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

TENSION Investigators; Martin Bendszus; 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 Zeleňák; Rolf A Blauenfeldt; Bastian Cheng; Angélique Denis; Hannes Deutschmann; Franziska Dorn; Fabian Flottmann; Susanne Gellißen; Johannes C Gerber; Mayank Goyal; Jozef Haring; Christian Herweh; Silke Hopf-Jensen; Vi Tuan Hua; Märit Jensen; Andreas Kastrup; Christiane Fee Keil; Andrej Klepanec; Egon Kurča; Ronni Mikkelsen; Markus Möhlenbruch; Stefan Müller-Hülsbeck; Nico Münnich; Paolo Pagano; Panagiotis Papanagiotou; Gabor C Petzold; Mirko Pham; Volker Puetz; Jan Raupach; Gernot Reimann; Peter Arthur Ringleb; Maximilian Schell; Eckhard Schlemm; Silvia Schönenberger; Bjørn Tennøe; Christian Ulfert; Kateřina Vališ; Eva Vítková; Dominik F Vollherbst

doi:10.1016/S0140-6736(23)02032-9

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

TENSION Investigators, Martin Bendszus, 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 Zeleňák, Rolf A Blauenfeldt, Bastian Cheng, Angélique Denis, Hannes Deutschmann, Franziska Dorn, Fabian Flottmann, Susanne GellißenJohannes C Gerber, Mayank Goyal, Jozef Haring, Christian Herweh, Silke Hopf-Jensen, Vi Tuan Hua, Märit Jensen, Andreas Kastrup, Christiane Fee Keil, Andrej Klepanec, Egon Kurča, Ronni Mikkelsen, Markus Möhlenbruch, Stefan Müller-Hülsbeck, Nico Münnich, Paolo Pagano, Panagiotis Papanagiotou, Gabor C Petzold, Mirko Pham, Volker Puetz, Jan Raupach, Gernot Reimann, Peter Arthur Ringleb, Maximilian Schell, Eckhard Schlemm, Silvia Schönenberger, Bjørn Tennøe, Christian Ulfert, Kateřina Vališ, Eva Vítková, Dominik F Vollherbst

Publikation: Beitrag in Fachzeitschrift › Fallbericht › Begutachtung

Abstract

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 2·58 [95% CI 1·60-4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46-0·98]; p=0·038). 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.

FUNDING: EU Horizon 2020.

Originalsprache	Englisch
Seiten (von - bis)	1753-1763
Seitenumfang	11
Fachzeitschrift	LANCET
Jahrgang	402
Ausgabenummer	10414
DOIs	https://doi.org/10.1016/S0140-6736(23)02032-9
Publikationsstatus	Veröffentlicht - 11 Nov. 2023

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10.1016/S0140-6736(23)02032-9

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TENSION Investigators, Bendszus, M., Fiehler, J., Subtil, F., Bonekamp, S., Aamodt, A. H., Fuentes, B., Gizewski, E. R., Hill, M. D., Krajina, A., Pierot, L., Simonsen, C. Z., Zeleňák, K., Blauenfeldt, R. A., Cheng, B., Denis, A., Deutschmann, H., Dorn, F., Flottmann, F., ... Vollherbst, D. F. (2023). Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial. LANCET , 402(10414), 1753-1763. https://doi.org/10.1016/S0140-6736(23)02032-9

TENSION Investigators ; Bendszus, Martin ; Fiehler, Jens et al. / Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial. in: LANCET 2023 ; Jahrgang 402, Nr. 10414. S. 1753-1763.

@article{27ae5224ecd8423290364a94ffdcde97,

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

abstract = "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 2·58 [95% CI 1·60-4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46-0·98]; p=0·038). 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.FUNDING: EU Horizon 2020.",

keywords = "Humans, Stroke/diagnostic imaging, Brain Ischemia/diagnostic imaging, Prospective Studies, Thrombectomy/methods, Intracranial Hemorrhages/etiology, Ischemic Stroke/diagnostic imaging, Endovascular Procedures/methods, Infarction/complications, Alberta, Treatment Outcome",

