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Mardi Gomberg-Maitland, Nanette K. Wenger, Jan Feyzi, Maria Lengyel, Annabelle S. Volgman, Palle Petersen, Lars Frison, Jonathan L. Halperin, Anticoagulation in women with non-valvular atrial fibrillation in the stroke prevention using an oral thrombin inhibitor (SPORTIF) trials, European Heart Journal, Volume 27, Issue 16, August 2006, Pages 1947–1953, https://doi.org/10.1093/eurheartj/ehl103
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Aims The risk of stroke is greater among women with atrial fibrillation (AF) than men. Warfarin protects against stroke, but treatment-related bleeding occurs more often in women than in men.
Methods and results SPORTIF III (open label, n=3410) and V (double-blind, n=3922) included 2257 women with AF and one or more stroke risk factors randomized to warfarin [target international normalized ratio (INR) 2.0–3.0] or ximelagatran (36 mg twice daily). Primary outcomes were all stroke (ischaemic/haemorrhagic) and systemic embolic event. Women were older, on average, than men, 73.4±8.0 vs. 69.8±9.0 years (P<0.0001). More women were >75-years old and women had more risk factors than men had (P<0.0001). The INR on warfarin (mean 2.5±0.7) was within target range for 67% of follow-up regardless of gender. Women more often developed primary events [2.08%/year, 95% confidence interval (CI) 1.60–2.56%/year vs. 1.44%/year, 95% CI 1.18–1.71%/year in men; P=0.016). Major bleeding rates were similar (P=0.766) but women experienced more overall (major/minor) bleeding (P<0.001). Warfarin was associated with more overall bleeding in both genders and more major bleeding in women than in men (P=0.001).
Conclusion When compared with men with AF, women in these studies were older and had more stroke risk factors. Women were more prone to anticoagulant-related bleeding; the higher rate of thrombo-embolism among women was related to more frequent interruption of anticoagulant therapy.
- anticoagulants
- anticoagulation
- atrial fibrillation
- warfarin
- ischemia
- hemorrhage
- cerebrovascular accident
- nonvalvular atrial fibrillation
- ischemic stroke
- follow-up
- international normalized ratio
- gender
- embolism
- thrombin inhibitors
- ximelagatran
- stroke prevention
- stroke risk
- sportif trial
- bleeding rate