Masato Nakamura1, Kazushige Kadota2, Koichi Nakao3, Yoshihisa Nakagawa4, Junya Shite5, Hiroyoshi Yokoi6, Ken Kozuma7, Kengo Tanabe8, Takashi Akasaka9, Toshiro Shinke10, Takafumi Ueno11, Atsushi Hirayama12, Shiro Uemura13, Atsushi Harada14, Takeshi Kuroda14, Atsushi Takita15, Raisuke Iijima1, Yoshitaka Murakami16, Shigeru Saito17. 1. Division of Cardiovascular Medicine, Toho University Ohashi Medical Center. 2. Department of Cardiology, Kurashiki Central Hospital. 3. Division of Cardiology, Saiseikai Kumamoto Hospital. 4. Department of Cardiovascular Medicine, Shiga University of Medical Science. 5. Division of Cardiology, Osaka Saiseikai Nakatsu Hospital. 6. Cardiovascular Medicine Center, Fukuoka Sanno Hospital. 7. Division of Cardiology, Department of Internal Medicine, Teikyo University Hospital. 8. Division of Cardiology, Mitsui Memorial Hospital. 9. Department of Cardiovascular Medicine, Wakayama Medical University. 10. Division of Cardiology, Department of Medicine, Showa University School of Medicine. 11. Department of Cardiovascular Medicine, Fukuoka Kinen Hospital. 12. Department of Cardiology, Osaka Police Hospital. 13. Department of Cardiology, Kawasaki Medical School. 14. Medical Science Department, Daiichi Sankyo Co., Ltd. 15. Data Intelligence Department, Daiichi Sankyo Co., Ltd. 16. Department of Medical Statistics, School of Medicine, Toho University. 17. Division of Cardiology & Catheterization Laboratories, Shonan Kamakura General Hospital.
Abstract
BACKGROUND: Outcomes with prasugrel single antiplatelet therapy (SAPT) vs. dual antiplatelet therapy (DAPT) in Japanese percutaneous coronary intervention (PCI) patients with high bleeding risk (HBR) are currently unknown.Methods and Results: Data from 1,173 SAPT and 2,535 DAPT patients from the PENDULUM mono and PENDULUM registry studies (respective median DAPT durations: 108 vs. 312 days) were compared. The adjusted cumulative incidence of Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding from 1 to 12 months after PCI (primary endpoint) was 2.8% (95% confidence interval [CI], 1.9-4.2) and 4.1% (95% CI, 3.3-5.1), respectively (hazard ratio [HR], 0.69; 95% CI, 0.45-1.06; P=0.090). The adjusted cumulative incidences of BARC 2, 3, or 5 bleeding from 0 to 12 months after PCI (secondary endpoint) were 3.8% (95% CI, 2.7-5.3) and 5.6% (95% CI, 4.7-6.7), respectively (HR, 0.68; 95% CI, 0.47-0.98; P=0.039). There was no significant difference in major adverse cardiac and cerebrovascular events (MACCE) from 1 to 12 months after PCI (HR, 0.93; 95% CI, 0.63-1.37; P=0.696) and at 12 months after PCI (HR, 0.85; 95% CI, 0.61-1.19; P=0.348) between the groups. CONCLUSIONS: Prasugrel SAPT may reduce BARC 2, 3, or 5 bleeding, without increasing MACCE, in Japanese patients with HBR.
BACKGROUND: Outcomes with prasugrel single antiplatelet therapy (SAPT) vs. dual antiplatelet therapy (DAPT) in Japanese percutaneous coronary intervention (PCI) patients with high bleeding risk (HBR) are currently unknown.Methods and Results: Data from 1,173 SAPT and 2,535 DAPT patients from the PENDULUM mono and PENDULUM registry studies (respective median DAPT durations: 108 vs. 312 days) were compared. The adjusted cumulative incidence of Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding from 1 to 12 months after PCI (primary endpoint) was 2.8% (95% confidence interval [CI], 1.9-4.2) and 4.1% (95% CI, 3.3-5.1), respectively (hazard ratio [HR], 0.69; 95% CI, 0.45-1.06; P=0.090). The adjusted cumulative incidences of BARC 2, 3, or 5 bleeding from 0 to 12 months after PCI (secondary endpoint) were 3.8% (95% CI, 2.7-5.3) and 5.6% (95% CI, 4.7-6.7), respectively (HR, 0.68; 95% CI, 0.47-0.98; P=0.039). There was no significant difference in major adverse cardiac and cerebrovascular events (MACCE) from 1 to 12 months after PCI (HR, 0.93; 95% CI, 0.63-1.37; P=0.696) and at 12 months after PCI (HR, 0.85; 95% CI, 0.61-1.19; P=0.348) between the groups. CONCLUSIONS: Prasugrel SAPT may reduce BARC 2, 3, or 5 bleeding, without increasing MACCE, in Japanese patients with HBR.