Real World Comparison of Rivaroxaban and Warfarin in Korean Patients with Atrial Fibrillation: Propensity Matching Cohort Analysis

Abstract

Rivaroxaban has emerged as a potential alternative to warfarin for the prevention of thromboembolism in patients with atrial fibrillation (AF). However, there has been concern for the risk of major bleeding, especially in Asian patients. We investigated the efficacy and safety of rivaroxaban compared to warfarin in Korean real world practice. A total of 2,208 consecutive non-valvular AF patients were divided into the Warfarin group (n=990) and the Rivaroxaban group (n=1218). Propensity matched 1-year clinical outcomes were compared (Warfarin, n=804; Rivaroxaban, n=804). The efficacy outcome was defined as stroke/systemic embolism (SE). The safety outcome was major bleeding. The primary net clinical benefit (NCB) was defined as the composite of stroke/SE, major bleeding, and all-cause mortality. Secondary, NCB was defined as the composite of stroke, SE, and major bleeding. Rivaroxaban had the similar efficacy in terms of thromboembolic event prevention [hazard ratio (HR) 0.69, 95% confidence interval (CI) 0.37–1.32, p=0.266] compared to warfarin. Rivaroxaban significantly lowered the risk of major bleeding [HR 0.41, 95% CI 0.22–0.76, p=0.004]. Primary NCB was significantly low in the rivaroxaban group [HR 0.54, 95% CI 0.36–0.81, p=0.003]. Secondary NCB was also low in the rivaroxaban group [HR 0.62, 95% CI 0.40–0.99, p=0.041]. Both rivaroxaban 15 mg and 20 mg groups had similar efficacy and significantly lower risks of major bleeding as well as primary and secondary NCB compared to the warfarin group. In patients with non-valvular AF, rivaroxaban had a similar efficacy to warfarin in Korean real world practice. However, rivaroxaban had better safety and net clinical outcomes compared to warfarin.

Benefits and Harms of Low-Dose Rivaroxaban in Asian Patients With Atrial Fibrillation: A Systematic Review and Meta-analysis of Real-World Studies

“…46 full-text articles were obtained for further assessment of eligibility, and 34 articles were excluded for reasons listed in Supplementary Table S3 . Finally, 12 studies ( Kohsaka et al, 2017 ; Chan et al, 2018 ; Cho et al, 2018 ; Huang et al, 2018 ; Lai et al, 2018 ; Lee et al, 2018 ; Okumura et al, 2018 ; Chan et al, 2019 ; Jeong et al, 2019 ; Lee et al, 2019 ; Cho et al, 2020 ; Kohsaka et al, 2020 ) involving 292,815 Asian patients with AF were included, with 169,383 patients using rivaroxaban and 123,432 patients using warfarin. Among them, eight studies with on-label low-dose rivaroxaban were conducted in Japan (3 studies) and Taiwan (5 studies), and four studies with off-label low-dose rivaroxaban were implemented in Korea ( Table 1 ).…”

“…Another United States national prospective registry study indicated that low-dose DOACs were associated with an obvious increase in mortality ( Steinberg et al, 2016 ). In recent years, many more contemporary real-world studies that focused on low-dose rivaroxaban in Asian have been published ( Kohsaka et al, 2017 ; Chan et al, 2018 ; Cho et al, 2018 ; Huang et al, 2018 ; Lai et al, 2018 ; Lee et al, 2018 ; Okumura et al, 2018 ; Chan et al, 2019 ; Jeong et al, 2019 ; Lee et al, 2019 ; Cho et al, 2020 ; Kohsaka et al, 2020 ). It is well-known that real-world studies by integrating data from electronic health records (EHRs), claims databases, and disease registries could extend findings of RCTs to large patient populations in real-world practice.…”

The Risk of Gastrointestinal Bleeding between Non-Vitamin K Antagonist Oral Anticoagulants and Vitamin K Antagonists in the Asian Atrial Fibrillation Patients: A Meta-Analysis

“…Then sixty-four articles without GIB data or using inappropriate statistical methods were ruled out. Fifteen articles probably extracted from the identical database or the same population were not applied [ 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 ]. Sixteen articles investigating non-Asians or not fully Asians were not enrolled [ 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 ].…”

Efficacy and Safety of Non-Vitamin K Antagonist Oral Anticoagulants in Asians With Nonvalvular Atrial Fibrillation: A Network Meta-Analysis

“…All 18 included studies were conducted in China, 12,13,15,18,26 –28 Singapore, 12,15,19 Korea, 12 –15,17 –19,29 Japan, 12,13,15,30,31 India 12 , Malaysia, 11,12,15,16,32 the Philippines, 12,15 Turkey, 33 Israel, 34 or Thailand. 12 A total of 71 227 anticoagulated patients with NVAF were studied.…”