CHOICE Postmarket Data Presented for Abbott's Carotid Stents and EPDs

October 10, 2013—The CHOICE trial of carotid artery stenting (CAS) in a postmarket setting was presented by Chris Metzger, MD, at a late-breaking trial session during the VIVA 2013: Vascular Interventional Advances conference, being held October 8–11 in Las Vegas, Nevada.

CHOICE is a prospective, single-arm study to obtain postmarket surveillance information from commercial use of two Abbott Vascular (Santa Clara, CA) carotid stents (Xact and Acculink) and two embolic protection devices (EPD) (Emboshield/Emboshield NAV6 and Accunet [Abbott Vascular]) by a wide range of physicians in a patient population at high risk for endarterectomy (CEA). CHOICE represents the largest single prospective CAS data set completed and presented to date, noted Dr. Metzger.

Between 2006 and 2012, 18,719 patients were enrolled in the study. Of the 18,719 patients, 17,925 patients were deemed evaluable. Patients were followed through 30 days.

National Institutes of Health Stroke Scale (NIHSS) assessments were performed by an independent NIHSS-certified medical professional or independent neurologist preprocedure, postprocedure, and at 30 days. Strokes and suspected strokes were adjudicated; myocardial infarctions (MI) and deaths were site-reported. Subgroup analyses, including age and symptomatic status, were summarized for the primary endpoint.

At 30 days, the overall primary endpoint (death, stroke, and MI [DSMI]) rate was 4.2% (death, 1%; stroke, 3.3%; and MI, 0.5%); DS rate was 3.8%; death/major stroke rate was 1.4%; the major ipsilateral stroke rate was 0.8%. Significant differences (P < .05) in DS event rates were seen between octogenarians versus nonoctogenarians (6.4% vs 3%) and between symptomatic versus asymptomatic patients (5.3% vs 3.5%).

Within the nonoctogenarian group, the DS rate for symptomatic patients was 3.9% and the DS rate for asymptomatic patients was 2.9%. Results are in line with other large, high-risk, real-world studies, noted Dr. Metzger.

The overall study DS rate (5.3%) for symptomatic patients and the DS rates for nonoctogenarians (both the symptomatic and asymptomatic) were within the AHA guidelines for carotid treatment of standard surgical risk nonoctogenarian patients (< 6% and < 3% rates, respectively) in this high-surgical-risk population.