Circulation Journal
Online ISSN : 1347-4820
Print ISSN : 1346-9843
ISSN-L : 1346-9843
Coronary Revascularization
1-Year Safety of 3-Month Dual Antiplatelet Therapy Followed by Aspirin or P2Y12 Receptor Inhibitor Monotherapy Using a Bioabsorbable Polymer Sirolimus-Eluting Stent
Ken KozumaYoshihisa KinoshitaHirofumi HiokiMamoru NanasatoYoshiaki ItoJunichi YamaguchiNobuo ShiodeKiyoshi HibiKengo TanabeJunya AkoYoshihiro MorinoAtsushi HirohataShinjo SonodaYoshihisa NakagawaYuji Ikarifor the MODEL U-SES Study Investigators
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Supplementary material

2021 Volume 85 Issue 1 Pages 19-26

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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.

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© 2021 THE JAPANESE CIRCULATION SOCIETY

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