Left atrial appendage occlusion vs standard of care in high stroke risk atrial fibrillation patients ineligible for anticoagulation - COMPARE-LAAO

Sep 30, 2026

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Guidelines recommend considering left atrial appendage occlusion (LAAO) for atrial fibrillation (AF) patients with contraindications to oral anticoagulation, yet randomized trial evidence in this subgroup is lacking. COMPARE-LAAO was a multicenter, prospective, randomized open trial comparing LAAO versus standard of care in patients with increased thromboembolic risk and OAC contraindication. The study terminated early after slow enrollment, providing insufficient statistical power. Limited stroke/TIA/SE event counts prevented definitive conclusions.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages9

Reading Time23 min

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Abstract

Introduction

Methods

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Original Article Neth Heart J (2026) 34:18–26 [https://doi.org/10.1007/s12471-025-02005-7](https://doi.org/10.1007/s12471-025-02005-7) Left atrial appendage occlusion vs standard of care in high stroke risk atrial ﬁbrillation patients ineligible for anticoagulation: COMPARE-LAAO Errol W. Aarnink · Marina F. M. Huijboom · Frank van der Kley · Richard Folkeringa · Joris R. de Groot · Pepijn H. van der Voort · Yuri Blaauw · Marisevi Chaldoupi · Jeroen Stevenhagen · George J. Vlachojannis · Nicolas M. van Mieghem · Martin J. Swaans · Vincent F. van Dijk · Marcel G. Dijkgraaf · Ewoud J. van Dijk · Jan G. P. Tijssen · Lucas V. A. Boersma Received: 17 March 2025 / Accepted: 5 November 2025 / Published online: 16 December 2025 © The Author(s) 2025 Abstract Introduction The left atrial appendage is the dominant source of cardioembolic stroke in patients with atrial ﬁbrillation (AF) . Contemporary guidelines recommend considering left atrial appendage occlusion (LAAO) in AF patients contraindicated to oral anticoagulation therapy (OAC), but randomized controlled trial (RCT) data for this subpopulation are lacking. Methods COMPARE LAAO was designed as an eventdriven, multicenter, prospective, randomized, open, Supplementary Information The online version of this article ([https://doi.org/10.1007/s12471-025-02005-7](https://doi.org/10.1007/s12471-025-02005-7)) contains supplementary material, which is available to authorized users. E. W. Aarnink (􀀂) · M. F. M. Huijboom · M. J. Swaans · V. F. van Dijk · L. V. A. Boersma (􀀂) Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands [errolaarnink@msn.com](errolaarnink@msn.com) [L. V. A. Boersma](L. V. A. Boersma) (􀀂) [l.boersma@antoniusziekenhuis.nl](l.boersma@antoniusziekenhuis.nl) [F. van der Kley](F. van der Kley) Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands R. Folkeringa Department of Cardiology, Medical Center Leeuwarden, Leeuwarden, The Netherlands J. R. de Groot · L. V. A. Boersma Department of Cardiology, Amsterdam University Medical Center, location AMC, Amsterdam, The Netherlands P. H. van der Voort Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands Y. Blaauw Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands blinded endpoint (PROBE) trial that randomized AF patients with an increased thromboembolic risk anda contraindication to OAC 2:1 to LAAO or standard-ofcare (SOC) . The co-primary endpoints comprised 1) time to ﬁrst occurrence of ischemic/hemorrhagic/ undetermined stroke and 2) time to ﬁrst occurrence of all-cause stroke/TIA/SE. The trial aimed to enroll 609 patients. M. Chaldoupi Department of Cardiology, Maastricht University Medical Center, Maastricht, The Netherlands J. Stevenhagen Department of Cardiology, Medical Spectrum Twente, Enschede, The Netherlands G. J. Vlachojannis Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands N. M. van Mieghem Department of Cardiology, Erasmus University Medical Center, Rotterdam, The Netherlands M. G. Dijkgraaf Department of Epidemiology and Data Science, Location AMC, Amsterdam University Medical Center, Amsterdam, The Netherlands E. J. van Dijk Department of Neurology, Radboud University Medical Center, Nijmegen, The Netherlands Department of Neurology, University Medical Center Utrecht, Utrecht, The Netherlands J. G. P. Tijssen Department of Cardiology, Clinical Epidemiology & Biostatistics, Amsterdam University Medical Center, Amsterdam, The Netherlands 18 COMPARE-LAAO: LAA occlusion vs standard care in high-risk AF Original Article Results After randomization of 69 patients, the trial was terminated prematurely by the sponsor due toa slow inclusion rate. Results are discussed brieﬂy without formal statistical testing. All-cause stroke occurred in 7/48 and 2/21 patients randomized to LAAO and SOC, re

FAQs

Why was left atrial appendage occlusion considered for these AF patients?

LAAO is considered for AF patients who cannot take oral anticoagulation. The rationale is linked to observational evidence of thrombus formation in the left atrial appendage after thromboembolic events.

How was COMPARE-LAAO designed and what did it compare?

COMPARE-LAAO was a multicenter, prospective, randomized, open trial. It randomized AF patients with increased thromboembolic risk and OAC contraindication 2:1 to LAAO or standard of care, with co-primary time-to-event endpoints.

Why were conclusions limited in COMPARE-LAAO?

The trial was terminated prematurely due to a slow inclusion rate, resulting in insufficient statistical power. Additionally, loss of perceived clinical equipoise between LAAO and standard of care hindered successful trial completion.

Sep 30, 2026

Uploaded by Asher