107 FRAIL-AF RANDOMISED CONTROLLED TRIAL: RESULTS What is new? · In this pragmatic randomised trial in older patients with atrial fibrillation (AF), living with frailty, more major and clinically relevant non-major bleeding complications were observed when switching from vitamin K antagonist (VKA) treatment to a non-VKA oral anticoagulant (NOAC), compared to continuing VKA treatment. · This higher bleeding risk with NOACs was not offset by a reduction in thromboembolic events, albeit the risk of thromboembolic events was low in both treatment arms. What are the clinical implications? · Without a clear indication, switching from VKA treatment to a NOAC should not be considered in older patients with AF living with frailty. INTRODUCTION Atrial fibrillation (AF) is associated with an increase in many adverse outcomes, including stroke, heart failure, renal failure, cognitive decline, and all-cause mortality.1 The risk of developing AF is strongly related to age and comorbidity. Stroke prevention is the cornerstone of AF management. Here, patients are prescribed anticoagulants, either a vitamin K antagonist (VKA) or a non–VKA oral anticoagulant (NOAC). In newly diagnosed non-frail patients with AF, NOACs are preferred over VKAs, because, in landmark trials, NOAC treatment was associated with a lower risk of (major) bleeding at similar efficacy regarding stroke prevention, compared with VKAs.2 However, there is a large population of older patients with AF who are (still) taking a VKA; ±30% to 40% of all patients with AF.3,4 Many of these patients have the frailty syndrome, a clinical entity of accumulating comorbidities and polypharmacy, defined by a high biological vulnerability, dependency on others, and a reduced capacity to resist stressors.5–7 These patients with AF living with frailty, currently receiving VKA treatment, are managed mainly in an outpatient setting, close to the communities where they live, by family medicine specialists, cardiologists, and/or internists. The high proportion of older patients with AF that is prescribed a VKA instead of a NOAC is, at least in part, attributable to the lack of convincing trial evidence on the superiority of NOACs in older individuals with AF living with frailty. Previous studies on the effect of frailty on bleeding outcomes in AF were mainly observational, because frail patients were underrepresented in the landmark trials.8–10 However, observational studies on the efficacy and side effects of drugs are sensitive to confounding bias. In 7
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