Meanwhile, the University of Medicine and Dentistry of New Jersey (UMDNJ) has expanded the scope of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) study by including asymptomatic participants and increasing the number participating trial sites from 70 to 110. CREST is a randomised clinical trial to evaluate patients who are at normal risk for surgery, the efficacy of CAS as compared to CEA in preventing stroke, myocardial infarction and death in the 30-day period immediately following the procedures, and ipsilateral stroke (occurring on the same side of the brain in which the stent was placed) during a multi-year follow-up period. More than 1,000 participants have been enrolled in the lead-in phase, and more than 400 participants have been enrolled in the randomised phase of the trial. Previous to January 2005, only participants with symptomatic carotid disease were included in the randomised arm of CREST.
The lead-in (or credentialing) phase of CREST includes both high-surgical-risk and low-surgical-risk patients with carotid stenosis treated by stenting. Preliminary results, which were discussed at the International Stroke Conference in February 2005, from more than 1,000 participants in this stage of the study show 30-day all-cause stroke and death rates of 3.0% and 2.7% for symptomatic and asymptomatic subjects less than 80 years of age, respectively.
Dr Robert Hobson, the principal investigator for the trial said, “Broadening the scope will benefit more patients, enhance clinical understanding and allow us to better gauge the safety and effectiveness of carotid stenting versus surgery in the broad-base population currently receiving surgical treatment.”