Key result
Maintaining a mean INR of 1.6-2.6 significantly reduced the primary net-clinical outcome of stroke and major bleeding by 50% (HR 0.50) compared to other INR ranges in Korean patients with non-valvular atrial fibrillation.
Why the study?
Universal warfarin anticoagulation criteria (INR 2.0-3.0 and TTR ≥70%) have not been well proven to be suitable in Korean patients with AF.
Does warfarin therapy with mean INR 1.6-2.6 improve net clinical outcomes compared to mean INR 2.0-3.0 in Korean patients with non-valvular atrial fibrillation?
Observational (n=710)
No
Does warfarin therapy with mean INR 1.6-2.6 improve net clinical outcomes compared to mean INR 2.0-3.0 in Korean patients with non-valvular atrial fibrillation?
In Korean patients with non-valvular atrial fibrillation, a lower mean INR target of 1.6-2.6 may provide better net clinical outcomes than the standard 2.0-3.0 target, though outcomes are similar if time in therapeutic range is ≥70%.
Answers are grounded in this paper and cite their sources.
May support lower INR targets for net benefit in Korean NVAF; hypothesis-generating and should not yet change practice.
BACKGROUND AND OBJECTIVES: Although anticoagulation with warfarin is recommended as an international normalized ratio (INR) of prothrombin time between 2.0 and 3.0 and mean time in the therapeutic range (TTR) ≥70%, little has been proven that universal criteria might be suitable in Korean atrial fibrillation (AF) patients. METHODS: We analyzed 710 patients with non-valvular AF who took warfarin. INR value and clinical outcomes were assessed during 2-year follow-up. Intensity of anticoagulation was assessed as mean INR value and TTR according to target INR range. Primary net-clinical outcome was defined as the composite of new-onset stroke and major bleeding. Secondary net-clinical outcome was defined as the composite of new-onset stroke, major bleeding and death. RESULTS: Thromboembolism was significantly decreased when mean INR was over 1.6. Major bleeding was significantly decreased when TTR was over 70% and mean INR was less than 2.6. Mean INR 1.6-2.6 significantly reduced thromboembolism (adjusted hazard ratio [HR], 0.40; 95% confidence interval [CI], 0.19-0.85), major bleeding (HR, 0.43; 95% CI, 0.23-0.81), primary (HR, 0.50; 95% CI, 0.29-0.84) and secondary (HR, 0.45; 95% CI, 0.28-0.74) net-clinical outcomes, whereas mean INR 2.0-3.0 did not. Simultaneous satisfaction of mean INR 1.6-2.6 and TTR ≥70% was associated with significant risk reduction of major bleeding, primary and secondary net-clinical outcomes. CONCLUSIONS: Mean INR 1.6-2.6 was better than mean INR 2.0-3.0 for the prevention of thromboembolism and major bleeding. However, INR 1.6-2.6 and TTR ≥70% had similar clinical outcomes to INR 2.0-3.0 and TTR ≥70% in Korean patients with non-valvular AF.
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Lee et al. (2019) conducted an observational in Non-valvular atrial fibrillation (n=710). Warfarin (mean INR 1.6-2.6) vs. Warfarin (mean INR <1.6 or >2.6) was evaluated on Primary net-clinical outcome (composite of new-onset stroke and major bleeding) (HR 0.50, 95% CI 0.29-0.84, p=0.008). Maintaining a mean INR of 1.6-2.6 significantly reduced the primary net-clinical outcome of stroke and major bleeding by 50% (HR 0.50) compared to other INR ranges in Korean patients with non-valvular atrial fibrillation.
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