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Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage.
N Engl J Med. 2016 09 15; 375(11):1033-43.NEJM

Abstract

BACKGROUND

Limited data are available to guide the choice of a target for the systolic blood-pressure level when treating acute hypertensive response in patients with intracerebral hemorrhage.

METHODS

We randomly assigned eligible participants with intracerebral hemorrhage (volume, <60 cm(3)) and a Glasgow Coma Scale (GCS) score of 5 or more (on a scale from 3 to 15, with lower scores indicating worse condition) to a systolic blood-pressure target of 110 to 139 mm Hg (intensive treatment) or a target of 140 to 179 mm Hg (standard treatment) in order to test the superiority of intensive reduction of systolic blood pressure to standard reduction; intravenous nicardipine to lower blood pressure was administered within 4.5 hours after symptom onset. The primary outcome was death or disability (modified Rankin scale score of 4 to 6, on a scale ranging from 0 [no symptoms] to 6 [death]) at 3 months after randomization, as ascertained by an investigator who was unaware of the treatment assignments.

RESULTS

Among 1000 participants with a mean (±SD) systolic blood pressure of 200.6±27.0 mm Hg at baseline, 500 were assigned to intensive treatment and 500 to standard treatment. The mean age of the patients was 61.9 years, and 56.2% were Asian. Enrollment was stopped because of futility after a prespecified interim analysis. The primary outcome of death or disability was observed in 38.7% of the participants (186 of 481) in the intensive-treatment group and in 37.7% (181 of 480) in the standard-treatment group (relative risk, 1.04; 95% confidence interval, 0.85 to 1.27; analysis was adjusted for age, initial GCS score, and presence or absence of intraventricular hemorrhage). Serious adverse events occurring within 72 hours after randomization that were considered by the site investigator to be related to treatment were reported in 1.6% of the patients in the intensive-treatment group and in 1.2% of those in the standard-treatment group. The rate of renal adverse events within 7 days after randomization was significantly higher in the intensive-treatment group than in the standard-treatment group (9.0% vs. 4.0%, P=0.002).

CONCLUSIONS

The treatment of participants with intracerebral hemorrhage to achieve a target systolic blood pressure of 110 to 139 mm Hg did not result in a lower rate of death or disability than standard reduction to a target of 140 to 179 mm Hg. (Funded by the National Institute of Neurological Disorders and Stroke and the National Cerebral and Cardiovascular Center; ATACH-2 ClinicalTrials.gov number, NCT01176565 .).

