Study Debunks Operation to Prevent Strokes

I'm sorry to see that this attempt also failed. I discussed the failed use of stents to prevent strokes here. But I just want to emphasize that $20 million is quite a bit of money that could have gone to health clinics to avail patients of exercise machinery, or subsidies to provide better nutrition, education, or even improved drug compliance. $20 million is not nothing. And it was used to subsidize the study of a very expensive procedure that made logical sense, but turned out to be bust. I commented on the persistence of the medical establishment to use treatments that don't work here. There is a tyranny of "logic," or "what makes sense" even though it turns out to be dangerous. Maybe we need to rethink our models. Just sayin'.
info on my practice here. Excerpts from the article follow, emphases mine.
November 8, 2011

Study Debunks Operation to Prevent Strokes
By DENISE GRADY

An operation that doctors hoped would prevent strokes in people with poor circulation to the brain does not work, researchers are reporting. A $20 million study, paid for by the government, was cut short when it became apparent that the surgery was not helping patients who had complete blockages in one of their two carotid arteries, which run up either side of the neck and feed 80 percent of the brain.

The surgery was a bypass that connected a scalp artery to a deeper vessel to improve blood flow to the brain.

The new study, published on Wednesday in The Journal of the American Medical Association, is the second in recent months to find that a costly treatment, one that doctors had high hopes for, did not prevent strokes. In September, researchers reported that stents being used to prop open blocked arteries deep in the brain were actually causing strokes. That study was also cut short.

Both the stents and the bypass operation seemed to make sense medically, and doctors thought they should work. Their failure highlights the peril of assuming that an apparent improvement on a lab test or X-ray, like better blood flow or a wider artery, will translate into something that actually helps patients, warned an editorial that accompanied the new findings. Only rigorous studies can tell for sure.

The editorial writer, Dr. Joseph P. Broderick, chairman of neurology at the University of Cincinnati College of Medicine, also cautioned that other stroke treatments were being used without sufficient study, particularly devices to remove clots. Dr. Broderick said doctors liked new technology, were paid well to use it and tended to believe in what they were doing, even without data.

The bypass operations were performed at 49 hospitals in the United States and Canada. All the patients given the surgery had had a stroke or transient ischemic attack (sometimes called a mini-stroke) during the previous 120 days, and were at high risk for another stroke. About 24,000 people a year in the United States were thought to be candidates for the operation.

...

The surgery costs about $40,000, probably 10 times the price of a year’s worth of medicine to reduce the risk of stroke, according to Dr. William J. Powers, the lead author of the study and chairman of neurology at the University of North Carolina in Chapel Hill...

Dr. David Langer, a brain surgeon and associate professor at the Hofstra North Shore-Long Island Jewish School of Medicine, said the study was well done and important.

“Surgeons don’t want to be doing bad operations,” Dr. Langer said. “Whenever you have a paper like this, we’re all disappointed, because we like to operate. But in the end it’s a good thing...”

Stents Fail to Stop Strokes in Study

I would say "oh well," except strokes are a serious and can be extremely debilitating so it's a tragic study.  Again, I think we'll find prevention, though not glamorous nor exciting has got to be mission. I wrote about stents here, and medical device controversy here, here and here. You may want to read the article in its entirety if these topics interest you.  The stents cost $21,000 to insert, and Medicare would only pay if the patients were part of a study.  $21,000 could probably pay for a private nurse to go to the patient's house every day for 5 years to make sure they took their meds, ate their green leafies, and took their walk.  I know I'm being churlish...

Study Is Ended as a Stent Fails to Stop Strokes
By GINA KOLATA

A promising but expensive device to prop open blocked arteries in the brain in the hope of preventing disabling or fatal strokes failed in a rigorous study, researchers reported on Wednesday. Those who got the device actually had so many more strokes than those assigned to control risk factors, like blood pressure, cholesterol and diabetes, that the study was abruptly terminated.

The Food and Drug Administration approved the device six years ago on the basis of a humanitarian exemption, which did not require solid evidence that it would prevent strokes. Thousands of patients got the devices since then, according to the study’s lead researcher. The finding that the devices actually more than doubled the rate of stroke or death raised serious questions about whether the F.D.A.’s procedures for approving such a medical device ended up putting patients at risk.

The study comes just a month after an expert panel at the Institute of Medicine, a major scientific group, recommended that the F.D.A. replace its more usual regulatory system for devices because it failed to establish the safety and efficacy of less risky devices, like artificial hips, before licensing.

While neurologists were deeply disappointed by the study’s outcome, they also said it was better to find out that the treatment was, on balance, harmful before it became standard medical practice.

Larry Kessler, an expert on medical devices and a former director in the F.D.A.’s Center for Devices and Radiological Health, said that the humanitarian exemption made sense sometimes, but that the new study showed its dangers.

If the study’s findings hold up, Dr. Kessler said the approval of the brain stents “should be something the F.D.A. is very concerned about.” The agency, he added, has the authority to withdraw its approval...

The study’s results, published online Wednesday in The New England Journal of Medicine, were sobering. Thirty three patients, or 14.7 percent, who got the stent had a stroke in the first month, and five died. Among those who had medical therapy, 13 patients, 5.8 percent, had strokes in the first month. One died, but not from a stroke.

The medical therapy group actually did better than expected, perhaps because they were prompted and hounded to get their risk factors under control and also, Dr. Chimowitz said, because they took two drugs to prevent clots, aspirin and clopidogrel, for 90 days.

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