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    Influence of Multiple Long-Term Conditions on Outcome after Thrombolysis for Acute Ischaemic Stroke: Secondary Analysis of the ENCHANTED Trial
    (S. Karger AG, 2025-08-06)
    Xinwen Ren
    ;
    Yang Zhao
    ;
    Menglu Ouyang
    ;
    Qiang Li
    ;
    Chen Chen
    Introduction: The influence of multiple long-term conditions on the outcomes from acute ischaemic stroke (AIS) is not well defined. This study aimed to determine the association of multiple long-term conditions in participants of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED). Methods: ENCHANTED was an international, multicentre, 2 × 2 quasi-factorial, open, randomized controlled, blinded endpoint assessed trial that assessed the effectiveness and safety of intensive blood pressure lowering and low-dose thrombolysis against standard of care in adults with AIS. Multiple long-term condition was defined as two or more coexisting chronic conditions according to medical history. The primary outcome was function recovery (distribution of scores on the modified Rankin scale) and mortality at 90 days post-randomization. Associations were estimated in multivariate logistic regression models, and an assessment of heterogeneity was undertaken in subgroups including age, sex, baseline systolic blood pressure, and clinical features. Results: In 4,566 AIS participants (mean age 66.7 years, 37.8% female), those with multiple long-term conditions were older, more often female, and had more severe neurological impairment. Multiple long-term conditions increased the odds of poor functional outcome (adjusted odds ratio [aOR] 1.16, 95% confidence interval [CI]: 1.03–1.30; p = 0.020) and mortality (aOR 1.35, 95% CI: 1.04–1.76; p = 0.024). The association between multiple long-term conditions and mortality/functional outcome was consistent across all subgroups. Conclusion: Individuals with multiple long-term conditions have higher odds of poor functional outcome and death after thrombolytic treatment for AIS.
      9
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    Scopus© Citations 1  2
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    Influence of renal function on blood pressure control and outcome in thrombolyzed patients after acute ischemic stroke: post-hoc analysis of the ENCHANTED trial
    (Frontiers Media SA, 2024-12-09)
    Xinwen Ren
    ;
    Chen Chen
    ;
    Xia Wang
    ;
    Qiang Li
    ;
    Yang Zhao
    <jats:sec><jats:title>Background</jats:title><jats:p>The effect of renal impairment in patients who receive intravenous thrombolysis for acute ischemic stroke (AIS) is unclear. We aimed to determine the associations of renal impairment and clinical outcomes and any modification of the effect of intensive versus guideline-recommended blood pressure (BP) control in the BP arm of the International Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We conducted a <jats:italic>post-hoc</jats:italic> analysis of the ENCHANTED BP arm, which involved 2,196 thrombolyzed AIS patients. Logistic regression models were used to define the association between eGFR and clinical outcomes of death, death or major disability [modified Rankin scale (mRS) scores 3–6], and major disability (mRS 3–5) at 90 days.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of the 2,151 patients with available baseline renal function data (mean age 66.9 years; 38% women), 993 (46.2%), 822 (38.2%), and 336 (15.6%) had normal (eGFR ≥ 90 mL/min/1.73 m<jats:sup>2</jats:sup>), mildly (60–89), and moderate-to-severely impaired (&amp;lt;60) renal function, respectively. Compared with patients with normal eGFR, mortality was higher in those with moderate-to-severe renal impairment (adjusted odds ratio 1.77, 95% confidence interval 1.05–2.99; <jats:italic>p</jats:italic> = 0.031 for trend). However, the difference in death or major disability (mRS 3–6) was not significant between groups. There was no heterogeneity in the effect of intensive versus guideline-recommended BP-lowering treatment on death by grades of renal function (<jats:italic>p</jats:italic> for interaction = 0.545).</jats:p></jats:sec><jats:sec><jats:title>Discussion</jats:title><jats:p>The presence of moderate-to-severe renal impairment is associated with increased mortality in thrombolyzed patients with AIS. Renal function does not modify the effect of early intensive BP-lowering treatment on death in this patient group.</jats:p></jats:sec>
