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Emergency Department Workflow Times of Intravenous Thrombolysis with Tenecteplase versus Alteplase in Acute Ischemic Stroke: A Prospective Cohort Study before and during the COVID-19 Pandemic
(S. Karger AG, 2025-02-03)
Matias Guzman
;
LAVADOS GERMAIN, PABLO MANUEL
;
Gabriel Cavada
;
Alejandro M. Brunser
;
Veronica V. Olavarria
Introduction: Tenecteplase (TNK) has demonstrated to be non-inferior to alteplase (ALT) for intravenous thrombolysis (IVT) in acute ischemic stroke (AIS). There are potential workflow benefits associated with TNK use, aiming to reduce patient length of stay in the emergency department. Our aim was to investigate whether the routine use of TNK during the COVID-19 pandemic influenced workflow times compared to historical use of ALT, while maintaining non-inferior clinical outcomes in a non-drip and ship scenario of a comprehensive stroke center. Methods: We included patients with AIS admitted from September 2019 to September 2022 and compared those treated with TNK during the COVID-19 pandemic to those treated with ALT in the period immediately before. We compared emergency department length of stay (EDLOS), door-to-needle time (DTN), door-to-groin puncture time (DTG), clinical and safety outcomes with adjusted general linear regression models. Results: 110 patients treated with TNK and 111 with ALT were included in this study. Mean EDLOS was 251 (SD = 164) min for TNK users versus 240 (SD = 148) min for ALT (p = 0.62). Mean DTN was 43 (SD = 25) min for TNK versus 46 (SD = 27) min for ALT users (p = 0.39). Mean DTN under 60 min was achieved in 86 (78.2%) patients and in 85 (76.5%) patients of the TNK and ALT groups, respectively (p = 1.0). DTN under 45 min was achieved in 65.4% and 58.6% (p = 0.65) of the TNK and ALT groups, respectively. DTG time was 114 (SD = 43) min for TNK versus 111 (58 = SD) min in the ALT group (p = 0.88). DTG under 90 min was achieved in 32% of the TNK group and 35% of the ALT group (p = 0.69). There were no differences in any of the clinical or safety outcomes between groups at 90 days. Conclusions: The adoption of TNK during COVID-19 pandemic did not result in a change in EDLOS, DTN, or DTG times when compared to ALT in this cohort. Safety and clinical outcomes were similar between groups. Probably a greater benefit could have been seen in a drip and ship thrombolysis setting. Further research is needed to assess the potential advantages of TNK in drip and ship scenarios of IVT.
Scopus© Citations 2 2
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Safety and efficacy of low-intensity versus standard monitoring following intravenous thrombolytic treatment in patients with acute ischaemic stroke (OPTIMISTmain): an international, pragmatic, stepped-wedge, cluster-randomised, controlled non-inferiority trial
(Elsevier BV, 2025-05)
Craig S Anderson
;
Debbie Summers
;
Menglu Ouyang
;
Yi Sui
;
Brenda Johnson
2Scopus© Citations 15
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Validation of the simplified modified Rankin scale for stroke trials: Experience from the ENCHANTED alteplase-dose arm
(2020)
Xiaoying Chen
;
Jingwei Li
;
Craig S Anderson
;
Richard I Lindley
;
Maree L Hackett
<jats:sec><jats:title>Background and aims</jats:title><jats:p> The structured, simplified modified Rankin scale questionnaire (smRSq) may increase reliability over the interrogative approach to scoring the modified Rankin scale (mRS) in acute stroke research and practice. During the conduct of the alteplase-dose arm of the international ENhanced Control of Hypertension ANd Thrombolysis StrokE stuDy (ENCHANTED), we had an opportunity to compare each of these approaches to outcome measurement. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Baseline demographic data were recorded together with the National Institutes of Health Stroke Scale (NIHSS). Follow-up measures obtained at 90 days included mRS, smRSq, and the 5-Dimension European Quality of life scale (EQ-5D). Agreements between smRSq and mRS were assessed with the Kappa statistic. Multiple logistic regression was used to identify baseline predictors of Day 90 smRSq and mRS scores. Treatment effects, based on Day 90 smRSq/mRS scores, were tested in logistic and ordinal logistic regression models. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> SmRSq and mRS scores had good agreement (weighted Kappa 0.79, 95% confidence interval (CI) 0.78–0.81), while variables of age, atrial fibrillation, diabetes mellitus, pre-morbid mRS (1 vs. 0), baseline NIHSS scores, and imaging signs of cerebral ischemia, similarly predicted their scores. Odds ratios for death or disability, and ordinal shift, 90-day mRS scores using smRSq were 1.05 (95% CI 0.91–1.20; one-sided P = 0.23 for non-inferiority) and 0.98 (95% CI 0.87–1.11; P = 0.02 for non-inferiority), similar to those using mRS. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> This study demonstrates the utility of the smRSq in a large, ethnically diverse clinical trial population. Scoring of the smRSq shows adequate agreement with the standard mRS, thus confirming it is a reliable, valid, and useful alternative measure of functional status after acute ischemic stroke. </jats:p></jats:sec><jats:sec><jats:title>Clinical Trial registration</jats:title><jats:p> URL: http://www.clinicaltrials.gov . Unique identifier: NCT01422616. </jats:p></jats:sec>
