Martin Bendszus1, Götz Thomalla2, Michael Knauth3, Werner Hacke4, Susanne Bonekamp1, Jens Fiehler5. 1. Neuroradiology, University of Heidelberg, Heidelberg, Germany. 2. Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany. 3. Neuroradiology, University Medicine Goettingen, Goettingen, Germany. 4. Neurology, Ruprecht-Karls-University of Heidelberg, Heidelberg, Germany. 5. Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Abstract
RATIONALE: A relevant proportion of patients with acute ischemic stroke are ineligible for intravenous thrombolysis with recombinant tissue plasminogen activator. Mechanical thrombectomy offers a treatment alternative for these patients; however, only few data are available on its safety and efficacy. AIMS AND/OR HYPOTHESIS: The aim of this study was to compare safety and efficacy of stent retrievers as device class with best medical care alone in acute stroke patients with large intracranial vessel occlusion in the anterior circulation who are not eligible for intravenous thrombolysis withrecombinant tissue plasminogen activator up to eight-hours of symptom onset. DESIGN: 'Thrombectomy in patients ineligible for iv tPA' is a prospective, open-label, blinded end-point, binational (Germany and Austria), two-arm, randomized, controlled, post-market study. STUDY OUTCOME(S): Primary end-point is the modified Rankin Score shift analysis 90 days (±14) after stroke. Secondary end-points are excellent neurological outcomes (modified Rankin Score ≤ 1), good neurological outcomes (modified Rankin Score ≤ 2 or National Institutes of Health Stroke Scale improvement ≥ 10), difference between predicted infarct volume and actual core infarct volume (computed tomography or magnetic resonance imaging) at 30 (±6) h post-ictus, successful recanalization (thrombolysis in cerebral infarction score 2b or 3), functional health status 90 (±14) days after stroke (European Quality of Life-5 Dimensions) as well as common safety end-points (adverse event, serious adverse event, symptomatic intracranial haemorrhage at 30 (±6) h, death, or dependency). DISCUSSION: Whether mechanical thrombectomy in patients with acute ischemic stroke who are not eligible for intravenous thrombolysis withrecombinant tissue plasminogen activator improves clinical outcomes is unclear. 'Thrombectomy in patients ineligible for iv tPA' may change clinical practice by providing evidence of an effective and safe treatment for such patients.
RCT Entities:
RATIONALE: A relevant proportion of patients with acute ischemic stroke are ineligible for intravenous thrombolysis with recombinant tissue plasminogen activator. Mechanical thrombectomy offers a treatment alternative for these patients; however, only few data are available on its safety and efficacy. AIMS AND/OR HYPOTHESIS: The aim of this study was to compare safety and efficacy of stent retrievers as device class with best medical care alone in acute strokepatients with large intracranial vessel occlusion in the anterior circulation who are not eligible for intravenous thrombolysis with recombinant tissue plasminogen activator up to eight-hours of symptom onset. DESIGN: 'Thrombectomy in patients ineligible for iv tPA' is a prospective, open-label, blinded end-point, binational (Germany and Austria), two-arm, randomized, controlled, post-market study. STUDY OUTCOME(S): Primary end-point is the modified Rankin Score shift analysis 90 days (±14) after stroke. Secondary end-points are excellent neurological outcomes (modified Rankin Score ≤ 1), good neurological outcomes (modified Rankin Score ≤ 2 or National Institutes of Health Stroke Scale improvement ≥ 10), difference between predicted infarct volume and actual core infarct volume (computed tomography or magnetic resonance imaging) at 30 (±6) h post-ictus, successful recanalization (thrombolysis in cerebral infarction score 2b or 3), functional health status 90 (±14) days after stroke (European Quality of Life-5 Dimensions) as well as common safety end-points (adverse event, serious adverse event, symptomatic intracranial haemorrhage at 30 (±6) h, death, or dependency). DISCUSSION: Whether mechanical thrombectomy in patients with acute ischemic stroke who are not eligible for intravenous thrombolysis with recombinant tissue plasminogen activator improves clinical outcomes is unclear. 'Thrombectomy in patients ineligible for iv tPA' may change clinical practice by providing evidence of an effective and safe treatment for such patients.
Authors: F Dorn; S Prothmann; M Patzig; H Lockau; C Kabbasch; O Nikoubashman; T Liebig; C Zimmer; H Brückmann; M Wiesmann; H Stetefeld; H Poppert; A Reich; L Kellert; G Fesl Journal: AJNR Am J Neuroradiol Date: 2015-09-03 Impact factor: 3.825
Authors: Chee-Keong Wee; William McAuliffe; Constantine C Phatouros; Timothy J Phillips; David Blacker; Tejinder P Singh; Ellen Baker; Graeme J Hankey Journal: Cerebrovasc Dis Extra Date: 2017-05-02
Authors: Georgios Tsivgoulis; Apostolos Safouris; Aristeidis H Katsanos; Adam S Arthur; Andrei V Alexandrov Journal: Brain Behav Date: 2016-01-07 Impact factor: 2.708