Lower Rate of Major Bleeding in Very High-Risk Patients Undergoing Left Atrial Appendage Occlusion: A Propensity-Matched Comparison with Direct Oral Anticoagulation.

BACKGROUND:Long-term oral anticoagulation is the mainstay therapy for thromboembolic (TE) prevention in patients with atrial fibrillation (AF). However, left atrial appendage occlusion (LAAO) could be a safe alternative to direct oral anticoagulants (DOACs) in patients with a very high thromboembolic risk profile. OBJECTIVE:to compare the safety and efficacy of LAAO versus DOACs among AF patients at very high stroke risk (CHA2DS2-VASc score ≥ 5). METHODS:Data from patients with a CHA2DS2-VASc score ≥ 5 were extracted from a prospective multicenter database. To attenuate the imbalance in covariates between groups, propensity score matching was used (co-variates: CHA2DS2-VASc and HAS-BLED scores), which resulted in a matched population of 277 patients per group. The primary endpoint was a composite of cardiovascular death, TE events, and clinically-relevant bleeding during follow-up. RESULTS:Among 2381 patients, 554 very high-risk patients were included in the study (79 ± 7 years; CHA2DS2-VASc: 5.8 ± 0.9; HAS-BLED: 3.0 ± 0.9). The mean follow-up duration was 25±11 months. A higher incidence of the composite endpoint was documented with DOACs compared to LAAO [14.9/100 patient-years (py) in DOAC vs 9.4/100py in LAAO group; p=0.03). The annualized clinically-relevant bleeding risk was higher with DOACs (6.3% vs 3.2%; p = 0.04), while the risk of TE events was not different between groups (4.1 % vs 3.2%; p = 0.63). CONCLUSIONS:Among high-risk patients, LAAO had similar stroke prevention efficacy but a significantly lower risk of clinically-relevant bleeding when compared with DOACs. LAAO clinical benefit became significant after 18 months of follow-up.