Left atrial appendage closure in patients with failure of anticoagulation therapy: A multicenter comparative study on the hybrid strategy using DOACs and VKAs.

Patients with non-valvular atrial fibrillation (nvAF) who experienced a cardioembolic (CE) event despite adequate oral anticoagulation (OAC) are at high risk of recurrence and the combination between percutaneous left atrial appendage closure (LAAC) and long-term OAC may be a valuable option. The aim of this study was to compare the safety and the efficacy of post-LAAC long-term assumption of direct oral anticoagulants (DOACs) vs. vitamin K antagonists (VKAs) in this population. Consecutive nvAF patients who experienced OAC failure despite adequate OAC therapy and underwent LAAC were retrospectively enrolled from three Italian centers. Patients were divided according to the anticoagulation strategy following LAAC: DOAC group and VKA group. The primary endpoint was a composite of all-cause death, CE event, and major bleeding, while secondary endpoint was a composite of CE event and major bleeding. Overall, 132 patients (39 % females; mean age 69 ± 11 years), including 73 patients on DOAC and 59 patients on VKA, were enrolled. At a median follow up of 61 ± 23 months, the DOAC group reported lower rate of primary endpoint (HR 0.42, 95 %CI 0.18-0.99, p = 0.038) and lower rate of secondary endpoint (HR 0.28, 95 %CI 0.09-0.89, p = 0.02). No significant differences were detected regarding the type of DOAC assumed. Previous cerebrovascular events, CHA2DS2-VASc, CHADS2, HAS-BLED, and renal dysfunction were predictors of the primary endpoint. Long-term DOAC assumption was associated with higher free from primary and secondary endpoint with respect to VKA in nvAF patients undergoing LAAC for OAC failure.

Preda A ，Falasconi G ，Melillo F ，Margonato D ，Posteraro GA ，Vella C ，Marzi A ，Guarracini F ，Bella PD ，Agricola E ，Gaspardone A ，Montorfano M ，Mazzone P ... -  《-》

Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation.

Percutaneous left atrial appendage closure (LAAC) is noninferior to vitamin K antagonists (VKAs) for preventing atrial fibrillation (AF)-related stroke. However, direct oral anticoagulants (DOACs) have an improved safety profile over VKAs, and their effect on cardiovascular and neurological outcomes relative to LAAC is unknown. This study sought to compare DOACs with LAAC in high-risk patients with AF. Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation (PRAGUE-17) was a multicenter, randomized, noninferiority trial comparing LAAC with DOACs. Patients were eligible to be enrolled if they had nonvalvular AF; were indicated for oral anticoagulation (OAC); and had a history of bleeding requiring intervention or hospitalization, a history of a cardioembolic event while taking an OAC, and/or a CHA2DS2-VASc of ≥3 and HAS-BLED of >2. Patients were randomized to receive LAAC or DOAC. The primary composite outcome was stroke, transient ischemic attack, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications. The primary analysis was by modified intention to treat. A high-risk patient cohort (CHA2DS2-VASc: 4.7 ± 1.5) was randomized to receive LAAC (n = 201) or DOAC (n = 201). LAAC was successful in 181 of 201 (90.0%) patients. In the DOAC group, apixaban was most frequently used (192 of 201; 95.5%). At a median 19.9 months of follow-up, the annual rates of the primary outcome were 10.99% with LAAC and 13.42% with DOAC (subdistribution hazard ratio [sHR]: 0.84; 95% confidence interval [CI]: 0.53 to 1.31; p = 0.44; p = 0.004 for noninferiority). There were no differences between groups for the components of the composite endpoint: all-stroke/TIA (sHR: 1.00; 95% CI: 0.40 to 2.51), clinically significant bleeding (sHR: 0.81; 95% CI: 0.44 to 1.52), and cardiovascular death (sHR: 0.75; 95% CI: 0.34 to 1.62). Major LAAC-related complications occurred in 9 (4.5%) patients. Among patients at high risk for stroke and increased risk of bleeding, LAAC was noninferior to DOAC in preventing major AF-related cardiovascular, neurological, and bleeding events. (Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in Atrial Fibrillation [PRAGUE-17]; NCT02426944).

