XaMINA: A Real-World, Prospective, Observational Study of Treatment-Naive Patients Treated with Rivaroxaban for Stroke Prevention in Atrial Fibrillation in Asia
- Authors
- Liu, Ping-Yen; Choi, Eue-Keun; Kim, Tae-Seok; Kuo, Jen-Yuan; Lee, Jung Myung; On, Young Keun; Park, Sang-Weon; Park, Hyung-Wook; Shin, Dong-Gu; Wang, Lili; Yen, Hsueh-Wei; Lee, Moon-Hyoung
- Issue Date
- Jul-2022
- Publisher
- SPRINGER
- Keywords
- Atrial fibrillation; Rivaroxaban; Stroke; Non-vitamin K antagonist oral anticoagulant; Thrombosis; Real-world evidence; Direct oral anticoagulant
- Citation
- ADVANCES IN THERAPY, v.39, no.7, pp 3316 - 3333
- Pages
- 18
- Indexed
- SCIE
SCOPUS
- Journal Title
- ADVANCES IN THERAPY
- Volume
- 39
- Number
- 7
- Start Page
- 3316
- End Page
- 3333
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/97945
- DOI
- 10.1007/s12325-022-02102-8
- ISSN
- 0741-238X
1865-8652
- Abstract
- Introduction The efficacy and safety of rivaroxaban for the prevention of stroke and systemic embolism have been demonstrated in Asian and non-Asian patients with non-valvular atrial fibrillation (NVAF) in multiple studies. However, limited published data exist on its use specifically in treatment-naive patients from the Asia region. Patients in South Korea and Taiwan can now receive rivaroxaban as first-line therapy, allowing for data generation in this patient group. Methods XaMINA was a prospective, real-world, multicenter, single-arm, observational cohort study of patients with NVAF in South Korea and Taiwan naive to anticoagulation and initiating rivaroxaban. The primary outcome was major bleeding; secondary outcomes included all-cause mortality, symptomatic thromboembolic events, and treatment persistence. Results In total, 1094 patients were included and the follow-up was 1 year. The baseline mean CHADS(2) score was 1.63 +/- 0.98, mean CHA(2)DS(2)-VASc score was 2.92 +/- 1.42, and mean HAS-BLED score was 1.00 +/- 0.75. The primary outcome occurred in 20 (1.8%) patients [incidence rate 2.1 events per 100 patient-years (95% CI 1.35-3.25)]. Thromboembolic events occurred in 9 (0.8%) patients, of whom 5 (0.5%) had stroke, 3 (0.3%) myocardial infarction, and 1 (0.1%) a transient ischemic attack. There were no cases of non-central nervous system systemic embolism, and 735 (67.2%) patients persisted with rivaroxaban treatment for 1 year. Conclusion XaMINA demonstrated low incidence rates of major bleeding events and thromboembolic events in patients with NVAF newly initiating rivaroxaban in South Korea and Taiwan, consistent with previous real-world studies reconfirming the results of the ROCKET AF study.
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