Table 2.
Long-term outcomes in AF patients using mAFA, comparted to usual care in mAFA II cluster randomized trial.
| mAFA | Usual care | mAFA | Usual care | Hazard ratio (adjusted)* (mAFA vs. Usual care) | 95%CI | P | |
| no./total no. | events/per 1000 patient-years | ||||||
| Primary endpoint | |||||||
| Composite outcome of IS/TE, death, and rehospitalization | 87 /1261 | 165 /1212 | 0.10 | 0.26 | 0.18 | 0.13–0.25 | <0 0.001 |
| Secondary outcomes | |||||||
| Thromboembolism | |||||||
| • Ischaemic stroke | 6 /1261 | 50 /1212 | 0.01 | 0.08 | 0.11 | 0.05–0.27 | <0 0.001 |
| • Other TE | 5/1261 | 11 /1212 | 0.01 | 0.02 | 0.29 | 0.09–0.94 | 0.03 |
| Bleeding events | |||||||
| • Intracranial bleeding | 0 /1261 | 5 /1212 | 0.00 | 0.01 | – | – | – |
| • Extracranial bleeding | 20 /1261 | 41 /1212 | 0.02 | 0.07 | 0.37 | 0.20–0.70 | 0.002 |
| Recurrent AF or AF symptom | 46 /1261 | 95/1212 | 0.05 | 0.15 | 0.33 | 0.23–0.48 | <0 0.001 |
| Heart failure | 28 /1261 | 57 /1212 | 0.03 | 0.09 | 0.40 | 0.24–0.66 | <0 0.001 |
| Rehospitalization | 69 /1261 | 89 /1212 | 0.08 | 0.14 | 0.69 | 0.49–0.97 | 0.03 |
| All-cause death | 12 /1261 | 32/1212 | 0.01 | 0.05 | 0.94 | 0.39–2.23 | 0.89 |
Data are n (%). * The effect of mAFA intervention on the clinical events after adjustment for cluster effect, age, gender, hypertension, coronary artery disease, diabetes mellitus, heart failure, peripheral artery disease, pulmonary disease (chronic obstructive pulmonary disease, obstructive sleep apnoea syndrome, pulmonary hypertension), dilated cardiomyopathy, prior ischaemic stroke, prior other thromboembolism, prior intracranial bleeding, prior other bleeding, liver/ renal dysfunction based on the baseline characteristics. IS: ischaemic stroke. TE: thromboembolism. Extracranial bleeding included gastrointestinal, urogenital, skin, mouth bleeding, and other non-major bleeding. For the composite outcome of IS/TE, death, and rehospitalization: (i) in ‘usual care’, there were 9 patients with all 3 outcomes of ischaemic stroke, rehospitalization, and death, 47 patients with two of three outcomes, and 109 patients with any of the three outcomes; (ii) for patients with mAFA, there were 4 patients with all 3 outcomes of ischaemic stroke, rehospitalization, and death, 2 patients with two of three outcomes, and 81 patients with any of the three outcomes. Other TE and extracranial bleeding events are in Supplementary Table 3.
Reasons for rehospitalization included any cause for AF, heart failure, thromboembolism, major bleeding, artery coronary disease, and other cardiovascular disease. mAFA: mobile Atrial Fibrillation Application.CI: confidence interval.