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@ARTICLE{Thomalla:154345,
author = {Thomalla, Götz and Boutitie, Florent and Ma, Henry and
Koga, Masatoshi and Ringleb, Peter and Schwamm, Lee H and
Wu, Ona and Bendszus, Martin and Bladin, Christopher F and
Campbell, Bruce C V and Cheng, Bastian and Churilov, Leonid
and Ebinger, Martin and Endres, Matthias and Fiebach, Jochen
B and Fukuda-Doi, Mayumi and Inoue, Manabu and Kleinig,
Timothy J and Latour, Lawrence L and Lemmens, Robin and
Levi, Christopher R and Leys, Didier and Miwa, Kaori and
Molina, Carlos A and Muir, Keith W and Nighoghossian,
Norbert and Parsons, Mark W and Pedraza, Salvador and
Schellinger, Peter D and Schwab, Stefan and Simonsen, Claus
Z and Song, Shlee S and Thijs, Vincent and Toni, Danilo and
Hsu, Chung Y and Wahlgren, Nils and Yamamoto, Haruko and
Yassi, Nawaf and Yoshimura, Sohei and Warach, Steven and
Hacke, Werner and Toyoda, Kazunori and Donnan, Geoffrey A
and Davis, Stephen M and Gerloff, Christian and Acosta,
Boris Raul and Aegidius, Karen and Albiker, Christian and
Alegiani, Anna and Almendrote, Miriam and Alonso, Angelika
and Althaus, Katharina and Amarenco, Pierre and Amiri,
Hemasse and Anders, Bettina and Aniculaesei, Adriana and
Appleton, Jason and Arenillas, Juan and Back, Christina and
Bähr, Christian and Bardutzky, Jürgen and
Baronnet-Chauvet, Flore and Bathe-Peters, Rouven and
Bayer-Karpinska, Anna and Becerra, Juan L. and Beck,
Christoph and Belchí Guillamon, Olga and Benoit, Amandine
and Berhoune, Nadia and Bindila, Daniela and Birchenall,
Julia and Blanc-Lasserre, Karine and Blanco Gonzales, Miguel
and Bobinger, Tobias and Bodechtel, Ulf and Bodiguel, Eric
and Bojaryn, Urszula and Bonnet, Louise and Bouamra,
Benjamin and Bourgeois, Paul and Boutitie, Florent and
Breuer, Lorenz and Breynaert, Ludovic and Broughton, David
and Brouns, Raf and Brugirard, Sébastian and Bruneel, Bart
and Buggle, Florian and Cakmak, Serkan and Calleja, Ana and
Calvet, David and Carrera, David and Chen, Hsin-Chieh and
Cheng, Bastian and Cheripelli, Bharath and Cho, Tae-Hee and
Choe, Chi-un and Choy, Lillian and Christensen, Hanne and
Ciatipis, Mareva and Cloud, Geoffrey and Cogez, Julien and
Cortijo, Elisa and Crozier, Sophie and Damgaard, Dorte and
Dani, Krishna and De Coene, Beatrijs and De Hollander,
Isabel and De Keyser, Jacques and De Klippel, Nina and De
Maeseneire, Charlotte and De Smedt, Ann and del Mar
Castellanos Rodrigo, Maria and Deltour, Sandrine and
Demeestere, Jelle and Derex, Laurent and Desfontaines,
Philippe and Dittrich, Ralf and Dixit, Anand and Dobbels,
Laurens and Domigo, Valérie and Dorado, Laura and Druart,
Charlotte and Dupont, Kristina Hougaard and Dusart, Anne and
Dziewas, Rainer and Ebinger, Martin and Ebner, Matthias and
Edjali-Goujon, Myriam and Eisele, Philipp and El Tawil,
Salwa and Elhfnawy, Ahmed and Etexberria, Ana and Evans,
Nicholas and Fandler, Simon and Fazekas, Franz and Felix,
Sandra and Fiebach, Jochen B. and Fiehler, Jens and Filipov,