      2
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    Intensive Blood Pressure Lowering and Renal Function in Ischemic Stroke Patients: Secondary Analysis of the ENCHANTED Trial
    (2024)
    Chen Chen
    ;
    Xinwen Ren
    ;
    Yang Zhao
    ;
    Menglu Ouyang
    ;
    Qiang Li Mbiostat
    <jats:p>&lt;b&gt;&lt;i&gt;Introduction:&lt;/i&gt;&lt;/b&gt; Renal failure is a major safety concern of intensive systolic blood pressure (SBP) lowering. We aimed to determine the effect of this treatment on early change in renal function in participants of the international Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED). &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; Post hoc analysis of the ENCHANTED BP-arm in which thrombolyzed patients with acute ischemic stroke (AIS) were randomized to intensive (target 130–140 mm Hg within 1 h) or guideline-recommended (target &amp;lt;180 mm Hg) management within 6 h of symptom onset. Primary outcome is the early change in renal function, defined by a difference in estimated glomerular filtration rate (&lt;b&gt;∆&lt;/b&gt;eGFR = 24 h – baseline eGFR), analyzed using linear regression with adjustment for clinical variables. Key SBP parameters were attained (mean), variability (standard deviation), and magnitude of reduction within 24 h. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; Of 2,151 participants (mean age 66.9 years; 38% female) included with the available baseline eGFR, there were significant differences in attained 144.3 ± 10.2 versus 149.8 ± 12.0 [Δ5.5 mm Hg]; &lt;i&gt;p&lt;/i&gt; &amp;lt; 0.0001), variation (15.1 ± 5.4 vs. 14.0 ± 5.6 mm Hg; &lt;i&gt;p&lt;/i&gt; &amp;lt; 0.0001), and magnitude of reduction (44.6 ± 16.2 vs. 38.7 ± 17.6 mm Hg; &lt;i&gt;p&lt;/i&gt; &amp;lt; 0.0001) in SBP within 24 h. 1,718 (79.9%) participants with complete follow-up eGFR were included in the primary analysis, and there was no significant difference in &lt;b&gt;∆&lt;/b&gt;eGFR (adjusted mean difference −1.10, 95% confidence interval [CI] −3.14 to −0.94; &lt;i&gt;p&lt;/i&gt; = 0.29) between the intensive and guideline groups, respectively. The neutral effect on &lt;b&gt;∆&lt;/b&gt;eGFR was consistent in patients with different baseline eGFR stages and in sensitivity analysis after multiple imputations for missing follow-up eGFR. SBP variability was significantly associated with decreasing &lt;b&gt;∆&lt;/b&gt;eGFR (per 5 mm Hg increase by category: adjusted mean difference −1.35, 95% CI: −2.43 to −0.28; &lt;i&gt;p&lt;/i&gt; for trend = 0.01). &lt;b&gt;&lt;i&gt;Conclusion:&lt;/i&gt;&lt;/b&gt; Intensive SBP lowering with a target of 130–140 mm Hg had no impact on early renal function in thrombolyzed AIS patients. Wide SBP variability was associated with a larger decline in eGFR. </jats:p>
      1
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    Rapid Blood-Pressure Lowering in Patients with Acute Intracerebral Hemorrhage
    (2013)
    Craig S. Anderson
    ;
    Emma Heeley
    ;
    Yining Huang
    ;
    Jiguang Wang
    ;
    Christian Stapf
    Scopus© Citations 1333  1
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    Statistical analysis plan for the second INTEnsive blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT2): a large-scale investigation to solve longstanding controversy over the most appropriate management of elevated blood pressure in the hyperacute phase of intracerebral hemorrhage
    (2013)
    Craig Anderson
    ;
    Emma Heeley
    ;
    Stephane Heritier
    ;
    Hisatomi Arima
    ;
    Mark Woodward
    The Statistical analysis plan (SAP) for the second INTEnsive blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT2).
      2Scopus© Citations 10
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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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    Scopus© Citations 5  5
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      9Scopus© Citations 16