Protocol for CREST-2 Trial Published
May 4, 2017—The protocol for the Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) was published online ahead of print in the International Journal of Stroke by Virginia J. Howard, PhD, et al on behalf of the CREST-2 study investigators.
CREST-2 is evaluating whether carotid endarterectomy (CEA) or carotid artery stenting (CAS) plus contemporary intensive medical therapy is superior to intensive medical therapy alone in the primary prevention of stroke in patients with high-grade asymptomatic carotid stenosis. The trial will also evaluate whether CEA or CAS have favorable effects on cognition. CREST-2 is sponsored by Thomas G. Brott, MD, of the Mayo Clinic in Jacksonville, Florida, in collaboration with the National Institute of Neurological Disorders and Stroke (NINDS).
As summarized in the International Journal of Stroke, CREST-2 is two multicenter randomized trials of revascularization plus intensive medical therapy versus intensive medical therapy alone. One trial randomizes patients to CEA plus intensive medical therapy versus intensive medical therapy alone. The other trial randomized patients to CAS plus intensive medical therapy versus intensive medical therapy alone. The risk factor targets of centrally directed intensive medical therapy are low-density lipoprotein cholesterol < 70 mg/dL and systolic blood pressure < 140 mm Hg.
The primary outcome is the composite of stroke and death within 44 days after randomization and stroke ipsilateral to the target vessel thereafter, up to 4 years. Change in cognition and differences in major and minor stroke are secondary outcomes.
Each trial will enroll 1,240 patients, providing 85% power to detect a treatment difference if the event rate in the intensive medical therapy alone arm is 4.8% higher or 2.8% lower than an anticipated 3.6% rate in the revascularization arm, advised the CREST-2 investigators in the International Journal of Stroke.
In early 2016, the Mayo Clinic announced the publication of the 10-year CREST results by Dr. Brott et al in The New England Journal of Medicine (2016;374:1021–1031). At that time, the Mayo Clinic noted that despite the results of CREST, which demonstrated that CEA and CAS are equally effective at lowering the long-term risk of stroke from a narrowed carotid artery, the question of the best way to manage stroke risk had not yet been answered. As a result, CREST-2 was launched in December 2014 to compare stenting and surgery to medical management. CREST-2 is expected to end in 2022 and is being funded by a $39.5 million grant from the NINDS.