Effectiveness and Safety of Standard- and Low-Dose Rivaroxaban in Asians With Atrial Fibrillation
Yi-Cheng Lin, Shu-Chen Chien, Yi-Chen Hsieh, Chun-Ming Shih, Feng-Yen Lin, Nai-Wen Tsao, Chih-Wei Chen, Yung-Ta Kao, Kuang-Hsing Chiang, Wan-Ting Chen, Li-Nien Chien, Chun-Yao Huang, Yi-Cheng Lin, Shu-Chen Chien, Yi-Chen Hsieh, Chun-Ming Shih, Feng-Yen Lin, Nai-Wen Tsao, Chih-Wei Chen, Yung-Ta Kao, Kuang-Hsing Chiang, Wan-Ting Chen, Li-Nien Chien, Chun-Yao Huang
Abstract
Background: Low-dose rivaroxaban (10 mg/day) has been widely used in Asia for patients with atrial fibrillation (AF), although there is a lack of evidence regarding its effectiveness. In Asians, it is unclear whether low-dose rivaroxaban is equally effective as that of the standard dose or is associated with less bleeding risk.
Objectives: The aim of this study was to evaluate the effectiveness and safety of standard-dose (15 or 20 mg/day) and low-dose (10 mg/day) rivaroxaban in Asians with AF.
Methods: Using data files from the National Health Insurance Research Database between May 1, 2014, and September 30, 2015, a retrospective population-based cohort study was conducted in patients diagnosed with AF or atrial flutter and treated with low- or standard-dose rivaroxaban. Patients were followed up until the first occurrence of the study outcome or the end of the observation period (December 31, 2015).
Results: Among 6,558 eligible patients, a total of 2,373 and 4,185 patients took low- and standard-dose rivaroxaban, respectively. Compared to standard-dose rivaroxaban, low-dose rivaroxaban was associated with a significantly higher risk of myocardial infarction (subdistribution hazard ratio: 2.26; 95% confidence interval: 1.13 to 4.52), with similar risk of ischemic stroke, systemic embolism, major bleeding, and nonmajor clinically relevant bleeding.
Conclusions: Compared to standard-dose rivaroxaban, low-dose rivaroxaban in Asian patients with AF was associated with similar risks of thromboembolism and bleeding except myocardial infarction.
Keywords: bleeding; embolism; myocardial infarction; non–vitamin K antagonist oral anticoagulant; stroke.
Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed