- The Washington Times - Tuesday, July 8, 2003

ASSOCIATED PRESS

Doctors got a stern warning yesterday to properly use a popular new drug-coated heart stent that has been linked to blood clots in almost three dozen people, including five who died.

The Cypher stent is a tiny metal scaffold that props open a cleaned-out artery and, unlike other stents, emits a drug to reduce the chances the artery will clog again.

But the drug doesn’t prevent a different risk posed by all stents: blood clots that form around the device and can cause a heart attack.

The Food and Drug Administration has received reports of blood clots in 34 recipients of the Cypher stent. Five of those patients died, although FDA doesn’t know whether the clots caused the deaths, a spokesman said.

In a letter to more than 1,200 cardiac centers, the manufacturer, Johnson & Johnson’s Cordis, called the risk rare considering 50,000 patients have been treated with a Cypher stent since the eagerly awaited device began selling in April.

Cordis also said some of the clots happened after doctors improperly used the Cypher by choosing stents that were too small, implanting them improperly or not giving patients appropriate anticlotting medicine afterward.

The Food and Drug Administration echoed that warning yesterday.

In studies of cases in which Cypher was implanted under strict conditions, it proved no more likely to cause blood clots than long-used bare-metal stents, the FDA said.

It’s not yet known whether clots among Cypher patients are occurring more often today than in those studies, said FDA cardiovascular-devices chief Dr. Bram Zuckerman.

He said clearly some physicians are incorrectly using the Cypher and should heed safe-use guidelines.

Those guidelines include using Cypher stents for new patients and ensuring recipients take anticlotting drugs for three months, instead of the two weeks prescribed for bare-metal stents.


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