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‘Safety concerns’ for majority of stent patients

/ Source: news services

Members of the Food and Drug Administration panel that reviewed the safety of popular drug-coated stents would like doctors to use them less often in certain types of patients, the chairman of the panel said Friday.

The problem is the drug-eluting versions of the tiny mesh tubes used to prop open arteries carry a greater risk of causing blood clots, which can lead to heart attacks and death. And there are more severe "safety concerns" when the devices are implanted for off-label uses, the FDA panel warned.

More than 60 percent of the 3 million Americans with drug-coated stents have gotten them for "off-label" indications — including putting them in more than one vessel, after an acute heart attack or in patients with complications such as diabetes.

Still, the panel, wrapping up two days of debate on Friday, was split on the strength of the evidence concerning the risks.

Patients with these types of stents in their arteries face an increased risk of heart attacks and death, but it’s unclear to what extent their already poor health or the devices are to blame, the federal advisers concluded.

“I think the panel would like to see the amount of off-label use go down,” Dr. William Maisel of Beth Israel Deaconess Medical Center told reporters after the panel meeting.

Panelists recommended stent patients take blood-thinning drugs for at least a year. They also said the labels on the devices should be updated to warn doctors that off-label use won’t give the same results as seen in generally simpler cases involving healthier patients.

Majority of patients 'off-label'

A day earlier, the same panel concluded that the drug-coated stents are safe when used as directed but may put patients at risk for blood clots. Use as directed involves healthier patients with less complex problems. They account for fewer than 40 percent of cases.

“If these stents are really doing what they’re supposed to do, please help alleviate the fear that many of us are experiencing,” stent patient Rick Dulin, 51, told the panel Friday. The Rockville, Md., resident urged the medical establishment to provide stent patients with more support and more current information.

The device in question is a tiny artery scaffold with a drug coating. The drugs elute, or dissolve, into the body to prevent reclogging of arteries that can require follow-up surgery. That’s their advantage over the plain, bare-metal stents.

The FDA is concerned by a small but significant increased risk of clotting associated with the drug-eluting stents. The agency convened the outside panel of experts to examine the issue and provide recommendations.

Several of the panelists pointed to a Swedish study of 60,000 patients showing that patients with these types of stents have a 20 percent higher death rate than those getting the older bare metal stents.

Stronger labels urged

Dr. Steve Nissen of the Cleveland Clinic suggested strengthening the language on the devices’ labels to reflect the uncertainty of their safety in broader populations.

“I want to warn people a little more than we do now,” Nissen said.

But the lack of evidence from studies left some panelists unable to make a strong recommendation.

“I haven’t heard anything today that’s going to change my practice when I go back Monday morning,” said Dr. Christopher White, of the Ochsner Clinic in New Orleans.

Some suggested any evidence of increased risk compared to on-label use is muddied by the health of the patients.

“The differences, if there are any, are likely to be confounded by differences in the patient population,” said panel member Dr. Warren Laskey, of the University of New Mexico’s medical school.

The two companies with U.S. approval to sell the stents, Boston Scientific Corp. and Johnson & Johnson, said there is no increased risk in off-label patients or, if there is, that it’s probably attributable to their health status.

The panelists also told the FDA that companies seeking to bring new drug-coated stents to market should carry out longer and larger trials in humans to understand the clotting risk. Both Medtronic Inc. and Abbott Laboratories hope to enter the more than $5 billion U.S. market for the drug-coated stents.

NBC's Robert Bazell, Reuters and The Associated Press contributed to this report.