The Chemical Optimization of Cerebral Embolectomy trial: Study protocol

2019 ◽  
pp. 174749301989565 ◽  
Author(s):  
Arturo Renú ◽  
Jordi Blasco ◽  
Mónica Millán ◽  
Joan Martí-Fàbregas ◽  
Pere Cardona ◽  
...  

Rationale The potential value of rescue intraarterial thrombolysis in patients with large vessel occlusion stroke treated with mechanical thrombectomy has not been assessed in randomized trials. Aim The CHemical OptImization of Cerebral Embolectomy trial aims to establish whether rescue intraarterial thrombolysis is more effective than placebo in improving suboptimal reperfusion scores in patients with large vessel occlusion stroke treated with mechanical thrombectomy. Sample size estimates A sample size of 200 patients allocated 1:1 to intraarterial thrombolysis or intraarterial placebo will have >95% statistical power for achieving the primary outcome (5% in the control versus 60% in the treatment group) for a two-sided (5% alpha, and 5% lost to follow-up). Methods and design We conducted a multicenter, randomized, placebo-controlled, double blind, phase 2b trial. Eligible patients are 18 or older with symptomatic large vessel occlusion treated with mechanical thrombectomy resulting in a modified treatment in cerebral ischemia score 2b at end of the procedure. Patients will receive 20–30 min intraarterial infusion of recombinant tissue plasminogen activator or placebo (0.5 mg/ml, maximum dose limit 22.5 mg). Study outcome(s) The primary outcome is the proportion of patients with an improved modified treatment in cerebral ischemia score 10 min after the end of the study treatment. Secondary outcomes include the shift analysis of the modified Rankin Scale, the infarct expansion ratio, the proportion of excellent outcome (modified Rankin Scale 0–1), the proportion of infarct expansion, and the infarction volume. Mortality and symptomatic intracerebral bleeding will be assessed. Discussion The study will provide evidence whether rescue intraarterial thrombolysis improves brain reperfusion in patients with large vessel occlusion stroke and incomplete reperfusion (modified treatment in cerebral ischemia 2b) at the end of mechanical thrombectomy.

2021 ◽  
pp. 159101992110694
Author(s):  
Hiroaki Neki ◽  
Takehiro Katano ◽  
Takuma Maeda ◽  
Aoto Shibata ◽  
Hiroyuki Komine ◽  
...  

Background Achieving rapid and complete reperfusion is the ultimate purpose for ischemic stroke with large vessel occlusion (LVO). Although mechanical thrombectomy (MT) had been a proverbially important procedure, medium vessel occlusion (MeVO) with thrombus migration can sporadically occur after MT. Moreover, the safe and effective approach for such had been unknown. We reported thrombolysis with intraarterial urokinase for MeVO with thrombus migration after MT. Methods We included 122 patients who were treated by MT with LVO stroke at our institution between April 2019 and March 2021. Of 26 patients (21.3%) who developed MeVO with thrombus migration after MT, 11 (9.0%) underwent additional MT (MT group) and 15 (12.3%) received intraarterial urokinase (UK group). The procedure time; angiographically modified Treatment in Cerebral Ischemia Scale (mTICI); functional independence, which was defined as modified Rankin Scale 0–2, on day 30 or upon discharge; and symptomatic and asymptomatic intracerebral hemorrhage (ICH) were compared between the UK and MT groups. Results The procedure time, mTICI, and asymptomatic ICH did not significantly differ between the groups. In the UK group, 8 of 15 (53.3%) patients obtained functional independence, and the functional independence rate was significantly higher in the UK group than in the MT group ( p < 0.05). Symptomatic ICH did not occur in the UK group, and its incidence was significantly smaller than that in the MT group ( p < 0.05). Conclusion The results of this study suggest that intraarterial urokinase for MeVO with thrombus migration after MT may safely improve angiographic reperfusion.


2019 ◽  
Vol 2 (2) ◽  
pp. 105-110
Author(s):  
Saima Ahmad ◽  
Umair Rashid Chaudhry ◽  
Ossama Yassin Mansour

Introduction: Mechanical thrombectomy has become the cornerstone and standard of care for acute stroke patients. Early reperfusion in patients experiencing acute ischemic stroke is the most important factor. The motivation behind this investigation is to display the aftereffects of mechanical thrombectomy in patients with large vessel occlusion in anterior and posterior circulation and to demonstrate that it lessens the level of handicap 3 months post stroke. Methods: A retrospective analysis was conducted of patients who presented with acute ischemic stroke at our center from 2015 to 2018 and received mechanical thrombectomy using combined manual aspiration with a stent retriever and with large bore catheters without the bridging technique. Result factors including recanalization rate and modified Rankin Scale at 90 days post procedure were assessed. An aggregate of 30 patients were included. Results: About 30 patients presented at the institute and met the inclusion criteria for the study. Successful recanalization (the Thrombolysis in Cerebral Infarction Score [TICI 2B]) was accomplished in 90% of patients, TICI 3 score was accomplished in 56% of the patients. 67% of the patients had good modified Rankin Scale score 0-2 result at 90 days. There were 3 symptomatic hemorrhages and 3 procedure and comorbidity-related deaths (10%). Conclusion: Mechanical thrombectomy using combined manual aspiration with a stent retriever and with large bore catheters alone without the bridging technique is an effective and safe procedure for endovascular revascularization of large vessel occlusion presenting with acute ischemic stroke.


