Management of Carotid Atherosclerosis

The Centers for Medicare & Medicaid Services (CMS) has convened this meeting for the panel to review available evidence on various clinical strategies for the management of carotid atherosclerosis. Carotid artery atherosclerosis can increase the risk of disabling or fatal stroke. Stroke, according to the Centers for Disease Control (CDC), is the third leading cause of death and the leading cause of serious long-term disability in the United States. Treatments and technologies used in the management of carotid atherosclerosis include medical therapy, carotid endarterectomy (CEA) and carotid artery stenting (CAS).

Medical therapy may involve utilization of anti-platelet drugs, statins, antihypertensives, risk factor modification (smoking cessation and diabetic control), plus lifestyle modification (exercise). CEA is an open surgical procedure in which fatty deposits or plaques are excised from the atherosclerotic segment of the carotid artery. CAS is a catheter-based procedure in which a stent is placed within the atherosclerotic carotid artery. CAS strategies include use of an embolic protection device helps to minimize debris that may dislodge during the procedure.

The meeting will focus on the impact on patient health outcomes of these strategies for management of carotid atherosclerosis and prevention of stroke in both symptomatic and asymptomatic patients, as well as evaluating generalizability of the available evidence to patients of different age, gender, and racial/ethnic backgrounds. Medicare addresses coverage of CAS in section 20.7 of the national coverage determination (NCD) manual (Pub. 100-03) entitled Percutaneous Transluminal Angioplasty (PTA). Sections B2, B3 and B4 of this NCD address coverage of CAS. The NCD is available at http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=201&ncdver=9.

November 18, 2011

November 22, 2011

January 20, 2012

January 26, 2012

January 31, 2012

May 10, 2012

Clifford Goodman, PhD, Chair
Steve Phurrough, MD, Vice Chair
Louis Jacques, MD, Director, Coverage and Analysis Group
Maria Ellis, Executive Secretary

7:30 - 8:00 AM

8:00 - 8:15 AM

8:15 - 8:25 AM

8:25 - 9:10 AM

9:10 - 9:30 AM

9:30 - 9:50 AM

9:50 - 10:10 AM

10:10 - 10:25 AM

10:25 - 10:30 AM

10:30 - 11:20 AM

Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting.

11:20 - 11:30 AM

Public Attendees who wish to address the panel will be given that opportunity p

11:30 - 12:00 PM

12:00 - 1:00 PM

1:00 - 2:00 PM

2:00 - 3:00 PM

The Chairperson will ask each panel member to state his or her position on the voting questionsp

3:00 - 4:00 PM

4:00 - 4:30 PM

The primary focus of this MEDCAC meeting is on whether or not carotid artery stenting (CAS), carotid endarterectomy (CEA) and best medical therapy (BMT) improve outcomes in symptomatic and asymptomatic persons with carotid atherosclerosis.

In discussing the management of such individuals, CMS is most interested in stroke prevention; and the health outcomes of interest are stroke (all stroke) and death (all cause mortality).

Symptomatic means: (1) the presence or absence of focal signs or symptoms of a transient ischemic attack (reversible and lasting < 24 hours), (2) amaurosis fugax (sudden loss of vision in one eye) or (3) an ischemic stroke in either cerebral hemisphere. Asymptomatic means the absence of all of these events.

We also seek the panel’s input on whether or not the published evidence for these strategies is generalizable to the Medicare population – for both men and women, as well as persons of different racial/ethnic backgrounds.

Please use the following scale identifying your level of confidence - with a score of 1 being low or no confidence, and 5 representing high confidence.

1. How confident are you that there is adequate evidence to determine if persons in the Medicare population who are asymptomatic for carotid atherosclerosis can be identified as being at high risk for stroke in either cerebral hemisphere?

Discussion: If there is at least intermediate confidence (score ≥ 2.5 above), are there ethical concerns to conducting randomized controlled trials of CAS/CEA/BMT in the general asymptomatic population? Would such trials only be appropriate for those identified to be at high risk for stroke?

