Background and Purpose—
Using
a novel study design with virtual comparators based on predictive
modeling, we investigated whether next-generation mechanical
thrombectomy devices improve outcomes in patients with ischemic stroke.
We hypothesized that this new study design shows that a next-generation
mechanical thrombectomy system is superior to intravenous tPA
(tissue-type plasminogen activator) therapy (IVT) alone.
Methods—
ERASER
(Eric Acute Stroke Recanalization) was an investigator-initiated,
prospective, multicenter, single-arm (virtual 2-arm) study that
evaluated the effectiveness of a new recanalization device together with
a specific intermediate catheter (Embolus Retriever with Interlinked
Cages/SOFIA, Microvention) in stroke patients with internal carotid
artery or middle cerebral artery occlusions. The
primary end point was
the volume of saved tissue(Wrong endpoint, should be 100% recovery). Volume of saved tissue was defined as the
difference of actual infarct volume and brain volume predicted to
develop infarction using a machine learning model based on data from
intravenous tPA therapy patients.
Results—
Eighty-one
patients were enrolled. The median patient age was 71 years
(interquartile range, 61–77). National Institutes of Health Stroke Scale
score was 14 (interquartile range, 12–18). The actual infarct volume
was smaller than predicted by the intravenous tPA therapy model, with a
median volume of saved tissue of 50 mL (interquartile range, 19–103;
P<0.0001).
Good clinical outcome (modified Rankin Scale, 0–2 at 90 days) was
observed in 48 out of 69 (70%). The recanalization rate (Thrombolysis in
Cerebral Infarction 2b/3) was 95%.
Conclusions—
ERASER
is the first mechanical thrombectomy study with a primary end point
based on predictive analytics enabling intraindividual virtual
comparisons. The next-generation mechanical thrombectomy method resulted
in smaller infarcts than predicted after intravenous tPA therapy alone
and showed a high rate of
good clinical outcome. The novel study design
with virtual comparisons is promising for further application and
testing in the neurovascular arena.
Clinical Trial Registration—
URL:
https://www.clinicaltrials.gov. Unique identifier: NCT02534701.
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