Carotid Stenting Safe in Post-Approval Settings
Carotid stenting with embolic protection shows good results with variety of physician expertise
MONDAY, Jan. 1 (HealthDay News) -- In the real world, carotid stenting with embolic protection can be safely performed by physicians with varying levels of experience in diverse settings, researchers report in the January issue of Catheterization and Cardiovascular Interventions.
William A. Gray, M.D., of Columbia University in New York City, and colleagues assessed the safety of carotid stenting in 3,500 high-risk patients treated by 353 physicians who were enrolled in the CAPTURE trial (Carotid Acculink/Accunet Post-Approval Trial to Uncover Unanticipated or Rare Events).
The researchers found a similar 6.3 percent 30-day event rate, ranging from 5.3 percent for the most experienced physicians, to 7.4 percent for the least experienced. Physician specialties had no major impact on results, and the device had no unexpected adverse effects.
"The results of the CAPTURE study compare favorably to those achieved in the predicate pivotal investigations, and suggest that the post-approval transfer of this new therapy to the community practice setting via carotid stent training programs is effective in preparing physicians with varying experience levels and specialty training backgrounds," the authors conclude.