Study is most significant stroke treatment clinical trial since NINDS-2 says Society of NeuroInterventional Surgery
WASHINGTON, DC – December 17, 2014 – A new study published in the New England Journal of Medicine confirms that the addition of inside-the-artery clot removal is more effective than IV-administered “clot-busting” tissue plasminogen activator (IV-tPA) therapy alone for the treatment of stroke. These endovascular (or neurointerventional) procedures have potential life-saving benefits for almost 300,000 people in the United States who suffer a stroke with a large vessel blockage, says the Society of NeuroInterventional Surgery (SNIS).
Of 695,000 people who suffer acute ischemic stroke in the U.S., 40 percent have a large-vessel blockage, which often leads to death or permanent disability. MR CLEAN (Multicenter Randomized Clinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands) evaluated the effect of endovascular treatment for patients with acute ischemic stroke caused by a clot obstructing one of the major intracranial arteries. The study showed that inside-the-artery clot removal during early treatment nearly doubled the likelihood of a good neurological outcome and that it worked well for patients who had received IV-tPA and for those who had contra-indications for IV-tPA.
“The MR CLEAN Study confirms what we are seeing in everyday practice,” said Peter Rasmussen, MD, director of the Cerebrovascular Center, Cleveland Clinic in Cleveland, Ohio, and president of SNIS, “Within-the-artery procedures, which are performed by neurointerventional surgeons, are not the appropriate treatment for every patient suffering from stroke, but for many patients they are life-saving, viable and effective therapies that offer many benefits over traditional treatments, including shorter recovery times and a better chance to return to normal activities.”
According to Dr. Donald Frei, a neurointerventional surgeon at Radiology Imaging Associates in Denver, Colo., and president-elect of SNIS, MR CLEAN is the most significant randomized, controlled stroke treatment study since the NINDS-2 trial in 1995 and subsequent FDA approval of IV-tPA. While IV-tPA revolutionized stroke care, it must be administered within 4.5 hours. Neurointerventional surgery can be performed up to 6 hours from the onset of stroke, significantly expanding the treatment window.
“MR CLEAN is an important milestone in the transformation of care for stroke patients, but it is not the end of the story,” said Dr. Frei. “Neurointerventional surgery is a relatively young and rapidly changing field that typically outpaces clinical research, and we need to ensure that these treatments—their success evident in thousands of lives saved—continue to be evaluated in clinical trials. We are confident that when designed and implemented correctly, clinical studies will continue to show positive results.”
Frei also said that neurointerventional surgery is a critical piece of a system of stroke care that has helped reduce death rates from stroke by more than 35 percent from 2000 to 2010. This includes public education to reduce risk factors and recognize the symptoms of stroke, emergency medical services processes and protocols to appropriately assess patients and emergency transport guidelines that immediately get stroke patients to a hospital that is equipped to provide the best evidence-based interventions for ischemic and hemorrhagic stroke management.
SNIS works to develop general standards to define principles of practice that will produce high quality care and provides guidance on standardized techniques, procedures and practices in the neurointerventional field, not only to improve health care outcomes but also to define the core practice from which this specialty can build and grow.
Stroke is the leading cause of disability and the fourth cause of death in U.S. In 2010, stroke cost the U.S. an estimated $54 billion, including the cost of healthcare services, medications and missed days of work. Strokes cost $74 billion in healthcare expenditures annually for treatment due to disability.
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