Ethics in Medicine

Stents Fail to Stop Strokes in Study

Kristen Sparrow • September 08, 2011

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

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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