Thirty-Day EMBOLDEN Data Evaluate the Gore Embolic Filter for CAS
January 16, 2018—The 30-day results from the EMBOLDEN clinical study were published by William A. Gray, MD, et al online in Catheterization and Cardiovascular Interventions. The EMBOLDEN study was conducted to test the safety and efficacy of the Gore embolic filter (GEF; Gore & Associates), which is a novel embolic protection filter designed for use in carotid artery stenting (CAS) in patients with severe carotid stenosis who are at high risk of operative complications from carotid endarterectomy (CEA).
The investigators noted that general considerations for filter design usually involve trade-offs between trackability/profile and wall apposition/capture efficiency. The GEF is intended to address these design goals via a hybrid construction.
As summarized in Catheterization and Cardiovascular Interventions, the study was composed of 250 patients who were high risk for CEA and were treated with CAS using the GEF device paired with a US Food and Drug Administration–approved carotid stent. The primary outcome was death, stroke, and myocardial infarction (MI) at 30 days compared to a predetermined performance goal. Neurologic outcomes were judged by an independent assessor, and angiographic results were evaluated by an independent central core lab.
The investigators reported that 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% of patients and was significantly lower than the predefined performance goal (P < .001). The 30-day rate of death and major stroke was 1.2%. The rate of death and any stroke was 3.6%. The rate of major adverse events was 5.4% among octogenarians and 3.2% among nonoctogenarians.
In patients who are high risk for CEA undergoing CAS, the GEF device 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, concluded the investigators in Catheterization and Cardiovascular Interventions.