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Authors+Show Affiliations

Qureshi AI
From the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., R.L.M.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.); the Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore (D.F.H.), and the Neurological Institute, National Institute of Neurological Disorders and Stroke, Bethesda (C.S.M.) - both in Maryland; China Medical University, Taichung, Taiwan (C.Y.H.); the Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, and the Department of Neurology, Heidelberg University Hospital, Heidelberg - both in Germany (T.S.); the Department of Neurology, Baylor College of Medicine, Houston (J.I.S.); the Departments of Cerebrovascular Medicine (K.T.) and Data Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan; Beijing Tiantan Hospital, Beijing (Y.W.); and the Department of Neurology, Seoul National University Hospital, Seoul, South Korea (B.-W.Y.).
Palesch YY
From the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., R.L.M.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.); the Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore (D.F.H.), and the Neurological Institute, National Institute of Neurological Disorders and Stroke, Bethesda (C.S.M.) - both in Maryland; China Medical University, Taichung, Taiwan (C.Y.H.); the Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, and the Department of Neurology, Heidelberg University Hospital, Heidelberg - both in Germany (T.S.); the Department of Neurology, Baylor College of Medicine, Houston (J.I.S.); the Departments of Cerebrovascular Medicine (K.T.) and Data Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan; Beijing Tiantan Hospital, Beijing (Y.W.); and the Department of Neurology, Seoul National University Hospital, Seoul, South Korea (B.-W.Y.).
Barsan WG
From the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., R.L.M.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.); the Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore (D.F.H.), and the Neurological Institute, National Institute of Neurological Disorders and Stroke, Bethesda (C.S.M.) - both in Maryland; China Medical University, Taichung, Taiwan (C.Y.H.); the Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, and the Department of Neurology, Heidelberg University Hospital, Heidelberg - both in Germany (T.S.); the Department of Neurology, Baylor College of Medicine, Houston (J.I.S.); the Departments of Cerebrovascular Medicine (K.T.) and Data Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan; Beijing Tiantan Hospital, Beijing (Y.W.); and the Department of Neurology, Seoul National University Hospital, Seoul, South Korea (B.-W.Y.).
Hanley DF
From the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., R.L.M.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.); the Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore (D.F.H.), and the Neurological Institute, National Institute of Neurological Disorders and Stroke, Bethesda (C.S.M.) - both in Maryland; China Medical University, Taichung, Taiwan (C.Y.H.); the Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, and the Department of Neurology, Heidelberg University Hospital, Heidelberg - both in Germany (T.S.); the Department of Neurology, Baylor College of Medicine, Houston (J.I.S.); the Departments of Cerebrovascular Medicine (K.T.) and Data Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan; Beijing Tiantan Hospital, Beijing (Y.W.); and the Department of Neurology, Seoul National University Hospital, Seoul, South Korea (B.-W.Y.).
Hsu CY
From the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., R.L.M.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.); the Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore (D.F.H.), and the Neurological Institute, National Institute of Neurological Disorders and Stroke, Bethesda (C.S.M.) - both in Maryland; China Medical University, Taichung, Taiwan (C.Y.H.); the Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, and the Department of Neurology, Heidelberg University Hospital, Heidelberg - both in Germany (T.S.); the Department of Neurology, Baylor College of Medicine, Houston (J.I.S.); the Departments of Cerebrovascular Medicine (K.T.) and Data Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan; Beijing Tiantan Hospital, Beijing (Y.W.); and the Department of Neurology, Seoul National University Hospital, Seoul, South Korea (B.-W.Y.).
Martin RL
From the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., R.L.M.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.); the Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore (D.F.H.), and the Neurological Institute, National Institute of Neurological Disorders and Stroke, Bethesda (C.S.M.) - both in Maryland; China Medical University, Taichung, Taiwan (C.Y.H.); the Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, and the Department of Neurology, Heidelberg University Hospital, Heidelberg - both in Germany (T.S.); the Department of Neurology, Baylor College of Medicine, Houston (J.I.S.); the Departments of Cerebrovascular Medicine (K.T.) and Data Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan; Beijing Tiantan Hospital, Beijing (Y.W.); and the Department of Neurology, Seoul National University Hospital, Seoul, South Korea (B.-W.Y.).
Moy CS
From the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., R.L.M.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.); the Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore (D.F.H.), and the Neurological Institute, National Institute of Neurological Disorders and Stroke, Bethesda (C.S.M.) - both in Maryland; China Medical University, Taichung, Taiwan (C.Y.H.); the Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, and the Department of Neurology, Heidelberg University Hospital, Heidelberg - both in Germany (T.S.); the Department of Neurology, Baylor College of Medicine, Houston (J.I.S.); the Departments of Cerebrovascular Medicine (K.T.) and Data Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan; Beijing Tiantan Hospital, Beijing (Y.W.); and the Department of Neurology, Seoul National University Hospital, Seoul, South Korea (B.-W.Y.).
Silbergleit R
