Key result
The mAFA intervention significantly reduced the risk of stroke, thromboembolism, death, and rehospitalization in AF patients with diabetes (aHR 0.36; 95% CI 0.18-0.73).
Why the study?
Following the mAFA-II trial showing the efficacy of an mHealth-implemented ABC pathway in AF, the effect of the mAFA intervention according to diabetes mellitus status needed evaluation.
Does a mobile health-implemented ABC pathway reduce the composite outcome of stroke, thromboembolism, death, and rehospitalizations in AF patients with diabetes mellitus?
RCT (n=3,324)
cluster randomized
Yes
Does a mobile health-implemented ABC pathway reduce the composite outcome of stroke, thromboembolism, death, and rehospitalizations in AF patients with diabetes mellitus?
Hazard Ratio: 0.36 (95% CI 0.18–0.73)
p-value: p=0.941 for interaction
A mobile health-implemented integrated care pathway significantly reduces adverse clinical outcomes in atrial fibrillation patients, regardless of concurrent diabetes mellitus.
Background The Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA‐II) prospective randomized trial showed the efficacy of a mobile health (mHealth) implemented ‘Atrial fibrillation Better Care’ (ABC) pathway for the integrated care management of patients with atrial fibrillation (AF). In this ancillary analysis, we evaluated the effect of mAFA intervention according to the history of diabetes mellitus (DM). Methods The mAFA‐II trial enrolled 3324 AF patients across 40 centres in China, between June 2018 and August 2019. In this analysis, we assessed the interaction between history of DM and the effect of mAFA intervention on the risk of the primary composite outcome of stroke, thromboembolism, all‐cause death and rehospitalizations. Results were expressed as adjusted hazard ratio (aHR) and 95% confidence intervals (95%CI). The effect of mAFA intervention on exploratory secondary outcomes was also assessed. Results Overall, 747 (22.5%) patients had DM (mean age: 72.7 ± 12.3, 39.6% females; 381 allocated to mAFA intervention). mAFA intervention was associated with a significant risk reduction for the primary composite outcome both in patients with and without DM (aHR [95%CI]: .36 [.18–.73] and .37 [.23–.61], respectively, p for interaction = .941). A significant interaction was found only for the composite of recurrent AF, heart failure and acute coronary syndromes ( p int =.025), with lower effect of mAFA intervention in patients with DM. Conclusions A mHealth‐technology implemented ABC pathway showed a consistent effect in reducing the risk of the primary composite outcome in AF patients with and without DM. Trial Registration WHO International Clinical Trials Registry Platform (ICTRP) Registration number: ChiCTR‐OOC‐17014138.
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Guo et al. (2023) conducted an RCT in atrial fibrillation with diabetes mellitus (n=3,324). mAFA intervention (mHealth implemented ABC pathway) was evaluated on composite outcome of stroke, thromboembolism, all-cause death and rehospitalizations (aHR 0.36, 95% CI 0.18-0.73, p=0.941 for interaction). The mAFA intervention significantly reduced the risk of stroke, thromboembolism, death, and rehospitalization in AF patients with diabetes (aHR 0.36; 95% CI 0.18-0.73).
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