- The Washington Times - Tuesday, December 5, 2006

A medical report published online in advance of Food and Drug Administration hearings this week finds that extended use of the anti-clotting drug, Plavix, is linked to a “significant reduction in risk for death or heart attack” in patients implanted with drug-coated stents.

“We now have reasonably good evidence that patients (with drug-coated stents) should take Plavix for at least 12 months” after stent implantation, even though current labels recommend that it be taken only three to six months, said Dr. David Kong, assistant professor at Duke University Medical Center and an author of the report released yesterday.

The findings come as an advisory panel to the FDA holds hearings tomorrow and Friday to review the long-term safety of the so-called drug-eluting stents (DES), introduced in April 2003, that release medicine when placed in clogged arteries.

Cardiovascular disease patients worldwide have been rushing to acquire the new stents, rather than the bare-metal stents (BMS) that preceded them because the new ones eliminate the formation of scar tissue and the need for a repeat procedure to reopen a blood vessel.

But there has been growing concern among doctors that DES raise the risk of life-threatening blood clots, known as “late stent thrombosis,” in some patients once they are taken off the blood thinner Plavix, known by the generic name clopidogrel. And there is uncertainty about how long such stent patients can safely remain on Plavix, which can cause bleeding, and whether the recommended dosages of the drug are sufficient.

The advisory panel plans to address these concerns during two days of hearings.

In an interview yesterday, Dr. Augusto Pichard, director of the cardiac catheterization unit at the Washington Hospital Center, said patients with DES have been “panicking” over news of the hearings and reports that some people with the devices are dying in the first year after stent implantation.

“They should not panic,” he said. He puts the risk for clots at between 3 to 6 patients in 1,000.

The new report by Duke researchers, posted online yesterday in Journal of the American Medical Association, will be published in JAMA next month.

Dr. Kong and his colleagues conducted an observational study of 4,666 patients who underwent balloon angioplasty for blocked coronary arteries and had stents implanted between Jan. 1, 2000, and July 31, 2005. The patients, who were twice as likely to get BMS as DES, were followed for at least one year.

Among patients with drug-coated stents who remained free of complications for six months after the device was implanted, those on Plavix had only half the risk for heart attack or death as those not on the drug. The Plavix advantage continued at 12 months and 24 months. But Dr. Pichard noted that the number of patients in the study still on the drug for two years was small.

“These data suggest it is most important to stay on Plavix for one year,” he said. He acknowledged both this research and some prior European studies “suggest the drug could also be beneficial” for patients with DES longer than a year.

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