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26.05.2022 | Original Research

XaMINA: A Real-World, Prospective, Observational Study of Treatment-Naïve Patients Treated with Rivaroxaban for Stroke Prevention in Atrial Fibrillation in Asia

verfasst von: Ping-Yen Liu, Eue-Keun Choi, Tae-Seok Kim, Jen-Yuan Kuo, Jung Myung Lee, Young Keun On, Sang-Weon Park, Hyung-Wook Park, Dong-Gu Shin, Lili Wang, Hsueh-Wei Yen, Moon-Hyoung Lee, The XaMINA Investigators

Erschienen in: Advances in Therapy | Ausgabe 7/2022

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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-naïve 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 naïve 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 CHADS₂ score was 1.63 ± 0.98, mean CHA₂DS₂-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.

Trial Registration

The trial was registered on ClinicalTrials.gov (identifier NCT03284762) on 15 September 2017.

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Titel: XaMINA: A Real-World, Prospective, Observational Study of Treatment-Naïve Patients Treated with Rivaroxaban for Stroke Prevention in Atrial Fibrillation in Asia
verfasst von: Ping-Yen Liu
Eue-Keun Choi
Tae-Seok Kim
Jen-Yuan Kuo
Jung Myung Lee
Young Keun On
Sang-Weon Park
Hyung-Wook Park
Dong-Gu Shin
Lili Wang
Hsueh-Wei Yen
Moon-Hyoung Lee
The XaMINA Investigators
Publikationsdatum: 26.05.2022
Verlag: Springer Healthcare
Erschienen in: Advances in Therapy / Ausgabe 7/2022
Print ISSN: 0741-238X
Elektronische ISSN: 1865-8652
DOI: https://doi.org/10.1007/s12325-022-02102-8

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XaMINA: A Real-World, Prospective, Observational Study of Treatment-Naïve Patients Treated with Rivaroxaban for Stroke Prevention in Atrial Fibrillation in Asia