Adishwar Rao, Venkatesh Ravi, Mukunthan Murthi, Rahul Chikatimalla, Vennela Talla, Nihal Nagaraj, Gaurav Dhar, Neeraj Jolly, Aviral Vij
In patients with atrial fibrillation, LAAC is associated with a higher risk of ischemic stroke, but lower risk of nonprocedural major bleeding compared with OAC, with no significant differences in composite thromboembolic outcomes or mortality, underscoring the importance of individualized risk-benefit assessment in stroke prevention strategies.
BACKGROUND: Left atrial appendage closure (LAAC) is an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation, but randomized controlled trials have primarily focused on composite end points, potentially obscuring differences in individual clinical outcomes. We compared the efficacy and safety of LAAC versus OAC with an emphasis on individual clinical outcomes.
METHODS: A systematic review and meta-analysis of randomized controlled trials comparing LAAC with OAC in adults with atrial fibrillation was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Databases were searched from January 2000 to March 2026. The primary efficacy end point was any stroke, and the primary safety end point was major bleeding. Risk ratios (RRs) with 95% CIs were pooled using a random-effects model.
RESULTS: Six randomized controlled trials comprising 7004 patients (3681 LAAC; 3323 OAC) were included. LAAC was associated with a higher risk of ischemic stroke (RR, 1.41 [95% CI, 1.04-1.91]; P=0.03; 3.2% versus 2.1%), without a significant difference in any stroke (RR, 1.08 [95% CI, 0.82-1.42]; P=0.60) or the composite of stroke, systemic embolism, or death (RR, 0.99 [95% CI, 0.77-1.29]; P=0.96). Cardiovascular mortality (RR, 0.88; P=0.40) and all-cause mortality (RR, 0.92; P=0.36) were similar between groups. Major bleeding, including procedural events, did not differ significantly (RR, 0.93; P=0.40), although LAAC was associated with a significantly lower risk of nonprocedural major bleeding (RR, 0.57 [95% CI, 0.43-0.77]; P<0.01; 6.2% versus 10.7%).
CONCLUSIONS: In patients with atrial fibrillation, LAAC is associated with a higher risk of ischemic stroke, but lower risk of nonprocedural major bleeding compared with OAC, with no significant differences in composite thromboembolic outcomes or mortality, underscoring the importance of individualized risk-benefit assessment in stroke prevention strategies.