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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

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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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Acknowledgements

We would like to express our thanks to all participants of the study.

Funding

This study was funded by Bayer AG. The Rapid Service Fee was funded by Bayer AG.

Medical Writing and Editorial Assistance

The authors would like to acknowledge Tom Rowles from Chameleon Medical Communications, who provided medical writing services with funding from Bayer AG.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Author Contributions

All authors have contributed to design, analysis, interpretation of data, drafting and reviewing the manuscript and have read and approved the final draft for submission.

Disclosures

All authors were investigators for XaMINA and were paid for their participation. Eue-Keun Choi has also received research grants from Bayer, Bristol Myers Squibb/Pfizer, Biosense Webster, Chong Kun Dang, Daiichi-Sankyo, Dreamtech Co., Ltd, Medtronic, Samjinpharm, Sanofi-Aventis, Seers Technology, Skylabs, and Yuhan. Lili Wang is an employee of Bayer. Ping-Yen Liu, Tae-Soek Kim, Jen-Yuan Kuo, Jung Myung Lee, Young Keun On, Hyung-Wook Park, Sang-Weon Park, Dong-Gu Shin, Hsueh-Wei Yen, and Moon-Hyoung Lee have no further conflicts of interest to disclose.

Compliance with Ethics Guidelines

The study was carried out within an approved indication in accordance with guidelines and regulations of EMA, FDA, and applicable local laws and regulations. In all countries where reference to an independent ethics committee or institutional review board is required, documented approvals from appropriate groups were obtained. Informed consent was obtained from every patient in writing before the documentation of any data.

Data Availability

Study results will be disclosed in a publicly available database within the standard timelines.

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Authors and Affiliations

  1. Division of Cardiology, Internal Medicine, College of Medicine, National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan

    Ping-Yen Liu

  2. Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea

    Eue-Keun Choi

  3. The Catholic University of Korea, Daejeon St. Mary’s Hospital, Daejeon, Republic of Korea

    Tae-Seok Kim

  4. Division of Cardiology, Mackay Memorial Hospital, Taipei, Taiwan

    Jen-Yuan Kuo

  5. Department of Medicine, Mackay Medical College, New Taipei, Taiwan

    Jen-Yuan Kuo

  6. Kyung Hee University Medical Center, Seoul, Republic of Korea

    Jung Myung Lee

  7. Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

    Young Keun On

  8. Bucheon Sejong Hospital, Bucheon, Republic of Korea

    Sang-Weon Park

  9. Chonnam National University, Gwangju, Republic of Korea

    Hyung-Wook Park

  10. Yeungnam University Medical Center, Daegu, Republic of Korea

    Dong-Gu Shin

  11. Bayer (South East Asia) Pte Ltd, Singapore, Singapore

    Lili Wang

  12. Kaohsiung Medical University, Kaohsiung, Taiwan

    Hsueh-Wei Yen

  13. Severance Hospital, Yonsei University, 50-1 Yonsei-ro, Sinchon-dong, Seodaemun-gu, Seoul, Republic of Korea

    Moon-Hyoung Lee

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  1. Ping-Yen Liu
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The XaMINA Investigators

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Correspondence to Moon-Hyoung Lee.

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Liu, PY., Choi, EK., Kim, TS. et al. XaMINA: A Real-World, Prospective, Observational Study of Treatment-Naïve Patients Treated with Rivaroxaban for Stroke Prevention in Atrial Fibrillation in Asia. Adv Ther 39, 3316–3333 (2022). https://doi.org/10.1007/s12325-022-02102-8

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