Panel: Drug-Coated Stents Are Safe

Health Advisers Dismiss Heart Attack, Death Risk Of Drug-Coated Stents For Some Patients

(CBS/AP)  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.

About 800,000 Americans a year receive the stents, reports CBS News medical correspondent Dr. Jon LaPook, so even a small risk can translate into serious problems for a significant number of patients.

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 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 re-clogging 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.

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 Thursday apply only to the minority of patients for whom the FDA-approved labeling says use of the stents is appropriate — and not to the broader, "real-world" use.

Today, more than 60 percent of drug-coated stents are used in patients not covered by the labels, including cases when they're implanted to fix narrower arteries or more complex blockages than those studied in trials done to win FDA approval. The panel of FDA advisers was to discuss that so-called off-label use and its risks Friday.

Boston Scientific Corp. and Johnson & Johnson, the two manufacturers with U.S. approval to sell the drug-coated stents, also said the benefits of the devices outweigh their risks.

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Re: "Drug-Coated Stents Are Safe"

Hmmm. How about candy-coated buttplugs?