High Hopes for High-Risk Stroke Patients

Originally Published MDDI October 2004

EDITOR'S PAGE

High Hopes for High-Risk Stroke Patients

New stroke treatments using distal embolic protection devices are all the rage in the vascular community, but are they more hype than hope?

FDA has approved a minimally invasive treatment for high-risk patients with carotid artery disease. Guidant's carotid stent and embolic protection system is the first such system to receive FDA clearance. The Guidant system is designed to offer an alternative to endarterectomy. Traditional carotid endarterectomy requires an incision in the patient's neck and artery to remove plaque. During a carotid stenting procedure, the embolic protection system is positioned, and a stent is deployed into a small puncture in the patient's groin.

Physicians appear to be excited about the new distal protection system. “We believe carotid artery stenting with embolic protection will lead to a completely new paradigm for the approach to carotid artery disease,” says Kenneth Rosenfield, MD, chair of the Society for Cardiovascular Angiography and Interventions (SCAI) Committee on Peripheral Vascular Disease. He is also director of cardiac and vascular services at Massachusetts General Hospital in Boston.

The idea of stenting and distal protection, however, is not new. “Distal protection came up in the early days of angioplasty,” says Mike Drues, PhD, principal of Vascular Sciences (North Grafton, MA). “Just because a method is less invasive doesn't mean it should replace a well-established treatment,” says Drues. “I ask designers of these systems, ‘If your relative had TIA [transient ischemic attack] and was diagnosed with carotid artery disease, would you recommend the new devices over traditional endarterectomy?' They aren't sure.”

Endarterectomy has been around a long time, Drues explains. “It is a relatively low-risk procedure. Any new therapy has to show that it is better than what is being done now.”

For companies developing these new embolic protection systems, Drues says their biggest competition is the current standard of care. “They must show that the minimally invasive technique is as effective—or more effective—than endarterectomy. They must show it is as safe or safer. And, they must show a cost benefit as well,” he says.

Rosenfield calls Guidant's system a major step forward in the prevention of stroke. “It will make treatment equally safe, or even safer, than carotid endarterectomy and may even lower the threshold for opening up carotid narrowings,” he says.

The approval of a carotid stent provides an option for patients at risk of stroke who are ineligible for traditional surgery, says Beverly Huss, president of Guidant's Endovascular Solutions.

“This is truly a breakthrough technology in stroke prevention that will offer a less-invasive option for treatment of carotid disease in high-risk patients,” says Christopher U. Cates, MD, director of vascular intervention at Emory University Hospitals in Atlanta.

Drues speculates that perhaps the idea of distal protection is simply “back in vogue” with physicians. “Cardiologists may want it simply because the neurologist down the hall has it,” he says.

“An alternative to surgery that involves a small catheter placement via the groin rather than an open incision is especially important for people who are at high risk for the standard surgical procedure,” says Ted Feldman, MD, professor of medicine at Northwestern University Medical School and director of the cardiac catheterization laboratory at Evanston Hospital in Evanston, IL. In clinical trials, Guidant's system reduced the likelihood of stroke in the area of the blockage compared with traditional surgery.

Feldman predicts that with FDA's official sanction of the system, “demand for the procedure will mushroom.” Similar products are on the market or under development. Several companies—including Abbott Vascular, ArteriA, Boston Scientific, Cordis, ev3, and Medtronic—have systems approved for use outside the United States. CMS is now considering broader coverage for patients at high risk for carotid endarterectomy. It plans to complete its review in early 2005.

When device manufacturers develop new therapies, one key factor they must consider is whether they are providing a truly a meaningful benefit to physicians and patients. Ultimately, they should focus on the value to the patient population.

The Editors

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