Adnan I Qureshi1, Lydia D Foster2, Iryna Lobanova3, Wei Huang3, Jose I Suarez4. 1. Zeenet Qureshi Stroke Institute and Department of Neurology, University of Missouri, Columbia, Missouri, USA, qureshai@gmail.com. 2. Division of Biostatistics and Epidemiology, Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA. 3. Zeenet Qureshi Stroke Institute and Department of Neurology, University of Missouri, Columbia, Missouri, USA. 4. Neurosciences Critical Care, Departments of Anesthesiology and Critical Care Medicine, Neurology, and Neurosurgery, Johns Hopkins University School of Medicine Baltimore, Baltimore, Maryland, USA.
Abstract
OBJECTIVE: To study the effect of intensive blood pressure reduction in patients with moderate to severe intracerebral hemorrhage (ICH) within the subjects recruited in Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 trial. DESIGN: Randomized, multicenter, 2 group, open-label clinical trial. SETTING:A total of 110 sites in the USA, Japan, China, Taiwan, South Korea, and Germany. PATIENTS: A total of 1,000 patients underwent randomization from May 2011 till September 2015. INTERVENTIONS: We analyzed the effect of intensive (goal 110-139 mm Hg) over standard (goal 140-179 mmHg) systolic blood pressure (SBP) reduction using intravenous nicardipine within 4.5 h of symptom onset in moderate to severe grade subjects with ICH in a non-prespecified analysis. Moderate to severe grade was defined by Glasgow Coma Scale score <13 or baseline National Institutes of Health Stroke Scale score≥10 or baseline intraparenchymal hemorrhage volume ≥30 mL or presence of intraventricular hemorrhage. The primary outcome was death or disability (score 4-6 on the modified Rankin scale) at 3 months after randomization ascertained by a blinded investigator. MEASUREMENTS AND MAIN RESULTS: Of a total of 682 subjects who met the definition of moderate to severe grade (mean age 61.9± 13.1 years, 62.5% men) with a mean baseline SBP of 174.7 ± 24.8 mm Hg, the frequency of hematoma expansion was significantly lower among subjects randomized to intensive SBP reduction than among subjects randomized to standard SBP reduction (20.4 vs. 27.9%, relative risk [RR]: 0.7; 95% confidence interval [CI]: 0.55-0.96). The primary endpoint of death or disability was observed in 52.5% (170/324) of subjects receiving intensive SBP reduction and 48.9% (163/333) of subjects receiving standard SBP reduction (RR: 1.1; 95% CI: 0.9-1.2). CONCLUSIONS: Intensive SBP lowering reduced the frequency of hematoma expansion but did not reduce the rate of death or disability in patients with moderate to severe grade ICH.
RCT Entities:
OBJECTIVE: To study the effect of intensive blood pressure reduction in patients with moderate to severe intracerebral hemorrhage (ICH) within the subjects recruited in Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 trial. DESIGN: Randomized, multicenter, 2 group, open-label clinical trial. SETTING: A total of 110 sites in the USA, Japan, China, Taiwan, South Korea, and Germany. PATIENTS: A total of 1,000 patients underwent randomization from May 2011 till September 2015. INTERVENTIONS: We analyzed the effect of intensive (goal 110-139 mm Hg) over standard (goal 140-179 mm Hg) systolic blood pressure (SBP) reduction using intravenous nicardipine within 4.5 h of symptom onset in moderate to severe grade subjects with ICH in a non-prespecified analysis. Moderate to severe grade was defined by Glasgow Coma Scale score <13 or baseline National Institutes of Health Stroke Scale score ≥10 or baseline intraparenchymal hemorrhage volume ≥30 mL or presence of intraventricular hemorrhage. The primary outcome was death or disability (score 4-6 on the modified Rankin scale) at 3 months after randomization ascertained by a blinded investigator. MEASUREMENTS AND MAIN RESULTS: Of a total of 682 subjects who met the definition of moderate to severe grade (mean age 61.9 ± 13.1 years, 62.5% men) with a mean baseline SBP of 174.7 ± 24.8 mm Hg, the frequency of hematoma expansion was significantly lower among subjects randomized to intensive SBP reduction than among subjects randomized to standard SBP reduction (20.4 vs. 27.9%, relative risk [RR]: 0.7; 95% confidence interval [CI]: 0.55-0.96). The primary endpoint of death or disability was observed in 52.5% (170/324) of subjects receiving intensive SBP reduction and 48.9% (163/333) of subjects receiving standard SBP reduction (RR: 1.1; 95% CI: 0.9-1.2). CONCLUSIONS: Intensive SBP lowering reduced the frequency of hematoma expansion but did not reduce the rate of death or disability in patients with moderate to severe grade ICH.
Authors: Sebastian Rauch; Hans-Peter Müller; Jens Dreyhaupt; Albert C Ludolph; Jan Kassubek; Katharina Althaus Journal: J Clin Med Date: 2022-06-13 Impact factor: 4.964