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Systolic blood pressure lowering to 160 mmHg or less using nicardipine in acute intracerebral hemorrhage: a prospective, multicenter, observational study (the Stroke Acute Management with Urgent Risk-factor Assessment and Improvement-Intracerebral Hemorrhage study)

Koga, Masatoshia; Toyoda, Kazunorib; Yamagami, Hiroshid; Okuda, Satoshie; Okada, Yasushif; Kimura, Kazumig; Shiokawa, Yoshiakih; Nakagawara, Jyojii; Furui, Eisukej; Hasegawa, Yasuhirok; Kario, Kazuomil; Osaki, Masatob; Miyagi, Tetsuyab; Endo, Kaorub; Nagatsuka, Kazuyukic; Minematsu, Kazuob; for the Stroke Acute Management with Urgent Risk-factor Assessment and Improvement (SAMURAI) Study Investigators

doi: 10.1097/HJH.0b013e328359311b
ORIGINAL PAPERS: Cerebrovascular disease

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: toyoda@hsp.ncvc.go.jp

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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© 2012 Lippincott Williams & Wilkins, Inc.