Alexandra and Filipski, Katharina and Fleischmann, Robert
and Foerch, Christian and Ford, Ian and Gaenslen, Alexandra
and Galinovic, Ivana and Gancedo, Elena Meseguer and
Ganeshan, Ramanan and García Esperón, Carlos and Garrido,
Alicia and Gattringer, Thomas and Geraghty, Olivia and
Geran, Rohat and Gerloff, Christian and Gerner, Stefan and
Godon-Hardy, Sylvie and Göhler, Jos and Golsari, Amir and
Gomis, Meritxell and Gorriz, David and Gramse, Verena and
Grau, Laia and Griebe, Martin and Guerrero, Cristina and
Guerzoglu, Damla and Guettier, Sophie and Guiraud, Vincent
and Gumbinger, Christoph and Gunreben, Ignaz and Haertig,
Florian and Hametner, Christian and Hanseeuw, Bernard and
Hansen, Andreas and Hansen, Jakob and Harbo, Thomas and
Harloff, Andreas and Harmel, Peter and Häusler, Karl Georg
and Heinen, Florian and Held, Valentin and Hellwig, Simon
and Hemelsoet, Dimitri and Hennerici, Michael and Herm,
Juliane and Hermans, Sylvia and Hernández, María and
Hervas Vicente, Jose and Hjort, Niels and Hobeanu, Cristina
and Hobohm, Carsten and Höfner, Elmar and Hohenbichler,
Katharina and Hommel, Marc and Hoppe, Julia and Hornberger,
Eva and Hoyer, Carolin and Huang, Xuya and Ipsen, Nils and
Isern, Irina and Ispierto, Lourdes and Iversen, Helle and
Jeppesen, Lise and Jimenez, Marta and Jungehülsing, Jan and
Jüttler, Eric and Kalladka, Dheeraj and Kallmünzer, Bernd
and Kar, Arindam and Kellert, Lars and Kemmling, André and
Kessler, Tobias and Khan, Usman and Klein, Matthias and
Kleinschnitz, Christoph and Klockziem, Matti and Knops,
Michael and Koehler, Luzie and Koehrmann, Martin and
Kohlfürst, Heinz and Kollmar, Rainer and Kraft, Peter and
Krause, Thomas and Kristensen, Bo and Kröber, Jan M. and
Kurka, Natalia and Ladoux, Alexandre and Laloux, Patrice and
Lamy, Catherine and Landrault, Emmanuelle and Lauer, Arne
and Lebely, Claire and Leempoel, Jonathan and Lees, Kennedy
and Leger, Anne and Legrand, Laurence and Lemmens, Robin and
Li, Lin and Löbbe, Anna-Mareike and London, Frederic and
Lopez-cancio, Elena and Lorenz, Matthias and Louw, Stephen
and Lovelock, Caroline and Lozano Sánchez, Manuel and
Lucente, Giuseppe and Lückl, Janos and Luna, Alain and
Macha, Kosmas and Machet, Alexandre and Mackenrodt, Daniel
and Madzar, Dominik and Majoie, Charles and Männer, Anika
and Maqueda, Vicky and Marstrand, Jacob and Martinez, Alicia
and Marzina, Annika and Mechthouff, Laura and Meden, Per and
Meersman, Guy and Meier, Julia and Mellerio, Charles and
Menn, Oliver and Meyer, Nadja and Michalski, Dominik and
Michels, Peter and Michelsen, Lene and Millán Torne, Monica
and Minnerup, Jens and Modrau, Boris and Moeller, Sebastian
and Møller, Anette and Morel, Nathalie and Moreton, Fiona
and Morin, Ludovic and Moulin, Thierry and Moynihan, Barry
and Mueller, Anne K. and Muir, Keith W. and Mulero, Patricia
and Mundiyanapurath, Sibu and Mutzenbach, Johannes and
Nagel, Simon and Naggara, Oliver and Nallasivan, Arumugam
and Navalpotro, Irene and Nave, Alexander H. and Nederkoorn,
