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. 2020 Oct 13;82:105–111. doi: 10.1016/j.ejim.2020.09.024

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.