March 10, 2009 - Carotid artery stenting (CAS) has demonstrated outcomes consistent with the American Heart Association’s (AHA) long-established guidelines for treatment of patients who have blockages in their carotid arteries and are at risk for standard carotid surgery, according to an analysis of two large, prospective studies published online Friday in the journal Circulation: Cardiovascular Interventions.
Based on these and other data, the Society for Cardiovascular Angiography and Interventions (SCAI) is calling on the Centers for Medicare and Medicaid Services (CMS) to expand coverage of CAS to include all FDA-approved indications, which would provide additional treatment options for a larger group of patients who are at risk for stroke. This would reverse the agency’s Oct. 16, 2008, decision not to expand coverage of CAS at that time, which cited a lack of published, peer-reviewed data.
The newly published analysis looked at results from two post-market studies, CAPTURE 2 and EXACT, examining the safety and effectiveness of two different FDA-approved carotid stent and embolic protection systems. Data show both symptomatic and asymptomatic patients undergoing CAS achieved the outcomes recommended by the AHA for 30-day death and stroke rates for carotid endarterectomy. This standard surgical procedure to remove carotid artery blockages has not been subjected to the same level of scrutiny in these at-risk patients.
“Previously, neither surgery nor CAS had demonstrated these outcomes in a multicenter, prospective trial of high-surgical-risk patients,” said William A. Gray, M.D., director of the endovascular services at the Center for Interventional Vascular Therapy, New York-Presbyterian Hospital and Columbia University. “In the 10 years since the AHA guidelines for carotid endarterectomy were published, there has not been a similarly rigorous study demonstrating that carotid endarterectomy meets these guidelines in high-risk patients.”
"The results of CAPTURE 2 and EXACT extend results we've seen from the CAS studies in high-risk patients to those who have not yet suffered a stroke. It is exciting to learn the growing body of evidence demonstrates carotid stenting is as safe and effective as surgery in all patient groups," said Steven R. Bailey, M.D., FSCAI, SCAI president-elect. "The EXACT and CAPTURE 2 data strongly support the case that CAS should be considered an appropriate option to treat patients with carotid stenosis and surgical risks."
Currently, CAS is only covered by CMS in certain high-risk patients who cannot undergo surgery due to severe blockages or other factors, while surgery is fully covered. These data follow similar findings from the Stenting and Angioplasty with Protection of Patients with High Risk for Endarterectomy (SAPPHIRE Worldwide) trial, published in Catheterization and Cardiovascular Interventions (CCI) in October, just one day after CMS announced its decision. The CCI data, coupled with the results of the CAPTURE 2 and EXACT trials, show an almost overwhelming case for the option to offer CAS to these patients.
“Evidence in support of CAS is growing,” said Bonnie H. Weiner, M.D., MSEC, MBA, FSCAI, SCAI immediate past president. “Patients at risk for stroke deserve access to the best possible treatment options for their condition, and the physicians caring for them deserve to have the opportunity to provide the best care for their patients. We are disappointed CMS did not expand coverage of CAS, but are hopeful these data will hold enough merit for CMS to quickly reconsider its decision.”
Stroke is the No. 3 cause of death in the U.S., according to the American Stroke Association.
For more information: www.Seconds-Count.org, www.scai.org, www.seconds-count.org