Neuroradiology

, Volume 54, Issue 12, pp 1303–1312 | Cite as

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

Part II: methodology of future trials
  • Jens Fiehler
  • Michael Söderman
  • Francis Turjman
  • Philip M. White
  • Søren Jacob Bakke
  • Salvatore Mangiafico
  • Rüdiger von Kummer
  • Mario Muto
  • Christophe Cognard
  • Jan Gralla
Invited Review

Abstract

Based on current data and experience, the joint working group of the European Society of Minimally Invasive Neurological Therapy (ESMINT) and the European Society of Neuroradiology (ESNR) make suggestions on trial design and conduct aimed to investigate therapeutic effects of mechanical thrombectomy (MT). We anticipate that this roadmap will facilitate the setting up and conduct of successful trials in close collaboration with our neighbouring disciplines.

Keywords

Stroke Interventional neuroradiology Thrombectomy Thrombolysis 

Abbreviations

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

References

  1. 1.
    Saver JL (2011) Optimal end points for acute stroke therapy trials: best ways to measure treatment effects of drugs and devices. Stroke 42:2356–2362PubMedCrossRefGoogle Scholar
  2. 2.
    Barclay-Goddard R, Epstein JD, Mayo NE (2009) Response shift: a brief overview and proposed research priorities. Qual Life Res 18:335–346PubMedCrossRefGoogle Scholar
  3. 3.
    Eckert B, Kusel T, Leppien A, Michels P, Muller-Jensen A, Fiehler J (2011) Clinical outcome and imaging follow-up in acute stroke patients with normal perfusion CT and normal CT angiography. Neuroradiology 53:79–88PubMedCrossRefGoogle Scholar
  4. 4.
    Mlynash M, Lansberg MG, De Silva DA et al (2011) Refining the definition of the malignant profile: insights from the DEFUSE-EPITHET pooled data set. Stroke 42:1270–1275PubMedCrossRefGoogle Scholar
  5. 5.
    Thomalla G, Hartmann F, Juettler E et al (2010) Prediction of malignant middle cerebral artery infarction by magnetic resonance imaging within 6 hours of symptom onset: a prospective multicenter observational study. Ann Neurol 68:435–445PubMedCrossRefGoogle Scholar
  6. 6.
    Minnerup J, Wersching H, Ringelstein EB et al (2011) Prediction of malignant middle cerebral artery infarction using computed tomography-based intracranial volume reserve measurements. Stroke 42:3403–3409PubMedCrossRefGoogle Scholar
  7. 7.
    Coutts SB, Modi J, Patel SK, Demchuk AM, Goyal M, Hill MD (2012) CT/CT angiography and MRI findings predict recurrent stroke after transient ischemic attack and minor stroke: results of the prospective CATCH study. Stroke 43:1013–1017PubMedCrossRefGoogle Scholar
  8. 8.
    von Kummer R, Allen KL, Holle R et al (1997) Acute stroke: usefulness of early CT findings before thrombolytic therapy. Radiology 205:327–333Google Scholar
  9. 9.
    Barber PA, Demchuk AM, Zhang J, Buchan AM (2000) Validity and reliability of a quantitative computed tomography score in predicting outcome of hyperacute stroke before thrombolytic therapy. ASPECTS Study Group. Alberta Stroke Programme Early CT Score. Lancet 355:1670–1674PubMedCrossRefGoogle Scholar
  10. 10.
    Menon BK, Puetz V, Kochar P, Demchuk AM (2011) ASPECTS and other neuroimaging scores in the triage and prediction of outcome in acute stroke patients. Neuroimaging Clin N Am 21:407–423, xiiPubMedCrossRefGoogle Scholar
  11. 11.
    Sillanpaa N, Saarinen JT, Rusanen H et al (2011) The clot burden score, the Boston Acute Stroke Imaging Scale, the cerebral blood volume ASPECTS, and two novel imaging parameters in the prediction of clinical outcome of ischemic stroke patients receiving intravenous thrombolytic therapy. NeuroradiologyGoogle Scholar
  12. 12.
    Goyal M, Menon BK, Coutts SB, Hill MD, Demchuk AM (2011) Effect of baseline CT scan appearance and time to recanalization on clinical outcomes in endovascular thrombectomy of acute ischemic strokes. Stroke 42:93–97PubMedCrossRefGoogle Scholar
  13. 13.
    Riedel CH, Jensen U, Rohr A et al (2010) Assessment of thrombus in acute middle cerebral artery occlusion using thin-slice nonenhanced Computed Tomography reconstructions. Stroke 41:1659–1664PubMedCrossRefGoogle Scholar
  14. 14.
    Riedel CH, Zimmermann P, Jensen-Kondering U, Stingele R, Deuschl G, Jansen O (2011) The importance of size: successful recanalization by intravenous thrombolysis in acute anterior stroke depends on thrombus length. Stroke 42:1775–1777PubMedCrossRefGoogle Scholar
