Endovascular thrombectomy for acute ischaemic stroke with
established large infarct (TENSION): 12-month outcomes of a
multicentre, open-label, randomised trial

J 2024

Endovascular thrombectomy for acute ischaemic stroke with established large infarct (TENSION): 12-month outcomes of a multicentre, open-label, randomised trial

THOMALLA, Goetz, Jens FIEHLER, Fabien SUBTIL, Susanne BONEKAMP, Anne Hege AAMODT et. al.

Základní údaje

Originální název

Endovascular thrombectomy for acute ischaemic stroke with established large infarct (TENSION): 12-month outcomes of a multicentre, open-label, randomised trial

Autoři

THOMALLA, Goetz, 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 (203 Česká republika, domácí), Eva VITKOVA, Dominik F VOLLHERBST, Wolfgang WICK a Martin BENDSZUS

Vydání

Lancet Neurology, New York, Elsevier, 2024, 1474-4422

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30210 Clinical neurology

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 48.000 v roce 2022

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1016/S1474-4422(24)00278-3

UT WoS

001330619400001

Klíčová slova anglicky

acute ischaemic stroke; endovascular thrombectomy

Štítky

14110119, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 25. 10. 2024 10:52, Mgr. Tereza Miškechová

Anotace

V originále

Background Long-term data showing the benefits of endovascular thrombectomy for stroke with large infarct are scarce. The TENSION trial showed the safety and efficacy of endovascular thrombectomy in patients with ischaemic stroke and large infarct at 90 days. We aimed to investigate the safety and efficacy at 12 months of endovascular thrombectomy in patients who were enrolled in the TENSION trial. Methods TENSION was an open-label, blinded endpoint, randomised trial done at 40 hospitals across Europe and one hospital in Canada. We included patients (aged >= 18 years) with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and who had a large infarct, as indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 on standard-of-care stroke imaging. We randomly assigned patients (1:1) to receive either endovascular thrombectomy with medical treatment or medical treatment only up to 12 h from stroke onset. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days. Here, we report the prespecified 12-month follow-up analyses for functional outcome (using the simplified modified Rankin Scale questionnaire), quality of life (using the Patient-Reported Outcomes Measurement Information System 10-item [PROMIS-10] and EQ-5D questionnaires), post-stroke anxiety and depression (using the Patient Health Questionnaire-4 [PHQ-4]), and overall survival. Outcomes (except survival) were assessed in the intention-to-treat population; the survival analysis was based on treatment received. This trial is registered with ClinicalTrials.gov, NCT03094715, and is completed. Findings We enrolled patients between July 17, 2018, and Feb 21, 2023, when the trial was stopped early for efficacy. 253 patients were randomly assigned, 125 (49%) to endovascular thrombectomy and 128 (51%) to medical treatment only. Median follow-up was 836 months (IQR 002-1200). Endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better functional outcome at 12 months (adjusted common odds ratio 239 [95% CI 147-390]). Endovascular thrombectomy was also associated with a better quality of life compared with medical treatment only, as reflected by median scores on the EQ-5D questionnaire index (07 [IQR 04-09] vs 04 [02-07]), median scores for health status on the EQ-5D questionnaire visual analogue scale (50 [IQR 35-70] vs 30 [5-60]), and median global physical health scores on the PROMIS-10 questionnaire (T-score 398 [IQR 374-508] vs 374 [324-449]); although there was not enough evidence to suggest a difference between groups in global mental health scores on PROMIS-10 (411 [IQR 363-483] vs 388 [313-447]) or the numbers of patients reporting anxiety (13 [22%] of 58 vs 15 [42%] of 36) and depression (18 [31%] vs 18 [50%]) on PHQ-4. Overall survival was slightly better in the endovascular thrombectomy group compared with medical treatment only (adjusted hazard ratio 070 [95% CI 050-099]).

Citovat

THOMALLA, Goetz, 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 a Martin BENDSZUS. Endovascular thrombectomy for acute ischaemic stroke with established large infarct (TENSION): 12-month outcomes of a multicentre, open-label, randomised trial. Lancet Neurology. New York: Elsevier, 2024, roč. 23, č. 9, s. 883-892. ISSN 1474-4422. Dostupné z: https://dx.doi.org/10.1016/S1474-4422(24)00278-3.

