Swedish Study Finds Drug-Coated Stents are Safe After All

A study released this week by Swedish researchers dispels earlier research that found drug-coated heart stents are less safe than bare-metal ones.

Research released in December 2006 by the same group concluded that patients who got drug-eluting stents were 18 percent more likely to die within three years. That conclusion caused the sales of stents by medical device makers such as Natick, Mass.-based Boston Scientific and New Brunswick, N.J.-based Johnson & Johnson to plummet.

“The immediate impact was a decrease in the use of drug-eluting stents and a lot of scrutiny on safety,” said Professor Franz Eberli from the University Hospital Zurich in Switzerland in a statement. Eberli said the latest paper looking at the same group of patients “provides a lot of reassurance.”

The results from the recent study, headed up by Dr. Stefan James of Uppsala University Hospital in Sweden and published in the New England Journal of Medicine, confirmed that the risk of death or heart attack is no greater among those who received drug-eluting stents or bare-metal stents.

Results from the Swedish study of about 48,000 patients show the devices work as promised, especially in high-risk patients, who had a 74 percent lower risk of having a clogged stent compared with similar patients who got a bare metal stent.

For more information on the cardiovascular device industry, read the June issue of Medical Product Outsourcing.