Drug-coated heart stents to carry a warning

Dec 11 2006

An advisory panel for the Food and Drug Administration (FDA) in the U.S. has recommended that the drug-coated stents used in patients with cardiovascular disease should carry a warning.

The panel says the popular stents, which are mesh tubes used to keep arteries open after an angioplasty, are implanted in as many as one million Americans each year.

The panel of experts are concerned over two brands in particular Taxus, made by Boston Scientific and Cypher, made by Cordis, a division of Johnson & Johnson which hit the markets in 2003 and 2004.

The stents provided a non-surgical alternative to bypass surgery for many patients with artery disease but it is now thought they may increase the risk of heart attacks and sudden deaths by as much as 0.5 percent per year, beginning a year after implantation.

When new data was released earlier in the year questioning the safety of the devices the FDA quickly assembled an expert panel to decide on a course of action.

The panel has suggested that the benefits of the drug-coated stents outweigh the risks for average patients but the problem has arisen because the original approval for the stents was granted after the devices had been tested in patients with single, smaller artery blockages; however many doctors soon started to use them in patients with blockages in multiple vessels and in those with larger blockages or additional diseases such as diabetes.

According to the FDA such 'off-label' use of the drug-coated stents means that 60 percent or more of all implants are being done in patients for whom they were not intended with the result that more complicated patients are put at an increased risk of dangerous blood clots, heart attack and sudden death.

The advisory panel has also said that the use of the blood-thinning drug Plavix should be extended from six months to one year in patients who receive drug-coated stents off-label.

The recommendations which were the consensus of the panel members, will be made public and communicated to both patients and doctors but the experts say there is no need for patients with the drug-coated stents to have them removed as clots and heart attacks associated with the stents are relatively rare.

Experts and researchers believe the new warnings will lead to a more conservative use of the drug coated stents and many doctors may now revert to traditional bypass surgery for patients with multiple blockages or diabetes.