By Susan Kreimer | May 16, 2024 | Read this story at NeurologyToday
Article In Brief
In the ENRICH trial, patients with an acute intracerebral hemorrhage who underwent a minimally invasive hematoma had better scores on the modified Rankin Scale at 180 days compared with those who received standard medical management. The study is the first randomized, controlled trial to show that surgery performs better than medical management alone for patients with ICH.
Patients undergoing minimally invasive hematoma removal within 24 hours after an acute intracerebral hemorrhage (ICH) had better functional outcomes at 180 days compared with those treated with guideline-based medical management alone. This effect applied to intervention for lobar supratentorial hemorrhages, a new multicenter, randomized trial revealed.
Results of the prospective and adaptive Early Minimally Invasive Removal of Intracerebral Hemorrhage (ENRICH) trial, overseen by a multidisciplinary team at Emory University School of Medicine in Atlanta, were published April 11 in the New England Journal of Medicine.
Prior randomized trials had not demonstrated any functional benefit from surgical hematoma evacuation, other than some studies that involved patients with superficially located lobar hemorrhages. For this reason, “current treatment guidelines for spontaneous ICH support surgical evacuation of the hematoma by means of conventional craniotomy only as life-saving treatment,” the study’s authors noted.
In addition, meta-analyses have examined several minimally invasive surgical alternatives to conventional craniotomy. The options included minimally invasive, catheter-based evacuation with thrombolysis, which did not lead to improved scores on the modified Rankin Scale (mRS) at one year.
Preliminary studies attested to the safety of “minimally invasive trans-sulcal para-fascicular ICH evacuation with access through a port in a sulcus oriented along the long axis of the white-matter tracts.” This surgery can successfully remove a significant amount of hematoma.
Investigators embarked on the ENRICH trial to determine if minimally invasive trans-sulcal para-fascicular surgery could benefit patients with ICH, said the study’s lead author, Gustavo Pradilla, MD, FAANS, an associate professor in Emory’s department of neurological surgery.
Shedding light on the devastating impact of ICH is particularly important in the buckle of the Stroke Belt, an 11-state region in the Southeast US with much higher stroke death rates than the rest of the country, Dr. Pradilla told Neurology Today. The incidence is even more pronounced in Atlanta because of dietary factors and the high rate of smoking, he said.
Dr. Pradilla is co-director of the Emory Skull Base Surgery Center and chief of neurosurgery at Grady Memorial Hospital, the public hospital in Atlanta.
When Dr. Pradilla began designing the ENRICH trial seven years ago, “the length of [hospital] stay for those patients was quite long because their intracerebral hemorrhages were not being treated surgically,” he said. “At the time, there was no evidence provided by the medical literature to support doing surgical treatment to improve the survival or neurological function of ICH.”
As a result, patients in this predicament had a roughly 40 percent morality rate and a disability burden as high as 80 percent. Back then, “that was the state of the disease,” Dr. Pradilla said, adding, “that’s the reason why I wanted to treat those patients.”
The ENRICH study is “the first randomized, controlled trial to show that surgery is better than medical management [alone] for patients with ICH,” he said. Surgery improved the rates of mortality, improved neurologic function at six months, and reduced the length of stay in the ICU and the hospital.
“Patients who had surgery had substantially less adverse events,” Dr. Pradilla said. For instance, only five patients in the surgical group underwent a decompressive hemicraniectomy, whereas 30 patients in the medical management group needed the emergency salvage procedure. “So combined, all of these positive events make this a paradigm shift for ICH patients,” he said.
Other potential interventions for ICH have excluded patients with positive spot sign—a well-established marker on CT angiography that predicts hematoma expansion and clinical outcomes. However, the ENRICH trial permitted the use of minimally invasive techniques on patients with positive spot sign, and surgery led to successful management of their active bleeding, Dr. Pradilla said.
Study Details
The study involved a total of 300 patients treated by 59 neurosurgeons at 37 US centers. Of these participants, 30.7 percent had anterior basal ganglia hemorrhages, and 69.3 percent had lobar hemorrhages, with a hematoma volume of 30 to 80 mL. After enrollment reached 175 patients, an adaptation rule applied, allowing only individuals with lobar hemorrhages to enter the trial.
“Within 24 hours after the time that the patient was last known to be well,” investigators randomly assigned half of participants to the surgery intervention arm and the other half to the control group. The intervention arm underwent minimally invasive surgical hematoma evacuation and guideline-based medical management, while the control group only received guideline-based medical management.
Researchers set the primary efficacy endpoint as the score on the utility-weighted mRS at 180 days. Higher scores, based on patients’ assessments, pointed to a better outcome.
The mean mRS score at 180 days was 0.458 in the surgery group compared with 0.374 in the control group. This resulted in “a between-group difference of 0.084 … in the total population (posterior probability of superiority, 0.981, exceeding the 0.975 prespecified threshold to conclude superiority of surgery).”