An independent panel monitoring the experiment halted the research prematurely in April when that pattern became clear. The New England Journal of Medicine published the results early online Wednesday because of the immediate public health implications.
“Without the trial, this procedure seemed destined to become the standard of care,” said H. Gilbert Welch, a professor of medicine at the Dartmouth Institute for Health Policy & Clinical Practice. “With it, we have another example in which the best medical care is not the most medical care.”
“We’re usually trying to play catch-up: The technology is out the door, and we’re trying to rein it back in,” said Walter J. Koroshetz of the National Institute of Neurological Diseases and Stroke. “This is an example of how to do it right.”
How it works
The Gateway-Wingspan gently widens a narrowed artery in the brain with a tiny balloon and then props the passageway open with a miniature expanding mesh scaffolding. As many as 90,000 Americans every year suffer the kind of stroke the treatment was designed to prevent.
“Intuitively, it made a lot of sense,” said Koroshetz, whose institute funded the study. “People thought we could fix these lesions in the brain just like we do with coronary arteries.”
The Food and Drug Administration approved the device based on a small, less rigorous study suggesting it might keep many survivors of strokes caused by narrowed arteries in their brains from suffering another attack that would severely incapacitate or kill them. Blacks and Asians are especially at risk. Regulators wanted to make what appeared to be a life-saving advance available quickly on a “compassionate” basis. Thousands of patients began to undergo the procedure.
But the Centers for Medicare & Medicaid Services (CMS), which administers the health-care system for the elderly, agreed to pay only for the procedures in studies verifying that it really worked, significantly limiting the proliferation of the procedure. Some powerful medical groups pressured CMS to pay for it unconditionally.
“You can see the respective societies and physicians advocating for reimbursement (some of their members do the procedure),” e-mailed Joseph P. Broderick of the University of Cincinnati College of Medicine, who authored an editorial accompanying the study. “CMS made the right call.”
In the meantime, the National Institutes of Health launched the $20 million study to evaluate the procedure on 764 patients ages 30 to 80 who had already suffered a stroke or mini-stroke. All the subjects received an aggressive regimen of drugs to lower blood pressure, cholesterol and blood clotting, along with detailed advice about how to exercise, eat better, quit smoking and control diabetes. That cost about $3,400 for the first year, said Marc I. Chimowitz, a professor of neuroscience at the Medical University of South Carolina, who led the eagerly awaited study. Half also received the Gateway-Wingspan, which added at least about another $20,000 for each patient, he said.
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