title: Anticoagulation in women with non-valvular atrial fibrillation in the stroke prevention using an oral thrombin inhibitor (SPORTIF) trials.
abstract: OBJECTIVE
  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.
  
  
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Medicine, Section of Cardiology, University of Chicago Hospitals, University of Chicago, 5841 S Maryland Avenue, MC2016, Chicago, IL 60637, USA. mgomberg@medicine.bsd.uchicago.edu
authors.forename: Mardi
authors.initials: M
authors.lastname: Gomberg-Maitland
authors.forename: Nanette K
authors.initials: NK
authors.lastname: Wenger
authors.forename: Jan
authors.initials: J
authors.lastname: Feyzi
authors.forename: Maria
authors.initials: M
authors.lastname: Lengyel
authors.forename: Annabelle S
authors.initials: AS
authors.lastname: Volgman
authors.forename: Palle
authors.initials: P
authors.lastname: Petersen
authors.forename: Lars
authors.initials: L
authors.lastname: Frison
authors.forename: Jonathan L
authors.initials: JL
authors.lastname: Halperin
mesh_terms: D000284:Administration, Oral; D000367:Age Factors; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D001281:Atrial Fibrillation / Q000188:drug therapy*; D001384:Azetidines / Q000008:administration & dosage* / Q000009:adverse effects; D001596:Benzylamines / Q000008:administration & dosage* / Q000009:adverse effects; D056486:Chemical and Drug Induced Liver Injury; D004311:Double-Blind Method; D015914:Estrogen Replacement Therapy; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D012307:Risk Factors; D012727:Sex Characteristics; D012737:Sex Factors; D020521:Stroke / Q000517:prevention & control*; D013923:Thromboembolism / Q000517:prevention & control; D014859:Warfarin / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000925:Anticoagulants; D001384:Azetidines; D001596:Benzylamines; C426686:ximelagatran; D014859:Warfarin