scholarly journals Response by Fukuda-Doi et al to Letter Regarding Article, “Sex Differences in Blood Pressure–Lowering Therapy and Outcomes Following Intracerebral Hemorrhage: Results From ATACH-2”

Stroke ◽  
2020 ◽  
Vol 51 (12) ◽  
Author(s):  
Mayumi Fukuda-Doi ◽  
Kazunori Toyoda ◽  
Haruko Yamamoto
Keyword(s):  
Blood Pressure ◽  
Sex Differences ◽  
Intracerebral Hemorrhage ◽  
Blood Pressure Lowering ◽  
Lowering Therapy ◽  
Pressure Lowering

Statistical analysis plan for pooled individual patient data from two landmark randomized trials (INTERACT2 and ATACH-II) of intensive blood pressure lowering treatment in acute intracerebral hemorrhage

2018 ◽  
Vol 14 (3) ◽  
pp. 321-328 ◽  
Author(s):  
Tom J Moullaali ◽  
Xia Wang ◽  
Renee' H Martin ◽  
Virginia B Shipes ◽  
Adnan I Qureshi ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Intracerebral Hemorrhage ◽  
Systolic Blood Pressure ◽  
Functional Recovery ◽  
Modified Rankin Scale ◽  
Blood Pressure Lowering ◽  
Safety Outcomes ◽  
Pressure Lowering ◽  
Acute Intracerebral Hemorrhage ◽  
Intensive Blood Pressure

Background There is persistent uncertainty over the benefits of early intensive systolic blood pressure lowering in acute intracerebral hemorrhage. In particular, over the timing, target, and intensity of systolic blood pressure control for optimum balance of potential benefits (i.e. functional recovery) and risks (e.g. cerebral ischemia). Aims To determine associations of early systolic blood pressure lowering parameters and outcomes in patients with a hypertensive response in acute intracerebral hemorrhage. Secondary aims are to identify the modifying effects of patient characteristics and an optimal systolic blood pressure lowering profile. Methods Individual participant data pooled analyses of two large, multicenter, randomized controlled trials specifically undertaken to assess the effects of early intensive systolic blood pressure reduction on clinical outcomes in acute intracerebral hemorrhage: the Intensive Blood Pressure in Acute Intracerebral Hemorrhage Trial (INTERACT2) and the Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II) trial. Combined data will include baseline characteristics; systolic blood pressure in the first 24 h; process of care measures; and key efficacy and safety outcomes. Outcomes The primary outcome is functional recovery, defined by an ordinal distribution of scores on the modified Rankin scale at 90 days post-randomization. Secondary outcomes include various standard binary cut-points for disability-free survival on the modified Rankin scale, and health-related quality of life at 90 days. Safety outcomes include symptomatic hypotension requiring corrective therapy and early neurologic deterioration within 24 h, and deaths, any serious adverse event, and cardiac and renal serious adverse events, within 90 days. Discussion A pre-determined protocol was developed to facilitate successful collaboration and reduce analysis bias arising from prior knowledge of the findings. Clinical trial registration URL: http://www.clinicaltrials.gov . Unique identifiers for INTERACT2 (NCT00716079) and ATACH-II (NCT01176565).

scholarly journals Regional differences in the response to acute blood pressure lowering after cerebral hemorrhage

Neurology ◽  
2020 ◽  
pp. 10.1212/WNL.0000000000011229
Author(s):  
Kazunori Toyoda ◽  
Yuko Y Palesch ◽  
Masatoshi Koga ◽  
Lydia Foster ◽  
Haruko Yamamoto ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Adverse Events ◽  
Intracerebral Hemorrhage ◽  
East Asia ◽  
Functional Outcomes ◽  
Intensive Treatment ◽  
Hematoma Expansion ◽  
Blood Pressure Lowering ◽  
Pressure Lowering ◽  
Intensive Blood Pressure

Objective:To compare the impact of intensive blood pressure (BP) lowering right after intracerebral hemorrhage (ICH) on clinical and hematoma outcomes among patients from different geographic locations, we performed a prespecified sub-analysis of the randomized, multi-national, two-group, open-label trial to determine the efficacy of rapidly lowering BP in hyperacute ICH (ATACH-2), involving 537 patients from East Asia and 463 recruited outside of Asia.Methods:Eligible patients were randomly assigned to a systolic BP (SBP) target of 110-139 mmHg (intensive treatment) or 140-179 mmHg (standard treatment). Pre-defined outcomes were: poor functional outcome (modified Rankin Scale score of 4-6 at 90 days), death within 90 days, hematoma expansion at 24 hours; and cardio-renal adverse events within 7 days.Results:Poor functional outcomes (32.0% versus 45.9%), death (1.9% versus 13.3%), and cardio-renal adverse events (3.9% versus 11.2%) occurred significantly less in patients from Asia than those outside of Asia. The treatment-by-cohort interaction was not significant for any outcomes. Only patients from Asia showed a lower incidence of hematoma expansion with intensive treatment (adjusted RR 0.56, 95% CI 0.38-0.83). Both Asian (3.53, 1.28-9.64) and non-Asian cohorts (1.71, 1.00-2.93) showed a higher incidence of cardio-renal adverse events with intensive treatment.Conclusions:Poor functional outcomes and death 90 days after ICH were less common in patients from East Asia than those outside of Asia. Hematoma expansion, a potential predictor for poor clinical outcome, was attenuated by intensive BP lowering only in the Asian cohort.Clinicaltrials.gov identifierNCT01176565.Classification of evidence:This study provides Class II evidence that, for patients from East Asia with intracerebral hemorrhage, intensive blood pressure lowering significantly reduces the risk of hematoma expansion.

scholarly journals Earlier Blood Pressure-Lowering and Greater Attenuation of Hematoma Growth in Acute Intracerebral Hemorrhage

Stroke ◽  
2012 ◽  
Vol 43 (8) ◽  
pp. 2236-2238 ◽  
Author(s):  
Hisatomi Arima ◽  
Yining Huang ◽  
Ji Guang Wang ◽  
Emma Heeley ◽  
Candice Delcourt ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Intracerebral Hemorrhage ◽  
Blood Pressure Lowering ◽  
Pressure Lowering ◽  
Hematoma Growth ◽  
Acute Intracerebral Hemorrhage
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