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

作者：Götz Thomalla, Jens Fiehler, Fabien Subtil, Susanne Bonekamp, Anne Hege Aamodt, Blanca Fuentes, Elke Ruth 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 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 Alfred 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, Wolfgang Wick, Martin Bendszus, Anne Hege Aamodt, 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 Bengtson Argren, Anne Assmann, Michael Augustin, Elke Bach, Michal Bar, Maria Barleben, Flore Baronnet, Andrés Javier Barrios, Xénia Bavúzová, Rikke BayThomsen, Sandra Becker, Sylvia Beer, Daniel Behme, Maximilian Bellut, Martin Bendszus, Joachim Berkefeld, Maximillian Bester, Felix Jürgen Bode, Christian Boehme, Ramona Boese, Ferdinand Oliver Bohmann, Susanne Bonekamp, Jan Borggrefe, Erendira Gabriela Boss, Maria Boutchakova, Elfi Boxhammer, Annemarie Brandhofe, Michael O. Breckwoldt, Casper Brekenfeld, Alex Brehm, Christian Brem, Stella Breuer, Tobias Breyer, Petra Brodová, Gabriel Broocks, Christoph Brosinski, Nele Bubel, Jiří Búřil, Martin Čábal, Laura Casado, Elena de Celis, Emmanuel Chabert, Daniel Charissé, Bastian Cheng, Vendelı́n Chovanec, Peter Cidlinsky, Juraj Cisár, Frédéric Clarençon, Sophie Crozier, Nina Čurdová, Michele Damaskinos, Dorte Damgaard, Martin Daniš, Florian Dazinger, Milani Deb‐Chatterji, Asima Delalic, Agnieszka Monika 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 Anthony B. 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 Gellißen, Johannes C. Gerber, Michail Panagiotis Giannakakis, Karin Gindlhuber, Elke Ruth Gizewski, Bernhard Glodny, Tim Godel, Einar Goebell, David Goldemund, Michael Wolfgang Görtler, Mayank Goyal, Astrid Ellen Grams, Joachim Gruber, Katharina Gruber, Thomas Günthner‐Lengsfeld, Kathrin Haase, Floriana Hacker-Ivan, Erika Hallerstig, Christian Hametner, Uta Meta Paula Hanning, Jozef Haring, Michal Haršány, Ján Haršány, Christian Johannes Hartmann, Eva Maria Hassler, Kristina Hauptmann, Karl Georg Hæusler, Constantin Hecker, Victoria Hellstern, Hans H. Henkes, Victoria Hernández, Christian Herweh, Tim Hilgenfeld, Michael D. Hill, Niels Hjort, Nina HjortJensen, Maya Christina 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 Janjic, Kirsten Jaramillo, Angela Jedlitschka, Schiela Jensen, Märit Jensen, Jessica Jesser, Leonie Jestaedt, Sabine N. Johnson, Tomáš Jonszta, Peter I. Kalmar, Sanja Karabegovic, Kollo Karen, Andreas Kastrup, Hopp Katja, Natalia Keeba, Petra Keese, Christina Kefaloykos, Fee Christiane Keil, Lars Kellert, Christoph Kellinghaus, Roxane‐Isabelle Kestner, Stefan Julia Kiechl, Monika Killer‐Oberpfalzer, Andrej Klepanec, Casjupea Knispel, Michael Knoflach, Sabine Köhler, Konstantin David Kohlhase, Alexander Marco Kollikowski, Martin Kovář, Antonı́n Krajina, Michael Kral, Georgi Krastev, Lars Udo Krause, Rudolf Kreidenhuber, Tomáš Křivka, Adam Krkoška, Jan Robert Kröger, Moritz Kronlage, Paweł Krukowski, Julia Kühn, Egon Kurča, Natalia Kurka, Michael Kuschnerow, Rita Lachmund, Susanne Lamprecht, Rüdiger Lange, Monika