TY - JOUR
T1 - Effectiveness and Safety of Standard- and Low-Dose Rivaroxaban in Asians With Atrial Fibrillation
AU - Lin, Yi Cheng
AU - Chien, Shu Chen
AU - Hsieh, Yi Chen
AU - Shih, Chun Ming
AU - Lin, Feng Yen
AU - Tsao, Nai Wen
AU - Chen, Chih Wei
AU - Kao, Yung Ta
AU - Chiang, Kuang Hsing
AU - Chen, Wan Ting
AU - Chien, Li Nien
AU - Huang, Chun Yao
N1 - Funding Information:
This retrospective population-based cohort study was conducted using data files from the National Health Insurance Research Database (NHIRD) maintained by the Health and Welfare Data Science Center. The NHIRD is a claims-based database managed by the National Health Insurance Administration of Taiwan, which covers health care use and costs for 99% of residents in Taiwan. The NHIRD files include inpatient, outpatient, pharmaceutical claims, and disease diagnoses, and were coded by the International Classification of Diseases-9th Revision-Clinical Modification. In addition, the enrollment files of beneficiaries and providers were included. The data period used in this study was 2010 to 2015. This study was approved by the Joint Institutional Review Board of Taipei Medical University (TMU-JIRB No. N201701018).
Publisher Copyright:
© 2018 American College of Cardiology Foundation
PY - 2018/7/31
Y1 - 2018/7/31
N2 - 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.
AB - 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.
KW - bleeding
KW - embolism
KW - myocardial infarction
KW - non–vitamin K antagonist oral anticoagulant
KW - stroke
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U2 - 10.1016/j.jacc.2018.04.084
DO - 10.1016/j.jacc.2018.04.084
M3 - Article
AN - SCOPUS:85049923232
SN - 0735-1097
VL - 72
SP - 477
EP - 485
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 5
ER -