Key result
Low-intensity warfarin yields similar net clinical outcomes to standard-intensity in Asian patients with AF.
Why the study?
Warfarin anticoagulation in Asian patients with AF is often reduced to INR 1.6-2.6 due to bleeding concerns, despite universal guidelines recommending INR 2.0-3.0.
Does low-intensity anticoagulation with warfarin reduce the composite of stroke, systemic embolism, major bleeding, and death compared to standard-intensity anticoagulation in Asian patients with atrial fibrillation?
RCT (n=616)
Open-label
Yes
Does low-intensity anticoagulation with warfarin reduce the composite of stroke, systemic embolism, major bleeding, and death compared to standard-intensity anticoagulation in Asian patients with atrial fibrillation?
In Asian patients with atrial fibrillation, low-intensity warfarin (INR 1.6-2.6) resulted in similar rates of stroke, major bleeding, and net clinical outcomes compared to standard-intensity warfarin (INR 2.0-3.0).
Low-intensity warfarin may suit Asian AF patients; leaves open noninferiority confirmation given wide CIs in this modest RCT.
Anticoagulation with warfarin in Asian patients with atrial fibrillation (AF) often has been decreased as an international normalized ratio (INR) of prothrombin time 1.6-2.6 due to fear of bleeding, although universal criteria recommend an INR of 2.0-3.0. In this randomized, open-label trial, low-intensity anticoagulation (INR 1.6-2.6) was compared with standard-intensity anticoagulation (INR 2.0-3.0) with warfarin. A total 616 patients with AF and at least 1 risk factor for stroke were randomized to low-intensity anticoagulation (n = 308) and standard-intensity anticoagulation (n = 308) groups. The intention-to-treat analysis was performed to determine differences. The baseline characteristics of the two groups were comparable. New-onset stroke occurred in 2 patients (0.44% per year) in the low-intensity group and 5 patients (1.05% per year) in the standard-intensity group (HR 0.42, 95% CI 0.08-2.15). Major bleeding occurred in 4 patients (0.89% per year) in the low-intensity group and 5 patients (1.06% per year) in the standard-intensity group (HR 0.84, 95% CI 0.22-3.11). The rate of the net clinical outcome (composite of stroke, systemic embolism, major bleeding, and death) was 1.33% per year in the low-intensity group compared with 2.12% per year in the standard-intensity group (HR 0.63, 95% CI 0.23-1.72). In Asian patients with AF, clinical outcomes were not different between low-intensity and standard-intensity anticoagulation with warfarin.
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Cho et al. (2023) conducted an RCT in Atrial fibrillation (n=616). Low-intensity warfarin vs. Standard-intensity warfarin (Target INR 2.0-3.0) was evaluated on Net clinical outcome (composite of stroke, systemic embolism, major bleeding, and death) (HR 0.63, 95% CI 0.23-1.72). Low-intensity warfarin (INR 1.6-2.6) yielded similar net clinical outcomes compared to standard-intensity (INR 2.0-3.0) in Asian patients with atrial fibrillation (HR 0.63; 95% CI 0.23-1.72).
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