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STUDY: CAROTID STENTING AS SAFE IN 'REAL WORLD' SETTINGS AS IN UNIVERSITY HOSPITALS

December 13, 2006

The largest-ever study of carotid stenting in high-risk surgical patients found that community physicians are just as successful at using catheter-based techniques to unclog carotid arteries (arteries in the neck that supply blood to the brain) as those who pioneered the procedure at major university medical centers, the Society for Cardiovascular Angiography and Interventions (SCAI) announced Dec. 14.

Results of the Carotid ACCULINK/ACCUNET Post-approval Trial to Uncover Unanticipated or Rare Events (CAPTURE) were posted online at www.scai.org, and will be published in the January issue of Catheterization and Cardiovascular Interventions: Journal of the Society for Cardiovascular Angiography and Interventions.

The study involved 3,500 patients at increased surgical risk for carotid endarterectomy (the removal of plaque from a blocked artery) at 144 hospitals across the U.S., SCAI said.

The CAPTURE registry was developed to collect FDA-mandated data to assess the ongoing safety of the Rx Acculink carotid stent and the Rx Accunet filter, which were approved by the FDA in 2004 to treat patients with severe plaque buildup in carotid artery -- a condition that increases the risk of stroke, the group said.

The Centers for Medicare & Medicaid Services (CMS) currently provides coverage for carotid stenting for patients who are at high risk for surgery and have symptoms before the procedure, but not for those who are symptom-free despite severely narrowed carotid arteries, SCAI said. "CMS is now reevaluating that policy in light of data from CAPTURE and other postmarket surveillance studies," it added.