From the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., R.L.M.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.); the Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore (D.F.H.), and the Neurological Institute, National Institute of Neurological Disorders and Stroke, Bethesda (C.S.M.) - both in Maryland; China Medical University, Taichung, Taiwan (C.Y.H.); the Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, and the Department of Neurology, Heidelberg University Hospital, Heidelberg - both in Germany (T.S.); the Department of Neurology, Baylor College of Medicine, Houston (J.I.S.); the Departments of Cerebrovascular Medicine (K.T.) and Data Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan; Beijing Tiantan Hospital, Beijing (Y.W.); and the Department of Neurology, Seoul National University Hospital, Seoul, South Korea (B.-W.Y.).
Steiner T
From the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., R.L.M.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.); the Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore (D.F.H.), and the Neurological Institute, National Institute of Neurological Disorders and Stroke, Bethesda (C.S.M.) - both in Maryland; China Medical University, Taichung, Taiwan (C.Y.H.); the Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, and the Department of Neurology, Heidelberg University Hospital, Heidelberg - both in Germany (T.S.); the Department of Neurology, Baylor College of Medicine, Houston (J.I.S.); the Departments of Cerebrovascular Medicine (K.T.) and Data Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan; Beijing Tiantan Hospital, Beijing (Y.W.); and the Department of Neurology, Seoul National University Hospital, Seoul, South Korea (B.-W.Y.).
Suarez JI
From the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., R.L.M.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.); the Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore (D.F.H.), and the Neurological Institute, National Institute of Neurological Disorders and Stroke, Bethesda (C.S.M.) - both in Maryland; China Medical University, Taichung, Taiwan (C.Y.H.); the Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, and the Department of Neurology, Heidelberg University Hospital, Heidelberg - both in Germany (T.S.); the Department of Neurology, Baylor College of Medicine, Houston (J.I.S.); the Departments of Cerebrovascular Medicine (K.T.) and Data Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan; Beijing Tiantan Hospital, Beijing (Y.W.); and the Department of Neurology, Seoul National University Hospital, Seoul, South Korea (B.-W.Y.).
Toyoda K
From the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., R.L.M.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.); the Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore (D.F.H.), and the Neurological Institute, National Institute of Neurological Disorders and Stroke, Bethesda (C.S.M.) - both in Maryland; China Medical University, Taichung, Taiwan (C.Y.H.); the Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, and the Department of Neurology, Heidelberg University Hospital, Heidelberg - both in Germany (T.S.); the Department of Neurology, Baylor College of Medicine, Houston (J.I.S.); the Departments of Cerebrovascular Medicine (K.T.) and Data Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan; Beijing Tiantan Hospital, Beijing (Y.W.); and the Department of Neurology, Seoul National University Hospital, Seoul, South Korea (B.-W.Y.).
Wang Y
From the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., R.L.M.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.); the Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore (D.F.H.), and the Neurological Institute, National Institute of Neurological Disorders and Stroke, Bethesda (C.S.M.) - both in Maryland; China Medical University, Taichung, Taiwan (C.Y.H.); the Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, and the Department of Neurology, Heidelberg University Hospital, Heidelberg - both in Germany (T.S.); the Department of Neurology, Baylor College of Medicine, Houston (J.I.S.); the Departments of Cerebrovascular Medicine (K.T.) and Data Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan; Beijing Tiantan Hospital, Beijing (Y.W.); and the Department of Neurology, Seoul National University Hospital, Seoul, South Korea (B.-W.Y.).
Yamamoto H
From the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., R.L.M.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.); the Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore (D.F.H.), and the Neurological Institute, National Institute of Neurological Disorders and Stroke, Bethesda (C.S.M.) - both in Maryland; China Medical University, Taichung, Taiwan (C.Y.H.); the Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, and the Department of Neurology, Heidelberg University Hospital, Heidelberg - both in Germany (T.S.); the Department of Neurology, Baylor College of Medicine, Houston (J.I.S.); the Departments of Cerebrovascular Medicine (K.T.) and Data Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan; Beijing Tiantan Hospital, Beijing (Y.W.); and the Department of Neurology, Seoul National University Hospital, Seoul, South Korea (B.-W.Y.).
Yoon BW
From the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q.); the Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., R.L.M.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.); the Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore (D.F.H.), and the Neurological Institute, National Institute of Neurological Disorders and Stroke, Bethesda (C.S.M.) - both in Maryland; China Medical University, Taichung, Taiwan (C.Y.H.); the Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, and the Department of Neurology, Heidelberg University Hospital, Heidelberg - both in Germany (T.S.); the Department of Neurology, Baylor College of Medicine, Houston (J.I.S.); the Departments of Cerebrovascular Medicine (K.T.) and Data Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita, Japan; Beijing Tiantan Hospital, Beijing (Y.W.); and the Department of Neurology, Seoul National University Hospital, Seoul, South Korea (B.-W.Y.).
ATACH-2 Trial Investigators and the Neurological Emergency Treatment Trials Network
No affiliation info available

