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In patients with spontaneous supratentorial intracerebral hemorrhage (ICH), minimally invasive surgery (MIS) does not significantly improve outcomes compared with medical management alone, according to findings published in JAMA Neurology.
Researchers conducted a prospective, open-label, multicenter randomized clinical trial (MIND; ClinicalTrials.gov Identifier: NCT03342664) to evaluate the efficacy and safety of MIS with the Artemis Neuro Evacuation Device in patients with moderate- to large-volume ICH. A total of 236 patients were randomized 2:1 across 32 international sites, with 154 assigned to MIS plus medical management and 82 to medical management alone.
Eligible patients were 18 to 80 years old, had hematoma volumes of 20 to 80 mL, National Institutes of Health Stroke Scale scores of 6 or higher, Glasgow Coma Scale scores of 5 to 15, and symptom onset within 24 hours before initial imaging. The cohort had a median (IQR) age of 60 (50-70) years, 36.9% were women, 62.3% were White, 69.5% had deep hemorrhages (primarily basal ganglia), and 30.5% had lobar bleeds. The median (IQR) baseline ICH volume was 39 (29-55) mL, and the median (IQR) NIHSS score at presentation was 18 (14-22).
The primary endpoint was functional outcome at 180 days, measured by modified Rankin Scale (mRS). The researchers found no significant difference in mRS between patients who underwent MIS plus medical management and those who received medical management alone (odds ratio [OR], 1.03; 96% CI, 0.62-1.72; P =.45). Adjusted analyses were similarly nonsignificant (OR, 1.10; 96% CI, 0.66-1.85; P =.35).
Further, 30-day mortality was 7.2% in the MIS group compared with 9.8% in the medical management group (difference, -2.5%; 95% CI, -11.7% to 4.8%). At 180 days, mortality was 13.2% for MIS and 18.3% for medical management (difference, -5.1%; 95% CI, -16.1% to 4.5%).
Exploratory analyses of ordinal mRS assessed at different time points indicated better functional outcomes at 30 days in the MIS group (OR, 4.23; 95% CI, 2.36-7.57), but these early benefits were not maintained at later follow-ups. Serious adverse events occurred in 52.6% of MIS patients compared with 68.3% of medical management patients within 180 days.
Study limitations included early trial termination, extended enrollment overlapping with the COVID-19 pandemic, and limited follow-up.
“MIS with the Artemis Neuro Evacuation Device did not result in an improvement in 180-day disability or 30-day mortality rates in patients with spontaneous supratentorial ICH compared to standard [medical management] alone,” the study authors concluded.
Disclosures: This research was supported by Penumbra, Inc. Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
