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

医学 缺血性中风 打开标签 冲程(发动机) 随机对照试验 血管内治疗 急性中风 外科 物理疗法 内科学 缺血 组织纤溶酶原激活剂 动脉瘤 机械工程 工程类
作者
Götz Thomalla,Jens Fiehler,Fabien Subtil,Susanne Bonekamp,Anne Tybjærg‐Hansen,Blanca Fuentes,Elke R. Gizewski,Michael D. Hill,Antonı́n Krajina,Laurent Pierot,Claus Z Simonsen,Kamil Zeleňák,Rolf Ankerlund Blauenfeldt,Bastian Cheng,Angélique Denis,Hannes Deutschmann,Franziska Dorn,Fabian Flottmann,Susanne Siemonsen,Johannes Gerber,Mayank Goyal,Jozef Haring,Christian Herweh,Silke Hopf-Jensen,Vi Tuan Hua,Märit Jensen,Andreas Kastrup,C 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 Vanacker,Maximilian Schell,Eckhard Schlemm,Silvia Schönenberger,Bjørn Tennøe,Christian Ulfert,Kateřina Vališ,Eva Vítková,Dominik F. Vollherbst,Wolfgang Wick,Martin Bendszus,Anne Tybjærg‐Hansen,Olaf Adamczewski,Kirill Alektoror,März Alexander,Maria Eleni Alexandrou,Quentin Alias,Fadha Elawi Al-Kuzae,Julien Allard,Rahman Al-Schameri,Alberto Álvarez,Grethe Andersen,Rolf AnkerlundBlaufeldt,Riedel Antje,Hannes Appelbohm,Maria Argren,Anne Assmann,Michael Augustin,Elsa Bach,Michal Bar,Maria Barleben,Flore Baronnet,Andrés Barrios,Xénia Bavúzová,Rikke BayThomsen,Sandra Becker,Sandra Beer,Daniel Behme,Maximilian Bellut,Martin Bendszus,Joachim Berkefeld,Maxim Bester,Felix J. Bode,Christian Boehme,Robert J. Boese,Ferdinand O. Bohmann,Susanne Bonekamp,Jan Borggrefe,Erendira Gabriela Boss,Maria Boutchakova,Elke Boxhammer,Annemarie Brandhofe,Michael O. Breckwoldt,Caspar Brekenfeld,Alex Brehm,Christian Brem,Stella Breuer,Thiemo Breyer,Petra Brodová,Gabriel Broocks,Christoph Brosinski,Nele Bubel,Jiří Búřil,Martin Čábal,Laura Casado‐Fernández,Elena de Celis,Emmanuel Chabert,Daniel Charissé,Bastian Cheng,Vendelín Chovanec,Peter Cidlinsky,J Cisar,Frédéric Clarençon,Sophie Crozier,Nina Čurdová,Michele Damaskinos,Dorte Damgaard,Martin Daniš,Florian Dazinger,Milani Deb‐Chatterji,Asima Delalic,Agnieszka Delekta,Stephen Delorme,Hannes Deutschmann,Elie Diamandis,Tove Diedrichsen,Irena Doležalová,Franziska Dorn,Franziska Dorn,Richard du Mesnil de Rochemont,Kristina DupontHougaard,Taraneh Ebrahimi,Florian Eff,Ilona Eliášová,Brian Enriquez,Mostafa Ergawy,Fabian Essig,Maiken Falkesgaard,Simon Fandler-Höfler,Andrés Fernández,Jean‐Christophe Ferré,Anna Ferrier,Jens Fiehler,Krystian Figlewski,Sebastian Fischer,Urs Fischer,Fabian Flottmann,Robert Forbrig,Christian Förch,Annette Fromm,Blanca Fuentes,Ines Gaedke,Romana Galczak,Malik Galijašević,Bernhard Ganser,Thomas Gattringer,Matthias Gawlitza,Sarah Gelhard,Susanne Siemonsen,Johannes Gerber,Michail Panagiotis Giannakakis,Karin Gindlhuber,Elke R. Gizewski,Bernhard Glodny,Tim Godel,Einar Goebell,David Goldemund,Michael Görtler,Mayank Goyal,Astrid Grams,Joachim Gruber,Katharina Gruber,Thomas Günthner‐Lengsfeld,Kathrin Haase,Floriana Hacker-Ivan,Erika Hallerstig,Christian Hametner,Uta Hanning,Jozef Haring,Michal Haršány,Ján