Adnan I Qureshi1, Yuko Y Palesch2, Lydia D Foster2, William G Barsan3, Joshua N Goldstein4, Daniel F Hanley5, Chung Y Hsu6, Claudia S Moy7, Mushtaq H Qureshi8, Robert Silbergleit3, Jose I Suarez9, Kazunori Toyoda10, Haruko Yamamoto10. 1. From the Department of Neurology, Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q., M.H.Q.) qureshai@gmail.com. 2. Department of Public Health Sciences, Medical University of South Carolina, Charleston (Y.Y.P., L.D.F.). 3. Department of Emergency Medicine, University of Michigan, Ann Arbor (W.G.B., R.S.). 4. Department of Emergency Medicine, Massachusetts General Hospital, Boston (J.N.G.). 5. Department of Neurology, Johns Hopkins University, Baltimore, MD (D.F.H.). 6. Department of Neurology, China Medical University, Taichung, Taiwan (C.Y.H.). 7. Division of Clinical Research, National Institutes of Health, Bethesda, MD (C.S.M.). 8. From the Department of Neurology, Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis (A.I.Q., M.H.Q.). 9. Department of Neurology, Baylor College of Medicine, Houston, TX (J.I.S.). 10. Department of Neurology, National Cerebral and Cardiovascular Center, Suita, Japan (K.T., H.Y.).
Abstract
BACKGROUND AND PURPOSE: We compared the rates of death or disability, defined by modified Rankin Scale score of 4 to 6, at 3 months in patients with intracerebral hemorrhage according to post-treatment systolic blood pressure (SBP)-attained status. METHODS: We divided 1000 subjects with SBP ≥180 mm Hg who were randomized within 4.5 hours of symptom onset as follows: SBP <140 mm Hg achieved or not achieved within 2 hours; subjects in whom SBP <140 mm Hg was achieved within 2 hours were further divided: SBP <140 mm Hg for 21 to 22 hours (reduced and maintained) or SBP was ≥140 mm Hg for at least 2 hours during the period between 2 and 24 hours (reduced but not maintained). RESULTS: Compared with subjects without reduction of SBP <140 mm Hg within 2 hours, subjects with reduction and maintenance of SBP <140 mm Hg within 2 hours had a similar rate of death or disability (relative risk of 0.98; 95% confidence interval, 0.74-1.29). The rates of neurological deterioration within 24 hours were significantly higher in reduced and maintained group (10.4%; relative risk, 1.98; 95% confidence interval, 1.08-3.62) and in reduced but not maintained group (11.5%; relative risk, 2.08; 95% confidence interval, 1.15-3.75) compared with reference group. The rates of cardiac-related adverse events within 7 days were higher among subjects with reduction and maintenance of SBP <140 mmHg compared to subjects without reduction (11.2% versus 6.4%). CONCLUSIONS: No decline in death or disability but higher rates of neurological deterioration and cardiac-related adverse events were observed among intracerebral hemorrhage subjects with reduction with and without maintenance of intensive SBP goals. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01176565.
RCT Entities:
BACKGROUND AND PURPOSE: We compared the rates of death or disability, defined by modified Rankin Scale score of 4 to 6, at 3 months in patients with intracerebral hemorrhage according to post-treatment systolic blood pressure (SBP)-attained status. METHODS: We divided 1000 subjects with SBP ≥180 mm Hg who were randomized within 4.5 hours of symptom onset as follows: SBP <140 mm Hg achieved or not achieved within 2 hours; subjects in whom SBP <140 mm Hg was achieved within 2 hours were further divided: SBP <140 mm Hg for 21 to 22 hours (reduced and maintained) or SBP was ≥140 mm Hg for at least 2 hours during the period between 2 and 24 hours (reduced but not maintained). RESULTS: Compared with subjects without reduction of SBP <140 mm Hg within 2 hours, subjects with reduction and maintenance of SBP <140 mm Hg within 2 hours had a similar rate of death or disability (relative risk of 0.98; 95% confidence interval, 0.74-1.29). The rates of neurological deterioration within 24 hours were significantly higher in reduced and maintained group (10.4%; relative risk, 1.98; 95% confidence interval, 1.08-3.62) and in reduced but not maintained group (11.5%; relative risk, 2.08; 95% confidence interval, 1.15-3.75) compared with reference group. The rates of cardiac-related adverse events within 7 days were higher among subjects with reduction and maintenance of SBP <140 mmHg compared to subjects without reduction (11.2% versus 6.4%). CONCLUSIONS: No decline in death or disability but higher rates of neurological deterioration and cardiac-related adverse events were observed among intracerebral hemorrhage subjects with reduction with and without maintenance of intensive SBP goals. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01176565.
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