  15. 15.
    Lev MH (2012) Acute stroke imaging: what is sufficient for triage to endovascular therapies? Ajnr Am J Neuroradiol 33:790–792PubMedCrossRefGoogle Scholar
  16. 16.
    Fiehler J, Foth M, Kucinski T et al (2002) Severe ADC decreases do not predict irreversible tissue damage in humans. Stroke 33:79–86PubMedCrossRefGoogle Scholar
  17. 17.
    Fiehler J, Knudsen K, Kucinski T et al (2004) Predictors of apparent diffusion coefficient normalization in stroke patients. Stroke 35:514–519PubMedCrossRefGoogle Scholar
  18. 18.
    Yoo AJ, Chaudhry ZA, Nogueira RG et al (2012) Infarct volume is a pivotal biomarker after intra-arterial stroke therapy. Stroke 43:1323–1330PubMedCrossRefGoogle Scholar
  19. 19.
    Puetz V, Dzialowski I, Hill MD et al (2008) Intracranial thrombus extent predicts clinical outcome, final infarct size and hemorrhagic transformation in ischemic stroke: the clot burden score. Int J Stroke 3:230–236PubMedCrossRefGoogle Scholar
  20. 20.
    Alfke K, Jensen U, Pool C et al (2011) Contrast-enhanced magnetic resonance angiography in stroke diagnostics: additional information compared with time-of-flight magnetic resonance angiography? Clin Neuroradiol 21:5–10PubMedCrossRefGoogle Scholar
  21. 21.
    Wintermark M, Sincic R, Sridhar D, Chien JD (2008) Cerebral perfusion CT: technique and clinical applications. J Neuroradiol 35:253–260PubMedCrossRefGoogle Scholar
  22. 22.
    Dani KA, Thomas RG, Chappell FM et al (2011) Computed tomography and magnetic resonance perfusion imaging in ischemic stroke: definitions and thresholds. Ann Neurol 70:384–401PubMedCrossRefGoogle Scholar
  23. 23.
    Pulli B, Schaefer PW, Hakimelahi R et al (2012) Acute ischemic stroke: infarct core estimation on CT angiography source images depends on CT angiography protocol. Radiology 262:593–604PubMedCrossRefGoogle Scholar
  24. 24.
    Rosso C, Colliot O, Valabregue R et al (2011) Tissue at risk in the deep middle cerebral artery territory is critical to stroke outcome. Neuroradiology 53:763–771PubMedCrossRefGoogle Scholar
  25. 25.
    Wu O, Christensen S, Hjort N et al (2006) Characterizing physiological heterogeneity of infarction risk in acute human ischaemic stroke using MRI. Brain 129:2384–2393PubMedCrossRefGoogle Scholar
  26. 26.
    Willats L, Connelly A, Christensen S, Donnan GA, Davis SM, Calamante F (2012) The role of bolus delay and dispersion in predictor models for stroke. StrokeGoogle Scholar
  27. 27.
    Solomon MJ, McLeod RS (1995) Should we be performing more randomized controlled trials evaluating surgical operations? Surgery 118:459–467PubMedCrossRefGoogle Scholar
  28. 28.
    Fiehler J, Bakke SJ, Clifton A et al (2010) Plea of the defence-critical comments on the interpretation of EVA3S, SPACE and ICSS. Neuroradiology 52:601–610PubMedCrossRefGoogle Scholar
  29. 29.
    Halm EA, Lee C, Chassin MR (2002) Is volume related to outcome in health care? A systematic review and methodologic critique of the literature. Ann Intern Med 137:511–520PubMedGoogle Scholar
  30. 30.
    van der Linden W (1980) Pitfalls in randomized surgical trials. Surgery 87:258–262PubMedGoogle Scholar
  31. 31.
    Verzini F, De Rango P, Parlani G, Panuccio G, Cao P (2008) Carotid artery stenting: technical issues and role of operators' experience. Perspect Vasc Surg Endovasc Ther 20:247–257PubMedCrossRefGoogle Scholar
  32. 32.
    Brinjikji W, Cloft HJ, Fiorella D, Lanzino G, Kallmes DF (2011) Estimating the proportion of intracranial aneurysms likely to be amenable to treatment with the pipeline embolization device. J Neurointerv SurgGoogle Scholar
  33. 33.
    Verzini F, Cao P, De Rango P et al (2006) Appropriateness of learning curve for carotid artery stenting: an analysis of periprocedural complications. J Vasc Surg 44:1205–1211, discussion 1211-1202PubMedCrossRefGoogle Scholar
  34. 34.
    Mas JL, Chatellier G (2008) Carotid angioplasty and stenting. Stroke 39:e19–e20PubMedCrossRefGoogle Scholar
  35. 35.
    Ederle J, Dobson J, Featherstone RL et al (2010) Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial. Lancet 375:985–997PubMedCrossRefGoogle Scholar
  36. 36.
    Kadkhodayan Y, Cross DT 3rd, Derdeyn CP, Moran CJ (2007) Carotid angioplasty and stenting in the elderly. Neuroradiology 49:933–938PubMedCrossRefGoogle Scholar
  37. 37.
