Gender specific aspects of digital screening for atrial fibrillation: insights from the randomized eBRAVE-AF trial.

Aims: Smartphone-based digital screening was shown to increase the detection rate of atrial fibrillation (AF) requiring oral anticoagulation (OAC) compared with usual care. In this pre-specified subgroup analysis of the eBRAVE-AF trial, we explored sex-specific differences in digital AF-screening.

Methods and results: In eBRAVE-AF (NCT04250220), participating policyholders of a German health insurance company were randomly assigned to a 6-month digital or conventional AF-screening strategy. For digital screening, participants used smartphone-based photoplethysmography (PPG) to detect pulse wave irregularities, which were confirmed using 14-day external ECG-recorders. The primary endpoint was newly diagnosed AF treated with OAC. After 6 months, participants were assigned to a second, cross-over study-phase. The efficacy of AF-screening in women and men was assessed by Cox-regression analysis. 5551 (31% females; 55% ≥ 65 years) of 67 488 invited policyholders free of AF participated in the study and were randomly assigned to digital screening (n = 2860) or usual care (n = 2691). Participation rate was significantly higher among men than women (8.7% vs. 7.3%; P < 0.001). Male sex was a significant predictor for reaching the primary endpoint (HR 1.74; 95% CI: 1.08-2.82, P = 0.023), which was pronounced in patients undergoing digital screening (HR 2.48; 95% CI: 1.52-4.05, P < 0.001). Digital screening did not significantly increase the detection rate of AF requiring OAC in women (HR 1.83; 95% CI: 0.74-4.54; P = 0.193; P-interaction = 0.563).

Conclusion: Men showed higher willingness to participate in this digital study and digital AF-screening was effective for them. While digital screening increased the detection rate of AF with OAC in women, the effect was not statistically significant, likely due to limited power.