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

TY - JOUR

T1 - Stroke treatment academic industry roundtable: research priorities in the assessment of neurothrombectomy devices

AU - Saver, Jeffrey L

AU - Jovin, Tudor G

AU - Smith, Wade S

AU - Albers, Gregory W

AU - Baron, Jean-Claude

AU - Boltze, Johannes

AU - Broderick, Joseph P

AU - Davis, Lisa A

AU - Demchuk, Andrew M

AU - DeSena, Salvatore

AU - Fiehler, Jens

AU - Gorelick, Philip B

AU - Hacke, Werner

AU - Holt, Bill

AU - Jahan, Reza

AU - Jing, Hui

AU - Khatri, Pooja

AU - Kidwell, Chelsea S

AU - Lees, Kennedy R

AU - Lev, Michael H

AU - Liebeskind, David S

AU - Luby, Marie

AU - Lyden, Patrick

AU - Megerian, J Thomas

AU - Mocco, J

AU - Muir, Keith W

AU - Rowley, Howard A

AU - Ruedy, Richard M

AU - Savitz, Sean I

AU - Sipelis, Vitas J

AU - Shimp, Samuel K

AU - Wechsler, Lawrence R

AU - Wintermark, Max

AU - Wu, Ona

AU - Yavagal, Dileep R

AU - Yoo, Albert J

AU - STAIR VIII Consortium

PY - 2013/12/1

Y1 - 2013/12/1

N2 - 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.

AB - 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.

KW - Brain Ischemia

KW - Clinical Trials as Topic

KW - Fibrinolytic Agents

KW - Humans

KW - Research Design

KW - Stroke

KW - Thrombectomy

KW - Thrombolytic Therapy

U2 - 10.1161/STROKEAHA.113.002769

DO - 10.1161/STROKEAHA.113.002769

M3 - SCORING: Journal article

C2 - 24193797

VL - 44

SP - 3596

EP - 3601

JO - STROKE

JF - STROKE

SN - 0039-2499

IS - 12

ER -