Coated Stents Should Stay on Market, U.S. Advisers Say

But all patients at heightened risk of blood clots, FDA panel concludes

By Amanda Gardner
HealthDay Reporter

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FRIDAY, Dec. 8 (HealthDay News) -- In the face of incomplete evidence on the safety of drug-coated stents in the real world, a panel of U.S. heart experts said Friday that the devices should stay on the market, but with certain caveats.

The U.S. Food and Drug Administration panel charged with investigating the safety of such stents said that all patients receiving the devices are at heightened risk for blood clots, and that many patients receiving the devices are at risk for heart attacks and death.

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But there isn't enough evidence to say if the danger of heart attacks and strokes is due to the devices or the patients' poor health, the panelists added.

The group also noted that the data on the danger of off-label use was inconclusive, and that patients receiving drug-eluting stents should receive blood thinners for at least a year after the procedure.

"We feel that there are significant uncertainties, and it is difficult to make conclusive judgments regarding this issue," panel chairman Dr. William Maisel, of Beth Israel Deaconess Medical Center in Boston, said during the hearing, according to the Associated Press.

The panelists did recommend that the labels on the devices be updated to warn doctors that off-label use won't produce the same results as seen in generally simpler cases involving healthier patients, the wire service reported.

Experts noted the lack of information on the safety of coated stents poses a serious problem.

"The first question was [whether] there's a huge safety signal that should take stents off the market, and it sounds like they're comfortable that evidence was not strong enough for anything like that," said Dr. Kevin Schulman, director of the Health Sector Management Program at Duke University, in Durham, N.C.

"This reflects an uncertainty about the level of evidence, which is unfortunate given the number of people who receive procedures each year," he added. "There's a real need to get better evidence very quickly to answer these questions."

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