 patients with stable or acute coronary syndromes undergoing Nobori stent implantation. They were randomized 1:1 to receive DAPT for 6 or 18 months. The primary endpoint was net adverse clinical and cerebrovascular events (NACCE) (all-cause mortality, myocardial infarction, stroke, and major bleeding) from 6 to 18 months after stenting. Intention-to-treat analysis was performed in 3,307 patients who were followed for at least 6 months. RESULTS:NACCE occurred in 34 patients (2.1%) receiving short-term DAPT and 24 patients (1.5%) receiving long-term DAPT (difference 0.6%, 95% confidence interval [CI]: 1.5 to 0.3). Because the lower limit of the 95% CI was inside the specified margin of -2%, noninferiority of short-term DAPT was confirmed. Mortality was 1.0% with short-term DAPT versus 0.4% with long-term DAPT, whereas myocardial infarction was 0.2% versus 0.1%, and major bleeding was 0.7% versus 0.7%, respectively. The estimated probability of NACCE was lower in the long-term DAPT group (hazard ratio: 1.44, 95% CI: 0.86 to 2.43). CONCLUSIONS: Six months of DAPT was not inferior to 18 months of DAPT following implantation of a DES with a biodegradable abluminal coating. However, this result needs to be interpreted with caution given the open-label design and wide noninferiority margin of the present study. (Nobori Dual Antiplatelet Therapy as Appropriate Duration [NIPPON]; NCT01514227).
Authors: Pierre Sabouret; Gilles Lemesle; Anne Bellemain-Appaix; Pierre Aubry; Pier-Paolo Bocchino; Erik Rafflenbeul; Loïc Belle; Jim Nolan; Marco Bernardi; Giuseppe Biondi-Zoccai; Michael P Savage; Maciej Banach; Guillaume Cayla Journal: Arch Med Sci Date: 2022-06-23 Impact factor: 3.707
Authors: Davide Capodanno; Deepak L Bhatt; C Michael Gibson; Stefan James; Takeshi Kimura; Roxana Mehran; Sunil V Rao; Philippe Gabriel Steg; Philip Urban; Marco Valgimigli; Stephan Windecker; Dominick J Angiolillo Journal: Nat Rev Cardiol Date: 2021-08-23 Impact factor: 32.419