PROTECT AF

Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation

Patient / Population Intervention / Exposition Comparaison Critère de jugement

In 707 patients with non-valvular atrial fibrillation eligible for warfarin, Watchman left atrial appendage closure was non-inferior for stroke, systemic embolism, or cardiovascular death compared with warfarin.

707

Schéma

Open-label non-inferiority RCT (2:1 device:warfarin)

Critère

Composite of stroke, cardiovascular/unexplained death, and systemic embolism

Pertinence

RésultatAt mean 3.8-year follow-up, LAA closure met both non-inferiority and superiority vs warfarin (rate ratio 0.60, 95% CrI 0.41-1.05; superiority probability 96%). Original 2009 report showed non-inferiority.

Reddy VY, et al. JAMA. 2014;312(19):1988-1998. 10.1001/jama.2014.15192

Discussion et critique

Early benefit offset by frequent procedural complications (pericardial effusion), and the warfarin comparator predates DOACs. Established percutaneous LAA closure as an alternative to warfarin and led to Watchman approval.