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Thromb Haemost 2023; 123(11): 1042-1048
DOI: 10.1055/s-0043-1769612
New Technologies, Diagnostic Tools and Drugs

Mobile Health-Technology-Integrated Care for Atrial Fibrillation: A Win Ratio Analysis from the mAFA-II Randomized Clinical Trial

Giulio Francesco Romiti    *
1   Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
2   Department of Translational and Precision Medicine, Sapienza—University of Rome, Rome, Italy
,
Yutao Guo   *
1   Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
3   Department of Pulmonary Vessel and Thrombotic Disease, Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China
,
Bernadette Corica
1   Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
2   Department of Translational and Precision Medicine, Sapienza—University of Rome, Rome, Italy
,
Marco Proietti
1   Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
4   Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy
5   Geriatric Unit, IRCCS Istituti Clinici Scientifici Maugeri, Milan, Italy
,
Hui Zhang
3   Department of Pulmonary Vessel and Thrombotic Disease, Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China
,
Gregory Y. H. Lip 
1   Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
3   Department of Pulmonary Vessel and Thrombotic Disease, Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China
6   Danish Center for Clinical Health Services Research, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
,
on behalf of the mAF-App II trial investigators › Author Affiliations Funding This research was funded by the National Natural Science Foundation of China (82170309). This study was an investigator-initiated project, with limited funding by independent research and educational grants.
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Abstract

Background The Mobile Health (mHealth) Technology for Improved Screening and Optimized Integrated Care in atrial fibrillation (AF) (mAFA-II) cluster randomized trial assessed the efficacy of an integrated care approach in improving the prognosis of AF patients. In this study, we provide a reanalysis of the trial outcomes using the win ratio (WR) approach.

Methods The mAFA-II trial allocated patients to receive a mHealth-technology implemented Atrial Fibrillation Better Care (ABC) pathway (mAFA intervention) or usual care. The primary outcome was the composite of all-cause death, ischemic stroke or systemic thromboembolism, and rehospitalization. The efficacy of the mAFA intervention was analyzed according to the WR method using the unmatched pairs approach, with the components of the primary outcome analyzed hierarchically as follows: (1) all-cause death; (2) ischemic stroke or thromboembolism; (3) rehospitalization. Results were reported as WR and 95% confidence intervals (CIs). In addition, we calculated win odds (WO) and 95% CI.

Results A total of 3,324 patients were enrolled in the mAFA-II trial and included in this analysis (1,646 allocated to mAFA intervention and 1,678 to usual care). Among 2,761,988 unmatched pairs comparisons, the number of wins was higher in the mAFA intervention group, with a WR: 2.78 (95% CI: 1.85–4.17). WO confirmed the effect of mAFA intervention, although with a lower magnitude (WO: 1.06; 95% Cl: 1.04–1.08).

Conclusion In this posthoc WR analysis of the mAFA-II trial, a mHealth-technology-implemented integrated care approach was effective in reducing the risk of the primary composite outcome of all-cause death, ischemic stroke or thromboembolism, and rehospitalization, even when prioritizing fatal events.

Keywords

atrial fibrillation - integrated care - composite outcomes - win ratio

* Joint first authors.


The review process for this paper was fully handled by Christian Weber, Editor in Chief.




Publication History

Received: 13 March 2023

Accepted: 28 April 2023

Article published online:
29 May 2023

© 2023. Thieme. All rights reserved.

Georg Thieme Verlag KG
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