Ken Kozuma1, Yoshihisa Kinoshita2, Hirofumi Hioki1, Mamoru Nanasato3, Yoshiaki Ito4, Junichi Yamaguchi5, Nobuo Shiode6, Kiyoshi Hibi7, Kengo Tanabe8, Junya Ako9, Yoshihiro Morino10, Atsushi Hirohata11, Shinjo Sonoda12, Yoshihisa Nakagawa13, Yuji Ikari14. 1. Department of Cardiology, Teikyo University. 2. Department of Cardiology, Toyohashi Heart Center. 3. Department of Cardiology, Sakakibara Heart Institute. 4. Department of Cardiology, Saiseikai Yokohamashi Tobu Hospital. 5. Department of Cardiology, Tokyo Women's Medical University. 6. Department of Cardiology, Hiroshima City Hiroshima Citizens Hospital. 7. Division of Cardiology, Yokohama City University Medical Center. 8. Division of Cardiology, Mitsui Memorial Hospital. 9. Department of Cardiology, Kitazato University Hospital. 10. Department of Cardiology, Iwate Medical University. 11. Department of Cardiology, The Sakakibara Heart Institute of Okayama. 12. Department of Cardiology, Hospital of the University of Occupational and Environmental Health. 13. Department of Cardiology, Shiga University of Medical Science Hospital. 14. Department of Cardiology, Tokai University Hospital.
Abstract
BACKGROUND: This study evaluated the safety of 3-month dual antiplatelet therapy (DAPT) after implantation of a bioresorbable polymer sirolimus-eluting stent (BP-SES) and compared P2Y12inhibitor with aspirin monotherapy 3 months after DAPT.Methods and Results: Patients who underwent percutaneous coronary intervention using BP-SES were enrolled and followed for 1 year. Patients with a history of stent thrombosis were excluded. The primary endpoint was a composite of all-cause death, myocardial infarction, stroke (ischemic and hemorrhagic), definite or probable stent thrombosis, and severe bleeding at 12 months. The BP-SES arm of the CENTURY II trial was used as a conventional DAPT group for comparison. After DAPT, patients were maintained on either aspirin (n=846) or a P2Y12inhibitor (n=674 patients).In all, 1,695 patients were enrolled in the study across 65 centers. The primary endpoint occurred in 4.3% of patients at 1 year. After propensity score adjustment, the incidence of the primary endpoint was not inferior in those receiving DAPT for 3 months compared with conventional DAPT (5.5%; Pnon-inferiority<0.0001). The incidence of the primary endpoint and severe bleeding did not differ between the aspirin and P2Y12inhibitor monotherapy groups. CONCLUSIONS: After adjustment, 3-month DAPT was not inferior to longer DAPT after BP-SES implantation in terms of net adverse clinical events. There was no difference in bleeding and thrombotic events between P2Y12inhibitor and aspirin monotherapy after 3 months DAPT.
BACKGROUND: This study evaluated the safety of 3-month dual antiplatelet therapy (DAPT) after implantation of a bioresorbable polymer sirolimus-eluting stent (BP-SES) and compared P2Y12inhibitor with aspirin monotherapy 3 months after DAPT.Methods and Results: Patients who underwent percutaneous coronary intervention using BP-SES were enrolled and followed for 1 year. Patients with a history of stent thrombosis were excluded. The primary endpoint was a composite of all-cause death, myocardial infarction, stroke (ischemic and hemorrhagic), definite or probable stent thrombosis, and severe bleeding at 12 months. The BP-SES arm of the CENTURY II trial was used as a conventional DAPT group for comparison. After DAPT, patients were maintained on either aspirin (n=846) or a P2Y12inhibitor (n=674 patients).In all, 1,695 patients were enrolled in the study across 65 centers. The primary endpoint occurred in 4.3% of patients at 1 year. After propensity score adjustment, the incidence of the primary endpoint was not inferior in those receiving DAPT for 3 months compared with conventional DAPT (5.5%; Pnon-inferiority<0.0001). The incidence of the primary endpoint and severe bleeding did not differ between the aspirin and P2Y12inhibitor monotherapy groups. CONCLUSIONS: After adjustment, 3-month DAPT was not inferior to longer DAPT after BP-SES implantation in terms of net adverse clinical events. There was no difference in bleeding and thrombotic events between P2Y12inhibitor and aspirin monotherapy after 3 months DAPT.
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