The conventional arm reflected atrial fibrillation screening in real world practice which can be by symptoms, routine ECG screening, and other methods. In both groups, information on newly detected atrial fibrillation was collected by the researchers via app-based questionnaires, telephone calls as well as insurance claims data.
A total of 2,860 participants were assigned to digital screening and 2,691 participants were assigned to conventional screening. The primary efficacy endpoint was newly diagnosed atrial fibrillation within six months leading to initiation of oral anticoagulation by an independent physician. The primary endpoint occurred in 38 participants (1.33%) in the digital arm and 17 (0.63%) in the conventional arm, for an odds ratio (OR) of 2.12 (95% confidence interval [CI] 1.19–3.76; p=0.010).
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Those who did not reach the primary endpoint in the first six months were invited to take part in a second six-month study phase with crossover assignment to conventional or digital screening, respectively. This gave all participants the opportunity to undergo digital screening, increased the statistical power for secondary analyses, and enabled validation of the primary results. A total of 4,752 (85.6%) participants crossed over and entered the second study phase. Again, digital screening was superior to conventional screening in detecting atrial fibrillation that was then treated with oral anticoagulation (33 of 2,387 versus 12 of 2,365 participants; OR 2.95; 95% CI 1.52–5.72; p=0.001).
In secondary analyses, atrial fibrillation, PPG-detected atrial fibrillation, and abnormal PPG findings significantly predicted major adverse cardiac and cerebrovascular events (MACCE), with hazard ratios of 6.13 (95% CI 3.07–12.21; p<0.001), 3.22 (95% CI 1.01–10.33; p=0.049) and 2.74 (95% CI 1.25–6.00; p=0.012), respectively.
Professor Bauer said: “This trial focused on a target population for atrial fibrillation screening, rather than all-comers. We found that digital screening was well received by older participants, who tended to perform even more PPG measurements than younger participants in the study. Digitally detected atrial fibrillation as well as abnormal PPG measurements per se were of prognostic significance as they predicted MACCE.”
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