More data needed on carotid atherosclerosis, CMS advisers agree

Finally someone agrees we need a much better data collection and registry. In this case for carotid problems, which would have meant my doctors should have sent my data to them except that they didn't find my blockage.
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The panel that advises the Centers for Medicare & Medicaid Services (CMS) on coverage issues is still unsure how to answer several key questions about the treatment of carotid atherosclerosis [1].

"If there was ever a moving-target problem in assessing healthcare interventions, this is one," committee chair Dr Clifford Goodman (The Lewin Group, Falls Church, VA) said during the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) January 25, 2012 meeting at CMS headquarters. "The epidemiology is changing, the patient population is changing accordingly, all of the interventions continue to change, and we've not been keeping up in our data collection for the safety and effectiveness of these interventions as they continue to evolve. This means that to the extent that the CMS is going revisit this as a coverage decision over time, this is an ongoing data-collection issue."

The panel met to discuss the latest data on carotid stenting, carotid endarterectomy surgery, and best medical management for carotid atherosclerosis. The panel did not address the CMS's national coverage policy for these therapies, but the agency is expected to reopen the policy for reconsideration later this year. Currently, Medicare covers carotid stenting with embolic protection only in patients with carotid stenosis >70% who would be at high risk for complications during carotid endarterectomy.

The seminal Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) trial showed similar composite outcomes with stenting or carotid endarterectomy in 2502 high-risk patients. Many interventionalists see the CREST results as justification for discussing both options with their patients, but some physicians argue that surgery is still the best option in these patients, because the 30-day stroke rate was significantly higher with stenting than surgery (4.1% vs 2.3%) in CREST. Those in favor of at least offering stenting to these patients point out that the rate of major strokes was about the same—under 1%—for both therapies and that MI was higher with surgery than stenting (2.3% vs 1.1%).

This diversity of opinion was reflected by MEDCAC. The panel was asked to rate, on a scale of 1 to 5, their confidence in the evidence comparing stenting, surgery, or best medical therapy to decrease stroke or death in asymptomatic, standard-risk patients with carotid stenosis over 60% by angiography (>70% by ultrasound). Several panelists voted 1, indicating they believe the available data are inadequate to determine which of these therapies is best for these patients. On the other end of the spectrum, neurologist Dr J David Spence (University of Western Ontario, London) voted 5 on this question, but overall, the panel's confidence in this evidence was 2 out of 5, so they didn't discuss which therapy they believe is best for these patients.

The panel did discuss the different therapies for symptomatic carotid-atherosclerosis patients at standard risk during surgery. For that group, the panel gave the highest score (3.44) to endarterectomy surgery as the favored option, while stenting scored a 2 and best medical therapy scored a 1.56.

For asymptomatic patients at standard risk for stroke in either cerebral hemisphere, the panel agreed that optimal medical therapy is best option, although a few panelists said they are not confident in the evidence on any therapy in this population.

An ongoing data-collection problem

Dr Kenneth Rosenfield (Massachusetts General Hospital, Boston), who spoke on behalf of the American College of Cardiology (ACC) at the MEDCAC meeting, told heartwire, "The take-away lesson [from the meeting] is that carotid artery disease and the management of it is a moving target. . . . We have really good evidence from 10 to 15 years ago on the management at that time," but results for surgery, medical management, and stenting have all improved over the years, and the data collection hasn't caught up to contemporary practice, he said.

"Some of us say that in the absence of pure clarity, are these treatments pretty darn close? Yes, they are," Rosenfield said. "Given that these are pretty even treatments, patients should be aware of that, and the treatment should be individualized to each patient and the patients should have access to everything.

"But everyone agrees we need to develop better evidence that is timelier and applies to today's results." Rosenfield expects one of the manufacturers of carotid stents to ask the CMS to reopen its coverage policy on carotid-atherosclerosis treatment. He said that the ACC will argue that the CMS should require Medicare-covered carotid procedures to be recorded in a national registry. "If [Medicare] is going to pay for it, shouldn't they and the doctors doing it be responsible for collecting the data on what they are doing? Shouldn't everyone be mandated to look at their own outcomes? It's also unbelievable that it doesn't happen now."

Several panelists also pushed for more ongoing data collection from carotid-atherosclerosis patients. "We need some high-quality registries, of both the procedures and the patients, to figure out what is going on in the real world," Dr Mark Hlatky (Stanford University, CA) said.

Will there be another CREST trial?

Rosenfield and several MEDCAC panelists also expressed support for the proposed CREST II trial, currently spearheaded by neurologist Dr Thomas Brott (Mayo Clinic, Jacksonville, FL). The investigators are currently discussing plans for the study with the National Institutes of Health.

CREST II would randomize about 950 asymptomatic patients with high-grade stenosis to either best medical management or revascularization. Patients randomized to revascularization would work with their doctors to choose either surgery or stenting. The primary outcome of CREST II would be the composite of stroke or death within 30 days of enrollment or ipsilateral stroke up to four years thereafter. The trial is designed to show a 4.8% (1.2% per year) treatment difference between revascularization and medical management, Brott explained during a presentation at the MEDCAC meeting.

Rosenfield is concerned that CREST II may have trouble enrolling patients. "I imagine that a lot of doctors and patients have preconceived notions such that if [patients] have [for example] a 90% narrowing, they want to get it fixed. They won't want to enroll in a randomized trial that might just leave them on best medical therapy. Some doctors might believe, in their own mind, 'This patient is higher risk, so I don't want to randomize them,' " he said. "If you get a lot of people in the trial who have 70% to 75% narrowing but none with higher degrees of narrowing, then you may not be able to show a difference. The trial shows something only about the people it enrolls, not the ones it doesn't enroll, so it will be important to track those patients who aren't enrolled."