Percutaneous Left Atrial Appendage Closure for Stroke Prophylaxis in Patients With Atrial Fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic…
By Vivek Y. Reddy, S. Doshi, H. Sievert, M. Buchbinder, P. Neužil, K. Huber, J. Halperin, David R. Holmes III. Circulation, 2013
625 citations recorded by the source corpus.
Background— The multicenter PROTECT AF study (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) was conducted to determine whether percutaneous left atrial appendage closure with a filter device (Watchman) was noninferior to warfarin for stroke prevention in atrial fibrillation. Methods and Results— Patients (n=707) with nonvalvular atrial fibrillation and at least 1 risk factor (age >75 years, hypertension, heart failure, diabetes, or prior stroke/transient ischemic attack) were randomized to either the Watchman device (n=463) or continued warfarin (n=244) in a 2:1 ratio. After device implantation, warfarin was continued for ≈45 days, followed by clopidogrel for 4.5 months and lifelong aspirin. Study discontinuation rates were 15.3% (71/463) and 22.5% (55/244) for the Watchman and warfarin groups, respectively. The time in therapeutic range for the warfarin group was 66%. The composite primary efficacy end point included stroke, systemic embolism, and cardiovascular death, and the primary analysis was by intention to treat. After 1588 patient-years of follow-up (mean 2.3±1.1 years), the primary efficacy event rates were 3.0% and 4.3% (percent per 100 patient-years) in the Watchman and warfarin groups, respectively (relative risk, 0.71; 95% confidence interval, 0.44%–1.30% per year), which met the criteria for noninferiority (probability of noninferiority >0.999). There were more primary safety events in the Watchman group (5.5% per year; 95% confidence interval, 4.2%–7.1% per year) than in the control group (3.6% per year; 95% confidence interval, 2.2%–5.3% per year; relative risk, 1.53; 95% confidence interval, 0.95–2.70). Conclusions— The “local” strategy of left atrial appendage closure is noninferior to “systemic” anticoagulation with warfarin. PROTECT AF has, for the first time, implicated the left atrial appendage in the pathogenesis of stroke in atrial fibrillation. Clinical Trial Registration:— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00129545.
Subfields: Cardiology and Cardiovascular Medicine
View Paper: https://www.semanticscholar.org/paper/3a38ad0a7e4411fff77af092b9dba5997b839bfb
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Citations in the corpus
- Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. (2014, background): “In the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) study, LAA occlusion was documented to be noninferior to warfarin for the primary efficacy endpoint of stroke, cardiovascular death, and systemic embolism (SE) (17,18).”
- Guidelines for the Primary Prevention of Stroke (2011, positive): “At 1588 patient-years of follow-up, the rate of the primary efficacy end point of stroke, systemic embolism, and cardiovascular death was not inferior for the WATCHMAN device compared with warfarin.(437) Although this approach appears promising, there are substantial reasons for proceeding cautiousl”
- Stroke Risk Factors, Genetics, and Prevention (2017, methodology): “In both trials, the Watchman device was noninferior in efficacy for the prevention of ischemic stroke.(274,275) Pericardial effusion, periprocedural stroke, and device embolization accounted for the major complications.”