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Use of a novel embolic filter in carotid artery stenting: 30‐Day results from the EMBOLDEN Clinical Study
Author(s) -
Gray William A.,
Mehta Manish,
Alani Firas,
Kasirajan Karthikeshwar,
Begg Richard J.,
Bacharach J. Michael,
Soukas Peter A.
Publication year - 2018
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27474
Subject(s) - medicine , carotid endarterectomy , stroke (engine) , clinical endpoint , stenosis , carotid stenting , myocardial infarction , cardiology , carotid artery disease , stent , endarterectomy , surgery , randomized controlled trial , mechanical engineering , engineering
Objectives The EMBOLDEN study was conducted to test the safety and efficacy of a novel emboli protection filter design for use in carotid artery stenting (CAS) in patients with severe carotid stenosis who were at high risk of operative complications from carotid endarterectomy (CEA). Background General considerations for filter design usually involve trade‐offs between trackability/profile and wall apposition/capture efficiency. The GORE ® Embolic Filter (GEF) is intended to address these design goals via a hybrid construction. Methods Patients at high risk for CEA ( N = 250) were treated with CAS using the GEF study device paired with an FDA‐approved carotid stent. The primary outcome was death, stroke, and myocardial infarction (MI) at 30 days, compared to a pre‐determined performance goal. Neurologic outcomes were judged by an independent assessor and angiographic results evaluated by an independent central core lab. Results The GEF study device was successfully deployed in 96.4% of procedures. The primary endpoint of 30‐day death, stroke, and MI occurred in 4.0% of subjects and was significantly lower than the pre‐defined performance goal ( P < 0.001). The 30‐day rate for death and major stroke was 1.2% and for death and any stroke was 3.6%. The rate of major adverse events was 5.4% among octogenarians and 3.2% among non‐octogenarians. Conclusion In patients at high risk for CEA undergoing CAS, the GEF not only showed high rates of successful deployment but also met the primary endpoint of low death, stroke, and MI rates, thus demonstrating safety and effectiveness.