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Randomized Controlled Trial
. 2025 Oct;22(10):2585-2594.
doi: 10.1016/j.hrthm.2025.04.029. Epub 2025 Apr 25.

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

Walid Saliba  1 , Devi Nair  2 , Vijendra Swarup  3 , Terri Hall  4 , Vivek Iyer  5 , Germán Calle Pérez  6 , Stanislav Weiner  7 , Manish Shah  8 , Nilofar Islam  9 , Marek Grygier  10 , Brian Schuler  11 , José Luis Ibáñez Criado  12 , Guillaume Duthoit  13 , Y Madhu Reddy  14 , Vivek Y Reddy  15 , Moussa Mansour  16 , Andrea Natale  17 , Krystal Leger  18 , Thomas Christen  18 , Kenneth Stein  18 , Brad Sutton  18 , Oussama Wazni  19
Affiliations
Free article
Randomized Controlled Trial

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

Walid Saliba et al. Heart Rhythm. 2025 Oct.
Free article

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.

Keywords: Atrial fibrillation; Cardiac ablation; Concomitant procedures; Left atrial appendage closure; Oral anti-coagulation.

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Conflict of interest statement

Disclosures WS has served as an advisory board member for Boston Scientific and a consultant for Biosense Webster. DN has served as a consultant and advisor and received research grants from Boston Scientific, Medtronic, Abbott, Biosense Webster, and Siemens. VW has received consulting fees from Biosense Webster, Boston Scientific, and Abbott. SW has served as a consultant to Boston Scientific, Medtronic, and Abbott. MG has served as an advisory board member for Boston Scientific, a proctor for Boston Scientific and Abbott, and received fees for lectures and travel grants from Boston Scientific, Abbott, Occlutech, and Pfizer. B. Schuler has served as an advisor board member, speaker, and consultant for Boston Scientific. YMR has served as an advisory board member for Boston Scientific and Biosense Webster. VYR Receives grant support from and serves as an unpaid consultant to Boston Scientific; and unrelated to this manuscript, he serves as a consultant for and has equity in Ablacon-Cortex, Affera-Medtronic, Anumana, APN Medical, Append Medical, Aquaheart, Atacor, Autonomix, Axon Therapies, BioSig, CardiaCare, Cardiofocus, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EP Frontiers, Field Medical, Focused Therapeutics, Heartbeam, HRT, Intershunt, Javelin, Kardium, Laminar Medical, Medlumics, Nuvera-Biosense-JNJ MedTech, Orchestra Biomed, Pulse Biosciences, Restore Medical, Sirona Medical, Volta Medical; and unrelated to this work, he has served as a consultant for Abbott, Adagio Medical, AtriAN, Biosense-JNJ MedTech, Biotronik, Biosense-JNJ MedTech, Cairdac, Cardionomic, Conformal Medical, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Novo Nordisk, Philips; and unrelated to this work, he has equity in Atraverse, DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Soundcath, Surecor, and Vizaramed. MM has served as a consultant for Boston Scientific, Biosense Webster, Medtronic, and Abbot, and holds equity in NewPace Ltd. AN has served as a consultant and advisory board member for Boston Scientific. KL, TC, KS, and B. Sutton are employees and shareholders of Boston Scientific. The remaining authors report no conflicts of interest.

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