Sex Differences in Ischemic and Bleeding Outcomes in Patients With Non-ST-Segment-Elevation Acute Coronary Syndrome
Jean-Guillaume Dillinger1, Gregory Ducrocq2, Yedid Elbez2
1Université de Paris, Hôpital Lariboisière, AP-HP, Inserm U-942, Paris, France (J.-G.D., P.H.).
Insights
Female sex was not an independent predictor of ischemic or bleeding events in non-ST-segment-elevation acute coronary syndrome patients undergoing invasive management. However, females experienced higher bleeding risks unrelated to coronary artery bypass graft surgery.
Area of Science:
- Cardiology
- Clinical Research
- Sex Differences in Health
Background:
- Previous studies indicate poorer outcomes for females post-myocardial infarction.
- Factors like older age and reduced percutaneous coronary intervention use in females may contribute to worse outcomes.
- This study investigates sex as an independent predictor of outcomes in acute coronary syndrome.
Purpose of the Study:
- To determine if female sex is an independent risk factor for ischemic and bleeding outcomes.
- To analyze outcomes in non-ST-segment-elevation acute coronary syndrome (NSTE-ACS) patients treated invasively.
- To evaluate sex-based differences in a large clinical trial cohort.
Main Methods:
- Post hoc analysis of the TAO trial data.
- Inclusion of patients with NSTE-ACS undergoing invasive treatment.
- Analysis of primary ischemic (death, myocardial infarction) and safety (bleeding) endpoints by sex.
Main Results:
- Females (30.1%) were older, had more comorbidities, and received less revascularization than males.
- Initially, females showed higher risks for ischemic and bleeding events.
- Multivariate analysis revealed no independent link between female sex and ischemic/bleeding outcomes, except for non-CABG related bleeding.
Conclusions:
- In NSTE-ACS patients with invasive management, female sex is not an independent predictor of ischemic or bleeding events.
- Females had a higher risk of non-coronary artery bypass graft related Thrombolysis in Myocardial Infarction major bleeding.
- Findings highlight the need for tailored risk assessment in female ACS patients.
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.
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