Endovascular treatment for medium or distal vessel occlusion stroke (DISTAL): 12-month outcomes of a multicentre, open-label, randomised trial
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: Long-term evidence for endovascular treatment in medium or distal vessel occlusion stroke is scarce. Three out of four randomised trials reported no benefit of endovascular treatment over best medical treatment at 90 days. We aimed to assess efficacy of endovascular treatment plus best medical treatment versus best medical treatment alone at 12 months in patients enrolled in the DISTAL trial, as well as overall survival. METHODS: DISTAL was an open-label, randomised trial with blinded endpoint assessment conducted at 55 hospitals in Europe and the Middle East. Adults (≥18 years) with acute ischaemic stroke due to medium or distal vessel occlusion (occlusion of co-dominant or non-dominant M2 or M3-M4 middle cerebral artery, A1-A3 anterior cerebral artery, or P1-P3 posterior cerebral artery) presenting from home within 6 h of last known well, or between 6 h and 24 h if neuroimaging demonstrated potentially salvageable tissue, were randomly assigned (1:1) through a centralised web-based system to endovascular treatment plus best medical treatment or best medical treatment alone. The prespecified primary outcome at 12 months was disability measured by use of the ordinal modified Rankin Scale (mRS; scores 5 and 6 combined) in the intention-to-treat population. The only safety outcome was overall survival. The trial is registered on ClinicalTrials.gov (NCT05029414) and is completed. FINDINGS: Between Dec 16, 2021, and July 10, 2024, we enrolled 553 patients. Ten patients declined post-hoc consent, leaving 543 participants in the analysis (239 [44%] females and 304 [56%] males; median age 77 years, IQR 68-84). 271 (50%) were assigned to endovascular treatment plus best medical treatment and 272 (50%) to best medical treatment alone. The median NIHSS score at admission was 6 (IQR 5-9); 355 (65%) participants received intravenous thrombolysis. Predominant occlusion locations were the M2 (239 [44%]), M3 (146 [27%]), P2 (73 [13%]), and P1 (30 [6%]) segments. 12-month data were available for 524 (97%) participants. The median mRS score was 2 (IQR 1-4) in the endovascular treatment plus best medical treatment group and 2 (1-4) in the best medical treatment alone group. There was no difference in 12-month mRS distribution between endovascular treatment plus best medical treatment and best medical treatment alone (adjusted common odds ratio for better functional outcome 0·81, 95% CI 0·59-1·12; p=0·20). Overall survival was similar between the two groups (hazard ratio 1·46, 95% CI 0·93-2·30; p=0·10). INTERPRETATION: In patients with a medium or distal vessel occlusion stroke, endovascular treatment plus best medical treatment was not associated with a reduction of disability or death at 12 months compared with best medical treatment. These results are consistent with the 90-day results. Routine endovascular treatment is therefore not supported for patients with mild-to-moderate medium or distal vessel occlusion stroke. FUNDING: Swiss National Science Foundation, Gottfried und Julia Bangerter-Rhyner-Foundation, Medtronic, Stryker Neurovascular, Phenox, Rapid Medical, and Penumbra.