2021 ◽  
pp. 1-9
Author(s):  
Marie Luby ◽  
José G. Merino ◽  
Rachel Davis ◽  
Saeed Ansari ◽  
Marc Fisher ◽  
...  

<b><i>Introduction:</i></b> Despite complete recanalization by mechanical thrombectomy, abnormal perfusion can be detected on MRI obtained post-endovascular therapy (EVT). The presence of residual perfusion abnormalities post-EVT may be associated with blood-brain barrier breakdown in response to mechanical disruption of the endothelium from multiple-pass thrombectomy. We hypothesize that multiple-pass versus single-pass thrombectomy is associated with a higher rate of residual hypoperfusion and increased lesion growth at 24 h. <b><i>Materials and Methods:</i></b> For this analysis, we included patients presenting to one of two stroke centers between January 2015 and February 2018 with an acute ischemic stroke within 12 h from symptom onset if they had a large vessel occlusion of the anterior circulation documented on magnetic resonance angiography or CTA, baseline MRI pre-EVT with imaging evidence of hypoperfusion, underwent EVT, and had a post-EVT MRI with qualitatively interpretable perfusion-weighted imaging data at 24 h. MRI <i>T</i><sub>max</sub> maps using a time delay threshold of &#x3e;6 s were used to quantitate hypoperfusion volumes. Residual hypoperfusion at 24 h was solely defined as <i>T</i><sub>max</sub> volume &#x3e;10 mL with &#x3e;6 s delay. Complete recanalization was defined as modified treatment in cerebral infarction visualized on angiography at EVT completion. Hyperintense acute reperfusion injury marker was assessed on post-EVT pre-contrast fluid-attenuated inversion recovery at 24 h. Major early neurological improvement was defined as a reduction of the admission National Institutes of Health Stroke Scale by ≥8 points or a score of 0–1 at 24 h. Good functional outcome was defined as 0–2 on the modified Rankin Scale on day 30 or 90. <b><i>Results:</i></b> Fifty-five patients were included with median age 67 years, 58% female, 45% Black/African American, 36% White/Caucasian, median admission National Institutes of Health Stroke Scale 19, large vessel occlusion locations: 71% M1, 14.5% iICA, 14.5% M2, 69% treated with intravenous recombinant tissue plasminogen activator. Of these, 58% had multiple-pass thrombectomy, 39% had residual perfusion abnormalities at 24 h, and 64% had severe hyperintense acute reperfusion injury marker at 24 h. After adjusting for complete recanalization, only multiple-pass thrombectomy (odds ratio, 4.3 95% CI, 1.07–17.2; <i>p</i> = 0.04) was an independent predictor of residual hypoperfusion at 24 h. Patients with residual hypoperfusion had larger lesion growth on diffusion-weighted imaging (59 mL vs. 8 mL, <i>p</i> &#x3c; 0.001), lower rate of major early neurological improvement (24% vs. 70%, <i>p</i> = 0.002) at 24 h, and worse long-term outcome based on the modified Rankin Scale at 30 or 90 days, 5 versus 2 (<i>p</i> &#x3c; 0.001). <b><i>Conclusions:</i></b> Our findings suggest that incomplete reperfusion on post-EVT MRI is present even in some patients with successful recanalization at the time of EVT and is associated with multiple-pass thrombectomy, lesion growth, and worse outcome. Future studies are needed to investigate whether patients with residual hypoperfusion may benefit from immediate adjunctive therapy to limit lesion growth and improve clinical outcome.


Stroke ◽  
2021 ◽  
Vol 52 (1) ◽  
pp. 232-240
Author(s):  
Jean-Marc Olivot ◽  
Jean-François Albucher ◽  
Adrien Guenego ◽  
Claire Thalamas ◽  
Michael Mlynash ◽  
...  

