Drug-Coated Stents: High Marks for Safety
Studies Show Drug-Coated Stents Have Lower Risk of Renarrowing of Arteries Than Bare-Metal Stents
May 6, 2009 -- Heart patients treated with drug-coated stents to open clogged arteries are no more likely to die than patients treated with non-drug-coated stents, and they have a lower risk of having their arteries renarrow, two studies show.
The studies should help calm fears raised several years ago about the safety of drug-coated stents, also called drug-eluting stents, which have been linked to an increased risk for blood clots.
In one study, patients who got stents during a heart attack that were coated with the drug paclitaxel were less likely than patients treated with bare-metal stents to need repeat procedures over the next year to reopen a treated artery.
In another study, which followed everyone in Sweden who got stents between 2003 and 2006, treatment with drug-coated stents was also associated with a lower risk of having treated arteries renarrow -- a condition known as restenosis.
Death Rates for Stents
Death rates were similar in both treatment groups in both studies, which appear in the May 7 issue of the New England Journal of Medicine.
A third study, presented at a meeting of the American College of Cardiology, compared outcomes among 262,700 Medicare patients across the U.S. treated with drug-coated or bare-metal stents.
In that trial, treatment with a drug-coated stent was associated with a slight decrease in deaths and nonfatal heart attacks.
Cardiologist Glenn N. Levine, a spokesman for the American Heart Association, tells WebMD that the latest studies have reduced, but not eliminated, concerns about the safety of drug-coated stents.
Levine is a professor of medicine at Houston's Baylor College of Medicine and directs the coronary care unit at Baylor's Michael E. DeBakey Medical Center.
"It is certainly reassuring that in these large registries, as well as the large randomized trial, we do not see any significant increase in death or even a signal for an increase" associated with drug-coated stents, he says.
Drug-coated stents are essentially normal metal stents treated with a drug designed to help prevent arteries from reclogging.
In 2007, researcher Stefan K. James, MD, and colleagues studying outcomes among Swedish heart patients were among the first to confirm a link between coated stents and potentially life-threatening blood clots.