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Risk of major bleeding and thromboembolism in Asian patients with nonvalvular atrial fibrillation using direct oral anticoagulants versus warfarin

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Abstract

Background Bleeding and thromboembolism prevention is important in patients with nonvalvular atrial fibrillation receiving anticoagulants, including direct oral anticoagulants and warfarin. Asians have higher risks of bleeding complications when taking anticoagulants. However, evidence that considers laboratory parameters is lacking. Objective We aimed to compare the safety and effectiveness between direct oral anticoagulants and warfarin in Asian patients with nonvalvular atrial fibrillation. Setting Retrospective design using hospital-based data. Method This propensity score-matched cohort study included data extracted from the electronic medical records of the En Chu Kong Hospital Research Database. Main outcome measure Outcome measures were major bleeding and thromboembolism. Cox proportional hazard models were applied for evaluating hazard ratios with 95% confidence intervals. Results Among 1075 patients with nonvalvular atrial fibrillation, 687 and 388 were administered direct oral anticoagulants and warfarin, respectively. After propensity score matching, 264 patient pairs were selected. Compared with warfarin use, direct oral anticoagulant use was associated with similar risks for major bleeding and thromboembolism; however, the latter was associated with increased gastrointestinal bleeding risks (adjusted hazard ratio 3.59; 95% confidence interval, 1.31–11.39). Notably, an approximately 10 fold increased risk of gastrointestinal bleeding was observed in 0–6 month direct oral anticoagulant users (adjusted hazard ratio 10.13, 95% confidence interval 1.27–80.89). Conclusion Direct oral anticoagulant use was not associated with major bleeding and thromboembolism occurrence in Asian patients with nonvalvular atrial fibrillation. However, direct oral anticoagulant use was associated with increased gastrointestinal bleeding risks, especially when used within 0–6 months of direct oral anticoagulant use.

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Data availability

The authors are restricted from sharing the analyzed data in this study because public access to the electronic medical records is forbidden by the current laws of Taiwan. To request access to the data, En Chu Kong Hospital, Taiwan should be contacted (https://www.eck.org.tw/).

Code availability

The STATA code for statistical analysis is shown in Online Resource 4.

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Acknowledgements

We would like to express our greatest appreciation to En Chu Kong Hospital for allowing us to use their analyzed claims database and Mrs. You-Meei Lin for giving administrative support. We also thank Professor Yi-Ting Hwang, affiliated to the Department of Statistics, National Taipei University, for the assistance in the statistical analysis.

Funding

This study was supported in part by a grant from the En Chu Kong Hospital, New Taipei City, Taiwan (ECKH_D10802). The funder did not participate in study design, collection, analysis, data interpretation, or manuscript writing.

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Author notes

  1. Ching-Yao Chen and Ching-Chi Chu contributed equally to the submitted work.

Authors and Affiliations

  1. Department of Pharmacy, En Chu Kong Hospital, New Taipei City, Taiwan, ROC

    Ya-Ling Huang, Ching-Yao Chen & Ching-Chi Chu

  2. Department of Cardiology, En Chu Kong Hospital, New Taipei City, Taiwan, ROC

    Ching-Chi Chu

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  1. Ya-Ling Huang
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Correspondence to Ching-Yao Chen or Ching-Chi Chu.

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Conflicts of interests

The authors declare that they have no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years, and there are no other relationships or activities that could appear to have influenced the submitted work.

Consent to participate

This study is a de-identified database-based study, and, therefore, was exempt from a full review of the Institutional Review Committee on Human Research of En Chu Kong Hospital (Registration no. ECKIRB1081201), and the need for obtaining participant informed consent was waived.

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The corresponding authors (Chen CY and Chu CC) confirm that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.

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Huang, YL., Chen, CY. & Chu, CC. Risk of major bleeding and thromboembolism in Asian patients with nonvalvular atrial fibrillation using direct oral anticoagulants versus warfarin. Int J Clin Pharm 44, 34–43 (2022). https://doi.org/10.1007/s11096-021-01309-z

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  • DOI: https://doi.org/10.1007/s11096-021-01309-z

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