Analysis of MAVERIC Studies Supports Medtronic's Exponent CAS System

January 25, 2010—In Stroke, (Randall T. Higashida, MD, et al published findings from a combined analysis of the MAVERIC (Medtronic AVE Self-Expanding Carotid Stent System With Distal Protection) I and II trials to evaluate the safety and feasibility of this system among patients at high risk for surgical endarterectomy (2010;41:e102-e109).

According to the investigators, 498 patients were enrolled in the MAVERIC I (99 patients) and MAVERIC II (399 patients) studies from June 2001 to October 2004. The results were pooled for statistical analysis of a common primary endpoint, which was the 365-day rate of major adverse events. Clinical follow-up was done at 30 days, 6 months, and 365 days postprocedure.

The investigators reported in Stroke that the 365-day major adverse event rate was 12.5% (defined as death, stroke, or myocardial infarction within 30 days and death, ipsilateral stroke, or myocardial infarction from days 31 to 365). The incidence of neurological death through 365 days was 1.1%. The 30-day major adverse event rate was 5.4%. Subgroup analyses showed no notable differences in the 365-day major adverse event rate for symptomatic patients compared with asymptomatic patients.

The data demonstrate that treatment of carotid artery disease with carotid artery stenting with a self-expanding stent and distal embolic protection results in a low 30-day adverse event rate, including the occurrence of stroke in patients at high risk for carotid endarterectomy, the investigators concluded.