Discussion
death, bleeding, PAD, stroke, CAD
BLEEDING, STROKE, PATHOPHYSIOLOGY, PAD, SECONDARY, EVENTS, CAD
In this ancillary analysis of the mAFA-II trial, our principal findings are as follows: (i) the mAFA intervention reduced the risk of the primary composite outcome of IS, TE, all-cause death, and re-hospitalization in both sexes; (ii) the magnitude of the risk reduction appeared higher among males; and (iii) a sex-based interaction was observed for some of the exploratory secondary outcomes, including all-cause death and bleeding events, with the effect of mAFA intervention being higher among male patients.There has been growing interest in the potential sex-based differences in AF patients, from the pathophysiology and the accumulation of risk factors to the risk of adverse outcomes, including stroke [Recent international guidelines [In this post hoc analysis from the mAFA-II trial, we showed how a mHealth-technology implemented ABC pathway consistently reduces the risk of the primary composite outcome of IS/TE, all-cause death, and re-hospitalizations in both sexes, without a statistically significant sex-based interaction. Nevertheless, we observed a trend toward a higher magnitude of risk reduction among male patients, and this finding was consistent with the analysis of the exploratory secondary outcomes, which showed a sex-based interaction for the effect of the ABC pathway on the risk of all-cause death, bleeding events, and the composite of non-fatal cardiovascular outcomes.Several hypotheses may contribute to the results observed. First, in our study, male patients allocated to mAFA intervention were younger than those allocated to usual care, and with an overall lower burden of comorbidities at baseline, including CAD, PAD, and history of previous IS and bleeding events. On the other side, women allocated to mAFA showed higher prevalence of HF, PAD. and a history of IS. Taken together, while these imbalances in baseline characteristics can be explained by the cluster randomization design of the trial, they may have contributed to the higher magnitude of the effect observed among male patients compared to females allocated to mAFA intervention.Moreover, both males and females allocated to mAFA intervention more frequently received OAC—and, specifically, NOACs—when compared to those who received usual care. The higher uptake of OAC can be seen both as a direct effect of the implementation of the mAFA intervention in these patients (with optimisation of stroke prevention as part of the mHealth-implemented ABC pathway), and one key determinants of the beneficial effects of mAFA in these patients. These findings reinforce the hypothesis that a holistic or integrated care approach improves management of AF patients, leading to better outcomes.Nonetheless, it has already been shown that women may present with atypical symptoms of AF [Finally, the role of social determinants of health in influencing the natural history and outcomes in AF is increasingly recognized [Overall, while confirming the efficacy of the ABC pathway in both sexes for the primary composite outcome, our findings are consistent with the previously reported trend of a potential sex-based difference in the efficacy of the ABC pathway [