Source: The Lancet Neurology
Authors: Urs Fischer, Urs Fischer, Alex Brehm, Marc Ribo, Federica Rizzo, Daniel Strbian, Silja Räty, Juan F Arenillas, Mario Martínez-Galdámez, Steven D Hajdu, Patrik Michel, Jan Gralla, Eike I Piechowiak, Daniel P O Kaiser, Volker Puetz, Frans Van den Bergh, Sylvie De Raedt, Flavio Bellante, Anne Dusart, Victoria Hellstern, Ali Khanafer, Guillermo Parrilla, Ana Morales, Jan S Kirschke, Silke Wunderlich, Jens Fiehler, Götz Thomalla, Robin Lemmens, Jo P Peluso, Manuel Bolognese, Alexander von Hessling, Adriaan van Es, Nyika D Kruyt, Jonathan M Coutinho, Carlos Castaño, Jens Minnerup, Wim van Zwam, Elisabeth Dhondt, Christian H Nolte, Paolo Machi, Christian Loehr, Heinrich P Mattle, Jan-Hendrik Buhk, Johannes Kaesmacher, Tomas Dobrocky, Panagiotis Papanagiotou, Angelika Alonso, Markus Holtmannspoetter, Andrea Zini, Leonardo Renieri, Fee Keil, Ido van den Wijngaard, Georg Kägi, Mikel Terceño, Martin Wiesmann, Sergio Amaro, Isabel Fragata, Mira Katan, Ronen R Leker, Jeffrey L Saver, Julie Staals, Nikki Rommers, Luzia Balmer, Marios Psychogios, Marios Psychogios, Aad van der Lugt, Adriaan van Es, Aikaterini Anastasiou, Ainara Sanz Monllor, Åke Holmberg, Ala Jamous, Alejandro Rodriguez-Vazquez, Alejandro Tomassello, Alessandro Cianfoni, Alex Brehm, Alexander Salerno, Alexander Vanhoorne, Alexander von Hessling, Ali Khanafer, Alicia Sierra-Gómez, Alvaro Gracia-Tornel, Ana Isabel Calleja Sanz, Ana Morales Ortiz, Ana Paiva Nunes, Andrea Boghi, Andrea Naldi, Andrea Zini, Andreas Kastrup, Andreas Luft, Andreea Gottschalk, Angela H. Schmolling, Angelika Alonso, Anil Man Tuladhar, Anissa Ourtani, Anke Wouters, Anna Poggesi, Annahita Sedghi, Anne Sophie Desloovere, Anne van der Meij, Antonio Doncel-Moriano, Arianna Rustici, Arno Reich, Bart Emmer, Bas van der Kallen, Bastian Cheng, Benedetta Piccardi, Benedikt Kügelgen, Benjamin Wagner, Bernd Eckert, Bob Roozenbeek, Bruno Bartolini, Carla Ciobanu, Carlo Cereda, Carlos Gómez-Escalonilla, Carlos Pérez-García, Carmen-Alexandra Vieriu, Casjupea Knispel, Charles Majoie, Charlotte S. Weyland, Chiara Comelli, Christiaan van der Leij, Christian Commodaro, Christian Riedel, Christian Hartmann, Christian Loehr, Christian Maegerlein, Christian Nolte, Christian Roth, Christian Thaler, Christoph Globas, Christoph Groden, Christoph Riegler, Christophe Cognard, Claudia Hader, Claus Zimmer, Daniel Kaiser, Daniel Pielenz, Daniel Santana, Daniel Strbian, David Julian Seiffge, Davide Castellano, Davide Strambo, Denis Brisbois, Dennis Hedderich, Diana Aguiar Sousa, Diederik W.J. Dippel, Dimitri Hemelsoet, Donald Lobsien, Eckhard Schlemm, Eddie Kinsella-Perks, Eike Immo Piechowiak, Eilsabeth Dirren, Eleni Markomanolaki, Elias Auer, Elke Leinisch, Ellis S. van Etten, Elmar Lobsien, Elyas Ghariq, Emmanuel Carrera, Enrico Fainardi, Erno Peltola, Estefania Garcia Molina, Eva Neumaier-Probst, Fabian Flottmann, Fabio Capilli, Federica Rizzo, Fee Christiane Keil, Fenne Vandervorst, Flavio Bellante, Flavio Giordano, Florian Eff, Florian Peters, Francesco Capasso, Francesco Puccinelli, François Delvoye, Frans Van den Bergh, Franziska Lieschke, Frederick J.A. Meijer, Fréderick Van Gool, Friedericke Austein, Geert Lycklama a Nijeholt, Geert Vanhooren, Georg Kägi, Georgios Tsivgoulis, Gian