Left Atrial Appendage Closure Versus Oral Anticoagulation in Atrial Fibrillation: An Updated Meta-Analysis of RCTs Using Reconstructed Individual Patient Data.

Abstract

Left atrial appendage closure (LAAC) is a reasonable alternative to oral anticoagulation (OAC) in selected patients with atrial fibrillation (AF). We conducted an updated meta-analysis of RCTs comparing LAAC vs. OAC in patients with AF. The primary efficacy endpoint was a composite of all stroke, systemic embolism, or cardiovascular/all-cause death. The primary safety endpoint was major bleeding. Secondary endpoints included net adverse clinical events, all-cause death, non-procedure related bleeding, and ischemic stroke. Reconstructed IPD meta-analysis using a two-stage approach and study-level meta-analysis using random-effects models were performed. Six trials enrolling 7,004 patients randomized to LAAC (n=3,681) or OAC (n=3,323) were included. There were no significant differences between LAAC vs. OAC for the primary efficacy endpoint (∆RMST -0.006 years; 95% CI -0.027 to 0.015 years, p=0.56) or primary safety endpoint (∆RMST 0.004 years; 95% CI -0.025 to 0.034 years; p=0.77) at 3 years. Non-procedure related bleeding was significantly lower with LAAC vs. OAC (∆RMST 0.162 years; 95% CI 0.104 to 0.220 years, p<0.001) with no difference in all-cause death (∆RMST 0.029 years, 95% CI -0.031 to 0.089 years, p=0.34). In a study-level meta-analysis, ischemic stroke was not significantly different with LAAC vs. OAC (RR 1.32; 95% CI 0.94 to 1.86; p=0.09). In conclusion, the trade-off between a statistically significant lower risk of non-procedure related bleeding and a numerically, but not statistically, higher risk of ischemic stroke with LAAC vs. OAC necessitates individualized risk assessment and shared decision making for patients with AF at elevated risk of stroke.