Integrated care management for older multimorbid patients with atrial fibrillation: Rationale, design and baseline characteristics for the atrial fibrillation integrated approach in frail, multimorbid and polymedicated older people (AFFIRMO) trial.
Atrial fibrillation (AF) is the most common arrhythmia in older people, with an increasing prevalence of various geriatric conditions, such as multimorbidity, and frailty. A contemporary integrated approach is effective in reducing the risk of clinical adverse events, particularly when streamlined through the application of the Atrial Fibrillation Better Care (ABC) pathway, as proven in 2 non-European trials. The atrial fibrillation integrated approach in frail, multimorbid and polymedicated older people (AFFIRMO) trial, a European multicenter, open-label, cluster-randomized study, will examine whether a mobile-health integrated care approach based on the ABC pathway combined with a multidimensional Comprehensive Geriatric Assessment (CGA) can reduce the 12-month risk of unplanned all-cause hospitalizations in patients with AF ≥65 years with ≥1 concomitant chronic condition(s). The AFFIRMO trial enrolled 1,260 patients with AF (mean age 74 [SD 6] years; 44.4% female) across 6 European countries (Bulgaria, Denmark, Italy, Romania, Serbia, and Spain). At baseline, the median (IQR) CHA2DS2-VASc score was 4 (3-5), and the median (IQR) HAS-BLED score was 1 (1-2). Hypertension was reported in 992 (78.7%) patients, and diabetes mellitus in 369 (29.3%) patients. Among the enrolled patients, 507 (40.5%) were prefrail, and 171 (13.7%) were frail. Oral anticoagulants (OACs) were prescribed for 1,225 (97.2%) patients, with 1,149 (91.2%) patients receiving non-VKAs oral anticoagulants (NOACs). Follow-up is ongoing and planned to be completed in January 2026. The AFFIRMO trial will provide evidence on the efficacy of the ABC pathway in conjunction with the CGA approach in reducing the risk of unplanned all-cause hospitalizations and other clinical adverse events in older, multimorbid patients with AF. ClinicalTrials.gov identifier: NCT06775028.
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