Marco De Marchis, Gianluigi Guarnieri, Gianmarco Bernava, Giovanni Bianco, Giuseppe Leone, Gonzalo De Paco, Götz Thomalla, Grzegorz Marek Karwacki, Guillaume Marie, Guillaume Saliou, Guillaume Thevoz, Guillem Dolz, Guillermo Parrilla, Hajo Hund, Hamza Jubran, Hani Ridwan, Heinrich P. Mattle, Hendrik Lesch, Ida Rangus, Ido van den Wijngaard, Ilko Maier, Illario Tancredi, Ioannis Farah, Ioannis Tsogkas, Irina Dragancea, Isabel Fragata, Isabel Rodríguez, Isabel Vielba, Issa Metanis, Jan Gralla, Jan Kirschke, Jan Liman, Jan-Hendrik Buhk, Jan-Hendrik Schäfer, Janis Rauch, Jasper Martens, Jawid Madjidyar, Jeannette Hofmeijer, Jeffrey L. Saver, Jelle Demeestere, Jens Fiehler, Jens Minnerup, Jeremy Hofmeister, Jesse Marrannes, Jo Lansley, Jo P. Peluso, Joachim Klisch, João Pinho, Jochen Vehoff, Johan Ghekiere, Johan Wasselius, Johanna Härtl, Johanna Herget, Johannes C. Gerber, Johannes Kaesmacher, Jonathan Coutinho, Joost Kager, Jordi Blasco, Jörg B. Schulz, Jorge Galván, Jori Ruuskanen, Jose Díaz-Pérez, Jose E. Cohen, Juan Alvarez-Cienfuegos, Juan F. Arenillas, Julia Åivo, Julian Elias Heierle, Julie Staals, Jürgen Den Hollander, Justus Kleine, Ken Wong, Koenraad Nieboer, Krassen Nedeltchev, Kristina Szabo, Kristine Ann Blackham, Lars-Peder Pallesen, Laura Mannismäki, Laura Albert Lacal, Lawrence Bonne, Lehel-Barna Lakatos, Leonardo Renieri, Levan Makalanda, Lieselotte Vandewalle, Liisa Tomppo, Louise Maes, Luc Defreyne, Luca Remonda, Ludovico Ciolli, Luigi Simonetti, Luzia Balmer, Maarten Uyttenboogaart, Magretha M.Q. Robbe, Manuel Bolognese, Manuel Moreu Gamazo, Manuel Requena, Marc Ribo, Marc Rodrigo-Gispert, Marcel Arnold, Marco Pileggi, Maria Alexandrou, Maria Messe, Mariana Baptista, Mariano Werner, Marielle Ernst, Marina Martínez, Mário Alcatrão, Mario Martinez-Galdamez, Mario Muto, Marios Psychogios, Marios Psychogios, Marta Olive-Gadea, Martí Boix, Martijn Verdam, Martin Arndt, Martin Renz, Martin Schlösser, Martin Sterrenberg, Martin Wiesmann, David Marton Gyurko, Massimo Muto, Matias Sinisalo, Matteo Paolucci, Maud Eurlings, Mauro Gentile, Maximilian Rauch, Maximilian Schell, Mercedes de Lera, Michael Bartl, Michail Panagiotis Giannakakis, Michelle Simons, Miguel Schüller, Mikel Terceno, Miou Koopman, Mira Kata, Mohamed Elsharkawy, Nadinja Bouwmans, Nastassia Trachsel, Natalia Kurka, Natàlia Pérez de la Ossa, Nicola Limbucci, Nicolas Cavez, Nicolas Martinez-Majander, Nikki Rommers, Nikolaos Ntoulias, Noah Ayadi, Nyika Kruyt, Olivier Cornet, Olivier Francois, Olivier Vander Elst, Panagiotis Papanagiotou, Paolo Machi, Pasquale Mordasini, Patricia Simal, Patrick Samp, Patrik Michel, Paul Cernohorsky, Paul Stracke, Pauli Ylikotila, Pervinder Bhogal, Peter Sporns, Peter Vanacker, Peter Vanlangenhove, Philipp Erdmann, Philipp Gruber, Philippe Desfontaines, Pia Niederau, Pieter Jan van Doormaal, Reinoud Bokkers, Riitta Rautio, Rimpal Patoliya, Robin Lemmens, Robrecht R. Knapen, Ronen R. Leker, Rosa García-Sort, Rüdiger Hilker-Roggendorf, Rüdiger Lange, Saima Bashir, Salvatore Isceri, Sara Pilgram-Pastor, Sarah Vermeer, Sergio Amaro, Sherif Mohamed, Silja Räty, Silke Wunderlich, Sjoerd F.M. Jenniskens, Sofie Deblauwe, Sofie Haniotis, Sophie Pitersky, Stephanie Pflugi, Sterre Dassen, Steven Hajdu, Sylvie Antoine, Sylvie De Raedt, Tamara Dofferhoff-Vermeulen, Tamara Zeschky, Tamer Joubeh, Tatjana Wittenberg, Tatu Kokkonen, Teresa Ullberg, Till Illies, Tilman Schubert, Tim Friede, Timo Kahles, Tobias Boeckh-Behrens, Tobias Faizy, Tomas Dobrocky, Tomàs Xuclà, Urs Fischer, Urs Fischer, Veerle De Herdt, Victor Schulze-Zachau, Victoria Hellstern, Volker Pütz, Wilma Hörnell, Wim van Zwam, Wolfram Schwindt, Yoel Schwartzmann, Yolanda Silva, Zsolt Kulcsar
