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N Engl J Med. 2016 Sep 15;375(11):1033-43. doi: 10.1056/NEJMoa1603460. Epub 2016 Jun 8.

Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage.

Collaborators (463)

Qureshi AI, Hussein H, Novitzke JM, Witzel C, Connelly B, Chaudhry SA, Abbott EI, Maland ET, France KA, Rahim B, Miller Z, Caceres AJ, Brau LJ, Qureshi MH, Thomas JK, Afzal MR, Rech N, Palesch YY, Martin R, Zhao W, Foster L, Speiser J, Dillon C, Kim J, Conner C, Henry A, Clasen K, Cassarly C, Hanley DF, Hanley DF, Kase CS, Carhuapoma J, McBee N, Moy C, Janis S, Hemphill J III, Hoh BL, Zucharello M, Parides MK, Barsan W, Silbergleit R, Goldstein JN, Stevenson V, Bengelink E, Black J, Speers M, Harsh D, Van Huysen C, Caveney A, Deyampert A, Grundman B, DuRoss A, Claassen J, Biros M, Wright D, Quinn J, Mann R, Baren J, Welch R, Aufderheide T, Mena M, Chopskie E, Humphries R, Mendoza-Moore M, Lamond K, Callahan R, Howell M, McNelis PM, Reimer H, Stasinski G, Barnhart B, McCormick R, Ramirez AM, Suarez JI, Toyoda K, Yamamoto H, Koga M, Sato S, Yoshimura S, Fukuda-Doi M, Hirase K, Okazaki S, Ohara H, Wang Y, Ding Z, Wang D, Xu N, Hsu CY, Lin D, Suzuki M, Hsu CT, Hsu JP, Ho E, Steiner T, Seidel‐Glätzer A, Simonis C, Berlet U, Yoon B, Yoo D, Lee Y, Jo JY, Park J, Hu E, Toyoda K, Nagatsuka K, Hirase K, Wang Y, Ding Z, Sakai N, Todo K, Yoshihira S, Hara T, Matsukami M, Wang Z, Chen J, Jeng JS, Tang SC, Tsai LK, Yeh SJ, Wang YT, Agarwal S, Mayer SA, Falo M, Velasquez A, Suri MF, Freese MA, Shah QA, Jonczak K, Businger P, Suarez JI, Sergot PB, Calvillo E, Keene KR, Kirmani JF, Panezai S, Porbeni C, Uhegwu N, DeCarvalho B, Lin CH, Lo YK, Hsu YT, Sethi P, Sabir R, Harbison W, Shiokawa Y, Torii M, Hasegawa Y, Ohta Y, Takenoshita S, Liu CL, Tseng LT, Bergman TA, Rodriguez GJ, France K, Miller K, Iwama T, Yoshimura S, Egashira Y, Takagi T, Bösel J, Beck P, Kamiyama K, Fujii R, Chiba M, Pradilla G, Hall AJ, Lunney MP, Palmieri K, Lele A, Henning R, Thomas-Dodson S, Ballew A, Venkatasubramanian C, Wijman C, Thiessen R, Garcia M, Okada A, Hoshino H, Arakawa C, Chen Y, Li J, Chang TR, Ottman M, Hassan AE, Sanchez O, Furui E, Osanai A, Lien LM, Yeh HL, Lee IY, Yoon BW, Chae YJ, Jo JY, Hays AN, Alexandrov AV, Murphy S, Sisson A, Merritt L, Goldstein JN, Tirrell G, Cohen A, McNamara K, Barton L, Ueda T, Kaji Y, Okada Y, Nakamura A, Maeda K, Ren X, Ye K, Vatter H, Güresir E, Boströem A, Iwuchukwu I, Afshinnik A, Gaines K, Nganongo WI, Gentile NT, Kalugdan VS, Freeman B, Anyanwu B, Chase-Gregory C, Colston K, Lewandowski C, Miller JB, Berry-Hymon S, Mays-Wilson K, Lundell AM, Messe S, Gallatti N, Okuda S, Nakamura K, Bambakidis N, Cwiklinski V, Schumacher