Results from the largest-ever multi-center U.S. registry on the efficacy of carotid stenting shows that the procedure is safe in patients who are at high risk for standard surgical therapy.
The registry, an FDA-required post-approval study, known as CAPTURE (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) was presented at the American College of Cardiology's 55th Annual Session in Atlanta. The multi-center study was led by Columbia University Medical Center researchers at NewYork-Presbyterian Hospital/Columbia.
Patients with carotid artery blockage have an increased risk of stroke, even if they experience none of the disease's symptoms, which can include weakness, paralysis, visual problems or speech difficulties. The risk of stroke over five years in asymptomatic patients is about one in eight if carotid artery disease is treated only with medical therapy. The Center for Medicare and Medicaid Services currently does not cover carotid stenting for these asymptomatic patients, so many turn to surgery to clear blocked arteries. However, some patients are ineligible for surgery because of other medical conditions.
In CAPTURE, the researchers collected data on 2,500 patients at increased risk for surgery. They were treated by 240 interventionalists at 188 medical centers across the country. All patients received Guidant's FDA-approved RX ACCULINK Carotid Stent System with RX ACCUNET Embolic Protection System. Neurologists otherwise unaffiliated with the study also evaluated patients immediately before and after stenting, and again 30 days later to judge the outcomes of the procedure.
Among asymptomatic patients, the trial found that the rate of major complications (death, stroke or heart attack) within 30 days of the stenting procedure was 5.7 percent, which is lower than the rate found in other studies of similar patients who undergo surgery.
"The scope of this landmark trial provides us with a clear picture of the patients who benefit the most from carotid artery stenting. We hope these results will expand coverage to asymptomatic patients who are risky candidates for surgery," said William Gray, M.D., principal investigator on the study and associate professor of clinical medicine at Columbia University Medical Center and director of endovascular services at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia and the Cardiovascular Research Foundation.
Preliminary results on 1,600 patients in the CAPTURE trial were presented at the Cardiovascular Research Foundation's Transcatheter Cardiovascular Therapeutics (TCT) meeting in October 2005. The results from the 2500 patients confirm the earlier suggestion that carotid artery stenting is highly beneficial for asymptomatic high-risk patients.