87 FRAIL-AF RANDOMISED CONTROLLED TRIAL: RATIONALE AND DESIGN Strengths and limitations of this study · This is the first randomised controlled trial that will demonstrate whether it is safe to switch from vitamin K antagonist (VKA) to non-VKA oral anticoagulant in frail elderly patients with atrial fibrillation. · In addition to major or clinically relevant non-major (CRNM) bleeding events (primary outcome), thromboembolic events, quality of life and costeffectiveness will be examined. · An interim analysis in this superiority trial will be performed after having observed 160 major or CRNM bleeding events so that the study can be halted if necessary for futility or efficacy reasons. · Due to the open-label pragmatic design of this study, reporting bias might be an important factor that needs to be taken into account during the interim and final analysis. INTRODUCTION Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia with a prevalence rising to above 15% in the elderly.1,2 The most feared complication of AF is a thromboembolic event, notably ischaemic stroke.3 Anticoagulants are prescribed to reduce this risk, with vitamin K antagonists (VKA) long being the cornerstone of stroke prevention. Although highly effective, VKAs are well known for their multiple food and drug interactions as well as changes in anticoagulation levels due to intercurrent diseases, both leading to the need for frequent international normalised ratio (INR) monitoring and subsequent dose adjustments. Despite intensive INR monitoring, we know from clinical practice that thromboembolic and bleeding complications still occur in patients with AF treated with VKA. This is notably problematic in frail elderly, that is, those that due to a combination of components such as multimorbidity, social isolation, mood disorders, insufficient food and variable vitamin K intake, and/ or cognitive decline are more susceptible for the side effects of anticoagulants, in particular VKAs.4 Treatment with a non-VKA oral anticoagulant (NOAC) is considered a convenient alternative for VKAs, also for the elderly. Monitoring of anticoagulation status is no longer needed and the standard daily dosage, where possible combined with the use of a medicine sachet system, makes it easier to use, which may result in increased treatment persistence and compliance.5,6 Importantly, large randomised trials and postmarketing surveillance studies in non-frail patients demonstrated that NOACs, compared with VKAs, were at least non-inferior in preventing ischaemic stroke with an overall better safety profile, notably a markedly decreased risk of intracranial 6
RkJQdWJsaXNoZXIy MTk4NDMw