Abstract 128: Intensive Blood Pressure Lowering in Patients with Moderate to Severe Grade Acute Cerebral Hemorrhage: Post Hoc Subgroup Analysis of Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-2 Trial

Abstract

Background: The intent to treat analysis of ATACH-2 trial did not demonstrate any difference in rates of death or disability with intensive systolic blood pressure (SBP) reduction compared with standard SBP reduction in patients with intracerebral hemorrhage (ICH). The benefit may have been obscured due to relatively high proportion of good grade patients (ceiling effect) in both treatment groups. Methods: We evaluated the effect of intensive (goal 110-139 mmHg) over standard (goal 140-179 mmHg) SBP reduction using intravenous nicardipine within 4.5 hours of symptom onset in a subgroup of moderate to severe grade subjects with ICH. Moderate to severe grade was defined by Glasgow coma scale score <13 or baseline National Institutes of Health Stroke Scale score ≥10 or baseline intraparenchymal hemorrhage volume ≥30cm 3 or presence of intraventricular hemorrhage. The primary outcome was death or disability (score 4-6 on modified Rankin scale) at 3-months post-randomization ascertained by a blinded investigator. Results: A total of 682 subjects (336 in intensive and 346 in standard groups) met the definition of moderate to severe grade. The primary endpoint of death or disability was observed in 52.5% of subjects receiving intensive treatment and 48.9% subjects receiving standard treatment (relative risk: 1.07; 95% confidence interval: 0.86 to 1.33). Serious adverse events were significantly higher (relative risk: 1.38; 95% confidence interval: 1.04 to 1.84), among patients randomized to intensive treatment (32.7% and 23.7% for intensive and standard treatment groups, respectively). Conclusions: Similar to the conclusion from the overall ATACH-2 Trial sample, the rate of death or disability in the moderate to severe ICH subjects was similar, but significantly higher rate of serious adverse events were observed in subjects randomized to intensive SBP reduction.