WASHINGTON – 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 characterizing the degree of the increased clotting risk 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. Drugs that coat the stents elute, or dissolve, into the bloodstream to prevent reclogging of arteries.
“The message is drug-eluting stents are safe and that the safety concerns are far outweighed by evident clinical benefit,” panel chairman Dr. William Maisel, of Beth Israel Deaconess Medical Center in Boston, told reporters.
Talk to us
> Give us your news tips.
> Send us a letter to the editor.
> More Herald contact information.