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

Percutaneous left atrial appendage occlusion in the current practice

“…This issue was recently addressed in the non-inferiority PRAGUE-17 RCT[28] that enrolled 402 moderate-to high-risk patients (CHA2DS2VASc 4.7 ± 1.5, HAS-BLED 3.0 ± 0.9). LAAO indications included history of clinically relevant bleeding in 47.7% patients and prior cardioembolic event while on OAC in 35.3%.…”

Double-blind, placebo-controlled randomised clinical trial to evaluate the effect of ASPIRIN discontinuation after left atrial appendage occlusion in atrial fibrillation: protocol of the ASPIRIN LAAO trial

“…Among multiple LAAO devices, the Watchman device (Boston Scientific, Marlborough, Massachusetts, USA) was shown to be non-inferior to warfarin or direct OAC on reducing outcome events in randomised controlled trials. [13][14][15] The safety and effectiveness of Watchman devices in realworld clinical practice has been further confirmed by the EWOLUTION (Registry on WATCHMAN Outcomes in Real-Life Utilization), POST-FDA (Post-Approval by the US Food and Drug Administration) and the most recent NCDR (National Cardiovascular Data Registry) LAAO registries, [16][17][18][19] both exhibiting acceptable periprocedural complications and consistently low rates of stroke and bleeding during the follow-up. However, even patients with successful LAAO device implantation are not completely free from antithrombotic (anticoagulation and/or antiplatelet) treatment, in order to allow sufficient endothelialisation and prevent thrombus formation on the surface of the device.…”

“…First, among multiple LAAO devices, Watchman is the only device to be studied in randomised trials to date. [13][14][15] Second, Watchman device is the most implanted LAAO device in China and worldwide. Third, focusing on one device might avoid potential discrepancy among different devices.…”

‘Will the king ever be dethroned?’ The relationship and the future of oral anticoagulation therapy versus LAA closure devices

“…Especially at an early stage (e.g., the results of PROTECT-AF at two years [19]: 7.4 per 100 patient-years, 95%CI 5.5-9.7 vs. 4.4 per 100 patient-years, 95% CI 2.5-6.7; RR 1.69, 1.01--3.19), periprocedural complications were high, as are those of PRAGUE-17 (major LAAO-related complications occurred in 9 (4.5%) patients [10]). However, as the experience of various centers increased, complications declined (e.g., the results of PROTECT-AF at four years [8]: the rate of composite primary safety events was similar in the two groups -3.6 events per 100 patient-years in the device group vs. 3.1 in the warfarin group (HR, 1.21; 95% CI, 0.78-1.94, P = 0.41).…”

“…There is a lack of randomized controlled trials (RCTs) comparing LAAO to OAT in populations with contraindication to OAT. In fact, the only three existing RCTs comparing LAAO with OAT, both VKAs and DOACs, are all made in populations that had an indication but did not have a contraindication for OAT [8][9][10].…”