The Management of Anticoagulants in Patients With Atrial Fibrillation and History of Falls or Risk of Falls: The Liverpool Af-falls Project. Protocol for a Systematic Review and Meta-analysis

Abstract

BackgroundAtrial fibrillation affects an estimated 33 million individuals worldwide and is a major cause of stroke, heart failure, and death. Anticoagulants substantially reduces risk of stroke but are also associated with an increased risk of bleeding and especially intracranial hemorrhages which are the most feared complication. Because of this many patients are not offered anticoagulants, particularly patients at risk of falls or with history of falls. It is unclear what anticoagulant treatment these patients should be offered, and the Liverpool AF-Falls project aims to investigate this area. This protocol for a systematic review and meta-analysis aims to define what is the most appropriate anticoagulant treatment option for the for the management of atrial fibrillation patients at risk of falls or with a history of falls. MethodsThis systematic review and meta-analysis will include randomized and non-randomized studies evaluating safety and efficacy of different anticoagulant treatments (vitamin K antagonist, non-vitamin K antagonist oral anti-coagulant, anti-platelet agent and no treatment). Bibliographic databases (Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Scopus, CINAHL, Web of Science and ClinicalTrials.gov) will be searched according to a pre-specified search strategy. Titles, abstracts, and full texts will be assessed by two independent reviewers and disagreement resolved with a third independent reviewer. The Cochrane Risk of Bias tool 2 will be used to assess risk of bias in randomized trials and the Newcastle-Ottawa-Scale tool will be used for non-randomized studies. Pairwise meta-analysis based on the fixed and random-effects models will be conducted. Publication bias will be evaluated with a funnel plot and the Egger’s test. Heterogeneity will be assessed with the I2 statistic. If conditions for indirect comparison are met and sufficient data are available, a network meta-analysis will be conducted using frequentist and Bayesian methodologies. DiscussionThis review will be the first to summarize direct and indirect evidence on safety and efficacy of anticoagulant treatments in atrial fibrillation patients at risk of falls or with history of falls. The findings will be important to patients, clinicians, and health policy-makers to inform best practice in the use of these treatments. Systematic review registrationPROSPERO registry number: CRD42020201086