The impact of the DWI-FLAIR-mismatch in the ECASS-4 trial - A post hoc analysis.

Autor:	Pfaff JA; Heidelberg University Hospital, Department of Neuroradiology, Heidelberg, Germany., Bendszus M; Heidelberg University Hospital, Department of Neuroradiology, Heidelberg, Germany., Donnan G; National Stroke Research Institute, Neurosciences Bldg, Heidelberg Heights, Australia., Molina C; Hospital Universitari Vall d'Hebron, Department of Neurosciences, Barcelona, Spain., Leys D; Hopital Roger Salengro, Service de neurologie et pathologie neurovasculaire, Lille Cedex, France., Schellinger PD; University Hospital Erlangen, Department of Neurology, Erlangen, Germany., Schwab S; Hospital Policlinico Umberto I, Emergency Department Stroke Unit, Rome, Italy., Toni D; Karolinska Institutet, Department of Clinical Neurosciences, Stockholm, Sweden., Wahlgren N; Karolinska Institutet, Department of Clinical Neurosciences, Stockholm, Sweden., Hacke W; Heidelberg University Hospital, Department of Neurology, Heidelberg, Germany., Ringleb PA; Heidelberg University Hospital, Department of Neurology, Heidelberg, Germany.
Jazyk:	angličtina
Zdroj:	European stroke journal [Eur Stroke J] 2020 Dec; Vol. 5 (4), pp. 370-373. Date of Electronic Publication: 2020 Apr 23.
DOI:	10.1177/2396987320920114
Abstrakt:	Introduction: To investigate the impact of a mismatch between diffusion-weighted imaging (DWI) and fluid attenuated inversion recovery (FLAIR) on functional outcome in patients with acute stroke in a prolonged time window or unknown time of symptom onset randomized to intravenous thrombolysis or placebo. Patients and Methods: We performed a post-hoc analysis of the European Cooperative Acute Stroke Study-4 (ECASS-4) trial. ECASS-4 was an investigator driven, phase 3, multi-center, double-blind, placebo-controlled study which randomized ischemic stroke patients presenting within 4.5 and 9h of stroke onset or unknown time-window to either rt-PA or placebo after MR-imaging. Two subgroups "no mismatch" (nMM) and "any mismatch" (aMM) were created by applying a DWI-FLAIR-mismatch criterion. We calculated frequency of nMM and aMM and performed a univariate analysis (Fisher's Test) for excellent clinical outcome (mRS 0-1) and mortality (mRS=6). Results: MR-Imaging of n=111/119 (93.2%) patients was suitable for this analysis. DWI-FLAIR mismatch was found in 49 patients (44.1%). Proportions of mismatch nMM and aMM were comparable in treatment-groups (aMM: Placebo 46.3%, Alteplase 42.1%; p=0.70). Patients with nMM showed no benefit of rt-PA-treatment (OR (95%CI) mRS 0-1: 0.95 (0.29-3.17)). Patients with aMM showed a point estimate of the odds ratio in favour of a treatment benefit of rt-PA (mRS 0-1: OR (95%CI) 2.62 (0.68-11.1)). Mortality within 90 days was not different in patients treated with rt-PA if nMM (15.2%) or aMM (12.5%) was present. Discussion: In this analysis no significant evidence, but subtle indication towards patients treated with rt-PA in a prolonged time window reaching an excellent clinical outcome if a DWI-FLAIR-mismatch is present on initial stroke MR-imaging. Conclusion: A DWI-FLAIR mismatch in the region of ischemia as imaging based surrogate parameter for patient selection for i.v. rt-PA should be strongly pursued. Competing Interests: Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The sponsor of the trial (ECASS-4: ExTEND) is the University Hospital Heidelberg. Monitoring was done by Trial Form Support International, Sweden. (© European Stroke Organisation 2020.)
Databáze:	MEDLINE
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