    Rothwell PM, Warlow CP (1999) Interpretation of operative risks of individual surgeons. European Carotid Surgery Trialists' Collaborative Group. Lancet 353:1325PubMedCrossRefGoogle Scholar
  38. 38.
    Menon BK, Goyal M (2011) A systems approach towards intra-arterial management of acute ischemic stroke: need for novel outcome measures and a focus on sequence rather than steps. Interv Neuroradiol 17:296–298PubMedGoogle Scholar
  39. 39.
    Fiehler J, Jansen O, Berger J, Eckstein HH, Ringleb PA, Stingele R (2008) Differences in complication rates among the centres in the SPACE study. Neuroradiology 50:1049–1053PubMedCrossRefGoogle Scholar
  40. 40.
    Brinjikji W, Rabinstein AA, Lanzino G, Kallmes DF, Cloft HJ (2011) Patient outcomes are better for unruptured cerebral aneurysms treated at centers that preferentially treat with endovascular coiling: a study of the national inpatient sample 2001-2007. Ajnr Am J Neuroradiol 32:1065–1070PubMedCrossRefGoogle Scholar
  41. 41.
    Heck DV (2012) Do no harm: the rush to abbreviated training of stroke interventionalists is premature and ill advised. J Neurointerv Surg 4:3–6PubMedCrossRefGoogle Scholar
  42. 42.
    Hopkins LN, Roubin GS, Chakhtoura EY et al (2010) The Carotid Revascularization Endarterectomy versus Stenting Trial: credentialing of interventionalists and final results of lead-in phase. J Stroke Cerebrovasc Dis 19:153–162PubMedCrossRefGoogle Scholar
  43. 43.
    Chimowitz MI, Lynn MJ, Derdeyn CP et al (2011) Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med 365:993–1003PubMedCrossRefGoogle Scholar
  44. 44.
    Abou-Chebl A, Lin R, Hussain MS et al (2010) Conscious sedation versus general anesthesia during endovascular therapy for acute anterior circulation stroke: preliminary results from a retrospective, multicenter study. Stroke 41:1175–1179PubMedCrossRefGoogle Scholar
  45. 45.
    McDonagh DL, Olson DM, Kalia JS, Gupta R, Abou-Chebl A, Zaidat OO (2010) Anesthesia and sedation practices among neurointerventionalists during acute ischemic stroke endovascular therapy. Front Neurol 1:118PubMedGoogle Scholar
  46. 46.
    Davis MJ, Menon BK, Baghirzada LB et al (2012) Anesthetic management and outcome in patients during endovascular therapy for acute stroke. Anesthesiology 116:396–405PubMedCrossRefGoogle Scholar
  47. 47.
    Jumaa MA, Zhang F, Ruiz-Ares G et al (2010) Comparison of safety and clinical and radiographic outcomes in endovascular acute stroke therapy for proximal middle cerebral artery occlusion with intubation and general anesthesia versus the nonintubated state. Stroke 41:1180–1184PubMedCrossRefGoogle Scholar
  48. 48.
    Nichols C, Carrozzella J, Yeatts S, Tomsick T, Broderick J, Khatri P (2010) Is periprocedural sedation during acute stroke therapy associated with poorer functional outcomes? J Neurointerv Surg 2:67–70PubMedCrossRefGoogle Scholar
  49. 49.
    Eesa M, Almekhlafi MA, Mitha AP, Wong JH, Goyal M (2012) Manual aspiration thrombectomy through balloon-tipped guide catheter for rapid clot burden reduction in endovascular therapy for ICA L/T occlusion. NeuroradiologyGoogle Scholar
  50. 50.
    (2009) The penumbra pivotal stroke trial: safety and effectiveness of a new generation of mechanical devices for clot removal in intracranial large vessel occlusive disease. Stroke 40:2761-2768Google Scholar
  51. 51.
    Costalat V, Machi P, Lobotesis K et al (2011) Rescue, combined, and stand-alone thrombectomy in the management of large vessel occlusion stroke using the solitaire device: a prospective 50-patient single-center study: timing, safety, and efficacy. Stroke 42:1929–1935PubMedCrossRefGoogle Scholar
  52. 52.
    Gralla J, Schroth G, Remonda L, Nedeltchev K, Slotboom J, Brekenfeld C (2006) Mechanical thrombectomy for acute ischemic stroke: thrombus-device interaction, efficiency, and complications in vivo. Stroke 37:3019–3024PubMedCrossRefGoogle Scholar
  53. 53.
    Davalos Aea (2012) Stroke in pressGoogle Scholar
  54. 54.
    Lazzaro MA, Zaidat OO (2012) Multimodal endovascular reperfusion therapies: adjunctive antithrombotic agents in acute stroke. Neurology 78:501–506PubMedCrossRefGoogle Scholar
  55. 55.
    Smith WS, Sung G, Saver J et al (2008) Mechanical thrombectomy for acute ischemic stroke: final results of the Multi MERCI trial. Stroke 39:1205–1212PubMedCrossRefGoogle Scholar
  56. 56.
    (2007) The Interventional Management of Stroke (IMS) II Study. Stroke 38:2127-2135Google Scholar
  57. 57.