Lauer, 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 Carmezini Marques, David Matyáš, Gabriele Maurer, Matthias Mauritz, Thormann Maximilian, Lukas Mayer-Süß, Stephan Meckel, Oldřich Medek, Julius Nicolai Meißner, Pavel Mencl, Andrea Merkle, Birte Mesche, Dominik Michalski, Robert Mikulík, Boris Modrau, Markus Alfred Möhlenbruch, Alexander Mohr, Christoph Mönninghoff, Tobias Moser, Ramona Mücke, Stefan Müller‐Hülsbeck, Erasmia Broussalis, Sebastian Mutzenbach, Pedro Navía, Ulf Neuberger, Hermann Neugebauer, Jens H. L. 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 Otto Pelz, Inga Petersen, Martina Petersen, Gabor C. Petzold, Johannes Alex Rolf Pfaff, Johannes Alex Rolf Pfaff, Waltraud Pfeilschifter, Mirko Pham, Alexander Pichler, Laurent Pierot, Slaven Pikija, Jan PlougmannPovlsen, Christoph Polkowski, Nenad Polomac, Rupert Horst Portugaller, Marika Suzuki Poulsen, Michael Preiß, Kévin Premat, Sjur Prestsæter, Rocío Prieto‐Pérez, Marios Nikos Psychogios, Volker Puetz, Jan Christoph Purrucker, Heike Rai, Maximilian Rauch, Jan Raupach, Gernot Reimann, Georg Reimann, Sarah Christina Reitz, Ondřej Renc, Jasmin Retzlaff, Ricardo Rigual, Peter Arthur Ringleb, Carlota Rivera-Bengoa, Jorge Rodríguez, Stefan Rohde, Siegfried Rohler, Charlotte Rosso, Christian Roth, Thomas Röttcher, Martin Roubec, Milada Roztočilová, Svetlana Rudnicka, Gerardo Ruiz, Stephen T Ryan, Karla J. Ryckborst, Simen Sandvik, Jan-Hendrik Schäfer, Martin Schaller, Maximillian Schell, Peter Dieter Schellinger, Eckhard Schlemm, Florian Alexander Schmid, C. G. Schmidt, Marie Louise Schmitz, Claus G. Schneider, Jan‐Erik Scholtz, Silvia Schönenberger, Andreas Schröter, Daniel F. Schwarz, Stephan K. W. Schwarz, Daniel Schwarzenhofer, Thomas Seifert‐Held, Alexander Seiler, Fatih Şeker, Eimad Shotar, Claus Z. Simonsen, Maria Theresa Simonsen, Jozef Sivák, Karolina Ryeng Skagen, Mona Skjelland, Alena Šnajdrová, Lazlo Solymosi, Jesper Sømark, Michael Sonnberger, Jakub Soršák, Nader Antoine Sourour, Jogrim Søyland, Daniel E. Spitzer, Peter Bernhard Sporns, Michael Städt, Eike Steidl, Anne Margrethe Kaalaas Størdal, Sebastian Stösser, Sarah Strickmann, Ondřej Strýček, Igor Suškevič, Ján Sýkora, Bjørn Tennøe, Daniela Thaler, Sara Theisen, Götz Thomalla, Petar Trendafilov, Johannes Trenkler, Christoph Gregor Trumm, Ioannis Tsogkas, Jon‐Anders Tunold, Lars H. Tveit, Christian Ulfert, Kateřina Vališ, Jiří Vaníček, Christine Vassilev, Eva Vítková, Heinz-Leonhard 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 M Weller, Katharina Wenger-Alakmeh, Cyrill Weyland, Friedrich Weymayr, Ulrike Wießpeiner, Johannes Willeit, Aymeric Wittwer, Frank Arne Wollenweber, Ginette Wortmann, Silke Wunderlich, Yanyan Xiong, Se-Jong You, Lasse ZachoSpeiser, Mahtab Zamani, Kamil Zeleňák, Jana Zeleňáková, Seraphine Zubel · 发表于：The Lancet Neurology · 年份：2024 · DOI：10.1016/s1474-4422(24)00278-3 · 被引用次数：76 · 研究领域：Acute Ischemic Stroke Management、Stroke Rehabilitation and Recovery、Cerebrovascular and Carotid Artery Diseases

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...