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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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    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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    Scopus© Citations 17  1
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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
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    Intracerebral hemorrhage location and outcome among INTERACT2 participants
    (2017)
    Candice Delcourt
    ;
    Shoichiro Sato
    ;
    Shihong Zhang
    ;
    Else Charlotte Sandset
    ;
    Danni Zheng
    <jats:sec><jats:title>Objective:</jats:title><jats:p>To clarify associations between intracerebral hemorrhage (ICH) location and clinical outcomes among participants of the main phase Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2).</jats:p></jats:sec><jats:sec><jats:title>Methods:</jats:title><jats:p>Associations between ICH sites and poor outcomes (death [6] or major disability [3–5] of modified Rankin Scale) and European Quality of Life Scale (EQ-5D) utility scores at 90 days were assessed in logistic regression models.</jats:p></jats:sec><jats:sec><jats:title>Results:</jats:title><jats:p>Of 2,066 patients included in the analyses, associations were identified between ICH sites and poor outcomes: involvement of posterior limb of internal capsule increased risks of death or major disability (odds ratio [OR] 2.10) and disability (OR 1.81); thalamic involvement increased risks of death or major disability (OR 2.24) and death (OR 1.97). Involvement of the posterior limb of the internal capsule, thalamus, and infratentorial sites were each associated with poor EQ-5D utility score (≤0.7 [median]; OR 1.87, 2.14, and 2.81, respectively). Posterior limb of internal capsule involvement was strongly associated with low scores across all health-related quality of life domains. ICH encompassing the thalamus and posterior limb of internal capsule were associated with death or major disability, major disability, and poor EQ-5D utility score (OR 1.72, 2.26, and 1.71, respectively).</jats:p></jats:sec><jats:sec><jats:title>Conclusion:</jats:title><jats:p>Poor clinical outcomes are related to ICH affecting the posterior limb of internal capsule, thalamus, and infratentorial sites. The highest association with death or major disability and poor EQ-5D utility score was seen in ICH encompassing the thalamus and posterior limb of internal capsule.</jats:p></jats:sec><jats:sec><jats:title>ClinicalTrials.gov registration:</jats:title><jats:p>NCT00716079.</jats:p></jats:sec>
    Scopus© Citations 121  1
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    Associations with health-related quality of life after intracerebral haemorrhage: pooled analysis of INTERACT studies
    (2017)
    Candice Delcourt
    ;
    Danni Zheng
    ;
    Xiaoying Chen
    ;
    Maree Hackett
    ;
    Hisatomi Arima
      8Scopus© Citations 26