Doctors should think twice before using drug-coated stents in some heart attack patients, experts said Tuesday.
Dr. Gabriel Steg presented research at a meeting of the European Society of Cardiology in Vienna showing that patients who received drug-coated stents in an emergency situation were five times more likely to die after two years than those who received bare metal stents.
The tiny, metal-mesh tubes that ooze drugs are used in one of the world's most common procedures, an angioplasty, which uses a balloon to prop open clogged heart vessels.
Dr. Valentin Fuster, director of the Cardiovascular Institute at Mount Sinai School of Medicine in New York, said drug-lined stents are also used to open up vessels in up to 30 percent of people having heart attacks in the United States. Fuster said the stents were less commonly used in Europe, and were implanted in only about 15 percent of patients there.
The research from Steg, of the Hospital Bichat-Claude Bernard in Paris, and colleagues was based on data from 94 hospitals in 14 countries, and followed 2,298 patients for two years after they had received either a drug-eluting or a bare metal stent.
Experts emphasized that there were differences in the patients who received the different types of stents, and that the data was not definitive.
"With this increased mortality, we perhaps need to take a step back from our use of drug-eluting stents," said Steg.
The study was funded by Sanofi-Aventis. Steg has received grants from Sanofi-Aventis, and consults for Bristol-Myers Squibb.
Given the controversy surrounding drug-coated stents - which have been linked to fatal blood clots in patients - doctors said the study would likely affect how heart patients are treated.
Last year, the United States' Food and Drug Administration convened a special meeting to consider the use of drug-lined stents. They concluded that the stents should only be used in certain conditions. The health advisory body in the United Kingdom recently suggested that it would stop paying for them.
Research presented on Sunday at the Vienna meeting from Swedish doctors showed that after four years, there was virtually no difference in the death rate between patients receiving drug-coated or bare mental stents.
But because that study was based on stable patients, as opposed to patients having a heart attack, experts said the results were not contradictory.
"Drug-eluting stents are not for everyone," said Dr. Eckhart Fleck, director of cardiology at the German Heart Institute in Berlin and a spokesman for the European Society of Cardiology.
"What this study shows is that the higher price of a drug-eluting stent is not necessarily worth it."
Drug-lined stents typically cost about US$2,300 (EUR1,700), compared to about US$700 (EUR510) for a bare metal version.
In emergency situations where heart attack patients already have a blood clot after an artery has burst, Fleck said that a drug-eluting stent could make the situation worse by causing even more clotting and blocking blood flow.
"This study will make doctors less enthusiastic about using drug-eluting stents," said Dr. Spencer King, a cardiologist at Fuqua Arts Center in Atlanta and spokesman for the American College of Cardiology. "The concerns about safety may make doctors shy away."
When drug stents were first introduced in 2003, they became the fastest-selling medical device in recent history.
But when worries arose that they could lead to fatal clots in some patients, sales plummeted. In the U.S., use has dropped from about more than 90 percent of eligible heart patients to about 70 percent.
Doctors think the initial response to stents may have been an overreaction. "A lot of the decrease we're seeing now is just a correction of that excitement," King said.
While experts called for more long-term data on drug-lined stents, they said the devices should not be avoided altogether. "There is absolutely a place for drug-eluting stents," Steg said.
Fleck said that the ideal recipient of a drug stent would be a stable patient with small vessels who could take anti-clotting medicine for at least six months.
"It would be outlandish to stop using drug-eluting stents," Steg said. "We just have to be more careful about which patients receive them."
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