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Minerva Medica 2021 Jun 28

DOI: 10.23736/S0026-4806.21.07432-2


language: English

Safety and efficacy of Direct Oral Anticoagulants (DOACs) in very elderly patients (≥ 85 years old) with non-valvular atrial fibrillation. The Experience of an Italian tertiary care center

Claudia RUBINO 1, Fabiana BLUNDA 1, Francesca BODEGA 1, Francesco MELILLO 1, Anita RUSSI 1, Paolo MATTIELLO 2, Anna SALERNO 1, Michela CERA 1, Davide MARGONATO 3, Patrizio MAZZONE 4, Paolo DELLA BELLA 4, Alessandro CASTIGLIONI 5, 6, Ottavio ALFIERI 5, 6, Michele DE BONIS 5, 6, Matteo MONTORFANO 7, Massimo FILIPPI 6, 8, Moreno TRESOLDI 6, 9, Alberto CAPPELLETTI 1, Alberto ZANGRILLO 6, 10, Alberto MARGONATO 1, 6, Cosmo GODINO 1, 6 , on behalf of the INSigHT (Italian DOACs San Raffaele Hospital) registry investigators

1 Cardiology Unit, IRCCS San Raffaele Hospital, Milan, Italy; 2 Information Systems Unit, IRCCS San Raffaele Hospital, Milan, Italy; 3 Department of Cardiology, Policlinico di Monza, Monza, Italy; 4 Arrhythmia and Electrophysiology Unit, IRCCS San Raffaele Hospital, Milan, Italy; 5 Cardiac Surgery Unit, IRCCS San Raffaele Hospital, Milan, Italy; 6 Vita-Salute San Raffaele University, Milan, Italy; 7 Interventional Cardiovascular Unit, IRCCS San Raffaele Hospital, Milan, Italy; 8 Neurology Unit, IRCCS San Raffaele Hospital, Milan, Italy; 9 General Medicine and Advanced Care Unit, IRCCS San Raffaele Hospital, Milan, Italy; 10 Department of Anaesthesia and Intensive Care, IRCCS San Raffaele Hospital, Milan, Italy


BACKGROUND: Limited real-world data are available regarding the comparison about safety and efficacy of DOACs prescription in very elderly patients (≥85 years) with non-valvular atrial fibrillation (NVAF). Concern about the risk of bleeding with anticoagulation in very older patients still represents an important challenge for clinicians.
OBJECTIVE: To evaluate the different prevalence of major bleeding and thromboembolic events between very elderly NVAF patients (≥85 years) compared to those non very elderly (<85 years).
METHODS: Single center multidisciplinary registry including NVAF patients treated with DOACs. Primary safety endpoint was 2-year rate of major bleeding. Primary efficacy endpoint was 2-year rate of thromboembolic events. Event-free survival curves among groups were compared using Cox-Mantel test.
RESULTS: 908 NVAF consecutive patients were included, of these, 805 patients were <85 years (89%) and 103 patients were very elderly patients with ≥85 years (11%). Compared to patients <85 years, those very elderly have higher CHA2DS2-VASc score (p=0.001), higher rate of hypertension (p=0.001), diabetes mellitus (p=0.030), previous bleeding events (p<0.001), previous stroke/TIA/SE (p=<0.001), heart failure (p=<0.001), and lower creatinine clearance (p<0.001). In terms of safety endpoints (overall ISTH-major bleeding) no significative difference between two groups (p=0.952) were observed up to 2-year follow-up. Systemic thromboembolic event (primary efficacy endpoint) was significantly higher in patients with ≥85 years (p=0.027). The incidence of all-cause death was significantly higher in very elderly patients (p<0.001).
CONCLUSIONS: This single center registry, showed that the use of DOACs in very elderly NVAF was safe and is a therapeutic option to be pursued for stroke prevention especially for those who are at high risk of ischemic events.

KEY WORDS: Non-valvular atrial fibrillation; Direct oral anticoagulant; Elderly patients

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