The medical community had high hopes for a device that would prevent strokes using a mechanism similar to that used to prevent heart attacks but the study was abruptly halted as the number of strokes in patients with the device continued to rise.
The device in question is called a stent, which physicians typically use to open blocked coronary arteries in order to prevent heart attacks. In this instance, stroke specialists believed that opening the blocked cerebral arteries that can lead to stroke could be equally successful. However, as the researchers report in the current New England Journal of Medicine, the stroke rate among stented patients in the study s first month was nearly 15 percent compared to a rate of just under 6 percent in patients who had been treated with standard medical therapy to control risk factors such as blood pressure, cholesterol, and diabetes.
The device, while still being tested, had been on the market since 2005, when the F.D.A. approved it on the basis of a humanitarian device exemption, which allows the agency to approve devices that would benefit fewer than 4,000 patients as long as the device has not been found to pose a significant risk. However, the unfortunate results of this more advanced clinical trial will most likely result in the removal of the stent from the market. It will not, as physicians had hoped, become a standard treatment for prevention of stroke.
ACSH's Dr. Gilbert Ross agrees that the reasoning behind the device made sense, based on its analogous mechanism in coronary arteries. Evidently, though, he says, there is a difference in its application to the smaller arteries of the brain.
