Comparison of left atrial appendage closure and oral anti-coagulation after catheter ablation for atrial fibrillation: Concomitant and sequential cohorts of the OPTION randomized controlled trial

Abstract

Background

Left atrial appendage closure (LAAC) can be performed in separate procedures with cardiac ablation (sequentially) or concomitantly in the same operative session.

Objective

The OPTION trial aims to compare the efficacy and safety of LAAC with oral anticoagulation (OAC) in patients who have undergone catheter ablation for atrial fibrillation (AF). The objective of this sub-analysis is to evaluate LAAC vs OAC within concomitant and sequential ablation timings.

Methods

OPTION is a multicenter, prospective randomized clinical trial. Patients with AF and an elevated CHA₂DS₂-VASc score undergoing catheter ablation were randomly assigned (1:1) to catheter-based LAAC (Device) vs OAC (Control). Randomization was stratified by AF catheter ablation procedure timing: Sequential (90–180 days prior to randomization) or Concomitant (within 10 days of randomization, 99% of procedures happened the same day). The primary safety end point was non-procedural major or clinically-relevant non-major bleeding. The primary efficacy end point was the composite of all-cause death, stroke, or systemic embolism at 36 months.

Results

In both the Concomitant (n = 654) and Sequential (n = 946) groups, the Device arm compared with Control had fewer primary safety end point events and similar rates of primary efficacy events and secondary safety events. Rates of acute safety events were low and similar between the Device and Control arms within the Concomitant group; the addition of LAAC to cardiac ablation sessions did not result in increased procedural events.

Conclusions

For both Concomitant and Sequential ablation timing strategies, LAAC has similar efficacy compared with OAC and a lower risk of clinically important post-procedure bleeding in high-risk patients following AF ablation.