From the Department of Interventional Angiology, Herzzentrum Leipzig GmbH and Park-Krankenhaus, Leipzig, Germany (D.S., A.S.); Department of Clinical and Invasive Cardiology, Humanitas Clinica and Research Center, Rozzano (Milan), Italy (B.R.); Department of Interventional Cardio-Angiology, Villa Maria Cecilia, Cotignola (RA), Italy (A.C.); Department Internal Medicine, Cardiology and Vascular Medicine, CardioVascular Center, Frankfurt, Germany (H.S.); Department of Radiology and Neuroradiology, Klinikum Dortmund, Dortmund, Germany (S.R.); Department of Cardiology, Hamburg University Cardiovascular Center, Hamburg, Germany (J.S.); Department of Cardiology, Klinikum Neuperlach, Munchen, Germany (H.G.M.); Department of Vascular Surgery, AZ Sint Blasius, Dendermonde, Belgium (M.B.); Department Angiology Internist, Universitats Herzzentrum, Bad Krozingen, Germany (T.Z.); Department of Cardiology, Mirano Hospital, Italy (A.P.); and Bnai Zion Medical Center, Technion-Israel Institute of Technology, Haifa, Israel (U.R.).
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Background—Embolic protection during carotid artery stenting reduces the rate of thromboembolic events. The Wirion Embolic Protection System is used to deploy an independent distal filter using any 0.014″ guidewire. WISE study (Wirion Study Europe) evaluated the safety and performance of Wirion Embolic Protection System in patients undergoing carotid artery stenting.Methods and Results—A prospective, multicenter, nonrandomized, open-label, single-arm study of carotid artery stenting in high surgical risk patients was performed. The primary end point, a composite of death, stroke, and myocardial infarction at 30 days, was compared with performance goal derived from historical controls. Secondary end points were components of the primary end point and the device, angiographic, procedural, and clinical success rates. Preplanned interim analysis was performed on the first 120 patients. At interim analysis, the primary end point was significantly lower for the Wirion Embolic Protection System group, compared with historical data (3.3% versus 6.3%, respectively; P value =0.0008). Analysis of primary end point components in the WISE group, compared with the historical control group, shows numerically lower mortality (0% versus 1.7%, respectively; P=0.21), stroke (2.5% versus 4.6%, respectively; P=0.18), and myocardial infarction (0.8% versus 1.5%, respectively; P=0.50). Device, angiographic, procedural, and clinical success was achieved in 99.2%, 99.1%, 98.3%, and 96.6% of cases, respectively.Conclusions—The data suggest that independent modular filter use in carotid artery stenting in high surgical risk patients is safe and effective. The outcomes suggest that use of an independent modular filter may be associated with a lower rate of embolic complications associated with carotid stent placement.Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01783639.