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European Atrial Fibrillation Trial - EAFT
Description:
Warfarin vs. aspirin for ischemic stroke in atrial fibrillation.
Hypothesis:
Anticoagulation or aspirin may provide a preventive benefit for patients with a recent transient ischemic attack (TIA) or minor ischemic stroke.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 1,007
Mean Follow Up: 2.3 years
Female: 45
Patient Populations:
> Age 25 years
Recent TIA or minor ischemic stroke in previous 3 months
Atrial fibrillation proven electrocardiographically at time of stroke or TIA; or, in paroxysmal atrial fibrillation, in the preceding 24 months
Exclusions:
Rheumatic valvular disease.
Atrial fibrillation secondary to other disorders.
Taking non-steroidal anti-inflammatory drugs, other anti-platelet-aggregating drugs, or oral anticoagulants.
Other sources of cardiac emboli, such as prosthetic valves, cardiac aneurysm, atrial myxoma, cardiothoracic ratio exceeding 0.65%, myocardial infarction (MI) in the preceding 3 months, or disorders of blood coagulation.
Scheduled for carotid endarterectomy or coronary surgery within the next 3 months.
Primary Endpoints:
Death from vascular disease
Non-fatal stroke, including intracranial hemorrhage
Non-fatal MI
Systemic embolism
Secondary Endpoints:
Death from all causes
All strokes, fatal or non-fatal
Major thromboembolic events (vascular death, major stroke, major systemic embolism, or MI)
Drug/Procedures Used:
Oral anticoagulants to achieve a therapeutic international normalized ratio range of 2.5-4.0 (aim 3.0).
Aspirin, 300 mg/day.
Patients with contraindications to anticoagulants were randomized to aspirin or placebo.
Principal Findings:
Annual rate of outcome events was 8% of patients on anticoagulants, vs. 17% on placebo in group 1 (patients eligible for anticoagulants) (hazard ratio [HR] of 0.53; 95% confidence interval [CI] 0.36 to 0.79).
Risk of stroke alone was reduced from 12% to 4% per year (HR 0.34; 95% CI 0.20-0.57).
Among all patients assigned to aspirin, annual incidence of outcome events was 15%, compared with 19% on placebo (HR 0.83, 95% CI 0.65 -1.05).
Anticoagulation was significantly more effective than aspirin (HR 0.60; 95% CI 0.41-0.87).
Incidences of major bleeding events was low: 2.8% per year on anticoagulants, 0.9% on aspirin
No intracranial bleeds were identified in anticoagulation patients.
In multivariate models, six independent predictors of major vascular events were identified: history of previous thromboembolism, ischemic heart disease, enlarged cardiothoracic ratio on chest roentgenogram, systolic blood pressure greater than 160 mm Hg at study entry, atrial fibrillation for more than 1 year, and presence of an ischemic lesion on CT scan.
Interpretation:
Anticoagulation is effective in reducing the risk of recurrent vascular events in NRAF patients with recurrent TIA or minor ischemic stroke. In absolute terms: 90 vascular events, mainly strokes, are prevented if 1,000 patients are treated with anticoagulation for 1 year. Aspirin is a safe, though less effective, alternative when anticoagulation is contraindicated. It prevents 40 vascular events for every 1,000 treated patients.
References:
1. Lancet 1993;324:1255-62. Final results
2. Stroke 1995;26:801-6. Predictors of major vascular events
Keywords: Thromboembolism, Stroke, Myocardial Ischemia, Ischemic Attack, Transient, Platelet Aggregation Inhibitors, Warfarin, Blood Pressure
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