Left Atrial Appendage Occlusion versus Oral Anticoagulation in Atrial Fibrillation: A Meta-Analysis of Randomized Trials

Emergence of direct oral anticoagulants as the first-line therapy for stroke prevention in nonvalvular atrial fibrillation has redefined the comparator benchmark for left atrial appendage occlusion (LAAO).

The objective of the study was to compare the efficacy and temporal safety of LAAO vs oral anticoagulation (OAC).

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).

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).

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. These findings quantify the benefit-harm tradeoff central to LAAO decisions.