The ENRICH (Early MiNimally-invasive Removal of ICH) trial was designed to evaluate minimally invasive parafascicular surgery (MIPS) and ICH removal using the BrainPath® and Myriad® devices versus medical management alone, as defined by the American Heart Association/American Stroke Association guidelines.
The trial was sponsored by NICO Corporation, the company that developed the specialized MIPS tools.
Randomized clinical trial comparing early minimally invasive surgery with combination technologies (BrainPath/Myriad) to standard guideline-based management alone for intracerebral hemorrhage evacuation
• Trial began in December 2016
• Trial completion March 2023
• Protocol publication
– https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10061000/
Here are the results for the primary endpoint
Per the shift analysis, all mRS groups improved in MIPS OVER MM (point out dotted lines)
The trial met its primary endpoint with the MIPS group achieving a statistically significant improvement in UW-mRS at 180 days compared to MM.
The posterior probability of MIPS being superior to Medical Management overall was 98.1%.
This is analogous to a p-value of 0.032
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The numbers in each mRS color represents the number of patients (N)
The x-axis is the percentage of patients
In the MIPS group, 50% of patients had mRS 0-3
In the MM group, 41% of patients had mRS 0-3
This is a graph of the Bayesian analysis of the results or the “posterior distribution of the treatment effect”
We can see here the overwhelmingly positive effect in the lobar location
ABG: Blue - Neutral - some did very well, some didn't
Lobar: Red - Superior
Combined: Grey - Trial combines the two locations to meet the primary endpoint threshold for a POSITIVE Trial!
Was overwhelming positive within lobar but still statistically significant and positive with both locations combined
There is still much to be learned about why ABG didn’t do well
Y-axis: Probability density
Probability of different treatment effects (peak is the most common)
You can see here the traditional ordinal logistic regression analysis
The benefit of MIPS on mRS was observed early and consistently through follow-up
Here you have the analogous result of p = 0.032 to our primary endpoint
ENRICH also met its safety endpoints.
MIPS was associated in a lower rate of all-cause mortality through 30 days
The favorable short-term mortality through 30 days was maintained through 180 days.
Patients from MM died early and from ICH
Patients from MIPS died later on, from other complications
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MISTIE:
Remember that for MISTIE, randomization didn't happen until later (3 days)
Which means that many of them may have stabilized prior to the procedure
MIPS was shown to significantly reduce length of stay in the ICU, and significantly reduce the total in-hospital length of stay.
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MISTIE: no change in ICU LOS
ICU LOS
MISTIE arm 10 (7-17) days
Control arm 10 (5-16) days
Some other interesting result that will be discussed in the final paper
We were able to achieve a median EOT ICH volume of 7 mL
With 88% ICH reduction
In light of those metrics, there will be analyses looking at improvement in mRS based on EOT volume and % ICH reduction
MISTIE's showed improved functional outcome with:
< 15 mL end-of-treatment (EOT) volume of ICH
> 70% ICH reduction