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. 2025 Aug 29:e2515440.
doi: 10.1001/jama.2025.15440. Online ahead of print.

Remote Screening for Asymptomatic Atrial Fibrillation: The AMALFI Randomized Clinical Trial

Affiliations

Remote Screening for Asymptomatic Atrial Fibrillation: The AMALFI Randomized Clinical Trial

Rohan Wijesurendra et al. JAMA. .

Abstract

Importance: Screening for atrial fibrillation (AF) might reduce stroke if it increases long-term AF detection and anticoagulation use compared with usual care.

Objective: To investigate the long-term efficacy of AF screening in older individuals at moderate to high risk of stroke using 14-day, patch-based continuous ambulatory electrocardiogram (ECG) monitoring.

Design, setting, and participants: A parallel-group, unblinded, remote randomized clinical trial recruiting from 27 UK primary care practices from May 2, 2019, to February 28, 2022. All eligible individuals 65 years or older with a CHA2DS2VASc score of 3 or higher (men) or 4 or higher (women) with no previous AF or atrial flutter were identified via automated electronic health record searches. Last follow-up was on August 29, 2024, and statistical analysis was conducted from May to July 2025.

Intervention: Participants were randomized to receive and return an ECG patch monitor by postal mail (intervention, n = 2520) or usual care (control, n = 2520).

Main outcomes and measures: Intention-to-treat analysis of the proportion of participants with AF recorded in primary care records within 2.5 years postrandomization. Exploratory outcomes included exposure to oral anticoagulation and stroke.

Results: Of the 22 044 individuals invited, 5040 (22.9%) were randomized. The participants' mean (SD) age was 78 (6) years, 47% were female, and the median (IQR) CHA2DS2VASc score was 4 (3-5). A total of 2126 participants (84.4%) wore and returned the patch. AF was detected by patch in 89 participants (4.2%), 55% of whom had an AF burden less than 10%. After 2.5 years, a postrandomization record of AF was present in 172 individuals (6.8%) in the intervention group vs 136 (5.4%) in the control group (ratio of proportions, 1.26 [95% CI, 1.02-1.57]; P = .03), with consistent results in prespecified subgroups. Mean exposure to oral anticoagulation by 2.5 years was 1.63 months (95% CI, 1.50-1.76) in the intervention group and 1.14 months (95% CI, 1.01-1.26) in the control group (difference, 0.50 months [95% CI, 0.24-0.75]; P < .001). Stroke occurred in 69 participants (2.7%) in the intervention group and 64 (2.5%) in the control group (rate ratio, 1.08 [95% CI, 0.76-1.53]).

Conclusions and relevance: In this remote randomized clinical trial, mail-based AF screening with an ECG patch in older patients at moderate to high risk of stroke led to a modest long-term increase in AF diagnosis at 2.5 years.

Trial registration: ISRCTN Identifier: 15544176.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Harper reported receiving grants from Novo Nordisk outside the submitted work. Dr Bulbulia reported receiving grants from the British Heart Foundation (BHF) outside the submitted work. Dr Jones reported receiving grants from Wellcome Trust and National Institute for Health and Care Research (NIHR) Academic Clinical Fellowship outside the submitted work. Dr Casadei reported serving as a board member of the Novo Nordisk Foundation outside the submitted work. Dr Bowman reported receiving grants from Novartis, Novo Nordisk, and BHF outside the submitted work. No other disclosures were reported.

References

    1. Wijesurendra RS, Casadei B. Mechanisms of atrial fibrillation. Heart. 2019;105(24):1860-1867. doi: 10.1136/heartjnl-2018-314267 - DOI - PubMed
    1. Friberg L, Rosenqvist M, Lindgren A, Terént A, Norrving B, Asplund K. High prevalence of atrial fibrillation among patients with ischemic stroke. Stroke. 2014;45(9):2599-2605. doi: 10.1161/STROKEAHA.114.006070 - DOI - PubMed
    1. Tereshchenko LG, Henrikson CA, Cigarroa J, Steinberg JS. Comparative effectiveness of interventions for stroke prevention in atrial fibrillation: a network meta-analysis. J Am Heart Assoc. 2016;5(5):e003206. doi: 10.1161/JAHA.116.003206 - DOI - PMC - PubMed
    1. Thind M, Holmes DN, Badri M, et al. ; ORBIT-AF Investigators and Patients . Embolic and other adverse outcomes in symptomatic versus asymptomatic patients with atrial fibrillation (from the ORBIT-AF Registry). Am J Cardiol. 2018;122(10):1677-1683. doi: 10.1016/j.amjcard.2018.07.045 - DOI - PubMed
    1. Wallenhorst C, Martinez C, Freedman B. Risk of ischemic stroke in asymptomatic atrial fibrillation incidentally detected in primary care compared with other clinical presentations. Thromb Haemost. 2022;122(2):277-285. doi: 10.1055/a-1541-3885 - DOI - PubMed

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