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Massachusetts Personal Injury Library

Coated Heart Stents Safe to Use

A recent long-term study of heart stents coated with drugs found that they are as safe as uncoated ones to keep blood flowing to the heart muscle, according to The Boston Globe.

The study led by Dr. Stefan James of Uppsala University Hospital in Sweden was published in the New England Journal of Medicine. The article said the risk of death or heart attack is no greater among those who got the stents with medicine or the older bare metal stents.

What is a heart stent?

The Federal Drug Administration (FDA), says a stent is:

  • a small, lattice-shaped, metal tube that is inserted permanently into an artery.
  • helps hold open an artery so that blood can flow through it.
  • drug-eluting stents are stents that contain drugs that potentially reduce the chance the arteries will become blocked again.
  • A stent is used to hold open an artery that has become too narrow due to atherosclerosis. In atherosclerosis, plaque builds up on the inner walls of arteries, the blood vessels that carry oxygen-rich blood throughout the body.

A previous study done in 2007 reported that there was a safety difference between the two kinds of stents and it affected sales of the bare metal stents. The new study analyzed records of 48,000 patients which showed that the devices work as they should, with high-risk patients showing a 74% lower risk of having a clogged artery, said the article.

Another study

Another study published in the same journal studied how heart devices performed with heart attack patients. Their conclusion showed there was no difference in the risk of death or heart attack from the stents, said the article. In this study the researchers found that the stent that was coated with medicine did a better job of keeping the blood vessels free of clogs.

Complications with coronary medical devices

The FDA is continuing to closely monitor drug-eluting stents. Research shows that:

  • coronary drug-eluting stents remain safe and effective when used for the FDA-approved indications
  • have significantly reduced the need for a second surgery to treat restenosis for thousands of patients each year

The FDA wants patients to know that the stent placement procedure can cause:

  • infection
  • blood clots
  • bleeding
  • rare complications include chest pain, heart attack, or tearing of the blood vessel.
  • it can move out of place
  • plaque can reappear in the stented artery
  • drug-eluting stents have additional risks

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