Doctors implant Drug Eluting Stents (DES) in the hearts of about a million Americans a year to treat coronary artery disease. Unfortunately, many of these devices may be doing more harm than good. Blood clotting, or thrombosis, associated with drug coated heart stents such as Johnson & Johnson's Cypher Stent, is four to five times more likely than with regular metal stents, according to a Cleveland Clinic study released November 29, 2006.
What is a drug eluting stent?
Stents are small, lattice-shaped, metal tubes that are inserted permanently into arteries. They are used to hold open arteries that have narrowed due to plaque build-up caused by atherosclerosis.
Who makes drug eluting stents?
One drug eluting stent is made by Cordis Corporation (Johnson & Johnson) and is marketed under the brand name of Cypher. This stent is made of stainless steel and uses a polymer as the carrier and releases a powerful immunosuppressant drug called Sirolimus. A second stent is manufactured by Boston Scientific and uses paclitaxel, another antiproliferative drug that is used against various types of cancer. It is marketed under the name Taxus.
What are the dangers?
The U. S. Food and Drug Administration (FDA) raised concerns about the safety of the Taxus and Cypher brand stents as early as September 14, 2006. It a Statement on Coronary Drug-Eluting Stents, the FDA noted that: "We are aware of recent data suggesting a small but significant increase in the rate of death and myocardial infarction (heart attack) possibly due to stent thrombosis (a blood clot in the stent) in patients treated with DES *** The small but significant increase in the rate of death and myocardial infarction observed in these studies was noted in patients followed 18 months to 3 years after stent implantation."
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