MINNEAPOLIS -- Drug-coated stents, mesh devices that help prop open clogged arteries, are used in off-label, or unapproved, ways about half the time in the United States, doubling the risk of a heart attack or death in some cases, studies show.
Complications are more common when stents are used for conditions that haven't been approved by US regulators after human testing, according to two studies published in the Journal of the American Medical Association. This includes cases in which blood vessels are totally blocked, or where the vessels branch at the point where plaque buildup occurs, and those that have lesions in previously treated arteries.
In one study, 10.9 percent of patients who got stents for unapproved conditions died, had a heart attack, or needed further work to clear the artery, compared with 5 percent of those with routine blockages. After a year, the number of complications rose to 17.5 percent versus 8.9 percent.
"Patients should realize every procedure we do has some risk, and now we have data to quantify that risk," said E. Magnus Ohman, director of the program for advanced coronary disease at Duke University Medical Center in Durham, N.C., in a telephone interview.
Sales of the drug-coated devices made by Johnson & Johnson, based in New Brunswick, N.J., and Natick -based Boston Scientific Corp. have flagged since they were linked to potentially fatal blood clots.
Drug-coated stents that generate more than $5 billion worldwide now account for about 71 percent of US sales as doctors turn back to older, bare-metal models that haven't been linked to the clotting.