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Author: search.filters.author.Hisatomi ArimaSubject: search.filters.subject.intracerebral hemorrhage

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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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    Clinical Prediction Algorithm (BRAIN) to Determine Risk of Hematoma Growth in Acute Intracerebral Hemorrhage
    (2015)
    Xia Wang
    ;
    Hisatomi Arima
    ;
    Rustam Al-Shahi Salman
    ;
    Mark Woodward
    ;
    Emma Heeley
    <jats:sec> <jats:title>Background and Purpose—</jats:title> <jats:p>We developed and validated a simple algorithm to predict the risk of hematoma growth in acute spontaneous intracerebral hemorrhage (ICH) to better inform clinicians and researchers in their efforts to improve outcomes for patients.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods—</jats:title> <jats:p>We analyzed data from the computed tomography substudies of the pilot and main phases of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials (INTERACT1 and 2, respectively). The study group was divided into a derivation cohort (INTERACT2, n=964) and a validation cohort (INTERACT1, n=346). Multivariable logistic regression was used to identify factors associated with clinically significant (≥6 mL) increase in hematoma volume at 24 hours after symptom onset. A parsimonious risk score was developed on the basis of regression coefficients derived from the logistic model.</jats:p> </jats:sec> <jats:sec> <jats:title>Results—</jats:title> <jats:p> A 24-point BRAIN score was derived from INTERACT2 (C-statistic, 0.73) based on baseline ICH volume (mL per score, ≤10=0, 10–20=5, &gt;20=7), recurrent ICH (yes=4), anticoagulation with warfarin at symptom onset (yes=6), intraventricular extension (yes=2), and number of hours to baseline computed tomography from symptom onset (≤1=5, 1–2=4, 2–3=3, 3–4=2, 4–5=1, &gt;5=0) predicted the probability of ICH growth (ranging from 3.4% for 0 point to 85.8% for 24 points) with good discrimination (C-statistic, 0.73) and calibration (Hosmer–Lemeshow <jats:italic>P</jats:italic> =0.82) in INTERACT1. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>The simple BRAIN score predicts the probability of hematoma growth in ICH. This could be used to improve risk stratification for research and clinical practice.</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: NCT00226096 and NCT00716079. </jats:p> </jats:sec>
      3Scopus© Citations 117
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    Poor utility of grading scales in acute intracerebral hemorrhage: results from the INTERACT2 trial
    (2015)
    Emma Heeley
    ;
    Craig S. Anderson
    ;
    Mark Woodward
    ;
    Hisatomi Arima
    ;
    Thompson Robinson
    <jats:sec><jats:title>Background</jats:title><jats:p> Several simple clinical grading scores have been developed for intracerebral hemorrhage, primarily to predict 30-day mortality. </jats:p></jats:sec><jats:sec><jats:title>Aims</jats:title><jats:p> We aimed to determine the accuracy of three popular scores (original intracerebral hemorrhage, modified intracerebral hemorrhage, and intracerebral hemorrhage grading scale) on 30-day mortality and 90-day death or major disability, and whether the magnitude of benefit varies according to prognosis graded by the three predictive scores. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Data from the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial which included 2839 intracerebral hemorrhage patients (&lt;6 hours) and elevated systolic blood pressure (150–220 mmHg), randomized to intensive (target systolic blood pressure &lt;140 mmHg) or guideline-based (&lt;180 mmHg) blood pressure management. Discrimination of scales for predicting death and poor outcome (modified Rankin scale 3–6) was evaluated in area under receiver operator characteristic curves. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> Among 2556 (90%) participants with available data, the modified intracerebral hemorrhage had the highest discrimination (receiver operator characteristic 0·75) for 90-day poor outcome compared with the original intracerebral hemorrhage (receiver operator characteristic 0·68) and intracerebral hemorrhage grading scale (receiver operator characteristic 0·69). All scores had good positive predictive value (approximately 80–90%) for poor outcome but poor sensitivity and positive predictive value for death. The scores do not clearly discriminate a patient group most likely to benefit from blood pressure lowering. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> Intracerebral hemorrhage prognostic scores are not useful in defining patients at high probability of early death, but they are reliable for predicting poor outcome, defined by death or major disability. Potential benefits of early intensive blood pressure lowering are broadly applicable across grades of severity defined by such scores. </jats:p></jats:sec>
      7Scopus© Citations 23
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      8Scopus© Citations 41
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    Rapid Blood Pressure Lowering According to Recovery at Different Time Intervals after Acute Intracerebral Hemorrhage: Pooled Analysis of the INTERACT Studies
    (2015)
    Xia Wang
    ;
    Hisatomi Arima
    ;
    Rustam Al-Shahi Salman
    ;
    Mark Woodward
    ;
    Emma Heeley
    <jats:p>&lt;b&gt;&lt;i&gt;Background and Purpose:&lt;/i&gt;&lt;/b&gt; Early intensive blood pressure (BP) lowering has been shown to improve functional outcome in acute intracerebral hemorrhage (ICH), but the treatment effect is modest and without a clearly defined underlying explanatory mechanism. We aimed at more reliably quantifying the benefits of this treatment according to different time periods in the recovery of participants in the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT) studies. &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; Pooled analysis of the pilot INTERACT1 (n = 404) and main INTERACT2 (n = 2,839) involving patients with spontaneous ICH (&lt;6 h) and elevated systolic BP (SBP 150-220 mm Hg) who were randomized to intensive (target SBP &lt;140 mm Hg) or guideline-recommended (target SBP &lt;180 mm Hg) BP lowering treatment. Treatment effects were examined according to repeated measures analysis of an ordinal (‘shift') across all 7 levels of the modified Rankin Scale (mRS) assessed during follow-up at 7, 28, and 90 days, post-randomization. Clinical trial registration information: http://www.clinicaltrials.gov, NCT00226096 and NCT00716079. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; Intensive BP lowering resulted in a significant favorable distribution of mRS scores for better functioning (odds ratio 1.13, 95% confidence interval 1.00-1.26; p = 0.042) over 7, 28 and 90 days, and the effect was consistency for early (7-28 days) and later (28-90 days) time periods (p homogeneity 0.353). Treatment effects were also consistent across several pre-specified patient characteristic subgroups, with trends favoring those randomized early, and with higher SBP and milder neurological severity at baseline. &lt;b&gt;&lt;i&gt;Conclusions:&lt;/i&gt;&lt;/b&gt; Intensive BP lowering provides beneficial effects on physical functioning that manifests consistently through the early and later phases of recovery from ICH.</jats:p>
    Scopus© Citations 23  1
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      2Scopus© Citations 14
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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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    Scopus© Citations 9  1