MeSH

AgedAntihypertensive AgentsCerebral HemorrhageFemaleGlasgow Coma ScaleHumansHypertensionInfusions, IntravenousMaleMiddle AgedNicardipineTreatment FailureTreatment Outcome

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, N.I.H., Intramural

Language

eng

PubMed ID

27276234

Clinical Trial Links

Clinical trial which this article describes
Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage
Proper Timing of Control of Hypertension and Outcome in Acute Spontaneous Intracerebral Hemorrhage.

Citation

Qureshi, Adnan I., et al. "Intensive Blood-Pressure Lowering in Patients With Acute Cerebral Hemorrhage." The New England Journal of Medicine, vol. 375, no. 11, 2016, pp. 1033-43.
Qureshi AI, Palesch YY, Barsan WG, et al. Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage. N Engl J Med. 2016;375(11):1033-43.
Qureshi, A. I., Palesch, Y. Y., Barsan, W. G., Hanley, D. F., Hsu, C. Y., Martin, R. L., Moy, C. S., Silbergleit, R., Steiner, T., Suarez, J. I., Toyoda, K., Wang, Y., Yamamoto, H., & Yoon, B. W. (2016). Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage. The New England Journal of Medicine, 375(11), 1033-43. https://doi.org/10.1056/NEJMoa1603460
Qureshi AI, et al. Intensive Blood-Pressure Lowering in Patients With Acute Cerebral Hemorrhage. N Engl J Med. 2016 09 15;375(11):1033-43. PubMed PMID: 27276234.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage. AU - Qureshi,Adnan I, AU - Palesch,Yuko Y, AU - Barsan,William G, AU - Hanley,Daniel F, AU - Hsu,Chung Y, AU - Martin,Renee L, AU - Moy,Claudia S, AU - Silbergleit,Robert, AU - Steiner,Thorsten, AU - Suarez,Jose I, AU - Toyoda,Kazunori, AU - Wang,Yongjun, AU - Yamamoto,Haruko, AU - Yoon,Byung-Woo, AU - ,, Y1 - 2016/06/08/ PY - 2016/6/9/entrez PY - 2016/6/9/pubmed PY - 2016/9/23/medline SP - 1033 EP - 43 JF - The New England journal of medicine JO - N Engl J Med VL - 375 IS - 11 N2 - BACKGROUND: Limited data are available to guide the choice of a target for the systolic blood-pressure level when treating acute hypertensive response in patients with intracerebral hemorrhage. METHODS: We randomly assigned eligible participants with intracerebral hemorrhage (volume, <60 cm(3)) and a Glasgow Coma Scale (GCS) score of 5 or more (on a scale from 3 to 15, with lower scores indicating worse condition) to a systolic blood-pressure target of 110 to 139 mm Hg (intensive treatment) or a target of 140 to 179 mm Hg (standard treatment) in order to test the superiority of intensive reduction of systolic blood pressure to standard reduction; intravenous nicardipine to lower blood pressure was administered within 4.5 hours after symptom onset. The primary outcome was death or disability (modified Rankin scale score of 4 to 6, on a scale ranging from 0 [no symptoms] to 6 [death]) at 3 months after randomization, as ascertained by an investigator who was unaware of the treatment assignments. RESULTS: Among 1000 participants with a mean (±SD) systolic blood pressure of 200.6±27.0 mm Hg at baseline, 500 were assigned to intensive treatment and 500 to standard treatment. The mean age of the patients was 61.9 years, and 56.2% were Asian. Enrollment was stopped because of futility after a prespecified interim analysis. The primary outcome of death or disability was observed in 38.7% of the participants (186 of 481) in the intensive-treatment group and in 37.7% (181 of 480) in the standard-treatment group (relative risk, 1.04; 95% confidence interval, 0.85 to 1.27; analysis was adjusted for age, initial GCS score, and presence or absence of intraventricular hemorrhage). Serious adverse events occurring within 72 hours after randomization that were considered by the site investigator to be related to treatment were reported in 1.6% of the patients in the intensive-treatment group and in 1.2% of those in the standard-treatment group. The rate of renal adverse events within 7 days after randomization was significantly higher in the intensive-treatment group than in the standard-treatment group (9.0% vs. 4.0%, P=0.002). CONCLUSIONS: The treatment of participants with intracerebral hemorrhage to achieve a target systolic blood pressure of 110 to 139 mm Hg did not result in a lower rate of death or disability than standard reduction to a target of 140 to 179 mm Hg. (Funded by the National Institute of Neurological Disorders and Stroke and the National Cerebral and Cardiovascular Center; ATACH-2 ClinicalTrials.gov number, NCT01176565 .). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/27276234/Intensive_Blood_Pressure_Lowering_in_Patients_with_Acute_Cerebral_Hemorrhage_ DB - PRIME DP - Unbound Medicine ER -