Comments and Opinions Stroke Treatment Academic Industry Roundtable (STAIR) Recommendations for Maximizing the Use of Intravenous Thrombolytics and Expanding Treatment Options With Intra-arterial and Neuroprotective Therapies Gregory W. Albers, MD; Larry B. Goldstein, MD; David C. Hess, MD; Lawrence R. Wechsler, MD; Karen L. Furie, MD; Philip B. Gorelick, MD; Patty Hurn, PhD; David S. Liebeskind, MD; Raul G. Nogueira, MD; Jeffrey L. Saver, MD; for the STAIR VII Consortium* Background and Purpose—The goal of the Stroke Treatment Academic Industry Roundtable (STAIR) meetings is to advance the development of acute and restorative stroke therapies. Summary of Review—At the STAIR VII recommendations for strategies to maximize the use of intravenous thrombolytics through targeting public education, and the refinement of current treatment exclusion criteria were proposed. Increased utilization of mechanical devices for intra-arterial recanalization can be achieved by obtaining more definitive evidence of efficacy in randomized clinical trials, identification of patient characteristics associated with treatment efficacy, optimization of technical approaches, clarification of effective time windows, and development of approaches to limit complications. Neuroprotective strategies remain viable; recommendations for further study of these agents include an emphasis on rapid administration, consideration of the systemic effects of ischemic stroke, prevention of complications associated with early reperfusion, a focus on agents with multiple mechanisms of action, and consideration of possible interactions between neuroprotective and thrombolytic therapies. Conclusions—Extending intravenous thrombolysis to a broader patient population, clarifying the risk and benefits of intra-arterial reperfusion therapies, and further development of neuroprotective therapies were the key recommendations from STAIR VII. (Stroke. 2011;42:2645-2650.) Key Words: acute stroke  basic science  drug trials  neuroprotection  thrombolysis T he Stroke Treatment Academic Industry Roundtable (STAIR) meetings bring together academic physicians, industry representatives, and regulators to discuss ways to enhance the development of acute and restorative stroke therapies. 1 The first 6 STAIR meetings produced recommen- dations for the preclinical evaluation of stroke therapies, Phase II and Phase III trial design, enhancing trial implemen- tation and completion, novel approaches for measuring out- come, and regulatory considerations. Despite major advances in the understanding of the pathophysiology of brain ischemia and considerable investment in therapeutic trials, currently only a small fraction of patients with ischemic stroke receive acute treatment. The goals of STAIR VII were to propose strategies to maximize the use of intravenous (IV) thrombolytics and to suggest research priorities for the assessment of mechanical devices and neuroprotective ther- apies. This report is based on expert opinion distilled from discussions and workshops at the STAIR VII meeting held on September 11 and 12, 2010, in Washington, DC. Maximizing the Use of IV Tissue-Type Plasminogen Activator Within 4.5 Hours of Symptom Onset Although the benefit is greatest with the shortest possible symptom onset-to-treatment interval, significant IV tissue- type plasminogen activator (tPA)-related functional improve- ments are found when the drug is administered up to approximately 4.5 hours after symptom onset. 2,3 Given the available data, placebo-controlled trials for patients who qualify and can be treated within this timeframe are no longer appropriate. Placebo-controlled trials evaluating the use of thrombolytic agents in patients selected using advanced neuroimaging technologies in later time windows and trials of new thrombolytic strategies compared with IV tPA within 4.5 hours remain viable. Received February 25, 2011; accepted April 27, 2011. Bo Norrving, MD, PhD, was the Consulting Editor for this paper. From the Stanford Stroke Center (G.W.A.), Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA; Duke University Medical Center (L.B.G.), Durham, NC; the Medical College of Georgia (D.C.H.), Augusta, GA; the University of Pittsburgh Medical Center (L.R.W.), Pittsburgh, PA; Massachusetts General Hospital (K.L.F.), Boston, MA; the University of Illinois College of Medicine (P.B.G.), Chicago, IL; University of Texas System (P.H.), Austin, TX; UCLA Medical Center (D.S.L., J.L.S.), Los Angeles, CA; and Emory University School of Medicine (R.G.N.), Atlanta, GA. Correspondence to Gregory W. Albers, MD, Stanford Stroke Center, 780 Welch Road, Suite 205, Palo Alto, CA 94304. E-mail albers@stanford.edu © 2011 American Heart Association, Inc. Stroke is available at http://stroke.ahajournals.org DOI: 10.1161/STROKEAHA.111.618850 2645 Downloaded from http://ahajournals.org by on October 12, 2021