Weili Li1, Zhifeng Qi1, Qingfeng Ma1, Jiayue Ding1, Chuanjie Wu1, Haiqing Song1, Qi Yang1, Jiangang Duan1, Lan Liu1, Huining Kang1, Longfei Wu1, Kangxiang Ji2, Wenbo Zhao1, Chuanhui Li1, Chenghe Sun1, Na Li1, Marc Fisher1, Xunming Ji2, Ke Jian Liu1. 1. From the Cerebrovascular Diseases Research Institute (W.L., Z.Q., X.J.) and the Departments of Neurology (Q.M., Jiayue Ding, C.W., H.S., L.W., K.J., W.Z., C.S., N.L.), Radiology (Q.Y.), Emergency (Jiangang Duan, C.L.), and Neurosurgery (X.J.), Xuanwu Hospital of Capital Medical University, Beijing; Beijing Institute of Brain Disorders, Laboratory of Brain Disorders, Ministry of Science and Technology (W.L., X.J.), Collaborative Innovation Center for Brain Disorders, Capital Medical University, Beijing, China; School of Statistics (L.L.), University of Minnesota at Twin Cities, Minneapolis; Department of Internal Medicine (H.K.), University of New Mexico, Albuquerque; Department of Neurology (M.F.), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; and Department of Pharmaceutical Sciences (K.J.L.), University of New Mexico Health Sciences Center, Albuquerque. 2. From the Cerebrovascular Diseases Research Institute (W.L., Z.Q., X.J.) and the Departments of Neurology (Q.M., Jiayue Ding, C.W., H.S., L.W., K.J., W.Z., C.S., N.L.), Radiology (Q.Y.), Emergency (Jiangang Duan, C.L.), and Neurosurgery (X.J.), Xuanwu Hospital of Capital Medical University, Beijing; Beijing Institute of Brain Disorders, Laboratory of Brain Disorders, Ministry of Science and Technology (W.L., X.J.), Collaborative Innovation Center for Brain Disorders, Capital Medical University, Beijing, China; School of Statistics (L.L.), University of Minnesota at Twin Cities, Minneapolis; Department of Internal Medicine (H.K.), University of New Mexico, Albuquerque; Department of Neurology (M.F.), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; and Department of Pharmaceutical Sciences (K.J.L.), University of New Mexico Health Sciences Center, Albuquerque. jixm@ccmu.edu.cn.
Abstract
BACKGROUND AND OBJECTIVES: To investigate the safety and efficacy of normobaric hyperoxia (NBO) combined with endovascular treatment (EVT) in patients with acute ischemic stroke (AIS). METHODS: In this single-center, proof-of-concept, assessor-blinded, randomized, controlled pilot study, patients with AIS in the acute anterior circulation with large vessel occlusion who had an indication for EVT were randomly assigned to the EVT group or the NBO + EVT group. The NBO + EVT group was given 100% oxygen through a face mask initiated before vascular recanalization (10L/min for 4 hours), while the EVT group was given room air. The primary endpoint was infarct volume measured by MRI within 24-48 hours after randomization. RESULTS: A total of 231 patients were screened, and 86 patients were randomized into a ratio of 1:1 (EVT group, n = 43; NBO + EVT group, n = 43). The median infarction volume of the NBO + EVT group at 24-48 hours after randomization was significantly smaller than that of the EVT group (median 20.1 vs 37.7 mL, p < 0.01). The median mRS score at 90 days was 2 for the NBO + EVT group when compared with 3 for the EVT group (adjusted value 1.8, 95% CI 1.3-4.2; p = 0.038). Compared with the EVT group, the NBO + EVT group had a lower incidence of symptomatic intracranial hemorrhagic (7% vs 12%), mortality (9% vs 16%), and adverse events (33% vs 42%); however, such a difference was not statistically significant. DISCUSSION: NBO in combination with EVT seems to be a safe and feasible treatment strategy that could significantly reduce infarct volume, improve short-term neurobehavioral test score, and enhance clinical outcomes at 90 days when compared with EVT alone in patients with AIS. These observations need to be further confirmed by a large, multicenter, randomized clinical trial. CLINICAL TRIALS REGISTRATION: NCT03620370. CLASSIFICATION OF EVIDENCE: This pilot study provides Class I evidence that NBO combined with standard EVT decreases infarction volume in patients with acute anterior circulation stroke.
BACKGROUND AND OBJECTIVES: To investigate the safety and efficacy of normobaric hyperoxia (NBO) combined with endovascular treatment (EVT) in patients with acute ischemic stroke (AIS). METHODS: In this single-center, proof-of-concept, assessor-blinded, randomized, controlled pilot study, patients with AIS in the acute anterior circulation with large vessel occlusion who had an indication for EVT were randomly assigned to the EVT group or the NBO + EVT group. The NBO + EVT group was given 100% oxygen through a face mask initiated before vascular recanalization (10L/min for 4 hours), while the EVT group was given room air. The primary endpoint was infarct volume measured by MRI within 24-48 hours after randomization. RESULTS: A total of 231 patients were screened, and 86 patients were randomized into a ratio of 1:1 (EVT group, n = 43; NBO + EVT group, n = 43). The median infarction volume of the NBO + EVT group at 24-48 hours after randomization was significantly smaller than that of the EVT group (median 20.1 vs 37.7 mL, p < 0.01). The median mRS score at 90 days was 2 for the NBO + EVT group when compared with 3 for the EVT group (adjusted value 1.8, 95% CI 1.3-4.2; p = 0.038). Compared with the EVT group, the NBO + EVT group had a lower incidence of symptomatic intracranial hemorrhagic (7% vs 12%), mortality (9% vs 16%), and adverse events (33% vs 42%); however, such a difference was not statistically significant. DISCUSSION: NBO in combination with EVT seems to be a safe and feasible treatment strategy that could significantly reduce infarct volume, improve short-term neurobehavioral test score, and enhance clinical outcomes at 90 days when compared with EVT alone in patients with AIS. These observations need to be further confirmed by a large, multicenter, randomized clinical trial. CLINICAL TRIALS REGISTRATION: NCT03620370. CLASSIFICATION OF EVIDENCE: This pilot study provides Class I evidence that NBO combined with standard EVT decreases infarction volume in patients with acute anterior circulation stroke.