Endovascular thrombectomy for childhood stroke (Save ChildS Pro): an international, multicentre, prospective registry study.

Journal

The Lancet. Child & adolescent health
ISSN: 2352-4650
Titre abrégé: Lancet Child Adolesc Health
Pays: England
ID NLM: 101712925

Informations de publication

Date de publication:
11 Oct 2024
Historique:
received: 28 04 2024
revised: 20 08 2024
accepted: 21 08 2024
medline: 15 10 2024
pubmed: 15 10 2024
entrez: 14 10 2024
Statut: aheadofprint

Résumé

Emerging evidence suggests that endovascular thrombectomy is beneficial for treatment of childhood stroke, but the safety and effectiveness of endovascular thrombectomy has not been compared with best medical treatment. We aimed to prospectively analyse functional outcomes of endovascular thrombectomy versus best medical treatment in children with intracranial arterial occlusion stroke. In this prospective registry study, 45 centres in 12 countries across Asia and Australia, Europe, North America, and South America reported functional outcomes for children aged between 28 days and 18 years presenting with arterial ischaemic stroke caused by a large-vessel or medium-vessel occlusion who received either endovascular thrombectomy plus best medical practice or best medical treatment alone. Intravenous thrombolysis was considered part of best medical treatment and therefore permitted in both groups. The primary outcome was the difference in median modified Rankin Scale (mRS) score between baseline (pre-stroke) and 90 days (±10 days) post-stroke, assessed by the Wilcoxon rank test (α=0·05). Efficacy outcomes in the endovascular thrombectomy and best medical treatment groups were compared in sensitivity analyses using propensity score matching. The Save ChildS Pro study is registered at the German Clinical Trials Registry, DRKS00018960. Between Jan 1, 2020, and Aug 31, 2023, of the 241 patients in the Save ChildS Pro registry, 208 were included in the analysis (115 [55%] boys and 93 [45%] girls). 117 patients underwent endovascular thrombectomy (median age 11 years [IQR 6-14]), and 91 patients received best medical treatment (6 years [3-12]; p<0·0001). The median Pediatric National Institutes of Health Stroke Scale (PedNIHSS) score on admission was 14 (IQR 10-19) in the endovascular thrombectomy group and 9 (5-13) in the best medical treatment group (p<0·0001). Both treatment groups had a median pre-stroke mRS score of 0 (IQR 0-0) at baseline. The change in median mRS score between baseline and 90 days was 1 (IQR 0-2) in the endovascular thrombectomy group and 2 (1-3) in the best medical treatment group (p=0·020). One (1%) patient developed a symptomatic intracranial haemorrhage (this patient was in the endovascular thrombectomy group). Six (5%) patients in the endovascular thrombectomy group and four (5%) patients in the best medical treatment group had died by day 90 (p=0·89). After propensity score matching for age, sex, and PedNIHSS score at hospital admission (n=79 from each group), the change in median mRS score between baseline and 90 days was 1 (IQR 0-2) in the endovascular thrombectomy group and 2 (1-3) in the best medical treatment group (p=0·029). Regarding the primary outcome for patients with suspected focal cerebral arteriopathy, endovascular thrombectomy (n=18) and best medical treatment (n=33) showed no difference in 90-day median mRS scores (2 [IQR 1-3] vs 2 [1-4]; p=0·074). Clinical centres tended to select children with more severe strokes (higher PedNIHSS score) for endovascular thrombectomy. Nevertheless, endovascular thrombectomy was associated with improved functional outcomes in paediatric patients with large-vessel or medium-vessel occlusions compared with best medical treatment. Future studies need to investigate whether the positive effect of endovascular thrombectomy is confined to older and more severely affected children. None.

