Surgical intervention linked to better outcomes at 180 days for intracerebral hemorrhage

Key takeaways:

• 300 individuals with ICH received either surgical intervention and medical management, or management alone.
• A total of 9.3% of patients in the surgery group and 18% in the control group died by 30 days.

For patients diagnosed with intracerebral hemorrhage, surgical intervention within 24 hours led to better functional outcomes at 180 days compared with medical management alone, researchers wrote in the New England Journal of Medicine.

“With its high rates of morbidity and mortality and the combined cost of both acute treatment and long-term recovery, [intracerebral hemorrhage] is the costliest, most deadly and debilitating form of stroke, but despite these facts, no surgical approach has produced level 1 evidence to intervene until now,” Jim Pearson, president and CEO of study sponsor NICO Corp., said in a release related to the study.

Researchers sought to determine whether early minimally invasive surgical removal for those who suffer intracerebral hemorrhage (ICH) would result in better outcomes compared with standard medical management.

The multicenter, randomized ENRICH trial included 300 individuals diagnosed with an acute ICH (30.7% with anterior basal ganglia hemorrhages, 69.3% with lobar hemorrhages), hematoma volume of 30 ml to 80 ml and and Glasgow Coma Scale score between 5 and 14. They were assigned 1:1, within 24 hours after last known wellness, to undergo surgical removal of the hematoma plus guideline-based medical management (surgery group) or to be given guideline-based medical management alone (control group).

The primary efficacy endpoint was mean score on the utility-weighted modified Rankin scale (mRS), obtained from a structured interview at 30, 90 and 180 days following randomization, with higher scores indicating better outcomes at 180 days and a prespecified threshold for posterior probability of superiority of 0.975 or higher. The primary safety endpoint was death within 30 days following trial enrollment.

The mean score on the utility-weighted mRS at 180 days was 0.458 for the surgery group and 0.374 in the control group (difference, 0.084; 95% CI, 0.005-0.163; posterior probability of superiority of surgery, 0.981).

Mean between-group difference was 0.127 (95% CI: 0.035-0.219) among patients with lobar hemorrhages and 0.013 (95% CI: 0.147 to 0.116) among those with anterior basal ganglia hemorrhages, data further show.

Additionally, 9.3% of patients in the surgery group and 18% in the control group died by 30 days.

“The results of the ENRICH trial not only demonstrate the efficacy and safety of [minimally invasive parafascicular surgery], but they also herald a transformative milestone for the entire stroke community, changing the ICH treatment paradigm through a standardized approach and advanced technology,” Gustavo Pradilla, MD, co-lead author of the study and associate professor of neurosurgery at Emory University School of Medicine, said in the release.

Reference:

The New England Journal of Medicine publishes complete data from ENRICH, the first positive trial to improve functional and economic outcomes for intracerebral hemorrhage. https://niconeuro.com/news/the-new-england-journal-of-medicine-publishes-complete-data-from-enrich-the-first-positive-trial-to-improve-functional-and-economic-outcomes-for-intracerebral-hemorrhage-ich/. Posted April 11, 2024. Accessed May 7, 2024.