154345 20240222134207.0 10.1016/S0140-6736(20)32163-2 doi 0023-7507 ISSN 0099-5355 ISSN 0140-6736 ISSN 1474-547X ISSN altmetric:93901870 altmetric pmid:33176180 pmid DZNE-2021-00199 English 610 Thomalla, Götz 0 Intravenous alteplase for stroke with unknown time of onset guided by advanced imaging: systematic review and meta-analysis of individual patient data London [u.a.] 2020 Elsevier article DRIVER Output Types/Journal article DataCite Journal Article journal journal PUB:(DE-HGF)16 1708605671_31173 PUB:(DE-HGF) Review Article ARTICLE BibTeX JOURNAL_ARTICLE ORCID Journal Article 0 EndNote ISSN 0140-6736 not unique: **3 hits**. 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. 344 - Clinical and Health Care Research (POF3-344) G:(DE-HGF)POF3-344 POF3-344 POF III 0 Dataset connected to CrossRef, Journals: pub.dzne.de Boutitie, Florent 1 Ma, Henry 2 Koga, Masatoshi 3 Ringleb, Peter 4 Schwamm, Lee H 5 Wu, Ona 6 Bendszus, Martin 7 Bladin, Christopher F 8 Campbell, Bruce C V 9 Cheng, Bastian 10 Churilov, Leonid 11 Ebinger, Martin 12 Endres, Matthias P:(DE-2719)2811033 13 dzne Fiebach, Jochen B 14 Fukuda-Doi, Mayumi 15 Inoue, Manabu 16 Kleinig, Timothy J 17 Latour, Lawrence L 18 Lemmens, Robin 19 Levi, Christopher R 20 Leys, Didier P:(DE-HGF)0 21 Miwa, Kaori 22 Molina, Carlos A 23 Muir, Keith W 24 Nighoghossian, Norbert 25 Parsons, Mark W 26 Pedraza, Salvador 27 Schellinger, Peter D 28 Schwab, Stefan 29 Simonsen, Claus Z 30 Song, Shlee S 31 Thijs, Vincent 32 Toni, Danilo 33 Hsu, Chung Y 34 Wahlgren, Nils 35 Yamamoto, Haruko 36 Yassi, Nawaf 37 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W. 737 Zhao, H. 738 Zhao, L. 739 Althaus-Knaurer, Katharina 740 Bendszus, Martin 741 Berrouschot, Jörg 742 Bluhmki, Erich 743 Bovi, Paolo 744 Chatellier, Gilles 745 Cove, Lynda 746 Davis, Stephen 747 Dixit, A. 748 Donnan, Geoffrey 749 Dziewas, Rainer 750 Ehrenkrona, Christina 751 Eschenfelder, Christoph 752 Fatar, Marc 753 Francisco Arenillas, Juan 754 Gruber, Franz 755 Hacke, Werner 756 Kala, Lalit 757 Kapeller, Peter 758 Kaste, Markku 759 Kessler, Christof 760 Köhrmann, Martin 761 Laage, Rico 762 Lees, Kennedy R. 763 Luna Rodriguez, Alain 764 Mas, Jean-Louis 765 Mikulik, Robert 766 Molina, Carlos 767 Muddegowda, Girish 768 Muir, Keith 769 Niederkorn, Kurt 770 Nuñez, Xavier 771 Oppenheim, Catherine 772 Poli, Sven 773 Ringleb, Peter 774 Schellinger, Peter 775 Schwab, Stefan 776 Serena, Joaquin 777 Sobesky, Jan 778 Steiner, Thorsten 779 Svenson, Ann-Sofie 780 Toni, Danilo 781 Veltkamp, Roland 782 von Kummer, Rüdiger 783 Wahlgren, Nils 784 Wardlaw, Joanna 785 Betensky, Rebecca A. 786 Boulouis, Gregoire 787 Carandang, Raphael A. 788 Copen, William A. 789 Cougo, Pedro 790 Cutting, Shawna 791 Drake, Kendra 792 Ford, Andria L. 793 Hallenbeck, John 794 Harris, Gordon J. 795 Hoesch, Robert 796 Hsia, Amie 797 Kase, Carlos 798 Latour, Lawrence 799 Lauer, Arne 800 Lev, Michael H. 801 Muzikansky, Alona 802 Nagaraja, Nandakumar 803 Schwamm, Lee H. 804 Searls, Eric 805 Song, Shlee S. 806 Starkman, Sidney 807 Warach, Steven 808 Wu, Ona 809 Yoo, Albert J. 810 Zand, Ramin 811 10.1016/S0140-6736(20)32163-2 Vol. 396, no. 10262, p. 1574 - 1584 PERI:(DE-600)1476593-7 10262 1574 - 1584 The lancet <London> 396 2020 0140-6736 http://pub.dzne.de/record/154345/files/DZNE-2021-00199_Restricted.pdf http://pub.dzne.de/record/154345/files/DZNE-2021-00199_Restricted.pdf?subformat=pdfa pdfa VDB oai:pub.dzne.de:154345 Deutsches Zentrum für Neurodegenerative Erkrankungen I:(DE-588)1065079516 DZNE 13 P:(DE-2719)2811033 DE-HGF Gesundheit Erkrankungen des Nervensystems G:(DE-HGF)POF3-340 G:(DE-HGF)POF3-344 G:(DE-HGF)POF3 G:(DE-HGF)POF3-300 G:(DE-HGF)POF Clinical and Health Care Research 0 DE-HGF Programmungebundene Forschung ohne Programm G:(DE-HGF)POF4-890 G:(DE-HGF)POF4-899 G:(DE-HGF)POF4 G:(DE-HGF)POF4-800 G:(DE-HGF)POF ohne Topic 0 2020 DBCoverage StatID:(DE-HGF)0160 StatID Essential Science Indicators 2021-01-27 DBCoverage StatID:(DE-HGF)1190 StatID Biological Abstracts 2021-01-27 WoS StatID:(DE-HGF)0113 StatID Science Citation Index Expanded 2021-01-27 Nationallizenz StatID:(DE-HGF)0420 StatID 2022-11-17 ger DBCoverage StatID:(DE-HGF)0200 StatID SCOPUS 2022-11-17 DBCoverage StatID:(DE-HGF)0300 StatID Medline 2022-11-17 DBCoverage StatID:(DE-HGF)0199 StatID Clarivate Analytics Master Journal List 2022-11-17 DBCoverage StatID:(DE-HGF)0150 StatID Web of Science Core Collection 2022-11-17 DBCoverage StatID:(DE-HGF)1050 StatID BIOSIS Previews 2022-11-17 DBCoverage StatID:(DE-HGF)1110 StatID Current Contents - Clinical Medicine 2022-11-17 DBCoverage StatID:(DE-HGF)1030 StatID Current Contents - Life Sciences 2022-11-17 JCR StatID:(DE-HGF)0100 StatID LANCET : 2021 2022-11-17 DBCoverage StatID:(DE-HGF)0600 StatID Ebsco Academic Search 2022-11-17 Peer Review StatID:(DE-HGF)0030 StatID ASC 2022-11-17 IF >= 90 StatID:(DE-HGF)9990 StatID LANCET : 2021 2022-11-17 I:(DE-2719)1811005 AG Endres Interdisciplinary Dementia Research 0 journal VDB I:(DE-2719)1811005 UNRESTRICTED