Abstract WP396: Analysis of Patients With Excessively High Pre-Randomization Systolic Blood Pressure and Effect of Intensive Systolic Blood Pressure Reduction in Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) 2

Abstract

Background: Current guidelines recommend for intracerebral hemorrhage (ICH) patients with the systolic blood pressure (SBP) >220 mmHg, unlike those with initial SBP 150-220 mm, Hg, the efficacy of aggressive reduction of SBP is less well established and further studies are recommended. Methods: We analyzed data from ATACH 2 trial which randomized patients with initial SBP >180 mm Hg to intensive (goal 110-139 mmHg) and standard (goal 140-179 mmHg) SBP reduction using IV nicardipine within 4.5 hours of symptom onset. We compared the characteristics and outcomes between patients with pre- randomization SBP ≥220 mm Hg and those with initial SBP <220 mm Hg. We analyzed the modifying effect (interaction test) of pre-randomization SBP ≥220 mm Hg on treatment effect (intensive versus standard) on death or disability (score 4-6 on modified Rankin scale) at 3-months post-randomization ascertained by a blinded investigator. Results: Of 1000 randomized subjects, 48 subjects had a pre-randomization SBP ≥ 220 mm Hg (mean age 57.8 years, 65% men); 24 were assigned to intensive-treatment and standard-treatment each. The rate of death or disability at 3 months (47.9% versus 37.7%, odds ratio (OR): 1.52, 95% confidence interval (CI): 0.43 to 1.5, 0.85 to 2.72) and hematoma expansion within 24 hours (30.0% versus 21.2%, OR: 1.60; 95% CI: 0.80 to 3.20) was not different among subjects with SBP≥220 mm Hg SBP and those with SBP < 220 mm Hg. Rates of hematoma expansion (19% and 27.3%, OR: 0.63; 95% CI: 0.15 to 2.6) and neurological deterioration (8.7% versus 17.4%, OR: 0.45; 95% CI: 0.07 to 2.8) within 24 hours were not different between those randomized to intensive treatment and those to standard treatment in patients with SBP≥220 mm Hg. The interaction between initial SBP ≥220 mm Hg and treatment effect on death or disability was significant (p=0.0111). Conclusions: Patients with pre-randomization SBP ≥220 mm Hg did not have higher rates of hematoma expansion or death or disability compared to those with SBP <220 mm Hg. The interaction of pre- randomization SBP ≥220 mm Hg with the treatment effect and a non-significantly higher rate of death or disability associated with intensive treatment requires further studies.