Why the study?
Atrial fibrillation is increasingly prevalent in CKD patients, but the efficacy and safety of NOACs in this population remain unknown.
Do non-vitamin K antagonist oral anticoagulants improve net clinical benefit compared to warfarin in patients with atrial fibrillation and chronic kidney disease?
Do non-vitamin K antagonist oral anticoagulants improve net clinical benefit compared to warfarin in patients with atrial fibrillation and chronic kidney disease?
This protocol outlines a planned meta-analysis to evaluate the net clinical benefit of NOACs versus warfarin in patients with concurrent atrial fibrillation and chronic kidney disease.
BACKGROUND: Atrial fibrillation (AF) is increasingly prevalent in chronic kidney disease (CKD) patients. The efficacy and safety of non-vitamin K antagonist oral anticoagulants (NOACs) in AF and CKD patients remains unknown. This systematic review and meta-analysis will mainly assess net clinical benefit (NCB) property of NOACs versus warfarin in patients with AF and CKD by a pooled-analysis. METHODS: We will search Medline, Embase, Cochrane Library, and Clinical Trials.gov Website comprehensively for eligible randomized controlled trials that report the efficacy and safety outcomes according to renal function of NOACs. Relative risks and their 95% confidence intervals will be calculated using fixed- and random-effects models. Subgroup, sensitivity, and regression analyses will be performed to evaluate intertrial heterogeneity and bias of the results. NCB that balance stroke/systemic embolism (SSE) and major bleeding will be calculated using Singer's method. RESULTS: This systemic review and meta-analysis will evaluate the NCB of NOACs versus warfarin via SSE, major bleeding and all-cause death in patients with CKD. CONCLUSIONS: This study will provide new evidence for clinical profile of NOACs on SSE, major bleeding, all-cause death, and NCB in CKD patients. PROSPERO REGISTRATION NUMBER: CRD42019116940.
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Shen et al. (2019) studied this question.
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