Majority of Drug-Coated Stent Use Not Approved by FDA

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Medicare is reviewing whether it will continue to pay for off-label use of the coated stents, Curfman said. "We have no idea what Medicare will do," he said. "Obviously, it would be a major step if they did not reimburse for off-label use."

The newer studies are aimed at heightening awareness of the issue, Farb said. "When you have any type of medical intervention, when you see more complicated patients or lesions, you will see a higher rate of adverse events," he said. "That is what has been observed in these studies. Our goal is to make the medical community at large aware of the issue."

In part because of such findings, "the percentage of drug-eluting stents that are being implanted has declined over the past few months," said Dr. William Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston, who wrote another perspective piece for the journal.

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Studies are needed to answer questions about off-label use, Maisel said. "Data currently are not sufficient to make a decision," he said. "It is important to make a distinction between something you know to be bad and something you don't know the answer to, and to many off-label uses we don't know the answer," he said.

An FDA statement released after the December meeting "had specific language on off-label use," Farb said. "When patients receive such stents in off-label situations, the results may not be the same as for patients treated with on-label use."

Another pressing issue is that of late thrombosis, or blood clots, in stent recipients, both Maisel and Farb said. Studies show a slight but definite increase of these clots, generally linked to discontinuation of the anti-clotting medications Plavix and aspirin.

"We are collaborating with professional societies on antiplatelet [clot-preventing] therapy," Farb said. "The optimum duration of antiplatelet therapy is unknown, and we need more work on studies of this topic to minimize the risk of stent thrombosis."

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