PROTECT AF
Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation
Doente / População Intervenção / Exposição Comparação Desfecho
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.
N
707
Desenho
Open-label non-inferiority RCT (2:1 device:warfarin)
Desfecho
Composite of stroke, cardiovascular/unexplained death, and systemic embolism
Relevância
3
ResultadoAt 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
Discussão e crítica
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.