Excess Stroke Risk Halts Brain Stent Study

September 8th, 2011

Stents have been used successfully for years in people with atherosclerosis to keep arteries around the heart open and prevent a first, second, or third heart attack. About six years ago, stents were approved for use in the brain, with the hopes of preventing strokes.

The brain stents failed miserably. A study designed to test the efficacy of these stents was stopped prematurely because the devices actually doubled the rate of stroke.

According to an article in The New York Times, the study’s injury rate also raised serious questions about whether the F.D.A.’s procedures for approving such a medical device ended up putting patients at risk. The stent was made by Boston Scientific. It was a risky endeavor from the beginning–brain arteries are more fragile than arteries in other parts of the body, and they are notoriously unforgiving of bleeding.

The Food and Drug Administration approved the new stent in August 2005 for high-risk patients who failed medical management….Yet doctors, eager to help patients with dire prognoses, put the stents in thousands of patients, said Dr. Marc Chimowitz of the Medical College of South Carolina and the principal investigator of the new study. Private insurance often paid the more than $21,000 for the stent and its insertion in the brain artery, a price that did not include a stay in intensive care afterward. The average age of patients in the new study was about 60.

The study’s results showed that nearly 15 percent of patients who got the stent had a stroke within a month. Five died. Compare that to the “control group,” the patients who were not given a stent—only 5.8 percent had strokes in the first month, and none died of stroke.

“Quite frankly, the results were a surprise,” said Dr. Joseph Broderick, chairman of neurology at the University of Cincinnati College of Medicine.

The word “surprise” seems like an understatement. The patients who had the extra strokes probably would use words like “devastating” or “tragic” or “life-altering.” Surprises are for magic shows and birthday parties. Medicine should be predictable and scientific.

To read the full article in The New York Times, click here:  Study Is Ended as a Stent Fails to Stop Strokes