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Observational Study
. 2018 Mar 9:360:k949.
doi: 10.1136/bmj.k949.

Endovascular treatment for acute ischaemic stroke in routine clinical practice: prospective, observational cohort study (MR CLEAN Registry)

Ivo G H Jansen, Maxim J H L Mulder, Robert-Jan B Goldhoorn; MR CLEAN Registry investigators
Collaborators
Observational Study

Endovascular treatment for acute ischaemic stroke in routine clinical practice: prospective, observational cohort study (MR CLEAN Registry)

Ivo G H Jansen et al. BMJ. .

Abstract

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.

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Conflict of interest statement

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.

Figures

Fig 1
Fig 1
Distribution of modified Rankin Scale (mRS) score at 90 days in MR CLEAN Registry (before imputation) and MR CLEAN trial intervention and control arms. The proportion of deaths is calculated as 398 of 1363 patients instead of 1488 patients and therefore inflated by 2% because in this figure the denominator does not include 125 patients with missing mRS scores. The mRS category 0 for the MR CLEAN control arm is small (n=1, 0.4%) and therefore not visible in the figure
See this image and copyright information in PMC

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