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

Jeffrey L. Saver, Tudor G. Jovin, Wade S. Smith, Gregory W. Albers, Jean Claude Baron, Johannes Boltze, Joseph P. Broderick, Lisa A. Davis, Andrew M. Demchuk, Salvatore Desena, Jens Fiehler, Philip B. Gorelick, Werner Hacke, Bill Holt, Reza Jahan, Hui Jing, Pooja Khatri, Stella Kidwell, Kennedy R. Lees, Michael H. LevDavid S. Liebeskind, Marie Luby, Patrick Lyden, J. Thomas Megerian, J. Mocco, Keith W. Muir, Howard A. Rowley, Richard M. Ruedy, Sean I. Savitz, Vitas J. Sipelis, Samuel K. Shimp, Lawrence R. Wechsler, Max Wintermark, Ona Wu, Dileep R. Yavagal, Albert J. Yoo

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)3596-3601
Number of pages6
JournalStroke
Volume44
Issue number12
DOIs
StatePublished - Dec 2013
Externally publishedYes

Fingerprint

Industry
Stroke
Equipment and Supplies
Fibrinolysis
Research
Therapeutics
Reperfusion
Thrombectomy
Random Allocation
Clinical Trials
Wounds and Injuries
Population

Keywords

  • Endovascular recanalization
  • Ischemic
  • Reperfusion
  • Stroke

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Clinical Neurology
  • Advanced and Specialized Nursing

Cite this

Saver, J. L., Jovin, T. G., Smith, W. S., Albers, G. W., Baron, J. C., Boltze, J., ... Yoo, A. J. (2013). Stroke treatment academic industry roundtable: Research priorities in the assessment of neurothrombectomy devices. Stroke, 44(12), 3596-3601. https://doi.org/10.1161/STROKEAHA.113.002769

Stroke treatment academic industry roundtable : Research priorities in the assessment of neurothrombectomy devices. / Saver, Jeffrey L.; Jovin, Tudor G.; Smith, Wade S.; Albers, Gregory W.; Baron, Jean Claude; Boltze, Johannes; Broderick, Joseph P.; Davis, Lisa A.; Demchuk, Andrew M.; Desena, Salvatore; Fiehler, Jens; Gorelick, Philip B.; Hacke, Werner; Holt, Bill; Jahan, Reza; Jing, Hui; Khatri, Pooja; Kidwell, Stella; Lees, Kennedy R.; Lev, Michael H.; Liebeskind, David S.; Luby, Marie; Lyden, Patrick; Megerian, J. Thomas; Mocco, J.; Muir, Keith W.; Rowley, Howard A.; Ruedy, Richard M.; Savitz, Sean I.; Sipelis, Vitas J.; Shimp, Samuel K.; Wechsler, Lawrence R.; Wintermark, Max; Wu, Ona; Yavagal, Dileep R.; Yoo, Albert J.

In: Stroke, Vol. 44, No. 12, 12.2013, p. 3596-3601.

Research output: Contribution to journalArticle

Saver, JL, Jovin, TG, Smith, WS, Albers, GW, Baron, JC, Boltze, J, Broderick, JP, Davis, LA, Demchuk, AM, Desena, S, Fiehler, J, Gorelick, PB, Hacke, W, Holt, B, Jahan, R, Jing, H, Khatri, P, Kidwell, S, Lees, KR, Lev, MH, Liebeskind, DS, Luby, M, Lyden, P, Megerian, JT, Mocco, J, Muir, KW, Rowley, HA, Ruedy, RM, Savitz, SI, Sipelis, VJ, Shimp, SK, Wechsler, LR, Wintermark, M, Wu, O, Yavagal, DR & Yoo, AJ 2013, 'Stroke treatment academic industry roundtable: Research priorities in the assessment of neurothrombectomy devices', Stroke, vol. 44, no. 12, pp. 3596-3601. https://doi.org/10.1161/STROKEAHA.113.002769
Saver, Jeffrey L. ; Jovin, Tudor G. ; Smith, Wade S. ; Albers, Gregory W. ; Baron, Jean Claude ; Boltze, Johannes ; Broderick, Joseph P. ; Davis, Lisa A. ; Demchuk, Andrew M. ; Desena, Salvatore ; Fiehler, Jens ; Gorelick, Philip B. ; Hacke, Werner ; Holt, Bill ; Jahan, Reza ; Jing, Hui ; Khatri, Pooja ; Kidwell, Stella ; Lees, Kennedy R. ; Lev, Michael H. ; Liebeskind, David S. ; Luby, Marie ; Lyden, Patrick ; Megerian, J. Thomas ; Mocco, J. ; Muir, Keith W. ; Rowley, Howard A. ; Ruedy, Richard M. ; Savitz, Sean I. ; Sipelis, Vitas J. ; Shimp, Samuel K. ; Wechsler, Lawrence R. ; Wintermark, Max ; Wu, Ona ; Yavagal, Dileep R. ; Yoo, Albert J. / Stroke treatment academic industry roundtable : Research priorities in the assessment of neurothrombectomy devices. In: Stroke. 2013 ; Vol. 44, No. 12. pp. 3596-3601.
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abstract = "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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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, Stella

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

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AU - Yoo, Albert J.

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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.

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KW - Endovascular recanalization

KW - Ischemic

KW - Reperfusion

KW - Stroke

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