Scopus© Citations 9 7
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Breaking the breach in Latin America: A pilot study of mechanical thrombectomy in the public healthcare system in Chile
(2020)
Rodrigo Rivera
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Cristian Amudio
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Enzo Brunetti
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Pascual Catalan
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Juan Gabriel Sordo
<jats:sec><jats:title>Background</jats:title><jats:p> Mechanical Thrombectomy (MT) is the standard of care for treatment of large vessel occlusion stroke. Until the beginning of 2020 MT was not funded nor widely implemented at the public healthcare level in Chile. </jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p> To describe the results of a pilot program created to provide access to public MT in Santiago - Chile. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Analysis from a prospectively collected database of MT cases performed between September 2017 and September 2019 in one center. A stroke network was developed with a single MT capable stroke center and five primary stroke centers. The primary efficacy endpoint was the rate of functional independence (mRS 0-2) at 90 days. Successful reperfusion was defined as 2 b-3 according to the thrombolysis in cerebral infarction scale. Safety outcomes include the rates of symptomatic intracranial hemorrhage and 90-day mortality. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> A total of 100 patients were treated over the study period. Their mean age was 62.8 ± 11.8 years and median baseline National Institute of Health Stroke Scale (NIHSS) measurement was 17. Seventy-seven percent of the patients received intra venous thrombolysis. Successful reperfusion was achieved in 95% of the cases. NIHSS at 24 hours showed a median drop of 7 points from baseline (p < 0.00001) and 50% of the follow-up patients were functionally independent at 90 days. Symptomatic Intracerebral hemorrhage occurred in 5% of the patients and 90-day all case mortality was 11%. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> We demonstrated the feasibility of a publicly funded MT program in Chile, with similar results as other international randomized control trials. </jats:p></jats:sec>
Scopus© Citations 10 4
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Smoking influences outcome in patients who had thrombolysed ischaemic stroke: the ENCHANTED study
(2021)
Lingli Sun
;
Lili Song
;
Jie Yang
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Richard I Lindley
;
Thompson Robinson
<jats:sec><jats:title>Background and purpose</jats:title><jats:p>As studies vary in defining the prognostic significance of smoking in acute ischaemic stroke (AIS), we aimed to determine the relation of smoking and key outcomes in patient participants who had thrombolysed AIS of the international quasi-factorial randomised Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Post-hoc analyses of ENCHANTED, an international quasi-factorial randomised evaluation of intravenous alteplase-dose comparison and levels of blood pressure control in patients who had thrombolysed AIS. Multivariable logistic regression models with inverse probability of treatment weighting (IPTW) propensity scores were used to determine associations of self-reported smoking status and clinical outcomes, according to 90-day modified Rankin Scale (mRS) scores and symptomatic intracerebral haemorrhage (sICH).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of 4540 patients who had an AIS, there were 1008 (22.2%) current smokers who were younger and predominantly male, with more comorbidities of hypertension, coronary artery disease, atrial fibrillation and diabetes mellitus, and greater baseline neurological impairment, compared with non-smokers. In univariate analysis, current smokers had a higher likelihood of a favourable shift in mRS scores (OR 0.88, 95% CI 0.77 to 0.99; p=0.038) but this association reversed in a fully adjusted model with IPTW (adjusted OR 1.15, 95% CI 1.04 to 1.28; p=0.009). A similar trend was also apparent for dichotomised poor outcome (mRS scores 2–6: OR 1.18, 95% CI 1.05 to 1.33; p=0.007), but not with the risk of sICH across standard criteria.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Smoking predicts poor functional recovery in patients who had thrombolysed AIS.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT01422616">NCT01422616</jats:ext-link>.</jats:p></jats:sec>
Scopus© Citations 8
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Comparative effects of intensive-blood pressure versus standard-blood pressure-lowering treatment in patients with severe ischemic stroke in the ENCHANTED trial
