scholarly journals MR CLEAN-LATE, a multicenter randomized clinical trial of endovascular treatment of acute ischemic stroke in The Netherlands for late arrivals: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
F. A. V. ( Anne) Pirson ◽  
◽  
Wouter H. Hinsenveld ◽  
Robert-Jan B. Goldhoorn ◽  
Julie Staals ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Time Window ◽  
Ct Perfusion ◽  
Controlled Trial ◽  
Stroke Severity ◽  
Collateral Flow ◽  
Open Label ◽  
Link Type ◽  
Mr Clean

Abstract Background Endovascular therapy (EVT) for acute ischemic stroke due to proximal occlusion of the anterior intracranial circulation, started within 6 h from symptom onset, has been proven safe and effective. Recently, EVT has been proven effective beyond the 6-h time window in a highly selected population using CT perfusion or MR diffusion. Unfortunately, these imaging modalities are not available in every hospital, and strict selection criteria might exclude patients who could still benefit from EVT. The presence of collaterals on CT angiography (CTA) may offer a more pragmatic imaging criterion that predicts possible benefit from EVT beyond 6 h from time last known well. The aim of this study is to assess the safety and efficacy of EVT for patients treated between 6 and 24 h from time last known well after selection based on the presence of collateral flow. Methods The MR CLEAN-LATE trial is a multicenter, randomized, open-label, blinded endpoint trial, aiming to enroll 500 patients. We will investigate the efficacy of EVT between 6 and 24 h from time last known well in acute ischemic stroke due to a proximal intracranial anterior circulation occlusion confirmed by CTA or MRA. Patients with any collateral flow (poor, moderate, or good collaterals) on CTA will be included. The inclusion of poor collateral status will be restricted to a maximum of 100 patients. In line with the current Dutch guidelines, patients who fulfill the characteristics of included patients in DAWN and DEFUSE 3 will be excluded as they are eligible for EVT as standard care. The primary endpoint is functional outcome at 90 days, assessed with the modified Rankin Scale (mRS) score. Treatment effect will be estimated with ordinal logistic regression (shift analysis) on the mRS at 90 days. Secondary endpoints include clinical stroke severity at 24 h and 5–7 days assessed by the NIHSS, symptomatic intracranial hemorrhage, recanalization at 24 h, follow-up infarct size, and mortality at 90 days, Discussion This study will provide insight into whether EVT is safe and effective for patients treated between 6 and 24 h from time last known well after selection based on the presence of collateral flow on CTA. Trial registration NL58246.078.17, ISRCTN19922220, Registered on 11 December 2017

Abstract WP31: Asymmetrical Internal Veins Sign In Acute Ischemic Stroke: A New Marker For Poor Collateral Circulation.

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Lavinia Dinia ◽  
David Carrera ◽  
Delgado-Mederos Raquel ◽  
Martí-Fàbregas Joan ◽  
Josep Lluis Munuera Del Cerro
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Collateral Circulation ◽  
Ct Perfusion ◽  
High Specificity ◽  
Venous Drainage ◽  
Stroke Severity ◽  
Cerebral Vein ◽  
Collateral Flow ◽  
Anterior Circulation

INTRODUCTION: Changes in venous drainage imaging have been directly related to parenchymal damage in acute ischemic stroke during endovascular treatment. Venous asymmetry assessed by CT prior to treatment may be directly related to delayed flow in the hypoperfused territory. We investigated the prevalence of asymmetry in internal cerebral vein (AIV) drainage and its correlation with collateral flow in patients with acute ischemic stroke by a multimodal CT protocol. Subjects and methods: We retrospectively evaluated clinical and radiological data of 29 consecutive patients with acute anterior circulation ischemic stroke within 6 hours from symptoms onset. Collateral status was graded as good or poor depending on the extent of contrast visualized distal to the occlusion on CT angiography (CTA). Presence and AIV (analyzed by density units, time to peak and volume) and arterial collateral score were blinded assessed on CT perfusion (PCT), CTA source images (CTASI) and MIP reconstructions. Results: We included 29 patients, with a median age of 77 ± 15 y, and 31% of them were men. Median baseline NIHSS was 11 ± 7. Mean infarct ASPECTS was 9.3 ± 1 and size 2 cm3 ± 4. Asymmetrical veins were present in 33% of patients. This sign was more prevalent in patients with proximal occlusions than in distal occlusions (67% versus 33%) and in patients with poor collaterals compared to those with good collaterals (62% versus 29%). AIV was significantly associated with increasing age (p= 0.03), increasing baseline NIHSS (p= 0.02) and poor collaterals (p=0.01). Presence of AIV reached high specificity (93%) and good sensitivity (66%) for poor arterial collaterals prediction (p=0.001). Conclusion: Impairment of venous circulation, assessed by means of AIV, is present in one third of the patients and was associated with stroke severity and low effectiveness of collateral flow. Presence of internal veins asymmetry is highly specific in detecting poor collateral circulation in acute stroke and may be a predictor of clinical and radiological severity, possibly useful for patients selection in planning reperfusion therapy strategies.

