Effectiveness and Safety of Standard- and Low-Dose Rivaroxaban in Asians With Atrial Fibrillation
Journal
Journal of the American College of Cardiology
Journal Volume
72
Journal Issue
5
Pages
477-485
Date Issued
2018
Author(s)
Lin, Yi-Cheng
Chien, Shu-Chen
Hsieh, Yi-Chen
Shih, Chun-Ming
Lin, Feng-Yen
Tsao, Nai-Wen
Chen, Chih-Wei
Kao, Yung-To
Chiang, Kuang-Hsing
Chen, Wan-Ting
Chien, Li-Nien
Huang, Chun-Yao
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. ? 2018 American College of Cardiology Foundation
Subjects
bleeding; embolism; myocardial infarction; non–vitamin K antagonist oral anticoagulant; stroke
SDGs
Other Subjects
rivaroxaban; blood clotting factor 10a inhibitor; rivaroxaban; adult; aged; Article; Asian; atrial fibrillation; bleeding; brain ischemia; cardiovascular risk; CHA2DS2-VASc score; cohort analysis; comorbidity; controlled study; drug dose comparison; drug efficacy; drug safety; embolism; female; follow up; gastrointestinal hemorrhage; heart infarction; human; incidence; low drug dose; major clinical study; male; non ST segment elevation myocardial infarction; observational study; outcome assessment; priority journal; retrospective study; risk factor; ST segment elevation myocardial infarction; time to treatment; Asian continental ancestry group; atrial fibrillation; bleeding; chemically induced; dose response; factual database; middle aged; Taiwan; thromboembolism; treatment outcome; trends; very elderly; young adult; Adult; Aged; Aged, 80 and over; Asian Continental Ancestry Group; Atrial Fibrillation; Cohort Studies; Databases, Factual; Dose-Response Relationship, Drug; Factor Xa Inhibitors; Female; Hemorrhage; Humans; Male; Middle Aged; Retrospective Studies; Rivaroxaban; Taiwan; Thromboembolism; Treatment Outcome; Young Adult
Type
journal article