Lower systolic BP fails to improve outcomes in intracerebral hemorrhage
Click Here to Manage Email Alerts
Treatment of patients with intracerebral hemorrhage targeting a systolic BP of 110 mm Hg to 139 mm Hg did not yield a lower rate of death or disability when compared with reduction to a range of 140 mm Hg to 179 mm Hg, according to a study published in The New England Journal of Medicine.
Adnan I. Qureshi, MD, from the Zeenat Qureshi Stroke Research Center, University of Minnesota, Minneapolis, and colleagues compared targets for systolic BP levels when treating patients with intracerebral hemorrhage, as previous data were limited aside from the INTERACT2 trial.
The researchers crafted the ATACH-2 trial to determine the effectiveness of quickly lowering the systolic BP level in patients in an earlier time window after symptom onset than studied in previous trials.
The researchers randomly assigned 1,000 patients (mean age, 62 years; 38% women; 56% Asian; mean baseline systolic BP, 200.6 mm Hg) from 110 sites in six countries from May 2011 to September 2015 to lower and maintain hourly minimum systolic BP in the range of 140 mm Hg to 179 mm Hg (n = 500) or in the range of 110 mm Hg to 139 mm Hg (n = 500) through 24 hours after randomization.
IV antihypertensive medication, including nicardipine, could be administered before randomization to lower the systolic BP to less than 180 mm Hg, but patients were not eligible if systolic BP was lowered to less than 140 mm Hg.
After randomization, nicardipine, administered by IV infusion, was the first-line antihypertensive agent and was initiated at a dose of 5 mg per hour.
The primary outcome was death or disability, defined as modified Rankin scale score 4 to 6, at 3 months.
According to the researchers, the trial was stopped for futility after an interim analysis showed no effect on the primary outcome (intensive-treatment group, 38.7%; standard-treatment group, 37.7%; adjusted RR = 1.04; 95% CI, 0.85-1.27).
The percentage of patients with treatment-related serious adverse events within 72 hours after randomization was 1.6% in the intensive-treatment group and 1.2% in the standard-treatment group. However, the percentage of patients with any serious adverse event at 3 months after randomization was higher in the intensive-treatment group than in the standard-treatment group (25.6% vs. 20%; adjusted RR, 1.3; 95% CI, 1-1.69).
Qureshi and colleagues wrote that renal adverse events at 7 days were higher in the intensive-treatment group (9% vs. 4%; P = .002). – by James Clark
Disclosure: Qureshi reports receiving nonfinancial support from Astellas Pharma and Chiesi USA. One other researcher reports receiving nonfinancial support from Astellas Pharma Korea.