Study: J&J neck stent is as effective as surgery
Johnson & Johnson's neck stent is as effective as surgery in clearing blocked blood vessels to the brain that can cause strokes and death, according to a company-funded study in tomorrow's New England Journal of Medicine.
High-risk patients treated with the device, a tiny mesh tube threaded up to the carotid artery from the groin, showed no greater risk of death, heart attack, or stroke after one month than patients who had their neck arteries cut open and cleared, the study found. Johnson & Johnson's stent cut death rates as effectively as surgery for up to one year, researchers said.
Johnson & Johnson is seeking to catch up to Guidant Corp., which won US Food and Drug Administration approval to sell a similar neck device in August. Both companies already sell their neck stents outside the United States, and Guidant has estimated the worldwide market for the devices may rise to as much as $300 million within four years from about $40 million this year.
"If you do have carotid-artery disease and you happen to be elderly or have another complicating factor, you will do better with the less-invasive procedure," lead researcher Jay S. Yadav, director of vascular intervention at the Cleveland Clinic Foundation, said in a telephone interview. "The choice is pretty self-evident."
Still, the FDA has criticized several aspects of Johnson & Johnson's study, including procedures and oversight, and said the New Brunswick, N.J.-based company must conduct additional work before its Precise device is cleared for sale in the United States.
The study involved 334 patients with health problems that could have been exacerbated by surgery. Twenty patients who got the stent had a stroke, heart attack, or died, compared with 32 patients who underwent surgery. The results didn't prove that stents were better, only that they weren't inferior, the researchers said.
The study wasn't large enough and the findings weren't definitive enough to show which patients with clogged neck arteries should get stents and which would benefit more from surgery, said Richard P. Cambria, a vascular surgeon from Massachusetts General Hospital, in an editorial.
"Physicians, industry sponsors, and regulatory agencies should collectively insist on large-scale, multicenter trials in order to clarify the appropriate role of carotid-artery stenting" among different groups of patients, he wrote.
