ABSTRACT
BACKGROUND: Although mechanical thrombectomy for acute ischemic stroke has a high recanalization rate, procedurally challenging lesions remain in approximately 10% of the cases. Type III aortic arches, due to their anatomical configuration, are a fundamental problem impacting this procedure. This study aimed to determine whether optimal catheter selection for type III aortic arches, using magnetic resonance angiography (MRA)-based road mapping of the para-aortic transfemoral access route, reduces the time required for mechanical thrombectomy. METHODS: We retrospectively evaluated 203 consecutive patients who underwent mechanical thrombectomy at multiple centers between April 2018 and July 2022. 23 patients were diagnosed with a type III aortic arch using MRA-based road mapping performed to visualize the para-aortic access route before neuro-interventional procedures. Among the 23 patients with type III aortic arches, 10 received a Simmons-type catheter (initial Simmons group) and 13 received a JB-2-type catheter (initial JB-2 group) as their first inner catheter. The time required for mechanical thrombectomy was compared between the groups. RESULTS: Compared with the initial JB-2 group, the initial Simmons group exhibited a significantly shorter "puncture-to-recanalization time" (105 vs. 53 minutes, P = 0.009) and "door-to-recanalization time" (164 vs. 129 minutes, P = 0.032). CONCLUSIONS: Optimal catheter selection by identifying the aortic arch before mechanical thrombectomy using MRA-based road mapping effectively reduced the mechanical thrombectomy time. This suggests that even in type III aorta cases, appropriate catheter selection may shorten the mechanical thrombectomy time and improve acute ischemic stroke prognosis.
ABSTRACT
Importance: Cell therapy is a promising treatment approach for stroke and other diseases. However, it is unknown whether MultiStem (HLCM051), a bone marrow-derived, allogeneic, multipotent adult progenitor cell product, has the potential to treat ischemic stroke. Objective: To assess the efficacy and safety of MultiStem when administered within 18 to 36 hours of ischemic stroke onset. Design, Setting, and Participants: The Treatment Evaluation of Acute Stroke Using Regenerative Cells (TREASURE) multicenter, double-blind, parallel-group, placebo-controlled phase 2/3 randomized clinical trial was conducted at 44 academic and clinical centers in Japan between November 15, 2017, and March 29, 2022. Inclusion criteria were age 20 years or older, presence of acute ischemic stroke (National Institutes of Health Stroke Scale [NIHSS] score of 8-20 at baseline), confirmed acute infarction involving the cerebral cortex and measuring more than 2 cm on the major axis (determined with diffusion-weighted magnetic resonance imaging), and a modified Rankin Scale (mRS) score of 0 or 1 before stroke onset. Data analysis was performed between May 9 and August 15, 2022. Exposure: Patients were randomly assigned to either intravenous MultiStem in 1 single unit of 1.2 billion cells or intravenous placebo within 18 to 36 hours of ischemic stroke onset. Main Outcomes and Measures: The primary end points were safety and excellent outcome at day 90, measured as a composite of a modified Rankin Scale (mRS) score of 1 or less, a NIHSS score of 1 or less, and a Barthel index score of 95 or greater. The secondary end points were excellent outcome at day 365, mRS score distribution at days 90 and 365, and mRS score of 0 to 1 and 0 to 2 at day 90. Statistical analysis of efficacy was performed using the Cochran-Mantel-Haenszel test. Results: This study included 206 patients (104 received MultiStem and 102 received placebo). Their mean age was 76.5 (range, 35-95) years, and more than half of patients were men (112 [54.4%]). There were no between-group differences in primary and secondary end points. The proportion of excellent outcomes at day 90 did not differ significantly between the MultiStem and placebo groups (12 [11.5%] vs 10 [9.8%], P = .90; adjusted risk difference, 0.5% [95% CI, -7.3% to 8.3%]). The frequency of adverse events was similar between treatment groups. Conclusions and Relevance: In this randomized clinical trial, intravenous administration of allogeneic cell therapy within 18 to 36 hours of ischemic stroke onset was safe but did not improve short-term outcomes. Further research is needed to determine whether MultiStem therapy for ischemic stroke has a beneficial effect in patients who meet specific criteria, as indicated by the exploratory analyses in this study. Trial Registration: ClinicalTrials.gov Identifier: NCT02961504.