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Persistent Target Mismatch Profile >24 Hours After Stroke Onset in DEFUSE 3.

ABSTRACT: Background and Purpose- Efficacy of endovascular thrombectomy has been demonstrated up to 24 hours after stroke onset in patients selected with perfusion imaging. We hypothesized that a persistent favorable perfusion profile exists in some patients beyond 24 hours from the onset and can be predicted by a lower baseline hypoperfusion intensity ratio, which indicates favorable collaterals. Methods- We identified control arm patients from the DEFUSE 3 trial (The Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke) with a diffusion weighted imaging and perfusion magnetic resonance imaging performed 24 hours following randomization and compared imaging and clinical variables between patients with persistent mismatch versus patients who no longer had a mismatch 24 hours after randomization. Results- Eighteen percent of the control arm patients had a persistent favorable profile >38 hours after last known well time. These patients had similar baseline diffusion weighted imaging and Tmax >6 seconds volumes as patients whose initially favorable perfusion profile became unfavorable (diffusion weighted imaging lesion 7 versus 17 mL; P=0.17, Tmax >6 seconds 98 versus 100 mL; P=0.48) yet experienced less infarct growth (15 versus 59 mL; P<0.001) and had 3-fold smaller infarct volumes (15 versus 59 mL; P<0.001) 24 hours after randomization. Patients with a persistent favorable perfusion profile had a significantly lower hypoperfusion intensity ratio on baseline imaging (0.2 versus 0.4; P<0.01). Favorable clinical outcome at 90 days occurred in only 10% of the persistent mismatch patients. Conclusions- About 20% of patients with a middle cerebral artery or internal carotid artery occlusion who present in an extended time window and are not treated with thrombectomy have a persistent mismatch for at least an additional 24 hours. These patients have a favorable hypoperfusion intensity ratio at presentation, may experience delayed infarct expansion, and have poor clinical outcomes. Clinical trials are needed to determine if patients with a favorable perfusion profile benefit from reperfusion beyond 24 hours. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT02586415.

SUBMITTER: Christensen S

PROVIDER: S-EPMC9230534 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Persistent Target Mismatch Profile >24 Hours After Stroke Onset in DEFUSE 3.

Christensen Søren S Mlynash Michael M Kemp Stephanie S Yennu Amarnath A Heit Jeremy J JJ Marks Michael P MP Lansberg Maarten G MG Albers Gregory W GW

Stroke 20190301 3

Background and Purpose- Efficacy of endovascular thrombectomy has been demonstrated up to 24 hours after stroke onset in patients selected with perfusion imaging. We hypothesized that a persistent favorable perfusion profile exists in some patients beyond 24 hours from the onset and can be predicted by a lower baseline hypoperfusion intensity ratio, which indicates favorable collaterals. Methods- We identified control arm patients from the DEFUSE 3 trial (The Endovascular Therapy Following Imagi ...[more]

PMID: 30735466

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Project description:BACKGROUND:In acute ischemic stroke, blood pressure (BP) tends to rise initially and fall to a baseline level within 24-48 hours. Previous studies reported several different effects of BPs during acute ischemic stroke on clinical outcomes, which was partly due to the different time intervals from stroke onset to BP measurement. METHODS:All patients with acute ischemic stroke (onset ≤3 hours) who lived independently before the stroke, were consecutively enrolled for a 62-month period. BPs at 0, 12, and 24 hours after admission were collected. A favorable outcome was defined as a modified Rankin Scale (mRS) score 0-2 at discharge. For different standards of BP management, patients were grouped and analyzed according to intravenous (IV) tissue plasminogen activator (tPA) treatment and favorable outcome. RESULTS:Among the 446 enrolled patients, 227 patients underwent IV tPA treatment and 216 had mRS score 0-2 at discharge. Patients with favorable outcomes had lower initial NIH Stroke Scale (NIHSS) scores, less frequent progressive neurological deficits, and lower systolic BP (SBP) 12 and 24 hours after admission than patients with unfavorable outcomes, regardless of whether they underwent tPA treatment or not (p <0.05). The BP decreased over a period of 24 hours after admission. In logistic regression analysis, the independent variables associated with favorable outcome were the initial NIHSS score, a progressive neurological deficit, a previous stroke, and the SBP 24 hours after admission in the patients who underwent tPA treatment and the initial NIHSS score and a progressive neurological deficit in the patients who did not undergo tPA treatment (p <0.05). CONCLUSIONS:The SBPs at 12 and 24 hours after admission were lower in acute stroke patients with favorable outcomes than in the other patients, regardless of whether the patients underwent tPA therapy and the SBP at 24 hours was an independent predictor of favorable outcomes among the patients who underwent tPA treatment.

