As compared with more conservative management, early intensive lowering of blood pressure (BP) for patients with spontaneous intracranial bleeds does not significantly decrease mortality. However, this approach may result in better functional outcomes and quality of life. (LOE = 1b-)
Study design: randomized controlled trial, non-blinded
Setting: Inpatient / ICU
Patients who presented with spontaneous intracranial hemorrhage within the previous 6 hours were randomly assigned, using concealed allocation, to receive intensive BP-lowering therapy (n = 1403) or standard BP management according to current guidelines (n = 1436). Patients with structural causes for the bleed, those who were in a deep coma, or those who required early hematoma evacuation were excluded. In the intensive treatment group, intravenous and oral BP medications were used to lower the systolic BP to less than 140 mm Hg within 1 hour and maintain it at this level for 1 week. Those in the standard treatment group received BP-lowering agents only if their systolic BP was greater than 180 mm Hg. The mean age of the patients in the 2 groups was 64 years and the median presenting Glasgow Coma Scale score was 14. As compared with the standard therapy group, the intensive treatment group started BP-lowering therapy earlier after onset of intracranial hemorrhage (4.0 hours vs 4.5 hours; P < .001) and was more likely to receive intravenous agents (90% vs 43%; P < .001). At 90 days, there was no difference in the primary outcome of death or major disability, defined as a score of 3 to 5 on the modified Rankin scale (0 to 6, where 0 indicates no symptoms and 6 indicates death). Overall, 12% of the patients in each group died. When looking at disability alone, the intensive treatment group had significantly lower modified Rankin scores than the standard therapy group (odds ratio = 0.87; 95% CI, 0.77-1.0; P = .04) and had higher health-related quality of life scores (0.60 vs 0.55; P = .002). As this trial was not masked, the possibility exists that patients in the 2 groups were managed differently beyond just the 2 BP-lowering strategies.