Standard-Intensity Versus Low-Intensity Anticoagulation with Warfarin in Asian Patients with Atrial Fibrillation: A Multi-Center, Randomized Controlled Trialopen access
- Authors
- Cho, Jeong Gwan; Lee, Ki Hong; Kim, Yoo Ri; Kim, Sunah; Gwak, Jisoo; Cho, Eunbit; Sin, Yourim; Shin, Seung Yong; Park, Hyung Wook; Ko, Jum Suk; Kim, Nam Ho; Park, Yae Min; Lee, Jung Myung; Yoon, Nam Sik; Kim, Sung Soo; Kim, Jun Hyung; Kim, Dong Min
- Issue Date
- Apr-2023
- Publisher
- SAGE PUBLICATIONS INC
- Keywords
- warfarin; prothrombin time; atrial fibrillation; thromboembolism; safety
- Citation
- CLINICAL AND APPLIED THROMBOSIS-HEMOSTASIS, v.29
- Journal Title
- CLINICAL AND APPLIED THROMBOSIS-HEMOSTASIS
- Volume
- 29
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/87783
- DOI
- 10.1177/10760296231171081
- ISSN
- 1076-0296
- Abstract
- 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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