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Use of stents to prevent strokes discouraged

October 19th, 2006 by

By Thomas H. Maugh II and Denise Gellene
Los Angeles Times

The increasingly common practice of preventing strokes by using wire-mesh stents to prop open neck arteries is much riskier than the traditional method of surgically removing plaque and should be curtailed, according to two large European studies.

Patients receiving the stents were nearly 2 ½ times as likely to have a stroke or die, French researchers reported today in the New England Journal of Medicine. The results were so clear, the researchers said, that they terminated the study prematurely and stopped using the stents.

In a larger German study reported earlier in October, researchers found a smaller, but statistically significant, increased risk associated with the stents and also called for a halt to their use.

Some American researchers, however, said the findings are in conflict with U.S. studies that showed the stents are safer than surgery.

Researchers on both sides are at a loss to explain why the findings are so different. Most agree, however, that a definitive conclusion may not be available until the completion of other studies, including a large study sponsored by the U.S. National Institutes of Health.

An estimated 700,000 Americans suffer strokes each year, and many are caused by the buildup of plaque in the carotid arteries, which provide blood to the brain.

The gold standard for treatment of the condition is surgery to remove plaque from the blood vessels, a process called “carotid endarterectomy.”

Two years ago, the Food and Drug Administration approved new stents designed for use in carotid arteries. Just like the larger stents used in coronary arteries to prevent heart attacks, the new stents compress the plaque and hold the artery open.

No one knows how many carotid-artery-stenting procedures are done each year, but they are growing in favor because they are less invasive, require a shorter hospitalization and are cheaper.

The French study at 30 medical centers, led by Dr. Jean-Louis Mas of the Sainte-Anne Hospitals in Paris, enrolled 527 patients who had at least a 60 percent blockage of the carotid artery.

Half underwent stenting and half endarterectomy.

At the end of six months, 11.7 percent of the 247 patients who received a stent had suffered a stroke or died, compared to 6.1 percent of the 257 patients who underwent an endarterectomy.

The study was sponsored by the French Ministry of Health.

The German study, reported in the medical journal Lancet, enrolled 1,183 patients who were also suffering symptoms from their blockage. Dr. Warner Hacke of the University of Heidelberg and his colleagues at 35 medical centers found that after one month, 6.51 percent of those receiving a stent suffered a stroke, compared to 5.14 percent of those receiving an endarterectomy.

The trial, which was also halted early, was sponsored by several government and private agencies, as well as the companies who manufacture the stents. Hacke reported that he has received fees from Sanofi-Aventis, one of those companies.

The European results “are surprising given that the death and stroke rate after stenting seems higher than in previous U.S. studies,” said Dr. Spencer King of the Fuqua Heart Center in Atlanta, a past president of the American College of Cardiology.

A U.S. study of 334 patients, in contrast, found that 20.1 percent of those receiving endarterectomies had a stroke, a heart attack or died in the year after surgery, compared to 12.2 percent of those receiving stents.

Filed under: Health Care News |

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