HC, Knapp K, Nabhan S, Hartman L, Itoh Y, Abe T, Takahashi S, Okamoto M, Chen CH, Hsueh YF, Kulstad E, Stanek MT, Hesse K, Law SW, Valsamis H, Levine SR, Petty B, Weingast SZ, Kunnakkat SD, Shah B, Arnedo V, Li Y, Chen Q, Bae HJ, Kim J, Park J, Zwank MD, Emiru T, Mischel E, Wewerka S, Meyer D, Rapp K, Kelly N, Chavez R, Rzesiewicz T, Sen S, Kennedy E, Vaughan K, Lollar S, Altschul D, Katz A, Dikovytska B, Titus M, Wartenberg KE, Herale D, Seidl S, Poli S, Ziemann U, Härtig F, Ribitsch M, Richter H, Ebner M, Gaenslen A, Zeller J, El Khoury R, Jones E, Martin-Schild S, Stell A, Carmody C, Norris GM, Mika V, Greer DM, Kunze K, Halliday JR, Freeman W, Edwards E, Gamble D, Luke S, Rose DZ, McTigue T, Shah JJ, Remmel KS, Jerde A, Helms A, Zhong L, Das E, Chang I, Novak A, Greeley L, Fisk P, Bittner A, Neeper L, Zubkov AY, Staugaitis A, France K, Miller K, Zacko J, Hoffman D, Krell KE, Garland E, Whatmore DN, Thornley A, Ahmed I, Dunalewicz S, Feeback JW, Akins A, McCann P, Ma HI, Hsiao PM, Miley JT, Lachance L, Merck LH, Thompson BB, Lerch J, Molyneaux BJ, Callaway CW, Rittenberger JC, DiFiore S, Fazio P, Armbuster K, Norris GM, Mohamed W, Ibrahim MS, Mika VH, Spencer A, Boyer C, Levine SR, Petty B, Weingast SZ, Kunnakkat SD, Shah B, Bushey M, Arnedo V, Seder DB, Riker RR, McCrum BF, Mahmood A, Guillen M, Carter T, Tran H, Malkoff M, Wussow T, Brown A, Lowenkopf T, Rodriguez M, Fatar M, Knoll K, Rodriguez GJ, Maud A, Ledger E, Smith W, Meeker M, Pettigrew LC, Dechtenberg L, Short J, Denninghoff K, Kidwell CS, Laine A, Khatri R, Carroll J, Uschmann H, Ehtisham A, Bankston M, Torbey M, Miller C, Behrouz R, Patel N, Basobas L, Henderson G, Chou S, Clark S, Renault S, Santos G, Suh S, Lieu K, Merkin R, Burns JD, Lau H, Cruz-Floes S, Holzemer M, Eller S, Brown S, Filla-Taylor J, Brown D, Whitaker L, Sun MC, Hsiao PJ, Michalski D, Hobohm C, Urban D, Nishijima DK, Jickling GC, Jones LB, Sanghera T, Khanna A, Hedna VS, Kizza R, Marriott E, Yanny L, Miley JT, LaChance L, von Eberstein AM, Molyneaux BJ, Callaway CW, Rittenberger JC, Difiore S, Pradilla G, Hall AJ, Lunney MP, Lee M, Visweswaran A, Swor R, Branoff M, Gebel JM, Hudock D, Lovick D, Brion B, Lodi YM, Reddy V, Peters T, Froehler MT, Kirshner HS, Warrick MM, Sidorov E, Shhadeh A, Hightower B, Kimura K, Shibazaki K, Chern CM, Lin CH, Hsu CW, Steiner T, Epple C, Lichti MC, Trabert J, Flügel AK, Ritter SJ, Audebert CH, Denes J.

Author information

1
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.).

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 .).

PMID:
27276234
PMCID:
PMC5345109
DOI:
10.1056/NEJMoa1603460
[Indexed for MEDLINE]
Free PMC Article
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