Posted on 12/09/2006 2:14:41 PM PST by neverdem
GAITHERSBURG, Md., Dec. 8 — A panel of experts recommended Friday that doctors and patients be given stronger warnings about the dangers associated with the use of drug-coated stents in high-risk patients.
The panelists also recommended that the Food and Drug Administration warn doctors that if possible, such patients should remain on aspirin and Plavix, an anticlotting drug, for at least a year after a drug-coated stent implant.
The label on the Cypher stent, from Johnson & Johnson, approved for sale in the United States in 2003, calls for the anticlotting therapy for just three months. The label on the Taxus stent, from Boston Scientific, approved the next year, calls for six months on the drug.
At the end of the two-day hearing here, the panelists struggled to reach a consensus on most of the questions posed to it by the F.D.A. about whether it should restrict the use of the tiny devices, which are implanted to prop open heart arteries.
As the session ended, Daniel Schult, head of the drug agency’s Center for Devices and Radiological Health, said it was too soon to discuss what specific actions the F.D.A. might take. “What I heard loud and clear is that we need to do a better job communicating to doctors and patients the best and latest information,” Dr. Schult said.
The challenge the agency faces is that most of the stents — over 60 percent by the F.D.A.’s estimates — are being implanted in patients with more complex cardiovascular problems than those of the patients the devices were tested on.
The experts told F.D.A. officials that there was little reliable research comparing the risks associated with such “off label” use to the outcomes with drug treatment or surgery. And what research there is suggests that the risks of clotting, heart...
(Excerpt) Read more at nytimes.com ...
This is the third time this week that I have read about the coated stents. When they put the one in me,I don't recall being asked my preference. It wouldn't have mattered anyway I just wanted the pains gone.
" This is the third time this week that I have read about the coated stents. When they put the one in me,I don't recall being asked my preference. It wouldn't have mattered anyway I just wanted the pains gone."
They wanted to put one in me four years ago. I had a 20% blockage of ONE artery. I decided to wait for a while.
A huge study that came out in the NEJM about 8 months ago sttes that cardiac sugery is better than stents if more than one artery require revascularization. The risks of stent occlusion acutely and the number that are being put in make this non-invasive technique more dangerous in the long run than bypass surgery...something interesting to think about.
A huge study that came out in the NEJM about 8 months ago sttes that cardiac sugery is better than stents if more than one artery require revascularization. The risks of stent occlusion acutely and the number that are being put in make this non-invasive technique more dangerous in the long run than bypass surgery...something interesting to think about.
"I had a 20% blockage of ONE artery"
Mine was 70% on one artery.
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" Mine was 70% on one artery."
I couldn't believe mine was 20%. I was raised in the South and practically everything was fried in lard.
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