National Outcomes Registry Data Results on CAS vs. CEA

Newswise — The Outcomes Committee of Society for Vascular Surgery (SVS) developed the Vascular Registry on Carotid Procedures in response to the Centers for Medicare and Medicaid Services' (CMS) National Coverage Decision (NCD) on carotid artery stenting (CAS). The NCD requires institutions that are performing this procedure to provide data points that include mortality and major vascular complications rates. Although CMS requires data submission only on CAS, SVS designed the Vascular Registry to collect similar data on carotid endarterectomy (CEA) to allow comparison of outcomes, with potential for expansion to other procedures. Current outcomes were presented at the 62nd Annual Meeting of the SVS, June 5-8, in San Diego, Calif.

According to Anton N. Sidawy, MD, chief of surgery at the Veterans Medical Center in Washington, D.C., vice-president of the SVS, and member of the SVS Vascular Registry Outcomes Committee, the registry is on-line and offers provider-reported data including pre-procedure demographics, medical history and symptom status; diagnostic imaging; procedural information; complications; and follow-up. An independent data center maintains the database, which is HIPAA-compliant and auditable. Both CAS and CEA providers from seven specialties contribute data to the Registry.

Electronic data entry began July 11, 2005. Currently, 6,403 procedures with discharge data have been entered by 287 providers at 56 centers on 2,763 CAS patients (1,450 with 30-day outcomes, 52.5 percent) and 3,259 CEA patients (1,368 with 30-day outcomes, 42 percent).

Of the total cohort, 98 percent of CEA and 70.7 percent of CAS were done for atherosclerotic disease; and 22.3 percent and 4.5 percent of CAS were done for restenosis and radiation-induced stenosis, respectively. 49.2 percent of CAS and 42.4 percent of CEA were performed for symptomatic disease.

The CAS patients had higher prevalence of pre-procedure stroke, amaurosis fugax, coronary artery disease, myocardial infarction (MI), congestive heart failure, chronic obstructive pulmonary disease and cardiac arrhythmia. For CAS, death/stroke/MI at 30-days was 7.13 percent for symptomatic patients and 4.60 percent for asymptomatic patients. For CEA, death/stroke/MI at 30-days was 3.75 percent in symptomatic patients and 1.97 percent in asymptomatic patients. After risk-adjustment for age, history of stroke, diabetes and ASA grade (i.e., significant confounders in outcomes using backwards elimination), logistic regression analysis demonstrated better outcomes following CEA.

"The SVS Vascular Registry provides an excellent venue for collection of CAS data to meet CMS facility recertification requirements," said Dr. Sidawy. "With continued enrollment and follow-up, analysis of the SVS Registry will supplement randomized trials by providing real-world comparisons of CAS and CEA with sufficient numbers to serve as an outcome assessment tool of important patient subsets and across the spectrum of peripheral vascular procedures."

About the Society for Vascular SurgeryThe Society for Vascular Surgery (SVS) is a not-for-profit society that seeks to advance excellence and innovation in vascular health through education, advocacy, research and public awareness. SVS is the national advocate for 2,400 vascular surgeons dedicated to the prevention and cure of vascular disease. Visit the website at http://www.VascularWeb.org.