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Author: search.filters.author.Craig S. AndersonSubject: search.filters.subject.blood pressure

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    Effects of Intensive Blood Pressure Lowering on Brain Swelling in Thrombolyzed Acute Ischemic Stroke: The ENCHANTED Results
    (Ovid Technologies (Wolters Kluwer Health), 2025-06)
    Guobin Zhang
    ;
    Chen Chen
    ;
    Xinwen Ren
    ;
    Yang Zhao
    ;
    Menglu Ouyang
      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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    Scopus© Citations 221  1
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    Scopus© Citations 12  1
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    INTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial
    (2021)
    Lili Song
    ;
    Xin Hu
    ;
    Lu Ma
    ;
    Xiaoying Chen
    ;
    Menglu Ouyang
    <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>Early intensive blood pressure (BP) lowering remains the most promising treatment for acute intracerebral hemorrhage (ICH), despite discordant results between clinical trials and potential variation in the treatment effects by approach to control BP. As the third in a series of clinical trials on this topic, the INTEnsive care bundle with blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT3) aims to determine the effectiveness of a goal-directed care bundle protocol of early physiological control (intensive BP lowering, glycemic control, and pyrexia treatment) and reversal of anticoagulation, in acute ICH.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>INTERACT3 is a pragmatic, international, multicenter, stepped-wedge (4 phases/3 steps), cluster-randomized controlled trial to determine the effectiveness of a multifaceted care package in adult (age ≥ 18 years) patients (target 8360) with acute ICH (&lt; 6 h of onset) recruited from 110 hospitals (average of 19 consecutive patients per phase) in low- and middle-income countries. After a control phase, each hospital implements the intervention (intensive BP lowering, target systolic &lt; 140 mmHg; glucose control, target 6.1–7.8 mmol/L and 7.8–10.0 mmol/L in those without and with diabetes mellitus, respectively; anti-pyrexia treatment to target body temperature ≤ 37.5 °C; and reversal of anticoagulation, target international normalized ratio &lt; 1.5 within 1 h). Information will be obtained on demographic and baseline clinical characteristics, in-hospital management, and 7-day outcomes. Central trained blinded assessors will conduct telephone interviews to assess physical function and health-related quality of life at 6 months. The primary outcome is the modified Rankin scale (mRS) at 6 months analyzed using ordinal logistic regression. The sample size of 8360 subjects provides 90% power (<jats:italic>α</jats:italic> = 0.05) to detect a 5.6% absolute improvement (shift) in the primary outcome of the intervention versus control standard care, with various assumptions.</jats:p> </jats:sec><jats:sec> <jats:title>Discussion</jats:title> <jats:p>As the largest clinical trial in acute ICH, INTERACT3 is on schedule to provide an assessment of the effectiveness of a widely applicable goal-directed care bundle for a serious condition in which a clearly proven treatment has yet to be established.</jats:p> </jats:sec><jats:sec> <jats:title>Trial registration</jats:title> <jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://clinicaltrials.gov">ClinicalTrials.gov</jats:ext-link> NCT03209258. Registered on 1 July 2017. Chinese Trial Registry ChiCTR-IOC-17011787. Registered on 28 June 2017</jats:p> </jats:sec>
    Scopus© Citations 15  1
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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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    Ethnicity and Other Determinants of Quality of Functional Outcome in Acute Ischemic Stroke
    (2020)
    Xiaoying Chen
    ;
    Xia Wang
    ;
    Candice Delcourt
    ;
    Jingwei Li
    ;
    Hisatomi Arima
    <jats:sec> <jats:title>Background and Purpose—</jats:title> <jats:p>Patient-centered outcomes are important. We aimed to determine predictors of health-related quality of life (HRQoL) and develop utility-weighted modified Rankin Scale (mRS) scores in thrombolyzed acute ischemic stroke patients from both arms of ENCHANTED (Enhanced Control of Hypertension and Thrombolysis Stroke Study).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods—</jats:title> <jats:p>ENCHANTED was an international quasi-factorial clinical trial of different doses of intravenous alteplase and intensities of blood pressure control in acute ischemic stroke patients, with outcomes on the 5-Dimensional European Quality of Life Scale and mRS assessed at 90 days post-randomization. Logistic regression models were used to identify baseline predictors of poor HRQoL (≤mean 5-Dimensional European Quality of Life Scale utility scores). Ordinary least squares regression derived utility-weighted mRS scores.</jats:p> </jats:sec> <jats:sec> <jats:title>Results—</jats:title> <jats:p>In 4016 acute ischemic stroke patients with complete 5-Dimensional European Quality of Life Scale and mRS data, independent predictors of poor HRQoL were older age (odds ratio, 1.19 [95% CI, 1.12–1.27], per 10-year increase), non-Asian ethnicity (1.91 [1.61–2.27]), greater stroke severity on the National Institutes of Health Stroke Scale (1.11 [1.09–1.12]), diabetes mellitus (1.41 [1.18–1.69]), premorbid disability (mRS score 1 versus 0; 1.62 [1.33–1.97]), large vessel atheromatous pathogenesis (1.32 [1.12–1.54]), and proxy respondent (2.35 [2.01–2.74]). Sensitivity analyses indicate the ethnicity influence on HRQoL was driven by the high proportion of Chinese (62.9% of Asian) participants with better HRQoL compared with non-Chinese or other Asian groups. Derived utility values across mRS scores 0 to 5 were 0.977, 0.885, 0.748, 0.576, 0.194, and −0.174, respectively. Correlations between mRS and 5-Dimensional European Quality of Life Scale scores were stronger in Asians.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>HRQoL is worse after thrombolyzed acute ischemic stroke in the elderly, non-Asians, with greater initial severity, diabetes mellitus, premorbid disability, due to large vessel atheroma, and proxy assessment. The broader significance of better HRQoL in Asians is tempered by Chinese participants dominating analyses. From utility-weighted mRS scores indicating the greatest steps in mRS scores are between 5 and 3, treatments to avoid major disability provide the greatest benefits for 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>
      6Scopus© Citations 8
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    Acute Treatment of Stroke (Except Thrombectomy)
    (2018)
    MUÑOZ VENTURELLI, PAULA ANDREA  
    ;
    Jason P. Appleton
    ;
    Craig S. Anderson
    ;
    Philip M. Bath
      4Scopus© Citations 5