ESOC 2024 | Results of the RICH-2 trial of remote ischemic conditioning in ICH
Wenbo Zhao, MD, PhD, Xuanwu Hospital, Capital Medical University, Beijing, China, shares the results of the RICH-2 trial, which randomized 458 patients with acute intracerebral hemorrhage (ICH) to receive remote ischemic conditioning (RIC) or sham RIC for seven days. The trial was based on evidence of accelerated hematoma absorption and improved neurological outcomes in animal models treated with RIC. The pilot RICH-1 trial demonstrated the safety of RIC in patients with ICH and suggested an association with improved hematoma resolution rate and perihematomal edema. In the RICH-2 randomized, Phase III trial, there was no difference in functional independence rates at 90 days between the two trial arms. Dr Zhao comments on possible explanations for these findings, including the mild severity of ICH in the trial. A subgroup analysis indicated that patients with a hematoma volume of 21-30ml favored RIC treatment. This interview took place at the 10th European Stroke Organisation Conference (ESOC) 2024 in Basel, Switzerland.
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Transcript
Remote ischemic conditioning is a physical strategy that can be applied on calves or arms and which was initiated by the several cycles of brief ischemia in arms and it can protect against the subsequent prolonged ischemia in distant organs or reduce the ischemic injuries in distant organs. This strategy has been investigated in the field of stroke, acute cardiac infarction, and the field of renal protection...
Remote ischemic conditioning is a physical strategy that can be applied on calves or arms and which was initiated by the several cycles of brief ischemia in arms and it can protect against the subsequent prolonged ischemia in distant organs or reduce the ischemic injuries in distant organs. This strategy has been investigated in the field of stroke, acute cardiac infarction, and the field of renal protection. A previous study has found that remote ischemic conditioning can protect the heart, the brain, and the kidney. In my previous study, we have determined that remote ischemic conditioning can prevent the recurrent ischemic stroke in patient with symptomatic intracranial artery stenosis. In our previous study we found that remote ischemic conditioning can accelerate the hematoma absorption in animal models of intracerebral hemorrhage and accelerate the neurological recovery.
In our pilot clinical trial, the RICH-1 trial, we found that this strategy remote ischemic conditioning can be safely performed in these parts of patients. We all know that intracerebral hemorrhage is the least treatable type of stroke and we have a no effective therapies for patients who receive the surgical therapy, so in this part of patient we want to detect whether remote ischemic conditioning can perform as a neuroprotective strategy to accelerate the hematoma absorption and improve the functional outcome this part of patients.
The RICH-2 trial was performed in 20 comprehensive stroke centers in China and we enrolled 459 patients from 2021 to 2023. During this three years of study, we enrolled 459 patients and all the patients didn’t undergo surgical therapy and all of them supratentorial intracerebral hemorrhage and the years of these patients was between 18 to 80 years old with NIH stroke scale between 6-20 points. For patients with intracerebral hemorrhage secondary to other reasons such as the tumor or traumatic injury were excluded. Patients with subarachnoid hemorrhage or intraventricular hemorrage were also excluded.
The main findings of this clinical trial was the 90 day functional outcome. The functional mRS was not significantly different between the two groups and the functional independence rates was 68.1% in the RIC group and 72.1% in the sham group. Other clinical outcomes including the excellent outcomes evaluated by the mRS score of 0-1 and the good outcome evaluated by the mRS score 0-3 also showed no significant difference between two groups. We also detected the NIH stroke scale within 7 days and the result also showed no significant difference. The secondary outcomes including the incidence of death and the neurological deterioration and the early improvements and the serious adverse events also showed no significant difference.
The findings of the RICH-2 trial is not what we have expected and we think that the neutral result of the RICH-2 trial can mainly be attributed to the mild severity of ICH of all the included patients. The baseline of the patients including NIH stroke scale is about 10 to 11 points and the baseline hematoma volume is about 11 to 13ml so the neutral result of the trial may be mainly attributed to the mild severity of stroke because most of these patients can achieve a good functional prognosis. We also can’t exclude the reason that the RIC protocol investigated in these patients was just used for seven days and once daily whereas other RIC protocols such as remote ischemic conditioning for two weeks or twice daily maybe need further investigations.
Although the RICH-2 trial didn’t show the efficacy of remote ischemic conditioning in patients with intracerebral hemorrhage, this is the first clinical trial performed in the field of intracerebral hemorrhage and it did determine that in these patients, remote ischemic conditioning can be safely performed and maybe in the future we need to investigate whether remote ischemic conditioning can benefit patients with much larger hematoma size or more severe intracerebral hemorrhage. Also it may be investigated in patients who were treated with surgical therapist and combined with remote ischemic conditioning it maybe can further improve the prognosis for these patients.
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