Paul and Neeb, Lars and Neugebauer, Hermann and
Neumann-Haefelin, Tobias and Nighoghossian, Norbert and
Oberndorfer, Stefan and Opherk, Christian and Oppel, Lorenz
and Oppenheim, Catherine and Orthgieß, Johannes and
Ostergaard, Leif and Paindeville, Perrine and Palomeras,
Ernest and Panitz, Verena and Patel, Bhavni and Peeters,
Andre and Peeters, Dirk and Pellisé, Anna and Pelz, Johann
and Pereira, Anthony and Pérez de la Ossa, Natalia and
Perry, Richard and Petraza, Salvador and Peysson, Stéphane
and Pfeilschifter, Waltraud and Pichler, Alexander and
Pierskalla, Alexandra and Pledl, Hans-Werner and Poli, Sven
and Pomrehn, Katrin and Poulsen, Marika and Prats, Luis and
Presas, Silvia and Prohaska, Elisabeth and Puetz, Volker and
Puig, Josep and Puig Alcántara, Josep and Purrucker, Jan
and Quenardelle, Veronique and Ramachandran,
Sankaranarayanan and Raphaelle, Soulliard and Raposo,
Nicolas and Reiff, Tilman and Remmers, Michel and Renou,
Pauline and Ribitsch, Martin and Richter, Hardy and Ringleb,
Peter and Ritter, Martin and Ritzenthaler, Thomas and
Rodier, Gilles and Rodriguez-Regent, Christine and
Rodríguez-Yáñez, Manuel and Roennefarth, Maria and Roffe,
Christine and Rosenbaum, Sverre and Rosso, Charlotte and
Röther, Joachim and Rozanski, Michal and Ruiz de Morales,
Noelia and Russo, Francesca and Rutgers, Matthieu and
Sagnier, Sharmilla and Samson, Yves and Sánchez, Josep and
Sauer, Tamara and Schäfer, Jan H. and Schieber, Simon and
Schill, Josef and Schlak, Dennis and Schlemm, Ludwig and
Schmidt, Sein and Schonewille, Wouter and Schröder, Julian
and Schulz, Andreas and Schurig, Johannes and Schwarting,
Sönke and Schwarz, Alexander and Schwarzbach, Christopher
and Seidel, Matthias and Seiler, Alexander and Sembill,
Jochen and Serena Leal, Joaquin and Shetty, Ashit and Sibon,
Igor and Simonsen, Claus Z. and Singer, Oliver and
Sivagnanaratham, Aravinth and Smets, Ide and Smith, Craig
and Soors, Peter and Sprigg, Nikola and Spruegel, Maximilian
and Stark, David and Steinert, Susanne and Stösser,
Sebastian and Stuermlinger, Markus and Swinnen, Bart and
Tamazyan, Ruben and Tembl, Jose and Terceno Izaga, Mikel and
Thijs, Vincent and Thomalla, Götz and Touze, Emmanuel and
Truelsen, Thomas and Turc, Guillaume and Turine, Gaetane and
Tütüncü, Serdar and Tyrell, Pippa and Ustrell, Xavier and
Vadot, Wilfried and Vallet, Anne-Evelyne and Vallet, Pauline
and van den Berg, Lucie and van den Berg, Sophie and van
Eendenburg, Cecile and Van Hooff, Robbert-Jan and van
Sloten, Isabelle and Vanacker, Peter and Vancaester, Evelien
and Vanderdonckt, Patrick and Vandermeeren, Yves and Vanhee,
Frederik and Veltkamp, Roland and Vestergaard, Karsten and
Viguier, Alain and Vilas, Dolores and Villringer, Kersten
and Voget, Dieke and von Schrader, Jörg and von Weitzel,
Paul and Warburton, Elisabeth and Weber, Claudia and Weber,
Jörg and Wegscheider, Karl and Wegscheider, Mirko and
Weimar, Christian and Weinstich, Karin and Weise,
Christopher and Weise, Gesa and Willems, Chris and Winder,
