title: Major Outcomes in Atrial Fibrillation Patients with One Risk Factor: Impact of Time in Therapeutic Range Observations from the SPORTIF Trials.
abstract: The benefits and harms of oral anticoagulation therapy in patients with only one stroke risk factor (ie, CHA2DS2-VASc = 1 in males, or 2 in females) has been a subject of debate.
  
  
  
  We analyzed all patients with only one stroke risk factor from the merged datasets of SPORTIF III and V trials. Anticoagulation control was defined according to time in therapeutic range (TTR).
  
  
  
  Of the original trial cohort, 1097 patients had only one stroke risk factor. Stroke/systemic thromboembolic event had an incidence of 0.9 per 100 patient-years, with an incidence of 1.6 per 100 patient-years for all-cause death and 2.3%/patient-years for the composite outcome of stroke/systemic thromboembolic event/all-cause death. There were no significant differences in the risk for stroke/systemic thromboembolic event between sexes, nor between the different stroke risk factors amongst these atrial fibrillation patients with only one stroke risk factor. Cox regression analysis in patients treated with warfarin found only TTR to be inversely associated with stroke/systemic thromboembolic event (P = .034) and all-cause death (P = .015). Chronic heart failure was significantly associated with the outcome of all-cause death (P = .0019) and the composite outcome of stroke/systemic thromboembolic event/all-cause death (P = .021). There was a significant inverse linear association between TTR and the cumulative risk for both stroke/systemic thromboembolic event and all-cause death (both P <.001).
  
  
  
  In atrial fibrillation patients with only one additional stroke risk factor (ie, CHA2DS2-VASc = 1 in males or 2 in females), rates of major adverse events (stroke/systemic thromboembolic event, mortality) were high, despite anticoagulation. TTR in warfarin-treated patients was inversely associated with the occurrence of both stroke/systemic thromboembolic event and all-cause death.
authors.affiliation: University of Birmingham Institute of Cardiovascular Sciences, City Hospital, UK.
authors.forename: Marco
authors.initials: M
authors.lastname: Proietti
authors.affiliation: University of Birmingham Institute of Cardiovascular Sciences, City Hospital, UK; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Denmark. Electronic address: g.y.h.lip@bham.ac.uk.
authors.forename: Gregory Y H
authors.initials: GY
authors.lastname: Lip
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D000991:Antithrombins / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D001384:Azetidines / Q000627:therapeutic use*; D001596:Benzylamines / Q000627:therapeutic use*; D002423:Cause of Death; D002908:Chronic Disease; D015897:Comorbidity; D005260:Female; D006333:Heart Failure / Q000453:epidemiology; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D009026:Mortality; D011379:Prognosis; D016016:Proportional Hazards Models; D012307:Risk Factors; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D013923:Thromboembolism / Q000209:etiology / Q000517:prevention & control*; D014859:Warfarin / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D001384:Azetidines; D001596:Benzylamines; C426686:ximelagatran; D014859:Warfarin
keywords: Atrial fibrillation; Oral anticoagulant; Thromboembolic risk