Haršány,Christian Hartmann,Eva Hassler,Karl Eugen Hauptmann,Karl Georg Hæusler,Constantin Hecker,Victoria Hellstern,Hans Henkes,Victoria Hernández,Christian Herweh,Tim Hilgenfeld,Michael D. Hill,Niels Hjort,Nina HjortJensen,Maya Hoelter,Karl‐Titus Hoffmann,Brigitte Holst,Markus Holtmannspoetter,Silke Hopf-Jensen,Julia Hoppe,Susanne Hörner,Leif HougaardSoerensen,Vi Tuan Hua,Alexander Hubert,Eva Hurtíková,Stanislava Jakubíček,Tanja Djurdjevic,Kirsten Jaramillo,Andreas Jedlitschka,Schiela Jensen,Märit Jensen,Jessica Jesser,Leonie Jestaedt,Sabine Johnson,Tomáš Jonszta,P. Kalmár,Sanja Karabegovic,Kollo Karen,Andreas Kastrup,Hopp Katja,Natalia Keeba,Petra Keese,Christina Kefaloykos,Fee Keil,Lars Kellert,Christoph Kellinghaus,Roxane‐Isabelle Kestner,Stefan Kiechl,Monika Killer‐Oberpfalzer,Andrej Klepanec,Casjupea Knispel,Michael G. Hennerici,Sabine Köhler,Konstantin Kohlhase,Alexander M. Kollikowski,Martin Kovář,Antonı́n Krajina,Michael Kral,Georgios Tsivgoulis,Lars Udo Krause,Rudolf Kreidenhuber,Tomáš Křivka,Adam Krkoška,Jan Robert Kroeger,Moritz Kronlage,Paweł Krukowski,Julia Kühn,Egon Kurča,Natalia Kurka,Michael Kuschnerow,Rita Lachmund,Susanne Lamprecht,Rüdiger Lange,M Müller-Eschner,Alonso de Leciñana,Sara Leder,Anne Léger,Nils Christian Lehnen,Dominik Lehrieder,Maximilian Leißner,Markus Leitinger,Ursula Leitner,Stéphanie Lenck,Eva Lenzenweger,Thomas Liebig,Stephan Lowens,Manuel Lunzer,Christian Maegerlein,Marton Magyar,Leonardo Marques,David Matyáš,Gerald Maurer,Matthias Mauritz,Thormann Maximilian,Lukas Mayer-Süß,Stephan Meckel,Oldřich Medek,Julius N. Meißner,Pavel Mencl,Antje Merkle,Birte Mesche,Dominik Michalski,Robert Mikulík,Boris Modrau,Markus Möhlenbruch,Alexander Mohr,Christoph Moenninghoff,Tobias Moser,Ralph Mücke,Stefan Müller‐Hülsbeck,Erasmia Broussalis,Sebastian Mutzenbach,Pedro Navía,Ulf Neuberger,Hermann Neugebauer,Jens Neumann,Anh Nguyên,Kurt Niederkorn,Vladimír Nosáľ,Richard Novobilský,Nikos Ntoulias,Lukas Nussbaum,Joanna Oder,Andreas Oldag,Marián Ondrejkovič,Ferdinand Otto,Dagmar Otto,Daniel Paech,Paolo Pagano,Lars‐Peder Pallesen,Michal Panský,Panagiotis Papanagiotou,Samp Patrick,Harald Paukisch,Johann Pelz,Inga Petersen,Martina Petersen,Gabor C. Petzold,Johannes Pfaff,Johannes Pfaff,Waltraud Pfeilschifter,Mirko Pham,Alexander Pichler,Laurent Pierot,Slaven Pikija,Jan PlougmannPovlsen,Christoph Polkowski,Nenad Polomac,Rupert Horst Portugaller,Marika Poulsen,Michael Preiß,Kévin Premat,Sjur Prestsæter,Rocío Prieto‐Pérez,Marios Psychogios,Volker Puetz,Jan Purrucker,Heike Rai,Maximilian Rauch,Jan Raupach,Gernot Reimann,G. Reimann,Sandra Reitz,Ondřej Renc,John Retzlaff,Ricardo Rigual,Peter Vanacker,Carlota Rivera-Bengoa,Jorge Rodríguez,Stefan Rohde,Siegfried Rohler,Charlotte Rosso,Christian Roth,Thomas Röttcher,Martin Roubec,Milada Roztočilová,Svetlana Rudnicka,Gerardo Ruiz,Stephen Ryan,Karla J. Ryckborst,Simen Sandvik,Jan Hendrik