ACT I: Women Reap More Long-term Benefits From Carotid Stenting vs CEA

LAS VEGAS, NV—Asymptomatic women with carotid artery disease have fewer ipsilateral strokes over the long term when treated with carotid artery stenting (CAS) compared with carotid endarterectomy (CEA), according to a subanalysis from the ACT I trial presented here at VIVA 2017. The new findings also showed that stenting bests surgery over time in patients who have CAD and peripheral vascular disease (PVD) on top of carotid disease.

The main ACT I trial results, published in early 2016, showed equivalent outcomes for CAS and surgery in asymptomatic patients out to 5 years. For the subanalysis, presented by Gary M. Ansel, MD (Riverside Methodist Hospital, Columbus, OH), researchers looked at two subgroups: gender and atherosclerotic burden subtypes (carotid disease alone, carotid disease + CAD, carotid disease + PVD, and carotid disease + CAD + PVD).

At 5 years, women had lower rates of ipsilateral stroke when treated with CAS compared with CEA (P = 0.02). Across the four categories of atherosclerotic burden, there were no differences between the two treatments for the primary endpoint of death, stroke, or MI within 30 days and ipsilateral stroke out to 5 years, except for the group with the combination of carotid artery disease, CAD, and PVD, in whom there was a statistically significant difference favoring stenting (P = 0.04).

ACT I randomized 1,453 asymptomatic patients enrolled at 62 US sites to stenting with the Xact stent and use of an Emboshield, Emboshield Pro, or Emboshield NAV6 protection device (all Abbott Vascular) or to endarterectomy.

Addressing the media prior to the presentation, ACT I principal investigator Kenneth Rosenfield, MD (Massachusetts General Hospital, Boston, MA), noted that the data on women are paradoxical compared to the data from CREST, which did not show a gender interaction for CAS. Asked about insight into the difference and how to tease out whether the ACT I findings are real, he said it remains an unknown given an abundance of conflicting data on either side of the equation.

Following the presentation, panelist Peter Schneider, MD (Kaiser Foundation Hospital, Honolulu, HI), said it seems as if patients at high risk for surgery are still being identified among the asymptomatic patient groups traditionally thought to be at normal risk.

Ansel noted that “we are getting smarter as we go along,” adding that it makes sense that patients with high atherosclerotic burden, who have “terrible pipes throughout their entire body,” would be at higher risk from an invasive procedure because they represent a different subset of the asymptomatic population.

Can Politics and Red Tape Get Out of the Way?

Currently, CAS is only reimbursed for symptomatic carotid artery disease of 70% or greater. For symptomatic patients with stenosis between 50% and 70%, or asymptomatic patients with stenosis of 80% or more, Centers for Medicare & Medicaid Services (CMS) reimbursement only applies to patient registries or trials.

Rosenfield was adamant that both CAS and CEA should be reimbursed since the data thus far are clear that patients should have the choice between the two. “The fact that they [do not] is probably because we haven’t gone about this the right way with collaboration amongst specialties, as has been the case in TAVR,” he said, adding that he is hopeful that CMS will take a fresh look, clearing the way for balanced decision-making.

Without a doubt, we have two good therapies that Medicare should get out of the way on. Gary Ansel

“We need to continue to produce data that demonstrate that this therapy is reasonable and [show that] for individual patients it might be the right therapy,” Rosenfield said.

Panelist Tamara Syrek Jensen, JD (Centers for Medicare & Medicaid Services, Baltimore, MD), asked how her agency can “help move this along,” so that CAS can become reimbursable for lower risk patients.

“Without a doubt, we have two good therapies that Medicare should get out of the way on,” Ansel responded. “We as physicians are the appliers of that. Without a doubt, we should be held to a high bar as far as our outcomes as operators, but realistically there is so much data on this therapy that to have this not available . . . is just to me unconscionable.” 

According to Ansel, the biggest dataset for CAS and CEA is among the asymptomatic patients, yet this is the “real-world” group in whom CMS reimburses for surgery only, unless patients are enrolled in a Food and Drug Administration-approved clinical trial. Like Rosenfield, he suggested that a multispecialty board is needed to reevaluate the therapy in the asymptomatic population and “get politics out of this.”