For First Time, Treatment Helps Patients With Worst Kind of Stroke, Study Says

A stent, basically a small wire cage, on the end of a catheter is inserted in the groin and threaded through an artery to the brain. Credit Covidien

After three decades of failure, researchers have found a treatment that greatly improves the prognosis for people having the most severe and disabling strokes. By directly removing large blood clots blocking blood vessels in the brain, they can save brain tissue that would have otherwise died, enabling many to return to an independent life.

The study, published online Wednesday in The New England Journal of Medicine and conducted by researchers in the Netherlands, is being met with an outpouring of excitement. One reason the treatment worked, researchers suspect, is that doctors used a new type of snare to grab the clots. It is a stent, basically a small wire cage, on the end of a catheter that is inserted in the groin and threaded through an artery to the brain. When the tip of the catheter reaches the clot, the stent is opened and pushed into the clot. It snags the clot, allowing the doctor to withdraw the catheter and pull out the stent with the clot attached.

“This is a game changer,” said Dr. Ralph L. Sacco, chairman of neurology at the University of Miami’s Miller School of Medicine.

“A sea change,” said Dr. Joseph Broderick, director of the neuroscience institute at the University of Cincinnati.

About 630,000 Americans each year have strokes caused by clots blocking blood vessels in the brain. In about a third to half, the clot is in a large vessel, which has potentially devastating consequences. People with smaller clots are helped by the drug tPA, which dissolves them. But for those with big clots, tPA often does not help.

The study involved 500 stroke patients. Ninety percent got tPA. Half were randomly assigned to get a second treatment, too. A doctor would try to directly remove the clot from the brain. The study did not specify how removal would happen. There are several methods, but the majority were treated with the new stent.

One in five who had tPA recovered enough to return to living independently. But 1 in 3 who also had their clot removed were able to take care of themselves after a stroke.

Companies began marketing various clot-snaring devices, but there were no studies showing they helped. Using them could be risky — some involved pushing wires through twisting blood vessels that often were damaged already from atherosclerosis, Dr. Koroshetz explained. “You could puncture an artery and if you do and get bleeding in the brain, you have a problem,” he said. Another problem was that sometimes fragments of a clot could break off and be swept deeper into the brain, causing new strokes.

The systems were also expensive. Giving a patient tPA cost about $11,100. Using one of the new devices could cost $23,000, Dr. Koroshetz said.

But some neurologists were enthusiastic. The Food and Drug Administration cleared the first device for clot removal in 2004, allowing it to be marketed. The clearance was granted because the agency considered the device to be equivalent to something already in use — devices used to snare pieces of wires or catheters that might break off in a blood vessel during a medical procedure.

That, other neurologists said, was not at all the same as going into the brain to grab a clot. “There was a lot of controversy,” Dr. Koroshetz said. But the devices quickly came into widespread use. It took time and experience for doctors to learn to use the devices, and not everyone had the necessary expertise. - The New York Times