NICO Corporation has announced initial positive results from the completed ENRICH trial at the 2023 American Association of Neurological Surgeons (AANS) annual scientific meeting (21–24 April, Los Angeles, USA). ENRICH was designed to evaluate the safety, efficacy, and economic outcomes for intracranial haemorrhage (ICH), or haemorrhagic stroke, comparing early minimally invasive parafascicular surgery (MIPS) using NICO’s complete technology solution—including BrainPath and Myriad—versus standard of care, which is medical management based on American Heart Association/American Stroke Association guidelines.
At six months, functional outcomes in ENRICH were assessed using the utility-weighted modified Rankin Scale (UWmRS) with differences greater than zero corresponding to improved outcomes. The mean UWmRS score was 0.458 in the MIPS group and 0.374 in those receiving MM—the difference showing a 98.1% posterior probability of superiority. These results met the primary endpoint demonstrating the MIPS group achieved a statistically significant and clinically meaningful improvement in UWmRS versus medical management.
The ENRICH study also found MIPS was safe and overall mortality at six months was 21.7% (20% for MIPS, 23.3% in the medical management group). In the MIPS group, the median haematoma evacuation was 88% with a median end-of treatment volume (EOTV) of 7.2mL. Overall, 73% achieved the EOTV goal of <15mL, which is considered the surgical standard in clot evacuation, according to a NICO press release.
“ENRICH is the first, randomised clinical trial to meet its primary endpoint demonstrating early MIPS with BrainPath and Myriad improves outcomes for these deadly strokes,” said Gustavo Pradilla (Emory University School of Medicine, Atlanta, USA), co-lead investigator for ENRICH. “I believe this trial will change how we treat haemorrhagic stroke moving forward and I look forward to sharing the further details of the ENRICH trial, which will be published soon.”
The ENRICH trial is a randomised, multicentre, adaptive, clinical trial designed to evaluate the effectiveness, safety and economics of a standardised early MIPS approach (within 24 hours) in 300 patients with spontaneous haemorrhagic stroke—92 patients with a haemorrhage in the anterior basal ganglia (ABG) location and 208 in the lobar location.
The primary intention-to-treat analysis evaluated whether the UWmRS, a standardised measure of global disability, at 180 days in the treatment group was superior to that of the control group. The safety endpoints were mortality at 30 days, change in haemorrhage volume between index and 24-hour computed tomography (CT) scan while the economic endpoints were quality-adjusted life years (QALY) at 90-, 120- and 180-days post haemorrhage. The randomised trial enrolled patients at 37 stroke centres across the USA.
“We are grateful to NICO for their support of our research and our colleagues at the 37 participating sites that so carefully randomised and expertly managed the enrolled patients,” Dan Barrow (Emory University, Atlanta, USA). “Principally, we thank our brave patients and their families for entrusting us with their care and agreeing to participate in a trial to advance scientific knowledge for the benefit of others. Their selfless behaviour is necessary to advance the scientific basis of medical care.”