Key result
The mAFA intervention reduced the composite of stroke, thromboembolism, all-cause death, and re-hospitalization in both male (aHR 0.30) and female (aHR 0.50) patients with atrial fibrillation.
Why the study?
Whether the clinical benefits of an mHealth-implemented ABC pathway apply equally to males and females with AF remained unclear, particularly given poorer outcomes in females.
Does a mobile health-implemented 'Atrial fibrillation Better Care' (ABC) pathway reduce the composite of stroke, thromboembolism, all-cause death, and re-hospitalization in male and female patients with atrial fibrillation?
RCT (n=3,324)
Cluster-randomized
Yes
Does a mobile health-implemented 'Atrial fibrillation Better Care' (ABC) pathway reduce the composite of stroke, thromboembolism, all-cause death, and re-hospitalization in male and female patients with atrial fibrillation?
Effect estimate: aHR 0.30 (males), aHR 0.50 (females) (95% CI 0.17-0.52 (males), 0.27-0.92 (females))
p-value: p=0.225 for interaction
mHealth ABC pathway reduces adverse events similarly in male and female AF patients; extends mAFA-II findings across sexes.
The Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA-II) cluster-randomized trial showed that a mobile health (mHealth)-implemented 'Atrial fibrillation Better Care' (ABC) pathway approach reduced the risk of adverse events in atrial fibrillation (AF) patients. Whether this benefit can be applied to both males and females is unclear, especially given the suboptimal management and poorer cardiovascular outcomes in females with AF. In this post-hoc analysis, we performed a sex-stratified analysis of the mAFA-II trial. Between June 2018 and August 2019, adult AF patients were enrolled across 40 centers in China. The primary outcome was the composite of stroke, thromboembolism, all-cause death, and re-hospitalization. The effect of mAFA intervention according to sex was evaluated through adjusted Cox-regression models. Among the 3,324 patients enrolled in the trial, 2,062 (62.0%) patients were males (mean age: 67.5 ± 14.3 years; 1,021 allocated to mAFA intervention) and 1,262 (38.0%) were females (mean age: 70.2 ± 13.0; 625 allocated to mAFA intervention). A significant risk reduction of the primary composite outcome in patients allocated to mAFA intervention was observed in both males (adjusted hazard ratio [aHR] and 95% confidence interval [CI] 0.30 [0.17-0.52]) and females (aHR [95%CI] 0.50 [0.27-0.92]), without statistically significant interaction (p = 0.225). Sex-based interactions were observed for other secondary outcomes, including all-cause death (p = 0.026) and bleeding events (p = 0.032). A mHealth-technology implemented ABC pathway was similarly effective in reducing the risk of adverse clinical events both in male and female patients. Secondary outcomes showed greater benefits of mAFA intervention in men.
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Guo et al. (2023) conducted an RCT in Atrial fibrillation (n=3,324). mHealth-implemented 'Atrial fibrillation Better Care' (ABC) pathway vs. Usual care was evaluated on Composite of stroke, thromboembolism, all-cause death, and re-hospitalization (aHR 0.30 (males), aHR 0.50 (females), 95% CI 0.17-0.52 (males), 0.27-0.92 (females), p=0.225 for interaction). The mAFA intervention reduced the composite of stroke, thromboembolism, all-cause death, and re-hospitalization in both male (aHR 0.30) and female (aHR 0.50) patients with atrial fibrillation.
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