American heart journal · 2026
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.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Proietti Marco, Lip Gregory Y H, Ainsworth John, Dan Gheorghe-Andrei, Frost Lars, Graffigna Guendalina, Lucci Donata, Marin Francisco, Potpara Tatjana S, Sanaullah Alam, Tokmakova Mariya, Johnsen Søren Paaske, Maggioni Aldo Pietro, AFFIRMO Study Investigators and Consortium
Аннотация
INTRODUCTION: 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.
METHODS: 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).
RESULTS: 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.
CONCLUSIONS: 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.
REGISTRATION: ClinicalTrials.gov identifier: NCT06775028.
METHODS: 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).
RESULTS: 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.
CONCLUSIONS: 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.
REGISTRATION: ClinicalTrials.gov identifier: NCT06775028.