(RxWiki News) Some patients with coronary blockage benefit from medicine-coated stents to prop the artery open. A new study confirms stents are safe with limited use.
Limiting the use of drug-eluting stents to a small group of patients did not increase the risk or death or heart attack within one year. In addition, their use is saving the U.S. healthcare system $400 million annually. Several 2006 studies previously suggested a high risk of heart problems.
"Ask if your doctor if you are a candidate for drug-eluting stents."
Dr. David J. Cohen, senior author and director of cardiovascular research at Saint Luke’s Mid America Heart and Vascular Institute, said that using drug-eluting stents in a relatively unselected way only resulted in marginal improvement as compared to selective use. When use of the stents was broader, Dr. Cohen said doctors put in many more drug-eluting stents, but benefited very few additional patients.
The selective use of drug-eluting stents, metal scaffolds inserted into an artery after angioplasty to hold it open, began in 2007. Angioplasty is used to open a blocked coronary artery. The stents are coated with a drug that helps prevent blood clots, and are believed to reduce recurrent artery narrowing as compared to non-coated stents.
In the analysis, researchers compared the use of drug-eluting stents in 2004 through 2006 to 2007 by using data from the Evaluation of Drug-Eluting Stents and Ischemic Events registry. The registry of percutaneous coronary interventions, also known as PCI or angioplasty, included 10,144 patients undergoing angioplasty at 55 medical centers.
The use of the coated stents decreased from 92 percent from 2004 through 2006 to 68 percent in 2007, while rates of death and heart attack remained unchanged. There was a slight increase in procedures to retreat blocked arteries, from 4.1 percent to 5.1 percent.
A number of 2006 studies found a higher risk of clotting, heart attacks and deaths in patients who received drug-eluting stents. The research also suggested that it was inefficient to use the stents in all patients. As a result the U.S. Food and Drug Administration voiced concern, and led an effort to gradually reduce their use.
Dr. Cohen said the FDA's concern at the time was warranted, but stressed that additional research indicates drug-eluting stents are safe and pose "no real excess risk."
The recent study found that when the use of drug-eluting stents declined in 2007, they were more likely to be placed in patients at the highest risk of re-blockage, including younger patients with smaller blood vessels. This change allowed doctors to use fewer drug-eluting stents while preserving the benefit and cutting the average healthcare cost per patient by $401.
Other studies are underway to determine which patients might be the best candidates for the treatment. The Evaluation of Drug-Eluting Stents and Ischemic Events registry, known as EVENT, was funded by Millennium Pharmaceuticals and Schering Plough, Inc.
The analysis was published in Circulation: Journal of the American Heart Association.