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Friday, October 31, 2003

Despite warning, stents worthwhile


Doctors: Benefits outweigh risks

By Tim Bonfield
The Cincinnati Enquirer

Local cardiac specialists are reacting cautiously to a government warning that hundreds of people have suffered blood clots and 60 people have died after receiving drug-eluting stents.

The product in question is the Cypher stent, made by Cordis Corp. of Miami Lakes, Fla. It is a tiny metal mesh tube covered with the drug sirolimus, which doctors use to prop open clogged coronary arteries.

Clinical trials have shown that the medicated stent sharply reduces the chances that an artery will be re-clogged by scar tissue.

Thousands of Greater Cincinnati patients already have received the stents, some as long as three years ago as part of clinical trials. Nationwide, about 260,000 Cypher stents have been shipped to hospitals this year.

The warning, issued Wednesday by the U.S. Food and Drug Administration, reports that 290 patients suffered blood clots within 30 days of receiving the stent and 60 died. About a half-dozen clots have been reported locally.

The complications reported so far reflect less than 1 percent of the overall number of stents placed. In fact, the FDA cannot say at this point that the risk is any higher than getting a bare-metal stent.

For now, doctors say they are not planning to stop using the new stents.

Dr. Dean Kereiakes, a cardiologist who has been involved in clinical trials of the Cypher stent, said the benefits of the new stents clearly outweigh the risks.

The Associated Press contributed to this story. E-mail tbonfield@enquirer.com




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