Safety and efficacy of low-dose rivaroxaban in Asian patients with atrial fibrillation and chronic kidney disease

Abstract

Abstract Background Low-dose rivaroxaban (10mg/day) has been commonly used in Asia for patients with atrial fibrillation (AF). However, its effectiveness and safety, particularly in patients with chronic kidney disease (CKD), is limited. Moreover, inappropriate low-dose rivaroxaban is frequently prescribed. We aimed to evaluate the effectiveness and safety of low-dose rivaroxaban in patients with or without CKD, compared to that of the standard dose in real-world practice. Methods 3122 patients with AF treated with rivaroxaban between October 2012 and December 2016 were included in this retrospective multicenter study. We compared the different doses of rivaroxaban stratified according to renal function in this cohort. Bleeding events and major adverse cardiovascular events (MACE) including CV death, MI, stroke, and thromboembolism were recorded. Results 1218 (39%) patients received standard-dose rivaroxaban (20mg/day). 1147 (36.7%) patients with eGFR>50 mL/min/1.73m2 and 757 (24.3%) patients with eGFR<50 mL/min/1.73m2 received low-dose rivaroxaban (10mg/day). The patients who received low-dose rivaroxaban were older, more likely to be female, and with more comorbidities. After adjustment, the use of low-dose rivaroxaban was significantly associated with increased risks of MACE in the patients without CKD compared to the patients with CKD (HR: 1.75; 95% CI: 1.07 to 2.89). Also, the risk of bleeding was highest in CKD patients despite low-dose rivaroxaban treatment. There was no difference in bleeding between the standard-dose and low-dose of rivaroxaban in patients without CKD (HR: 1.29; 95% CI: 0.8 to 2.08). Conclusions The use of inappropriate low-dose rivaroxaban in patients without CKD increased MACE significantly, compared to low-dose rivaroxaban in CKD patients. In addition, the risk of bleeding was strongly associated with CKD, not with the dose of rivaroxaban. Cumulative Event Rates Funding Acknowledgement Type of funding source: None