RESCUE-Japan LIMIT
Trial question
What is the role of endovascular therapy in patients with acute stroke with a large ischemic region?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 203
203 patients (90 female, 113 male)
Inclusion criteria: patients with occlusion of large cerebral vessels and sizable strokes on imaging
Key exclusion criteria: significant cerebral mass effect with midline shift; acute ICH on CT or MRI; high risk of hemorrhage; known allergy to contrast agents
Interventions
N=101 endovascular therapy (acute thrombectomy plus best medical treatment)
N=102 medical care (best medical treatment alone)
Primary outcome
Patients with modified Rankin Scale score < 4 at 90 days
31
12.7
31.0 %
23.3 %
15.5 %
7.8 %
0.0 %
Endovascular
therapy
Medical
care
Significant
increase ▲
NNT = 5
Significant increase in patients with mRS score < 4 at 90 days (31% vs. 12.7%; RR 2.43, 95% CI 1.35 to 4.37)
Secondary outcomes
Borderline significant increase in patients with of ≥ 8 points on the NIHSS score at 48 hours (31% vs. 8.8%; RR 3.51, 95% CI 1.76 to 7)
No significant difference in patients mRS score of 0-2 at 90 days (14% vs. 7.8%; RR 1.79, 95% CI 0.78 to 4.07)
Safety outcomes
No significant differences in symptomatic ICH at 48 hours, death at 90 days, recurrence of an ischemic stroke at 90 days.
Significant difference in ICH within 48 hours (58.0% vs. 31.4%).
Conclusion
In patients with occlusion of large cerebral vessels and sizable strokes on imaging, endovascular therapy was superior to medical care with respect to patients with mRS score < 4 at 90 days.
Reference
Shinichi Yoshimura, Nobuyuki Sakai, Hiroshi Yamagami et al. Endovascular Therapy for Acute Stroke with a Large Ischemic Region. N Engl J Med. 2022 Apr 7;386(14):1303-1313.
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