- Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.
Preliminary Key Questions
- What are the outcomes (effectiveness and harms) of carotid artery stenting (CAS) compared to carotid endarterectomy (CEA)?
- Are there patient subgroups who are likely to benefit more or less from CAS compared to CEA?
- What are the costs of CAS compared to CEA?
- What operator characteristics are associated with better outcomes for CEA and CAS?
- Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)
yes
- If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:
Carotid artery stenting (endovascascular treatment or repair) versus carotid endarterectomy
- What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)
Patients for whom carotid artery stenting is being considered (any age, gender or with any existing co-morbidities) including symptomatic patients and patients without symptoms but with stenoses of >50% of the internal carotid artery.
- Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)
Patients who are symptomatic and asymptomatic, those with varying degrees of occlusion of the carotid artery (e.g. 70% to 99%, 50% to 69%), and those who are deemed high risk surgical candidates compared to average surgical risk candidates.
- Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)
Hospital length of stays, recovery of activities of daily living, quality of life, complication rates, readmission rates, repeat surgeries, further disability
- Describe any health-related risks, side effects, or harms that you are concerned about.
Ipsilateral and contralateral stroke, mortality, myocardial infarction
Appropriateness for EHC Program
- Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?
yes
- Which priority area(s) and population(s) does this topic apply to? (check all that apply)
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- EHC Priority Conditions (updated in 2008)
- Cardiovascular disease, including stroke and hypertension
- Functional limitations and disability
- AHRQ Priority Populations
- Low income groups
- Minority groups
- Women
- Elderly
- Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care
- Federal Health Care Program
- Medicaid
- Medicare
Importance
- Describe why this topic is important.
Carotid stenting is a newer percutaneous procedure than carotid endarterectomy. A comparative effectiveness review of carotid stenting versus endarterectomy would help policy makers and clinicians weigh the benefits and risk of each procedure and help guide policy and coverage decisions – particularly for patients in usual health care setting compared with those entering clinical trials.
- Identifying operator characteristics associated with better outcomes for CAS and CEA would help professional societies and policymakers develop standards for those performing the procedures and possibly criteria for centers of excellence.
- What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)
Controversy remains among clinical groups and policymaker as to patient selection for CAS vs. CEA, in spite of two recent studies suggesting that a much smaller group of patients than initially thought would benefit from CAS over CEA. A framework from a health technology assessment that would synthesize information for systematic reviews/meta-analyses and large observational studies might provide clarity and guide clinical and policy decisions.
- Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)
yes
- If yes, please explain:
Recently published literature in the Journal of the American Medical Association (volume 302, number 12) has questioned the safety and efficacy of carotid stenting in a patient sample whose characteristics likely vary from those enrolled in RCTs.
- Ederle, J., Featherstone, R., & Brown, M.M. (2007). Percutaneous transluminal angioplasty and stenting for carotid artery stenosis. Cochrane Database of Systematic Reviews, Issue 4. Art. No.: CD000515. DOI.
- Murad, M.H., Shahrour, A., Shah, N.D., Montori, V.M., & Ricotta, J.J. (2011). A systematic review and meta-analysis of randomized trials of carotid endarterectomy vs stenting. Journal of Vascular Surgery, 53, 792-7.
Potential Impact
- How will an answer to your research question be used or help inform decisions for you or your group?
The information would be used by state legislatures and policy makers to develop policy regarding carotid artery stenting including standards for operators and possibly centers of excellence. In addition, the results would be disseminated by states to clinicians to help inform better practice.
- Describe the timeframe in which an answer to your question is needed.
One year.
- Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.
Answers to these questions would help determine a more effective and efficient approach to the use of carotid stenting.
Nominator Information
- Other Information About You: (optional)
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- Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)
The information would be used by state legislatures and policy makers to develop policy regarding carotid artery stenting including standards for operators and possibly centers of excellence. In addition, the results would be disseminated by states to clinicians to help inform better practice.
- Are you making a suggestion as an individual or on behalf of an organization?
Organization
- Please tell us how you heard about the Effective Health Care Program
MED Project, Center for Evidence-based Policy, Oregon Health and Science University
