In patients undergoing carotid artery stenting, use of the FiberNet Embolic Protection System (EPS) proved 97.5 percent effective and put stroke rate levels below the American Heart Association’s (AHA) standard of 3 percent following carotid endarterectomy, according to the EPIC trial published online March 3 in Catheterization and Cardiovascular Interventions.
Subbarao Myla, MD, of the Hoag Memorial Hospital in Newport Beach, Calif., and colleagues conducted a multicenter EPIC (FiberNet Embolic Protection System in Carotid Artery Stenting) trial of 237 patients with presence of a carotid stenosis in the common or internal carotid artery to evaluate the efficacy and safety of the FiberNet EPS.
Of the 237 enrolled patients, 20.3 percent were symptomatic with the presence of a carotid stenosis of 50 percent or greater. Patients' ages ranged from 46 to 89, with 21.1 percent over 80 years of age. All were treated with aspirin and clopidogrel or ticlopidine prior to the procedure.
According to the researchers, the FiberNet EPS (Lumen Biomedical) uses 4DG fiber technology to move fluids with effective containment of particles and requires no delivery system to advance the filter through lesions.
The trial's primary endpoints were major adverse events—death, stroke and MI—30 days post-procedure.
The FDA approved carotid stent systems Xact and NexStent (closed cell stents) were used in 43 percent of patients, while Acculink, Precise and Protégé (open cell stents) were used in 58 percent of patients.
Adverse events after 30 days were 3 percent, with a 2.1 percent rate of stroke. Five patients experienced stroke—four ischemic, one hemorrhagic. The rate of asymptomatic stroke was 1.6 percent.
Additionally, one death occurred after 24 days due to a cardiac event and two patients experienced MI (0.8 percent).
“The low stroke rate of 2.1 percent at 30 days in this study could be due to several factors, including the unique design of the FiberNet EPS with its low crossing profile, high capture efficiency and the overall ease of use, as well as operator expertise with carotid artery stenting,” the authors wrote.
The researchers noted that the FiberNet EPS allowed for a shortened procedural time and facilitated lesion crossing and filter placement.
The authors said that the study is limited to reviewing the efficacy of one device, the FiberNet EPS, and its results cannot be compared to other such devices used for stenting.