(2020)
Jatinder S. Minhas
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Xia Wang
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Richard I. Lindley
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Candice Delcourt
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Lili Song
9Scopus© Citations 16
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Associations of Early Systolic Blood Pressure Control and Outcome After Thrombolysis-Eligible Acute Ischemic Stroke: Results From the ENCHANTED Study
(2022)
Xia Wang
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Jatinder S. Minhas
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Tom J. Moullaali
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Gian Luca Di Tanna
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Richard I. Lindley
<jats:sec> <jats:title>Background and Purpose:</jats:title> <jats:p>In thrombolysis-eligible patients with acute ischemic stroke, there is uncertainty over the most appropriate systolic blood pressure (SBP) lowering profile that provides an optimal balance of potential benefit (functional recovery) and harm (intracranial hemorrhage). We aimed to determine relationships of SBP parameters and outcomes in thrombolyzed acute ischemic stroke patients.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods:</jats:title> <jats:p>Post hoc analyzes of the ENCHANTED (Enhanced Control of Hypertension and Thrombolysis Stroke Study), a partial-factorial trial of thrombolysis-eligible and treated acute ischemic stroke patients with high SBP (150–180 mm Hg) assigned to low-dose (0.6 mg/kg) or standard-dose (0.9 mg/kg) alteplase and intensive (target SBP, 130–140 mm Hg) or guideline-recommended (target SBP <180 mm Hg) treatment. All patients were followed up for functional status and serious adverse events to 90 days. Logistic regression models were used to analyze 3 SBP summary measures postrandomization: attained (mean), variability (SD) in 1–24 hours, and magnitude of reduction in 1 hour. The primary outcome was a favorable shift on the modified Rankin Scale. The key safety outcome was any intracranial hemorrhage.</jats:p> </jats:sec> <jats:sec> <jats:title>Results:</jats:title> <jats:p> Among 4511 included participants (mean age 67 years, 38% female, 65% Asian) lower attained SBP and smaller SBP variability were associated with favorable shift on the modified Rankin Scale (per 10 mm Hg increase: odds ratio, 0.76 [95% CI, 0.71–0.82]; <jats:italic>P</jats:italic> <0.001 and 0.86 [95% CI, 0.76–0.98]; <jats:italic>P</jats:italic> =0.025) respectively, but not for magnitude of SBP reduction (0.98, [0.93–1.04]; <jats:italic>P</jats:italic> =0.564). Odds of intracranial hemorrhage was associated with higher attained SBP and greater SBP variability (1.18 [1.06–1.31]; <jats:italic>P</jats:italic> =0.002 and 1.34 [1.11–1.62]; <jats:italic>P</jats:italic> =0.002) but not with magnitude of SBP reduction (1.05 [0.98–1.14]; <jats:italic>P</jats:italic> =0.184). </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions:</jats:title> <jats:p>Attaining early and consistent low levels in SBP <140 mm Hg, even as low as 110 to 120 mm Hg, over 24 hours is associated with better outcomes in thrombolyzed acute ischemic stroke patients.</jats:p> </jats:sec> <jats:sec> <jats:title>Registration:</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov">https://www.clinicaltrials.gov</jats:ext-link> ; Unique identifier: NCT01422616. </jats:p> </jats:sec>
Scopus© Citations 26 3
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Did COVID-19 impact stroke services? A multicenter study
(2022)
Hossam Shokri
;
Nevine El Nahas
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Ahmed El Basiony
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Thanh N. Nguyen
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Mohamad Abdalkader
<jats:title>Abstract </jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>It has been reported that acute stroke services were compromised during COVID-19 due to various pandemic-related issues. We aimed to investigate these changes by recruiting centers from different countries.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>Eight countries participated in this cross-sectional, observational, retrospective study by providing data from their stroke data base. We compared 1 year before to 1 year during COVID-19 as regards onset to door (OTD), door to needle (DTN), door to groin (DTG), duration of hospital stay, National Institute of Health Stroke Scale (NIHSS) at baseline, 24 h, and at discharge as well as modified Rankin score (mRS) on discharge and at 3 months follow-up.</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>During the pandemic year, there was a reduction in the number of patients, median age was significantly lower, admission NIHSS was higher, hemorrhagic stroke increased, and OTD and DTG showed no difference, while DTN time was longer, rtPA administration was decreased, thrombectomy was more frequent, and hospital stay was shorter. mRS was less favorable on discharge and at 3 months.</jats:p> </jats:sec><jats:sec> <jats:title>Conclusion</jats:title> <jats:p>COVID-19 showed variable effects on stroke services. Some were negatively impacted as the number of patients presenting to hospitals, DTN time, and stroke outcome, while others were marginally affected as the type of management.</jats:p> </jats:sec>
