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March 2016

Thirty Years After the National Institute of Neurological Disorders and Stroke Recombinant Tissue Plasminogen Activator TrialA New Era for Stroke Therapy

Author Affiliations
  • 1Departments of Neurology, Anesthesiology, and Surgery, University of Massachusetts Medical School, Worcester
  • 2Departments of Neurology, Anesthesiology, and Surgery, UMass Memorial Medical Center, Worcester, Massachusetts

Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA Neurol. 2016;73(3):265-267. doi:10.1001/jamaneurol.2015.4453

The results of recently completed clinical trials15 of acute ischemic stroke that report a clear and unequivocal benefit of stent-retriever devices used with intravenous recombinant tissue plasminogen activator (rtPA) vs rtPA alone are the second revolutionary therapeutic breakthrough in acute stroke care in the last 50 years. This breakthrough makes the case for a new standard of care for the treatment of acute ischemic stroke. When we look back at the controversy surrounding interventional acute stroke therapies after multiple trials6,7 of interventional treatment, most notably International Management of Stroke III (IMS III) and Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy (MR RESCUE), that failed to find superiority and even called into question the efficacy of interventional treatment, it is abundantly clear that we were in a different era back then. The trials raised fundamental questions about whether vessel recanalization, which many believed was the best marker of successful therapy, was the right end point and why that did not translate to better outcome. There were also concerns about how the stroke-treating community conducted clinical trials from flawed study designs, poor patient selection, the absence of true clinical equipoise that resulted in poor patient recruitment, and selection bias tainting the results of the trials. All these concerns were against the backdrop of improving primary and secondary prevention with medical therapies, systems, and protocols of care and rapidly developing technology and advances in devices that were rendering the trial results obsolete before they were published. The sense of urgency to address these issues in a timely manner was further heightened as the Centers for Medicare & Medicaid Services started to withhold reimbursements for interventional neuroradiologic cerebrovascular treatments, which many viewed as having potentially disastrous consequences for patient care, neurointerventional radiology practice, and possibly even clinical stroke research.

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