Project description:BackgroundThe mismatch between diffusion weighted imaging (DWI) lesion and perfusion imaging (PI) deficit volumes has been used as a surrogate of ischemic penumbra. This pathophysiology-orientated patient selection criterion for acute stroke treatment may have the potential to replace a fixed time window. Two recent trials - DEFUSE and EPITHET - investigated the mismatch concept in a multicenter prospective approach. Both studies randomized highly selected patients (n = 74/n = 100) and therefore confirmation in a large consecutive cohort is desirable. We here present a single-center approach with a 3T MR tomograph next door to the stroke unit, serving as a bridge from the ER to the stroke unit to screen all TIA and stroke patients. Our primary hypothesis is that the prognostic value of the mismatch concept is depending on the vessel status. Primary endpoint of the study is infarct growth determined by imaging, secondary endpoints are neurological deficit on day 5-7 and functional outcome after 3 months.Methods and design1000Plus is a prospective, single centre observational study with 1200 patients to be recruited. All patients admitted to the ER with the clinical diagnosis of an acute cerebrovascular event within 24 hours after symptom onset are screened. Examinations are performed on day 1, 2 and 5-7 with neurological examination including National Institute of Health Stroke Scale (NIHSS) scoring and stroke MRI including T2*, DWI, TOF-MRA, FLAIR and PI. PI is conducted as dynamic susceptibility-enhanced contrast imaging with a fixed dosage of 5 ml 1 M Gadobutrol. For post-processing of PI, mean transit time (MTT) parametric images are determined by deconvolution of the arterial input function (AIF) which is automatically identified. Lesion volumes and mismatch are measured and calculated by using the perfusion mismatch analyzer (PMA) software from ASIST-Japan. Primary endpoint is the change of infarct size between baseline examination and day 5-7 follow up.DiscussionsThe aim of this study is to describe the incidence of mismatch and the predictive value of PI for final lesion size and functional outcome depending on delay of imaging and vascular recanalization. It is crucial to standardize PI for future randomized clinical trials as for individual therapeutic decisions and we expect to contribute to this challenging task.Trial registrationclinicaltrials.gov NCT00715533.

Project description:BackgroundThe performance of intravenous tenecteplase in patients who had an acute ischaemic stroke with large/medium vessel occlusion or severe stenosis in an extended time window remains unknown. We investigated the promise of efficacy and safety of different doses of tenecteplase manufactured in China, in patients who had an acute ischaemic stroke with large/medium vessel occlusion beyond 4.5-hour time window.MethodsThe CHinese Acute tissue-Based imaging selection for Lysis In Stroke-Tenecteplase was an investigator-initiated, umbrella phase IIa, open-label, blinded-endpoint, Simon's two-stage randomised clinical trial in 13 centres across mainland China. Participants who had salvageable brain tissue on automated perfusion imaging and presented within 4.5-24 hours from time of last seen well were randomised to receive 0.25 mg/kg tenecteplase or 0.32 mg/kg tenecteplase, both with a bolus infusion over 5-10 s. The primary outcome was proportion of patients with promise of efficacy and safety defined as reaching major reperfusion without symptomatic intracranial haemorrhage at 24-48 hours after thrombolysis. Assessors were blinded to treatment allocation. All participants who received tenecteplase were included in the analysis.ResultsA total of 86 patients who had an acute ischaemic stroke identified with anterior large/medium vessel occlusion or severe stenosis were included in this study from November 2019 to December 2021. All of the 86 patients enrolled either received 0.25 mg/kg (n=43) or 0.32 mg/kg (n=43) tenecteplase, and were available for primary outcome analysis. Fourteen out of 43 patients in the 0.25 mg/kg tenecteplase group and 10 out of 43 patients in the 0.32 mg/kg tenecteplase group reached the primary outcome, providing promise of efficacy and safety for both doses based on Simon's two-stage design.DiscussionAmong patients with anterior large/medium vessel occlusion and significant penumbral mismatch presented within 4.5-24 hours from time of last seen well, tenecteplase 0.25 mg/kg and 0.32 mg/kg both provided sufficient promise of efficacy and safety.Trial registration numberClinicalTrials.gov Registry (NCT04086147, https://clinicaltrials.gov/ct2/show/NCT04086147).

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Persistent Target Mismatch Profile >24 Hours After Stroke Onset in DEFUSE 3.

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Persistent Target Mismatch Profile >24 Hours After Stroke Onset in DEFUSE 3.

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