Comparison of incidence of bleeding and mortality of men versus women with ST-elevation myocardial infarction treated with fibrinolysis.

Gender-related differences in the incidence of bleeding and its relation to subsequent mortality in patients with ST-segment elevation myocardial infarction (STEMI) treated with fibrinolysis are not well understood. We studied patients with STEMI receiving fibrinolysis enrolled in 6 clinical trials. Outcomes included moderate or severe bleeding defined using Global Utilization of Strategies to Open Occluded Arteries (GUSTO) criteria and adjusted 1-year mortality (excluding deaths in first 24 hours). Moderate or severe bleeding was 1.9-fold higher in women compared to men (13.3% vs 7.1%, p <0.0001). Bleeding remained higher in women even after adjustment for baseline differences (odd ratios 1.52, 95% confidence interval [CI] 1.42 to 1.62). In fact, female gender was second most important prognostic factor (Wald chi-square 153.6) after older age (Wald chi-square 241.2) in the multivariable bleeding model. Overall 1-year mortality was similar in women and men after adjusting for prognostically important baseline differences (hazard ratio [HR] 1.06, 95% CI 0.97 to 1.17). However, after adjustment for baseline confounders and bleeding, female gender was associated with a lower risk of 1-year death. Thus, adjusted 1-year mortality was similar in women compared to men without bleeding (HR 1.08, 95% CI 0.97 to 1.19) but lower in women compared to men with bleeding (HR 0.85, 95% CI 0.73 to 0.98, p for interaction of gender by bleeding = 0.0016). The highest adjusted 1-year mortality was observed in men with bleeding (HR 2.42, 95% CI 2.20 to 2.66) followed by women with bleeding (HR 2.05, 95% CI 1.80 to 2.33) and women without bleeding (HR 1.08, 95% CI 0.97 to 1.19, referent men without bleeding). In conclusion, in patients with fibrinolytic-treated STEMI, women had a higher incidence but lower mortality with bleeding than men. These data highlight the importance of understanding factors associated with gender-related differences in bleeding and represent an opportunity for improving outcomes of women and men with fibrinolytic-treated STEMI.