Abstract TMP2: Is Eptifibatide a Viable and Safe Option as Stand-alone Therapy for Acute Ischemic Stroke Patients?

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Daniel Korya ◽  
Mohammad Moussavi ◽  
Siddhart Mehta ◽  
Jaskiran Brar ◽  
Harina Chahal ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Time Window ◽  
T Test ◽  
Bleeding Complications ◽  
Stroke Severity ◽  
Paired Samples ◽  
Group A ◽  
Group B ◽  
Iv Tpa

Introduction: The list of contraindications for IV tPA in acute ischemic stroke (AIS) is often too long and may lead to physicians opting to offer no treatment for certain strokes. An alternative treatment is proposed in cases where IV tPA is not an option due to time-window restrictions or contraindications. We compared the stroke severity, outcomes and safety of IV eptifibatide when compared with IV tPA. Methods: Patients who presented to a community based university affiliated comprehensive stroke center from 2012-15 with AIS over a two-year period were included in the study. Those who qualified for IV tPA, and were treated, were compared with patients who only received IV eptifibatide. The initial NIH Stroke Score (NIHSS), 24-hour NIHSS, discharge NIHSS (DCNIHSS), discharge mRS (DCmRS) and symptomatic ICH rates were compared with a paired samples t-test to determine significance of difference between the means. SPSS Version 22 was used for all data analysis. Results: A total of 864 patients presented with AIS in the evaluated time period and of those 166 met study criteria. There were 119 patients who received IV tPA alone (group A) and 47 patients received eptifibatide (group B). The mean initial NIHSS, 24-NIHSS, DCNIHSS, DCmRS and percent bleeding complications for group A were: 11.2, 10.8, 8.6, 3.1 and 6%. For group B the figures were: 6.7, 4.8, 4.3, 1.7 and 0%, respectively. Group A was compared with group B in a paired samples T-test and yielded -4.3, -6.2, -6, -1.5 (p=.0001 to .04) for initial, 24-hour, discharge NIHSS and discharge mRS, respectively. The difference between initial and discharge NIHSS between the two groups was -2.7 (p=.009), favoring IV tPA. Conclusion: In patients who are either outside the time-window or with contraindications to IV tPA, eptifibatide may be a safe alternative and appears to be efficacious. None of the patients who were started on eptifibatide had bleeding complications and they had a statistically significant improvement in their level of disability and stroke severity at discharge. A limitation of this study is that patients in group A had significantly worse initial NIHSS compared with group B. To better evaluate the efficacy of eptifibatide, a larger, prospective study should be initiated.

Abstract WMP15: A Simple Tool to Predict Target Mismatch in Ischemic Stroke Patients with Anterior Circulation Occlusion

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Adam de Havenon ◽  
Steve O’Donnell ◽  
Alex Linn ◽  
Scott McNally ◽  
Bailey Dunleavy ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Perfusion Imaging ◽  
Time Window ◽  
Ct Perfusion ◽  
Volumetric Analysis ◽  
Stroke Patients ◽  
Anterior Circulation ◽  
Ct Angiogram

