DR. KEVIN BARRETT: I'm Dr. Kevin Barrett, a vascular neurologist at Mayo Clinic Florida and co-director of the Comprehensive Stroke Center. As you may know, Mayo Clinic has a robust research program focused on neurologic conditions, including stroke. We have more than 20 trials currently underway, and Mayo Clinic will be the clinical coordinating center for the CREST-2 clinical trial.
The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial, known as CREST-2, is a National Institutes of Health, National Institutes of Neurological Disorders and Stroke funded multi-center randomized study, designed to determine the optimal management of patients with high-grade, asymptomatic carotid stenosis.
Patients with asymptomatic carotid stenosis greater than 70% will be randomized to intensive medical management or intensive medical management plus carotid revascularization, with either endarterectomy or angioplasty and stenting. Intensive medical management will include antiplatelet therapy and protocol-driven modification of several vascular risk factors. Procedural lists that performe CEA and CAS will be credentialed, to insure only the most skilled operators will treat patients within the trial.
Patients will be followed for four years, and differences in stroke and death rates will be compared at the conclusion of follow-up. It is anticipated that 2,480 will be enrolled at greater than 120 centers in North America. Studies have demonstrated the superiority of endarterectomy over medical therapy for asymptomatic carotid stenosis were performed more than 20 years ago. And prior to the advances now available for treatment of several vascular risk factors, including blood pressure control and statins for reduction of LDL levels.
Modern medical therapy has been shown to significantly decrease historical stroke rates in other large artery atherosclerotic diseases such as intracranial stenosis. CREST-2 will include a lifestyle intervention called INTERVENT that has been shown to be effective in management of lifestyle risk factors including smoking cessation, weight loss, and increasing physical activity. CREST-2 will provide an option for patients to receive the most contemporary management of risk factors and carotid revascularization performed by proceduralists with the lowest procedural morbidity and mortality.
The best patients for CREST-2 are those that have carotid stenosis greater than 70%. The best screening study would be a carotid ultrasound, and a peak systolic velocity of greater than 230 centimeters per second would be initial eligibility criteria for CREST-2. When a patient's referred to Mayo Clinic, they'll meet with a vascular neurologist as well as a clinical research coordinator, and final eligibility will be determined after a comprehensive history, physical examination, and review of the imaging findings.
We anticipate the CREST-2 enrollment will begin in October of 2014. For additional information and to refer a patient for consideration of CREST-2 eligibility, call toll-free 844-956-1826. If you would like to refer other patients to Mayo Clinic, we invite you to do so, and are happy to speak to you about your specific patients and their unique situation.
