Leonardo M Knijnik, Birju Rao, David B DeLurgio
LAAO offers similar overall efficacy and safety to modern antithrombotics. It represents a clinical trade-off: accepting a known upfront procedural risk for a robust, long-term reduction in non-procedural bleeding, potentially at the cost of a slight numerical increase in ischemic stroke.
BACKGROUND: Landmark randomized controlled trials (RCTs) comparing left atrial appendage occlusion (LAAO) against direct oral anticoagulants (DOACs) are individually underpowered for small but clinically meaningful differences. We performed a pooled meta-analysis to provide more precise efficacy and safety data.
METHODS: Utilizing random-effects models, we pooled data from 5890 patients across four landmark RCTs (PRAGUE-17, CLOSURE-AF, OPTION, and CHAMPION-AF) at their longest follow-up.
RESULTS: There were no significant differences between LAAO and antithrombotics in cardiovascular mortality (5.3% vs. 4.8%, p = 0.33), all-cause stroke (3.3% vs. 2.8%, p = 0.31), systemic embolism (0.2% vs. 0.1%, p = 0.68), or major bleeding (6.6% vs. 6.8%, p = 0.85). Non-procedural bleeding was significantly lower with LAAO (9.2% vs. 16.7%; RR 0.55; 95% CI 0.47-0.64; p < 0.0001), though there was a numerical trend toward more ischemic stroke events (2.7% vs. 2.0%; RR 1.35; 95% CI 0.97-1.88; p = 0.08).
CONCLUSION: LAAO offers similar overall efficacy and safety to modern antithrombotics. It represents a clinical trade-off: accepting a known upfront procedural risk for a robust, long-term reduction in non-procedural bleeding, potentially at the cost of a slight numerical increase in ischemic stroke.