FDA panel recommends broadening indications for carotid stenting

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The FDA’s Circulatory System Devices Advisory Panel has recommended expanding the availability of carotid artery stenting to patients at standard risk for adverse events while undergoing surgery.

The panel’s recommendation (Yes: 7, No: 3, Abstain: 1) was based on the results of the CREST trial (New Engl J Med 2010;363:11-23), a randomized stroke prevention clinical trial, which found carotid artery stenting was equally safe and effective as the surgical procedure called carotid endarterectomy (CEA) for stroke prevention, including four-year follow-up. Using a combined primary endpoint of stroke, MI and death, CREST found the overall safety and efficacy of stenting versus surgery was largely the same.

The guidelines for secondary stroke prevention recently updated by the American Heart Association and American Stroke Association include broader recommendations for carotid artery stenting than those currently covered by the Centers for Medicare & Medicaid Services (CMS). Currently, the CMS and most U.S. insurers cover carotid artery stenting only for symptomatic patients at increased surgical risk, and those enrolled in clinical trials. All other patients must pay out of pocket for the procedure, receive medications only or undergo CEA, according to the Society for Cardiovascular Angiography and Interventions (SCAI).

“SCAI urges the FDA to accept the panel’s recommendation, as it would provide patients with a safe, effective and minimally invasive treatment option for carotid artery disease,” said Christopher J. White, MD, SCAI president-elect and chairman of the department of cardiology and  director of the Ochsner Heart & Vascular Institute in New Orleans. “This recommendation by the FDA panel to expand the labeled indication for the use of carotid artery stenting would be a step forward in preventing stroke, the third leading cause of death in the U.S.”

The FDA will take into account the panel's advice in making its decision on whether to expand the current indication to include patients at standard surgical risk, but the agency is not compelled to accept it.