A new study, released today by the Society for Cardiovascular Angiography and Interventions, shows that the minimally invasive technique of carotid stenting has made a successful transfer from the academic environment where it was created into the hands of real-world physicians who have received proper education and training.
The largest-ever study of carotid stenting in high-surgical risk patients has demonstrated that well-trained 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. Released online today at www.scai.org, the study 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 U.S. 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.”
The Rx Acculink carotid stent and its companion, the Rx Accunet filter, were approved by the FDA in 2004 for the treatment of patients who not only have severe plaque build-up in the arteries in the neck—a condition that hikes the risk of stroke—but other medical problems that make it risky to have the plaque removed surgically. The CAPTURE registry was developed to collect FDA-mandated data to assess the ongoing safety of the Rx Acculink and Rx Accunet devices in a large group of patients, as well as the effectiveness of a training program tailored to the experience level of each physician interested in performing carotid stenting.
For more information, contact Dr. Gray at 212-342-4747 or send of the journal, call 504-842-3717 or send an email to [email protected]