Drug-Coated Stents Considered Safe
It was just a little more than a month ago the Food and Drug Administration reacted to the concerns expressed by researchers that drug-coated stents could possibly cause complications including blood clots years after implementation. They did this by stating that they expected to issue new testing requirements for drug-coated stents.
Now, a study published in the New England Journal of Medicine concludes that the use of drug-eluting stents was not associated with an increased risk of death and supports their use for off-label indications.
About half of stents currently placed in heart patients in the United States are used “off-label” –for purposes not officially approved by the FDA. The earlier studies suggested drug-coated stents used off-label posed a small risk and warranted further examination by the FDA.
Narrowed coronary arteries deliver blood and oxygen to the heart muscle. To enlarge the artery, doctors install a wire mesh stent. The stent can cause scar tissue that again narrows the artery. Stents coated with an anti-inflammatory drug slows scar tissue growth and the narrowing of the arteries it causes.
