Sex-Based Outcomes in Patients With High Bleeding Risk After PCI With 1-Month DAPT: Results From the Onyx ONE Clear Trial

Background:The Onyx ONE Clear study demonstrated favorable 1-year efficacy and safety outcomes in patients with high bleeding risk (HBR) and 1 month of event-free dual antiplatelet therapy (DAPT) after treatment with Resolute Onyx zotarolimus-eluting stents (ZES).Differences in outcomes after early DAPT discontinuation by sex have not been fully defined.Methods: Eligible patients had 1 HBR criterion and underwent percutaneous coronary intervention with the Resolute Onyx ZES.Outcomes were evaluated in patients "clear" of 30-day adverse events.The primary end point was a composite of cardiac death or myocardial infarction (CD/MI).Bleeding and ischemic outcomes at 2 years were compared by sex in this prespecified subgroup analysis.Results: Among 1507 patients included, 32.2% were women.Women were older and more likely to present with acute coronary syndrome.The 2-year rates of CD/MI were 10.6% in women vs 12.6% in men (P = .29),and all-cause mortality was 10.1% vs 14.6% (P = .018),respectively.No sex-related differences were observed for the other ischemic outcomes.After propensity score adjustment, all-cause mortality did not differ significantly between groups.Based on multivariable Cox regression analysis, the number of HBR criteria, diabetes, and acute coronary syndrome presentation, but not sex, were associated with Bleeding Academic Research Consortium 3 to 5 bleeding through 2 years. Conclusions:In HBR patients treated with Resolute Onyx ZES and 1-month abbreviated DAPT, rates of CD or MI at 2 years were low, with no significant sexrelated differences in ischemic and bleeding events.These data support the use of abbreviated DAPT after ZES in women and men with HBR.