    del Zoppo GJ, Higashida RT, Furlan AJ, Pessin MS, Rowley HA, Gent M (1998) PROACT: a phase II randomized trial of recombinant pro-urokinase by direct arterial delivery in acute middle cerebral artery stroke. PROACT Investigators. Prolyse in Acute Cerebral Thromboembolism. Stroke 29:4–11PubMedCrossRefGoogle Scholar
  58. 58.
    Nahab F, Walker GA, Dion JE, Smith WS (2011) Safety of Periprocedural Heparin in Acute Ischemic Stroke Endovascular Therapy: The Multi MERCI Trial. J Stroke Cerebrovasc DisGoogle Scholar
  59. 59.
    (2000) Abciximab in acute ischemic stroke: a randomized, double-blind, placebo-controlled, dose-escalation study. The Abciximab in Ischemic Stroke Investigators. Stroke 31:601-609Google Scholar
  60. 60.
    (2005) Emergency administration of abciximab for treatment of patients with acute ischemic stroke: results of a randomized phase 2 trial. Stroke 36:880-890Google Scholar
  61. 61.
    Adams HP Jr, Effron MB, Torner J et al (2008) Emergency administration of abciximab for treatment of patients with acute ischemic stroke: results of an international phase III trial: Abciximab in Emergency Treatment of Stroke Trial (AbESTT-II). Stroke 39:87–99PubMedCrossRefGoogle Scholar
  62. 62.
    Lee DH, Jo KD, Kim HG et al (2002) Local intraarterial urokinase thrombolysis of acute ischemic stroke with or without intravenous abciximab: a pilot study. J Vasc Interv Radiol 13:769–774PubMedCrossRefGoogle Scholar
  63. 63.
    Eckert B, Koch C, Thomalla G et al (2005) Aggressive therapy with intravenous abciximab and intra-arterial rtPA and additional PTA/stenting improves clinical outcome in acute vertebrobasilar occlusion: combined local fibrinolysis and intravenous abciximab in acute vertebrobasilar stroke treatment (FAST): results of a multicenter study. Stroke 36:1160–1165PubMedCrossRefGoogle Scholar
  64. 64.
    Qureshi AI, Suri MF, Ali Z et al (2005) Intraarterial reteplase and intravenous abciximab for treatment of acute ischemic stroke. A preliminary feasibility and safety study in a non-human primate model. Neuroradiology 47:845–854PubMedCrossRefGoogle Scholar
  65. 65.
    Mangiafico S, Cellerini M, Nencini P, Gensini G, Inzitari D (2005) Intravenous glycoprotein IIb/IIIa inhibitor (tirofiban) followed by intra-arterial urokinase and mechanical thrombolysis in stroke. Ajnr Am J Neuroradiol 26:2595–2601PubMedGoogle Scholar
  66. 66.
    Kwon JH, Shin SH, Weon YC, Hwang JC, Baik SK (2011) Intra-arterial adjuvant tirofiban after unsuccessful intra-arterial thrombolysis of acute ischemic stroke: preliminary experience in 16 patients. Neuroradiology 53:779–785PubMedCrossRefGoogle Scholar
  67. 67.
    Gupta R, Vora NA, Horowitz MB et al (2006) Multimodal reperfusion therapy for acute ischemic stroke: factors predicting vessel recanalization. Stroke 37:986–990PubMedCrossRefGoogle Scholar
  68. 68.
    Shi ZS, Loh Y, Walker G, Duckwiler GR (2010) Endovascular thrombectomy for acute ischemic stroke in failed intravenous tissue plasminogen activator versus non-intravenous tissue plasminogen activator patients: revascularization and outcomes stratified by the site of arterial occlusions. Stroke 41:1185–1192PubMedCrossRefGoogle Scholar
  69. 69.
    Castano C, Dorado L, Guerrero C et al (2010) Mechanical thrombectomy with the Solitaire AB device in large artery occlusions of the anterior circulation: a pilot study. Stroke 41:1836–1840PubMedCrossRefGoogle Scholar
  70. 70.
    Machi P, Costalat V, Lobotesis K et al (2012) Solitaire FR thrombectomy system: immediate results in 56 consecutive acute ischemic stroke patients. J Neurointerv Surg 4:62–66PubMedCrossRefGoogle Scholar
  71. 71.
    Loh Y, Kim D, Shi ZS et al (2010) Higher rates of mortality but not morbidity follow intracranial mechanical thrombectomy in the elderly. AJNR Am J Neuroradiol 31:1181–1185PubMedCrossRefGoogle Scholar
  72. 72.
    Yin NS, Benavides S, Starkman S et al (2010) Autopsy findings after intracranial thrombectomy for acute ischemic stroke: a clinicopathologic study of 5 patients. Stroke 41:938–947PubMedCrossRefGoogle Scholar
  73. 73.
    Jansen O (2011) Neurovascular centers–a need for a change. Clin Neuroradiol 21:51PubMedCrossRefGoogle Scholar
  74. 74.
    Fiehler J, Stapf C (2008) ARUBA–beating natural history in unruptured brain AVMs by intervention. Neuroradiology 50:465–467PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag 2012

