May 29, 2020
Analysis of LEADERS FREE Supports Similar PCI Treatment in Women as in Men With High Bleeding Risk
May 29, 2020—The American College of Cardiology announced a recently published study that demonstrated that women with high bleeding risk should not be denied the benefits of percutaneous coronary intervention (PCI) when indicated and that bleeding avoidance strategies should be uniformly adopted for all patients, especially in women.
The secondary analysis of the LEADERS FREE randomized clinical trial was published online by Roxana Mehran, MD, et al in Journal of the American Medical Association (JAMA): Cardiology.
According to ACC, the investigators used data from the LEADERS FREE trial to assess the 2-year outcomes by sex in patients with high bleeding risk in the primary composite safety (cardiac death, myocardial infarction, or stent thrombosis) and efficacy (target lesion revascularization) endpoints. This cohort study was conducted at 68 sites in 20 countries. The cohort was composed of 2,432 patients with high bleeding risk and a mean age of 75 years.
As noted by ACC, the investigators stated, “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. Thus, it provides detailed sex-based descriptions of baseline demographic characteristics and long-term outcomes up to 2 years with drug-coated stents or bare-metal stent PCI and 1 month of dual antiplatelet therapy.”
Results reported in JAMA: Cardiology showed that women and men had a similar incidence of the 2-year primary and efficacy endpoints.
The drug-coated stent was superior compared with the bare-metal stent in both sexes, with the following outcomes:
- Lower target lesion revascularization (women, 6.3% vs 12.1%; men, 7% vs 12%)
- Similar rates of the primary safety endpoint (women, 12.4% vs 17%; men, 12.6% vs 14.5%)
Additionally, the investigators found:
- Major bleeding at 2 years was not statistically different between the sexes.
- Women experienced greater major bleeding within the first 30 days and greater vascular access site major bleeding than men.
- Vascular and nonvascular major bleeding were associated with greater 2-year mortality in both sexes.