Endovascular treatment for acute ischaemic stroke in routine clinical practice: prospective, observational cohort study (MR CLEAN Registry)BMJ 2018; 360 doi: https://doi.org/10.1136/bmj.k949 (Published 09 March 2018) Cite this as: BMJ 2018;360:k949
- Ivo G H Jansen, medical researcher,
- Maxim J H L Mulder, medical researcher,
- Robert-Jan B Goldhoorn, medical researcher
- for the MR CLEAN Registry investigators
- Correspondence to: I G H Jansen
- Accepted 21 February 2018
Objective To determine outcomes and safety of endovascular treatment for acute ischaemic stroke, due to proximal intracranial vessel occlusion in the anterior circulation, in routine clinical practice.
Design Ongoing, prospective, observational cohort study.
Setting 16 centres that perform endovascular treatment in the Netherlands.
Participants 1488 patients included in the Multicentre Randomised Controlled Trial of Endovascular Treatment for Acute Ischaemic Stroke in the Netherlands (MR CLEAN) Registry who had received endovascular treatment, including stent retriever thrombectomy, aspiration, and all alternative methods for acute ischaemic stroke within 6.5 hours from onset of symptoms between March 2014 and June 2016.
Main outcome measures The primary outcome was the modified Rankin Scale (mRS) score, ranging from 0 (no symptoms) to 6 (death) at 90 days after the onset of symptoms. Secondary outcomes were excellent functional outcome (mRS score 0-1), good functional outcome (mRS score 0-2), and favourable functional outcome (mRS score 0-3) at 90 days; score on the extended thrombolysis in cerebral infarction scale at the end of the intervention procedure; National Institutes of Health Stroke Scale score 24-48 hours after intervention; and complications that occurred during intervention, hospital admission, or three months’ follow up period. Outcomes and safety variables in the MR CLEAN Registry were compared with the MR CLEAN trial intervention and control arms.
Results A statistically significant shift was observed towards better functional outcome in patients in the MR CLEAN Registry compared with the MR CLEAN trial intervention arm (adjusted common odds ratio 1.30, 95% confidence interval 1.02 to 1.67) and the MR CLEAN trial control arm (1.85, 1.46 to 2.34). The reperfusion rate, with successful reperfusion defined as a score of 2B-3 on the extended thrombolysis in cerebral infarction score, was 58.7%, the same as for patients in the MR CLEAN trial. Duration from onset of stroke to start of endovascular treatment and from onset of stroke to successful reperfusion or last contrast bolus was one hour shorter for patients in the MR CLEAN Registry. Symptomatic intracranial haemorrhage occurred in 5.8% of patients in the MR CLEAN Registry compared with 7.7% in the MR CLEAN trial intervention arm and 6.4% in the MR CLEAN trial control arm.
Conclusion In routine clinical practice, endovascular treatment for patients with acute ischaemic stroke is at least as effective and safe as in the setting of a randomised controlled trial.
Ivo G H Jansen, medical researcher, Maxim J H L Mulder, medical researcher, Robert-Jan B Goldhoorn, medical researcher, Bart J Emmer, interventional radiologist, Adriaan C G M van Es, interventional radiologist, Bob Roozenbeek, neurologist, Wouter J Schonewille, neurologist, René van den Berg, interventional radiologist, Jonathan M Coutinho, neurologist, Julie Staals, neurologist, Alida A Postma, interventional radiologist, Geert J Lycklama à Nijeholt, interventional radiologist, Jeannette Hofmeijer, neurologist, Jasper M Martens, interventional radiologist, Heleen M den Hertog, neurologist, Emiel J C Sturm, interventional radiologist, H Bart van der Worp, neurologist, Rob H Lo, interventional radiologist, Roel J J Heijboer, interventional radiologist, Koos Keizer, neurologist, Maarten Uyttenboogaart, interventional neurologist, Omid Eshghi, interventional radiologist, Marieke J H Wermer, neurologist, Marianne A A van Walderveen, interventional radiologist, Ewoud J van Dijk, neurologist, Hieronymus D Boogaarts, interventional radiologist, Sebastiaan F de Bruijn, neurologist, Lukas C van Dijk, interventional radiologist, Jan S P van den Berg, neurologist, Boudewijn A A M van Hasselt, interventional radiologist, Paul L M de Kort, neurologist, Jo P P Peluso, interventional radiologist, Tobien H C M L Schreuder, neurologist, Leo A M Aerden, neurologist, René J Dallinga, interventional radiologist, Marieke E S Sprengers, interventional radiologist, Lonneke S F Yo, interventional radiologist, Sjoerd F M Jenniskens, interventional radiologist, Stefan D Roosendaal, interventional radiologist, Bas F W van der Kallen, interventional radiologist, Ido R van den Wijngaard, interventional neurologist, Joost C J Bot, interventional radiologist, Pieter J van Doormaal, interventional radiologist, H Zwenneke Flach, interventional radiologist, Esmee Venema, medical researcher, Hester F Lingsma, senior medical statistician, Ludo F M Beenen, radiologist, Albert J Yoo, interventional radiologist, Jelis Boiten, neurologist, Jan A Vos, interventional radiologist, Yvo B W E M Roos, professor of acute neurology, Robert J van Oostenbrugge, professor of vascular neurology, Aad van der Lugt, professor of neuroradiology and head/neck radiology, Wim H van Zwam, interventional radiologist, Diederik W J Dippel, professor of neurovascular diseases, Charles B L M Majoie, professor of neuroradiology, for the MR CLEAN Registry investigators (see supplementary file for full details of authors’ affiliations).
