Gender Differences in Efficacy and Safety of Direct Oral Anticoagulants in Atrial Fibrillation
Systematic Review and Network Meta-Analysis of Randomized Trials
2Department of Cardiology, Hadassah University Hospital
3Department of Medicine, Hadassah University Hospital
4Department of Cardiology,, Linda Joy Pollin Cardiovascular Wellness Center for Women , Hadassah University Hospital
Abstract:
Studies indicate that women with atrial fibrillation (AF) are less likely to be prescribed anticoagulants despite the higher risk of stroke in women with AF as compared to men.
Purpose:
To assess whether the efficacy and safety of DOACs differ in women with AF as compared to men. Our secondary aim was to examine gender differences in the safety and efficacy of specific DOACs.
Methods:
MEDLINE, EMBASE, Cochrane, and the Clinical Trials Registry (ClinicalTrials.gov) were searched to identify all randomized clinical trials that reported the outcomes of major bleeding and stroke of DOACs in women and men. Data were independently evaluated by two reviewers. Data were also extracted from the US Food and Drug Administration’s open access data website. Meta-analysis and network meta-analysis was performed using RevMan version 5.3 and the statistical package ‘netmeta’ in R.
Results:
Five trials met the inclusion criteria. Among 66,389 patients, 37.8% were women.
Women had a higher risk of stroke and systemic embolism compared to men (RR, 1.20; 95% CI, 1.07-1.34; I2=35%), regardless of which anticoagulant they received. In comparison to warfarin, DOACs were associated with a lower risk for stroke and a decreased risk of major bleeding in both women and men.
Women randomized to DOACs had a higher risk of stroke and systemic embolism in women compared to men (RR, 1.18; 95% CI, 1.05-1.34; I2=10%) but a significantly lower risk of major bleeding compared to men(RR, 0.85; 95% CI, 0.78-0.94; I2=0%). Network meta-analysis suggested differences between the various DOACs in the risks to men and women.
Conclusion:
Compare to warfarin, DOACs are safe and effective in women and men. These data suggest that under-treatment of women cannot be justified. Further investigation of DOACS including the potential protective role of dose adjustment in women and men is warranted.
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