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European Heart Journal Advance Access published online on June 14, 2006
European Heart Journal, doi:10.1093/eurheartj/ehl103
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European Heart Journal © The European Society of Cardiology 2006; all rights reserved
Received November 11, 2005
Revised May 15, 2006
Accepted May 26, 2006

Clinical research

Anticoagulation in women with non-valvular atrial fibrillation in the stroke prevention using an oral thrombin inhibitor (SPORTIF) trials

Mardi Gomberg-Maitland 1 *, Nanette K. Wenger 2, Jan Feyzi 3, Maria Lengyel 4, Annabelle S. Volgman 5, Palle Petersen 6, Lars Frison 7, and Jonathan L. Halperin 8

1 Department of Medicine, Section of Cardiology, University of Chicago Hospitals, University of Chicago, 5841 S Maryland Avenue, MC2016, Chicago, IL 60637, USA
2 Emory University School of Medicine, Atlanta, GA, USA
3 Informatics University of Wisconsin-Madison, Madison, WI, USA
4 Hungarian Institute of Cardiology, Budapest, Hungary
5 Rush University Medical Center, Chicago, IL, USA
6 Department of Neurology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
7 AstraZeneca R&D Mölndal, Mölndal, Sweden
8 Mount Sinai Medical Center, New York, NY, USA

* To whom correspondence should be addressed.
Mardi Gomberg-Maitland, E-mail: mgomberg{at}medicine.bsd.uchicago.edu


  Abstract

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.

Keywords: Atrial fibrillation; Women; Anticoagulation; Thromboembolism.
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