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Author: search.filters.author.Candice DelcourtSubject: search.filters.subject.alteplase

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      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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    Smoking influences outcome in patients who had thrombolysed ischaemic stroke: the ENCHANTED study
    (2021)
    Lingli Sun
    ;
    Lili Song
    ;
    Jie Yang
    ;
    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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      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
    ;
    Jatinder S. Minhas
    ;
    Tom J. Moullaali
    ;
    Gian Luca Di Tanna
    ;
    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 &lt;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> &lt;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 &lt;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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    Influence of Including Patients with Premorbid Disability in Acute Stroke Trials: The HeadPoST Experience
    (2021)
    Xia Wang
    ;
    Tom J. Moullaali
    ;
    Menglu Ouyang
    ;
    Laurent Billot
    ;
    Else Charlotte Sandset
    <jats:p>&lt;b&gt;&lt;i&gt;Background:&lt;/i&gt;&lt;/b&gt; 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. &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; 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. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; 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; &lt;i&gt;p&lt;/i&gt; &amp;#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 &lt;i&gt;p&lt;/i&gt; &amp;#x3c; 0.0001). There was no heterogeneity of the trial treatment effect by level of premorbid function. &lt;b&gt;&lt;i&gt;Conclusions:&lt;/i&gt;&lt;/b&gt; 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. &lt;b&gt;&lt;i&gt;Clinical Trial Registration:&lt;/i&gt;&lt;/b&gt; HeadPoST is registered at http://www.ClinicalTrials.gov (NCT02162017). </jats:p>
      1Scopus© Citations 2
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    Sex differences in treatment and outcome after stroke Pooled analysis including 19,000 participants
    (2019)
    Cheryl Carcel
    ;
    Xia Wang
    ;
    Else Charlotte Sandset
    ;
    Candice Delcourt
    ;
    Hisatomi Arima
    <jats:sec><jats:title>Objective</jats:title><jats:p>To explore the sex differences in outcomes and management after stroke using a large sample with high-quality international trial data.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Individual participant data were obtained from 5 acute stroke randomized controlled trials. Data were obtained on demographics, medication use, in-hospital treatment, and functional outcome. Study-specific crude and adjusted models were used to estimate sex differences in outcomes and management, and then pooled using random-effects meta-analysis.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>There were 19,652 participants, of whom 7,721 (40%) were women. After multivariable adjustments, women with ischemic stroke had higher survival at 3–6 months (odds ratio [OR] 0.82, 95% confidence interval [CI] 0.70–0.97), higher likelihood of disability (OR 1.20, 95% CI 1.06–1.36), and worse quality of life (weighted mean difference −0.07, 95% CI −0.09 to 0.04). For management, women were more likely to be admitted to an acute stroke unit (OR 1.17, 95% CI 1.01–1.34), but less likely to be intubated (OR 0.58, 95% CI 0.36–0.93), treated for fever (OR 0.82, 95% CI 0.70–0.95), or admitted to an intensive care unit (OR 0.83, 95% CI 0.74–0.93). For preadmission medications, women had higher odds of being prescribed antihypertensive agents (OR 1.22, 95% CI 1.13–1.31) and lower odds of being prescribed antiplatelets (OR 0.86, 95% CI 0.79–0.93), glucose-lowering agents (OR 0.86, 95% CI 0.78–0.94), or lipid-lowering agents (OR 0.85, 95% CI 0.77–0.94).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>This analysis suggests that women who had ischemic stroke had better survival but were also more disabled and had poorer quality of life. Variations in hospital and out-of-hospital management may partly explain the disparities.</jats:p></jats:sec>
      1Scopus© Citations 115  2