Switching vitamin K antagonist (VKA) treatment to a non-vitamin K antagonist oral anticoagulant (NOAC) in frail elderly patients with atrial fibrillation is associated with more bleeding complications compared to continuing VKA treatment.
Reviewed by Lily Ramsey, LLMAug 28 2023 That's the finding of late breaking research presented in a Hot Line session today at ESC Congress 2023.
The FRAIL-AF trial investigated whether switching VKA treatment to NOAC treatment was superior in terms of major and/or clinically relevant non-major bleeding complications in frail elderly patients with atrial fibrillation. Patients were at least 75 years of age, had a Groningen Frailty Indicator score of 3 or higher, and were currently managed with VKAs at one of the seven participating thrombosis centers in the Netherlands.
Between January 2018 and April 2022, a total of 1,330 patients were randomized. The mean age was 83 years and 38.8% were women. After 163 primary outcome events , the trial was stopped for futility on advice from the Data Safety and Monitoring Board following a prespecified futility analysis. The HR for the primary outcome of major or clinically relevant non-major bleeding was 1.69 for switching to a NOAC relative to continuing a VKA. The HR for thromboembolic events was 1.26 .
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