Female sex was not an independent predictor of ischemic outcomes (OR 1.04; 95% CI 0.90-1.19) or bleeding events compared to male sex in patients with NSTE-ACS undergoing invasive management.
RCT (n=13,229)
randomized
Is female sex an independent predictor of ischemic and bleeding outcomes in patients with NSTE-ACS treated with a systematic invasive approach?
In patients with NSTE-ACS undergoing invasive management, female sex is not an independent predictor of overall ischemic or bleeding events, suggesting worse crude outcomes in women are largely driven by older age and comorbidities.
Odds Ratio: 1.04 (95% CI 0.9–1.19)
Absolute Event Rate: 10.2% vs 9.1%
BACKGROUND: Previous studies have observed poorer outcomes in females with myocardial infarction, but older age and lower use of percutaneous coronary intervention in females are factors that potentially explain the worse outcome. This study sought to determine if female sex is an independent factor of ischemic and bleeding outcomes in non-ST-segment-elevation acute coronary syndrome treated with a systematic invasive approach. METHODS: The TAO trial (Treatment of Acute Coronary Syndrome With Otamixaban) randomized patients with non-ST-segment-elevation acute coronary syndrome treated invasively to heparin plus eptifibatide versus otamixaban. In this post hoc analysis, the primary ischemic end point (all-cause death, myocardial infarction within 180 days) and the primary safety end point (Thrombolysis in Myocardial Infarction major or minor bleeding within 30 days) were analyzed according to sex. RESULTS: Of 13 229 randomized patients, 3980 (30.1%) were females and 9249 (69.9%) were males. Females were older (64.8±11.0 versus 60.7±11.1 years), had more comorbidities, received less peri-procedural antithrombotic therapy, and underwent less frequently revascularization. Overall, females experienced a higher risk of ischemic (10.2% versus 9.1%; odds ratio OR, 1.15 1.01-1.30) and bleeding events (4.2% versus 3.4%; OR, 1.23 1.02-1.49) than males. After multivariate analysis, the risk of ischemic outcomes (OR, 1.04 0.90-1.19), death (OR, 1.00 0.75-1.23), or bleeding (OR, 1.05 0.85-1.28), were similar between females and males. Only, noncoronary artery bypass graft related Thrombolysis in Myocardial Infarction major bleeding were increased in females (OR, 1.69 1.11-2.56). CONCLUSIONS: In patients with non-ST-segment-elevation acute coronary syndrome with systematic invasive management, ischemic outcomes, bleeding events, and mortality were higher in females. After multivariate analyses, female sex was not an independent predictor of ischemic and bleeding events although noncoronary artery bypass graft related Thrombolysis in Myocardial Infarction major bleeding was higher in females. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01076764.
Dillinger et al. (Fri,) conducted a rct in Non-ST-segment-elevation acute coronary syndrome (n=13,229). Female sex vs. Male sex was evaluated on Ischemic outcomes (all-cause death, myocardial infarction within 180 days) (OR 1.04, 95% CI 0.90-1.19). Female sex was not an independent predictor of ischemic outcomes (OR 1.04; 95% CI 0.90-1.19) or bleeding events compared to male sex in patients with NSTE-ACS undergoing invasive management.