Compelo Medical Devices - Latest industry news and analysis is using cookies

We use them to give you the best experience. If you continue using our website, we'll assume that you are happy to receive all cookies on this website.

ContinueLearn More
Close
Dismiss

NIH Clinical Trial Shows Safety, Effectiveness Of Surgery, Stenting

National Institutes of Health (NIH) has presented results of CREST clinical trial which demonstrated that the people undergoing two medical procedures, designed to prevent future cardiac strokes are safe and effective overall.

CREST compared the safety and effectiveness of carotid endarterectomy (CEA) and carotid artery stenting (CAS) in patients with or without a previous stroke. The trial was funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health. The trail took place at 117 centers in the US and Canada over a nine-year period.

In the trial of 2,502 participants, CEA, a surgical procedure to clear blocked blood flow and considered the standard prevention treatment, was compared to CAS, a newer and less invasive procedure that involves threading a stent and expanding a small protective device in the artery to widen the blocked area and capture any dislodged plaque.

The overall safety and efficacy of the two procedures was largely the same with equal benefits for both men and for women, and for patients who had previously had a stroke and for those who had not. The study also found that the age of the patient also made a difference.

Approximately half the patients had recent symptoms due to carotid disease such as a minor stroke, or a transient ischemic attack (TIA), indicating a high risk for future stroke. The other half had no symptoms but were found to have narrowing of the carotid artery on one of a variety of tests assessing carotid narrowing and plaque. Such patients, termed asymptomatic, are at much lower risk of stroke than those with symptoms.

As a result, the pivotal differences were the lower rate of stroke following surgery and the lower rate of heart attack following stenting, according to the investigators. A year after the procedure, the patients who had suffered a stroke reported that the effects of the stroke had a greater impact on their quality of life than was reported by those patients who had suffered a heart attack.

The CREST investigators concluded that while CEA has a proven record and long term durability, both CAS and CEA are safe and useful tools in the right setting for stroke prevention, and technology continues to improve each procedure.

Thomas Brott, professor of neurology and director for research at Mayo Clinic in Jacksonville, and the national principal investigator of the study, said: “The CREST trial results show that we have two safe and effective methods to treat carotid artery disease directly, the tried and true CEA, and the new kid on the block, CAS. There was evidence that people who were younger than 70 did better with stents while those over 70 had better results with the surgery, but the results for all men and women were excellent.”