http://www.nytimes.com/2014/12/18/health/for-first-time-a-treatment-helps-patients-with-worst-kind-of-stroke-study-says.html 2014-12-17 16:34:40 For First Time, Treatment Helps Patients With Worst Kind of Stroke, Study Says Researchers have found that directly removing large blood clots in the brain greatly improves the prognosis for people having the most severe strokes. === 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 “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 lifesaving drug tPA, which dissolves them. But for those with big clots, tPA often does not help. Until now, no other treatments had been shown to work. The new study involved 500 One in five patients who had tPA alone recovered enough to return to living independently. But one in three who also had their clot removed directly were able to take care of themselves after their stroke. And that, said Dr. Larry B. Goldstein, director of the Duke Stroke Center, is “a significant and meaningful improvement in what people are able to do.” It has been a long road to this success, explained Dr. Walter J. Koroshetz, acting director of the National Institute of Neurological Disorders and Stroke. It began in the 1980s when researchers began testing intravenous tPA. It dissolved small clots and saved many patients’ brains but was not as effective in dissolving the big clots that are truly devastating. In 1995, when the first large study was published demonstrating tPA’s effectiveness, stroke experts were jubilant. They were left, though, with the problem of helping people with large clots. 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 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 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. Even so, said Dr. Diederik Dippel, professor of neurology at Erasmus University Medical Center and principal investigator for the new study, when his study was about to begin people questioned why it was even needed. “People said why bother with a clinical trial. Just do it,” Dr. Dippel said. The study began in 2010. In the meantime, several other large clinical trials testing clot removal were well underway, Two Gloom settled over the field. In the Netherlands, Dr. Dippel said, attitudes about the trial reversed. “Everyone said, ‘Why should we go on?'” Dr. Dippel said. But the Dutch study happened to start at a time when there were a few key developments that made it possible to hope for success. There was new technology that allowed doctors to quickly assess whether a stroke patient had a large clot and, if so, where it was. In previous studies they tried to guess from a patient’s symptoms. And the stent system for snagging a clot seemed safer and easier to use than previous devices. The stent system, said Dr. Dippel, “was clearly a better device than we were used to.” Of course, said Dr. Goldstein, he would like to see the results confirmed with other studies. But, he and others say, that may already have happened. Two other studies like the Dutch one were just ended early because the results were so positive. The data will be presented in February at the International Stroke Conference in Nashville. Now neurologists are increasingly confident that, at last, they have something in addition to tPA to offer patients. “I think this is the real thing,” Dr. Koroshetz said.