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AFASAK 2
Copenhagen Atrial Fibrillation, Aspirin, and Anticoagulation 2
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Author(s) |
(a) Koefoed BG, Feddersen C, Gulløv AL, Petersen P
(b) Gulløv AL, Koefoed BG, Petersen P
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Title(s) |
(a) Effect of fixed minidose warfarin, conventional dose warfarin and aspirin on INR and prothrombin fragment 1 + 2 in patients with atrial fibrillation
(b) Bleeding during warfarin and aspirin therapy in patients with atrial fibrillation
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Reference(s) |
(a) Thromb Haemost 1997;77:845-8
(b) Arch Intern Med 1999;159:1322-8
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Disease |
Atrial fibrillation
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Purpose |
To investigate the antithrombotic effects of fixed minidose warfarin alone or in combination with aspirin, of conventional dose-adjusted warfarin and of aspirin alone, and to determine the rate of bleeding events associated with thromboembolic events
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Study design |
Randomised, open
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Follow-up |
3 years (aim 6 years)
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Patients |
(a) 100 patients (59 men), aged 51-85 years
(b) 677 patients, aged 44-89 years
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Treatment regimen |
Warfarin, 1.25 mg/day, warfarin, 1.25 mg/day plus aspirin, 300 mg/day, aspirin, 300 mg/day, or dose-adjusted warfarin to target international normalised ratio (INR) 2.0-3.0
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Results |
(a ) After 3 months, the INR was significantly increased by fixed minidose warfarin (p = 0.032), fixed minidose warfarin plus aspirin (p = 0.002) and by dose-adjusted warfarin (p < 0.001); no significant difference was seen in the aspirin group. Prothrombin fragment 1 + 2 was significantly suppressed by fixed minidose warfarin plus aspirin (p = 0.04) and by dose-adjusted warfarin (p < 0.001); no significant difference was seen in those groups receiving either fixed minidose warfarin or aspirin alone
(b) After 3 years of treatment, there was no significant difference in the annual rates of major bleeding with fixed minidose warfarin, aspirin and dose-adjusted warfarin; the difference with fixed minidose warfarin plus aspirin was significant (p < 0.01). The cumulative rate of any bleeding was significantly higher in those receiving dose-adjusted warfarin than in other groups (p = 0.003).
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Comments |
The study was terminated prematurely because of the findings of other studies in which dose-adjusted warfarin was superior to less intensive antithrombotic treatments in preventing stroke in atrial fibrillation
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