BAFTA

Birmingham Atrial Fibrillation Treatment of the Aged (2007)

Condition

Prevention of stroke in elderly patients with AF

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Objective

To assess whether warfarin reduces the risk of major stroke, arterial embolism, or other intracranial hemorrhage compared with ASA in patients aged ≥75 years

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Trial design

Randomized, controlled phase III study
Active treatment: warfarin to target INR 2.0–3.0 (n=488)
Control treatment: ASA 75 mg once daily (n=485)

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Endpoints

Primary endpoint: composite of fatal or disabling stroke (ischemic or hemorrhagic), intracranial hemorrhage, and clinically significant arterial embolism
Secondary endpoints: composite of all major hemorrhages (intracranial and fatal bleeding, or one that resulted in the need for transfusion or surgery), all-cause mortality, other vascular mortality, or non-vascular deaths

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Trial participants

973 patients aged ≥75 years (mean age 81.5±4.2 years) with AF, recruited from primary-care settings

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Results

Efficacy outcome: There were 24 primary events (21 strokes, 2 other intra­cranial hemorrhages, and 1 systemic embolus) in patients assigned to warfarin and 48 primary events (44 strokes, 1 other intracranial hemorrhage, and 3 systemic emboli) in those assigned to ASA. The corresponding yearly risk was 1.8% vs. 3.8%. No differences were seen in secondary outcomes, including all-cause mortality, other vascular mortality, and non-vascular deaths
Safety outcome: The yearly risk of extracranial hemorrhage was 1.4% with warfarin and 1.6% with ASA. There was no difference between the composite of all major hemorrhages. Risks of bleeding rose by similar amounts with age in both groups

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Summary

Efficacy: Anticoagulation with warfarin was superior to ASA for primary stroke prevention in elderly patients with AF. Warfarin was as effective in people aged ≥85 years as it was in younger people. There were no differences in vascular events, all-cause mortality, other vascular mortality, and non-vascular deaths between the groups
Safety: No difference was seen in the risk for hemorrhage between the groups. Even in the highest age groups there was no increased bleeding risk with age

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Reference

Mant J, Hobbs FDR, Fletcher K, Roalfe A, Fitzmaurice D, Lip GYH, Murray E, on behalf of the BAFTA investigators and the Midland Research Practices Network (MidReC). Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial. Lancet 2007;370:493-503

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Corresponding author

Jonathan Mant, MD, Primary Care Clinical Sciences Building, University of Birmingham, Birmingham B15 2TT, UK, e-mail: j.w.mant@bham.ac.uk

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