New Carotid Disease Guidelines Take Cues from CREST
On the heels of last week’s vote by the US Food and Drug Administration Circulatory System Devices Panel in favor of expanding the indication for carotid artery stenting (CAS) to patients at standard risk for surgical complications, 14 medical societies have collaborated to develop a practice guideline for the management of patients with extracranial carotid and vertebral artery disease. The new recommendations view stenting as a viable alternative to surgery in many cases.
The full text of the guidelines is being published jointly in Circulation, Stroke, and the Journal of the American College of Cardiology.
Led by writing committee cochairs Jonathan L. Halperin, MD, of Mount Sinai School of Medicine (New York, NY), and Thomas G. Brott, MD, of the Mayo Clinic (Jacksonville, FL), the task force analyzed extensive data and developed the recommendations using evidence-based methodologies. The strength of the evidence supporting current recommendations is ranked as Level A, B, or C.
Validation for CAS
According to the guidelines, CAS is a safe and effective alternative to carotid endarterectomy (CEA) in symptomatic patients with > 50% stenosis and low to average surgical risk. The guidelines also state that prophylactic CAS might be considered in highly selected patients with asymptomatic carotid stenosis (minimum 60% by angiography, 70% by validated Doppler ultrasound), but add that its effectiveness compared with medical therapy alone in this situation is not well established.
In addition, the guidelines state that selection of asymptomatic patients for carotid revascularization should be guided by an assessment of comorbid conditions, life expectancy, and other individual factors and should include a thorough discussion of the risks and benefits of the procedure with an understanding of patient preferences.
“The guidelines attempt to define practices that meet the needs of most patients in most circumstances,” the authors write. “The ultimate judgment regarding care of a particular patient must be made by the health care provider and patient in light of all the circumstances presented by that patient. Thus, there are situations in which deviations from these guidelines may be appropriate.”
The guidelines also state that it is reasonable to choose CEA over CAS when revascularization is indicated in older patients, “particularly when arterial pathoanatomy is unfavorable for endovascular intervention.” On the other hand, it is reasonable to choose CAS over CEA when revascularization is indicated in patients with neck anatomy unfavorable for surgery, they state.
When Screening Is and Is Not Appropriate
The guidelines also address the issue of widespread screening or routine ultrasound for carotid disease, concluding that it is reasonable to perform duplex ultrasonography to detect hemodynamically significant carotid stenosis in asymptomatic patients with carotid bruit, and to repeat the ultrasound annually to assess the progression or regression of disease and response to therapeutic interventions in patients with atherosclerosis who have had stenosis greater than 50% previously detected.
However, ultrasound is not recommended for routine screening of asymptomatic patients who have no clinical manifestations of or risk factors for atherosclerosis, and routine serial imaging of the extracranial carotid arteries is not recommended for patients who have no risk factors for development of atherosclerotic carotid disease and no disease evident on initial vascular testing.
Impact of CREST Evident in Guidelines
In a telephone interview with TCTMD, Christopher J. White, MD, of the Ochsner Heart and Vascular Institute (New Orleans, LA), said he believes the task force is sending the strongest statement to date about the value of CAS.
“These guidelines are speaking to government regulators,” Dr. White said. “This paper, on top of the professional recommendation from the FDA panel, will be strong impetus to approve [CAS] and to accept the panel’s recommendation. But the more important part will be to take the FDA’s recommendation and use it to move [the Centers for Medicare and Medicaid Services] in the direction of [providing] reimbursement. Because you can approve anything you want, but if you don’t pay for it, you’re stuck. That’s the next step in this process. Now that we know that these treatments are equal, you should be able to prescribe the treatment that best serves your patient without worrying about who is going to pay for it.”
Dr. White added that the effect of the CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) results is evident in the recommendations. Originally published in the July 1, 2010, issue of NEJM, CREST randomized 2,502 patients with either symptomatic or asymptomatic disease to CEA or CAS. Overall, there was no significant difference in the estimated 4-year rates of the primary endpoint (composite of any periprocedural stroke, MI, or death, or the incidence of ipsilateral stroke within 4 years) between the 2 groups. However, there was a higher risk of periprocedural stroke with stenting and a higher risk of MI with surgery.
“The CREST trial was the bedrock on which this document was written,” Dr. White said. “CREST didn’t say everyone needs a carotid stent, but it provided the evidence necessary to show that it is a valid choice.”
A Good Place to Start
In a telephone interview with TCTMD, William A. Gray, MD, of Columbia University Medical Center (New York, NY), complimented the task force for tackling such a large subject and creating “a very good document, a good starting place.”
However, as with all guidelines, the recommendations stand still as new data march forward, Dr. Gray said. While the essential CREST results have been incorporated, he said, additional data that will be important from a practice perspective are still emerging through subanalyses of CREST. Some of those are scheduled for presentation at the annual American Stroke Association’s International Stroke Conference this month, he added.
Dr. Gray also commented that while the majority of the recommendations in the guidelines are reasonable, he felt that the message regarding asymptomatic patients was not as clear as it could be and took issue with the decision that it is reasonable to choose CEA over CAS in older patients, saying that was a reflection of the original CREST analysis, which has since been redone.
“Last week’s analysis [which was presented at the FDA panel meeting] tells us that CEA and CAS are both higher risk in older patients (over age 80) and there is no difference between the two,” Dr. Gray said. “Unfortunately, [the task force] was not able to get that new analysis into this paper.”
The guidelines were developed with the American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American Society of Neuroradiology, American College of Radiology, Congress of Neurological Surgeons, Society for Atherosclerosis Imaging and Prevention, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery. The American Academy of Neurology and the Society of Cardiovascular Computed Tomography collaborated in the process.
Brott TG, Halperin JL, Abbara S, et al. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease. Circulation. 2011;Epub ahead of print.
- Dr. Brott reports receiving research funding from Abbott and the National Institutes of Health and serving as the principal investigator of the CREST trial.
- Dr. Halperin reports serving as a consultant for Astellas Pharma, Bayer HealthCare, Biotronik, Boehringer Ingelheim, Daiichi Sankyo, the FDA's Cardiovascular and Renal Drugs Advisory Committee, GlaxoSmithKline, Johnson & Johnson, Portola, and Sanofi-Aventis, and receiving research funding from the National Heart, Lung, and Blood Institute.
- Dr. White reports having served as principal investigator of the CABANA study, which was sponsored by Boston Scientific.
- Dr. Gray reports having been an investigator in the CREST trial and serving as a consultant for Abbott.