FDA New Warning On Stents. A Food and Drug Administration 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 many patients.
Stents are mesh tubes used to hold arteries open after physicians clear away blockages, usually with an inflatable balloon angioplasty. Approximately one 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, a division of Johnson & Johnson have exploded in popularity since they came on the market in 2003 and 2004.
Stents are credited with providing a non-surgical 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 sudden deaths by as much as 0.5 percent per year, starting a year after implantation.
The data and resulting press coverage prompted FDA to organize a hastily-convened two-day expert panel to decide how the agency should react. 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 patients with blockages in multiple vessels and in those with larger blockages or co-existing diseases like diabetes.
Today, more than six in ten of all drug-coated stent implants are done “off-label,” or used beyond their approved indication, according to FDA.
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 Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston and chair of the advisory panel.
Patients Who Receive Stents Should Extend The Use Of Plavix
Experts also said physicians 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 implantation, although experts said that should be extended to one year.
The recommendations was not made by a formal vote but were the consensus of panel members. FDA does not have to follow advisory panels’ advice, but usually does.
FDA officials said they would move to communicate the recommendations to the public, although the method of that communication is yet to be decided. The agency could choose to add warnings to drug-coated stent labeling, communicate directly with physicians about the risks, or do both.
At the end of the day what I heard loud and clear is that we need to do better job..,communicating to patients and communicating to doctors the best and the latest information,” said Dan Schultz, MD, director of FDA’s Center for Devices and Radiologic Health. “This meeting needed to happen,” he said.
News of the potential for increased risk sparked anxious press reports and worry among many U.S. patients. Experts stressed Friday that there was little need for patients using drug-coated stents to have them removed. Suspected clots and heart attacks blamed on the stents are still thought to be relatively rare. Patients who take blood-thinning drugs according to physician recommendations reduce their risk.
Some experts described the two days of FDA meetings as a kind of reality check on the use of drug-coated stents by U.S. doctors.
“I think we’ve got to come back to Earth here,” said Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic Foundation and one of the FDA advisors.
There was dissent among panel members. Some worried the issuing new warnings would further frighten patients and physicians away from using stents.
“I haven’t seen anything today that’s going to change my practice on Mon morning when I go back,” said Christopher J. White, chairman of cardiology at the Ochsner Clinic Foundation in New Orleans, and a member of the FDA panel.
In an interview, Ralph G. Brindis, MD, a stent researcher at Kaiser Permanente of Northern California, predicted that the FDA hearings would lead physicians to “more conservatism” in their use of drug-coated stents. He said doctors may now be less likely to use the devices in diabetic patients with multiple blockages or diabetes, instead opting for traditional bypass surgery.
“I think doctors will get the message that rather than using multiple drug-eluting stents, that they’ll be a modest swing back to that procedure,” said Brindis, who is also chief medical officer of the American College of Cardiology.
Mark Turco, MD, a researcher at Washington Adventist Hospital in Washington, DC, said that drug-dispensing stents were greeted by “unbridled enthusiasm” that outpaced scientific proof for many patients. He said recent news of increased risks then swung public perception to one of near panic over the dangers.
“Hopefully we will soon move to a realistic application where the data will far outweigh the perceptions,” he said.