Introduction: The efficacy of endovascular thrombectomy in an extended time window for acute ischemic stroke patients with Target Mismatch (TM) on perfusion imaging was shown in a recent study and the ongoing DEFUSE-3 trial is studying thrombectomy in a 6-16 hour window for TM patients. A limitation of TM is that perfusion imaging is not widely available. We sought to identify a tool to predict TM based on clinical factors and CT angiogram (CTA) imaging, which is available at most hospitals. Methods: We reviewed acute ischemic stroke patients from 2010-2014 with proximal middle cerebral artery occlusion, CTA and CT perfusion (CTP) at hospital admission. TM was identified on CTP using the Olea Sphere volumetric analysis software with Bayesian deconvolution. TM was defined by the DEFUSE-3 criteria. ASPECTS was derived from the non-contrast CT head and the CTA source images (CTA-ASPECTS). Two collateral scores were derived from CTA source images. Results: 61 patients met inclusion criteria. The mean±SD age was 61±18 years and 61% were male. Mean NIH Stroke Scale (NIHSS) was 14.1±8.0 and median (IQR) follow-up modified Rankin Scale was 3 (1,6). TM was present in 35/61 (57%), who had lower mRS at follow-up (z=3.5, p<0.001). The predictor variables are shown in Table 1. The best combination of predictors was CTA-ASPECTS >4 and NIHSS <16, which had a sensitivity of 80% and specificity of 85% for TM (Figure 1). Discussion: We report a reliable, accessible, and clinically useful tool for predicting TM. This score warrants further study as a tool to guide transfer decisions from primary or secondary stroke centers to tertiary centers where endovascular intervention would be possible for selected patients.

Abstract 1911: Recanalization of Proximal Arterial Occlusion in the SENTIS Trial

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
David S Liebeskind ◽  
Ashfaq Shuaib ◽  
Martin Köhrmann ◽  
William P Dillon ◽  
Songling Liu ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Medical History ◽  
Controlled Trial ◽  
Arterial Occlusion ◽  
Stroke Severity ◽  
Nihss Score ◽  
Logistic Regression Models ◽  
Multivariable Logistic Regression

Background: Collateral circulation may enhance recanalization in acute ischemic stroke. Augmentation of collaterals with partial aortic occlusion may promote recanalization and thereby influence outcomes in the SENTIS randomized controlled trial of the NeuroFlo device. We conducted a post hoc analysis of angiography acquired in SENTIS to evaluate potential differences in recanalization rates between NeuroFlo-treated and non-treated arms, accounting for site of arterial occlusion. Methods: Blinded imaging expert review of baseline and 6-hour follow-up angiography (CTA, MRA, or DSA) from the core lab was conducted for evaluation of recanalization. Recanalization was defined as TIMI 2-3 in the arterial segment distal to baseline occlusion. Baseline demographics, stroke presentation characteristics, and medical history variables were analyzed with respect to recanalization in univariate and subsequent multivariable logistic regression models after adjusting by treatment arm. Results: Serial angiography was available in 109/515 SENTIS subjects, including 56 in the treatment arm and 53 in the non-treated arm. Baseline demographics, stroke presentation characteristics, and medical history variables did not differ statistically between arms. Across all sites of arterial occlusion, recanalization occurred in 25.7% of cases, with similar rates between device (25.0%) and medical therapy (26.4%) arms. Age and baseline stroke severity (NIHSS score) were significant predictors of recanalization in univariate analyses. Multivariable logistic regression analyses confirmed that baseline NIHSS score was the sole predictor of recanalization (OR 0.90, p=0.0458) per one unit increase, with decreased recanalization in more severe strokes. Device treatment was not associated with significant increases in recanalization rates (p=NS). Recanalization of terminal internal carotid artery (12.5%), proximal MCA or M1 (17.9%) and M2 (46.7%) occlusions was not different between arms (all p=NS). Recanalization of proximal arterial occlusion in acute ischemic stroke cases enrolled in SENTIS was more frequent in M2 occlusions. Conclusions: More severe strokes at baseline were less likely to recanalize and device therapy did not increase recanalization rates. Treatment with the NeuroFlo device may invoke mechanisms of collateral perfusion distinct from direct arterial recanalization.

Abstract WP28: Eligibility for Mechanical Thrombectomy in Acute Ischemic Stroke: a Phase IV Multi-center Screening Log Registry

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Georgios Tsivgoulis ◽  
Nitin Goyal ◽  
Robert Mikulik ◽  
Ramin Zand ◽  
Andromachi Roussopoulou ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Clinical Practice ◽  
Acute Ischemic Stroke ◽  
Mechanical Thrombectomy ◽  
Stroke Severity ◽  
Delayed Presentation ◽  
Inclusion Criteria ◽  
Everyday Clinical Practice ◽  
Nihss Score ◽  
Mr Clean

