Prevalence, risk factors, and prediction of inappropriate use of non-vitamin K antagonist oral anticoagulants in elderly Chinese patients with atrial fibrillation: A study protocol

Shu-Juan Zhao, Bo-Ya Chen, Xue-Jiao Hong, Yin-Ping Liu, Hai-Xia Cai, Song Du, Zhi-Chun Gu, Pei-Zhi Ma, Shu-Juan Zhao, Bo-Ya Chen, Xue-Jiao Hong, Yin-Ping Liu, Hai-Xia Cai, Song Du, Zhi-Chun Gu, Pei-Zhi Ma

Abstract

Background: Atrial fibrillation (AF) is an arrhythmia that is prevalent globally, and its incidence grows exponentially with aging. Non-vitamin K antagonist oral anticoagulants (NOACs) have been developed in recent years, and it challenges the supremacy of warfarin for thromboembolism prophylaxis in AF. Nevertheless, there are limited data specifically evaluating the real-life use of NOACs in elderly patients with AF in China.

Methods: This is a national, multicenter, non-interventional, cross-sectional study that enrolls patients with AF aged 75 years and above from 31 institutions across China. Data were collected using the Hospital Information System. The primary outcomes include (1) profiles of NOAC use in the elderly; (2) frequency of inappropriate NOAC use based on guidelines and approved labeling recommendations; (3) exploring potential risk factors related to NOACs inappropriate use; and (4) creating a prediction tool for inappropriate NOACs use.

Conclusion: The results of this study reveal the prevalence, risk factors, and corresponding prediction tool of inappropriate NOACs use in older patients with AF in China, as well as provide valuable insights into the clinical application of NOACs in high-risk populations in the real-world setting.

Clinical trial registration: www.ClinicalTrials.gov, identifier: NCT05361889.

Keywords: atrial fibrillation; drug utility; elderly; machine learning; non-vitamin K antagonist oral anticoagulants; prediction; real-world; risk factors.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Zhao, Chen, Hong, Liu, Cai, Du, Gu and Ma.

Figures

Figure 1
Figure 1
Design schematic of this registry. NOAC, non-vitamin K antagonist oral anticoagulant. a: Including the following details: basic information, disease information, history, latest laboratory data, co-administrations with NOACs, risk factors for thromboembolism (CHA2DS2-VASc score), and risk factors for bleeding (HAS-BLED score).
Figure 2
Figure 2
NOACs evaluation flowchart. NOAC, non-vitamin K antagonist oral anticoagulant; DDI, drug-drug interaction; NMPA, National Medical Products Administration; EHRA, European Heart Rhythm Association; AF, atrial fibrillation.

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