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Page: << Prev | 1 | 2 | 3 The key issue has been whether 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, 3 million of them in the United States.
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. And re-closures require repeat surgery.
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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The advisory panel's recommendations on the use of blood thinners are unlikely to change real-world practice and may even be inadequate, experts said.
"We've always recommended that patients be on aspirin and Plavix [a blood thinner] for one year, and in the subgroups that are at the highest risk for other problems continuously after that," said Dr. Scott Monrad, director of the cardiac catheterization lab at Montefiore Medical Center in New York City.
"Patients have to understand that they may have to stay on blood thinners a minimum of one year, but maybe for the rest of their lives," Schulman added.
There is also concern that stents are being used when conventional bypass surgery should really be used.
"This has made us a little more sober in recognizing that there are risks that go with the procedure, and we shouldn't be careless," said Monrad. "In some patients, bypass surgery may very well be the preferred approach."
At the same time, Monrad emphasized, stents have completely eliminated restenosis as a medical problem.
"That is a dramatic change in practice," he said. "When we fix something now, in virtually every patient it stays fixed."
And, overall, the incidence of problems is still very low, he added.
More information
Visit the American Heart Association (www.americanheart.org ) for more on stents.
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