Objective: Optimal blood pressure (BP) control in acute intracerebral hemorrhage (ICH) remains controversial. We determined the effects of SBP lowering to 160 mmHg or more using intravenous nicardipine for acute ICH patients.
Methods: This is a prospective, multicenter, observational study conducted in Japan, with the lack of control groups. Patients with supratentorial ICH within 3 h of onset, admission SBP 180 mmHg or more, Glasgow Coma Scale (GCS) 5 or more, and hematoma volume less than 60 ml were initially treated with intravenous nicardipine to maintain SBP between 120 and 160 mmHg with 24-h frequent BP monitoring. The primary endpoints were neurological deterioration within 72 h [GCS decrement ≥2 points or National Institutes of Health Stroke Scale (NIHSS) increment ≥4 points; estimated 90% confidence interval (CI) on the basis of previous studies: 15.2–25.9%] and serious adverse effects (SAE) to stopping intravenous nicardipine within 24 h (1.8–8.9%). The secondary endpoints included hematoma expansion more than 33% at 24 h (17.1–28.3%), modified Rankin Scale (mRS) 4 or more (54.5–67.9%) and death at 3 months (6.0–13.5%).
Results: We enrolled 211 Japanese patients (81 women, 65.6 ± 12.0 years old). At baseline, BP was 201.8 ± 15.7/107.9 ± 15.0 mmHg. Median hematoma volume was 10.2 ml (interquartile range 5.6–19.2), and NIHSS score was 13 (8–17). Neurological deterioration was identified in 17 patients (8.1%), SAE in two (0.9%), hematoma expansion in 36 (17.1%), mRS 4 or more in 87 (41.2%), and death in four (1.9%). All the results were equal to or below the estimated lower 90% CI.
Conclusion: SBP lowering to 160 mmHg or less using nicardipine appears to be well tolerated and feasible for acute ICH.
aDivision of Stroke Care Unit
bDepartment of Cerebrovascular Medicine
cDepartment of Neurology, National Cerebral and Cardiovascular Center, Suita
dDepartment of Neurology, Stroke Center, Kobe City General Hospital, Kobe
eDepartment of Neurology, National Hospital Organization Nagoya Medical Center, Nagoya
fDepartment of Cerebrovascular Disease, National Hospital Organization Kyushu Medical Center, Fukuoka
gDepartment of Stroke Medicine, Kawasaki Medical School, Kurashiki
hDepartments of Neurosurgery and Stroke Center, Kyorin University School of Medicine, Mitaka
iDepartment of Neurosurgery and Stroke Center, Nakamura Memorial Hospital, Sapporo
jDepartment of Stroke Neurology, Kohnan Hospital, Sendai
kDepartment of Neurology, St Marianna University School of Medicine, Kawasaki
lDivision of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Japan
Correspondence to Kazunori Toyoda, MD, Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, 5–7–1 Fujishiro-dai, Suita 565–8565, Japan. Tel: +81 6 6833 5012; fax: +81 6 6835 5267; e-mail: email@example.com
Abbreviations: ABC/2, (length × width × height)/2; AHA, American Heart Association; ASA, American Stroke Association; ATACH, Antihypertensive Treatment of Acute Cerebral Hemorrhage; BAT, Bleeding with Antithrombotic Therapy; BP, blood pressure; CI, confidence interval; CT, computed tomography; EUSI, European stroke initiative; GCS, Glasgow Coma Scale; ICH, intracerebral hemorrhage; INR, international normalized ratio; INTERACT, Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial; IQR, interquartile range; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; OR, odds ratio; SAE, serious adverse effect; SAMURAI, Stroke Acute Management with Urgent Risk-factor Assessment and Improvement
Received 9 May, 2012
Revised 20 July, 2012
Accepted 10 August, 2012
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