Jeong Hyung Ki, Lee Ki Hong, Park Hyung Wook, Yoon Nam Sik, Kim Min Chul, Lee Nuri, Kim Ji Sung, Ahn Youngkeun, Jeong Myung Ho, Park Jong Chun, Cho Jeong Gwan
Department of Cardiovascular Medicine, Chonnam National University Hospital, Gwangju, Korea.
Chonnam Med J. 2019 Jan;55(1):54-61. doi: 10.4068/cmj.2019.55.1.54. Epub 2019 Jan 25.
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.
利伐沙班已成为心房颤动(AF)患者预防血栓栓塞的一种潜在替代华法林的药物。然而,人们一直担心大出血风险,尤其是在亚洲患者中。我们在韩国的实际临床实践中研究了利伐沙班与华法林相比的疗效和安全性。总共2208例连续的非瓣膜性AF患者被分为华法林组(n = 990)和利伐沙班组(n = 1218)。比较了倾向评分匹配后的1年临床结局(华法林组,n = 804;利伐沙班组,n = 804)。疗效结局定义为卒中/全身性栓塞(SE)。安全性结局为大出血。主要净临床获益(NCB)定义为卒中/SE、大出血和全因死亡率的综合结果。次要的NCB定义为卒中和SE及大出血的综合结果。与华法林相比,利伐沙班在预防血栓栓塞事件方面具有相似的疗效[风险比(HR)0.69,95%置信区间(CI)0.37 - 1.32,p = 0.266]。利伐沙班显著降低了大出血风险[HR 0.41,95% CI 0.22 - 0.76,p = 0.004]。利伐沙班组的主要NCB显著更低[HR 0.54,95% CI 0.36 - 0.81,p = 0.003]。利伐沙班组的次要NCB也更低[HR 0.62,95% CI 0.40 - 0.99,p = 0.041]。与华法林组相比,利伐沙班15 mg和20 mg组均具有相似的疗效,且大出血风险以及主要和次要NCB均显著更低。在非瓣膜性AF患者中,在韩国的实际临床实践中利伐沙班与华法林疗效相似。然而,与华法林相比,利伐沙班具有更好的安全性和净临床结局。