No added risk found in drug-coated stents

Thursday, January 24, 2008
By Joe Fahy, Pittsburgh Post-Gazette

Compared to bare-metal stents, drug-coated stents are not associated with increased risk of death or heart attack after one year in patients with complex heart problems, according to a new study led by University of Pittsburgh researchers.

The study also found that repeat procedures to restore blood flow were significantly less frequent in patients who received drug-coated stents.

The findings were published today in the New England Journal of Medicine.

Examples of complex conditions include blockages that occur at branching points of coronary arteries, exceptionally long blockages and blockages within grafts from coronary artery bypass surgery, said Dr. Oscar Marroquin, the study's lead author and director of the Center for Interventional Cardiology Research at the University of Pittsburgh Medical Center's Cardiovascular Institute.

"We feel our study supports the continued use of drug-coated stents for patients with these complex heart issues," Dr. Marroquin said.

Stents are mesh-metal tubes used to prop open blocked coronary arteries. They are implanted during cardiac catheterization procedures. But the arteries can later narrow again from scar tissue formed in response to the stent.

In 2003, the U.S. Food and Drug Administration approved drug-coated stents, also known as drug-eluting stents, which contain drugs to help prevent arteries from again becoming blocked. The approval was based on the results of clinical trials in selected patients. Because of the apparent positive effects, however, doctors extended use of drug-coated stents to patients with features beyond those of patients in the trials, a use considered "off-label."

Two years ago, some reports raised questions about the safety of drug-coated stents for off-label use, Dr. Marroquin said, and an FDA panel called for more study.

The reports had a chilling effect on sales in the worldwide stent industry, which fell from nearly $6 billion in 2006 to about $5 billion last year.

But other study findings presented last year also suggest that drug-coated stents do not pose increased risk, noted Dr. Tony Farah, medical director of the cardiac catheterization laboratory at Allegheny General Hospital.

The latest study "adds to the comfort level," Dr. Farah said.

Recent positive findings about the stents could fuel a rebound in utilization, and some signs point in that direction, said Robert Faulkner, an analyst for Thomas Weisel Partners.

But a turnaround has yet to occur and will require rebuilding the confidence of physicians and patients, said Aaron Vaughn, a health care analyst for Edward Jones.

In the study published today, Dr. Marroquin and his colleagues analyzed data on 6,551 patients in the National Heart, Lung and Blood Institute Dynamic Registry, managed by the Epidemiology Data Center at the Pitt Graduate School of Public Health.

The study assessed whether patients received bare-metal or drug-coated stents and whether their use was standard or off-label.

Researchers found that after one year, there were no significant differences in the adjusted risk of death or heart attack in patients with drug-coated stents compared to those with bare-metal stents.

Off-label use of the drug-eluting stents also resulted in an estimated 36 percent risk reduction in the need for repeat procedures compared to bare-metal stents.

Another study also published today in the New England Journal found that in patients with multi-vessel coronary artery disea


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