FDA Panel: Drug-Coated Stents Don't Boost Mortality Risk
But the devices may have a greater embolism risk than bare-metal stents
FRIDAY, Dec. 8 (HealthDay News) -- Although drug-coated stents might pose a clotting risk, they do not increase the chances of heart attack or death, a U.S. Food and Drug Administration advisory panel concluded Thursday.
While the panel of 21 experts broadly dismissed the more serious risks, they split on saying the clotting danger was real in comparison with older, bare-metal stents. They agreed only that more study of the drug-coated devices is needed, the Associated Press reported.
"There may be something there. From an evidence-based perspective, I can't say definitively one way or another," said panel member Norman Kato, M.D., of the Cardiac Care Medical Group of Encino, Calif.
Another panelist, Steve Nissen, M.D., of the Cleveland Clinic, said the clotting risk was real and that only its magnitude was in question. "There is pretty unequivocal evidence," he said.
The panel, convened to advise the FDA on the safety of the stents, said any concerns fail to outweigh the benefits of the devices. On Friday, the panel will tackle the issue of the off-label use of drug-coated stents.