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Author: search.filters.author.Christian StapfSubject: search.filters.subject.hypertension

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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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    Sex differences in treatment, radiological features and outcome after intracerebral haemorrhage: Pooled analysis of Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials 1 and 2
    (2020)
    Else Charlotte Sandset
    ;
    Xia Wang
    ;
    Cheryl Carcel
    ;
    Shoichiro Sato
    ;
    Candice Delcourt
    <jats:sec><jats:title>Introduction</jats:title><jats:p> Reports vary on how sex influences the management and outcome from acute intracerebral haemorrhage. We aimed to quantify sex disparities in clinical characteristics, management, including response to blood pressure lowering treatment, and outcomes in patients with acute intracerebral haemorrhage, through interrogation of two large clinical trial databases. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Post-hoc pooled analysis of the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials 1 and 2, where patients with a hypertensive response (systolic, 150–220 mmHg) after spontaneous intracerebral haemorrhage (&lt;6 h) were randomised to intensive (target &lt;140 mmHg &lt;1 h) or guideline-recommended (&lt;180 mmHg) blood pressure lowering treatment. The interaction of sex on early haematoma growth (24 h), death or major disability (modified Rankin scale scores 3–6 at 90 days), and effect of randomised treatment were determined in multivariable logistic regression models adjusted for baseline confounding variables. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> In 3233 participants, 1191 (37%) were women who were significantly older, had higher baseline National Institutes of Health Stroke Scale scores and smaller haematoma volumes compared to men. Men had higher three-month mortality (odds ratio 1.48, 95% confidence interval 1.10–2.00); however, there was no difference between women and men in the combined endpoint of death or major disability. There were no significant sex differences on mean haematoma growth or effect of randomised blood pressure lowering treatment. </jats:p></jats:sec><jats:sec><jats:title>Discussion</jats:title><jats:p> Men included in the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials had more comorbidities, larger baseline haematoma volumes and higher mortality after adjustment for age, as compared with women. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Men included in the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials had a greater odds of dying after intracerebral haemorrhage than women, which could not be readily explained by differing casemix or patterns of blood pressure management. </jats:p></jats:sec><jats:sec><jats:title>Clinical trial registration</jats:title><jats:p> The Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials studies are registered with ClinicalTrials.gov (NCT00226096 and NCT00716079). </jats:p></jats:sec>
    Scopus© Citations 15  30
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    Rationale, design, and progress of the ENhanced Control of Hypertension ANd Thrombolysis strokE stuDy (ENCHANTED) trial: An international multicenter 2x2 quasi-factorial randomized controlled trial of low- vs. standard-dose rt-PA and early intensive vs. guideline-recommended blood pressure lowering in patients with acute ischaemic stroke eligible for thrombolysis treatment.
    (2015)
    Yining Huang
    ;
    Vijay K. Sharma
    ;
    Thompson Robinson
    ;
    Richard I. Lindley
    ;
    Xiaoying Chen
    <jats:sec><jats:title>Rationale</jats:title><jats:p> Controversy exists over the optimal dose of intravenous (iv) recombinant tissue plasminogen activator (rt-PA) and degree of blood pressure (BP) control in acute ischaemic stroke (AIS). Asian studies suggest low-dose (0·6 mg/kg) is more efficacious than standard-dose (0·9 mg/kg) iv rt-PA, and guidelines recommend reducing systolic BP to &lt;185 mmHg before and &lt;180 mmHg after use of iv rt-PA, despite observational studies indicating better outcomes at much lower (&lt;140 mmHg) systolic BP levels in this patient group. </jats:p></jats:sec><jats:sec><jats:title>Aims</jats:title><jats:p> The study aims to assess in