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Towards personalised intra-arterial treatment of patients with acute ischaemic stroke: a study protocol for development and validation of a clinical decision aid
  1. Maxim J H L Mulder1,
  2. Esmee Venema1,
  3. Bob Roozenbeek1,
  4. Joseph P Broderick2,
  5. Sharon D Yeatts3,
  6. Pooja Khatri2,
  7. Olvert A Berkhemer1,4,5,
  8. Yvo B W E M Roos4,
  9. Charles B L M Majoie4,
  10. Robert J van Oostenbrugge5,
  11. Wim H van Zwam5,
  12. Aad van der Lugt1,
  13. Ewout W Steyerberg1,6,
  14. Diederik W J Dippel1,
  15. Hester F Lingsma1
  1. 1Erasmus University Medical Center, Rotterdam, The Netherlands
  2. 2University of Cincinnati, Cincinnati, Ohio, USA
  3. 3Medical University of South Carolina, Charleston, South Carolina, USA
  4. 4Academic Medical Center, Amsterdam, The Netherlands
  5. 5Maastricht University Medical Center, Cardiovascular Research Institute Maastricht (CARIM), Maastricht, The Netherlands
  6. 6Leiden University Medical Center, Leiden, The Netherlands
  1. Correspondence to Esmee Venema; e.venema{at}erasmusmc.nl

Abstract

Introduction Overall, intra-arterial treatment (IAT) proved to be beneficial in patients with acute ischaemic stroke due to a proximal occlusion in the anterior circulation. However, heterogeneity in treatment benefit may be relevant for personalised clinical decision-making. Our aim is to improve selection of patients for IAT by predicting individual treatment benefit or harm.

Methods and analysis We will use data collected in the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) trial to analyse the effect of baseline characteristics on outcome and treatment effect. A multivariable proportional odds model with interaction terms will be developed to predict the outcome for each individual patient, both with and without IAT. Model performance will be expressed as discrimination and calibration, after bootstrap resampling and shrinkage of regression coefficients, to correct for optimism. External validation will be conducted on data of patients in the Interventional Management of Stroke III trial (IMS III). Primary outcome will be the modified Rankin Scale (mRS) at 90 days after stroke.

Ethics and dissemination The proposed study will provide an internationally applicable clinical decision aid for IAT. Findings will be disseminated widely through peer-reviewed publications, conference presentations and in an online web application tool. Formal ethical approval was not required as primary data were already collected.

Trial registration numbers ISRCTN10888758; Post-results and NCT00359424; Post-resultsc.

  • ischaemic stroke
  • intra-arterial therapy
  • mechanical thrombectomy
  • prediction model
  • decision aid
  • personalised treatment

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • MJHLM and EV contributed equally.

  • Contributors MJHLM and EV were involved in literature search, study design, writing (authors contributed equally). BR and HFL were involved in study conception and design, and writing. EWS and DWJD were involved in study conception and design, and critical review of the manuscript. JPB, SDY, PK, OAB, YBWEMR, RJvO, WHvZ, CBLMM and AvdL were involved in study conception and critical review of the manuscript.

  • Competing interests Erasmus MC received funds from Stryker®, Bracco Imaging® for consultations by DWJD. AMC received funds from Stryker® for consultations by CBLMM, YBWEMR and OAB. MUMC received funds from Stryker® and Codman® for consultations by WHvZ. JPB received study medication for intra-arterial tissue-type plasminogen activator supplied by Genentech. Catheters were supplied during early years of the IMS III trial by EKOS Corp, Concentric Medical, Cordis Neurovascular. He currently receives research monies to Department of Neurology and Rehabilitation Medicine from Genentech for Role on Steering Committee for A Study of the Efficacy and Safety of Activase (Alteplase) in Patients With Mild Stroke (PRISMS) trial. SDY research monies from Genentech for statistical role in the PRISMS trial. PKs department of Neurology received research support from Genentech, Inc for her role as lead principal investigator (PI) of the PRISMS trial and Penumbra, Inc for her role as neurology PI of the Assess the Penumbra System in the Treatment of Acute Stroke (THERAPY) trial; she has also received royalties from UpToDate, Inc and provided consultation for Grand Rounds Experts, St Jude’s and Biogen (DSMB).

  • Ethics approval Medical and Ethical Review Committee Erasmus MC.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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