PROTECT AF
Trial question
Is percutaneous closure of LAA noninferior to warfarin therapy in stroke prevention among patients with AF?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 707
707 patients (210 female, 497 male).
Inclusion criteria: adult patients with non-valvular AF.
Key exclusion criteria: contraindications to warfarin, comorbidities other than AF that required chronic warfarin use, LAA thrombus, a patent foramen ovale with atrial septal aneurysm and right-to-left shunt, mobile aortic atheroma, and symptomatic carotid artery disease.
Interventions
N=463 intervention (percutaneous closure of the LAA with subsequent discontinuation of warfarin).
N=244 control (warfarin treatment with a target INR between 2.0 and 3.0).
Primary outcome
Incidence of stroke, CV death, and systemic embolism
3
4.9
4.9/100 py
3.7/100 py
2.5/100 py
1.2/100 py
0.0/100 py
Intervention
Control
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in the incidence of stroke, CV death, and systemic embolism (3/100 py vs. 4.9/100 py; RR 0.62, 95% CI 0.35 to 1.25).
Secondary outcomes
Significant decrease in the incidence of cardiovascular or unexplained death (0.7/100 py vs. 2.7/100 py; RR 0.26, 95% CI 0.08 to 0.77).
Significant decrease in the incidence of hemorrhagic stroke (0.1/100 py vs. 1.6/100 py; RR 0.09, 95% CI 0 to 0.45).
No significant difference in the incidence of death from any cause (3/100 py vs. 4.8/100 py; RR 0.62, 95% CI 0.34 to 1.24).
Safety outcomes
No significant difference in major bleeding.
Significant differences in major bleeding, pericardial effusion, and device embolization (7.4 per 100 patient-years vs. 4.4 per 100 patient-years).
Conclusion
In adult patients with non-valvular AF, intervention was noninferior to control with respect to the incidence of stroke, CV death, and systemic embolism.
Reference
Holmes DR, Reddy VY, Turi ZG et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009 Aug 15;374(9689):534-42.
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