CANOPY Supports CAS as an Alternative to CEA for Stroke Prevention in Standard Risk Patients

November 4, 2014—VIVA Physicians, Inc. announced that D. Christopher Metzger, MD, presented findings from the CANOPY trial during a late-breaking trials session at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada. CANOPY is a prospective, multicenter, nonrandomized, single-arm, postapproval study to evaluate the safety and effectiveness of the RX Acculink carotid stent system (Abbott Vascular) in patients at standard risk for adverse events from carotid endarterectomy (CEA). CANOPY was mandated by the US Food and Drug Administration as a follow-up study to the CREST trial.

As summarized by the VIVA press release, there were 1,203 patients—symptomatic and asymptomatic—enrolled in the CANOPY trial. Patients with features known to be high risk for CEA were excluded. Patient follow-up occurred at 30 days and at 1, 2, and 3 years postprocedure.

The trial’s primary endpoint is a composite of periprocedural (within 30 days of the procedure) death and stroke, plus ipsilateral stroke between day 31 and 1 year. National Institutes of Health Stroke Scale (NIHSS) assessment was performed before the procedure, after the procedure, at 30 days, and at 1 year. Mean patient age was 69.5 ± 8.5 years, and 40.9% of the study patients were women. Patients 80 years of age or older were 9.8% of the trial population. There were 27.9% symptomatic patients, 35.9% diabetics, 91.4% hypertensive patients, and 92.6% patients with dyslipidemia.

Dr. Metzger reported that the primary endpoint rate was 4.4% ± 0.61 with an upper confidence interval of 5.4%, below the performance goal of 8.4%. The death and stroke rate at 30 days was 3.4% in the overall population, 5.8% in the symptomatic patients, and 2.5% in asymptomatic patients. These rates were primarily driven by minor strokes. Presence of neurological symptoms before the procedure was a risk factor for the occurrence of death and stroke, but age older than 80 years was not. There was no significant difference in primary endpoint rate between octogenarians and nonoctogenarians.

Data from the CANOPY trial provide further support of carotid artery stenting as an alternative option to CEA for stroke prevention in standard-risk patients, concluded Dr. Metzger.