Contributors: IGHJ, MJHLM, and RBG prepared the first draft. MJHLM, EV, HFL, and DWJD designed and did the statistical analyses. IGHJ, MJHLM, RBG, DWJD, CBLMM, RJvO, JAV, JB, YBWEMR, AvdL, and WHvZ participated in study design, data collection, data analysis, interpretation, and writing of the manuscript. GJLàN, MAAvW, MESS, SFMJ, RvdB, AJY, LFMB, SDR, BFWvdK, IRvdW, AvE, BJE, JMM, LSFY, JB, and PJvD participated in data analysis. IGHJ is the guarantor. The study coordinators, local investigators, and members of the executive, imaging, and complication committees designed the study, collected and analysed the data, wrote the manuscript, and made the decision to submit the manuscript for publication. The authors vouch for the accuracy and completeness of the data and for the fidelity of this report to the study protocol. All authors participated in patient enrolment and data collection, critically reviewed the manuscript, and approved the final version. IGHJ, MJHLM and RBG contributed equally, as did JB, JAV, YBWEMR, RJvO, AvdL, WHvZ, DWJD, and CBLMM.
Funding: This study was funded and carried out by the Erasmus University Medical Centre, the Academic Medical Centre Amsterdam, and the Maastricht University Medical Centre. The study was additionally funded by the Applied Scientific Institute for Neuromodulation (Toegepast Wetenschappelijk Instituut voor Neuromodulatie), which played no role in trial design and patient enrolment, nor in data collection, analysis, or writing of the manuscript. The corresponding author had full access to all the data. The executive committee had responsibility for the decision to submit for publication.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: BJE reports grants from Stryker Neurovascular and personal fees from Dekra and from Novartis, outside the submitted work. CBLMM reports grants from TWIN, during the conduct of the study and grants from CVON/Dutch Heart Foundation and from Stryker outside the submitted work (paid to institution). AAP reports personal fees from Bayer and from Siemens outside the submitted work. WHvZ reports personal fees from Codman and from Stryker outside the submitted work. RvdB reports a consultancy agreement with Codman Depuy outside the submitted work. HBW reports grants from the Dutch Heart Foundation outside the submitted work. AJY reports grants from Penumbra and Cerenovus/Neuravi and equity ownership interest from Insera Therapeutics outside the submitted work. AvdL reports consulting fees from Stryker outside the submitted work. DWJD reports grants from the Dutch Heart Foundation, AngioCare, Medtronic/Covidien/EV3, MEDAC/LAMEPRO, Penumbra, Top Medical/Concentric, and Stryker during conduct of the study; consultation fees from Stryker, Bracco Imaging, and Servier, received by the Erasmus University Medical Centre, outside the submitted work. All other authors did not receive support from any organisation for the submitted work, had no financial relationships with any organisations that might have an interest in the submitted work in the previous three years, and had no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: The central medical ethics committee of the Erasmus Medical Centre Rotterdam, the Netherlands, evaluated the study protocol (see supplementary file) and granted permission to carry out the study as a registry.
Data sharing: No additional data available.
Transparency: The lead author (IGHJ) affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
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