When treating an acute hypertensive response in patients with intracerebral hemorrhage, intensive blood pressure treatment does not result in a lower rate of death or disability than standard blood pressure treatment, according to a study published online ahead of print June 22 in the New England Journal of Medicine.
Chronic hypertension is the greatest risk factor for intracerebral hemorrhage, and an acute hypertensive response is common among patients with intracerebral hemorrhage. Studies have suggested that controlling blood pressure early and aggressively in patients with acute intracerebral hemorrhage may reduce hematoma expansion and rates of subsequent death or disability, but optimal blood pressure targets and treatment windows have not been established.
To test whether intensive reduction of blood pressure (ie, targeting a systolic blood pressure of 110 mm Hg to 139 mm Hg) is superior to standard blood pressure reduction (ie, a target of 140 mm Hg to 179 mm Hg), Adnan I. Qureshi, MD, Professor of Neurology, Neurosurgery, and Radiology at the Zeenat Qureshi Stroke Research Center at the University of Minnesota in Minneapolis, and colleagues conducted the Antihypertensive Treatment of Acute Cerebral Hemorrhage II (ATACH-2) trial. The trial was conducted at 110 sites in the United States, Japan, China, Taiwan, South Korea, and Germany.
Adnan I. Qureshi, MD
The investigators enrolled 1,000 patients with spontaneous supratentorial intracerebral hemorrhage who had a Glasgow Coma Scale score of five or more and at least one systolic blood pressure reading of 180 mm Hg or more between symptom onset and initiation of IV antihypertensive treatment.
Five hundred patients were assigned to intensive treatment, and 500 patients were assigned to standard treatment. Patients had a mean age of 61.9, 38% were women, and 56.2% were Asian. Patients had an average systolic blood pressure of 200.6 mm Hg at baseline.
Investigators administered IV nicardipine to lower blood pressure within four and a half hours following symptom onset, and researchers continued this treatment for the next 24 hours.
Investigators followed up with patients by telephone after a month and in person after three months. Death or disability (ie, modified Rankin scale score of 4 to 6) was the primary outcome.
The trial was designed to enroll 1,280 participants, but researchers stopped the trial early for futility after a prespecified interim analysis found that patients who received intensive treatment did not have a lower rate of death or disability than those who received standard treatment. The rate of death or disability was 38.7% in the intensive treatment group and 37.7% in the standard treatment group. "Our results do not support the notion that acute reduction to a target systolic blood pressure of 110 to 139 mm Hg in patients with intracerebral hemorrhage is more effective in improving functional outcome than a reduction to a target systolic blood pressure of 140 to 179 mm Hg," the researchers said.
Serious adverse events within 72 hours of randomization that were considered to be related to treatment were reported in 1.6% of patients in the intensive treatment group, compared with 1.2% of patients in the standard treatment group. The rate of renal adverse events within seven days was significantly higher in the intensive treatment group than in the standard treatment group (9% vs 4%).
The overall death and severe disability rate in this study was lower than that in previous stroke studies (38% vs 60%). This difference may be due to the inclusion of patients with relatively minor strokes in the current study. In addition, "we may have seen a global benefit of careful monitoring and standardized care for patients with acute cerebral hemorrhage," said Dr. Qureshi.
—Erica Robinson