author = "{TENSION Investigators} and Martin Bendszus and Jens Fiehler and Fabien Subtil and Susanne Bonekamp and Aamodt, {Anne Hege} and Blanca Fuentes and Gizewski, {Elke R} and Hill, {Michael D} and Antonin Krajina and Laurent Pierot and Simonsen, {Claus Z} and Kamil Zele{\v n}{\'a}k and Blauenfeldt, {Rolf A} and Bastian Cheng and Ang{\'e}lique Denis and Hannes Deutschmann and Franziska Dorn and Fabian Flottmann and Susanne Gelli{\ss}en and Gerber, {Johannes C} and Mayank Goyal and Jozef Haring and Christian Herweh and Silke Hopf-Jensen and Hua, {Vi Tuan} and M{\"a}rit Jensen and Andreas Kastrup and Keil, {Christiane Fee} and Andrej Klepanec and Egon Kur{\v c}a and Ronni Mikkelsen and Markus M{\"o}hlenbruch and Stefan M{\"u}ller-H{\"u}lsbeck and Nico M{\"u}nnich and Paolo Pagano and Panagiotis Papanagiotou and Petzold, {Gabor C} and Mirko Pham and Volker Puetz and Jan Raupach and Gernot Reimann and Ringleb, {Peter Arthur} and Maximilian Schell and Eckhard Schlemm and Silvia Sch{\"o}nenberger and Bj{\o}rn Tenn{\o}e and Christian Ulfert and Kate{\v r}ina Vali{\v s} and Eva V{\'i}tkov{\'a} and Vollherbst, {Dominik F} and Markus Holtmannsp{\"o}tter and Sabine Kohler and R{\"u}diger Lange and Monika Killer-Oberpfalzer and Erasmia M{\"u}ller-Thies-Broussalis and Sebastian Mutzenbach and Slaven Pikija and Constantin Hecker and Al-Schameri, {Abdul Rahman} and Manuel Lunzer and Michael Kral and Tobias Moser and Rudolf Kreidenhuber and {Delalic Mustafic}, Asima and Markus Leitinger and Johannes Pfaff and Ferdinand Otto and Matthias Mauritz and Angela Jedlitschka",

note = "Holtmansp{\"o}tter, Kohler, Lange, Voit-H{\"o}hne, Eff, St{\"a}dt, Galczak, Lamprecht: (study gr members): Klinikum N{\"u}rnberg S{\"u}d; Killer-Oberpfalzer, M{\"u}ller-Thies-Broussalis, Mutzenbach, Pikija,Hecker, Al-Schameri, Lunzer, Kral, Weymayr, Bubel, Ganser, Leitner, Hacker-Ivan, Moser, Kreidenhuber, Delalic, Leitinger, Pfaff, Volna, Otto, Mauritz, Jedlitschka (study gr members): Medical University Salzburg",

year = "2023",

month = nov,

day = "11",

doi = "10.1016/S0140-6736(23)02032-9",

language = "English",

volume = "402",

pages = "1753--1763",

journal = "LANCET ",

issn = "0140-6736",

publisher = "Elsevier ",

number = "10414",

}

TENSION Investigators, Bendszus, M, Fiehler, J, Subtil, F, Bonekamp, S, Aamodt, AH, Fuentes, B, Gizewski, ER, Hill, MD, Krajina, A, Pierot, L, Simonsen, CZ, Zeleňák, K, Blauenfeldt, RA, Cheng, B, Denis, A, Deutschmann, H, Dorn, F, Flottmann, F, Gellißen, S, Gerber, JC, Goyal, M, Haring, J, Herweh, C, Hopf-Jensen, S, Hua, VT, Jensen, M, Kastrup, A, Keil, CF, Klepanec, A, Kurča, E, Mikkelsen, R, Möhlenbruch, M, Müller-Hülsbeck, S, Münnich, N, Pagano, P, Papanagiotou, P, Petzold, GC, Pham, M, Puetz, V, Raupach, J, Reimann, G, Ringleb, PA, Schell, M, Schlemm, E, Schönenberger, S, Tennøe, B, Ulfert, C, Vališ, K, Vítková, E & Vollherbst, DF 2023, 'Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial', LANCET , Jg. 402, Nr. 10414, S. 1753-1763. https://doi.org/10.1016/S0140-6736(23)02032-9

Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial. / TENSION Investigators; Bendszus, Martin; Fiehler, Jens et al.
in: LANCET , Jahrgang 402, Nr. 10414, 11.11.2023, S. 1753-1763.

