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Sex-based outcomes in patients with a high bleeding risk after percutaneous coronary intervention: A secondary analysis of the LEADERS FREE randomized clinical trial

JAMA Cardiology Aug 23, 2020

Mehran R, Chandrasekhar J, Urban P, et al. - This study was undertaken to investigate the 2-year outcomes by gender in patients with a high bleeding risk who were enrolled in the LEADERS FREE trial. Between December 2012 and May 2014, a prespecified, gender-based secondary analysis of the LEADERS FREE double-blind, randomized clinical trial was conducted at 68 sites in 20 countries including patients with a high bleeding risk who had undergone percutaneous coronary intervention (PCI) and met the trial eligibility criteria at the participating sites and followed up for up to 2 years. This analysis enrolled a sum of 2,432 patients with high bleeding risk. No sex differences were found in the ischemic outcomes of patients with a high bleeding risk after PCI, but women seemed to illustrate greater early bleeding and major bleeding from the vascular access site. This study's findings demonstrate that both women and men with major bleeding appeared to experience worse 2-year mortality, implying that bleeding avoidance strategies should be uniformly adopted for all patients, with close attention dedicated to women to avoid denying them the benefits of PCI.

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