Endovascular thrombectomy for acute ischaemic stroke with
established large infarct: multicentre, open-label, randomised
trial

J 2023

Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial

BENDSZUS, Martin, Jens FIEHLER, Fabien SUBTIL, Susanne BONEKAMP, Anne Hege AAMODT et. al.

Basic information

Original name

Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial

Authors

Edition

Lancet, NEW YORK, ELSEVIER SCIENCE INC, 2023, 0140-6736

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30230 Other clinical medicine subjects

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

TENSION

Impact factor

Impact factor: 168.900 in 2022

RIV identification code

RIV/00216224:90249/23:00131960

DOI

http://dx.doi.org/10.1016/S0140-6736(23)02032-9

UT WoS

001116664800001

Keywords (in Czech)

METAANALYSIS; THERAPY; TENSION

Keywords in English

METAANALYSIS; THERAPY; TENSION

Abstract

V originále

Background Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice. Methods In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with ClinicalTrials.gov, NCT03094715.Findings From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2 center dot 58 [95% CI 1 center dot 60-4 center dot 15]; p=0 center dot 0001) and with lower mortality (hazard ratio 0 center dot 67 [95% CI 0 center dot 46-0 center dot 98]; p=0 center dot 038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone.Interpretation Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection.

Links

90249, large research infrastructures

Name: CZECRIN IV

Citovat

BENDSZUS, Martin, Jens FIEHLER, Fabien SUBTIL, Susanne BONEKAMP, Anne Hege AAMODT, Blanca FUENTES, Elke R GIZEWSKI, Michael D HILL, Antonin KRAJINA, Laurent PIEROT, Claus Z SIMONSEN, Kamil ZELENAK, Rolf A BLAUENFELDT, Bastian CHENG, Angelique DENIS, Hannes DEUTSCHMANN, Franziska DORN, Fabian FLOTTMANN, Susanne GELLISSEN, Johannes C GERBER, Mayank GOYAL, Jozef HARING, Christian HERWEH, Silke HOPF-JENSEN, Vi Tuan HUA, Maerit JENSEN, Andreas KASTRUP, Christiane Fee KEIL, Andrej KLEPANEC, Egon KURCA, Ronni MIKKELSEN, Markus MOEHLENBRUCH, Stefan MUELLER-HUELSBECK, Nico MUENNICH, Paolo PAGANO, Panagiotis PAPANAGIOTOU, Gabor C PETZOLD, Mirko PHAM, Volker PUETZ, Jan RAUPACH, Gernot REIMANN, Peter Arthur RINGLEB, Maximilian SCHELL, Eckhard SCHLEMM, Silvia SCHOENENBERGER, Bjorn TENNOE, Christian ULFERT, Kateřina VALIŠ, Eva VITKOVA, Dominik F VOLLHERBST, Wolfgang WICK and Goetz THOMALLA. Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial (Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial. Lancet. 2023 Oct 10:S0140-). Lancet. NEW YORK: ELSEVIER SCIENCE INC, 2023, vol. 402, No 10414, p. 1753-1763. ISSN 0140-6736. Available from: https://dx.doi.org/10.1016/S0140-6736(23)02032-9.

@article{2327279,
   author = {Bendszus, Martin and Fiehler, Jens and Subtil, Fabien and Bonekamp, Susanne and Aamodt, Anne Hege and Fuentes, Blanca and Gizewski, Elke R and Hill, Michael D and Krajina, Antonin and Pierot, Laurent and Simonsen, Claus Z and Zelenak, Kamil and Blauenfeldt, Rolf A and Cheng, Bastian and Denis, Angelique and Deutschmann, Hannes and Dorn, Franziska and Flottmann, Fabian and Gellissen, Susanne and Gerber, Johannes C and Goyal, Mayank and Haring, Jozef and Herweh, Christian and HopfandJensen, Silke and Hua, Vi Tuan and Jensen, Maerit and Kastrup, Andreas and Keil, Christiane Fee and Klepanec, Andrej and Kurca, Egon and Mikkelsen, Ronni and Moehlenbruch, Markus and MuellerandHuelsbeck, Stefan and Muennich, Nico and Pagano, Paolo and Papanagiotou, Panagiotis and Petzold, Gabor C and Pham, Mirko and Puetz, Volker and Raupach, Jan and Reimann, Gernot and Ringleb, Peter Arthur and Schell, Maximilian and Schlemm, Eckhard and Schoenenberger, Silvia and Tennoe, Bjorn and Ulfert, Christian and Vališ, Kateřina and Vitkova, Eva and Vollherbst, Dominik F and Wick, Wolfgang and Thomalla, Goetz},
   article_location = {NEW YORK},
   article_number = {10414},
   doi = {http://dx.doi.org/10.1016/S0140-6736(23)02032-9},
   keywords = {METAANALYSIS; THERAPY; TENSION},
   language = {eng},
   issn = {0140-6736},
   journal = {Lancet},
   title = {Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial},
   url = {https://www.sciencedirect.com/science/article/pii/S0140673623020329?via%3Dihub},
   volume = {402},
   year = {2023}
}

