Key result
LAAC linked to ~36% fewer major events versus medical management after severe GIB in AF.
Why the study?
Real-world data on the impact of percutaneous left atrial appendage closure in preventing events after severe gastrointestinal bleeding in anticoagulated patients with atrial fibrillation were scarce.
Does percutaneous left atrial appendage closure reduce the composite of stroke/TIA, systemic embolism, bleeding, or mortality in anticoagulated AF patients surviving a severe gastrointestinal bleeding compared to medical management?
Observational (n=1,041)
Yes
Does percutaneous left atrial appendage closure reduce the composite of stroke/TIA, systemic embolism, bleeding, or mortality in anticoagulated AF patients surviving a severe gastrointestinal bleeding compared to medical management?
Hazard Ratio: 0.64 (95% CI 0.42–0.99)
p-value: p=0.045
In AF patients surviving severe gastrointestinal bleeding, a LAAC strategy was associated with a significantly lower risk of a composite of thromboembolic events, bleeding, or mortality compared to medical management.
Hypothesis-generating for LAAC after severe GIB in AF; prospective RCTs needed before practice change.
Background There are paucity of "real world" data on the actual impact of percutaneous left atrial appendage closure (LAAC) in event prevention after a severe gastrointestinal bleeding (GIB) in anticoagulated patients with atrial fibrillation (AF). Purpose Our main objective was to investigate the impact of a LAAC strategy on events in follow-up in anticoagulated AF patients surviving a severe GIB versus those medically managed in Andalusia (South of Spain). Methods The PERSEO registry (Prevention of embolic events after a severe hemorrhage in anticoagulated patients with atrial fibrillation -in Spanish, Prevención de eventos Embólicos tras una hemoRragia SEvera en pacientes anticoagulados con fibrilaciOn auricular) was an observational, retrospective, multicentre study that included all consecutive patients discharged alive from January 1st, 2021 to December 31st, 2022, after an intracranial haemorrhage or severe GIB, who were previously anticoagulated for AF, in all public Andalusian hospitals with LAAC program, and who could be eligible either for LAAC or direct anticoagulant treatment. This analysis focuses in patients with GIB. The main end-point was a composite of stroke/transient ischemic attack, systemic embolism, major or clinically relevant non-major bleeding or all-cause mortality in follow-up. The secondary outcome was all-cause mortality. Associations of the treatment strategy (LAAC versus usual medical management) with events in follow up were investigated by univariate and multivariate analysis. Results Among a reference population of 7119044 inhabitants in 15 hospitals, 1403 patients were included in the study, and 1041 had a GIB and conform this study sample. Median age was 82 years [p25-75, 76-87 years] with 48.7% male patients. A LAAC procedure was performed in 70 patients (6.7%) at a median time of 5 [2-10] months after discharge. After the procedure, the 70 patients treated with the LAAC strategy had a numerically better survival free from the combined event (65% versus 48%, p=0.127) and overall survival (78% versus 61%, p=0.058) at 24 months (Figure, panels A and B, respectively). After multivariate adjusting in Cox proportional hazards models including all unbalanced variables between the two management strategies and all independent predictors of events, the benefit for the LAAC strategy was statistically significant for the combined event (HR 0.64 [0.42-0.99], p=0.045) and showed a non-significant trend for mortality (HR 0.64 [0.36-1.13], p=0.123). Conclusions In anticoagulated patients with AF who survived a severe GIB all public hospitals with LAAC program in a large European region in 2021-2022, and who were also eligible for anticoagulation with DOAC, only 6.7% of them were managed with a LAAC strategy. The LAAC strategy appeared to be associated with a better prognosis than medical management.Figure
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Esperon et al. (2025) conducted an observational in Atrial fibrillation with severe gastrointestinal bleeding (n=1,041). Percutaneous left atrial appendage closure (LAAC) vs. Usual medical management was evaluated on Composite of stroke/transient ischemic attack, systemic embolism, major or clinically relevant non-major bleeding or all-cause mortality (HR 0.64, 95% CI 0.42-0.99, p=0.045). Left atrial appendage closure was associated with a significantly lower risk of stroke, embolism, bleeding, or mortality compared to medical management (HR 0.64; 95% CI 0.42-0.99; p=0.045).
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