The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Percutaneous left atrial appendage closure compared to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation and high bleeding risk (HAS-BLED ≥3).

DOI: 10.4244/EIJ-D-19-00507

1. Cardiology Unit, San Raffaele Hospital, Milan, Italy
2. Ospedale San Raffaele, cardiology, Milan, Italy
3. Interventional Cardiovascular Unit, San Raffaele Hospital, Milan
4. Arrhythmia and Electrophysiology Unit, San Raffaele Hospital, Milan

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Aims: A relevant amount of patients with non-valvular atrial fibrillation (NVAF) are ineligible for non-vitamin K oral anticoagulants (NOACs) due to previous major bleeding or because at high bleeding risk (HBR). In this setting the indication for percutaneous left atrial appendage closure (LAAO) is a valuable alternative.We evaluated 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). After 1:1 PSM, 192 patients were enrolled in the final analysis (LAAO n=96; NOACs n=96). At 2-year follow-up, no significant difference in thromboembolic (7.3% vs. 6.3%, p=0.966) and ISTH-major bleeding events rate (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 groups. Significant independent predictors of all-cause death were dialysis (HR 5.65, 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 2-year follow-up. Our findings warrant further investigations in randomized trials and therefore can be considered as hypothesis generating.

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