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Sex-based outcomes in patients with a high bleeding risk after percutaneous coronary intervention and 1-month dual antiplatelet therapy

JAMA May 25, 2020

Mehran R, Chandrasekhar J, Urban P, et al. - By performing this secondary analysis of the LEADERS FREE double-blind, randomized clinical trial, researchers evaluated the 2-year outcomes by gender in patients carrying a high bleeding risk. Patients (n = 2,432) were randomly 1:1 assigned to either a bare-metal stent or a polymer-free, biolimus A9-eluting drug-coated stent with 1-month of dual antiplatelet therapy. A composite of cardiac death, myocardial infarction, or stent thrombosis was assessed as the primary safety endpoint and clinically driven target lesion revascularization was the primary efficacy endpoint. Experts identified the superiority of drug-coated stent, vs bare-metal stent, in both genders, with lower target lesion revascularization as well as similar rates of the primary safety endpoint. Overall, among patients with a high bleeding risk post-percutaneous coronary intervention (PCI), the observed ischemic outcomes did not differ by gender, however, women seemed to show greater early bleeding and major bleeding from the vascular access site. In both genders, patients with major bleeding appeared to have worse 2-year mortality, this implies that uniform adoption of bleeding avoidance strategies for all patients should be implemented, with close attention dedicated to women to prevent denying them the advantages of PCI.

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