Off-Hour Admission and Outcomes in Patients with Acute Intracerebral Hemorrhage in the INTERACT2 Trial

2015 ◽  
Vol 40 (3-4) ◽  
pp. 114-120 ◽  
Author(s):  
Shoichiro Sato ◽  
Hisatomi Arima ◽  
Emma Heeley ◽  
Yoichiro Hirakawa ◽  
Candice Delcourt ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Primary Outcome ◽  
Adverse Outcome ◽  
Multicenter Clinical Trial ◽  
Poor Clinical Outcome ◽  
Night Time ◽  
Similar Treatment ◽  
Acute Intracerebral Hemorrhage ◽  
Public Holidays ◽  
Intensive Blood Pressure

Background: Conflicting data exist of an association between off-hour (weekend, holiday, or night-time) hospital admission and adverse outcome in intracerebral hemorrhage (ICH). We determined the association between off-hour admissions and poor clinical outcome, and of any differential effect of early intensive blood pressure (BP) lowering treatment between off- and on-hour admissions, among participants of the Intensive BP Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2). Methods: Subsidiary analysis of INTERACT2, a multinational, multicenter, clinical trial of patients with spontaneous ICH with elevated systolic BP, randomly assigned to intensive (target systolic BP <140 mm Hg) or guideline-based (<180 mm Hg) BP management. Primary outcome was death or major disability (modified Rankin scale of 3-6) at 90 days. Off-hour admission was defined as night-time (4:30 p.m. to 8:30 a.m.) on weekdays, weekends (Saturday and Sunday), and public holidays in each participating country. Results: Of 2,794 patients with information on the primary outcome, 1,770 (63%) were admitted to study centers during off-hours. Off-hour admission was not associated with risk of poor outcome at 90 days (53% off-hour vs. 55% on-hour; p = 0.49), even after adjustment for comorbid risk factors (odds ratio 0.92; 95% CI 0.76-1.12). Consistency exists in the effects of intensive BP lowering between off- and on-hour admission (p = 0.85 for homogeneity). Conclusions: Off-hour admission was not associated with increased risks of death or major disability among trial protocol participants with acute ICH. Intensive BP lowering can provide similar treatment effect irrespective of admission hours.

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

2018 ◽  
Vol 14 (3) ◽  
pp. 321-328 ◽  
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).

scholarly journals Early Cognitive Impairment after Intracerebral Hemorrhage in the INTERACT1 Study

2017 ◽  
Vol 44 (5-6) ◽  
pp. 320-324 ◽  
Author(s):  
Shoujiang You ◽  
Xia Wang ◽  
Richard I. Lindley ◽  
Thompson Robinson ◽  
Craig S. Anderson ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Intracerebral Hemorrhage ◽  
Mini Mental State Examination ◽  
Multivariable Analysis ◽  
The Elderly ◽  
Background Data ◽  
Acute Intracerebral Hemorrhage ◽  
State Examination ◽  
Intensive Blood Pressure

Background: Data on cognitive impairment after acute intracerebral hemorrhage (ICH) are limited. This study is aimed at determining the frequency and predictors of cognitive impairment among participants of the pilot phase, Intensive Blood Pressure (BP) Reduction in Acute Cerebral Hemorrhage Trial (INTERACT1). Methods: INTERACT1 was an open randomized trial of early intensive (target systolic BP <140 mm Hg) compared with contemporaneous guideline-recommended BP lowering in 404 patients with elevated systolic BP (150–220 mm Hg) within 6 h of ICH onset. Cognitive impairment was defined by scores ≤24 on the Mini-Mental State Examination (MMSE) assessed by interview on follow-up at 90 days. Results: A total of 231 (64.5%) of 358 90-day survivors had MMSE scores for analyses, and 75 (32.5%) had cognitive impairment. In multivariable analysis, older age (OR 2.48, 95% CI 1.73–3.56 per 10-year increase; p < 0.001), female sex (OR 2.06, 95% CI 1.00–4.23; p = 0.049), prior ICH (OR 2.87, 95% CI 1.08–7.65; p = 0.035), high baseline National Institute of Health Stroke Scale score (OR 1.06, 95% CI 1.00–1.13; p = 0.044), and high mean systolic BP over the first 24 h post-randomization (OR 1.34, 95% CI 1.07–1.68/10 mm Hg increase; p = 0.011) were independently associated with cognitive impairment. Conclusions: One third of patients have significant cognitive impairment early after ICH, which is more frequent in the elderly, females, those with prior ICH, and more severe initial neurological deficit and with persistently high early systolic BP.

