Drug Coated Stents Increase Risks of Blood Clots Which May Lead To Heart Attack & Death.
In August of 2004 Boston Scientific and the FDA issued a recall of the Express and Taxus stents. The recall was issued as a result of several deaths and dozens of injuries.
Since the 2004 recall doctors have continued reporting injuries during the implantation of cardiac stents made by Boston Scientific as well as Cypher stents manufactured by Cordis a subsidiary of Johnson & Johnson.
Recently advisors to the FDA have been discussing problems with newer types of stents called "drug eluting stents". Like traditional stents drug eluting stents (also known as drug coated stents or medicated stents) are used to keep an artery open once doctors have unblocked it. But now there's
evidence that these new stents, which are coated with drugs, can cause blood
clots.
The new drug eluting stents have helped many patients avoid coronary bypass surgery. But like many advances in medical technology treatment with drug eluting stents has brought its own problem. More than 20 years ago, doctors discovered they could thread a tiny balloon through the arteries to reach an area that was blocked. The idea was to try without opening someone's chest to get the same effect and in fact, it was a huge success. But early on, doctors realized the balloon angioplasty technique wasn't perfect.
A problem that frequently occurred was that over time, the blockage would re-accumulate, so the patient would often need another procedure within the next six months.
Before long, though, doctors came up with what they thought was a perfect solution: stents, which are tubes made of wire mesh. Doctors used angioplasty to widen arteries and then kept them open with stents.
But doctors soon discovered that stents also led to re narrowing of arteries. Stents were less subject to that problem than balloon angioplasty alone, but it still occurred.
Arteries re-narrowed as scar tissue formed around the stent. If there was too much scarring, it could close off an artery. Once again, doctors turned to technology for a solution. Companies began to make stents coated with drugs that would keep scar tissue from forming, called drug-eluting stents or drug coated stents. The first model hit the market in 2003, and pretty soon, coated stents manufactured by Boston Scientific (Taxus Stent) and Cordis (Cypher Stent) dominated the field -- even though they cost twice as much. Millions of people are now walking around with drug-coated stents in their arteries.
Although stents have greatly reduced the number of patients who will need to have an artery reopened, some patients face a new risk of sudden clots which could produce a heart attack which in turn could lead to death.
No one knows for sure why the coated stents cause these blood clots. But doctors are once again looking for a solution. One clue comes from a study at Duke University. Researchers reviewed the medical records of hundreds of people who got drug-coated stents at the medical center there.
All the patients took a drug called Plavix to reduce the chance that clots would form. That's standard practice. But patients who kept taking Plavix longer than six months were far less likely to die or have a heart attack. David Kong, a cardiologist at Duke, says that a recent study suggests that long-term use of Plavix could offset the risk of blood clots from drug coated stents.
"Certainly, the previous recommendations that patients with drug-eluting stents receive Plavix for either three or six months are likely insufficient, given the data we know now," Kong says. Some doctors even think patients with the new stents should stay on Plavix for life.
But FDA advisers meeting this week to discuss new recommendations have no easy answers. Plavix, which can cause internal bleeding, carries its own risks.
Boston Scientific TAXUS Express Paclitaxel-Eluting Coronary Stent - Johnson Johnson (Cordis) Cypher Stent
On November 29, 2006, the results of a Cleveland Clinic meta analysis of 14 studies including 6675 patients were released.
The study, published in the December issue of the American Journal of Medicine, found that blood clotting is four to five times more likely to occur with the newer drug eluting coronary heart stents than with the older bare metal types of stents.
Blood clotting (thrombosis) can lead to heart attack and death. As a result, the researchers said that this late thrombosis required those with Johnson & Johnson Cypher stents, which emit the drug sirolimus (rapamycin), are required to take anti-clotting drugs for two to three months following implantation, and those with the Boston Scientific Taxus stents, which emit the drug paclitaxel, are required to take anti-clotting drugs for six months or more following implantation.
The FDA is scheduled to meet the first week of December 2006 to discuss the safety and risks of drug coated stents and to make a recommendation for future use of the devices.
If you or a loved one have been injured during surgical placement of a stent or have been injured as a result of an implanted drug eluting stent (drug coated stent) such as the Boston Scientific Taxus stent or the Johnson & Johnson Cypher stent you may be entitled to compensation. To learn more about the stent recalls, for information regarding your legal rights, or the possibility of a class action lawsuit contact our stent lawyers for a free, confidential, case evaluation today. Fill out our online case evaluation form or call us toll free at 1-800-856-6405. |
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