EAFT

European Atrial Fibrillation Trial (1993)

Condition

Secondary prevention of thromboembolic events in patients with non-rheumatic AF after TIA or minor stroke 

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Objective

To assess the preventive benefit of standard oral anticoagulation vs. ASA in patients with non-rheumatic AF after TIA or minor stroke

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Trial design

Randomized, open (oral anticoagulation), double-blind (ASA), placebo-controlled non-inferiority phase III trial

Active treatment: oral standard anticoagulation (target INR 2.5–4.0; the choice of anticoagulant type was free but most physicians chose coumarin derivatives); ASA 300 mg once daily

  • Group 1: patients eligible for anticoagulation (n=669) were randomly assigned to receive either open-label oral anticoagulants (n=225) or double-blind treatment with ASA 300 mg once daily (n=230) or placebo (n=214)
  • Group 2: patients ineligible for anticoagulation (n=338) were randomized to double-blind treatment with ASA 300 mg (n=174) or matching placebo (n=164)

Control treatment: placebo

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Endpoints

Primary endpoint: death from vascular disease, any stroke, myocardial infarction, or systemic embolism
Secondary endpoints: death from all causes, all strokes (fatal or non-fatal), and major thromboembolic events (vascular death, major stroke, major systemic embolism, or myocardial infarction)

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Trial participants

1007 patients ≥25 years (mean age 71 years) with recent TIA or minor ischemic stroke and non-rheumatic AF

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Results

Primary outcome:

  • Anticoagulation vs. placebo (group 1): In the intention-to-treat analysis, the annual rate of outcome events was 8% in patients assigned to anticoagulants vs. 17% in placebo-treated patients. Anticoagulation reduced the risk of stroke of any type from 12% to 4% per year and the risk of subsequent major disabling or fatal stroke by 62% (p=0.012). No significant benefit of oral anticoagulants was found on mortality, vascular death alone, or major thromboembolic events
  • Anticoagulation vs. ASA (group 1): Oral anticoagulation was more effective than ASA in preventing the occurrence of a primary outcome event (p=0.008), largely because of reducing the risk for all strokes significantly (p<0.001)
  • ASA vs. placebo (group 1 and 2): All patients assigned to ASA had a lower risk for primary outcome events (15% vs. 19% per year) and of stroke alone (10% vs. 12% per year) than those on placebo

Safety outcome: The incidence of major bleeding events was low, both on anticoagulation (2.8% per year) and on aspirin (0.9% per year) or placebo (0.7% per year). Significantly more bleeding complications occurred with anticoagulation than with ASA or placebo (p<0.001). No intracranial bleeds were found in patients assigned to anticoagulation

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Summary

Efficacy: Anticoagulant treatment almost halved the risk of vascular complications in patients with non-rheumatic AF and a recent TIA or minor stroke. The risk of recurrent stroke decreased by two-third. In patients with a contraindication, ASA alone is a safe, though significantly less effective alternative
Safety: The incidence of major bleeding events was low both on anticoagulation and on ASA

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Reference

(EAFT) European Atrial Fibrillation Trial Study Group. Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. Lancet 1993;342:1255-1262

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Corresponding author

Peter J. Koudstaal, MD, Department of Neurology, University Hospital Rotterdam, Dr. Molewaterplein 40, 3015 GD Rotterdam, Netherlands

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