May 8, 2007 (Insidermedicine) Many patients in the US receive drug-coated stents to open blocked coronary arteries, although in many cases their use has not been tested or approved. This has led to high rates of complications, say experts in a report published in the Journal of the American Medical Association. 

Heart attack patients are often treated with percutaneous coronary intervention, also known as angioplasty, to quickly open the blocked artery by inflating a small balloon and inserting a tiny metal structure called a stent to act as permanent scaffolding. The goal is to restore blood flow to the damaged heart muscle. The newer stents are coated with a drug that helps to prevent the artery from becoming re-blocked. In certain conditions, their use has helped save lives; however, they are regularly being used for untested indications that have not been approved by the FDA.  

To evaluate the frequency, safety, and effectiveness of using drug-coated stents, researchers studied nearly 8,000 patients who underwent balloon angioplasty over a six-month period. They found that nearly half of the patients had received stents for untested and unapproved conditions, which doubled their risk of death, heart attack, and formation of blood clots within 30 days. 

While the findings highlight the need for more prudent use of drug-coated stents, the overall risks associated with using drug-coated stents for unapproved conditions are still relatively low over the short and long term.  

Reporting for Insidermedicine, I’m Dr. Susan Sharma.

This is a transcript of a discussion between Dr. Sanjay Sharma, the Editor in Chief of Insidermedicine and Dr. Neil Kleiman who is the author of the article appearing in JAMA.

Dr. Sharma:  “This is Dr. Sanjay Sharma. I’m the Editor-in-Chief of Insidermedicine.  We have Dr. Neal Kleiman on the line, an international expert in heart disease joining us from The Methodist DeBakey Heart Center.  Welcome Dr. Kleiman.”

Dr. Sharma:  “Why the controversy over drug-eluting stents?”

Dr. Kleiman:  “There is controversy over them because they appeared to be extremely promising when they were first available in terms of preventing renarrowing inside an artery that had been dilated with stenting; and as such, they really eliminated what was known has the Achilles Heel of angioplasty; that is, re-stenosis.  We were all very enthusiastic about that, and I would say that we are really still are enthusiastic about them; however, it appears that it comes with a slight cost.  That cost was a very small risk, but a very real and very serious risk, of an acute thrombosis of clotting of the stents.