Background & Purpose: No eligibility screening logs were kept to support recent mechanical thrombectomy (MT) RCTs establishing safety and efficacy for acute ischemic stroke (AIS). We sought to evaluate the potential eligibility for MT among consecutive AIS patients in a prospective multicenter study. Methods: We prospectively evaluated consecutive patients admitted with the diagnosis of AIS in three tertiary care stroke centers during a twelve-month period. Admission stroke severity was documented using NIHSS-score, while all patients underwent baseline neurovascular imaging using MRA/CTA. Potential eligibility for MT was evaluated using inclusion criteria from MR CLEAN & REVASCAT as these protocols utilized imaging and selection methods that most closely mirrored everyday clinical practice. Results: Our study population consisted of 1161 AIS patients (mean age 66±14 years, 55% men, median admission NIHSS-score: 5 points, IQR 2-8). A total of 86 (7%, 95%CI: 6%-9%) and 66 (6%, 95%CI: 4%-7%) patients fulfilled the inclusion criteria for MR CLEAN & REVASCAT respectively, while 57 cases were eligible for inclusion in both trials (5%, 95%CI: 4%-6%). There was no evidence of heterogeneity (p>0.150) regarding the eligibility of AIS for MT across the three participating centers. Absence of proximal intracranial occlusion (70%), followed by hospital arrival outside the eligible time window (31% for MR CLEAN 6-hour window & 29% for REVASCAT 8-hour window), low baseline NIHSS-score (16% below the 2 point cut-off of MR Clean & 46% below the 6 point cut-off of REVASCAT) and posterior circulation cerebral ischemia (16%) were the four most common reasons for ineligibility for MT. Conclusion: Our everyday clinical practice experience suggests that approximately one out of fourteen to seventeen consecutive AIS may be eligible for MT if inclusion criteria for MR CLEAN and REVASCAT are strictly adhered to. Delayed presentation from symptom onset represents the only modifiable MT exclusion factor.

Abstract WP68: CT Perfusion Collateral Index in Assessment of Collaterals in Patients With Acute Ischemic Stroke: A New Imaging Biomarker

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Kambiz Nael ◽  
Jonathan Larson ◽  
Yu Sakai ◽  
Jared Goldstein ◽  
Jacob Deutsch ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Functional Outcome ◽  
Ct Perfusion ◽  
Imaging Biomarker ◽  
Collateral Flow ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Good Functional Outcome ◽  
Infarction Volume

Purpose: Perfusion collateral index (PCI) has been recently defined as a promising measure of collateral flow. We aim to evaluate the collateral status via CT-based PCI in association with outcome measures such as final infraction volume, recanalization status and functional outcome in patients presenting with acute ischemic stroke (AIS) and in a comparative analysis against CTA and DSA collateral scores. Methods: AIS patients with anterior circulation large vessel occlusion who had baseline CTA and CT perfusion and underwent endovascular treatment were included. CTA collateral scores were calculated using modified Tan score and DSA collateral scores were evaluated by ASITN grading. In addition, previously described PCI defined as the volume of moderately hypoperfused tissue (ATD 2-6sec ) multiplied by its corresponding rCBV was calculated in each patient. The association of CTA and DSA collateral scores and PCI were assessed against 3 measured outcomes: 1) Final infarction volume obtained from follow up MRI; 2) Final recanalization status defined by TICI scores; 3) Functional outcome measured by 90-day mRS. Results: A total of 53 patients met inclusion criteria (27F; mean/SD age: 70.1 ± 13 years; median NIHSS: 14). Final infarction volume (mean/SD: 30/40 mL), excellent recanalization defined by TICI >2C was achieved in 36 (68%) patients, and 23 patients (43%) had good functional outcome (mRS <2). Having good collaterals on all 3 modalities (CTA, DSA, CTP-PCI) were associated with significantly (p<0.05) smaller infarction volume. However only good collaterals determined by CTP-PCI was predictive of achieving excellent recanalization (p=0.001) or good functional outcome (p=0.01) ( Figure 1 ). Conclusion: Collateral status assessed via CT-PCI outperforms CTA and DSA collateral scores in prediction of excellent recanalization and good functional outcome and may be a promising imaging biomarker of collateral status in patients with AIS.

