Authors' objectives:

"To review and evaluate available evidence concerning outcomes of CAS with EPD alone and compared to alternatives (CEA and best medical therapy) for reducing stroke risk in patients with carotid artery stenosis. The Assessment specifically seeks the following evidence:

1. Can CAS be performed with periprocedural stroke/death rates established as clinically acceptable and associated with an overall net health benefit among symptomatic and asymptomatic patients at: a) average medical and anatomic risk, b) increased medical risk, and c) increased anatomic risk?

2. How do CAS, CEA, and best medical therapy compare in each of the above subgroups?" (from executive summary)

Authors' recommendations: Available evidence does not support concluding that CAS is performed with acceptable periprocedural stroke/death rates for symptomatic or asymptomatic patients, that it provides a net health benefit to patients at increased medical risk, or that it is equally effective as CEA. There is a clinical rationale and limited evidence suggesting CAS may be beneficial in the group of patients at increased anatomic risk; however, current evidence has not clearly differentiated outcomes for this subgroup according to symptomatic status. Based on the available evidence, the Blue Cross and Blue Shield Association Medical Advisory Panel (MAP) made the following judgments about whether carotid artery angioplasty and stenting (CAS) with or without distal embolic protection (EPD) meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria to reduce stroke risk from symptomatic or asymptomatic carotid stenosis. 1. The technology must have final approval from the appropriate governmental regulatory bodies. CAS with or without EPD is a procedure and thus does not require U.S. Food and Drug Administration (FDA) approval. However, the devices used for CAS and for EPD require FDA approval. As of this writing, five manufacturers' stents are FDA approved and indicated specifically for use in carotid arteries. The FDA has mandated postmarketing studies for these devices, including longer follow-up for patients already reported to the FDA, and additional registry studies primarily to compare outcomes as a function of clinician training and facility experience. The devices are indicated for combined use of a stent and EPD to reduce stroke risk in patients at increased risk for perioperative complications from CEA who are symptomatic with =50% stenosis or asymptomatic with >80% stenosis. CAS with these devices for patients outside these indications is an off-label use. 2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes. Available evidence permits conclusions regarding periprocedural complication rates (particularly stroke or death) following CAS in patients of average risk and increased medical risk. Periprocedural stroke/death rates surpassed those established as clinically acceptable and associated with an overall net health benefit following CEA. There is limited evidence and a clinical rationale to suggest CAS may be beneficial in the group of patients at increased anatomic risk, but present evidence has not clearly differentiated outcomes for this subgroup according to symptomatic status. Thus, there is insufficient evidence to draw conclusions regarding patients at increased anatomic risk. A number of large ongoing trials will yield more evidence in the near future (e.g., "Carotid Revascularization Endarterectomy versus Stent Trial" [symptomatic and asymptomatic]; "International Carotid Stenting Study" [symptomatic]; and the "Asymptomatic Carotid Surgery Trial," ACT-1). 3. The technology must improve the net health outcome. Available evidence does not support concluding that CAS with EPD improves the net health outcome among patients at average or increased medical risk. Evidence regarding patients at increased anatomic risk is suggestive of benefit, but insufficient to draw conclusions. 4. The technology must be as beneficial as any established alternatives. Available evidence does not support concluding that CAS with or without EPD is as beneficial as CEA for symptomatic patients at average risk or increased medical risk. Whether CAS with EPD is as beneficial as CEA for asymptomatic patients at average medical or anatomic risk cannot be determined because available evidence is insufficient to permit conclusions. There is no evidence comparing best medical therapy for symptomatic or asymptomatic patients at increased medical or anatomic risk, preventing conclusions. 5. The improvement must be attainable outside the investigational settings. Whether CAS with EPD improves health outcomes has not yet been demonstrated in the investigational setting. Based on the above, use of carotid artery angioplasty and stenting with or without embolic protection of the cerebral circulation for patients with carotid artery stenosis does not meet the TEC criteria. *There is theoretically a fourth group at increased anatomic and medical risk, but anatomic risk is presumed to be of greater clinical importance.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.bcbs.com/blueresources/tec/contact-tec.html

Year Published: 2007

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: BlueCross BlueShield Association

Contact Address: BlueCross BlueShield Association, Technology Evaluation Center, 225 North Michigan Ave, Chicago, Illinois, USA. Tel: 888 832 4321

Contact Name: tec@bcbsa.com

Contact Email: tec@bcbsa.com

Copyright: BlueCross BlueShield Association (BCBS)