Intensive blood pressure reduction in acute intracerebral hemorrhage: A meta-analysis

Neurology ◽  
2014 ◽  
Vol 83 (17) ◽  
pp. 1523-1529 ◽  
Author(s):  
G. Tsivgoulis ◽  
A. H. Katsanos ◽  
K. S. Butcher ◽  
E. Boviatsis ◽  
N. Triantafyllou ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Intracerebral Hemorrhage ◽  
Meta Analysis ◽  
Blood Pressure Reduction ◽  
Pressure Reduction ◽  
Acute Intracerebral Hemorrhage ◽  
Intensive Blood Pressure

Acute Hypertensive Response in Patients With Acute Intracerebral Hemorrhage: A Narrative Review

Neurology ◽  
2021 ◽  
pp. 10.1212/WNL.0000000000012276
Author(s):  
Maximiliano A. Hawkes ◽  
Alejandro A. Rabinstein
Keyword(s):  
Blood Pressure ◽  
Clinical Trials ◽  
Intracerebral Hemorrhage ◽  
Clinical Outcomes ◽  
Randomized Clinical Trials ◽  
Hematoma Expansion ◽  
Pressure Treatment ◽  
Blood Pressure Treatment ◽  
Acute Intracerebral Hemorrhage ◽  
Intensive Blood Pressure

ObjectiveTo review the role of the acute hypertensive response in patients with intracerebral hemorrhage, current treatment options and areas for further research.MethodsReview of the literature to assess 1) Frequency of acute hypertensive response in intracerebral hemorrhage 2) Consequences of acute hypertensive response in clinical outcomes 3) Acute hypertensive response and secondary brain injury: hematoma expansion and perihematomal edema 4) Vascular autoregulation, safety data side effects of acute antihypertensive treatment, and 5) Randomized clinical trials and meta-analyses.ResultsAn acute hypertensive response is highly frequent in patients with acute intracerebral hemorrhage, and it is associated with poor clinical outcomes. However, it is not clear whether high blood pressure is a cause poor clinical outcome, or it solely represents a marker of severity. Although current guidelines recommend intensive blood pressure treatment (<140 mmHg) in patients with intracerebral hemorrhage, two randomized clinical trials have failed to demonstrate a consistent clinical benefit from this approach, and new data suggest that intensive blood pressure treatment could be beneficial for some patients, but detrimental for others.ConclusionsIntracerebral hemorrhage is a heterogenous disease, thus, a one-fit-all approach for blood pressure treatment may be suboptimal. Further research should concentrate on finding subgroups of patients more likely to benefit from aggressive BP lowering, considering ICH etiology, ultra-early randomization and risk markers of hematoma expansion on brain imaging.

Abstract MP37: Race/Ethnicity Differences in Response to Intensive Blood Pressure Treatment After Intracerebral Hemorrhage: Analysis of the Atach-2 Trial

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Mohammad Anadani ◽  
Adam H De Havenon
Keyword(s):  
Blood Pressure ◽  
Intracerebral Hemorrhage ◽  
Primary Outcome ◽  
Right Hemisphere ◽  
Reference Group ◽  
Response To Treatment ◽  
Black Patients ◽  
Race Ethnicity ◽  
Intensive Blood Pressure ◽  
White Patients

Background: The main analysis of the ATACH-2 (Antihypertensive Treatment in Intracerebral Hemorrhage-2) trial suggested no benefit from intensive blood pressure lowering (BPL) treatment after intracerebral hemorrhage (ICH). However, whether outcome and response to treatment differs according to race was not sufficiently studied. Methods: This is a post-hoc analysis of the ATACH-2 trial. The primary outcome was death or disability (90-day modified Rankin Scale [mRS] 4-6). Patients were divided according to race/ethnicity. Logistic regression was fit to assess the association between race and the primary outcome. In addition, we assessed the interaction between intensive BPL treatment and race. Results: A total of 939 patients (White=206, Asian=549, Black=111, Hispanic=73) were included. Death and disability occurred more frequently in White patients than other races (Figure). However, after adjusting for patient age, sex, baseline Glasgow Coma Scale, intracranial hemorrhage volume in mL, presence of intraventricular hemorrhage, deep vs. lobar, left vs. right hemisphere, intubation and ATACH treatment arm, Black patients had higher odds of the primary outcome (OR=1.98, P=0.02) compared to White patients. In contrast, Asian and Hispanic patients had non-statistically significant lower odds of the primary outcome (OR=0.68, P=0.09; OR= 0.97; P=0.95, respectively) compared to White patients. We did not observe treatment-by-race interaction. the p values for the interaction of intensive BPL treatment vs. standard BPL were 0.508 in Blacks, 0.336 in Hispanics and 0.190 in Asians, with Whites as the reference group. Conclusion: Black patients had higher odds of death or disability after non-traumatic supratentorial intracerebral hemorrhage compared to White patients.

Rapid Blood Pressure Lowering According to Recovery at Different Time Intervals after Acute Intracerebral Hemorrhage: Pooled Analysis of the INTERACT Studies

2015 ◽  
Vol 39 (3-4) ◽  
pp. 242-248 ◽  
Author(s):  
Xia Wang ◽  
Hisatomi Arima ◽  
Rustam Al-Shahi Salman ◽  
Mark Woodward ◽  
Emma Heeley ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Intracerebral Hemorrhage ◽  
Repeated Measures ◽  
Treatment Effects ◽  
Blood Pressure Reduction ◽  
Pooled Analysis ◽  
Clinical Trial Registration ◽  
Acute Intracerebral Hemorrhage ◽  
Time Periods ◽  
Intensive Blood Pressure

Background and Purpose: 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. Methods: Pooled analysis of the pilot INTERACT1 (n = 404) and main INTERACT2 (n = 2,839) involving patients with spontaneous ICH (<6 h) and elevated systolic BP (SBP 150-220 mm Hg) who were randomized to intensive (target SBP <140 mm Hg) or guideline-recommended (target SBP <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. Results: 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. Conclusions: Intensive BP lowering provides beneficial effects on physical functioning that manifests consistently through the early and later phases of recovery from ICH.

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