Institutions: University of Bern, University Hospital of Bern, University Hospital of Basel, Vall d'Hebron Hospital Universitari, University of Helsinki, Helsinki University Hospital, Universidad de Valladolid, Consejo Superior de Investigaciones Científicas, Instituto de Biomedicina y Genética Molecular de Valladolid, Hospital Clínico Universitario de Valladolid, Centre Hospitalier Universitaire Vaudois, University Hospital Carl Gustav Carus, Technische Universität Dresden, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Hôpital Civil de Charleroi, Kantonsspital St. Gallen, Klinikum Stuttgart, Hospital Universitario Virgen de la Arrixaca, TUM Klinikum, Technical University of Munich, University Medical Center Hamburg-Eppendorf, KU Leuven, Universitair Ziekenhuis Leuven, Luzerner Kantonsspital, Leiden University, Leiden University Medical Center, Amsterdam University Medical Centers, University of Amsterdam, Hospital Universitari Germans Trias i Pujol, University of Münster, University of Lübeck, Maastricht University Medical Centre, Ghent University Hospital, Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, University Hospital of Geneva, Klinikum Vest, Asklepios Klinik St. Georg, Asklepios, National and Kapodistrian University of Athens, Aretaeio Hospital, Klinikum Bremen-Mitte, Heidelberg University, University Medical Centre Mannheim, Nuremberg Hospital, Ospedale Maggiore Carlo Alberto Pizzardi, Istituto delle Scienze Neurologiche di Bologna, Azienda Ospedaliero-Universitaria Careggi, Goethe University Frankfurt, University Hospital Frankfurt, Medisch Centrum Haaglanden, Stichting Haaglanden Medisch Centrum, Hospital Universitari de Girona Doctor Josep Trueta, Universitätsklinikum Aachen, RWTH Aachen University, Hospital Clínic de Barcelona, Unidade Local de Saúde de São José, Hospital de São José, Hadassah Medical Center, University of California, Los Angeles
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $7,280
Funders: National Science Foundation, Pfizer, AstraZeneca, Biogen, Stryker, Medtronic, Penumbra, Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Universiteit Leiden, Universiteit van Amsterdam, Universiteit Maastricht, Universitair Ziekenhuis Gent, KU Leuven, Universität zu Lübeck, Universiteit Gent, Westfälische Wilhelms-Universität Münster, Leids Universitair Medisch Centrum, Gottfried und Julia Bangerter-Rhyner-Stiftung, Siemens Healthineers
Awards: Safety and efficacy of intra-arterial thrombolytics: A study on Tenecteplase for non-complete reperfusion of intracranial occlusions (TECNO), IntraCranial Atherosclerosis Related large-vessel occlusion treated with Urgent Stenting - the ICARUS trial, Mechanical thrombectomy for Medium Vessel Occlusion stroke – a pragmatic, multicentre, randomized trial with blinded outcome assessment (DISTAL)
OpenAlex ID: W7160443874