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

Giulio Francesco Romiti; Yutao Guo; Bernadette Corica; Marco Proietti; Hui Zhang; Gregory Y. H. Lip; on behalf of the mAF-App II trial investigators

doi:10.1055/s-0043-1769612

Thrombosis and Haemostasis, Inhaltsverzeichnis

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

Autor*innen

Giulio Francesco Romiti ^*

¹Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom

²Department of Translational and Precision Medicine, Sapienza—University of Rome, Rome, Italy
Yutao Guo^*

¹Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom

³Department of Pulmonary Vessel and Thrombotic Disease, Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China
Bernadette Corica

¹Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom

²Department of Translational and Precision Medicine, Sapienza—University of Rome, Rome, Italy
Marco Proietti

¹Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom

⁴Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy

⁵Geriatric Unit, IRCCS Istituti Clinici Scientifici Maugeri, Milan, Italy
Hui Zhang

³Department of Pulmonary Vessel and Thrombotic Disease, Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China
Gregory Y. H. Lip

¹Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom

³Department of Pulmonary Vessel and Thrombotic Disease, Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China

⁶Danish Center for Clinical Health Services Research, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark

on behalf of the mAF-App II trial investigators

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

Volltext

Referenzen

References
1 Armstrong PW, Westerhout CM. Composite end points in clinical research: a time for reappraisal. Circulation 2017; 135 (23) 2299-2307
2 Palileo-Villanueva LM, Dans AL. Composite endpoints. J Clin Epidemiol 2020; 128: 157-158
3 Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J 2012; 33 (02) 176-182
4 Ferreira JP, Jhund PS, Duarte K. et al. Use of the win ratio in cardiovascular trials. JACC Heart Fail 2020; 8 (06) 441-450
5 Ferreira JP, Kraus BJ, Zwiener I. et al. Cardio/kidney composite end points: a post hoc analysis of the EMPA-REG outcome trial. J Am Heart Assoc 2021; 10 (07) e020053
6 Redfors B, Gregson J, Crowley A. et al. The win ratio approach for composite endpoints: practical guidance based on previous experience. Eur Heart J 2020; 41 (46) 4391-4399
7 Guo Y, Lane DA, Wang L. et al; mAF-App II Trial Investigators. Mobile health technology to improve care for patients with atrial fibrillation. J Am Coll Cardiol 2020; 75 (13) 1523-1534
8 Guo Y, Lane DA, Wang L, Chen Y, Lip GYH. mAF-App II Trial investigators. Mobile Health (mHealth) technology for improved screening, patient involvement and optimising integrated care in atrial fibrillation: The mAFA (mAF-App) II randomised trial. Int J Clin Pract 2019; 73 (07) e13352
9 Lip GYH. The ABC pathway: an integrated approach to improve AF management. Nat Rev Cardiol 2017; 14 (11) 627-628
10 Finkelstein DM, Schoenfeld DA. Combining mortality and longitudinal measures in clinical trials. Stat Med 1999; 18 (11) 1341-1354
11 Bebu I, Lachin JM. Large sample inference for a win ratio analysis of a composite outcome based on prioritized components. Biostatistics 2016; 17 (01) 178-187
12 Wang D, Pocock S. A win ratio approach to comparing continuous non-normal outcomes in clinical trials. Pharm Stat 2016; 15 (03) 238-245
13 Dong G, Hoaglin DC, Qiu J. et al. The Win Ratio: on interpretation and handling of ties. Stat Biopharm Res 2020; 12 (01) 99-106
14 Brunner E, Vandemeulebroecke M, Mütze T. Win odds: an adaptation of the win ratio to include ties. Stat Med 2021; 40 (14) 3367-3384
15 Therneau TM, Grambsch PM. Modeling Survival Data: Extending the Cox Model. Springer New York; 2000
16 Berwanger O, Pfeffer M, Claggett B. et al. Sacubitril/valsartan versus ramipril for patients with acute myocardial infarction: win-ratio analysis of the PARADISE-MI trial. Eur J Heart Fail 2022; 24 (10) 1918-1927
17 Romiti GF, Proietti M, Bonini N. et al; GLORIA-AF Investigators. Adherence to the Atrial Fibrillation Better Care (ABC) pathway and the risk of major outcomes in patients with atrial fibrillation: a post-hoc analysis from the prospective GLORIA-AF Registry. EClinicalMedicine 2022; 55: 101757
18 Romiti GF, Pastori D, Rivera-Caravaca JM. et al. Adherence to the ‘Atrial Fibrillation Better Care’ pathway in patients with atrial fibrillation: impact on clinical outcomes-a systematic review and meta-analysis of 285,000 patients. Thromb Haemost 2022; 122 (03) 406-414
19 Schnabel RB, Yin X, Gona P. et al. 50 year trends in atrial fibrillation prevalence, incidence, risk factors, and mortality in the Framingham Heart Study: a cohort study. Lancet 2015; 386 (9989): 154-162
20 Kornej J, Huang Q, Preis SR. et al. Temporal trends in cause-specific mortality among individuals with newly diagnosed atrial fibrillation in the Framingham Heart Study. BMC Med 2021; 19 (01) 170
21 Vinter N, Huang Q, Fenger-Grøn M, Frost L, Benjamin EJ, Trinquart L. Trends in excess mortality associated with atrial fibrillation over 45 years (Framingham Heart Study): community based cohort study. BMJ 2020; 370: m2724
22 Burdett P, Lip GYH. Atrial fibrillation in the UK: predicting costs of an emerging epidemic recognizing and forecasting the cost drivers of atrial fibrillation-related costs. Eur Heart J Qual Care Clin Outcomes 2022; 8 (02) 187-194
23 Guo Y, Romiti GF, Proietti M, Bonini N, Zhang H, Lip GYH. mAF-App II Trial Investigators. Mobile health technology integrated care in older atrial fibrillation patients: a subgroup analysis of the mAFA-II randomised clinical trial. Age Ageing 2022; 51 (11) afac245
24 Johnsen SP, Proietti M, Maggioni AP, Lip GYH. A multinational European network to implement integrated care in elderly multimorbid atrial fibrillation patients: the AFFIRMO Consortium. Eur Heart J 2022; 43 (31) 2916-2918