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Future trials of endovascular mechanical recanalisation therapy in acute ischemic stroke patients: a position paper endorsed by ESMINT and ESNR

Part I: Current situation and major research questions

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Abstract

A new era of stroke treatment may have begun with mechanical thrombectomy (MT) by fully deployed closed-cell self-expanding stents (stent-triever). Multiple case series and the first randomised controlled trials (RCTs) have now been published. More studies are under way involving large numbers of patients, which in turn has resulted in less strict “pragmatic” study protocols. Problems with current trials include a lack of standardisation in the conduct of the recanalisation procedure, the definition of primary endpoints such as the grade of arterial recanalisation and tissue reperfusion, and the post-surgical care provided. In Part 1 of this two part series, we outline the current situation and the major research questions.

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Abbreviations

ECASS:

European Cooperative Acute Stroke Study

ICSS:

International Carotid Stenting Study

IMS:

Interventional Management of Stroke

MC CLEAN:

Multicenter Randomized CLinical trial of endovascular treatment for acute ischemic stroke in The Netherlands.

NINDS:

National Institute of Neurological Disorders and Stroke

TREVO:

Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke

THRACE:

Trial and Cost Effectiveness Evaluation of Intra-arterial Thrombectomy in Acute Ischemic Stroke

THERAPY:

The Randomized, Concurrent Controlled Trial to Assess the Penumbra System’s Safety and Effectiveness in the Treatment of Acute Stroke

PISTE:

Pragmatic ischaemic stroke thrombectomy evaluation

REVASCAT:

RandomizEd trial of reVascularizAtion with Solitaire FR® device vs. best mediCal therapy in the treatment of Acute stroke due to anTerior circulation large vessel occlusion presenting within 8 h of symptom onset

RIVER:

Reperfuse Ischemic Vessels with Endovascular Recanalization

SPACE:

Stent-Protected Angioplasty vs. Carotid Endarterectomy

SYNTHESIS EXP:

SYNTHESIS Expansion

SWIFT:

SOLITAIRE FR With the Intention For Thrombectomy

ASPECTS:

Alberta Stroke Program Early CT

BCO:

balloon guiding catheter occlusion

BMT:

best medical therapy

CAS:

carotid stenting

CBF:

cerebral blood flow

CBV:

cerebral blood volume

CCA:

common carotid artery

CEA:

carotid endarterectomy

CS:

conscious sedation

CTA:

CT-angiography

CTP:

CT-perfusion

DSA:

digital subtraction angiography

DWI:

diffusion weighted imaging

EIC:

early ischemic signs

ESMINT:

European Society of Minimally Invasive Neurological Therapy

ESNR:

European Society of Neuroradiology

ESO:

European Stroke Organisation

FU:

follow up

GA:

general anaesthesia

ICA:

internal carotid artery

IMS III:

Interventional Management of Stroke III Trial

IVT:

intravenous thrombolytical therapy

MCA:

middle cerebral artery

mRS:

modified rankin scale

MT:

mechanical thrombectomy

NE-CT:

non-enhanced CT

NIH-SS:

National Institute of Health Stroke Scale

PI:

perfusion MRI

RCT:

randomised control trial

sICH:

symptomatic intracranial haemorrhage

stent-triever:

self-expanding stents

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Conflict of interest

JF consults for Stryker and Codman, and gives presentations to Covidien, Boehringer Ingelheim, Philips and Siemens MS has a Consultant agreement with Mindframe (now owned by Covidien) and is PI for the Rapid Medical study. FT consults for Stryker and Codman, is on the Codman Board, and has a proctoring agreement and holds workshops for Covidien. RVK receives personal compensation for serving on the Advisory Board of Lundbeck AC, serves as Co-Chair on the Steering Committee of the DIAS-3 and -4 trials, serves on the image adjudication committee for these trials and consults for Synarc; he is Section Editor, Interventional Neuroradiology, of the journal Neuroradiology. MM is a consultant for Synthes, AB Medica/Italy, gives presentations for Johnson & Johnson and has research support from ActiveO. CC consults for Covidien, Stryker, Codman and Microvention. JG is PI of the STAR Study (Covidien).

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Authors and Affiliations

  1. Department of Neuroradiology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany

    Jens Fiehler

  2. Department of Neuroradiology, Karolinska University Hospital, Stockholm, Sweden

    Michael Söderman

  3. Department of Neuroradiology, Hôpital Neurologique, Centre de Neurosciences Cognitives, Lyon, France

    Francis Turjman

  4. Department of Clinical Neurosciences, Western General Hospital, University of Edinburgh, Edinburgh, UK

    Philip M. White

  5. Department of Neuroradiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway

    Søren Jacob Bakke

  6. Interventional Neuroradiology Unit, University Hospital Careggi, Florence, Italy

    Salvatore Mangiafico

  7. Department of Neuroradiology, University of Dresden, Dresden, Germany

    Rüdiger von Kummer

  8. Department of Neuroradiology, University of Naples, Naples, Italy

    Mario Muto

  9. Service de Neuroradiologie, Hôpital Purpan, Toulouse, France

    Christophe Cognard

  10. Department of Neuroradiology, Inselspital Bern, Bern, Switzerland

    Jan Gralla

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  1. Jens Fiehler
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Fiehler, J., Söderman, M., Turjman, F. et al. Future trials of endovascular mechanical recanalisation therapy in acute ischemic stroke patients: a position paper endorsed by ESMINT and ESNR. Neuroradiology 54, 1293–1301 (2012). https://doi.org/10.1007/s00234-012-1075-z

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