I love me a good negative study. This is especially one that is well conducted in a high impact journal. The results are much more likely to be believed.
These authors of the ATACH-2 trial randomized patients with intraparenchymal hematoma to intensive systolic BP lowering (110 to 140 mm Hg) vs. standard treatment (140-180 mm Hg). They excluded patients with very low GCS and massive hematomas.
They mostly used nicardipine for BP reduction and this had to be started within 4.5 hours of onset of symptoms. The primary outcome was death or disability (mRS 4-6) at 3 months after randomization.
Patient enrolment was stopped because of futility at the 1000 mark. The primary outcome was observed in 39% of the intensive-treatment group vs. 38% in standard treatment. As you would imagine, there were more adverse events with intensive treatment.
Of course there were some limitations. Externally validity might be an issue with the drugs used and patient demographics. Treatment didn’t start very early. We could argue over the primary outcome. Most patients weren’t that sick (85% had a GCS of 12-15) so perhaps we can’t extrapolate this to the sicker cohort etc.
Nevertheless, the results look pretty convincing.
They even conducted an ordinal shift analysis. These are all the rage in the stroke thrombolysis literature as they have a high degree of statistical efficiency to find small differences. But even this showed nothing.
So what are we to conclude?
Targeting a systolic BP between 140 to 180 is just fine. As with many things in medicine, we shouldn’t mess around too much. Don’t just do something... stand there!
Qureshi, AI, Palesch YY, Barsan WG, et al. Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage. N Engl J Med 2016;375:1033-43.