1-Month or 3-Month DAPT in Women and Men at High Bleeding Risk Undergoing PCI.

Abstract

Background: In patients at high bleeding risk (HBR), short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) is associated with reduced bleeding and preserved ischemic protection.

Objectives: The aim of this study was to compare 2 short DAPT regimens, followed by aspirin monotherapy, in women and men at HBR undergoing PCI.

Methods: Data from 3 prospective, international studies (XIENCE Short DAPT Program) including patients at HBR undergoing PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (XIENCE) were analyzed. The primary endpoint was the composite of death or myocardial infarction (MI) at 1 year. The key secondary endpoint was Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding.

Results: Among 3,364 patients, 1,154 (34.3%) were women. At 1 year, the rates of death or MI (7.6% vs 8.1%) and BARC types 2 to 5 bleeding (9.5% vs 9.2%) were similar in women and men. One-month and 3-month DAPT conferred a similar risk for death or MI in women (adjusted HR: 0.86; 95% CI: 0.54-1.36) and men (adjusted HR: 1.04; 95% CI: 0.75-1.44) (P for interaction = 0.783). In both sexes, BARC types 2 to 5 bleeding was numerically lower with 1-month DAPT, although not significant after propensity score stratification (women: 7.1% vs 11.2%; adjusted HR: 0.66; 95% CI: 0.43-1.02; men: 8.5% vs 9.7%; adjusted HR: 0.78; 95% CI: 0.57-1.06) (P for interaction = 0.378).

Conclusions: Among patients at HBR undergoing PCI with everolimus-eluting stents, 1- and 3-month DAPT was associated with similar risk for ischemic events irrespective of sex. In both women and men, 1-month DAPT resulted in less clinically relevant bleeding, although the bleeding risk difference was not significant after propensity score stratification.