By Matthew E. Fink, MD

Professor and Chairman, Department of Neurology, Weill Cornell Medical College; Neurologist-in-Chief, New York Presbyterian Hospital

Dr. Fink reports he is a retained consultant for Procter & Gamble and Pfizer.

SOURCE: Qureshi AI, Palesch YY, Barsan WG, et al, for the ATCH-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;375:1033-1043.

Acute intracerebral hemorrhage comprises about 10% of all strokes in the United States, and continues to carry a high morbidity and mortality related to hematoma expansion. Acute lowering of high blood pressure has been a primary treatment for these patients, but the actual range of optimal blood pressure control has yet to be determined. This study was designed to randomize eligible patients with intracerebral hemorrhage, volume < 60 cc, and Glasgow Coma Scale score of 5 or more into two treatment groups, one with a target systolic blood pressure of 110-139 mmHg (intensive treatment group) and the other to a target systolic blood pressure of 140-179 mmHg (standard treatment group), to test the superiority of intensive reduction of blood pressure compared to standard. Intravenous nicardipine was used to lower blood pressure and was administered within 4.5 hours after symptom onset. The primary outcome was death or disability, using modified Rankin scale, at three months after randomization.

One thousand eligible participants had a mean systolic blood pressure of 200.6 ± 27.0 mmHg at baseline, and 500 were assigned to the intensive treatment group. The mean age of the patients was 61.9 years, and 56.2% were Asian. Enrollment was stopped before the planned endpoint because of futility determined after a pre-specified interim analysis. Death and disability was observed in 38.7% of the participants (186 of 481) in the intensive treatment group and 37.7% (181 of 480) in the standard treatment group, with no difference in relative risk, even after adjustment for age, initial Glasgow Coma Score, and presence of intraventricular hemorrhage. Serious adverse events occurred in the same proportions in both groups, but the rate of renal adverse events within seven days after randomization was significantly higher in the intensive treatment group then in the standard treatment group. In conclusion, treatment of patients with an intensive blood pressure-lowering regimen did not result in a lower rate of death or disability than standard reduction to a target systolic blood pressure of 140-179 mmHg.