Klemens and Wittayer, Matthias and Wolf, Marc and Wolf,
Martin and Wolff, Valerie and Wollboldt, Christian and
Wollenweber, Frank and Wouters, Anke and Yalo, Bertrand and
Yger, Marion and Younan, Nadia and Yperzeele, Laetita and
Zegarac, Vesna and Zeiner, Pia and Ziemann, Ulf and
Zonneveld, Thomas and Zuber, Mathieu and Akutsu, Tsugio and
Aoki, Junya and Aoki, Junya and Arakawa, Shuji and Doijiri,
Ryosuke and Egashira, Yusuke and Enomoto, Yukiko and
Fukuda-Doi, Mayumi and Furui, Eisuke and Furuta, Konosuke
and Gotoh, Seiji and Hamasaki, Toshimitsu and Hasegawa,
Yasuhiro and Hirano, Teryuki and Homma, Kazunari and
Ichijyo, Masahiko and Ide, Toshihiro and Igarashi, Shuichi
and Iguchi, Yasuyuki and Ihara, Masafumi and Ikenouchi,
Hajime and Inoue, Manabu and Inoue, Tsuyoshi and Itabashi,
Ryo and Ito, Yasuhiro and Iwama, Toru and Kamiyama, Kenji
and Kamiyoshi, Shoko and Kanai, Haruka and Kanematsu,
Yasuhisa and Kanzawa, Takao and Kimura, Kazumi and Kitayama,
Jiro and Kitazono, Takanari and Koga, Masatoshi and Kondo,
Rei and Kudo, Kohsuke and Kusumi, Masayoshi and Kuwahara,
Ken and Matsumoto, Shoji and Matsuoka, Hideki and Mihara,
Ban and Minematsu, Kazuo and Miura, Ken and Miwa, Kaori and
Morita, Naomi and Mouri, Wataru and Murata, Kayo and
Nagakane, Yoshinari and Nakase, Taizen and Ohara, Hiromi and
Ohara, Nobuyuki and Ohnishi, Hideyuki and Ohta, Hajime and
Ohtaki, Masafumi and Ohtani, Ryo and Ohtsuki, Toshiho and
Ohyama, Hideo and Okada, Takashi and Okada, Yasushi and
Osaki, Masato and Sakai, Nobuyuki and Sanbongi, Yoshiki and
Sasaki, Naoshi and Sasaki, Makoto and Sato, Shoichiro and
Seki, Kenta and Shimizu, Wataru and Shiokawa, Yoshiaki and
Sozu, Takashi and Suzuki, Junichiro and Suzuki, Rieko and
Takagi, Yasushi and Takizawa, Shunya and Tanahashi, Norio
and Tanaka, Eijiro and Tanaka, Ryota and Tateishi, Yohei and
Terada, Tomoaki and Terasaki, Tadashi and Todo, Kenichi and
Tokunaga, Azusa and Toyoda, Kazunori and Tsujino, Akira and
Ueda, Toshihiro and Uesaka, Yoshikazu and Uotani, Mihoko and
Urabe, Takao and Watanabe, Masao and Yagita, Yoshiki and
Yakushiji, Yusuke and Yamamoto, Haruko and Yasui, Keizo and
Yonehara, Toshiro and Yoshimura, Sohei and Yoshimura,
Shinichi and Aarnio, K. and Alemseged, F. and Anderson, C.
and Ang, T. and Archer, M. L. and Attia, J. and Bailey, P.
and Balabanski, A. and Barber, A. and Barber, P. A. and
Bernhardt, J. and Bivard, A. and Blacker, D. and Bladin, C.
F. and Brodtmann, A. and Cadilhac, D. and Campbell, B. C. V.
and Carey, L. and Celestino, S. and Chan, L. and Chang, W.
H. and ChangI, A. and Chen, C. H. and Chen, C.-I. and Chen,
H. F. and Chen, T. C. and Chen, W. H. and Chen, Y. Y. and
Cheng, C. A. and Cheong, E. and Chiou, Y. W. and Choi, P. M.
and Chu, H. J. and Chuang, C. S. and Chung, T. C. and
Churilov, L. and Clissold, B. and Connelly, A. and Coote, S.
and Coulton, B. and Cowley, E. and Cranefield, J. and
Curtze, S. and D'Este, C. and Davis, S. M. and Day, S. and
Desmond, P. M. and Dewey, H. M. and Ding, C. and Donnan, G.
