Masato Nakamura1, Yoshihiro Morino2, Tsunekazu Kakuta3, Yoshiki Hata4, Itaru Takamisawa5, Kengo Tanabe6, Hitoshi Anzai7, Akihiko Takahashi8, Kazushige Kadota9, Hiroshi Suzuki10, Tetsuzo Wakatsuki11, Hideki Okayama12, Jun Yamashita13, Takashi Akasaka14, Hiroyoshi Yokoi15, Takuo Nakagami16, Yoshiharu Higuchi17, Junichi Yamaguchi18, Takumi Kimura19, Atsushi Harada20, Takeshi Kuroda20, Atsushi Takita21, Raisuke Iijima1, Yoshitaka Murakami22, Shigeru Saito23. 1. Division of Cardiovascular Medicine, Toho University Ohashi Medical Center. 2. Department of Cardiology, Iwate Medical University Hospital. 3. Department of Cardiovascular Medicine, Tsuchiura Kyodo General Hospital. 4. Department of Cardiology, Minamino Cardiovascular Hospital. 5. Department of Cardiology, Sakakibara Heart Institute. 6. Division of Cardiology, Mitsui Memorial Hospital. 7. Department of Cardiology, Ota Memorial Hospital. 8. Department of Cardiology, Sakurakai Takahashi Hospital. 9. Department of Cardiology, Kurashiki Central Hospital. 10. Division of Cardiology, Showa University Fujigaoka Hospital. 11. Department of Cardiovascular Medicine, Tokushima University Hospital. 12. Department of Cardiology, Ehime Prefectural Central Hospital. 13. Department of Cardiology, Tokyo Medical University Hospital. 14. Department of Cardiovascular Medicine, Wakayama Medical University. 15. Cardiovascular Medicine Center, Fukuoka Sanno Hospital. 16. Department of Cardiovascular Medicine, Omihachiman Community Medical Center. 17. Cardiovascular Division, Osaka Police Hospital. 18. Department of Cardiology, Tokyo Women's Medical University Hospital. 19. Division of Cardiology, Iwate Prefectural Ofunato Hospital. 20. Medical Science Department, Daiichi Sankyo Co., Ltd. 21. Data Intelligence Department, Daiichi Sankyo Co., Ltd. 22. Department of Medical Statistics, School of Medicine, Toho University. 23. Division of Cardiology & Catheterization Laboratories, Shonan Kamakura General Hospital.
Abstract
BACKGROUND: The risks of bleeding and cardiovascular events in high bleeding risk (HBR) Japanese patients undergoing percutaneous coronary intervention (PCI) while receiving single-antiplatelet therapy (SAPT) remains unknown. We aimed to evaluate the frequency of bleeding and cardiovascular events associated with prasugrel monotherapy after short-term dual-antiplatelet therapy (DAPT) in Japanese HBR patients after PCI.Methods and Results: The PENDULUM mono study was a multicenter, non-interventional, prospective registry (n=1,173). The primary endpoint was the cumulative incidence of clinically relevant bleeding (CRB; Bleeding Academic Research Consortium types 2, 3, and 5) from 1 to 12 months after PCI. Secondary endpoints included major adverse cardiac and cerebrovascular events (MACCE). The proportion of patients who received prasugrel monotherapy at 12 months after PCI was 79.7%, and no cases of stent thrombosis were observed among these patients. The cumulative incidence of CRB was 3.2% from 1 to 12 months after PCI; that of MACCE was 3.8%. Severe anemia, chronic kidney disease, oral anticoagulant use at discharge, and heart failure were significantly associated with CRB. CONCLUSIONS: Among HBR patients undergoing PCI who were not suitable for concomitant aspirin and were scheduled for prasugrel monotherapy, most patients were on prasugrel monotherapy after DAPT. Cumulative incidences of CRB and MACCE after periprocedural period were 3.2% and 3.8%, respectively, and no cases of stent thrombosis were reported. SAPT might be a suitable alternative to DAPT.
BACKGROUND: The risks of bleeding and cardiovascular events in high bleeding risk (HBR) Japanese patients undergoing percutaneous coronary intervention (PCI) while receiving single-antiplatelet therapy (SAPT) remains unknown. We aimed to evaluate the frequency of bleeding and cardiovascular events associated with prasugrel monotherapy after short-term dual-antiplatelet therapy (DAPT) in Japanese HBR patients after PCI.Methods and Results: The PENDULUM mono study was a multicenter, non-interventional, prospective registry (n=1,173). The primary endpoint was the cumulative incidence of clinically relevant bleeding (CRB; Bleeding Academic Research Consortium types 2, 3, and 5) from 1 to 12 months after PCI. Secondary endpoints included major adverse cardiac and cerebrovascular events (MACCE). The proportion of patients who received prasugrel monotherapy at 12 months after PCI was 79.7%, and no cases of stent thrombosis were observed among these patients. The cumulative incidence of CRB was 3.2% from 1 to 12 months after PCI; that of MACCE was 3.8%. Severe anemia, chronic kidney disease, oral anticoagulant use at discharge, and heart failure were significantly associated with CRB. CONCLUSIONS: Among HBR patients undergoing PCI who were not suitable for concomitant aspirin and were scheduled for prasugrel monotherapy, most patients were on prasugrel monotherapy after DAPT. Cumulative incidences of CRB and MACCE after periprocedural period were 3.2% and 3.8%, respectively, and no cases of stent thrombosis were reported. SAPT might be a suitable alternative to DAPT.