1. Bleeding after percutaneous coronary intervention (PCI) was more common in women, but the effect of two antiplatelet strategies on death and new Q-wave myocardial infarction following PCI did not differ between men and women.
Evidence Rating Level: 1 (Excellent)
Percutaneous coronary intervention (PCI) is a highly effective treatment in coronary artery disease. However, the optimal strategy of antiplatelet therapy after PCI remains debated. The randomized, controlled GLOBAL LEADERS study found that post-PCI, ticagrelor monotherapy (a P2Y12 inhibitor) following one month of dual antiplatelet therapy (DAPT) with aspirin was safe, but not superior to conventional DAPT in reducing the composite of all-cause mortality or new Q-wave myocardial infarction (MI). The objective of this pre-specified subgroup analysis of the GLOBAL LEADERS study was to compare two-year outcomes between all female and male participants, and the association between sex and the efficacy and safety of the two antiplatelet strategies. The primary endpoint was the composite of all-cause mortality and new Q-wave MI within two years after the index PCI. Of the 15,968 patients enrolled in the GLOBAL LEADERS study, 76.7% were men, and 23.3% were women. Analysis of baseline characteristics revealed that, compared with men, women were older, had a higher prevalence of diabetes, hypertension, and impaired renal function, were more likely to be nonsmokers, and had a lower prevalence of prior MI and previous treatment with PCI and coronary artery bypass graft surgery. Researchers found that there was no difference in the primary endpoint between men and women (3.90% vs. 4.75% respectively, adjusted HR 1.00, 95% CI 0.83 to 1.20). However, women had a higher risk of Bleeding Academic Research Consortium type 3 or 5 bleeding (adjusted HR 1.32, 95% CI 1.04 to 1.67) and hemorrhagic stroke (adjusted HR 4.76, 95% CI 1.92 to 11.81) at two years. There was no between-sex difference in the efficacy and safety of the two antiplatelet strategies at two years, but at one year, ticagrelor monotherapy was associated with a lower risk of bleeding in men (HR 0.72, 95% CI 0.53 to 0.98) but not in women (HR 1.23, 95% CI 0.80 to 1.89, p for interaction = 0.045). In summary, this study suggests that women are at a higher risk of bleeding and hemorrhagic stroke after PCI, and that ticagrelor monotherapy may be associated with a decreased risk of bleeding at one year after PCI in men, but not in women.
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