Endovascular therapy for ischemic stroke

Neurology ◽  
2017 ◽  
Vol 88 (22) ◽  
pp. 2123-2127 ◽  
Author(s):  
Atte Meretoja ◽  
Mahsa Keshtkaran ◽  
Turgut Tatlisumak ◽  
Geoffrey A. Donnan ◽  
Leonid Churilov
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Endovascular Therapy ◽  
Treatment Time ◽  
Prediction Interval ◽  
Stroke Severity ◽  
Vessel Occlusion ◽  
Treatment Delays ◽  
Mr Clean

Objective:To quantify the patient lifetime benefits gained from reduced delays in endovascular therapy for acute ischemic stroke.Methods:We used observational prospective data of consecutive stroke patients treated with IV thrombolysis in Helsinki (1998–2014; n = 2,474) to describe distributions of age, sex, stroke severity, onset-to-treatment times, and 3-month modified Rankin Scale (mRS) in routine clinical practice. We used treatment effects by time of endovascular therapy in large vessel occlusion over and above thrombolysis as reported by the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) study to model the shift in 3-month mRS distributions with reducing treatment delays. From the 3-month outcomes we derived patient-expected lifetimes and cumulative long-term disability with incremental treatment delay reductions.Results:Each minute saved in onset-to-treatment time granted on average 4.2 days of extra healthy life, with a 95% prediction interval 2.3–5.4. Women gained slightly more than men due to their longer life expectancies. Patients younger than 55 years with severe strokes of NIH Stroke Scale score above 10 gained more than a week per each minute saved. In the whole cohort, every 20 minutes decrease in treatment delays led to a gain of average equivalent of 3 months of disability-free life.Conclusions:Small reductions in endovascular delays lead to marked health benefits over patients' lifetimes. Services need to be optimized to reduce delays to endovascular therapy.

Abstract WMP22: Multiparametric CT Perfusion to Determine the Collaterals Status in Patients With Acute Ischemic Stroke: A New Perfusion Index

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Ahmed J Awad ◽  
Sayedhedayatollah E Tadayon ◽  
Daniel Wei ◽  
Reham R Haroun ◽  
Thomas J Oxley ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Diagnostic Accuracy ◽  
Acute Ischemic Stroke ◽  
Independent Predictor ◽  
Ct Perfusion ◽  
Multivariate Logistic Regression Analysis ◽  
Perfusion Index ◽  
Repeated Measure ◽  
Collateral Flow ◽  
Sensitivity Specificity

Introduction: Good collateral flow is an independent predictor of reperfusion that can be used to extend the treatment window in the new era of endovascular therapies for patients with acute ischemic stroke (AIS). Using a multiparametric approach, we aimed to identify perfusion parameter/s that can represent the extent of collaterals in comparison to CTA. Methods: AIS patients with anterior circulation large vessel occlusion who had baseline CTA and CT perfusion were included. CT perfusion data were processed by Bayesian method to generate arterial tissue delay (ATD) maps at thresholds of 2 & 6 seconds. The volume of mild delayed perfusion (Vol-ATD >2sec ), moderate delayed (Vol-ATD 2-6sec ) and critical delayed perfusion (Vol-ATD >6sec ) in addition to corresponding rCBV and rCBF were calculated. Baseline CTA collaterals were scored using an established scoring scale1 and dichotomized to poor or good. The association of perfusion parameters and status of collaterals was assessed by repeated measure of analyses and receiver operating characteristic (ROC). Results: In 28 patients included, 16 had good collaterals on CTA. After controlling for age, sex, baseline NIHSS and type of treatment, multivariate logistic regression analysis identified rCBV (p<0.001) and ATD 2-6sec (p=0.003), but not rCBF, Vol-ATD > 2sec or Vol-ATD >6sec , as independent predictors of good collaterals. ROC analysis showed AUC of 0.88 (sensitivity/specificity: 75%/100%) for rCBV and AUC of 0.84 (sensitivity/specificity: 93%/67%) for Vol-ATD 2-6sec . We defined a perfusion collateral index (PCI) calculated from Vol-ATD 2-6sec x its rCBV, that remained an independent predictor of good collaterals with improved diagnostic accuracy over each measure alone resulting in nominal AUC of 1 (sensitivity/specificity: 100%/100%). Conclusions: Multiparametric CT perfusion can be used to assess the status of collaterals in patients with AIS. Perfusion collateral index (PCI) defined as Vol-ATD 2-6sec x rCBV is a new perfusion index with a nominal diagnostic accuracy of 100% compared to baseline CTA to predict status of collaterals in our small cohort. Our results need to be validated in a larger prospective cohort.

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