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Endovascular thrombectomy for childhood stroke (Save ChildS Pro): an international, multicentre, prospective registry study
PB. Sporns, K. Bhatia, T. Abruzzo, L. Pabst, S. Fraser, MG. Chung, W. Lo, A. Othman, S. Steinmetz, U. Jensen-Kondering, S. Schob, DPO. Kaiser, W. Marik, C. Wendl, I. Kleffner, H. Henkes, H. Kraehling, TDL. Nguyen-Kim, R. Chapot, U. Yilmaz, F....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu klinické zkoušky, časopisecké články, multicentrická studie
- MeSH
- cévní mozková příhoda chirurgie terapie MeSH
- dítě MeSH
- endovaskulární výkony * metody MeSH
- ischemická cévní mozková příhoda chirurgie terapie MeSH
- kojenec MeSH
- lidé MeSH
- mladiství MeSH
- novorozenec MeSH
- předškolní dítě MeSH
- prospektivní studie MeSH
- registrace * MeSH
- trombektomie * metody MeSH
- výsledek terapie MeSH
- Check Tag
- dítě MeSH
- kojenec MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- novorozenec MeSH
- předškolní dítě MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
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: 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: 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: 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: None.
Department of Diagnostic and Interventional Neuroradiology Medical School Hannover Hannover Germany
Department of Interventional Neuroradiology Careggi University Hospital Florence Italy
Department of Medical Imaging Children's Hospital at Westmead Sydney NSW Australia
Department of Neurology Baylor College of Medicine Houston TX USA
Department of Neurology Johns Hopkins School of Medicine Baltimore MD USA
Department of Neurology Massachusetts General Hospital Harvard Medical School Boston MA USA
Department of Neurology University of Texas Rio Grande Valley Harlingen TX USA
Department of Neuroradiology Aachen University Aachen Germany
Department of Neuroradiology Alfried Krupp Krankenhaus Essen Germany
Department of Neuroradiology Heidelberg University Hospital Heidelberg Germany
Department of Neuroradiology Hospital de Pediatría J P Garrahan Buenos Aires Argentina
Department of Neuroradiology LMU University Hospital LMU Munich Munich Germany
Department of Neuroradiology Medical University of Vienna Vienna Austria
Department of Neuroradiology Saarland University Hospital Homburg Germany
Department of Neuroradiology University Hospital Basel Basel Switzerland
Department of Neuroradiology University Medical Center Schleswig Holstein Lübeck Germany
Department of Neuroradiology University of Marburg Marburg Germany
Department of Neurosurgery Barrow Neurological Institute Phoenix AZ USA
Department of Neurosurgery Emory University School of Medicine Atlanta GA USA
Department of Radiology and Neuroradiology Sana Kliniken Duisburg Duisburg Germany
Department of Radiology and Neuroradiology Stadtspital Zürich Zürich Switzerland
Department of Radiology and Neuroradiology University Hospital Halle Halle Germany
Department of Radiology and Neuroradiology University Medical Center Schleswig Holstein Kiel Germany
Department of Radiology LMU University Hospital LMU Munich Munich Germany
Department of Radiology Phoenix Children's Hospital Phoenix AZ USA
Department of Radiology Texas Children's Hospital Baylor College of Medicine Houston TX USA
Diagnostic and Interventional Neuroradiology Department University Hospital of Tours Tours France
Division of Child Neurology Department of Neurology Stanford University Stanford CA USA
Division of Pediatric Neurology Oregon Health and Science University Portland OR USA
French Center for Pediatric Stroke Paris France
Graduate School for Health Sciences University of Bern Bern Switzerland
Institute of Radiology University Hospital Regensburg Regensburg Germany
Morozov Moscow Children Clinical Hospital Moscow Russia
Neuroendovascular Program Massachusetts General Hospital Harvard Medical School Boston MA USA
Neuroradiological Clinic Katharinenhospital Klinikum Stuttgart Stuttgart Germany
Pediatric Thrombosis and Hemostasis Unit Dr von Hauner Children's Hospital LMU Munich Munich Germany
Citace poskytuje Crossref.org
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- $a Sporns, Peter B $u 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
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- $a Endovascular thrombectomy for childhood stroke (Save ChildS Pro): an international, multicentre, prospective registry study / $c PB. Sporns, K. Bhatia, T. Abruzzo, L. Pabst, S. Fraser, MG. Chung, W. Lo, A. Othman, S. Steinmetz, U. Jensen-Kondering, S. Schob, DPO. Kaiser, W. Marik, C. Wendl, I. Kleffner, H. Henkes, H. Kraehling, TDL. Nguyen-Kim, R. Chapot, U. Yilmaz, F. Wang, MU. Hafeez, F. Requejo, N. Limbucci, B. Kauffmann, M. Möhlenbruch, O. Nikoubashman, PD. Schellinger, P. Musolino, A. Alawieh, J. Wilson, D. Grieb, AS. Gersing, T. Liebig, M. Olivieri, JP. Schwabova, A. Tomek, P. Papanagiotou, G. Boulouis, O. Naggara, CK. Fox, K. Orlov, A. Kuznetsova, C. Parra-Farinas, P. Muthusami, RW. Regenhardt, AA. Dmytriw, T. Burkard, M. Martinez, D. Brechbühl, M. Steinlin, LR. Sun, AE. Hassan, A. Kemmling, S. Lee, HJ. Fullerton, J. Fiehler, MN. Psychogios, M. Wildgruber
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- $a 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: 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: 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: 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: None.
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