5Scopus© Citations 5
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Low dosis of alteplase, for ischemic stroke after Enchanted and its determinants, a single center experience
(2020)
BRUNSER, ALEJANDRO
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MAZZON AGURTO, ENRICO
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Gabriel Cavada
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Eloy Mansilla
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Alexis Rojo
<jats:p>Abstract Background: Low-dose alteplase (LrtPA) has been shown not to be inferior to the standard-dose (SrtPA) with respect to death/disability. Objective: We aim to evaluate the percentage of patients treated with LrtPA at our center after the ENCHANTED trial and the factors associated with the use of this dosage. Methods: Prospective study in consecutive patients with an acute stroke admitted between June 2016 and November 2018. Results: 160 patients were treated with intravenous thrombolysis, 50% female; mean age 65.4±18.5 years. Of these, 48 patients (30%) received LrtPA. In univariate analysis, LrtPA was associated with patient's age (p=0.000), previous modified Rankin scale scores (mRS) (p<0.000), hypertension (p=0.076), diabetes mellitus (p=0.021), hypercholesterolemia (p=0.19), smoking (p=0.06), atrial fibrillation (p=0.10), history of coronary artery disease (p=0.06), previous treatment with antiplatelet agents (p<0.000), admission International Normalized Ratio-INR (p=0.18), platelet count (p=0.045), leukoaraiosis on neuroimaging (p<0.003), contraindications for thrombolytic treatment (p=0.000) and endovascular treatment (p=0.027). Previous relevant bleedings were determinants for treatment with LrtPA. Final diagnosis on discharge of stroke mimic was significant (p=0.02) for treatment with SrtPA. In multivariate analysis, mRS (OR: 2.21; 95%CI 1.37‒14.19), previous antiplatelet therapy (OR: 11.41; 95%CI 3.98‒32.70), contraindications for thrombolysis (OR: 56.10; 95%CI 8.81‒357.80), leukoaraiosis (OR: 4.41; 95%CI 1.37‒14.10) and diagnosis of SM (OR: 0.22; 95%CI 0.10‒0.40) remained independently associated. Conclusions: Following the ENCHANTED trial, LrtPA was restricted to 30% of our patients. The criteria that clinicians apply are based mostly on clinical variables that may increase the risk of brain or systemic hemorrhage or exclude the patient from treatment with lytic drugs.</jats:p>
Scopus© Citations 2 2
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Influence of Including Patients with Premorbid Disability in Acute Stroke Trials: The HeadPoST Experience
(2021)
Xia Wang
;
Tom J. Moullaali
;
Menglu Ouyang
;
Laurent Billot
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Else Charlotte Sandset
<jats:p>Background: Patients with premorbid functional impairment are generally excluded from acute stroke trials. We aimed to determine the impact of including such patients in the Head Positioning in acute Stroke Trial (HeadPoST) and early additional impairment on outcomes. Methods: Post hoc analyses of HeadPoST, an international, cluster-randomized crossover trial of lying-flat versus sitting-up head positioning in acute stroke. Associations of early additional impairment, defined as change in modified Rankin scale (mRS) scores from premorbid levels (estimated at baseline) to Day 7 (“early ΔmRS”), and poor outcome (mRS score 3–6) at Day 90 were determined with generalized linear mixed model. Heterogeneity of the trial treatment effect was tested according to premorbid mRS scores 0–1 versus 2–5. Results: Of 8,285 patients (38.9% female, mean age 68 ± 13 years) with complete data, there were 1,984 (23.9%) with premorbid functional impairment (mRS 2–5). A significant linear association was evident for early ∆mRS and poor outcome (per 1-point increase in ΔmRS, adjusted odds ratio 1.20, 95% confidence interval 1.14–1.27; p &#x3c; 0.0001). Patients with greater premorbid functional impairment were less likely to develop additional impairment, but their risk of poor 90-day outcome significantly increased with increasing (worse) premorbid mRS scores (linear trend p &#x3c; 0.0001). There was no heterogeneity of the trial treatment effect by level of premorbid function. Conclusions: Early poststroke functional impairment that exceeded premorbid levels was associated with worse 90-day outcome, and this association increased with greater premorbid functional impairment. Yet, including premorbid impaired patients in the HeadPoST did not materially affect the subsequent treatment effect. Clinical Trial Registration: HeadPoST is registered at http://www.ClinicalTrials.gov (NCT02162017). </jats:p>
1Scopus© Citations 2

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