Background and Purpose: Mechanical thrombectomy (MT) is the recommended treatment for acute ischemic stroke caused by anterior circulation large vessel occlusion. However, despite a high rate of reperfusion, the clinical response to successful MT remains highly variable in the early time window where optimal imaging selection criteria have not been established. We hypothesize that the baseline perfusion imaging profile may help forecast the clinical response to MT in this setting. Methods: We conducted a prospective multicenter cohort study of patients with large vessel occlusion–related acute ischemic stroke treated by MT within 6 hours. Treatment decisions and the modified Rankin Scale evaluation at 3 months were performed blinded to the results of baseline perfusion imaging. Study groups were defined a posteriori based on predefined imaging profiles: target mismatch (TMM; core volume <70 mL/mismatch ratio >1.2 and mismatch volume >10 mL) versus no TMM or mismatch (MM; mismatch ratio >1.2 and volume >10 mL) versus no MM. Functional recovery (modified Rankin Scale, 0–2) at 3 months was compared based on imaging profile at baseline and whether reperfusion (modified Thrombolysis in Cerebral Infarction 2bc3) was achieved. Results: Two hundred eighteen patients (mean age, 71±15 years; median National Institutes of Health Stroke Scale score, 17 [interquartile range, 12–21]) were enrolled. Perfusion imaging profiles were 71% TMM and 82% MM. The rate of functional recovery was 54% overall. Both TMM and MM profiles were independently associated with a higher rate on functional recovery at 3 months Adjusted odds ratios were 3.3 (95% CI, 1.4–7.9) for TMM and 5.9 (95% CI, 1.8–19.6) for MM. Reperfusion (modified Thrombolysis in Cerebral Infarction 2bc3) was achieved in 86% and was more frequent in TMM and MM patients. Reperfusion was associated with a higher rate of functional recovery in MM and TMM patients but not among those with no MM. Conclusions: In this cohort study, about 80% of the patients with a large vessel occlusion–related acute ischemic stroke had evidence of penumbra, regardless of infarction volume. Perfusion imaging profiles predict the clinical response to MT.


Author(s):  
D. Andrew Wilkinson ◽  
Sravanthi Koduri ◽  
Sharath Kumar Anand ◽  
Badih J. Daou ◽  
Vikram Sood ◽  
...  

Author(s):  
Simon Fandler-Höfler ◽  
Balazs Odler ◽  
Markus Kneihsl ◽  
Gerit Wünsch ◽  
Melanie Haidegger ◽  
...  

AbstractData on the impact of kidney dysfunction on outcome in patients with stroke due to large vessel occlusion are scarce. The few available studies are limited by only considering single kidney parameters measured at one time point. We thus investigated the influence of both chronic kidney disease (CKD) and acute kidney injury (AKI) on outcome after mechanical thrombectomy. We included consecutive patients with anterior circulation large vessel occlusion stroke receiving mechanical thrombectomy at our center over an 8-year period. We extracted clinical data from a prospective registry and investigated kidney serum parameters at admission, the following day and throughout hospital stay. CKD and AKI were defined according to established nephrological criteria. Unfavorable outcome was defined as scores of 3–6 on the modified Rankin Scale 3 months post-stroke. Among 465 patients, 31.8% had an impaired estimated glomerular filtration rate (eGFR) at admission (< 60 ml/min/1.73 m2). Impaired admission eGFR was related to unfavorable outcome in univariable analysis (p = 0.003), but not after multivariable adjustment (p = 0.96). Patients frequently met AKI criteria at admission (24.5%), which was associated with unfavorable outcome in a multivariable model (OR 3.03, 95% CI 1.73–5.30, p < 0.001). Moreover, patients who developed AKI during hospital stay also had a worse outcome (p = 0.002 in multivariable analysis). While CKD was not associated with 3-month outcome, we identified AKI either at admission or throughout the hospital stay as an independent predictor of unfavorable prognosis in this study cohort. This finding warrants further investigation of kidney–brain crosstalk in the setting of acute stroke.


2021 ◽  
pp. 197140092110091
Author(s):  
Hanna Styczen ◽  
Matthias Gawlitza ◽  
Nuran Abdullayev ◽  
Alex Brehm ◽  
Carmen Serna-Candel ◽  
...  

Background Data on outcome of endovascular treatment in patients with acute ischaemic stroke due to large vessel occlusion suffering from intravenous thrombolysis-associated intracranial haemorrhage prior to mechanical thrombectomy remain scarce. Addressing this subject, we report our multicentre experience. Methods A retrospective analysis of consecutive acute ischaemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion despite the pre-interventional occurrence of intravenous thrombolysis-associated intracranial haemorrhage was performed at five tertiary care centres between January 2010–September 2020. Baseline demographics, aetiology of stroke and intracranial haemorrhage, angiographic outcome assessed by the Thrombolysis in Cerebral Infarction score and clinical outcome evaluated by the modified Rankin Scale at 90 days were recorded. Results In total, six patients were included in the study. Five individuals demonstrated cerebral intraparenchymal haemorrhage on pre-interventional imaging; in one patient additional subdural haematoma was observed and one patient suffered from isolated subarachnoid haemorrhage. All patients except one were treated by the ‘drip-and-ship’ paradigm. Successful reperfusion was achieved in 4/6 (67%) individuals. In 5/6 (83%) patients, the pre-interventional intracranial haemorrhage had aggravated in post-interventional computed tomography with space-occupying effect. Overall, five patients had died during the hospital stay. The clinical outcome of the survivor was modified Rankin Scale=4 at 90 days follow-up. Conclusion Mechanical thrombectomy in patients with intravenous thrombolysis-associated intracranial haemorrhage is technically feasible. The clinical outcome of this subgroup of stroke patients, however, appears to be devastating with high mortality and only carefully selected patients might benefit from endovascular treatment.


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