Faculty Opinions recommendation of Degree and Timing of Intensive Blood Pressure Lowering on Hematoma Growth in Intracerebral Hemorrhage: Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial-2 Results.

Introduction 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. Patients and Methods 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 (<6 h) were randomised to intensive (target <140 mmHg <1 h) or guideline-recommended (<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. Results 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. Discussion 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. Conclusion 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. Clinical trial registration The Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials studies are registered with ClinicalTrials.gov (NCT00226096 and NCT00716079).

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Degree and Timing of Intensive Blood Pressure Lowering on Hematoma Growth in Intracerebral Hemorrhage

Stroke ◽

10.1161/strokeaha.116.013326 ◽

2016 ◽

Vol 47 (6) ◽

pp. 1651-1653 ◽

Cited By ~ 27

Author(s):

Cheryl Carcel ◽

Xia Wang ◽

Shoichiro Sato ◽

Christian Stapf ◽

Else Charlotte Sandset ◽

...

Keyword(s):

Blood Pressure ◽

Intracerebral Hemorrhage ◽

Blood Pressure Lowering ◽

Pressure Lowering ◽

Hematoma Growth ◽

Intensive Blood Pressure

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Practice Patterns for Neurosurgical Utilization and Outcome in Acute Intracerebral Hemorrhage: Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials 1 and 2 Studies

Neurosurgery ◽

10.1093/neuros/nyx129 ◽

2017 ◽

Vol 81 (6) ◽

pp. 980-985 ◽

Cited By ~ 5

Author(s):

Rui Guo ◽

David J. Blacker ◽

Xia Wang ◽

Hisatomi Arima ◽

Pablo M. Lavados ◽

...

Keyword(s):

Blood Pressure ◽

Intracerebral Hemorrhage ◽

Neurological Deficit ◽

Cerebral Hemorrhage ◽

Intraventricular Hemorrhage ◽

Blood Pressure Reduction ◽

Pressure Reduction ◽

Nihss Score ◽

Neurosurgical Intervention ◽

Intensive Blood Pressure

Abstract BACKGROUND The prognosis in acute spontaneous intracerebral hemorrhage (ICH) is related to hematoma volume, where >30 mL is commonly used to define large ICH as a threshold for neurosurgical decompression but without clear supporting evidence. OBJECTIVES To determine the factors associated with large ICH and neurosurgical intervention among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials (INTERACT). METHODS We performed pooled analysis of the pilot INTERACT1 (n = 404) and main INTERACT2 (n = 2839) studies of ICH patients (<6 h of onset) with elevated systolic blood pressure (SBP, 150-220 mm Hg) who were randomized to intensive (target SBP < 140 mm Hg) or contemporaneous guideline-recommended (target SBP < 180 mm Hg) management. Neurosurgical intervention data were collected at 7 d postrandomization. Multivariable logistic regression was used to determine associations. RESULTS There were 372 (13%) patients with large ICH volume (>30 mL), which was associated with nonresiding in China, nondiabetic status, severe neurological deficit (National Institutes of Health stroke scale [NIHSS] score ≥ 15), lobar location, intraventricular hemorrhage extension, raised leucocyte count, and hyponatremia. Significant predictors of those patients who underwent surgery (226 of 3233 patients overall; 83 of 372 patients with large ICH) were younger age, severe neurological deficit (lower Glasgow coma scale score, and NIHSS score ≥ 15), baseline ICH volume > 30 mL, and intraventricular hemorrhage. CONCLUSIONS Early identification of severe ICH, based on age and clinical and imaging parameters, may facilitate neurosurgery and intensive monitoring of patients.

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Abstract T P228: Greater Effect of Early Intensive Blood Pressure Lowering on Hematoma Growth in Non-Chinese Participants in the Interact2 Trial

Stroke ◽

10.1161/str.45.suppl_1.tp228 ◽

2014 ◽

Vol 45 (suppl_1) ◽

Author(s):

Craig Anderson ◽

Yining Huang ◽

Jiguang Wang ◽

Hisatomi Arima ◽

Emma Heeley ◽

...

Keyword(s):

Blood Pressure ◽

Blood Pressure Reduction ◽

Clinical Severity ◽

Blood Pressure Lowering ◽

Hematoma Volume ◽

Vital Status ◽

Pressure Lowering ◽

Hematoma Growth ◽

To Receive ◽

Intensive Blood Pressure

Background: We aimed to assess the effects of early intensive blood pressure (BP) lowering on hematoma growth separately for Chinese and non-Chinese participants in the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2). Methods: INTERACT2 was an open, randomised, multicentre clinical trial involving 2839 patients with spontaneous ICH and elevated systolic BP (150-220 mmHg) and capacity to receive intensive BP lowering treatment within 6 hours of onset. Participants were centrally randomized to receive intensive (target systolic <140 mmHg) or standard (target systolic <180 mmHg) BP management using intravenous agents. Vital status and disability were assessed over 90 days. Baseline and 24 hour CT digital images were analysed centrally in 964 (34%). Results: Compared to non-Chinese participants, the Chinese were significantly younger, had milder clinical severity, less co-morbid diabetes and coronary disease, and were randomised slightly later after the onset of ICH. However, baseline hematoma volumes were similar (median 11 ml). There were also significant differences in medical management. Effects of treatment on mean (95% CI) absolute hematoma growth at 24 hours (adjusted for baseline hematoma volume and time from onset of CT) were: (i) non-Chinese - intensive 2.8 (0.7-4.9) vs standard 6.2 (4.1-8.4), [[Unable to Display Character: ∆]]-3.5 (-6.5-0.5) groups, P=0.02; (ii) Chinese - intensive 3.4 (1.5-5.3) vs standard 2.0 (0.04-3.9), [[Unable to Display Character: ∆]]1.4 (-0.8-3.6) groups, P=0.21. Conclusions: There was a significantly greater effect of early intensive BP lowering on hematoma growth in non-Chinese participants, which could relate to less effective BP reduction and greater use of background medical therapy including mannitol, in the Chinese participants

