Women in GLOBAL LEADERS Study at Higher Bleeding Risk Post-PCI Than Men

Women from the GLOBAL LEADERS trial were at a higher risk for bleeding and stroke following percutaneous coronary intervention (PCI) despite two different antiplatelet strategies, a new analysis suggests.

“Women experience worse ischemic and bleeding outcomes after PCI,” the researchers wrote in their study. “To assess the association of sex with patient outcomes at two years after contemporary PCI and with the efficacy and safety of two antiplatelet strategies.”

The authors for the prespecified subgroup analysis looked at patients who had undergone PCI across 130 secondary/tertiary care hospitals between July 2013 and November 2015. Patients had outpatient clinical visits at 30 days, and then at three, six, nine, 12, 18, and 24 months. Patients were randomized to either a reference antiplatelet strategy (12 months of dual antiplatelet therapy plus 12 months of aspirin therapy) or experimental strategy (one month of dual antiplatelet therapy and 23 months of ticagrelor monotherapy). the primary outcome of interest was the composite of all-cause mortality and Q-wave myocardial infarction at two years, with a secondary safety endpoint of BARC type 3 or 5 bleeding.

The researchers included 15,968 participants in the analysis, of whom 3,714 (23.3%) were women. The risk for the primary endpoint was similar between men and women (adjusted HR=1.00; 95% CI, 0.83 to 1.20). Women were reported to have higher risk for BARC type 3 or 5 bleeding at two years (adjusted HR=1.32; 95% CI, 1.04 to 1.67), as well as hemorrhagic stroke at two years (adjusted HR=4.76; 95% CI, 1.92 to 11.81). There were no significant differences in safety and efficacy between the two antiplatelet strategies. Ticagrelor was associated with lower bleeding risk in men, but not women (P for interaction=0.45).

“In this prespecified subgroup analysis of the GLOBAL LEADERS randomized clinical trial, there was no between-sex difference in the risk of two-year all-cause mortality or new Q-wave myocardial infarction,” the researchers said of the findings. “The risks of bleeding and hemorrhagic stroke in women were higher than in men, and compared with dual antiplatelet therapy, ticagrelor monotherapy was associated with lower risk of bleeding at one year in men but not in women.”

They added that “antiplatelet strategy on bleeding at one year may be different between the sexes.”

The study was published in JAMA Cardiology.