Stroke patients whose blocked arteries are re-opened with surgical devices fared better in a study than those treated with intravenous drugs alone to dissolve clots, offering the first solid evidence of an effective new treatment.
In a trial of 500 Dutch patients with stroke caused by lack of blood flow in the brain, 33 percent had little or no disability 90 days after receiving the direct intervention, compared with 19 percent in the control group, according to an article published today in the New England Journal of Medicine. There was no increased risk of death following the treatments.
Stroke is the fourth-leading cause of death in the U.S., killing almost 130,000 a year, according to the Centers for Disease Control and Prevention. The standard treatment for patients with ischemic stroke -- those caused by a blocked blood vessel instead of a hemorrhage -- has been limited to enzymes that dissolve clots administered intravenously, and is only effective in the first four and half hours after a stroke. While some doctors have treated the blockage directly, until now there have been no conclusive studies showing that works.
The Dutch trial - called MR CLEAN, for Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands - was funded by the Dutch Heart Association and was conducted in 16 hospitals.
Patients had their arteries opened with either catheters that applied drugs at the point of blockage, received microsurgery to remove the clots, or both. They were treated within six hours of their stroke.
Earlier studies showed mixed results and were criticized for low recruitment rates, with many eligible patients not being enrolled, according to an editorial in the journal by Werner Hacke, a neurologist at the University of Heidelberg in Germany. The recruitment problem was solved in the Netherlands when the Dutch government refused to pay for the surgical devices for stroke victims unless they were used in the trial, he said.
This policy may be difficult to implement in other health systems but imagine what progress the medical-device field would see if this were the rule, Hacke said in the editorial.
To contact the reporter on this story: Oliver Staley in London at ostaley@bloomberg.net
To contact the editors responsible for this story: Phil Serafino at pserafino@bloomberg.net Bruce Rule, Marthe Fourcade
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Stroke Victims Benefit From Surgery on Blood Clots, Study Says