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International Study Shows Stent Risks

Posted on: Tuesday, 4 September 2007, 15:05 CDT

By MARIA CHENG

VIENNA, Austria - Even some heart attack patients would be better off if their doctors avoided using drug-coated stents to open their clogged arteries, an international study found, raising new concerns about the devices.

The study, presented Tuesday, showed that heart attack 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.

Previous studies have spotted risks from the drug-coated versions mainly when used to treat non-emergency heart cases - not people suffering acute heart attacks.

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. The stents are used to keep the vessels open.

Drug-lined stents are used in up to 30 percent of Americans having heart attacks, said Dr. Valentin Fuster, director of the Cardiovascular Institute at Mount Sinai School of Medicine in New York. Fuster said the stents are less commonly used in Europe, implanted in only about 15 percent of patients there.

The new research was presented by Dr. Gabriel Steg, of the Hospital Bichat-Claude Bernard in Paris, at a meeting of the European Society of Cardiology in Vienna. It 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.

Seventy-five percent of the patients had bare metal stents, and 27 of those died. Just 25 percent of the patients had drug-coated stents, but 49 in that group died.

Experts emphasized that there were differences among the patients in the study that could have affected the outcome, and that these findings are not the final word on the safety of drug-coated stents for heart attack patients.

However, Steg said, "With this increased mortality, we perhaps need to take a step back from our use of drug-eluting stents."

The study was funded by Sanofi-Aventis, and Steg has received grants from Sanofi-Aventis, and consults for Bristol-Myers Squibb. The two companies make anti-clotting drugs, which are also used to treat these heart problems.

Given the controversy surrounding drug-coated stents - which have been linked to fatal blood clots in other patient groups - doctors said the new research would likely affect doctors' treatment choices.

Last year, the U.S. Food and Drug Administration 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.

On Sunday at the European cardiology meeting, another study suggested the drug-coated stents did not raise the risk of blood clots among stable patients - appearing to contradict some earlier studies. Some experts said that more cautious use of the stents might help explain the new results.

"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.

Drug-lined stents typically cost about $2,300 compared to about $700 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.

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.

Source: Associated Press/AP Online

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