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Drug Eluting Heart Stent
CYPHER® :: TAXUS®
CYPHER® and TAXUS® are stents (drug eluting heart stent, drug coated stent, medicated stent, medicated heart stent, drug coated heart stent).
A stent is a small, expandable, stainless steel tubes used to prop open and offer support to arteries that would otherwise be collapsing.
The CYPHER® Sirolimus-eluting stent and TAXUS® Express Paclitaxel-eluting stent are medicated or drug eluting stents (DES). The stents are coated with a medication that is supposed to stop restenosis or the re-blocking of the artery.
Studies have linked medicated or drug eluting stents with possible side effects such as thrombosis (blood clotting) and the possible need for long-term costly anti-platelet medication therapy (e.g., plavix - clodiprogel) in order to prevent thrombosis.
In addition, the studies also found that the drug-coated stents may result in a higher death rate due to cardiac events such as heart attack when compared to metal stents without a drug coating.
Most recently, a study in connection with Plavix (clodiprogel) published in JAMA on August 26, 2009 - Association of Cytochrome P450 2C19 Genotype With the Antiplatelet Effect and Clinical Efficacy of Clopidogrel Therapy stated that "Individuals with this genotype [a common gene type or variation] have reduced protection from clopidogrel [plavix] in preventing cardiovascular disease–related events following PCI."
And, as reported by Reuters, this study postulates that "Those who had the [gene] variation and took Plavix after a procedure to open blocked heart arteries [e.g. drug eluting medicated stent via PCI] were 2.4 times more likely to die or have a heart attack or stroke than those who did not have the variant and took the drug."
The Reuters article goes on to report that "They tested their findings in a different study of 227 people undergoing treatment with a stent to prop open blocked heart arteries. Those who had the gene responded poorly to Plavix, and were twice as likely to have a heart attack or stroke in the year after their treatment."
U.S. FDA Action
The CYPHER Sirolimus-eluting stent first received approval for us on April 24, 2003, and the Taxus Express Paclitaxel-eluting stent received approval for use by the FDA on March 4, 2004.
On September 14, 2006, the FDA released a Statement in response to inquiries asking for the agency’s position on adverse events related to Coronary Drug-Eluting Stents (DES).
In addition, the FDA confirmed that studies released in 2006 suggest a 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 a Drug Eluting Stent (DES) like the Cypher or Taxus stent.
Additionally, the FDA issued a warning on January 26, 2009, in connection with recently released studies that indicate that Plavix may be less effective in patients that use Proton pump inhibitors to help decrease stomach acid and are used to treat frequent heartburn and stomach ulcers.
Clopidogrel (Plavix) can irritate the stomach so PPIs are commonly used with clopidogrel to help reduce this irritation.
PPIs include omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), rabeprazole (Aciphex), and esomeprazole (Nexium), which are all available by prescription. Omeprazole (Prilosec OTC) is also sold without a prescription (over-the-counter) for frequent heartburn.
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