Authors and Affiliations

  • Jens Fiehler
    • 1
  • Michael Söderman
    • 2
  • Francis Turjman
    • 3
  • Philip M. White
    • 4
  • Søren Jacob Bakke
    • 5
  • Salvatore Mangiafico
    • 6
  • Rüdiger von Kummer
    • 7
  • Mario Muto
    • 8
  • Christophe Cognard
    • 9
  • Jan Gralla
    • 10
  1. 1.Department of NeuroradiologyUniversity Medical Centre Hamburg-EppendorfHamburgGermany
  2. 2.Department of NeuroradiologyKarolinska University HospitalStockholmSweden
  3. 3.Department of NeuroradiologyHôpital neurologique, Centre de Neurosciences CognitivesLyonFrance
  4. 4.Department of Clinical Neurosciences, Western General HospitalUniversity of EdinburghEdinburghUK
  5. 5.Department of NeuroradiologyOslo University HospitalOsloNorway
  6. 6.Interventional Neuroradiology UnitUniversity Hospital CareggiFlorenceItaly
  7. 7.Department of NeuroradiologyUniversity of DresdenDresdenGermany
  8. 8.Department of NeuroradiologyUniversity of NaplesNaplesItaly
  9. 9.Service de NeuroradiologieHôpital PurpanToulouseFrance
  10. 10.Department of NeuroradiologyInselspital BernBernSwitzerland

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