Percutaneous left atrial appendage closure versus non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation and high bleeding risk

Abstract

Aims: A significant number of patients with non-valvular atrial fibrillation (NVAF) are ineligible for nonvitamin 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, 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.

Efficacy and safety of left atrial appendage occlusion in atrial fibrillation patients with chronic kidney disease: a systematic review and meta-analysis

“…Long-term follow-up of the PREVAIL and PROTECT AF trials showed that the LAAO group had significantly lower cardiovascular deaths (HR: 0.59, P < 0.01), disabling/fatal stroke (HR: 0.45, P = 0.05), hemorrhagic stroke (HR: 0.20, P < 0.01) and major bleeding (HR: 0.48, P < 0.01) relative to those on warfarin (Reddy et al, 2017). The PRAGUE-17 study revealed that LAAO was noninferior to NOAC in preventing ischemic/bleeding (HR: 0.84, P = 0.004) (Godino et al, 2020). Our data suggest that in CKD patients, the incidence of stroke/TIA (2.17%) or bleeding (4.53%) is low during follow-up period, indicating that LAAO is sufficiently safe and effective.…”

Cerebral Protection Devices during Transcatheter Interventions: Indications, Benefits, and Limitations

“…Procedure-related strokes occurred in 1.1% of the cases in the PROTECT AF trial and in 0.4% in the PREVAIL trial [15,16]. Godino et al report a periprocedural stroke in 6 (3.1%) of 193 left atrial appendage occlusion (LAAO) patients [17]. In the large National Cardiovascular Data Registry (NCDR) a peri-procedural ischemic stroke was apparent after 45 (0.12%) of the 38,151 LAAO procedures [18].…”

Effect of Left Atrial Appendage Closure in Combination With Catheter Ablation on Left Atrial Function for Persistent Atrial Fibrillation

“…The left atrial (LA) appendage is the main site of thrombus formation in patients with non-valvular AF. Closure of the left atrial appendage has been proposed as alternative to oral anticoagulation for stroke prophylaxis; studies have demonstrated that LAAC is as effective as warfarin and nonvitamin K oral anticoagulants in preventing strokes (3,4). LAAC in combination with AF ablation in a single procedure, might be effective in both controlling sinus rhythm and preventing stroke, without the additional risk of multiple procedures (5,6).…”