Schaefer,Martin Schaller,Maximillian Schell,Peter D. Schellinger,Eckhard Schlemm,Florian Schmid,C. G. Schmidt,Marie Louise Schmitz,Claus Schneider,Jan‐Erik Scholtz,Silvia Schönenberger,Andreas Schröter,Dániel Schwarz,Stephan Schwarz,Daniel Schwarzenhofer,Thomas Seifert,Alexander Seiler,Fatih Şeker,Eimad Shotar,Simon Fandler-Höfler,Merete Simonsen,Štefan Sivák,Karolina Skagen,Mona Skjelland,Alena Šnajdrová,L. Solymosi,Jesper Sømark,Michael Sonnberger,Jakub Soršák,Nader Sourour,Jogrim Søyland,Daniel Spitzer,Peter B. Sporns,Michael Städt,Eike Steidl,Anne Margrethe Kaalaas Størdal,Sebastian Stösser,Sarah Strickmann,Ondřej Strýček,Igor Suškevič,Ján Sýkora,Bjørn Tennøe,Daniela Thaler,Simon Theisen,Götz Thomalla,Petar Trendafilov,Johannes Trenkler,Christoph Trumm,Ioannis Tsogkas,Jon‐Anders Tunold,Lars Tveit,Christian Ulfert,Kateřina Vališ,Jiří Vaníček,Christine Vassilev,Eva Vítková,H Voit-Höhne,Bohuslav Vojtíšek,Karoline Volderauer,Dominik F. Vollherbst,Christoph Vollmuth,Kamila Volna,Ondřej Volný,Poul VonWeitzel-Mudersbach,Martin Vorčák,Marlies Wagner,Gaute Kjellevold Wathle,Werner Weber,Anushe Weber,Viktor Weiss,Johannes Weller,Katharina Wenger-Alakmeh,Charlotte S. Weyland,Friedrich Weymayr,Ulrike Wießpeiner,Johannes Willeit,Aymeric Wittwer,Frank A. Wollenweber,Ginette Wortmann,Silke Wunderlich,Yanyan Xiong,Se-Jong You,Lasse ZachoSpeiser,Mahtab Zamani,Kamil Zeleňák,Jana Zeleňáková,Seraphine Zubel
出处
期刊:Lancet Neurology [Elsevier]
卷期号:23 (9): 883-892 被引量:1
标识
DOI:10.1016/s1474-4422(24)00278-3
摘要

BackgroundLong-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.MethodsTENSION 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.FindingsWe 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 8·36 months (IQR 0·02–12·00). 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 2·39 [95% CI 1·47–3·90]). 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 (0·7 [IQR 0·4–0·9] vs 0·4 [0·2–0·7]), 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 39·8 [IQR 37·4–50·8] vs 37·4 [32·4–44·9]); although there was not enough evidence to suggest a difference between groups in global mental health scores on PROMIS-10 (41·1 [IQR 36·3–48·3] vs 38·8 [31·3–44·7]) 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 0·70 [95% CI 0·50–0·99]).InterpretationIn patients with acute ischaemic stroke from large vessel occlusion with established large infarct, compared with medical treatment only, endovascular thrombectomy was associated at 12 months after stroke with better functional outcome, quality of life, and overall survival. These findings suggest that the benefits of endovascular thrombectomy in patients with an ischaemic stroke and a large infarct are sustained in the long term and support the use of endovascular thrombectomy in these patients.FundingEuropean Union Horizon 2020 Research and Innovation Programme.
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