FRAIL-AF: Switching to NOACs From VKA Associated With Higher Bleeding Risk in Frail, Elderly Patients With AFib

In frail, elderly patients with atrial fibrillation (AFib), switching from vitamin K antagonist (VKA) treatment to a non-VKA oral anticoagulant (NOAC) was associated with a higher rate of bleeding complications compared with continuing VKA treatment, based on findings from the FRAIL-AF trial presented at ESC Congress 2023.

Researchers randomized a total of 1,330 frail, elderly patients in the Netherlands (mean age of 83 years; 38.8% women) who were being managed with VKAs to either continue with a VKA or switch to a NOAC. The choice of NOAC was left to the treating physician. Patients with severe renal impairment or with valvular AFib were excluded.

In terms of primary outcome, 101 major or clinically relevant non-major bleeding events occurred in the NOAC group compared with 62 events in VKA continued treatment group (Hazard Ratio: 1.69). The trial was stopped for futility on advice from the Data Safety and Monitoring Board following a prespecified futility analysis. Researchers noted 16 thromboembolic events occurred in the NOAC group vs. 13 in the VKA group.

"Switching VKA treatment to a NOAC in frail elderly patients with AFib was associated with more bleeding complications compared to continuing a VKA," said Linda Joosten, MD, of the Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht in the Netherlands. "This higher bleeding risk with NOACs was not offset by a lower risk of thromboembolic events."

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias, Heart Failure and Cardiomyopathies, Geriatric Cardiology

Keywords: ESC Congress, ESC23, ACC International, Atrial Fibrillation, Anticoagulants, Anticoagulation Management


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