This article is more than 5 years old. Information may no longer be current.
Data should help in debate of carotid artery stenting vs. endarterectomy
Click Here to Manage Email Alerts
Clinical trial data may be helping determine applicability and appropriateness of carotid artery stenting and endarterectomy in specific patient populations.
Christopher J. White, MD, chairman of the department of cardiology at Ochsner Clinic Foundation, and Kenneth Rosenfield, MD, section head of vascular medicine at Massachusetts General Hospital, discussed the results and implications of several pending stenting and endarterectomy clinical trials during a webcast sponsored by the American College of Cardiology.
The CREST trial completed a lead-in phase with 1,552 patients. The 30-day stroke and death rates were close to American Heart Association guidelines for carotid endarterectomy, which are 6.0% in symptomatic patients, 3.8% in asymptomatic patients. ACT I trial researchers plan to enroll more than 1,800 patients to demonstrate noninferiority of carotid artery stenting compared with endarterectomy.
Results from the SPACE trial failed to show non-inferiority of stenting vs. endarterectomy, but the results were attributed to inadequate patient enrollment.
“The French EVA-3S trial was terminated prematurely in part because of operator inexperience,” White said.
“One thing that was unusual about EVA-3S was that 13 of the patients were referred for emergency endarterectomy during the stenting procedure,” White said. “At Oschner, we have performed more than 1,200 stenting procedures, and we have never sent a patient for endarterectomy, so it is not clear to me what would cause someone to stop a stenting procedure to send a patient for surgery.”
The Centers for Medicare and Medicaid Services provides reimbursement for carotid artery stenting in symptomatic, high-risk patients, but not for asymptomatic high-risk patients unless they are involved with a post-marketing study or other post-market analysis.
“It is important to know that CMS has reopened the coverage decision for the asymptomatic high-risk patients, as a result of being requested last spring by several societies to do so,” Rosenfield said. “We will know the answer to that in October.”
For more information:
- National Cardiovascular Data Registry website. www.ncdr.com/WebNCDR/NCDRDocuments/accf_cas_webinar_final.pdf. Accessed: July 15, 2008.