Sex-related bleeding risk in acute coronary syndrome patients receiving dual antiplatelet therapy with aspirin and a P2Y12 inhibitor.

Aims To study sex differences in major bleeding in relation to dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). Methods and results The Collective Cardiology Research registry was designed to evaluate the application and outcomes of DAPT after ACS/PCI in the Rijnmond region in the Netherlands. Overall, 1172 women (median age 67.5 years) and 3087 men (62.2 years) with ACS/PCI were enrolled between August 2011 and June 2013. Based on a tailored regional DAPT guideline aiming at bleeding risk minimization, 52.6% women and 66.9% men received prasugrel as first-choice P2Y12 inhibitor, additional to aspirin. Women more frequently had contraindications for the use of prasugrel (and therefore received clopidogrel) than men (47.9 vs. 26.9%, p<0.001). Femoral access was more common in women than in men (47.6 vs. 38.1%, p<0.001). Women had higher incidence of TIMI major bleeding at 1 year than men (2.6 vs. 1.6%, p=0.018). After adjustment for established bleeding risk factors, female sex was associated with over two-fold higher risk of TIMI major bleeding (adjusted hazard ratio 2.33; 95% confidence interval 1.26 to 4.32). This difference was already apparent at discharge, and appeared to be caused by access site bleedings (0.9 vs. 0.1%, p<0.001). No sex differences were found in non-access site related TIMI major bleeding up to 1 year. Conclusion Women with ACS/PCI receiving DAPT had higher TIMI major bleeding risk caused by an excess in access-site bleeds, mainly in relation to the femoral approach.