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
Adnan I Qureshi, Yuko Y Palesch, William G Barsan 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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