Data from CAPTURE, the largest US registry of patients receiving carotid stents, shows that carotid stenting is safe and effective for patients at high risk for standard surgical therapy, according to a presentation at the annual meeting of the American College of Cardiology.

The registry, a required post-approval study, is known as CAPTURE (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events), was led by investigators at Columbia University Medical Center researchers at New York-Presbyterian Hospital/Columbia.

In CAPTURE, researchers collected data on 2,500 patients at increased risk for surgery who were treated by 240 interventionalists at 188 medical centers across the USA. 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 rate of major complications (death, stroke or myocardial infarction) 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, MD, principal investigator on the study and associate professor of clinical medicine at Columbia University Medical Center.

Preliminary results on 1,600 patients in the CAPTURE trial were presented at the Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics 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.

The FDA approved carotid artery stenting for symptomatic patients following the pivotal ARCHeR trial, which enrolled a significantly smaller number of patients at centers with expert experience in carotid artery stenting. The larger CAPTURE trial was designed to determine the safety and efficacy of carotid stenting among a broader group of interventionalists with more variable levels of experience.

At 5.7 percent, the CAPTURE trial had an even lower combined rate of death, stroke and myocardial infarction than the ARCHeR trial, which had an 8.3 percent rate. The current study also looked for complications that might have gone undetected in the ARCHeR trial, but did not find any.

The CAPTURE trial found that carotid artery stenting had better outcomes in younger patients. Stroke, death or myocardial infarction occurred in 8.9 percent of patients over the age of 80 years compared with 4.8 percent of patients under 80 years. The lowest percentage of adverse effects - 4.2 percent - was in asymptomatic patients under the age of 80 years.