Osmancik P ，Herman D ，Neuzil P ，Hala P ，Taborsky M ，Kala P ，Poloczek M ，Stasek J ，Haman L ，Branny M ，Chovancik J ，Cervinka P ，Holy J ，Kovarnik T ，Zemanek D ，Havranek S ，Vancura V ，Opatrny J ，Peichl P ，Tousek P ，Lekesova V ，Jarkovsky J ，Novackova M ，Benesova K ，Widimsky P ，Reddy VY ，PRAGUE-17 Trial Investigators ... -  《-》

Left atrial appendage closure: a new strategy for cardioembolic events despite oral anticoagulation.

Falasconi G ，Gaspardone C ，Godino C ，Gaspardone A ，Radinovic A ，Pannone L ，Leo G ，Posteraro GA ，Slavich M ，Melillo F ，Marzi A ，D'Angelo G ，Limite LR ，Frontera A ，Brugliera L ，Agricola E ，Margonato A ，Della Bella P ，Mazzone P ... -  《-》

Left atrial appendage closure in patients with atrial fibrillation and acute ischaemic stroke despite anticoagulation.

The occurrence of acute ischaemic stroke (AIS) while using oral anticoagulants (OAC) is an increasingly recognised problem among nonvalvular atrial fibrillation (NVAF) patients. We aimed to elucidate the potential role of left atrial appendage closure (LAAC) for stroke prevention in patients with AIS despite OAC use (AIS-despite-OAC). We retrospectively collected baseline and follow-up data from consecutive NVAF patients who had AIS-despite-OAC and subsequently underwent endovascular LAAC, between January 2015 and October 2021. The primary outcome measure was the occurrence of AIS after LAAC, and the safety outcome was symptomatic intracerebral haemorrhage (ICH). 29 patients had LAAC specifically because of AIS-despite-OAC. The mean age at the time of the procedure was 73.4±8.7, 13 were female (44.82%). The mean CHA2DS2-VASc score was 5.96±1.32, with an expected AIS risk of 8.44 per 100 patient-years. 14 patients (48%) had two or more past AIS-despite-OAC. After LAAC, 27 patients (93.10%) were discharged on OAC which was discontinued in 17 (58.62%) after transoesophageal echocardiogram at 6 weeks. Over a mean of 1.75±1.0 years follow-up after LAAC, one patient had an AIS (incidence rate (IR) 1.97 per 100 patient-years). One patient with severe cerebral microangiopathy had a small ICH while on direct OAC and antiplatelet 647 days after LAAC. LAAC in AIS-despite-OAC patients demonstrated a low annual AIS recurrence rate in our cohort (1.97%) compared with the expected IR based on their CHA2DS2-VASc scores (8.44%) and to recent large series of AIS-despite-OAC patients treated with OAC/aspirin only (5.3%-8.9%). These hypothesis-generating findings support randomised trials of LAAC in AIS-despite-OAC patients.

Abramovitz Fouks A ，Yaghi S ，Selim MH ，Gökçal E ，Das AS ，Rotschild O ，Silverman SB ，Singhal AB ，Kapur S ，Greenberg SM ，Gurol ME ... -  《-》

Left Atrial Appendage Closure Compared With Oral Anticoagulants for Patients With Atrial Fibrillation: A Systematic Review and Network Meta-Analysis.

Oliva A ，Ioppolo AM ，Chiarito M ，Cremonesi A ，Azzano A ，Miccichè E ，Mangiameli A ，Ariano F ，Ferrante G ，Reimers B ，Garot P ，Amabile N ，Mehran R ，Condorelli G ，Stefanini G ，Cao D ... -  《Journal of the American Heart Association》