ATACH II
Trial question
What is the role of intensive BP control in patients with acute cerebral hemorrhage?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 1000
1000 patients (380 female, 620 male)
Inclusion criteria: patients with intracerebral hemorrhage (volume, < 60 cm³) and a GCS score ≥ 5 (on a scale from 3 to 15, with lower scores indicating worse condition)
Key exclusion criteria: SBP was reduced to < 140 mmHg before randomization and randomization after 4.5 hours of symptom onset
Interventions
N=500 intensive treatment (systolic blood-pressure target of 110-139 mmHg)
N=500 standard treatment (SBP target of 140-179 mmHg)
Primary outcome
Death or disability
38.7
37.7
38.7 %
29.0 %
19.4 %
9.7 %
0.0 %
Intensive treatment
Standard treatment
No significant difference ↔
No significant difference in death or disability (38.7% vs. 37.7%; )
Secondary outcomes
No significant difference in hematoma expansion (18.9% vs. 24.4%; )
Safety outcomes
No significant difference in serious adverse events within 72 hours (1.6% vs. 1.2%).
Significant differences in renal adverse events within 7 days (9.0% vs. 4.0%, p = 0.002).
Conclusion
In patients with intracerebral hemorrhage (volume, < 60 cm³) and a GCS score ≥ 5 (on a scale from 3 to 15, with lower scores indicating worse condition), intensive treatment was not superior to standard treatment with respect to death or disability.
Reference
Qureshi AI, Palesch YY, Barsan WG et al. Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage. N Engl J Med. 2016 Sep 15;375(11):1033-43.
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