A. and Drew, R. and Eirola, S. and Field, D. and Frost, T.
and Garcia-Esperon, C. and George, K. and Gerraty, R. and
Grimley, R. and Guo, Y. C. and Hankey, G. and Harvey, J. and
Ho, S. C. and Hogan, K. and Howells, D. and Hsiao, P. M. and
Hsu, C. H. and Hsu, C. T. and Hsu, C.-S. and Hsu, J. P. and
Hsu, Y. D. and Hsu, Y. T. and Hu, C. J. and Huang, C. C. and
Huang, H. Y. and Huang, M. Y. and Huang, S. C. and Huang, W.
S. and Jackson, D. and Jeng, J. S. and Jiang, S. K. and
Kaauwai, L. and Kasari, O. and King, J. and Kleinig, T. J.
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and Kung, W. L. and Kyndt, C. and Lau, C. L. and Lee, A. and
Lee, C. Y. and Lee, J. T. and Lee, Y. and Lee, Y. C. and
Levi, C. and Levi, C. R. and Lien, L. M. and Lim, J. C. and
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and Mitchell, P. J. and Miteff, F. and Moore, A. and Muller,
C. and Ng, F. and Ng, F. C. and Ng, J-L. and O'Brian, W. and
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S. and Peng, G. S. and Pesavento, L. and Phan, T. and
Rodrigues, E. and Ross, Z. and Sabet, A. and Sallaberger, M.
and Salvaris, P. and Shah, D. and Sharma, G. and Sibolt, G.
and Simpson, M. and Singhal, S. and Snow, B. and Spratt, N.
and Stark, R. and Sturm, J. and Sun, M. C. and Sun, Y. and
Sung, P. S. and Sung, Y. F. and Suzuki, M. and Tan, M. and
Tang, S. C. and Tatlisumak, T. and Thijs, V. and Tiainen, M.
and Tsai, C. H. and Tsai, C. K. and Tsai, C. L. and Tsai, H.
T. and Tsai, L. K. and Tseng, C. H. and Tseng, L. T. and
Tsoleridis, J. and Tu, H. and Tu, H. T-H. and Vallat, W. and
Virta, J. and Wang, W. C. and Wang, Y. T. and Waters, M. and
Weir, L. and Wijeratne, T. and Williams, C. and Wilson, W.
and Wong, A. A. and Wong, K. and Wu, T. Y. and Wu, Y. H. and
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Yeh, H. L. and Yeh, J. H. and Yeh, S. J. and Yen, C. H. and
Young, D. and Ysai, C. L. and Zhang, W. W. and Zhao, H. and
Zhao, L. and Althaus-Knaurer, Katharina and Bendszus, Martin
and Berrouschot, Jörg and Bluhmki, Erich and Bovi, Paolo
and Chatellier, Gilles and Cove, Lynda and Davis, Stephen
and Dixit, A. and Donnan, Geoffrey and Dziewas, Rainer and
Ehrenkrona, Christina and Eschenfelder, Christoph and Fatar,
Marc and Francisco Arenillas, Juan and Gruber, Franz and
Hacke, Werner and Kala, Lalit and Kapeller, Peter and Kaste,
Markku and Kessler, Christof and Köhrmann, Martin and
Laage, Rico and Lees, Kennedy R. and Luna Rodriguez, Alain
and Mas, Jean-Louis and Mikulik, Robert and Molina, Carlos
and Muddegowda, Girish and Muir, Keith and Niederkorn, Kurt
and Nuñez, Xavier and Oppenheim, Catherine and Poli, Sven
and Ringleb, Peter and Schellinger, Peter and Schwab, Stefan
and Serena, Joaquin and Sobesky, Jan and Steiner, Thorsten
and Svenson, Ann-Sofie and Toni, Danilo and Veltkamp, Roland
and von Kummer, Rüdiger and Wahlgren, Nils and Wardlaw,
Joanna and Betensky, Rebecca A. and Boulouis, Gregoire and
Carandang, Raphael A. and Copen, William A. and Cougo, Pedro
and Cutting, Shawna and Drake, Kendra and Ford, Andria L.
