PRAGUE-17

Left Atrial Appendage Closure versus Novel Anticoagulation Agents in Atrial Fibrillation

Patient / Population Intervention / Exposition Comparaison Critère de jugement

In 402 high-risk patients with non-valvular atrial fibrillation, percutaneous left atrial appendage closure was non-inferior for a composite of cardiovascular and bleeding events compared with direct oral anticoagulants.

402

Schéma

Multicentre open-label non-inferiority RCT

Critère

Composite of stroke, TIA, systemic embolism, CV death, major/CRNM bleeding, or procedure/device complications

Pertinence

RésultatAnnualised 10.99% vs 13.42% (subdistribution HR 0.84, 95% CI 0.53-1.31; P=0.004 for non-inferiority). LAA closure non-inferior to DOACs.

Osmancik P, et al. J Am Coll Cardiol. 2020;75(25):3122-3135. 10.1016/j.jacc.2020.04.067

Discussion et critique

Modest size and few events limit precision, and findings apply to high-bleeding-risk patients. First RCT to show LAA occlusion non-inferior to DOACs, extending device evidence beyond the warfarin era.