Drug-Coated Stents Don't Boost Death Risk, U.S. Advisers Say
Friday, December 8, 2006; 12:00 AM
THURSDAY, Dec. 7 (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, which hold open the arteries of at least 3 million Americans, is needed, theAssociated Pressreported.
"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 panelist, 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," 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, which are inserted in patients during artery-clearing surgery called angioplasty.
The FDA isn't bound to follow the recommendations of its advisory panels, but usually does.
The key issue is whether the drug-coated stents, which have become dominant tools in the field of cardiovascular surgery since their introduction three years ago, create a heightened risk of potentially fatal blood clots. An estimated 6 million people worldwide have received the devices.
During testimony Thursday, FDA representatives concluded that existing data does indicate an increased risk for blood clots with drug-eluting stents. But they also noted the studies supporting such a conclusion were small and not necessarily conclusive.
FDA medical officer Dr. Takahiro Uchida told the panel: "It is important to note FDA does not regulate the practice of medicine. However, FDA is responsible for any use of a device that raises a public health concern," theAPreported.
The drug-coated stents release medicine designed to limit the incidence of arteries reclosing after angioplasty. The problem of reclosing is more frequently seen with traditional bare metal stents. Such re-closures require repeat surgery.
But a number of recent studies have suggested that drug-coated stents, which can cost thousands of dollars each, have long-term dangers -- most specifically, the risk of clots that could cause heart attacks. According to some estimates, drug-coated stents may cause an extra 2,160 deaths in the United States each year.
Reaction to the panel's judgment was mixed.