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Updated Sunday, February 28, 2010 2:29 pm TWN, By Marilynn Marchione, AP

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Stroke study finds neck stents safe, effective

To place them, doctors put a tube in a blood vessel in the groin and push it to the narrowed artery. A parachute-like filter is placed to trap bits of plaque that dislodge and keep them from traveling to the brain. A balloon is inflated to flatten the clog, the stent is placed to hold the artery open, and the filter is removed. The patient is awake but sedated.

The study involved 2,502 patients in the United States and Canada. Half had recent symptoms such as a ministroke. The rest had no symptoms but significantly narrowed neck arteries. They were given either surgery or a stent made by Abbott Vascular, a division of North Chicago, Illinois-based Abbott Labs, which helped sponsor the trial.

A month later, about 4 percent of the stent group had suffered strokes versus 2 percent of those who had surgery. About 2 percent of the surgery group had heart attacks compared to 1 percent of those given stents.

There were nine deaths in the stent group versus four in the surgery group, but the difference in a study this size was so small that it could have occurred by chance alone, Brott said.

Age mattered.

“If you were younger than 70, you were slightly better off with a stent,” while older patients fared better with surgery, Brott said.

There is no age limit for the surgery, said UCLA's Moore. “I've operated on people who are centenarians. If somebody lives to be 100 years old, they've got something going for them.”

The study did not include a group of patients treated only with medicines to control stroke risk factors, such as high blood pressure and cholesterol. Without such a comparison group, it's impossible to know just how many strokes either treatment prevented.

Dr. Charles Simonton, chief medical officer of Abbott Vascular, said the results “are particularly impressive” because the study started a decade ago, when neck stents were still a new technology.

About 30,000 neck stents were used last year compared to 100,000 surgeries, but more people might be treated if a non-surgical option becomes available, Brott said.

Medicare pays US$7,500 to US$11,000 for surgery; stents cost around US$12,000 because of the price of the devices, which range from US$3,500 to nearly US$5,000, said Dr. Charles Ross, vascular surgery chief at the University of Louisville.

If stents do win wider approval, patients should go to a place that offers both “so they can be given an unbiased opinion of how they would do with either procedure or medicines alone,” he said.

“There may be advantages and disadvantages in different types of cases” for stents or surgery, said Dr. Barry Katzen, medical director at Baptist Cardiac & Vascular Institute in Miami, who had patients in the study. “Like many areas of medicine, patients will have a choice.”

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