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PROTECT AF: Watchman Device Noninferior to Warfarin
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Among patients with nonvalvular atrial fibrillation, the Watchman percutaneous left atrial appendage closure device was noninferior to anticoagulation with warfarin with regard to stroke, systemic embolism and CV death, according to 2.3 year follow-up data from the PROTECT AF trial.
“After successful deployment, the local therapy of [left atrial appendage] closure proved to be superior to wellcontrolled systemic anticoagulation, and this was particularly true when the functional impact of major adverse clinical events is considered,” Vivek Y. Reddy, MD, and fellow PROTECT AF trial investigators wrote in the study recently published in Circulation.
The trial included 707 patients with nonvalvular AF who had at least one of the following risk factors: age greater than 75 years, hypertension, HF, diabetes and prior stroke/transient ischemic attack. Patients were randomly assigned to either the Watchman device (Atritech; n=463) or continued warfarin (Coumadin, Bristol-Myers Squibb; n=244). After device implantation, patients continued with warfarin therapy for approximately 45 days, followed by clopidogrel (Plavix, Sanofi-Aventis) for 4.5 months and lifelong aspirin.
Vivek Y. Reddy
Study discontinuation rates were 15.3% in the Watchman group and 22.5% in the warfarin group, and the time in therapeutic range for the warfarin group was 66%.
At mean follow-up of 2.3 years, the composite primary efficacy endpoint of stroke, systemic embolism and CV death was observed in 3.0% of patients in the Watchman group and 4.3% of the warfarin group (percents per 100 patient-years; RR=0.71; 95% CI, 0.44-1.30 per year), which met the criteria for noninferiority. Reddy and colleagues also reported more primary safety events in the Watchman group vs. the control group, including device-related and non-procedural events (5.5% per year vs. 3.6% per year; RR=1.53; 95% CI 0.95-2.70).
Disclosure: Reddy has received research grant support and consultant fees from Atritech. The trial was supported by Atritech.
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