NEJM Releases Studies on Stents

Stent manufacturers were looking to the positives after the release of a series of newly published studies on drug-coated stents .

The New England Journal of Medicine (NEJM) published five studies on the stents. Depending on your perspective, these new studies might offer reassurance that the stents are safe. Or they indicate that the stents should be used much more rarely than they are now. Or that they represent a failure of the regulatory system for medical devices.

Drug-coated stents are used as an alternative to open-heart surgery in a procedure where a balloon is used to open clogs in the arteries that feed the heart, usually as a way of relieving crushing chest pain.

The stents keep the arteries from reclosing after the balloons are withdrawn. Since 2003, millions of patients have gotten new drug-coated versions, which are more effective than older, bare-metal stents at keeping the arteries from closing up. That means patients may feel better and will be less likely to have to get repeat procedures.

But in the past year, some studies have shown that in rare instances deadly blood clots may form in the drug-coated stent, causing heart attacks or death. Sales of the devices have dropped, affecting the two leading makers, New Brunswick, NJ-based Johnson & Johnson and Natick, MA-based Boston Scientific.

All of the studies published last night were hashed out at a meeting organized by the U.S. Food and Drug Administration last December.