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Safety and Tolerability of Direct Ischemic Postconditioning Following Thrombectomy for Acute Ischemic Stroke

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机构： [1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China [2]Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China [3]Department of Neurosurgery, Tianjin Huanhu Hospital, China [4]Tianjin University, China [5]Department of Neurology, Tianjin Huanhu Hospital, China [6]Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China [7]Beijing Key Laboratory of Hypoxic Conditioning Translational Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China [8]Department of Neurology, Medical College of Georgia, Augusta University

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Experimental studies have demonstrated the neuroprotection of ischemic postconditioning (IPostC) in acute ischemic stroke by attenuating ischemia-reperfusion injury. This study aimed to investigate the safety and tolerability of direct IPostC in both a dog model and patients with acute ischemic stroke treated with thrombectomy.The study involved 2 parts. First, IPostC was induced by repeated balloon inflation and deflation in dogs, where a low-pressure balloon was navigated to the anterior spinal artery, and 4 cycles of 5-minute ischemia followed by 5-minute reperfusion were performed. Vascular injuries were assessed using angiography and vascular tissue specimens. Then, a 3+3 dose-escalation trial was conducted in patients with acute ischemic stroke following successful thrombectomy recanalization. Patients received direct IPostC with ischemia and reperfusion durations in progressive increments of 0, 1, 2, 3, 4, and 5 minutes ×4 cycles. Major adverse responses were defined as vessel perforation, rupture, dissection, reocclusion, severe vasospasm, thrombotic events, and rupture of the balloon.IPostC was investigated in 4 dogs. No vessel perforation or rupture, dissection, or vasospasm was observed under the angiography. Only 1 vessel experienced mild injury between the intima and the internal elastic membrane detected on a histopathologic slide. Then, 18 patients were recruited. The duration of IPostC was progressively escalated with no major response happened. No patient experienced agitation, discomfort, or other tolerability issues. Five patients (27.8%) experienced any intracranial hemorrhage after thrombectomy, and 1 (5.6%) was symptomatic. At 3-month follow-up, no patient died, and 9 patients (50%) achieved functional independence.Direct IPostC inducing by 4 cycles of 5-minute ischemia followed by 5-minute reperfusion is safe, feasible, and tolerable in patients with acute ischemic stroke treated with thrombectomy. Further investigations are needed to determine the safety and preliminary efficacy of direct IPostC.URL: https://www.gov; Unique identifier: NCT05153655.

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出版当年[2022]版：

大类 | 1 区

医学

小类 | 1 区外周血管病 1 区临床神经病学

最新[2025]版：

大类 | 1 区

医学

小类 | 1 区临床神经病学 1 区外周血管病

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出版当年[2021]版：

Q1 CLINICAL NEUROLOGY Q1 PERIPHERAL VASCULAR DISEASE

最新[2023]版：

Q1 CLINICAL NEUROLOGY Q1 PERIPHERAL VASCULAR DISEASE

影响因子： 7.9 最新[2023版] 8.2 最新五年平均 10.17 出版当年[2021版] 9.941 出版当年五年平均 7.914 出版前一年[2020版] 8.4 出版后一年[2022版]

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第一作者机构： [1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China

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通讯机构： [1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China [6]Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China [*1]Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, No. 45, Changchun St, Xicheng District, Beijing 100053, China [*2]Department of Neurology, Xuanwu Hospital, Capital Medical University, No. 45, Changchun St, Xicheng District, Beijing 100053, China

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