Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial

医学改良兰金量表冲程（发动机）中期分析人口随机对照试验临床试验血管内治疗缺血性中风内科学外科缺血缺血性中风动脉瘤环境卫生机械工程工程类

作者

Martin Bendszus,Jens Fiehler,Fabien Subtil,Susanne Bonekamp,Anne Hege Aamodt,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 Gellißen,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 Ringleb,Maximilian Schell,Eckhard Schlemm,Silvia Schönenberger,Bjørn Tennøe,Christian Ulfert,Kateřina Vališ,Eva Vítková,Dominik F. Vollherbst,Wolfgang Wick,Götz Thomalla,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 Argren,Anne Assmann,Michael Augustin,E 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 O. 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‐Fernández,Elena de Celis,Emmanuel Chabert,Daniel Charissé,Bastian Cheng,Vendelı́n 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 Forbig,Christian Förch,Annette Fromm,Blanca Fuentes,Ines Gaedke,Romana Galczak,Malik Galijašević,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 Grams,Joachim Gruber,Katharina Gruber,Thomas Günthner‐Lengsfeld,Kathrin Haase,Floriana Hacker-Ivan,Erika Hallerstig,Uta Hanning,Jozef Haring,Michal Haršány,Ján Haršány,Christian Hartmann,Eva Hassler,Kristina Hauptmann,Karl Georg Häusler,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 Janjic,Kirsten Jaramillo,Angela 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 Kefalaykos,Fee Keil,Lars Kellert,Christoph Kellinghaus,Roxane‐Isabelle Kestner,Stefan Kiechl,Monika Killer‐Oberpfalzer,Andrej Klepanec,Casjupea Knispel,Michael Knoflach,Sabine Köhler,Konstantin Kohlhase,Alexander M. 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 Marques,David Matyáš,Gerald 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 Möhlenbruch,Alexander Mohr,Christoph Mönninghoff,Tobias Moser,Ramona 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,Sarah C. Reitz,Ondřej Renc,Jasmin Retzlaff,Ricardo Rigual,Peter 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,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,Claus Z. Simonsen,Maria Theresa 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,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,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,Cyrill Weyland,Friedrich Weymayr,Ulrike Wießpeiner,Johannes Willeit,Aymeric Wittwer,Frank A. Wollenweber,Ginette Wortmann,Silke Wunderlich,Yanyan Xiong,Se-Jong You,Lasse ZachoSpeiser,Kamil Zeleňák,Jana Zeleňáková,Seraphine Zubel

出处

期刊：The Lancet [Elsevier]
日期：2023-10-11 卷期号：402 (10414): 1753-1763 被引量：151

链接

nih.govdoi.org

标识

DOI：10.1016/s0140-6736(23)02032-9

摘要

Summary

Background

Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice.

Methods

In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3–5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with ClinicalTrials.gov, NCT03094715.

Findings

From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2·58 [95% CI 1·60–4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46–0·98]; p=0·038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone.

Interpretation

Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection.

Funding

EU Horizon 2020.

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