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Title: | Functional Outcome of Intravenous Thrombolysis in Patients With Lacunar Infarcts in the WAKE-UP Trial | Authors: | Barow, Ewgenia Boutitie, Florent Cheng, Bastian Cho, Tae-Hee Ebinger, Martin Endres, Matthias Fiebach, Jochen B. Fiehler, Jens Ford, Ian Galinovic, Ivana Nickel, Alina Puig, Josep Roy, Pascal Wouters, Anke Magnus, Tim Thijs, Vincent Lemmens, Robin Muir, Keith W. Nighoghossian, Norbert Pedraza, Salvador Simonsen, Claus Z. Gerloff, Christian Thomalla, Goetz Thomalla, Gotz Gerloff, Christian Golsari, Amir Alegiani, Anna Beck, Christoph Choe, Chi-un Voget, Dieke Hoppe, Julia Schroder, Julian Rozanski, Michal Nave, Alexander H. Wollboldt, Christian Galinovic, Ivana van Sloten, Isabelle Gohler, Jos Herm, Juliane Jungehulsing, Jan Luckl, Janos Krober, Jan M. Schurig, Johannes Koehler, Luzie Schlemm, Ludwig Knops, Michael Roennefarth, Maria Ipsen, Nils Harmel, Peter Bathe-Peters, Rouven Fleischmann, Robert Ganeshan, Ramanan Geran, Rohat Hellwig, Simon Schmidt, Sein Tutuncu, Serdar Krause, Thomas Gramse, Verena Rother, Joachim Michels, Peter Michalski, Dominik Pelz, Johann Schulz, Andreas Hobohm, Carsten Weise, Christopher Weise, Gesa Orthgiess, Johannes Pomrehn, Katrin Wegscheider, Mirko Mueller, Anne K. Hennerici, Michael Griebe, Martin Alonso, Angelika Filipov, Alexandra Marzina, Annika Anders, Bettina Bahr, Christian Hoyer, Carolin Schwarzbach, Christopher Weber, Claudia Hornberger, Eva Pledl, Hans-Werner Klockziem, Matti Stuermlinger, Markus Wittayer, Matthias Wolf, Marc Meyer, Nadja Eisele, Philipp Steinert, Susanne Sauer, Tamara Held, Valentin Ringleb, Peter Nagel, Simon Veltkamp, Roland Schwarting, Sonke Schwarz, Alexander Gumbinger, Christoph Hametner, Christian Amiri, Hemasse Purrucker, Jan Ciatipis, Mareva Menn, Oliver Mundiyanapurath, Sibu Schieber, Simon Kessler, Tobias Reiff, Tilman Panitz, Verena Singer, Oliver Foerch, Christian Lauer, Arne Manner, Anika Seiler, Alexander Guerzoglu, Damla Schafer, Jan H. Filipski, Katharina Lorenz, Matthias Kurka, Natalia Zeiner, Pia Pfeilschifter, Waltraud Dziewas, Rainer Minnerup, Jens Albiker, Christian Ritter, Martin Seidel, Matthias Dittrich, Ralf Kallmunzer, Bernd Bobinger, Tobias Madzar, Dominik Stark, David Sembill, Jochen Macha, Kosmas Winder, Klemens Breuer, Lorenz Koehrmann, Martin Spruegel, Maximilian Gerner, Stefan Moeller, Sebastian Kraft, Peter Mackenrodt, Daniel Kleinschnitz, Christoph Elhfnawy, Ahmed Heinen, Florian Gunreben, Ignaz Poli, Sven Ziemann, Ulf Gaenslen, Alexandra Schlak, Dennis Haertig, Florian Russo, Francesca Richter, Hardy Ebner, Matthias Ribitsch, Martin Wolf, Martin Weimar, Christian Zegarac, Vesna Chen, Hsin-Chieh Althaus, Katharina Neugebauer, Hermann Juttler, Eric Meier, Julia Stosser, Sebastian Puetz, Volker Bodechtel, Ulf Simonsen, Claus. Z. Ostergaard, Leif Moller, Anette Damgaard, Dorte Dupont, Kristina Hougaard Poulsen, Marika Hjort, Niels de Morales, Noelia Ruiz von Weitzel, Paul Harbo, Thomas Marstrand, Jacob Hansen, Andreas Christensen, Hanne Aegidius, Karen Jeppesen, Lise Meden, Per Rosenbaum, Sverre Iversen, Helle Back, Christina Hansen, Jakob Michelsen, Lene Truelsen, Thomas Modrau, Boris Kristensen, Bo Vestergaard, Karsten Oppel, Lorenz Lemmens, Robin Thijs, Vincent Wouters, Anke Swinnen, Bart Smets, Ide Demeestere, Jelle Dobbels, Laurens Brouns, Raf De Smedt, Ann DeKeyser, Jacques Yperzeele, Laetita Van Hooff, Robbert-Jan Peeters, Andre Dusart, Anne Etexberria, Ana Hanseeuw, Bernard London, Frederic Leempoel, Jonathan Hohenbichler, Katharina Younan, Nadia Maqueda, Vicky Laloux, Patrice De Coene, Beatrijs De Maeseneire, Charlotte Turine, Gaetane Vandermeeren, Yves DE KLIPPEL, Nina Willems, Chris de Hollander, Isabel SOORS, Peter Hermans, Sylvia Hemelsoet, Dimitri Desfontaines, Philippe Vanacker, Peter Rutgers, Matthieu Druart, Charlotte Paindeville, Perrine Peeters, Dirk Bruneel, Bart