Randomized trial to assess safety and clinical efficacy of intensive blood pressure reduction in acute spontaneous intracerebral haemorrhage

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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Faculty Opinions recommendation of Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.1108248.793538772 ◽

2017 ◽

Author(s):

Lauren Sansing

Keyword(s):

Blood Pressure ◽

Blood Pressure Reduction ◽

Pilot Trial ◽

Cerebral Haemorrhage ◽

Pressure Reduction ◽

Intensive Blood Pressure

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Abstract W P250: The Impact of Acute Hypertensive Response on Mortality After Intracerebral Hemorrhage Differs Among Patients With and Without Left Ventricle Hypertrophy

Stroke ◽

10.1161/str.45.suppl_1.wp250 ◽

2014 ◽

Vol 45 (suppl_1) ◽

Author(s):

Octavio M Pontes-Neto ◽

Sergi Martinez-Ramirez ◽

Anand Viswanathan ◽

Timothy C Tan ◽

Maria C Nunes ◽

...

Keyword(s):

Blood Pressure ◽

Left Ventricle ◽

Acute Phase ◽

Blood Pressure Reduction ◽

Chronic Hypertension ◽

Pressure Reduction ◽

Left Ventricle Hypertrophy ◽

Ventricle Hypertrophy ◽

Haenszel Test ◽

Intensive Blood Pressure

Background: While acute hypertensive response (AHR) predicts worse outcome in intracerebral hemorrhage (ICH), the INTERACT-2 trial recently failed to definitively demonstrate a major benefit of intensive blood pressure reduction on these patients. A possible explanation is that the detrimental effect of AHR on outcome may differ among ICH patients with and without previous chronic hypertension. Objective: to explore whether the prognosis of patients with AHR during the acute phase of ICH differs according to the presence or absence of left ventricle hypertrophy (LVH), which is a marker of chronic hypertensive organ damage. Method: we performed a retrospective analysis of a prospective cohort of patients with primary ICH presenting to an academic hospital between January/2000 and December/2012 with age > 18 years, who had a transthoracic echocardiogram available. LVH was defined according to Penn convention. AHR was defined as systolic blood pressure > 180 mmHg on admission. Mantel-Haenszel test was initially used to assess if LVH status influenced the effect of AHR on mortality. For subsequent analyses, ICH patients were divided in 3 groups: without AHR (reference); AHR without LVH; AHR with LVH. A multivariate logistic regression model was then used to identify independent predictors of mortality at 30-days. Results: 430 patients met inclusion criteria. AHR was present in 196 (46.6%), LVH was present in 233 (54.2%); 30-day mortality was 15.6%. On Mantel-Haenszel test, we found a trend (p=0.09) suggesting that absence of LVH increased AHR effect on mortality (OR:1.64; 95% CI: 0.95-2.8; p=0.07). On multivariate analysis, patients with AHR without LVH had significantly higher mortality (OR: 2.65; 95%CI: 1.15 to 6.1; p=0.022) when compared to patients without AHR, after adjusting for baseline characteristics. There was only a trend towards increased mortality in the group of patients with AHR and LVH (OR:2.22; 95% CI: 0.99-5.0; p=0.053). Conclusions: Patients without chronic hypertension appear to be more susceptible to the detrimental effects of AHR during the acute phase of ICH. Stratification of patients with ICH may help to identify those that will have greater benefit with intensive blood pressure reduction in the acute phase of ICH.

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