Treatment of Intracerebral Hemorrhage: Early Surgery Tied to Better Outcomes

Minimally invasive surgery within 24 hours vs medical management alone for the treatment of acute intracerebral hemorrhage (ICH) leads to better functional outcomes at 180 days, according to the findings of a study published in the New England Journal of Medicine (NEJM).

Researchers conducted a multicenter, randomized trial (ENRICH; ClinicalTrials.gov Identifier: NCT02880878) to determine whether early evacuation of acute ICH, through minimally invasive surgery vs medical management alone could lead to better outcomes.

The primary endpoint for efficacy was a mean score on the utility-weighted modified Rankin scale (mRS; range, 0 to 1, with higher scores indicating better outcomes) at 180 days. Researchers required a posterior probability of superiority of 0.975 or higher in patients. The primary safety endpoint was survival at 30 days post-enrollment.

A total of 300 patients from 37 US centers were randomly assigned to either surgery with medical management or medical management alone (150 patients per cohort). The initial population included both lobar (208) and anterior basal ganglia (92) hemorrhages. Hematoma volume ranged from 30 ml to 80 ml and Glasgow Coma Scale score was between 5 and 14.

Median time from last known well to randomization was approximately 12.8 hours, and from randomization to surgery, 1.5 hours.

Surgery was beneficial to patients with lobar hemorrhages, with a mean score of 0.458 at 180 days compared with 0.374 in control individuals, and a between-group difference of 0.084 (95% Bayesian credible interval, 0.005 to 0.163; posterior probability of superiority, 0.981).

Mean difference in patients with lobar hemorrhages was 0.127 (95% Bayesian credible interval, 0.035 to 0.219), and in those with anterior basal ganglia hemorrhages, -0.013 (95% Bayesian credible interval, -0.147 to 0.116). Given poor outcomes for basal ganglia hemorrhages, the trial was modified to include only lobar hemorrhages.

The mean percent reduction in hematoma volume from baseline to 24 hours was 73.2±37.8% and mean post-surgery volume was 14.9±21.7 ml. After surgery, 72.7% of patients reached a hematoma volume of 15 ml or less. The odds ratios (ORs) for improved mRS values in this group were 0.376 at 7 days, 0.504 at 30 days, 0.665 at 90 days, and 0.658 at 180 days (95% Bayesian credible intervals: 0.230-0.577, 0.326-0.741, 0.437-0.970, and 0.433-0.957, respectively).

Surgical patients also experienced lower mortality and fewer adverse events (AEs). By 30 days, 9.3% surgical patients vs 18% of control group patients had died. Serious AEs occurred in 63.3% of surgical patients compared to 78.7% of control group patients. Rebleeding and neurologic deterioration only occurred in 3.3% of surgery patients. Study limitations included the mid-trial exclusion of anterior basal ganglia hemorrhages, and small sample sizes for certain subgroup analyses.

“In this trial of minimally invasive surgical evacuation of intracerebral hemorrhage of 30 to 80 ml within 24 hours after onset, weighted disability scores were better with surgery plus medical management than with medical management alone. The result was apparently attributable to intervention for lobar supratentorial hemorrhages,” the researchers concluded.

Disclosure: Several study authors declared affiliations with biotech and pharmaceutical companies. Please see the original reference for a full list of author disclosures.