2. How confident are you that there is adequate evidence to determine if persons in the Medicare population, who are considering carotid revascularization, can be identified as being at high risk for adverse events from CEA?

Discussion: If there is at least intermediate confidence (score ≥ 2.5 above), how does one reliably (across medical and surgical specialties) identify these individuals?

3. For persons with symptomatic carotid atherosclerosis and carotid narrowing ( ≥ 50% by angiography or ≥ 70% by ultrasound) who are not generally considered at high risk for adverse events from CEA:
   1. How confident are you that there is adequate evidence to determine whether or not either CAS or CEA is the favored treatment strategy, as compared to BMT alone, to decrease stroke or death in the Medicare population?
   2. If there is at least intermediate confidence (score ≥ 2.5 above), how confident are you that
      1. CAS is the favored treatment strategy in this population?
      2. CEA is the favored treatment strategy in this population?
      3. BMT alone is the favored treatment strategy in this population?

Discussion: If there is at least intermediate confidence (score ≥ 2.5 above) for questions 3.b.i, ii or iii above, please discuss the impact of the following on your conclusions:
1. Patient age, gender, and racial/ethnic background
2. Time to treatment, e.g., < 2 weeks or > 2 weeks from onset of symptoms

4. For persons with asymptomatic carotid atherosclerosis and carotid narrowing ( ≥ 60% by angiography or ≥ 70% by ultrasound) who are not generally considered at high risk for adverse events from CEA:
   1. How confident are you that there is adequate evidence to determine whether or not either CAS or CEA is the favored treatment strategy, as compared to BMT alone, to decrease stroke or death in the Medicare population?
   2. If there is at least intermediate confidence (score ≥ 2.5 above), how confident are you that
      1. CAS is the favored treatment strategy in this population?
      2. CEA is the favored treatment strategy in this population?
      3. BMT alone is the favored treatment strategy in this population?

Discussion: If the there is at least intermediate confidence (score ≥ 2.5 above), please discuss the impact of the following on your conclusions:
1. Patient age, gender, and racial/ethnic background (for questions 4.b.i,ii or iii)
2. Concurrent BMT (for questions 4.b.i or ii)

5. For persons with asymptomatic carotid atherosclerosis who are not generally considered at high risk for stroke in either cerebral hemisphere:
   1. How confident are you that there is adequate evidence to determine whether or not CAS or CEA or BMT alone is the favored treatment strategy to decrease stroke or death in the Medicare population?
   2. If there is at least intermediate confidence (score ≥ 2.5 above), how confident are you that
      1. CAS is the favored treatment strategy in this population?
      2. CEA is the favored treatment strategy in this population?
      3. BMT alone is the favored treatment strategy in this population?

Discussion: If the there is at least intermediate confidence (score ≥ 2.5 above), please discuss the impact of the following on your conclusions:
1. Patient age, gender, and racial/ethnic background (for questions 5.b.i,ii or iii)
2. Concurrent BMT (for questions 5.b.i or ii)

6. In the general Medicare population:
   1. How confident are you that there is adequate evidence to determine whether or not carotid artery screening of asymptomatic persons decreases stroke or death?
   2. If there is at least intermediate confidence (score ≥ 2.5 above), how confident are you that carotid artery screening of asymptomatic persons decreases stroke or death?

7. What unmet research needs, specific to the following issues, are important to consider and explore further?

   1. Should future stroke prevention trials
      1. Be powered to evaluate only symptomatic or asymptomatic patients?
      2. Be powered to draw conclusions regarding gender?
      3. Evaluate outcomes for more racially/ethnically diverse patient populations?

   2. So as to help delineate those who require carotid revascularization from those who do not, how should future trials best utilize and validate for the Medicare population the following tools to identify persons with asymptomatic carotid atherosclerosis who are at high risk for stroke?
      1. Advanced imaging, such as 3D ultrasound, for plaque morphology
      2. Transcranial Doppler (TCD) for cerebral microembolization
      3. Pre- and post-procedure diffusion weighted MRI (DW-MRI) for silent infarcts
      4. Risk assessment tools and predictive stroke models

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