A recently published data analysis suggests that patients undergoing carotid artery stenting (CAS) achieved the outcomes recommended by the American Heart Association (AHA; Dallas) for 30-day death and stroke rates for carotid surgery. But the Centers for Medicare & Medicaid Services (CMS) only covers stenting in certain high-risk patients who cannot undergo surgery due to severe blockages or other factors, while surgery is fully covered.

When the use of FDA-approved devices is not reimbursed by CMS, it creates a conflict between what is available and what is covered for the patient, William Gray, MD, of Columbia University's Center for Interventional Vascular Therapy (New York), told MDD.

CMS has largely stated that there is not enough data to support coverage of CMS and that the data it does have is not compelling enough, Gray noted. Although only time will tell, he said he is optimistic that these and other data will be enough to convince CMS to expand coverage of CAS procedures.

The AHA established guidelines for acceptable 30-day death and stroke rates for patients with severe carotid disease undergoing standard risk carotid endarterectomy: less than 3% for asymptomatic lesions and less than 6% for symptomatic lesions. CAS has not previously demonstrated these outcomes in multicenter, prospective assessments of high surgical risk patients.

According to Gray's study, recently published online in the AHA journal Circulation: Cardiovascular Interventions, data from two prospective, multicenter, post-market surveillance studies in high-surgical risk patients were analyzed. The study includes data from 2,145 patients from the Emboshield and Xact Post Approval Carotid Stent Trial (EXACT) and 4,175 patients from Carotid Acculink/Accunet Post Approval Trial to Uncover Rare Events (CAPTURE 2). Both EXACT and CAPTURE 2 studied the use of carotid stents made by Abbott (Abbott Park, Illinois) – the Xact and Acculink.

Both studies had pre- and post-procedure neurologic evaluation and independent adjunction of neurologic events. The overall 30-day death and stroke rate was 4.1% for EXACT and 3.4% for CAPTURE 2.

In the population comparable to AHA guidelines (patients younger than 80), the combined 30-day death and stroke rate was 5.3% for symptomatic patients and 2.9% for asymptomatic patients, independent of unfavorable risk factors. In patients 80 or older, this rate was 10.5% and 4.4%, respectively. In patients with anatomic features unfavorable for surgery, the 30-day death and stroke rates were 1.7% and 2.7% for symptomatic and asymptomatic cohorts respectively, independent of age.

Gray's study concludes that outcomes for CAS in non-octogenarian high-surgical risk patients have improved since the pivotal FDA approval trials and achieve AHA standards in both symptomatic and asymptomatic lesions.

Other medical device makers that have U.S. regulatory approval for CAS include Boston Scientific (Natick, Massachusetts), the Cordis (Miami Lakes, Florida) unit of Johnson & Johnson (New Brunswick, New Jersey), ev3 (Plymouth, Minnesota) and C.R. Bard (Murray Hill, New Jersey).

Last October CMS decided not to expand coverage of CAS, citing a lack of published, peer-reviewed data.

There are consequences of not being able to use FDA-approved products because of a lack of reimbursement coverage, Gray told MDD. First of all, it creates a fairness issue because there are some patients who can afford to pay for the procedure either out of pocket or by supplementing with private insurance, while others simply cannot have the procedure if Medicare and Medicaid won't pay for it.

Another problem Gray noted with the lack of CMS coverage of these devices is that device makers will stop making improvements to these products if they do not see a return on their investment.

"For a variety of reasons, this coverage decision is problematic," Gray said.

Earlier this month the Society for Cardiovascular Angiography and Interventions (SCAI; Washington) reported that, based on these and other data, it is calling on CMS to expand coverage of CAS to include all FDA-approved indications, which would provide additional treatment options for a larger group of patients who are at risk for stroke. This would reverse the agency's Oct. 16 decision not to expand coverage, which cited a lack of published, peer-reviewed data.

According to the SCAI, the standard surgical procedure to remove carotid artery blockages – endarterectomy – has not been subjected to the same level of scrutiny in at-risk patients as the CAS procedure has.

"Previously, neither surgery nor CAS had demonstrated these outcomes in a multicenter, prospective trial of high-surgical-risk patients," Gray said. "In the 10 years since the AHA guidelines for carotid endarterectomy were published, there has not been a similarly rigorous study demonstrating that carotid endarterectomy meets these guidelines in high-risk patients."

The SCAI said the new data analysis follow similar findings from the Stenting and Angioplasty with Protection of Patients with High Risk for Endarterectomy (SAPPHIRE Worldwide) trial, published in Catheterization and Cardiovascular Interventions in October, just one day after CMS reported its decision. That data, coupled with the results of the CAPTURE 2 and EXACT trials, show an "almost overwhelming case for the option to offer CAS to these patients," the SCAI said.

According to the SAPPHIRE study, patients with severe blocked carotid arteries, the main blood vessels in the neck leading to the brain, who underwent CAS with the Precise Nitinol Stent and the Angioguard Emboli Capture Guidewire – both developed by Cordis – were comparably protected from stroke, heart attack, death, and repeat revascularization procedures as patients who underwent the surgical endartectomy procedure (Medical Device Daily, April 11, 2008).

"The results of CAPTURE 2 and EXACT extend results we've seen from the CAS studies in high-risk patients to those who have not yet suffered a stroke. It is exciting to learn that the growing body of evidence demonstrates that carotid stenting is as safe and effective as surgery in all patient groups," said Steven Bailey, MD, SCAI president-elect. "The EXACT and CAPTURE 2 data strongly support the case that CAS should be considered an appropriate option to treat patients with carotid stenosis and surgical risks."

"Evidence in support of CAS is growing," said Bonnie Weiner, MD, SCAI immediate past president. "Patients at risk for stroke deserve access to the best possible treatment options for their condition, and the physicians caring for them deserve to have the opportunity to provide the best care for their patients. We are disappointed that CMS did not expand coverage of CAS, but are hopeful that these data will hold enough merit for CMS to quickly reconsider its decision."

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