Drug-coated stents that prop open the arteries of about 3 million people in the U.S. don't increase the risk of heart attack or death when used as labeled but may put patients at risk for blood clots, health advisers said Thursday.
While the panel of experts broadly dismissed the more serious risks, they split on saying the clotting risk was real in comparison with older, bare-metal stents. They agreed only that more study of the newer devices is needed.
"There may be something there. From an evidence-based perspective, I can't say definitively one way or another," said panel member Dr. Norman Kato of the Cardiac Care Medical Group of Encino, Calif.
Another panel member, Dr. Steve Nissen of the Cleveland Clinic, said the clotting risk was real and that only its magnitude was in question.
"There is pretty unequivocal evidence," Nissen said.
The panel also said any safety concerns fail to outweigh the benefits of the stents -- tiny mesh tubes used like scaffolding to keep blood free-flowing through the arteries.
The mixed verdict came at the outset of a two-day meeting of the Food and Drug Administration advisers, convened to discuss possible clotting and associated risks of the drug-coated stents. The panel's findings apply only to the minority of patients for whom the FDA-approved labeling says use of the devices is appropriate.
More than 60 percent of the drug-coated devices are implanted in higher-risk and other patients not covered by the labels. The panel of FDA advisers was to discuss that so-called off-label use and its risks Friday.