Towards personalised intra-arterial treatment of patients with acute ischaemic stroke: a study protocol for development and validation of a clinical decision aid.
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.



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.



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.



ISRCTN10888758; Post-results and NCT00359424; Post-resultsc.
Erasmus University Medical Center, Rotterdam, The Netherlands.
Maxim J H L
MJ
Mulder
Erasmus University Medical Center, Rotterdam, The Netherlands.
Esmee
E
Venema
Erasmus University Medical Center, Rotterdam, The Netherlands.
Bob
B
Roozenbeek
University of Cincinnati, Cincinnati, Ohio, USA.
Joseph P
JP
Broderick
Medical University of South Carolina, Charleston, South Carolina, USA.
Sharon D
SD
Yeatts
University of Cincinnati, Cincinnati, Ohio, USA.
Pooja
P
Khatri
Erasmus University Medical Center, Rotterdam, The Netherlands.|Academic Medical Center, Amsterdam, The Netherlands.|Maastricht University Medical Center, Cardiovascular Research Institute Maastricht (CARIM), Maastricht, The Netherlands.
Olvert A
OA
Berkhemer
Academic Medical Center, Amsterdam, The Netherlands.
Yvo B W E M
YB
Roos
Academic Medical Center, Amsterdam, The Netherlands.
Charles B L M
CB
Majoie
Maastricht University Medical Center, Cardiovascular Research Institute Maastricht (CARIM), Maastricht, The Netherlands.
Robert J
RJ
van Oostenbrugge
Maastricht University Medical Center, Cardiovascular Research Institute Maastricht (CARIM), Maastricht, The Netherlands.
Wim H
WH
van Zwam
Erasmus University Medical Center, Rotterdam, The Netherlands.
Aad
A
van der Lugt
Erasmus University Medical Center, Rotterdam, The Netherlands.|Leiden University Medical Center, Leiden, The Netherlands.
Ewout W
EW
Steyerberg
Erasmus University Medical Center, Rotterdam, The Netherlands.
Diederik W J
DW
Dippel
Erasmus University Medical Center, Rotterdam, The Netherlands.
Hester F
HF
Lingsma
D000066491:Clinical Decision-Making / Q000379:methods*; D003661:Decision Support Techniques; D057510:Endovascular Procedures / Q000379:methods*; D006801:Humans; D009426:Netherlands; D015203:Reproducibility of Results; D012107:Research Design; D020521:Stroke / Q000628:therapy*; D016896:Treatment Outcome
decision aid; intra-arterial therapy; ischaemic stroke; mechanical thrombectomy; personalised treatment; prediction model