NICO’s Minimally Invasive Evacuation Technology Outperforms Guideline-Based Medical Management as Intracerebral Hemorrhage Treatment

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At 180 days after surgery, weighted disability scores were better with surgery plus medical management than with medical management alone.

Jim Pearson, president and chief executive officer of NICO

Jim Pearson

Investigators have published the full dataset of the pivotal ENRICH trial (NCT02880878), the first positive trial to show improved functional and economic outcomes for intracerebral hemorrhage (ICH), in the New England Journal of Medicine. All told, results from the study showed that early intervention of minimally invasive hematoma evacuation using NICO’s technology, BrainPath and Myriad, was safe and resulted in better functional outcomes at 180 days than guideline-based medical management.1,2

In the multicenter, adaptive, clinical trial, 300 patients with either lobar (n = 208) or anterior basal ganglia (n = 92) hemorrhage were assigned 1:1 to either minimally invasive parafasicular surgery (MIPS) using NICO’s technology or guideline-based medical management (MM). At 180 days, results showed that the trial met its primary end point, with the surgery group demonstrating a mean utility-weighted modified Rankin scale (UWmRS) of 0.458 compared with 0.374 for MM (difference, 0.084; 95% Bayesian credible interval, 0.005-0.163). This correlated to a posterior probability of superiority of 0.981, exceeding the 0.975 prespecified threshold superiority of surgery.

Persons 18 to 80 years of age were eligible to enroll in the trial if they had CT evidence of a supratentorial, spontaneous, acute ICH with a hematoma volume of 30 to 80 ml, a Glasgow Coma Scale (GCS) score between 5 and 14, and a National Institute of Health Stroke Scale score of more than 5. In addition to meeting the primary end point, the percentage of patients who had died by 30 days was 9.3% in the surgery group and 18.0% in the control group. Death from any cause at the final follow-up at 180 days had occurred in 30 patients (20%) in the surgery group and in 35 (23%) in the control group.

"With its high rates of morbidity and mortality and the combined cost of both acute treatment and long-term recovery, ICH 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 chief executive officer of NICO, said in a statement.1 "The success of our trial on MIPS for ICH demonstrates the pivotal role of safe and effective clot removal using our technology, coupled with early intervention."

Additional data from the study showed a between-group difference of –0.013 (95% Bayesian credible interval, –0.147 to 0.116) on UWmRS among patients with hemorrhage in the anterior basal ganglia location and 0.127 (95% Bayesian credible interval, 0.035-0.219) among patients with hemorrhage in the lobar region. Within the surgery group, investigators recorded a mean percent reduction of 73.2 (±37.8) in hematoma volume from baseline to 24 hours, with a mean volume after the completion of surgery of 14.9 (±21.7) ml. Notably, nearly three-fourths (72.7%) of the patients in the surgery group had a volume of 15 ml or less after the completion of surgery.

Pearson added, "With intervention initiated within 24 hours, an average of 16 hours for trial participants, the MIPS group achieved a significant 88% median hematoma volume reduction and improved mortality compared to the standard of care. The results from the trial are clear: the more effectively and quickly we remove blood off of the brain, the greater the patient's chance of functional recovery and survival."

READ MORE: What Progress Have We Made in Mitigating Racial Disparities in Stroke?

For comparison, slightly more than half (50.3%) of the surgery group had mRS scores of 0 to 3 whereas only 41% (n = 57) of those in the control group achieved this range. Additionally, 49.7% of those in the surgery group had a score of 4 to 6 at 180 days vs 59.0% of those in the control group. Notably, 5 patients (3.3%) in the surgery group needed decompressive hemicraniectomy vs 30 (20.0%) in the control group.

Between the surgery and control groups, 63.3% and 78.7% of patients, respectively, had serious adverse events (AEs). Cardiac arrest occurred in 9 patients in the surgery group (8 of arrests occurred after discharge), as compared with 2 in the control group. Seizures and cerebral edema were reportedly higher in frequency in the control group. Also of note, 5 patients in the surgery group had rebleeding associated with neurologic deterioration after surgery.

"The results of the ENRICH trial not only demonstrate the efficacy and safety of MIPS, 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 investigator, associate professor of neurosurgery at Emory University School of Medicine, and chief of neurosurgery for Grady Memorial Hospital, said in a statement.1 "The ability to maximize the amount of clot evacuated in a safe manner is a pivotal advancement. We are steadfast in our commitment to collaborate with the medical community to educate on these interdisciplinary practices and foster their widespread adoption across institutions and specialties. Together, we aspire to significantly improve the outcomes and lives of ICH patients, caregivers and loved ones."

The study had some limitations, including that it was an open-label trial and excluded those with hematoma volumes less than 30 ml or more than 80 ml and thus, results cannot be applied to hematomas with those volumes. Similarly, the study did not include those with hemorrhages with substantial thalamic or intraventricular extension. The authors noted that because recruitment of patients with basal ganglia hemorrhages was halted for futility after relatively few patients had enrolled, inferences of potential benefit in basal ganglia are limited.

At the 2023 American Academy of Neurology Annual Meeting, investigators presented positive data from ENRICH showcasing the superiority of NICO’s technologies to standard of care for ICH. Stroke expert Andrew Russman, DO, head of the Stroke Program and Medical Director of the Comprehensive Stroke Center at Cleveland Clinic, who presented the results, provided thoughts on the data. In the link below, Russman spoke on the uniqueness of the trial, the benefits seen from MIPS, and the significance of effectively treating ICH.

REFERENCES
1. 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). NICO Corporation. April 11, 2024. Accessed April 11, 2024. https://www.prnewswire.com/news-releases/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-302114393.html
2. Pradilla G, Ratcliff JJ, Hall AJ, et al. Trial of early minimally invasive removal of intracerebral hemorrhage. NEJM. 2024;390(14). doi:10.1056/NEJMoa2308440
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