Key result
LAAO links to ~45-68% lower major bleeding and similar stroke rates versus DOACs in high-risk AF.
Why the study?
LAAO is an accepted alternative stroke prevention strategy for AF patients with contraindications to oral anticoagulation despite lacking randomised data, prompting comparison with DOACs in high bleeding risk patients.
Does left atrial appendage occlusion reduce the composite of stroke, cardiovascular death, or major bleeding in patients with atrial fibrillation and high bleeding risk compared to direct oral anticoagulation?
Does left atrial appendage occlusion reduce the composite of stroke, cardiovascular death, or major bleeding in patients with atrial fibrillation and high bleeding risk compared to direct oral anticoagulation?
In atrial fibrillation patients with high bleeding risk, left atrial appendage occlusion provides similar protection against stroke and cardiovascular death as DOACs, while significantly reducing the risk of major bleeding.
Associated with lower major bleeding and similar stroke/CV death in high-bleed-risk AF; leaves open composite endpoint benefit versus DOAC.
Study aims: Left atrial appendage occlusion (LAAO) is an accepted alternative stroke prevention strategy for patients with atrial fibrillation (AF) and contraindications to oral anticoagulation despite the lack of randomised data in this population. This study aims to compare the outcomes of LAAO and direct oral anticoagulation (DOAC) therapy in patients with high bleeding risk. Methods: This cardinality-matched analysis comprised data from the Beat-AF and Swiss-AF cohorts (n = 3960; enrolment from 2010 to 2014 and from 2014 to 2017, respectively), along with the Zurich LAAO Registry (n = 535; patients included between 2010 and 2023). The primary endpoint was a composite of stroke, cardiovascular death or major bleeding. The individual components constituted the secondary endpoints. Time-dependent cumulative incidence curves were constructed and a competing risk analysis was included. Results: After matching, 478 patients with a DOAC score ≥8 and 159 patients with previous major bleeding were compared in a 1:1 and 1:2 ratio, respectively, regarding their stroke prevention strategy (DOAC versus LAAO). After a median follow-up time of 4.9 years (interquartile range [IQR]: 2.2-6.1) in all patients with a DOAC score ≥8 and 4.4 years (IQR: 2.0-6.0) in all patients with previous major bleeding, there were no significant differences in the primary endpoint (hazard ratio [HR]: 0.88, 95% confidence interval [CI]: 0.67-1.14, p = 0.33 and HR: 0.79, 95% CI: 0.50-1.27, p = 0.33) and in the rates of stroke (HR: 0.74, 95% CI: 0.39-1.42, p = 0.36 and HR: 1.09, 95% CI: 0.33-3.62, p = 0.89) and cardiovascular death (HR: 0.97, 95% CI: 0.68-1.38, p = 0.85 and HR: 0.91, 95% CI: 0.50-1.64, p = 0.74). The rate of major bleedings was significantly lower in the LAAO group of both cohorts (HR: 0.55, 95% CI: 0.32-0.94, p = 0.029 and HR: 0.32, 95% CI: 0.13-0.79, p = 0.013). Conclusion: In this high bleeding risk population, LAAO was associated with similar effectiveness in preventing atrial fibrillation-related stroke and cardiovascular death and significantly lower rates of major bleeding compared to DOAC therapy. This strengthens the value of LAAO as an alternative stroke prevention strategy for patients at high risk of bleeding.
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Gilhofer et al. (2025) studied this question. Left atrial appendage occlusion reduced major bleeding by 45-68% with similar stroke and cardiovascular death rates versus direct oral anticoagulation in high bleeding risk AF patients.
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