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Health

Odds improve for drug-coated stent

Followup research shows the risk may not be as severe as thought.

VIENNA - Drug-coated heart stents may not increase the risk of blood clots as much as previously thought, according to research presented Sunday at a meeting of cardiologists.

Nearly 6-million people have the devices, which are implanted into the heart during an angioplasty to prevent new clogs from forming in arteries.

Last year, research suggested that the devices were responsible for an increased number of fatal blood clots. But on Sunday, Dr. Stefan James of the Uppsala Clinical Research Centre in Sweden presented followup results from last year's study to the European Society of Cardiology conference.

With more patients and an extra year of data, the numbers tell a different story.

After four years of tracking patients with the drug-coated stents, James said in Vienna that the results showed no significant difference between patients who received the drug stents and those who received bare metal ones: Patients with drug stents had only a 1 percent increased chance of dying.

In December, James told a Food and Drug Administration safety hearing that research from the first three years of the study indicated that patients with drug-emitting stents had an 18 percent increased chance of dying compared to patients with bare metal stents.

Those results were later published in the New England Journal of Medicine, and sales for the device have plummeted worldwide.

The FDA never restricted the stents' use but suggested doctors only recommend them in certain cases.

Caution may help

Experts are not entirely sure what might explain the research reversal, but more selective stent use might help explain the change, they said.

In the United States, use has dropped from more than 90 percent of eligible heart patients to about 70 percent.

"There's probably more awareness among doctors that drug-eluting stents aren't for everyone," said Dr. Bob Bonow, chief of cardiology at Northwestern University and a spokesman for the American Heart Association.

Bonow also said that doctors are probably paying more attention to ensuring that drug stent patients take anticlotting medication for at least six months.

Newer drug stents are also better than earlier versions, some of which were recalled.

Other experts said the backlash against drug-coated stents was an overreaction.

"There is a risk that the stents could cause a clot, but we understand better how to manage that risk," said Dr. Eckhart Fleck, director of cardiology at the German Heart Institute in Berlin and a spokesman for the European Society of Cardiology.

James said that while patients should be reassured, doctors should still pay close attention to their patients.

"The risk is not eliminated," he said. "We haven't solved the clot problem yet."

James said he has no ties to pharmaceutical companies and no conflict of interest. Sweden's government funded the study.

Fast facts

Stent studies

Heart stents: Implanted into the heart to prevent new clogs from forming in arteries.

Drug-coated heart stents: Leak drugs to prevent the growth of tissue that would reclog arteries.

Last year's report: A three-year study suggested that the devices were responsible for an increased number of fatal blood clots. Patients with drug-emitting stents had an 18 percent increased chance of dying compared to patients with bare metal stents, the study found.

This year's finding: With more patients and an extra year of data, the same researcher found that patients with drug stents had a 1 percent increased chance of dying over those with bare stents.

Why the difference? More selective stent use and medication may have helped. Newer drug stents are also better.

[Last modified September 3, 2007, 00:46:16]