FDA Panel: New Warnings for Stents
Drug-Coated Stents That Prop Open Arteries May Up Risk for Heart Attack
Dec. 8, 2006 -- An FDA advisory panel recommended new warnings Friday for popular medical devices used in millions of patients with cardiovascular disease.
Experts said the two brands of drug-coated stents available in the U.S. should carry new warnings that the devices may increase the risk of sudden heart attack or death in patients.
Stents are mesh tubes used to prop open arteries after surgeons clear away blockages, usually with an inflatable balloon procedure called angioplasty. As many as 1 million Americans receive stent implants each year.
The devices are made either of bare metal mesh or a newer coated metal that steadily releases a drug into artery walls to prevent formation of scar tissue. Two drug-coated stents -- Taxus, made by Boston Scientific, and Cypher, made by Cordis -- have exploded in popularity since they came on the market in 2003 and 2004.
Heart Bypass Alternative
Stents are credited with providing a nonsurgical alternative to heart bypass operations for many patients with artery disease. But new data released earlier this year suggested that drug-coated versions may increase the risk of heart attacks and death 18 months to three years after stent implantation.
The data and resulting media coverage prompted the FDA to organize a hastily convened two-day session of an expert panel to decide how the agency should proceed. Friday's conclusions came one day after the panel informally voted that the benefits of drug-coated stents outweigh the risks for average patients.
Studies leading to the approval of Taxus and Cypher tested the devices in patients with single, smaller artery blockages. But doctors quickly started using them in more complicated patients with blockages in multiple vessels and in those with larger blockages.
Experts said Friday that the devices' label inserts should now carry a warning that use in more complicated patients increases the risk of dangerous blood clots, heart attack, and sudden death.
"If [doctors] use the device in an off-label manner they're not going to get the results that they see in the label," said William H. Maisel, MD, a cardiologist at Beth Israel Deaconess Medical Center in Boston and chairman of the advisory panel. "Off-label" means using drugs or devices in ways not approved by the FDA.