and Hallenbeck, John and Harris, Gordon J. and Hoesch,
Robert and Hsia, Amie and Kase, Carlos and Latour, Lawrence
and Lauer, Arne and Lev, Michael H. and Muzikansky, Alona
and Nagaraja, Nandakumar and Schwamm, Lee H. and Searls,
Eric and Song, Shlee S. and Starkman, Sidney and Warach,
Steven and Wu, Ona and Yoo, Albert J. and Zand, Ramin},
title = {{I}ntravenous alteplase for stroke with unknown time of
onset guided by advanced imaging: systematic review and
meta-analysis of individual patient data},
journal = {The lancet},
volume = {396},
number = {10262},
issn = {0140-6736},
address = {London [u.a.]},
publisher = {Elsevier},
reportid = {DZNE-2021-00199},
pages = {1574 - 1584},
year = {2020},
note = {ISSN 0140-6736 not unique: **3 hits**.},
abstract = {BackgroundPatients who have had a stroke with unknown time
of onset have been previously excluded from thrombolysis. We
aimed to establish whether intravenous alteplase is safe and
effective in such patients when salvageable tissue has been
identified with imaging biomarkers.MethodsWe did a
systematic review and meta-analysis of individual patient
data for trials published before Sept 21, 2020. Randomised
trials of intravenous alteplase versus standard of care or
placebo in adults with stroke with unknown time of onset
with perfusion-diffusion MRI, perfusion CT, or MRI with
diffusion weighted imaging-fluid attenuated inversion
recovery (DWI-FLAIR) mismatch were eligible. The primary
outcome was favourable functional outcome (score of 0–1 on
the modified Rankin Scale [mRS]) at 90 days indicating no
disability using an unconditional mixed-effect
logistic-regression model fitted to estimate the treatment
effect. Secondary outcomes were mRS shift towards a better
functional outcome and independent outcome (mRS 0–2) at 90
days. Safety outcomes included death, severe disability or
death (mRS score 4–6), and symptomatic intracranial
haemorrhage. This study is registered with PROSPERO,
CRD42020166903.FindingsOf 249 identified abstracts, four
trials met our eligibility criteria for inclusion: WAKE-UP,
EXTEND, THAWS, and ECASS-4. The four trials provided
individual patient data for 843 individuals, of whom 429
$(51\%)$ were assigned to alteplase and 414 $(49\%)$ to
placebo or standard care. A favourable outcome occurred in
199 $(47\%)$ of 420 patients with alteplase and in 160
$(39\%)$ of 409 patients among controls (adjusted odds ratio
[OR] 1·49 $[95\%$ CI 1·10–2·03]; p=0·011), with low
heterogeneity across studies $(I2=27\%).$ Alteplase was
associated with a significant shift towards better
functional outcome (adjusted common OR 1·38 $[95\%$ CI
1·05–1·80]; p=0·019), and a higher odds of independent
outcome (adjusted OR 1·50 [1·06–2·12]; p=0·022). In
the alteplase group, 90 $(21\%)$ patients were severely
disabled or died (mRS score 4–6), compared with 102
$(25\%)$ patients in the control group (adjusted OR 0·76
[0·52–1·11]; p=0·15). 27 $(6\%)$ patients died in the
alteplase group and 14 $(3\%)$ patients died among controls
(adjusted OR 2·06 [1·03–4·09]; p=0·040). The
prevalence of symptomatic intracranial haemorrhage was
higher in the alteplase group than among controls (11
$[3\%]$ vs two $[<1\%],$ adjusted OR 5·58 [1·22–25·50];
p=0·024).InterpretationIn patients who have had a stroke
with unknown time of onset with a DWI-FLAIR or perfusion
mismatch, intravenous alteplase resulted in better
functional outcome at 90 days than placebo or standard care.
A net benefit was observed for all functional outcomes
despite an increased risk of symptomatic intracranial
haemorrhage. Although there were more deaths with alteplase
than placebo, there were fewer cases of severe disability or
death.},
subtyp = {Review Article},
cin = {AG Endres},
ddc = {610},
cid = {I:(DE-2719)1811005},
pnm = {344 - Clinical and Health Care Research (POF3-344)},
pid = {G:(DE-HGF)POF3-344},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:33176180},
doi = {10.1016/S0140-6736(20)32163-2},
url = {https://pub.dzne.de/record/154345},
}
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