Brain stents may cause higher rate of stroke

The same researchers recently stopped a trial for brain stents which have already been approved by the U.S. Food and Drug Administration.

The FDA first approved these stents for high-risk patients in 2005, bypassing their usual approach of waiting for solid evidence that such devices do what they claim.

These brain stents are a smaller version of the balloon angioplasty commonly used to keep heart arteries open. They also help keep carotid arteries in the neck open. The brain stents work in the same way, helping keep a previously blocked artery in the brain open to improve blood flow.

The stopped study, which looked at patients who had already suffered a transient ischemic stroke, provided aggressive medical therapy in an attempt to prevent blood flow from being blocked in the brain. Half of the people in the study received brain stents.

Researchers halted the study when it became evident that 14.7 percent of the patients who got the stent had a stroke in the first month. Almost a third of those patients died. The patients who did not receive stents only had a 5.8 percent rate of stroke in the first month.

The FDA is reviewing the study results before they make a final decision on these particular brain stents.