Endovascular thrombectomy for acute ischaemic stroke with established large infarct (TENSION): 12-month outcomes of a multicentre, open-label, randomised trial
Authors: Götz Thomalla, 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, Wolfgang Wick, Martin Bendszus, Anne Hege Aamodt, Olaf Adamczewski, Kirill Alektoror, März Alexander, Maria 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, Elke Bach, Michal Bar, Maria Barleben, Flore Baronnet, Andrés Barrios, Xénia Bavúzová, Rikke BayThomsen, Sandra Becker, Sylvia Beer, Daniel Behme, Maximilian Bellut, Martin Bendszus, Joachim Berkefeld, Maximillian Bester, Felix J. Bode, Christian Boehme, Ramona Boese, Ferdinand Bohmann, Susanne Bonekamp, Jan Borggrefe, Erendira Gabriela Boss, Maria Boutchakova, Elfi Boxhammer, Annemarie Brandhofe, Michael 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 Charisse, Bastian Cheng, Vendelín Chovanec, Peter Cidlinsky, Juraj Cisár, Fréderic 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 Galijasevic, Bernhard Ganser, Thomas Gattringer, Matthias Gawlitza, Sarah Gelhard, Susanne Gellißen, Johannes Gerber, Michail Panagiotis Giannakakis, Karin Gindlhuber, Elke R. Gizewski, Bernhard Glodny, Tim Godel, Einar Goebell, David Goldemund, Michael Görtler, Mayank Goyal, Astrid E. 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 Maria Hassler, Kristina Hauptmann, Karl Georg Haeusler, 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 Horner, 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 Johnson, Tomáš Jonszta, Peter Kalmar, 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 Knoflach, Sabine Kohler, Konstantin Kohlhase, Alexander Marco Kollikowski, Martin Kovář, Antonín Krajina, Michael Kral, Georgi Krastev, Lars Udo Krause, Rudolf Kreidenhuber, Tomáš Křivka, Adam Krkoška, Jan Robert Kröger, Moritz Kronlage, Pawel Krukowski, Julia Kühn, Egon Kurča, Natalia Kurka, Michael Kuschnerow, Rita Lachmund, Susanne Lamprecht, Rüdiger Lange, Monika Lauer, Alonso de Leciñana, Sara Leder, Anne Leger, Nils 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, Gabriele Maurer, Matthias Mauritz, Thormann Maximilian, Lukas Mayer-Süß, Stephan Meckel, Oldřich Medek, Julius N. Meissner, Pavel Mencl, Andrea Merkle, Birte Mesche, Dominik Michalski, Robert Mikulík, Boris Modrau, Markus A. Möhlenbruch, Alexander Mohr, Christoph Mönninghoff, Tobias Moser, Ramona Mücke, Stefan Müller-Hülsbeck, Erasmia Müller-Thies-Broussalis, Sebastian Mutzenbach, Pedro Navia, Ulf Neuberger, Hermann Neugebauer, Jens Neumann, Anh Nguyên, Kurt Niederkorn, Vladimír Nosál', 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, Rocio Prieto-Pérez, Marios Psychogios, Volker Puetz, Jan Purrucker, Heike Rai, Maximilian Rauch, Jan Raupach, Gernot Reimann, Georg Reimann, Sarah 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 Ryan, Karla J. Ryckborst, Simen Sandvik, Jan-Hendrik Schäfer, Martin Schaller-Paule, Maximillian Schell, Peter Schellinger, Eckhard Schlemm, Florian Schmid, Christoph Schmidt, Marie Louise Schmitz, Claus Schneider, Jan-Erik Scholtz, Silvia Schönenberger, Andreas Schröter, Daniel Schwarz, Stephan Schwarz, Daniel Schwarzenhofer, Thomas Seifert-Held, Alexander Seiler, Fatih Seker, Eimad Shotar, Claus Z. Simonsen, Maria Theresa Simonsen, Jozef Sivák, Karolina Skagen, Mona Skjelland, Alena Šnajdrová, Lazlo Solymosi, Jesper Sømark, Michael Sonnberger, Jakub Soršák, Nader Sourour, Jogrim Søyland, Daniel Spitzer, Peter Sporns, Michael Städt, Eike Steidl, Anne Margrethe Kaalaas Størdal, Sebastian Stösser, Sarah Strickmann, Ondřej Strýček, Igor Suškevič, Jan Sýkora, Bjørn Tennøe, Daniela Thaler, Sara 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, Heinz-Leonhard Voit-Höhne, Bohuslav Vojtíšek, Karoline Volderauer, Dominik 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 Wollenweber, Ginette Wortmann, Silke Wunderlich, Yanyan Xiong, Se-Jong You, Lasse ZachoSpeiser, Mahtab Zamani, Kamil Zelenak, Jana Zeleňáková, Seraphine Zubel
Journal: The Lancet Neurology (2024)

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.