UPDATE 1-Long-term safety of drug-coated stents questioned

Tue Mar 16, 2010 1:59pm EDT

* New research suggests old stents safer than drug stents

* Doctors say more long-term research is needed (Adds detail on study and comments from researcher)

By Debra Sherman and Bill Berkrot

ATLANTA, March 16 (Reuters) - New research shows more patients who got drug-coated stents right after suffering a severe heart attack later died from heart-related problems than those who received older, cheaper bare-metal models.

Seven years after the first drug-coated stent was approved in the United States, heart doctors gathering in Atlanta for the American College of Cardiology meeting debated the issue, saying more research is needed to understand the long-term effects.

Danish researchers conducted a trial of more than 600 patients examining the effectiveness and risks of the two types of stents implanted right after a major heart attack.

They found that after three years, patients who got bare-metal stents were more likely to have problems, such as requiring more intervention for blockages, while patients with the drug-coated variety were more likely to die from heart-related problems.

More than 6 percent of patients in the study who got the drug-coated stent died, compared with nearly 2 percent who got the bare metal stent, researchers said.

"The key message here is that we have shown that despite a finding of lower major adverse cardiac events, cardiac mortality was significantly higher in the drug-eluting stent group," said Dr. Peter Clemmensen of Copenhagen University Hospital.

Stents are tiny tubular devices used to prop open diseased heart arteries and have been used widely for almost 20 years. Newer and more expensive versions of the devices are coated with medicines that help keep treated arteries from reclogging.

When Johnson & Johnson (JNJ.N) began selling the first drug-coated stent in April 2003, it quickly became a big seller. The stent was considered to be revolutionary, and other medical device manufacturers raced to get their own versions on the market.

J&J, Medtronic Inc (MDT.N), Boston Scientific Corp (BSX.N) and Abbott Laboratories Inc (ABT.N) are the top manufacturers of stents and paid for the study by the Danish researchers.

Several years ago, there was a debate among doctors about the cause of a small, but potentially deadly risk that blood clots could develop around the stented area long after a drug-coated stent was implanted.

"Long-term data are scarce," Clemmensen said, adding that there needs to be a large study to answer safety questions. "I would say that devices are accepted on much less data." (Reporting by Debra Sherman and Bill Berkrot; Editing by John Wallace and Richard Chang)

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