The Cardiovascular Department, Chang Gung Memorial Hospital, Linkou, Taoyuan 33305, Taiwan; College of Medicine, Chang Gung University, Taoyuan 33302, Taiwan.
The Cardiovascular Department, Chang Gung Memorial Hospital, Linkou, Taoyuan 33305, Taiwan; College of Medicine, Chang Gung University, Taoyuan 33302, Taiwan; Microscopy Core Laboratory, Chang Gung Memorial Hospital, Linkou, Taoyuan 33305, Taiwan.
Int J Cardiol. 2018 Jun 15;261:78-83. doi: 10.1016/j.ijcard.2018.03.063. Epub 2018 Mar 14.
Rivaroxaban (20 mg/15 mg once daily) is an effective and safe alternative to warfarin for stroke prevention in patients with non-valvular AF (NVAF). Low-dose rivaroxaban (15 mg/10 mg once daily) has been only approved for NVAF patients in Japan and Taiwan, although its effectiveness and safety at low doses remain unclear among Asians with NVAF. The objective of the study is to compare the effectiveness and safety of low-dose rivaroxaban to those of warfarin among Asians with NVAF.
This dynamic cohort study used data from the Taiwan National Health Insurance Database (NHIRD) to enroll 14,971 patients taking 15 mg rivaroxaban, 11,029 patients taking 10 mg rivaroxaban, and 16,000 NVAF patients taking warfarin. Inverse probability of weighting using propensity scores was used to balance covariates across study groups.
The adjusted hazard ratio [95% confidence interval] comparing rivaroxaban 15 and 10 mg with warfarin (reference) was as follows: ischemic stroke/systemic embolism, 0.84 [0.74-0.96; P = 0.0080], and 0.84 [0.73-0.96; P = 0.0097]; myocardial infarction, 0.53 [0.37-0.74; P = 0.0002], and 0.88 [0.65-1.19; P = 0.3910]; intracranial hemorrhage, 0.44 [0.34-0.55; P < 0.0001], and 0.53 [0.42-0.66; P < 0.0001]; major gastrointestinal bleeding, 0.82 [0.67-0.99; P = 0.0387], and 0.58 [0.47-0.72; P < 0.0001]; all hospitalized major bleeding, 0.63 [0.55-0.73; P < 0.0001], and 0.56 [0.48-0.65; P < 0.0001]; and all-cause mortality, 0.55 [0.51-0.60; P < 0.0001], and 0.58 [0.53-0.63; P < 0.0001].
Both low doses of rivaroxaban were associated with a lower risk of ischemic stroke/systemic embolism, intracranial hemorrhage, gastrointestinal bleeding, all major bleeding, and all-cause mortality compared with warfarin in Asian NVAF patients. The 15 mg rivaroxaban dose was associated with a lower risk of acute myocardial infarction compared to warfarin.
利伐沙班（20mg/15mg 每日一次）是一种有效的、安全的非瓣膜性房颤（NVAF）患者中风预防替代药物，优于华法林。低剂量利伐沙班（15mg/10mg 每日一次）仅在日本和中国台湾被批准用于 NVAF 患者，尽管其在亚洲 NVAF 患者中的有效性和安全性尚不清楚。本研究的目的是比较亚洲 NVAF 患者使用低剂量利伐沙班与华法林的有效性和安全性。
本动态队列研究使用台湾全民健康保险数据库（NHIRD）的数据纳入了 14971 名服用 15mg 利伐沙班、11029 名服用 10mg 利伐沙班和 16000 名 NVAF 患者服用华法林。使用倾向评分逆概率加权法来平衡研究组之间的协变量。
与华法林（参照）相比，15mg 和 10mg 利伐沙班的调整后的危险比[95%置信区间]如下：缺血性中风/全身性栓塞，0.84[0.74-0.96；P=0.0080]和 0.84[0.73-0.96；P=0.0097]；心肌梗死，0.53[0.37-0.74；P=0.0002]和 0.88[0.65-1.19；P=0.3910]；颅内出血，0.44[0.34-0.55；P<0.0001]和 0.53[0.42-0.66；P<0.0001]；主要胃肠道出血，0.82[0.67-0.99；P=0.0387]和 0.58[0.47-0.72；P<0.0001]；所有住院的大出血，0.63[0.55-0.73；P<0.0001]和 0.56[0.48-0.65；P<0.0001]；全因死亡率，0.55[0.51-0.60；P<0.0001]和 0.58[0.53-0.63；P<0.0001]。
与华法林相比，亚洲 NVAF 患者使用两种低剂量利伐沙班均可降低缺血性中风/全身性栓塞、颅内出血、胃肠道出血、所有主要出血和全因死亡率的风险。与华法林相比，15mg 利伐沙班的急性心肌梗死风险较低。