Vancaester, Evelien Vanhee, Frederik Meersman, Guy Bourgeois, Paul Vanderdonckt, Patrick Nighoghossian, Norbert Benoit, Amandine Derex, Laurent Mechthouff, Laura Berhoune, Nadia Ritzenthaler, Thomas Amarenco, Pierre Hobeanu, Cristina Gancedo, Elena Meseguer Calvet, David Ladoux, Alexandre Machet, Alexandre Lamy, Catherine Mellerio, Charles Oppenheim, Catherine Rodriguez-Regent, Christine Bodiguel, Eric Turc, Guillaume Birchenall, Julia Legrand, Laurence Morin, Ludovic Edjali-Goujon, Myriam Naggara, Oliver Raphaelle, Soulliard Godon-Hardy, Sylvie Domigo, Valerie Guiraud, Vincent Samson, Yues Leger, Anne Rosso, Charlotte Baronnet-Chauvet, Flore Crozier, Sophie Deltour, Sandrine Yger, Marion Sibon, Igor Renou, Pauline Sagnier, Sharmilla Zuber, Mathieu Tamazyan, Ruben Rodier, Gilles Morel, Nathalie Felix, Sandra Vadot, Wilfried Wolff, Valerie Aniculaesei, Adriana Yalo, Bertrand Bindila, Daniela Quenardelle, Veronique Blanc-Lasserre, Karine Landrault, Emmanuelle Breynaert, Ludovic Cakmak, Serkan Peysson, Stephane Viguier, Alain Lebely, Claire Raposo, Nicolas Vallet, Anne-Evelyne Vallet, Pauline Brugirard, Sebastian Muir, Keith W. Cheripelli, Bharath Kalladka, Dheeraj Moreton, Fiona Dani, Krishna El Tawil, Salwa Ramachandran, Sankaranarayanan Huang, Xuya Warburton, Elisabeth Evans, Nicholas Perry, Richard Patel, Bhavni Cloud, Geoffrey Pereira, Anthony Moynihan, Barry Lovelock, Caroline Choy, Lillian Khan, Usman Roffe, Christine Tyrell, Pippa Smith, Craig Dixit, Anand Louw, Stephen Broughton, David Shetty, Ashit Appleton, Jason Sprigg, Nikola Gutierrez, Salvador Pedraza Acosta, Boris Raul van Eendenburg, Cecile Alcantara, Josep Puig Leal, Joaquin Serena Rodrigo, Maria del Mar Castellanos Izaga, Mikel Terceno Guillamon, Olga Belchi Arenillas, Juan Calleja, Ana Cortijo, Elisa Mulero, Patricia de la Ossa, Natalia Perez Garrido, Alicia Martinez, Alicia Esperon, Carlos Garcia Guerrero, Cristina Carrera, David Vilas, Dolores Lopez-Cancio, Elena Palomeras, Ernest Lucente, Giuseppe Gomis, Meritxell Isern, Irina Becerra, Juan L. Vicente, Jose Hervas Sanchez, Josep Dorado, Laura Grau, Laia Ispierto, Lourdes Prats, Luis Almendrote, Miriam Hernandez, Maria Jimenez, Marta Sanchez, Manuel Lozano Torne, Monica Millan Presas, Silvia Ustrell, Xavier Pellise, Anna Navalpotro, Irene Luna, Alain Schonewille, Wouter Nederkoorn, Paul Majoie, Charles van den Berg, Lucie van den Berg, Sophie Zonneveld, Thomas Remmers, Michel Fazekas, Franz Pichler, Alexander Fandler, Simon Gattringer, Thomas Mutzenbach, Johannes Weber, Jorg Hofner, Elmar Kohlfurst, Heinz Weinstich, Karin Kellert, Lars Bayer-Karpinska, Anna Opherk, Christian Wollenweber, Frank Klein, Matthias Neumann-Haefelin, Tobias Pierskalla, Alexandra Harloff, Andreas Bardutzky, Jurgen Buggle, Florian von Schrader, Jorg Kollmar, Rainer Schill, Josef Lobbe, Anna-Mareike Moulin, Thierry Bouamra, Benjamin Bonnet, Louise Touze, Emmanuel Bonnet, Anne-Laure Touze, Emmanuel Cogez, Julien Li, Lin Guettier, Sophie Kar, Arindam Sivagnanaratham, Aravinth Geraghty, Olivia Bojaryn, Urszula Nallasivan, Arumugam Gonzales, Miguel Blanco Rodriguez-Yanez, Manuel Tembl, Jose Gorriz, David Oberndorfer, Stefan Prohaska, Elisabeth |
Issue Date: | 2019 | Publisher: | AMER MEDICAL ASSOC | Source: | JAMA NEUROLOGY, 76(6), p. 641-649 | Abstract: | IMPORTANCE The rationale for intravenous thrombolysis in patients with lacunar infarcts is debated, since it is hypothesized that the microvascular occlusion underlying lacunar infarcts might not be susceptible to pharmacological reperfusion treatment. OBJECTIVE To study the efficacy and safety of intravenous thrombolysis among patients with lacunar infarcts. DESIGN, SETTING, AND PARTICIPANTS This exploratory secondary post hoc analysis of the WAKE-UP trial included patients who were screened and enrolled between September 2012 and June 2017 (with final follow-up in September 2017). The WAKE-UP trial was a