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
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
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
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
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.
Today more than 60% of all drug-coated stent implants are
"off-label," according to the FDA.
Experts also said doctors should be urged to extend the use of the
blood-thinning drug Plavix in patients who receive drug-coated stents
off-label. Current recommendations advise patients to take Plavix along with
aspirin for three to six months after stent placement, though experts said that
should be extended to one year.
The recommendations were not made by a formal vote but were the consensus of
panel members. The FDA does not have to follow the advice of advisory panels,
but it usually does.