Abstract 13529: Efficacy and Safety of Direct Oral Anticoagulants and the Watchman™ Atrial Appendage Closure Device in Non-Valvular Atrial Fibrillation: A Network Meta-Analysis of Randomized Controlled Trials

Abstract

Introduction: The efficacy and safety of the Watchman TM (WM) left atrial appendage closure device in atrial fibrillation (AF) was determined in randomized controlled trials (RCTs) with warfarin treatment of the control group. Direct oral anticoagulants (DOAC) have largely superseded warfarin in contemporary clinical practice for stroke and thromboembolism prevention in AF. Network meta-analysis (NMA) allows integration of direct and indirect evidence in evaluating relative effects of three or more interventions. Because there are no direct comparisons of WM with DOACs, we performed a NMA to compare the efficacy and safety of WM to DOACs in patients with AF. Methods: We searched PubMed, EMBASE, and Google Scholar from January 1990 until March 2021 for prospective RCTs that evaluated the efficacy and safety of warfarin, WM, and DOACs in pairwise comparisons of patients with AF. The co-primary outcomes of interest were i) thromboembolic events including stroke, and ii) major bleeding events. Comparative outcomes were assessed by odds ratios (OR) with 95% confidence intervals (CI). Stata version 17.0 software was used for the analysis. Results: A total of 60,652 patients with AF enrolled in 10 RCTs were included. There was no difference in stroke or thromboembolism prevention between WM and DOAC [OR =1.04 (95% CI: 0.61-1.75; 9 trials) (Figure panel A). Similarly, there was no significant difference in major bleeding risk between WM vs DOAC [OR = 1.87 (95% CI: 1.0 – 3.52] (Figure panel B). No significant heterogeneity or publication bias was found. Conclusions: Based on this NMA, WM appears to provide no benefit in prevention of thromboembolism/stroke compared to DOAC in patients with AF. However, a reduction in the risk of major bleeding with WM cannot be ruled out. Future RCTs are necessary to better quantify the risk and benefit of WM compared to DOAC for patients with AF.