WASHINGTON – The first randomized controlled study to evaluate a procedure that removes blood clots in the brain from patients experiencing severe strokes finds it delivers no better outcomes than non-invasive standard medications. In addition, the study found imaging techniques were not helpful in identifying patients who potentially would benefit most from clot removal.
The study, led by a Georgetown University Medical Center researcher, was published online today in the New England Journal of Medicine and simultaneously presented at the International Stroke Conference in Honolulu, Hawaii.
"The hope was, and to some degree still is, that if you pull out the clot within a certain period of time and there is salvageable brain tissue, there will be better outcomes," said lead researcher Chelsea Kidwell, M.D., professor of neurology and director of the Stroke Center at Georgetown University Medical Center.
Currently, the only proven effective treatment for a stroke caused by a blood clot (ischemic) is tPA (tissue plasminogen activator). The treatment, administered in the hospital, must be given within the first few hours after stroke symptoms appear. For patients who don't meet the timeline for treatment or whose clots do not respond to tPA, an interventional procedure to remove the is another option.
The study, named MR RESCUE (Mechanical Retrieval and REcanalization of Stroke Clots Using Embolectomy), was conducted at 22 institutions in the U.S. The trial evaluated outcomes in 118 patients at an average age of 65.5 who had suffered a severe ischemic stroke in one of the large blood vessels carrying blood to the front of the brain (the most common location for this type of stroke).
By removing the clot within the first eight hours of having the stroke, researchers hypothesized that the procedure would restore blood flow to the affected area of the brain. Prior to conducting the procedure, the patients received an array of MRI or CT scans, including a blood flow study, to help identify those with viable brain tissue who presumably would benefit if the clot was removed and blood flow restored.
After imaging studies were processed using study-specific software to determine if substantial salvageable brain tissue was present, the patients were randomized to receive either standard medical treatment (aspirin or other medicine) or clot removal with a special device. Patients who received tPA were allowed to enroll in the study if the treatment failed. Tools used to remove the clot included the MERCI Retriever (a tiny corkscrew-like device) or the Penumbra System (an aspiration device).
Researchers found no greater overall benefit in patients who had their clot removed compared to standard medicines. More specifically:
Kidwell says these findings may not apply to the newer clot removal tools that can open vessels better and faster. "The safety data for these tools examined in this study are encouraging, which is important as we move forward to evaluate newer and possibly better devices," she said