Position Statement Takes Aim at Alleged Overuse, Promotion of Carotid Artery Stenting

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Key Points:
  • Position statement criticizes trials, guideline recommendations supporting carotid stenting
  • Suggests stenting should not be expanded into routine practice due to higher stroke rate, costs
  • Attempt to deny patients access to technology in face of mounting evidence is wrong, outside source contends

By L.A. McKeown
Tuesday, March 26, 2013

Calls for more routine use of carotid artery stenting (CAS) as an alternative to carotid endarterectomy (CEA) are inappropriate and potentially confusing for patients, according to a position statement published online March 19, 2013, ahead of print in Stroke. The paper argues that the catheter-based treatment not only is associated with a higher rate of stroke or death but also costs more than surgery.

Anne L. Abbott, MD, PhD, of Monash University (Melbourne, Australia), and colleagues argue that while CAS and CEA both result in good outcomes when patients are carefully selected and skilled operators perform the procedures in experienced centers, CAS is still less effective than CEA. Moreover, “key indicators (such as 30‐day periprocedural stroke/death rates) must be accurately measured in routine (real‐world) practice, particularly as stroke and death rates here may be unacceptably higher than in trials,” the coauthors note.

They assert that the 2011 practice guidelines for extracranial carotid and vertebral artery disease issued collaboratively by 14 medical societies were “premature” in supporting CAS as an alternative to CEA for asymptomatic and low/average surgical risk symptomatic patients (Brott TG, et al. Circulation. 2011;124:e54-e130). By doing this, they say, “CAS may easily be misinterpreted by readers as being equivalent for stroke prevention.”

Efficacy and Cost Debate

Dr. Abbott and colleagues devote a large portion of their position statement to critiquing a recent editorial by Christopher J. White, MD, of the Ochsner Heart and Vascular Institute (New Orleans, LA), and Michael R. Jaff, DO, of Massachusetts General Hospital (Boston, MA), that debates reasonable and necessary use of CAS.

In the editorial, Drs. White and Jaff state that CREST (Carotid Revascularization Endarterectomy versus Stenting Trial) failed to show a difference in overall stroke rate between CAS and CEA. But Dr. Abbott and colleagues point out that for average surgical risk symptomatic patients, the periprocedural stroke and death rates were much higher for CAS vs. CEA (6.0% vs. 3.2%; HR 1.89; P = 0.02), with higher periprocedural risk of stroke or death in:

  • Older patients
  • Those undergoing the procedure within 7 days of incident cerebral or retinal ischemic
  • Those undergoing CAS outside clinical trials
  • Those with certain anatomic features

In addition, Dr. Abbott and colleagues state that no study has shown that CAS is more effective than CEA in preventing stroke and that “no randomized trial has been adequately powered to compare the procedural and longer term risk of CAS on stroke or death in low/average risk asymptomatic patients.”

But in a telephone interview with TCTMD, Dr. White called those statements “extremely unbalanced” and “inaccurate.” At 4 years, symptomatic patients in the CREST trial who underwent CAS did not have a significantly higher rate of stroke than the CEA group (48% vs. 37%; P = 0.25) and neither did asymptomatic patients (24% vs. 13%; P = 0.07), he reported.

“The authors miss the point that CAS complications are dramatically lower today than they were 10 years ago,” Dr. White said. “There were very few major strokes or deaths in the second half of the CREST trial. If you look at the results of the pre-[Food and Drug Administration]-approval trials, the rate of periprocedural complications is plummeting. CAS is getting safer every day.”

Regarding cost, Dr. Abbott and colleagues say most analyses indicate that CAS is considerably more expensive than surgery.

Dr. White countered, however, that projected 10-year outcomes from CREST demonstrate only “trivial differences” in overall healthcare costs and quality-adjusted life expectancy between the 2 strategies. If the CREST results can be replicated in clinical practice, he said, factors other than cost-effectiveness should be considered when deciding between treatment options in patients at standard risk for surgical complications.

Payments and Patients

Dr. White added that the position statement does not discuss “the significant co-morbidity of carotid surgery, which includes cranial nerve palsies in 5% of CEA patients [and] which can be significantly debilitating. Also the risk of wound infection is a serious complication of surgery that doesn't occur with stenting.”

Dr. Abbott and colleagues contend that for asymptomatic and low/average surgical risk symptomatic patients, CAS should still only be performed and paid for within well designed, adequately powered trials.

“The US Center for Medicare and Medicaid Services is doing its job and setting an excellent global example,” they write. “It is protecting Medicare beneficiaries from routine practice procedures, which are currently more likely to harm them and waste finite resources that could be used for their advantage.”

However, Dr. White said he believes Dr. Abbott and colleagues are “trying to hold back the tide of what patients want and that is wrong. This [position statement] is asking the government to deny that access.”

He added that “given the multi-societal guideline documents and the fact that the US Food and Drug Administration has approved 7 carotid stent devices, patients and doctors deserve wider access to carotid stents. In 5 to 10 years, CAS is going to be the dominant form of revascularization. . . . We’re not going backwards, surgery is not getting better, but stenting is and recent data are all pointing to that.”

 


Sources:
1. Abbott AL, Adelman MA, Alexandrov AV, et al. Why calls for more routine carotid stenting are currently inappropriate: An international, multispecialty, expert review and position statement. Stroke. 2013;Epub ahead of print.

2. White CJ, Jaff MR. Catch-22: Carotid stenting is safe and effective (Food and Drug Administration) but is it reasonable and necessary (Centers for Medicare and Medicaid Services)? J Am Coll Cardiol Cardiovasc Interv. 2012;5:694-696.

 

Disclosures:

  • Dr. Abbott reports no relevant conflicts of interest.
  • Dr. White reports serving as Chair of the NCDR CARE Registry steering committee.

 

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