The Centers for Medicare & Medicaid Services (CMS) has announced that it will revisit its decision on expanded coverage for carotid artery stenting (CAS).
Expanded coverage of CAS would include all FDA-approved indications would provide additional treatment options for a patient population who are at risk for stroke. This would reverse the agency's Oct. 16, 2008 decision not to expand coverage of CAS, which cited a lack of published, peer-reviewed data.
The Society for Cardiovascular Angiography and Interventions (SCAI) said that since CMS' 2008 decision, several newly published studies have shown CAS is as safe and effective as surgery for patients who have blockages in their carotid arteries. The more recent data also has provided further evidence that CAS achieves outcomes consistent with the American Heart Association's (AHA) guidelines for treatment of patients who have blockages in their carotid arteries and are at risk for standard carotid surgery.
"These new data demonstrate CAS has, in high-surgical-risk patients, achieved or exceeded the AHA endarterectomy guidelines," said William A. Gray, MD, director of endovascular services at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital and Columbia University in New York City.
Results from two post-market studies, CAPTURE 2 and EXACT, published in the March 2009 issue of Circulation: Cardiovascular Interventions (CCI), showed both symptomatic and asymptomatic patients undergoing CAS achieved the outcomes recommended by the AHA for 30-day death and stroke rates for carotid endarterectomy, SCAI said. These data follow similar findings from the SAPPHIRE Worldwide trial, published in CCI in October 2008. The SAPPHIRE trial found that 30 days after treatment, high-surgical-risk patients who received CAS had similar results to patients who received surgery.
"These studies demonstrate that CAS should be considered an appropriate option to treat patients with carotid stenosis and increased surgical risks," said Steven R. Bailey, MD, SCAI president-elect. "We applaud CMS for revisiting its decision on expanding coverage of CAS, and we hope CMS will agree that patients and physicians should have a wider range of treatment options to best suit each patient's specific condition."