Drug-Coated Stents Don't Boost Death Risk, U.S. Advisers Say

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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," the AP reported.

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.

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Reaction to the panel's judgment was mixed.

"I certainly hope this is a preliminary report since there is more information that should be reviewed and discussed before a final report is issued and a final decision made," said Dr. Robert Michler, director of the heart center at Montefiore Medical Center/Albert Einstein College of Medicine in New York City. "There are concerns regarding thrombosis [clotting], but there is a much broader issue here. There is widespread use of these devices which may have exceeded their appropriate use, and it's those patients we're even more concerned about."

Stents are widely used to treat three-vessel disease, although the scientific backing for their use only extends to one- and two-vessel disease, Michler explained. In addition, "there has never been demonstrated a survival benefit with stents," he said. "The only survival benefit for patients has been demonstrated with bypass surgery. We have widespread off-label use of stents for multi-vessel disease and patients dying who could have benefited from bypass surgery, and then you have the additional life-threatening situation of stent thrombosis. So what we are most concerned about is the public welfare in terms of receiving adequate informed consent about the limitations of widespread use of stents, drug-eluting stents in particular."

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