Key result
Left atrial appendage occlusion reduced nonprocedural major bleeding vs oral anticoagulation, with similar all-cause stroke and mortality.
Why the study?
The study aimed to compare the efficacy and temporal safety of left atrial appendage occlusion versus oral anticoagulation in patients with nonvalvular atrial fibrillation.
Does left atrial appendage occlusion improve efficacy and temporal safety outcomes compared to oral anticoagulation in patients with nonvalvular atrial fibrillation?
Meta-Analysis (n=7,004)
Randomized trials pooled
Does left atrial appendage occlusion improve efficacy and temporal safety outcomes compared to oral anticoagulation in patients with nonvalvular atrial fibrillation?
Answers are grounded in this paper and cite their sources.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“"If they truly can't take a DOAC, then I think these devices are terrific, but if a patient can take a DOAC, I would think that's still the way to go... I think it shows LAAO does have a role, but not necessarily in the population where it was being studied in this trial."”
“"I think the result was indeed somewhat unexpected for us, because this is exactly the patient population where we are now doing left atrial appendage closure... I think patients at high risk are probably not optimal candidates for this procedure."”
In patients with nonvalvular atrial fibrillation, left atrial appendage occlusion significantly reduces nonprocedural major and clinically relevant nonmajor bleeding compared to oral anticoagulation, with similar all-cause stroke and mortality rates.
Objectives The objective of the study was to compare the efficacy and temporal safety of LAAO vs oral anticoagulation (OAC). Methods Randomized trials of LAAO vs OAC in nonvalvular atrial fibrillation were pooled for incidence rate ratios (IRRs) per patient-year; key endpoints were assessed with trial sequential analysis (TSA) and Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Results Across 6 trials (N = 7,004), LAAO vs OAC was associated with higher ischemic stroke (130 vs 76 events; IRR: 1.43; 95% CI: 1.07-1.91; *P* = 0.01; number needed to harm: 101; GRADE: low); however, this was sensitive to individual trial exclusion and TSA indicated insufficient information (41% of required size). All-cause stroke (152 vs 114; IRR: 1.11; 95% CI: 0.86-1.43; *P* = 0.43) and all-cause mortality (403 vs 368; IRR: 0.93; 95% CI: 0.78-1.10; *P* = 0.39) were comparable. Total major bleeding did not differ (IRR: 0.91; *P* = 0.29), but LAAO significantly reduced nonprocedural major bleeding (194 vs 232; IRR: 0.71; 95% CI: 0.55-0.91; *P* = 0.01; number needed to treat: 19; GRADE: high) and clinically relevant nonmajor bleeding (145 vs 303; IRR: 0.48; 95% CI: 0.39-0.58; *P* < 0.001; number needed to treat: 15). Conclusions LAAO significantly reduces nonprocedural major bleeding (TSA-confirmed) and clinically relevant nonmajor bleeding vs OAC. A trend toward higher ischemic stroke was not TSA-confirmed and was sensitive to trial exclusion; all-cause stroke and mortality were similar.
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Babu et al. (2026) conducted a meta-analysis in Nonvalvular atrial fibrillation (n=7,004). Left atrial appendage occlusion (LAAO) vs. Oral anticoagulation (OAC) was evaluated on Nonprocedural major bleeding (IRR 0.71, 95% CI 0.55-0.91, p=0.01). Left atrial appendage occlusion reduced nonprocedural major bleeding vs oral anticoagulation, with similar all-cause stroke and mortality.
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