FDA Probes Safety of Popular Heart Stent
Sunday, December 3, 2006; 10:37 PM
-- Millions of chest pain and heart attack sufferers thought they were getting a phenomenal medical advance when tiny coils that ooze medicine were placed in their arteries to keep them from squeezing shut again.
These gizmos, called drug-coated stents, worked so much better than plain old metal ones that 6 million people worldwide received them in the few years they have been available. It was a modern record for any medical device.
Now their long-term safety is in question.
Doctors think these stents may raise the risk of life-threatening blood clots months and even years later unless people stay on Plavix, an anti-clotting drug whose long-term safety in stent patients has not been established.
Thousands of people are being urged to take the $4-a-day drug until more is known.
Thousands of others each day who develop new blockages are being treated by doctors no longer sure of what to do. Many are returning to the old metal stents, and some are fundamentally rethinking when to use stents at all and are considering alternatives like bypass surgery or medications.
A Food and Drug Administration panel will meet on the issue Thursday and Friday. Medical journals are rushing studies into print, and powerful doctor groups are reconsidering treatment guidelines.
"It's such a huge public health issue with so many people involved," said Dr. Robert Califf of Duke University, who worked on one study to be presented to the FDA.
Doctors also worry about overreacting to a risk that appears small _ five or fewer clots in every 1,000 patients.
"The benefit of having a drug-eluting stent is tremendous," said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute.
Stents are used in angioplasty. Through a blood vessel in the groin, doctors push a tube to a blocked heart artery, inflate a balloon to flatten the clog, and prop the artery open with a stent.
About 652,000 Americans had angioplasty in 2003 _ more than twice the 268,000 who had bypass operations, which are riskier, costlier and take far longer to heal. Angioplasty became more popular when the first drug-coated stent came out that year, virtually eliminating the procedure's main drawback: scar tissue requiring a repeat effort to reopen the vessel.