Stroke treatment academic industry roundtable: research priorities in the assessment of neurothrombectomy devices.

Stroke

From the Stroke Center and Department of Neurology, David Geffen School of Medicine at the University of California, Los Angeles (J.L.S.); Department of Neurology, University of Pittsburgh Medical Center Stroke Institute, PA (T.G.J.); Department of Neurology, University of California, San Francisco (W.S.S.); and Stroke Center and Department of Neurology, Stanford University School of Medicine, CA (G.W.A.).

Published: December 2013

Background And Purpose: The goal of the Stroke Treatment Academic Industry Roundtable (STAIR) meetings is to advance the development of stroke therapies. At STAIR VIII, consensus recommendations were developed for clinical trial strategies to demonstrate the benefit of endovascular reperfusion therapies for acute ischemic stroke.

Summary Of Review: Prospects for success with forthcoming endovascular trials are robust, because new neurothrombectomy devices have superior reperfusion efficacy compared with earlier-generation interventions. Specific recommendations are provided for trial designs in 3 populations: (1) patients undergoing intravenous fibrinolysis, (2) early patients ineligible for or having failed intravenous fibrinolysis, and (3) wake-up and other late-presenting patients. Among intravenous fibrinolysis-eligible patients, key principles are that CT or MRI confirmation of target arterial occlusions should precede randomization; endovascular intervention should be pursued with the greatest rapidity possible; and combined intravenous and neurothrombectomy therapy is more promising than neurothrombectomy alone. Among patients ineligible for or having failed intravenous fibrinolysis, scientific equipoise was affirmed and the need to randomize all eligible patients emphasized. Vessel imaging to confirm occlusion is mandatory, and infarct core and penumbral imaging is desirable in later time windows. Additional STAIR VIII recommendations include approaches to test multiple devices in a single trial, utility weighting of disability end points, and adaptive designs to delineate time and tissue injury thresholds at which benefits from intervention no longer accrue.

Conclusions: Endovascular research priorities in acute ischemic stroke are to perform trials testing new, highly effective neuro thrombectomy devices rapidly deployed in patients confirmed to have target vessel occlusions.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4142766PMC
http://dx.doi.org/10.1161/STROKEAHA.113.002769DOI Listing

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