thrombolysis-eligible AIS patients whether: (i) low-dose (0·6 mg/kg body weight; maximum 60 mg) iv rt-PA has non-inferior efficacy and lower risk of symptomatic intracerebral haemorrhage (sICH) compared to standard-dose (0·9 mg/kg body weight; maximum 90 mg) iv rt-PA; and (ii) early intensive BP lowering (systolic target 130–140 mmHg) has superior efficacy and lower risk of any ICH compared to guideline-recommended BP control (systolic target &lt; 180 mmHg). </jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p> The ENhanced Control of Hypertension And Thrombolysis strokE stuDy (ENCHANTED) trial is an independent, 2 × 2 quasi-factorial, active-comparison, prospective, randomized, open blinded endpoint (PROBE), clinical trial that is evaluating Arm [A] ‘rt-PA dose’ and/or Arm [B] ‘BP control’, using central Internet randomization and data collection in patients fulfilling local criteria for thrombolysis and clinician uncertainty over the study treatments. The treatment arms will be analyzed separately. </jats:p></jats:sec><jats:sec><jats:title>Study outcomes</jats:title><jats:p> The primary study outcome in both trial Arms is death or disability according to the modified Rankin scale (mRS, scores 2–6) assessed at 90 days. Secondary outcomes include sICH, any ICH, a shift (‘improvement’) in function across mRS scores, separately on death and disability, early neurological deterioration, recurrent major vascular events, health-related quality of life, length of hospital stay, need for permanent residential care, and health care costs. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> Following launch of the trial in February 2012, the study has recruited more than 2500 patients across a global network of approximately 100 sites in 15 countries. The required sample sizes are 3300 for Arm [A] and 2300 for Arm [B], which will provide &gt;90% power to detect non-inferiority of low-dose iv rt-PA and superiority of intensive BP lowering on the primary clinical outcome, respectively. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> Low-dose iv rt-PA and early intensive BP lowering could provide more affordable and safer use of thrombolysis treatment for patients with AIS worldwide. </jats:p></jats:sec>
      13Scopus© Citations 85
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    Significance of Cerebral Small-Vessel Disease in Acute Intracerebral Hemorrhage
    (2016)
    Shoichiro Sato
    ;
    Candice Delcourt
    ;
    Emma Heeley
    ;
    Hisatomi Arima
    ;
    Shihong Zhang
    <jats:sec> <jats:title>Background and Purpose—</jats:title> <jats:p>The significance of structural changes associated with cerebral small-vessel disease (SVD), including white matter lesions (WML), lacunes, and brain atrophy, to outcome from acute intracerebral hemorrhage is uncertain. We determined associations of computed tomographic radiological manifestations of cerebral SVD and outcomes, and in terms of any differential effect of early intensive blood pressure–lowering treatment, in the large-scale Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods—</jats:title> <jats:p>We graded WML (van Swieten scale), the presence of lacunes, and brain atrophy (2 linear measurements and visual rating) for 2069 of 2839 patients with available baseline brain computed tomography (&lt;6 hours of intracerebral hemorrhage onset) by 3 independent neurologists blind to clinical data.</jats:p> </jats:sec> <jats:sec> <jats:title>Results—</jats:title> <jats:p> WML grade and 2 linear measurements of brain atrophy were associated with death or major disability at 90 days: multivariable-adjusted odds ratios for WML (grade 3 and 4 versus 0), frontal ratio, and third ventricle Sylvian fissure distance (most versus least severe atrophy quartile) were 1.42 (95% confidence interval, 1.02–1.98), 1.47 (1.08–1.99), and 1.64 (1.21–2.22), respectively (all <jats:italic>P</jats:italic> for trend &lt;0.05). There was no association between lacunes and outcomes. There were no significant differences in the effects of intensive blood pressure–lowering across subgroups of cerebral SVD. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>Preexisting cerebral SVD manifestations of WML and brain atrophy predict poor outcome in acute intracerebral hemorrhage. There is no apparent hazard of early intensive lowering of blood pressure according to the INTERACT2 protocol, in patients with underlying cerebral SVD.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT00716079. </jats:p> </jats:sec>
