Women with high bleeding risk should not be denied the benefits of PCI when indicated and bleeding avoidance strategies should be uniformly adopted for all patients, especially in women, according to a study published May 20 in JAMA Cardiology.

Using data from the LEADERS FREE trial, Roxana Mehran, MD, FACC, et al., sought to assess the two-year outcomes by sex in patients with high bleeding risk. This cohort study was conducted at 68 sites in 20 countries, and included 2,432 patients with high bleeding risk and a mean age of 75 years.

Results showed that women and men had similar incidence of the two-year primary and efficacy end points. The drug-coated stent was found to be superior to the bare-metal stent in both sexes, with lower target lesion revascularization (women, 6.3% vs. 12.1%; men, 7.0% vs. 12.0%) and similar rates of the primary safety endpoint (women, 12.4% vs. 17.0%; men, 12.6% vs. 14.5%).

Furthermore, the researchers found that two-year major bleeding was not statistically different between the sexes, but women experienced greater major bleeding within the first 30 days and greater vascular access site major bleeding than men.

In both sexes, the researchers discovered that vascular and nonvascular major bleeding were associated with greater two-year mortality.

"We used a broad definition of high bleeding risk, but this analysis was the first sex-based subanalysis in patients with a high bleeding risk enrolled in a randomized clinical trial," the authors write. "Thus, it provides detailed sex-based descriptions of baseline demographic characteristics and long-term outcomes up to two years with a drug-coated stents or bare-metal stent PCI and one month of DAPT."

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Drug-Eluting Stents, Platelet Aggregation Inhibitors, Cohort Studies, Percutaneous Coronary Intervention, Stents, Metals

< Back to Listings