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Statistical analysis plan for pooled individual patient data from two landmark randomized trials (INTERACT2 and ATACH-II) of intensive blood pressure lowering treatment in acute intracerebral hemorrhage

International Journal of Stroke ◽

10.1177/1747493018813695 ◽

2018 ◽

Vol 14 (3) ◽

pp. 321-328 ◽

Cited By ~ 1

Author(s):

Tom J Moullaali ◽

Xia Wang ◽

Renee' H Martin ◽

Virginia B Shipes ◽

Adnan I Qureshi ◽

...

Keyword(s):

Blood Pressure ◽

Intracerebral Hemorrhage ◽

Systolic Blood Pressure ◽

Functional Recovery ◽

Modified Rankin Scale ◽

Blood Pressure Lowering ◽

Safety Outcomes ◽

Pressure Lowering ◽

Acute Intracerebral Hemorrhage ◽

Intensive Blood Pressure

Background There is persistent uncertainty over the benefits of early intensive systolic blood pressure lowering in acute intracerebral hemorrhage. In particular, over the timing, target, and intensity of systolic blood pressure control for optimum balance of potential benefits (i.e. functional recovery) and risks (e.g. cerebral ischemia). Aims To determine associations of early systolic blood pressure lowering parameters and outcomes in patients with a hypertensive response in acute intracerebral hemorrhage. Secondary aims are to identify the modifying effects of patient characteristics and an optimal systolic blood pressure lowering profile. Methods Individual participant data pooled analyses of two large, multicenter, randomized controlled trials specifically undertaken to assess the effects of early intensive systolic blood pressure reduction on clinical outcomes in acute intracerebral hemorrhage: the Intensive Blood Pressure in Acute Intracerebral Hemorrhage Trial (INTERACT2) and the Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II) trial. Combined data will include baseline characteristics; systolic blood pressure in the first 24 h; process of care measures; and key efficacy and safety outcomes. Outcomes The primary outcome is functional recovery, defined by an ordinal distribution of scores on the modified Rankin scale at 90 days post-randomization. Secondary outcomes include various standard binary cut-points for disability-free survival on the modified Rankin scale, and health-related quality of life at 90 days. Safety outcomes include symptomatic hypotension requiring corrective therapy and early neurologic deterioration within 24 h, and deaths, any serious adverse event, and cardiac and renal serious adverse events, within 90 days. Discussion A pre-determined protocol was developed to facilitate successful collaboration and reduce analysis bias arising from prior knowledge of the findings. Clinical trial registration URL: http://www.clinicaltrials.gov . Unique identifiers for INTERACT2 (NCT00716079) and ATACH-II (NCT01176565).

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Regional differences in the response to acute blood pressure lowering after cerebral hemorrhage

Neurology ◽

10.1212/wnl.0000000000011229 ◽

2020 ◽

pp. 10.1212/WNL.0000000000011229

Author(s):

Kazunori Toyoda ◽

Yuko Y Palesch ◽

Masatoshi Koga ◽

Lydia Foster ◽

Haruko Yamamoto ◽

...

Keyword(s):

Blood Pressure ◽

Adverse Events ◽

Intracerebral Hemorrhage ◽

East Asia ◽

Functional Outcomes ◽

Intensive Treatment ◽

Hematoma Expansion ◽

Blood Pressure Lowering ◽

Pressure Lowering ◽

Intensive Blood Pressure

Objective:To compare the impact of intensive blood pressure (BP) lowering right after intracerebral hemorrhage (ICH) on clinical and hematoma outcomes among patients from different geographic locations, we performed a prespecified sub-analysis of the randomized, multi-national, two-group, open-label trial to determine the efficacy of rapidly lowering BP in hyperacute ICH (ATACH-2), involving 537 patients from East Asia and 463 recruited outside of Asia.Methods:Eligible patients were randomly assigned to a systolic BP (SBP) target of 110-139 mmHg (intensive treatment) or 140-179 mmHg (standard treatment). Pre-defined outcomes were: poor functional outcome (modified Rankin Scale score of 4-6 at 90 days), death within 90 days, hematoma expansion at 24 hours; and cardio-renal adverse events within 7 days.Results:Poor functional outcomes (32.0% versus 45.9%), death (1.9% versus 13.3%), and cardio-renal adverse events (3.9% versus 11.2%) occurred significantly less in patients from Asia than those outside of Asia. The treatment-by-cohort interaction was not significant for any outcomes. Only patients from Asia showed a lower incidence of hematoma expansion with intensive treatment (adjusted RR 0.56, 95% CI 0.38-0.83). Both Asian (3.53, 1.28-9.64) and non-Asian cohorts (1.71, 1.00-2.93) showed a higher incidence of cardio-renal adverse events with intensive treatment.Conclusions:Poor functional outcomes and death 90 days after ICH were less common in patients from East Asia than those outside of Asia. Hematoma expansion, a potential predictor for poor clinical outcome, was attenuated by intensive BP lowering only in the Asian cohort.Clinicaltrials.gov identifierNCT01176565.Classification of evidence:This study provides Class II evidence that, for patients from East Asia with intracerebral hemorrhage, intensive blood pressure lowering significantly reduces the risk of hematoma expansion.

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