title: Comparison of incidence of bleeding and mortality of men versus women with ST-elevation myocardial infarction treated with fibrinolysis.
abstract: 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.
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina, USA. mehta007@dcri.duke.edu
authors.forename: Rajendra H
authors.initials: RH
authors.lastname: Mehta
authors.forename: Amanda S
authors.initials: AS
authors.lastname: Stebbins
authors.forename: Renato D
authors.initials: RD
authors.lastname: Lopes
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
authors.forename: Karen S
authors.initials: KS
authors.lastname: Pieper
authors.forename: Paul W
authors.initials: PW
authors.lastname: Armstrong
authors.forename: Frans
authors.initials: F
authors.lastname: Van de Werf
authors.forename: Judith S
authors.initials: JS
authors.lastname: Hochman
authors.forename: Harvey D
authors.initials: HD
authors.lastname: White
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Topol
authors.forename: John H
authors.initials: JH
authors.lastname: Alexander
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Granger
mesh_terms: D000368:Aged; D004562:Electrocardiography; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D016017:Odds Ratio; D011379:Prognosis; D011446:Prospective Studies; D012307:Risk Factors; D017678:Sex Distribution; D012737:Sex Factors; D015996:Survival Rate / Q000639:trends; D015912:Thrombolytic Therapy / Q000009:adverse effects / Q000379:methods*
chemical_list: D005343:Fibrinolytic Agents