Drug-Coated Stents Don't Boost Death Risk, U.S. Advisers Say

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"Essentially, this is a very precarious situation for patients to be in who may need therapy for coronary artery disease," Michler said. "It's an enormous public health issue."

"We need better information," added Dr. Kevin Schulman, a professor of medicine at Duke University School of Medicine. "This technology has been used in a lot of patients, and it's uncomfortable that we don't have more data on the outcomes of patients in real-world clinical trials and we still have fairly substantial questions on the appropriate way to use the technology."

But one expert seemed satisfied with the panel's decision.

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"My opinion is that the benefits do outweigh the risks," said Dr. Michael Attubato, associate director of invasive and interventional cardiology at New York University Medical Center. "It appears that there may be a small or increased risk of late clotting. I do believe this is a major advance in technology. Unless I see other data, I believe the benefits outweigh the risks."

Thursday's testimony was designed to address two main questions: who should or should not get the devices, and what supplementary therapies are appropriate.

According to the Washington Post, hundreds of people assembled in the large meeting room in Gaithersburg, Md., including representatives from Johnson & Johnson and Boston Scientific Corp., which make the two drug-eluting stents sold in the United States. Others present included medical device makers, physicians and patient advocates.

Anti-clotting medications such as Plavix (clopidogrel) and aspirin are often prescribed after the drug-coated stents have been implanted. And two studies published this week, in the Journal of the American College of Cardiology and the Journal of the American Medical Association, linked the increased risk of clots to discontinuation of Plavix.

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