      3Scopus© Citations 70
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    Significance of Hematoma Shape and Density in Intracerebral Hemorrhage The Intensive Blood Pressure Reduction in Acute Intracerebral Hemorrhage Trial Study
    (2016)
    Candice Delcourt
    ;
    Shihong Zhang
    ;
    Hisatomi Arima
    ;
    Shoichiro Sato
    ;
    Rustam Al-Shahi Salman
    <jats:sec> <jats:title>Background and Purpose—</jats:title> <jats:p>In patients with acute intracerebral hemorrhage (ICH), the shape and density of the hematoma are associated with its subsequent growth, but the impact of these parameters on clinical outcome is uncertain.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods—</jats:title> <jats:p>Baseline computed tomographic scans and clinical data were obtained in the Intensive Blood Pressure Reduction in Acute Intracerebral Hemorrhage Trial (INTERACT2). Three independent neurologists blind to clinical data assessed ICH for shape and density using a previously described scale. Shape was defined as irregular when the ICH had ≥2 extra lesions added to the ellipsoid-shaped ICH. Density was heterogeneous when there were ≥3 low-density lesions within the ICH. Outcome measures were death and major disability (modified Rankin scale score of 3–5), combined and separate at 90-day postrandomization. Multivariable logistic regression models were used to determine the significance of hematoma characteristics on outcome.</jats:p> </jats:sec> <jats:sec> <jats:title>Results—</jats:title> <jats:p>There were 2066 patient computed tomographic scans included in the analysis, with 46% and 38% having irregular and heterogeneous ICH, respectively. Irregular shape was independently associated with death/major disability (adjusted odds ratio, 1.60; 95% confidence interval [CI], 1.29–1.98) and major disability alone (adjusted odds ratio, 1.60; 95% CI, 1.31–1.95), but not with death alone (adjusted odds ratio, 0.97; 95% CI, 0.68–1.39). Heterogeneous density was not associated with clinical outcomes (adjusted odds ratio, 1.06; 95% CI, 0.85–1.33), 1.04 (95% CI, 0.73–1.48), and 1.14 (95% CI, 0.93–1.39), respectively, for death/major disability, death alone, and disability alone).</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>Irregular shape, but not heterogeneous density, is independently associated with poor outcome after ICH.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT00716079. </jats:p> </jats:sec>
      1Scopus© Citations 71
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    Early Blood Pressure Lowering Does Not Reduce Growth of Intraventricular Hemorrhage following A cut Intracerebral Hemorrhage: Results of the INTERACT Studies
    (2016)
    Edward Chan
    ;
    Craig S. Anderson
    ;
    Xia Wang
    ;
    Hisatomi Arima
    ;
    Anubhav Saxena
    <jats:p>&lt;b&gt;&lt;i&gt;Background:&lt;/i&gt;&lt;/b&gt; Intraventricular hemorrhage (IVH) extension is common following acute intracerebral hemorrhage (ICH) and is associated with poor prognosis. &lt;b&gt;&lt;i&gt;Aim:&lt;/i&gt;&lt;/b&gt; To determine whether intensive blood pressure (BP)-lowering therapy reduces IVH growth. &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; Pooled analyses of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials (INTERACT1 and INTERACT2) computed tomography (CT) substudies; multicenter, open, controlled, randomized trials of patients with acute spontaneous ICH and elevated systolic BP, randomly assigned to intensive (&lt;140 mm Hg) or guideline-based (&lt;180 mm Hg) BP management. Participants had blinded central analyses of baseline and 24-hour CT. Association of BP lowering to IVH growth was assessed in analysis of covariance. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; There was no significant difference in adjusted mean IVH growth following intensive (n = 228) compared to guideline-recommended (n = 228) BP treatment (1.6 versus 2.2 ml, respectively; p = 0.56). Adjusted mean IVH growth was nonsignificantly greater in patients with a mean achieved systolic BP ≥160 mm Hg over 24 h (3.94 ml; p trend = 0.26). &lt;b&gt;&lt;i&gt;Conclusions:&lt;/i&gt;&lt;/b&gt; Early intensive BP-lowering treatment had no clear effect on IVH in acute ICH.</jats:p>
    Scopus© Citations 8  1