A lower targeted systolic blood pressure (SBP) between 110 to 139 mm Hg in patients with intracerebral hemorrhage did not result in a lower rate of death or disability than the standard target reduction of 140 to 179 mm Hg, according to results from the ATACH-2 (Antihypertensive Treatment of Acute Cerebral Hemorrhage II) trial.
Investigators designed the trial to better guide the choice of SBP target when treating acute hypertensive response in patients with intracerebral hemorrhage since little data currently exist.
They randomly assigned patients (n=1000); mean age: 61.9 years) to a SBP target of 110 to 139 mm Hg (intensive treatment) or a target of 140 to 179 mm Hg (standard treatment) to test the superiority of intensive reduction vs standard reduction. Approximately 40% of patients were women and 56% were Asian. The trial was conducted throughout the United States, Japan, China, Taiwan, South Korea, and Germany at 100 sites. At baseline, the mean SBP was 200.6 ± 27.0 mm Hg.
Mean interval time from symptom onset and randomization was 182.2 ± 57.2 minutes in the intensive group and 184.8 ± 56.7 in the standard group. During the first 2 hours, the mean minimum SBP was 128.9 ± 16 mm Hg in the intensive group and 141.1 ± 14.8 mm Hg in the standard group.
Primary treatment failure occurred in 12.2% of the intensive group and only 0.8% of the standard group (P<.001). Secondary treatment failure occurred in 15.6% of the intensive group compared with 1.4% of the standard group (P<.001).
The primary outcome of death or disability occurred in 38.7% of patients in the intensive group vs 37.7% of patients in the standard group (relative risk [RR]: 1.04; 95% confidence interval [CI]: 0.85-1.27), with adjustments made for age, initial Glasgow Coma Scale score, and presence or absence of intraventricular hemorrhage. Researchers reported no significant between-group differences in death rates at 3 months or in neurologic deterioration at 24 hours.
Serious adverse events that investigators deemed related to treatment within 72 hours after randomization were documented in 1.6% of patients in the intensive group and 1.2% in the standard group. Three months after randomization, however, the event rate was higher in the intensive group vs the standard group (25.6% vs 20.0%, adjusted RR: 1.30; 95% CI: 1.00-1.69; P=.05).
Renal adverse events within 7 days after randomization were significantly higher in the intensive group vs the standard group (9.0% vs 4.0%; P=.002).
The trial was terminated for futility before researchers could reach the target enrollment of 1280 patients. Between the 2 treatment arms, the absolute difference in death or disability rate was 1 percentage point. Since a smaller difference in risk was expected to be found as “insufficient for broad acceptance of a new intervention,” the trial was powered to identify a difference in risk of 10 percentage points or more.
“In conclusion, our results do not support the notion that acute reduction to a target SBP of 110 to 139 mm Hg in patients with intracerebral hemorrhage is more effective in improving functional outcome than a reduce to a target SBP of 140 to 179 mm Hg,” researchers wrote.
Qureshi AI, Palesch YY, Barsan WG, et al; for the ATACH-2 Trial Investigators and the Neurological Emergency Treatment Trials Network. Intensive blood-pressure lowering in patients with acute cerebral hemorrhage. N Engl J Med. 2016. doi: 10.1056/NEJMoa1603460.