Study shows safety of carotid stenting in 'real-world' setting
The largest-ever study of carotid stenting in high-surgical risk patients has shown that with proper education and training, community physicians are just as successful at using catheter-based techniques to unclog arteries supplying blood to the brain as are those who pioneered the procedure at major university medical centers. The study was released online today at www.scai.org and will be published in the January 2007 issue of Catheterization and Cardiovascular Interventions: Journal of the Society for Cardiovascular Angiography and Interventions.
The CAPTURE study (short for Carotid ACCULINK/ACCUNET Post- Approval Trial to Uncover Unanticipated or Rare Events) involved 3,500 patients at increased surgical risk for carotid endarterectomy and 353 physicians at 144 hospitals across the United States. It addressed several questions critical to the evaluation of any new technology, among them: Could carotid stenting safely make the leap to "real-world," everyday use, or would the technique prove beneficial only in the hands of expert physicians"
"The ability to transfer the technology to the community was successful," said Dr. William A. Gray, Director of Endovascular Services and an Associate Professor of Clinical Medicine at Columbia University in New York City. "The study involved multiple physician specialties, multiple experience levels, and multiple sites with very broad geographic representation, and demonstrated that regardless of these differences, outcomes were similar across the board."
In carotid stenting, a physician threads a catheter through a small puncture in a leg artery and into the narrowed artery in the neck, which feeds blood to the brain. A filter is placed through this catheter and expanded above the blockage to protect the brain during the procedure. A flexible and crush-resistant stent is positioned in the blockage and then expanded with a balloon to hold the artery open. Once the procedure is complete, the filter is collapsed and removed.
The Rx Acculink carotid stent and its companion, the Rx Accunet filter, were approved by the Food and Drug Administration (FDA) in 2004 for the treatment of patients who not only have severe plaque build-up in the arteries in the neck