Sections du résumé

BACKGROUND BACKGROUND
Emerging evidence suggests that endovascular thrombectomy is beneficial for treatment of childhood stroke, but the safety and effectiveness of endovascular thrombectomy has not been compared with best medical treatment. We aimed to prospectively analyse functional outcomes of endovascular thrombectomy versus best medical treatment in children with intracranial arterial occlusion stroke.
METHODS METHODS
In this prospective registry study, 45 centres in 12 countries across Asia and Australia, Europe, North America, and South America reported functional outcomes for children aged between 28 days and 18 years presenting with arterial ischaemic stroke caused by a large-vessel or medium-vessel occlusion who received either endovascular thrombectomy plus best medical practice or best medical treatment alone. Intravenous thrombolysis was considered part of best medical treatment and therefore permitted in both groups. The primary outcome was the difference in median modified Rankin Scale (mRS) score between baseline (pre-stroke) and 90 days (±10 days) post-stroke, assessed by the Wilcoxon rank test (α=0·05). Efficacy outcomes in the endovascular thrombectomy and best medical treatment groups were compared in sensitivity analyses using propensity score matching. The Save ChildS Pro study is registered at the German Clinical Trials Registry, DRKS00018960.
FINDINGS RESULTS
Between Jan 1, 2020, and Aug 31, 2023, of the 241 patients in the Save ChildS Pro registry, 208 were included in the analysis (115 [55%] boys and 93 [45%] girls). 117 patients underwent endovascular thrombectomy (median age 11 years [IQR 6-14]), and 91 patients received best medical treatment (6 years [3-12]; p<0·0001). The median Pediatric National Institutes of Health Stroke Scale (PedNIHSS) score on admission was 14 (IQR 10-19) in the endovascular thrombectomy group and 9 (5-13) in the best medical treatment group (p<0·0001). Both treatment groups had a median pre-stroke mRS score of 0 (IQR 0-0) at baseline. The change in median mRS score between baseline and 90 days was 1 (IQR 0-2) in the endovascular thrombectomy group and 2 (1-3) in the best medical treatment group (p=0·020). One (1%) patient developed a symptomatic intracranial haemorrhage (this patient was in the endovascular thrombectomy group). Six (5%) patients in the endovascular thrombectomy group and four (5%) patients in the best medical treatment group had died by day 90 (p=0·89). After propensity score matching for age, sex, and PedNIHSS score at hospital admission (n=79 from each group), the change in median mRS score between baseline and 90 days was 1 (IQR 0-2) in the endovascular thrombectomy group and 2 (1-3) in the best medical treatment group (p=0·029). Regarding the primary outcome for patients with suspected focal cerebral arteriopathy, endovascular thrombectomy (n=18) and best medical treatment (n=33) showed no difference in 90-day median mRS scores (2 [IQR 1-3] vs 2 [1-4]; p=0·074).
INTERPRETATION CONCLUSIONS
Clinical centres tended to select children with more severe strokes (higher PedNIHSS score) for endovascular thrombectomy. Nevertheless, endovascular thrombectomy was associated with improved functional outcomes in paediatric patients with large-vessel or medium-vessel occlusions compared with best medical treatment. Future studies need to investigate whether the positive effect of endovascular thrombectomy is confined to older and more severely affected children.
FUNDING BACKGROUND
None.

Identifiants

DOI: 10.1016/S2352-4642(24)00233-5 PMID: 39401507
pubmed: 39401507
pii: S2352-4642(24)00233-5
doi: 10.1016/S2352-4642(24)00233-5
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests We declare no competing interests.

Auteurs

Peter B Sporns (PB)

Department of Neuroradiology, University Hospital Basel, Basel, Switzerland; Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Radiology and Neuroradiology, Stadtspital Zürich, Zürich, Switzerland. Electronic address: peter.sporns@hotmail.de.

Kartik Bhatia (K)

Department of Medical Imaging, Children's Hospital at Westmead, Sydney, NSW, Australia; Children's Hospital at Westmead Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.

Todd Abruzzo (T)

Department of Neurosurgery, Barrow Neurological Institute, Phoenix, AZ, USA; Department of Radiology, Phoenix Children's Hospital, Phoenix, AZ, USA.

Lisa Pabst (L)

Division of Pediatric Neurology, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA.

Stuart Fraser (S)

Division of Child and Adolescent Neurology, Department of Pediatrics, The University of Texas McGovern Medical School, Houston, TX, USA.

Melissa G Chung (MG)

Division of Critical Care Medicine and Division of Pediatric Neurology, Department of Pediatrics, Nationwide Children's Hospital and The Ohio State University, Columbus, OH, USA.

Warren Lo (W)

Department of Pediatrics and Department of Neurology, Nationwide Children's Hospital and The Ohio State University, Columbus, OH, USA.

Ahmed Othman (A)

Department of Neuroradiology, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.

Sebastian Steinmetz (S)

Department of Neuroradiology, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.

Ulf Jensen-Kondering (U)

Department of Radiology and Neuroradiology, University Medical Center Schleswig-Holstein, Kiel, Germany; Department of Neuroradiology, University Medical Center Schleswig-Holstein, Lübeck, Germany.

Stefan Schob (S)

Department of Radiology and Neuroradiology, University Hospital Halle, Halle, Germany.

Daniel P O Kaiser (DPO)

Institute of Neuroradiology, Medical Faculty and University Hospital Carl Gustav Carus, Dresden University of Technology, Dresden, Germany.

Wolfgang Marik (W)

Department of Neuroradiology, Medical University of Vienna, Vienna, Austria.

Christina Wendl (C)

Institute of Radiology, University Hospital Regensburg, Regensburg, Germany.

Ilka Kleffner (I)

Department of Neurology, University Hospital Knappschaftskrankenhaus, Ruhr University Bochum, Bochum, Germany.

Hans Henkes (H)

Neuroradiological Clinic, Katharinenhospital, Klinikum Stuttgart, Stuttgart, Germany.

Hermann Kraehling (H)

Clinic for Radiology, Department for Interventional Neuroradiology, University of Münster, Münster, Germany.

Thi Dan Linh Nguyen-Kim (TDL)

Department of Radiology and Neuroradiology, Stadtspital Zürich, Zürich, Switzerland.

René Chapot (R)

Department of Neuroradiology, Alfried-Krupp-Krankenhaus, Essen, Germany.

Umut Yilmaz (U)

Department of Neuroradiology, Saarland University Hospital, Homburg, Germany.

Furene Wang (F)

Department of Paediatrics, Khoo Teck Puat-National University Children's Medical Institute, National University Hospital, Singapore.

