Key result
Left atrial appendage closure had similar rates of thromboembolic events (7.3% vs 6.3%, p=0.966) and major bleeding compared to NOACs in patients with atrial fibrillation and high bleeding risk.
Why the study?
Many patients with NVAF cannot take NOACs due to prior major bleeding or high bleeding risk, making LAAO a potential alternative whose comparative efficacy and safety needed evaluation.
Does percutaneous left atrial appendage closure (LAAO) improve clinical outcomes compared to NOACs in patients with non-valvular atrial fibrillation and high bleeding risk?
Cohort (n=382)
Does percutaneous left atrial appendage closure (LAAO) improve clinical outcomes compared to NOACs in patients with non-valvular atrial fibrillation and high bleeding risk?
Absolute Event Rate: 7.3% vs 6.3%
p-value: p=0.966
LAAO and NOACs perform similarly regarding thromboembolic and major bleeding events up to two years in NVAF patients with high bleeding risk, suggesting LAAO is a viable alternative.
AIMS: A significant number of patients with non-valvular atrial fibrillation (NVAF) are ineligible for non-vitamin K oral anticoagulants (NOACs) due to previous major bleeding or because they are at high bleeding risk (HBR). In this setting the indication for percutaneous left atrial appendage closure (LAAO) is a valuable alternative. We aimed to evaluate the efficacy and safety of NOACs versus LAAO indication in NVAF patients at HBR (HAS-BLED ≥3). METHODS AND RESULTS: All consecutive patients who underwent successful LAAO (n=193) and those treated with NOACs (n=189) (dabigatran, apixaban or rivaroxaban) were included. A 1:1 propensity score matching (PSM) was used to match LAAO and NOACs patients. At baseline, patients in the LAAO group had higher HAS-BLED (4.2% vs 3.3%, p<0.001) and lower CHADS-VASc (4.3% vs 4.7%, p=0.005) scores. After 1:1 PSM, 192 patients were enrolled in the final analysis (LAAO n=96; NOACs n=96). At two-year follow-up, no significant differences in thromboembolic (7.3% vs 6.3%, p=0.966) and ISTH major bleeding event rates (6.7% vs 4.8% p=0.503) were found between the two unmatched groups. All-cause death was significantly higher in the LAAO group (18.7% vs 10.6%; p=0.049). After PSM, all-cause death, thromboembolic and ISTH major bleeding event rates were similar between the groups. Significant independent predictors of all-cause death were dialysis (HR 5.65, 95% CI: 2.16-14.85, p<0.001) and age (HR 1.08, 95% CI: 1.05-1.13, p<0.001). CONCLUSIONS: In NVAF patients at HBR, LAAO and NOACs performed similarly in terms of thromboembolic and major bleeding events up to two-year follow-up. Our findings warrant further investigation in randomised trials and therefore can be considered as hypothesis-generating.
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Godino et al. (2020) conducted a cohort in Non-valvular atrial fibrillation with high bleeding risk (n=382). Percutaneous left atrial appendage closure (LAAO) vs. Non-vitamin K oral anticoagulants (NOACs) was evaluated on Thromboembolic events (p=0.966). Left atrial appendage closure had similar rates of thromboembolic events (7.3% vs 6.3%, p=0.966) and major bleeding compared to NOACs in patients with atrial fibrillation and high bleeding risk.
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