In a disappointing development, this week it was disclosed that a stent that was being inserted in the brain to prevent strokes was a failure, with patients who had it installed actually suffering more strokes than those without it, according to The New York Times.
http://www.nytimes.com/2011/09/08/health/research/08stent.html?src=me&ref=general
A study of the stents, which were conditionally approved by the Food and Drug Administration six years ago, was halted because of the findings. The results of the study were published last week online by The New England Journal of Medicine.
http://www.nejm.org/doi/full/10.1056/NEJMoa1105335?query=featured_home
The brain stents worked the way that stents in the heart do. Heart stents are inserted to keep blocked arteries open, therefore preventing heart attacks. The brain stents were inserted in blocked arteries in the brain in order to prevent fatal or disabling strokes.
But the study of the use of stents in the brain found that the device “doubled the rate of stroke or death,” according to The Times.
The FDA had only approved the stents for “on the basis of a humanitarian exemption,” namely “high risk patients who failed medical management,” The Times reported. And thousands of people have had stents installed in their brains since then.
The stent in question was produced by Boston Scientific, and was very similar to stents used in blood vessels leading to the heart. It was also very expensive, costing $21,000 for the device and its insertion.
Enrollment in the test was stopped because the 30-day rate of stroke or death was 14.7 percent in the group with the stents, more than twice as high as the rate in the medical-management group, which was only 5.8 precent, according to The New England Journal of Medicine.
Those risk factors led to the plug being pulled on the study.
