Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke

• Published in: Stroke (1970) 2003-08, Vol.34 (8), p.e109
• Main Authors: Higashida, Randall T, Furlan, Anthony J, Roberts, Heidi, Tomsick, Thomas, Connors, Buddy, Barr, John, Dillon, William, Warach, Steven, Broderick, Joseph, Tilley, Barbara, Sacks, David
• Format: Article
• Language: English
• Subjects: Acute Disease; Brain Ischemia - complications; Brain Ischemia - diagnosis; Brain Ischemia - therapy; Clinical Trials as Topic - standards; Fibrinolytic Agents - administration & dosage; Humans; Injections, Intra-Arterial; Magnetic Resonance Imaging; Multicenter Studies as Topic - standards; Outcome Assessment (Health Care) - methods; Outcome Assessment (Health Care) - standards; Patient Selection; Research Design - standards; Stroke - complications; Stroke - diagnosis; Stroke - therapy; Technology Assessment, Biomedical; Terminology as Topic; Thrombolytic Therapy - adverse effects; Thrombolytic Therapy - standards; Time Factors; Tomography, X-Ray Computed; United States
• ISSN: 0039-2499; 1524-4628
• DOI: 10.1161/01.STR.0000082721.62796.09

The National Institutes of Health (NIH) estimates that stroke costs now exceed 45 billion dollars per year. Stroke is the third leading cause of death and one of the leading causes of adult disability in North America, Europe, and Asia. A number of well-designed randomized stroke trials and case series have now been reported in the literature to evaluate the safety and efficacy of thrombolytic therapy for the treatment of acute ischemic stroke. These stroke trials have included intravenous studies, intra-arterial studies, and combinations of both, as well as use of mechanical devices for removal of thromboemboli and of neuroprotectant drugs, alone or in combination with thrombolytic therapy. At this time, the only therapy demonstrated to improve outcomes from an acute stroke is thrombolysis of the clot responsible for the ischemic event. There is room for improvement in stroke lysis studies. Divergent criteria, with disparate reporting standards and definitions, have made direct comparisons between stroke trials difficult to compare and contrast in terms of overall patient outcomes and efficacy of treatment. There is a need for more uniform definitions of multiple variables such as collateral flow, degree of recanalization, assessment of perfusion, and infarct size. In addition, there are multiple unanswered questions that require further investigation, in particular, questions as to which patients are best treated with thrombolysis. One of the most important predictors of clinical success is time to treatment, with early treatment of