Muhammad Ubaid Hafeez (MU)

Department of Neurology, Baylor College of Medicine, Houston, TX, USA.

Flavio Requejo (F)

Department of Neuroradiology, Hospital de Pediatría J.P. Garrahan, Buenos Aires, Argentina.

Nicola Limbucci (N)

Department of Interventional Neuroradiology, Careggi University Hospital, Florence, Italy.

Birgit Kauffmann (B)

Department of Pediatrics and Adolescent Medicine, Eltern-Kind-Zentrum Prof Hess, Klinikum Bremen Mitte, Bremen, Germany.

Markus Möhlenbruch (M)

Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.

Omid Nikoubashman (O)

Department of Neuroradiology, Aachen University, Aachen, Germany.

Peter D Schellinger (PD)

Department of Neurology and Neurogeriatrics, University Clinic of the Ruhr-Universität Bochum, Minden, Germany.

Patricia Musolino (P)

Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.

Ali Alawieh (A)

Department of Neurosurgery, Emory University School of Medicine, Atlanta, GA, USA.

Jenny Wilson (J)

Division of Pediatric Neurology, Oregon Health & Science University, Portland, OR, USA.

Dominik Grieb (D)

Department of Radiology and Neuroradiology, Sana Kliniken Duisburg, Duisburg, Germany; Department of Diagnostic and Interventional Neuroradiology, Medical School Hannover, Hannover, Germany.

Alexandra S Gersing (AS)

Department of Neuroradiology, LMU University Hospital, LMU Munich, Munich, Germany.

Thomas Liebig (T)

Department of Neuroradiology, LMU University Hospital, LMU Munich, Munich, Germany.

Martin Olivieri (M)

Pediatric Thrombosis and Hemostasis Unit, Dr von Hauner Children's Hospital, LMU Munich, Munich, Germany.

Jaroslava Paulasova Schwabova (JP)

Department of Paediatric Neurology, Comprehensive Stroke Center, Second Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic; Department of Neurology, Comprehensive Stroke Center, Second Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic.

Ales Tomek (A)

Department of Neurology, Comprehensive Stroke Center, Second Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic.

Panagiotis Papanagiotou (P)

Department of Diagnostic and Interventional Neuroradiology, Hospital Bremen-Mitte/Bremen-Ost, Bremen, Germany; First Department of Radiology, School of Medicine, National & Kapodistrian University of Athens, Areteion Hospital, Athens, Greece.

Grégoire Boulouis (G)

Diagnostic and Interventional Neuroradiology Department, University Hospital of Tours, Tours, France; French Center for Pediatric Stroke, Paris, France.

Olivier Naggara (O)

French Center for Pediatric Stroke, Paris, France; Department of Pediatric Radiology, Faculté de Médecine, Necker Children's Hospital, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.

Christine K Fox (CK)

Department of Neurology and Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA.

Kirill Orlov (K)

Research Center of Endovascular Neurosurgery, Federal Center of Brain Research and Neuro Technologies of FMBA, Moscow, Russia; Morozov Moscow Children Clinical Hospital, Moscow, Russia.

Alexandra Kuznetsova (A)

Morozov Moscow Children Clinical Hospital, Moscow, Russia; Division of Neuroradiology and Division of Neurointervention, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.

Carmen Parra-Farinas (C)

Division of Neuroradiology and Division of Neurointervention, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.

Prakash Muthusami (P)

Division of Neuroradiology and Division of Neurointervention, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.

Robert W Regenhardt (RW)

Neuroendovascular Program, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.

Adam A Dmytriw (AA)

Neuroendovascular Program, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; Neurovascular Centre, Divisions of Therapeutic Neuroradiology and Neurosurgery, St Michael's Hospital, University of Toronto, ON, Canada.

Tanja Burkard (T)

Department of Radiology, LMU University Hospital, LMU Munich, Munich, Germany.

Mesha Martinez (M)

University Hospital, LMU Munich, Germany; Department of Radiology, Texas Children's Hospital, Baylor College of Medicine, Houston, TX, USA.

Daniel Brechbühl (D)

Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland; Graduate School for Health Sciences, University of Bern, Bern, Switzerland.

Maja Steinlin (M)

Division of Neuropaediatrics, Development and Rehabilitation, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.

Lisa R Sun (LR)

Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, USA.

Ameer E Hassan (AE)

Department of Neurology, University of Texas Rio Grande Valley, Harlingen, TX, USA.

André Kemmling (A)

Department of Neuroradiology, University of Marburg, Marburg, Germany.

Sarah Lee (S)

Division of Child Neurology, Department of Neurology, Stanford University, Stanford, CA, USA.

Heather J Fullerton (HJ)

Department of Neurology and Department of Pediatrics, University of California San Francisco, San Francisco, CA, USA.

Jens Fiehler (J)

Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Marios-Nikos Psychogios (MN)

Department of Neuroradiology, University Hospital Basel, Basel, Switzerland.

Moritz Wildgruber (M)

Department of Radiology, LMU University Hospital, LMU Munich, Munich, Germany.

Classifications MeSH