CREST-2 Completes Enrollment

August 13, 2024—CREST-2, the Carotid Revascularization Endarterectomy or Stenting Trial, has completed patient enrollment.

According to the CREST-2 website (www.crest2trial.org), a total of 2,485 patients were enrolled at 142 centers. The trial sought to enroll 2,480 patients across the United States, Canada, Spain, and Israel.

CREST-2 is sponsored by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health.

The Principal Investigator is Thomas G. Brott, MD, of the Mayo Clinic in Jacksonville, Florida. Brajesh K Lal, MD, serves as Co-Principal Investigator of the CREST-2 trial. Dr. Lal is Professor of Vascular Surgery at the University of Maryland School of Medicine in Baltimore, Maryland.

Drs. Brott and Lal commented on the trial’s milestone to Endovascular Today, “We are pleased to have achieved target enrollment in a complex trial such as CREST-2 despite the intervening pandemic. This is a testament to the contributions of our participating patients, physicians, coordinators, and clinical centers. We are looking forward to begin sharing results of the trials in the coming year.”

In September 2013, Dr. Lal et al provided an overview of the purpose and plans for CREST-2 in Endovascular Today.

In May 2017, Endovascular Today reported that the protocol for the study was published by Virginia J. Howard, PhD, et al on behalf of the CREST-2 study investigators online in the International Journal of Stroke.

As was summarized in the International Journal of Stroke, 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 is also evaluating whether CEA or CAS have favorable effects on cognition.

CREST-2 is composed of two multicenter randomized trials: one trial randomized 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 were low-density lipoprotein cholesterol < 70 mg/dL and systolic blood pressure < 140 mm Hg. Each trial was designed to 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.

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, advised the CREST-2 investigators in the International Journal of Stroke.