1-Year Safety of 3-Month Dual Antiplatelet Therapy Followed by Aspirin or P2Y12 Receptor Inhibitor Monotherapy Using a Bioabsorbable Polymer Sirolimus-Eluting Stent

• Published in: Circulation Journal Vol. 85; no. 1; pp. 19 - 26
• Main Authors: Ako, Junya, Ito, Yoshiaki, Kozuma, Ken, Hioki, Hirofumi, Tanabe, Kengo, Yamaguchi, Junichi, Hibi, Kiyoshi, Nanasato, Mamoru, Ikari, Yuji, Kinoshita, Yoshihisa, Hirohata, Atsushi, Shiode, Nobuo, Sonoda, Shinjo, Morino, Yoshihiro, for the MODEL U-SES Study Investigators, Nakagawa, Yoshihisa
• Format: Journal Article
• Language: English
• Published: The Japanese Circulation Society 25.12.2020
• Subjects: Aspirin; Drug-eluting stent (DES); Monotherapy; P2Y12 inhibitor; Short dual antiplatelet therapy (DAPT)
• ISSN: 1346-9843; 1347-4820; 1347-4820
• DOI: 10.1253/circj.CJ-20-0644

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.