Compared with medical care alone, patients with large cerebral infarctions had improved outcomes with endovascular therapy with the exception of increased rates of intracranial hemorrhages. These findings were published in The New England Journal of Medicine.
Endovascular therapy is the guideline-recommended therapy for patients with acute stroke caused by large vessel occlusion. Patients who have large infarctions have typically been excluded from endovascular therapy trials and it remains unclear whether outcomes may be improved with endovascular therapy.
The Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism-Japan Large Ischemic Core Trial (RESCUE-Japan LIMIT) was conducted at 45 Japanese hospitals in 2018-2021. Patients (N=203) with acute ischemic stroke (AIS) were stratified by age, interval between last known time to be well and hospital arrival, use of recombinant tissue plasminogen activator (rt-PA) and randomized in a 1:1 ratio to receive endovascular therapy with medical care (n=101) or medical care alone (n=102). Patient outcomes were assessed through 90 days.
Patients in the endovascular and control cohorts were aged mean 76.6±10.0 and 75.7±10.2 years, 54.5% and 56.9% were men, median time from stroke onset to hospital arrival was 190 (IQR, 85-390) and 170 (IQR, 83-335) minutes, and 73.3% and 68.6% had M1 segment occlusions, respectively.
The proportion of patients who had a modified Rankin scale (mRS) score of 0-3 at day 90 was 31.0% among the endovascular and 12.7% among the control cohorts (relative risk [RR], 2.43; 95% CI, 1.35-4.37; P =.002). The shift in mRS scores favored endovascular therapy (odds ratio [OR], 2.42; 95% CI, 1.46-4.01).
Within 48 hours, 58.0% of the endovascular and 31.4% of the control cohorts had intercranial hemorrhage (RR, 1.85; 95% CI, 1.33-2.58; P <.001). The endovascular cohort had numerically lower rates of death within 90 days (18.0% vs 23.5%; P =.33), recurrence of cerebral infarction within 90 days (5.0% vs 6.9%; P =.58), and decompressive craniectomy within 7 days (10.0% vs 13.7%; P =.41).
In subgroup analyses, endovascular therapy was favored among older patients (aged 75 years or older; RR, 3.05; 95% CI, 1.19-7.85), for short (<120 min) and long (³120 min) time from stroke to hospitalization (RR range, 2.32-2.60), for those with a shorter time (<6 hours) since last known well (RR, 2.43; 95% CI, 1.25-4.74), for low (<21) and high (³21) National Institutes of Health Stroke Scale scores (RR range, 2.22-3.21), and among rt-PA nonusers (RR, 2.52; 95% CI, 1.25-5.07).
This study was limited by the study population and findings may not be generalizable among non-Japanese populations. Additional study is needed to confirm these findings and to inform evidence-based guidelines.
The researchers concluded, “This trial conducted in Japan showed that among patients with acute stroke and a large ischemic region, functional outcomes at 90 days were better with endovascular therapy and medical care than with medical care alone, but endovascular therapy was associated with an increased incidence of intracranial hemorrhage.”
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Yoshimura S, Sakai N, Yamagami H, et al. Endovascular Therapy for Acute Stroke with a Large Ischemic Region. N Engl J Med. Published online February 9, 2022. doi:10.1056/NEJMoa2118191