Publikation: Beitrag in Fachzeitschrift › Fallbericht › Begutachtung

TY - JOUR

T1 - Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial

AU - TENSION Investigators

AU - Bendszus, Martin

AU - Fiehler, Jens

AU - Subtil, Fabien

AU - Bonekamp, Susanne

AU - Aamodt, Anne Hege

AU - Fuentes, Blanca

AU - Gizewski, Elke R

AU - Hill, Michael D

AU - Krajina, Antonin

AU - Pierot, Laurent

AU - Simonsen, Claus Z

AU - Zeleňák, Kamil

AU - Blauenfeldt, Rolf A

AU - Cheng, Bastian

AU - Denis, Angélique

AU - Deutschmann, Hannes

AU - Dorn, Franziska

AU - Flottmann, Fabian

AU - Gellißen, Susanne

AU - Gerber, Johannes C

AU - Goyal, Mayank

AU - Haring, Jozef

AU - Herweh, Christian

AU - Hopf-Jensen, Silke

AU - Hua, Vi Tuan

AU - Jensen, Märit

AU - Kastrup, Andreas

AU - Keil, Christiane Fee

AU - Klepanec, Andrej

AU - Kurča, Egon

AU - Mikkelsen, Ronni

AU - Möhlenbruch, Markus

AU - Müller-Hülsbeck, Stefan

AU - Münnich, Nico

AU - Pagano, Paolo

AU - Papanagiotou, Panagiotis

AU - Petzold, Gabor C

AU - Pham, Mirko

AU - Puetz, Volker

AU - Raupach, Jan

AU - Reimann, Gernot

AU - Ringleb, Peter Arthur

AU - Schell, Maximilian

AU - Schlemm, Eckhard

AU - Schönenberger, Silvia

AU - Tennøe, Bjørn

AU - Ulfert, Christian

AU - Vališ, Kateřina

AU - Vítková, Eva

AU - Vollherbst, Dominik F

A2 - Holtmannspötter, Markus

A2 - Kohler, Sabine

A2 - Lange, Rüdiger

A2 - Killer-Oberpfalzer, Monika

A2 - Müller-Thies-Broussalis, Erasmia

A2 - Mutzenbach, Sebastian

A2 - Pikija, Slaven

A2 - Hecker, Constantin

A2 - Al-Schameri, Abdul Rahman

A2 - Lunzer, Manuel

A2 - Kral, Michael

A2 - Moser, Tobias

A2 - Kreidenhuber, Rudolf

A2 - Delalic Mustafic, Asima

A2 - Leitinger, Markus

A2 - Pfaff, Johannes

A2 - Otto, Ferdinand

A2 - Mauritz, Matthias

A2 - Jedlitschka, Angela

N1 - Holtmanspötter, Kohler, Lange, Voit-Höhne, Eff, Städt, Galczak, Lamprecht: (study gr members): Klinikum Nürnberg Süd; Killer-Oberpfalzer, Müller-Thies-Broussalis, Mutzenbach, Pikija,Hecker, Al-Schameri, Lunzer, Kral, Weymayr, Bubel, Ganser, Leitner, Hacker-Ivan, Moser, Kreidenhuber, Delalic, Leitinger, Pfaff, Volna, Otto, Mauritz, Jedlitschka (study gr members): Medical University Salzburg

PY - 2023/11/11

Y1 - 2023/11/11

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 2·58 [95% CI 1·60-4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46-0·98]; p=0·038). 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.FUNDING: EU Horizon 2020.

AB - 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 2·58 [95% CI 1·60-4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46-0·98]; p=0·038). 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.FUNDING: EU Horizon 2020.

KW - Humans

KW - Stroke/diagnostic imaging

KW - Brain Ischemia/diagnostic imaging

KW - Prospective Studies

KW - Thrombectomy/methods

KW - Intracranial Hemorrhages/etiology

KW - Ischemic Stroke/diagnostic imaging

KW - Endovascular Procedures/methods

KW - Infarction/complications

KW - Alberta

KW - Treatment Outcome

U2 - 10.1016/S0140-6736(23)02032-9

DO - 10.1016/S0140-6736(23)02032-9

M3 - Case report

C2 - 37837989

SN - 0140-6736

VL - 402

SP - 1753

EP - 1763

JO - LANCET

JF - LANCET

IS - 10414

ER -

TENSION Investigators, Bendszus M, Fiehler J, Subtil F, Bonekamp S, Aamodt AH et al. Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial. LANCET . 2023 Nov 11;402(10414):1753-1763. doi: 10.1016/S0140-6736(23)02032-9

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

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