multicenter, double-blind, placebo-controlled randomized clinical trial to study the efficacy and safety of intravenous thrombolysis with alteplase in patients with an acute stroke of unknown onset time, guided by magnetic resonance imaging. All 503 patients randomized in the WAKE-UP trial were reviewed for lacunar infarcts. Diagnosis of lacunar infarcts was based on magnetic resonance imaging and made by consensus of 2 independent investigators blinded to clinical information. MAIN OUTCOMES AND MEASURES The primary efficacy variable was favorable outcome defined by a score of 0 to 1 on the modified Rankin Scale at 90 days after stroke, adjusted for age and severity of symptoms. RESULTS Of the 503 patients randomized in the WAKE-UP trial, 108 patients (including 74 men [68.5%]) had imaging-defined lacunar infarcts, whereas 395 patients (including 251 men [63.5%]) had nonlacunar infarcts. Patients with lacunar infarcts were younger than patients with nonlacunar infarcts (mean age [SD], 63 [12] years vs 66 [12] years; P=.003). Of patients with lacunar infarcts, 55 (50.9%) were assigned to treatment with alteplase and 53 (49.1%) to receive placebo. Treatment with alteplase was associated with higher odds of favorable outcome, with no heterogeneity of treatment outcome between lacunar and nonlacunar stroke subtypes. In patients with lacunar strokes, a favorable outcome was observed in 31 of 53 patients (59%) in the alteplase group compared with 24 of 52 patients (46%) in the placebo group (adjusted odds ratio [aOR], 1.67 [95% CI, 0.77-3.64]). There was 1 death and 1 symptomatic intracranial hemorrhage according to Safe Implementation of Thrombolysis in Stroke-Monitoring Study criteria in the alteplase group, while no death and no symptomatic intracranial hemorrhage occurred in the placebo group. The distribution of the modified Rankin Scale scores 90 days after stroke also showed a nonsignificant shift toward better outcomes in patients with lacunar infarcts treated with alteplase, with an adjusted common odds ratio of 1.94 (95% CI, 0.95-3.93). CONCLUSIONS AND RELEVANCE While the WAKE-UP trial was not powered to demonstrate the efficacy of treatment in subgroups of patients, the results indicate that the association of intravenous alteplase with functional outcome does not differ in patients with imaging-defined lacunar infarcts compared with those experiencing other stroke subtypes. | Notes: | [Barow, Ewgenia; Cheng, Bastian; Nickel, Alina; Magnus, Tim; Gerloff, Christian; Thomalla, Goetz; Thomalla, Gotz] Univ Med Ctr Hamburg Eppendorf, Klin & Poliklin Neurol, Kopf & Neurozentrum, Martinistr 52, D-20246 Hamburg, Germany. [Boutitie, Florent; Roy, Pascal] Hosp Civils Lyon, Serv Biostat, Lyon, France. [Boutitie, Florent] Univ Lyon 1, Villeurbanne, France. [Boutitie, Florent] CNRS, Unite Mixte Rech 5558, Lab Biometrie & Biol Evolut, Equipe Biostat Sante, Villeurbanne, France. [Cho, Tae-Hee; Nighoghossian, Norbert] Univ Claude Bernard Lyon 1, CNRS, Unite Mixte Rech 5220, Inst Natl Sci Appl,CREATIS,INSERM,U1206, Lyon, France. 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[Kar, Arindam; Sivagnanaratham, Aravinth; Geraghty, Olivia; Bojaryn, Urszula] Charing Cross Hosp London, London, England. [Nallasivan, Arumugam] Countess Chester Hosp, Chester, Cheshire, England. [Gonzales, Miguel Blanco; Rodriguez-Yanez, Manuel] Univ Santiago de Compostela, Hosp Clin Univ, Santiago, Spain. [Tembl, Jose; Gorriz, David] Hosp Univ & Politecn La Fe Valencia, Valencia, Spain. [Oberndorfer, Stefan; Prohaska, Elisabeth] Univ Klinikum St Polten, St Polten, Austria. | Document URI: | http://hdl.handle.net/1942/29063 | ISSN: | 2168-6149 | e-ISSN: | 2168-6157 | DOI: | 10.1001/jamaneurol.2019.0351 | ISI #: | 000474834200006 | Rights: | 2019 American Medical Association. All rights reserved. | Category: | A1 | Type: | Journal Contribution |
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