Authors
Ahmed Nazmy, Alaa Abdrabou Abouelmagd, Ahmed Sobhy, Mennatullah Ashour, Hassan El-Shirbiny, Moneeb Khalaph, Ahmed Yasser Shaban, Mahmoud Nazmy, Amroos Shabaan, Abdullah Farahat Elbanna, Abdelrahman Hafez, C Michael Gibson
Published in
Pacing and clinical electrophysiology : PACE. Oct 09, 2026. Epub Oct 09, 2026.
Abstract
Left atrial appendage occlusion (LAAO) has emerged as a non-pharmacological alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). Following the publication of recent CHAMPION-AF and CLOSURE-AF trials, an updated synthesis of evidence is warranted to clarify the long-term comparative efficacy and safety of LAAO versus OAC in patients with AF.
We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing LAAO with OAC in adults with AF. A comprehensive search of major databases was performed from inception to April 2026. The primary efficacy outcomes were major adverse cardiovascular events (MACE) and stroke. The primary safety outcome was non-procedure-related bleeding. Random-effects models were used to calculate pooled risk ratios (RRs) with 95% confidence intervals (CIs).
Six RCTs including 7,004 patients (3,681 LAAO; 3,323 OAC) were analyzed. No statistically significant difference was observed for MACE (7.5% vs 6.9%; RR 1.03, 95% CI 0.79-1.34) or stroke (3.7% vs 3.2%; RR 1.07, 95% CI 0.80-1.43). LAAO was associated with a significantly lower risk of non-procedure-related bleeding (9.8% vs 16.7%; RR 0.63, 95% CI 0.52-0.77), corresponding to an absolute risk reduction of 6.9% and an approximate number needed to treat of 15 based on crude pooled event rates over the observed trial follow-up. Trial sequential analysis indicated that the accumulated evidence for MACE and stroke remained inconclusive. Comparator-type subgroup analyses showed no significant interaction for MACE (p = 0.67) or stroke (p = 0.81) between contemporary predominantly-DOAC and VKA comparator trials.
LAAO was associated with lower non-procedure-related bleeding, while no statistically significant differences were observed for MACE or stroke. The available efficacy evidence remains inconclusive regarding equivalence or non-inferiority, and larger trials are needed. These findings support individualized consideration of LAAO when the long-term bleeding burden of anticoagulation is clinically important.
PMID:
42855979
Bibliographic data and abstract were imported from PubMed on 10 Oct 2026.
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