TY  - JOUR
ID  - 2327279
AU  - Bendszus, Martin - Fiehler, Jens - Subtil, Fabien - Bonekamp, Susanne - Aamodt, Anne Hege - Fuentes, Blanca - Gizewski, Elke R - Hill, Michael D - Krajina, Antonin - Pierot, Laurent - Simonsen, Claus Z - Zelenak, Kamil - Blauenfeldt, Rolf A - Cheng, Bastian - Denis, Angelique - Deutschmann, Hannes - Dorn, Franziska - Flottmann, Fabian - Gellissen, Susanne - Gerber, Johannes C - Goyal, Mayank - Haring, Jozef - Herweh, Christian - Hopf-Jensen, Silke - Hua, Vi Tuan - Jensen, Maerit - Kastrup, Andreas - Keil, Christiane Fee - Klepanec, Andrej - Kurca, Egon - Mikkelsen, Ronni - Moehlenbruch, Markus - Mueller-Huelsbeck, Stefan - Muennich, Nico - Pagano, Paolo - Papanagiotou, Panagiotis - Petzold, Gabor C - Pham, Mirko - Puetz, Volker - Raupach, Jan - Reimann, Gernot - Ringleb, Peter Arthur - Schell, Maximilian - Schlemm, Eckhard - Schoenenberger, Silvia - Tennoe, Bjorn - Ulfert, Christian - Vališ, Kateřina - Vitkova, Eva - Vollherbst, Dominik F - Wick, Wolfgang - Thomalla, Goetz
PY  - 2023
TI  - Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial
JF  - Lancet
VL  - 402
IS  - 10414
SP  - 1753-1763
EP  - 1753-1763
PB  - ELSEVIER SCIENCE INC
SN  - 01406736
KW  - METAANALYSIS
KW  - THERAPY
KW  - TENSION
UR  - https://www.sciencedirect.com/science/article/pii/S0140673623020329?via%3Dihub
N2  - Background Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice. Methods In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with ClinicalTrials.gov, NCT03094715.Findings From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2 center dot 58 [95% CI 1 center dot 60-4 center dot 15]; p=0 center dot 0001) and with lower mortality (hazard ratio 0 center dot 67 [95% CI 0 center dot 46-0 center dot 98]; p=0 center dot 038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone.Interpretation Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection.
ER  -

BENDSZUS, Martin, Jens FIEHLER, Fabien SUBTIL, Susanne BONEKAMP, Anne Hege AAMODT, Blanca FUENTES, Elke R GIZEWSKI, Michael D HILL, Antonin KRAJINA, Laurent PIEROT, Claus Z SIMONSEN, Kamil ZELENAK, Rolf A BLAUENFELDT, Bastian CHENG, Angelique DENIS, Hannes DEUTSCHMANN, Franziska DORN, Fabian FLOTTMANN, Susanne GELLISSEN, Johannes C GERBER, Mayank GOYAL, Jozef HARING, Christian HERWEH, Silke HOPF-JENSEN, Vi Tuan HUA, Maerit JENSEN, Andreas KASTRUP, Christiane Fee KEIL, Andrej KLEPANEC, Egon KURCA, Ronni MIKKELSEN, Markus MOEHLENBRUCH, Stefan MUELLER-HUELSBECK, Nico MUENNICH, Paolo PAGANO, Panagiotis PAPANAGIOTOU, Gabor C PETZOLD, Mirko PHAM, Volker PUETZ, Jan RAUPACH, Gernot REIMANN, Peter Arthur RINGLEB, Maximilian SCHELL, Eckhard SCHLEMM, Silvia SCHOENENBERGER, Bjorn TENNOE, Christian ULFERT, Kateřina VALIŠ, Eva VITKOVA, Dominik F VOLLHERBST, Wolfgang WICK and Goetz THOMALLA. Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial (Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial. Lancet. 2023 Oct 10:S0140-). \textit{Lancet}. NEW YORK: ELSEVIER SCIENCE INC, 2023, vol.~402, No~10414, p.~1753-1763. ISSN~0140-6736. Available from: https://dx.doi.org/10.1016/S0140-6736(23)02032-9.

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