EAFTEuropean Atrial Fibrillation Trial |
| Authors: |
(a) EAFT study group
(b) The European Atrial Fibrillation Trial study group |
| Titles: |
(a) Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke
(b) Optimal oral anticoagulant therapy in patients with nonrheumatic atrial fibrillation and recent cerebral ischemia |
| References: |
(a) Lancet 1993;342:1255-62
(b) N Engl J Med 1995;333:5-10 |
| Disease: |
Non-rheumatic atrial fibrillation, stroke |
| Purpose: |
To establish the preventive value of both anticoagulation and aspirin in patients with non-valvular atrial fibrillation and a transient ischaemic attack or minor stroke (secondary prevention trial) |
| Study Design: |
Randomised, open oral anticoagulant treatment, double-blind aspirin treatment, placebo-controlled. Patients with contraindications to oral anticoagulants were randomised for aspirin and placebo |
| Follow-up: |
Minimum 1 year, maximum 4.6 years (mean 2.3 years) |
| Patients: |
1007 patients with non-rheumatic atrial fibrillation and recent transient ischaemic attack or minor stroke. 669 received oral anticoagulants |
| Treatmentregimen: |
Oral anticoagulants to achieve a therapeutic international normalised ratio range 2.5-4.0 (aim 3.0). Aspirin, 300 mg/day, or placebo |
| Results: |
During mean follow-up the annual rate of outcome events was 8% in patients assigned to anticoagulants vs 17% in placebo-treated patients (relative risk, RR, 0.53). The risk of stroke was reduced from 12% to 4% per year (RR 0.34). The patients assigned to aspirin were grouped together whether they received anticoagulant treatment or not. These patients had an annual incidence of outcome events of 15% vs 19% in those on placebo (RR 0.83). Anticoagulation was significantly more effective than aspirin. Patients on anticoagulation suffered bleeding events significantly more often than patients on aspirin (p < 0.001) or placebo (p < 0.001), while patients on aspirin had more bleeding complications than patients on placebo (p = 0.39). The incidence of major bleeding events was low, both on anticoagulation (2.8% per year) and on aspirin (0.9% per year). The optimal level of anticoagulation with the lowest risk was with an international normalised ratio of 2-3.9. No treatment was effective with anticoagulation at international normalised ratio < 2, and most major bleeding complications occurred at values = 5 |