@article{2446226,
   author = {Thomalla, Goetz 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 Bendszus, Martin},
   article_location = {New York},
   article_number = {9},
   doi = {http://dx.doi.org/10.1016/S1474-4422(24)00278-3},
   keywords = {acute ischaemic stroke; endovascular thrombectomy},
   language = {eng},
   issn = {1474-4422},
   journal = {Lancet Neurology},
   title = {Endovascular thrombectomy for acute ischaemic stroke with established large infarct (TENSION): 12-month outcomes of a multicentre, open-label, randomised trial},
   url = {https://www.sciencedirect.com/science/article/pii/S1474442224002783?via%3Dihub},
   volume = {23},
   year = {2024}
}

TY  - JOUR
ID  - 2446226
AU  - Thomalla, Goetz - 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 - Bendszus, Martin
PY  - 2024
TI  - Endovascular thrombectomy for acute ischaemic stroke with established large infarct (TENSION): 12-month outcomes of a multicentre, open-label, randomised trial
JF  - Lancet Neurology
VL  - 23
IS  - 9
SP  - 883-892
EP  - 883-892
PB  - Elsevier
SN  - 14744422
KW  - acute ischaemic stroke
KW  - endovascular thrombectomy
UR  - https://www.sciencedirect.com/science/article/pii/S1474442224002783?via%3Dihub
N2  - Background Long-term data showing the benefits of endovascular thrombectomy for stroke with large infarct are scarce. The TENSION trial showed the safety and efficacy of endovascular thrombectomy in patients with ischaemic stroke and large infarct at 90 days. We aimed to investigate the safety and efficacy at 12 months of endovascular thrombectomy in patients who were enrolled in the TENSION trial. Methods TENSION was an open-label, blinded endpoint, randomised trial done at 40 hospitals across Europe and one hospital in Canada. We included patients (aged >= 18 years) with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and who had a large infarct, as indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 on standard-of-care stroke imaging. We randomly assigned patients (1:1) to receive either endovascular thrombectomy with medical treatment or medical treatment only up to 12 h from stroke onset. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days. Here, we report the prespecified 12-month follow-up analyses for functional outcome (using the simplified modified Rankin Scale questionnaire), quality of life (using the Patient-Reported Outcomes Measurement Information System 10-item [PROMIS-10] and EQ-5D questionnaires), post-stroke anxiety and depression (using the Patient Health Questionnaire-4 [PHQ-4]), and overall survival. Outcomes (except survival) were assessed in the intention-to-treat population; the survival analysis was based on treatment received. This trial is registered with ClinicalTrials.gov, NCT03094715, and is completed. Findings We enrolled patients between July 17, 2018, and Feb 21, 2023, when the trial was stopped early for efficacy. 253 patients were randomly assigned, 125 (49%) to endovascular thrombectomy and 128 (51%) to medical treatment only. Median follow-up was 836 months (IQR 002-1200). Endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better functional outcome at 12 months (adjusted common odds ratio 239 [95% CI 147-390]). Endovascular thrombectomy was also associated with a better quality of life compared with medical treatment only, as reflected by median scores on the EQ-5D questionnaire index (07 [IQR 04-09] vs 04 [02-07]), median scores for health status on the EQ-5D questionnaire visual analogue scale (50 [IQR 35-70] vs 30 [5-60]), and median global physical health scores on the PROMIS-10 questionnaire (T-score 398 [IQR 374-508] vs 374 [324-449]); although there was not enough evidence to suggest a difference between groups in global mental health scores on PROMIS-10 (411 [IQR 363-483] vs 388 [313-447]) or the numbers of patients reporting anxiety (13 [22%] of 58 vs 15 [42%] of 36) and depression (18 [31%] vs 18 [50%]) on PHQ-4. Overall survival was slightly better in the endovascular thrombectomy group compared with medical treatment only (adjusted hazard ratio 070 [95% CI 050-099]).
ER  -

THOMALLA, Goetz, 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 a Martin BENDSZUS. Endovascular thrombectomy for acute ischaemic stroke with established large infarct (TENSION): 12-month outcomes of a multicentre, open-label, randomised trial. \textit{Lancet Neurology}. New York: Elsevier, 2024, roč.~23, č.~9, s.~883-892. ISSN~1474-4422. Dostupné z: https://dx.doi.org/10.1016/S1474-4422(24)00278-3.

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