Key result
Watchman proves noninferior to warfarin for stroke, systemic embolism, and cardiovascular death.
Why the study?
The PROTECT AF study was conducted to determine whether percutaneous left atrial appendage closure with the Watchman device was noninferior to warfarin for stroke prevention in atrial fibrillation.
Does percutaneous left atrial appendage closure with the Watchman device prevent stroke, systemic embolism, and cardiovascular death in patients with nonvalvular atrial fibrillation compared to warfarin?
Population
707 patients with nonvalvular atrial fibrillation and at least 1 risk factor
Comparison
Watchman device with short-term warfarin and antiplatelet therapy vs continued warfarin
Design
Multicenter randomized controlled trial with 2:1 randomization
Follow-up
Mean 2.3 ± 1.1 years
Authors
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LAA closure noninferior to warfarin for AF stroke prevention; leaves open optimal patient selection and long-term device safety in broader populations.
RCT (n=707)
2:1
Yes
Does percutaneous left atrial appendage closure with the Watchman device prevent stroke, systemic embolism, and cardiovascular death in patients with nonvalvular atrial fibrillation compared to warfarin?
Relative Risk: 0.71 (95% CI 0.44–1.3)
Absolute Event Rate: 3% vs 4.3%
p-value: probability of noninferiority >0.999
Percutaneous left atrial appendage closure with the Watchman device is noninferior to systemic anticoagulation with warfarin for stroke prevention in patients with nonvalvular atrial fibrillation.
Mohan et al. (2013) conducted an RCT in nonvalvular atrial fibrillation (n=707). Watchman Left Atrial Appendage System vs. warfarin was evaluated on stroke, systemic embolism, and cardiovascular death (RR 0.71, 95% CI 0.44-1.30, p=probability of noninferiority >0.999). Left atrial appendage closure with the Watchman device was noninferior to warfarin for stroke, systemic embolism, and cardiovascular death (RR 0.71; probability of noninferiority >0.999).
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