Department of Neurology and Stroke Center, Luhe Hospital, Capital Medical University, Tongzhou District, No. 82 Xinhua SouthRoad, Beijing, 101149, China.
Department of Neurosurgery, Wayne State University School of Medicine, 550 E Canfield, Detroit, MI, 48201, USA.
Neurotherapeutics. 2023 Oct;20(6):1746-1754. doi: 10.1007/s13311-023-01432-x. Epub 2023 Oct 24.
Although endovascular therapy demonstrates robust clinical efficacy in acute ischemic stroke (AIS), not all stroke patients benefit from successful reperfusion. This study aimed to evaluate the safety, feasibility, and preliminary efficacy of intra-arterial administration of glyceryl trinitrate (GTN) after endovascular recanalization for neuroprotection. This is a prospective randomized controlled study. Eligible patients were randomized to receive 800 μg GTN or the same volume of normal saline through the catheter after recanalization. The primary outcome was symptomatic intracranial hemorrhage (ICH), while secondary outcomes included mortality, functional outcome, infarction volume, complications, and blood nitrate index (NO). A total of 40 patients were enrolled and randomized with no participants being lost to follow-up. There was no significant difference in the proportion of sICH between GTN and control groups. Additionally, no significant difference was observed in mortality or rates of neurological deterioration and other complications. Favorable trends, while non-significant, were noted in both outcome and imaging for functional independence at 90 days and reduction in final infarct volume (75.0% vs 65.0%; 33.2 vs 38.9 ml) for the GTN group. Moreover, the concentration of blood NO in the GTN group was significantly higher than in the control group at 2 h after GTN administration (26.2 vs 18.0 μmol/l, p < 0.05). The AGAIN study suggests intra-arterial administration of GTN post-endovascular therapy is safe and feasible and GTN successfully raised NO levels over controls at 2 h. A multi-center randomized controlled trial with a larger sample size is warranted to determine GTN neoadjuvant efficacy.
尽管血管内治疗在急性缺血性脑卒中(AIS)中显示出强大的临床疗效,但并非所有脑卒中患者都能从成功再灌注中获益。本研究旨在评估血管内再通后动脉内给予硝酸甘油(GTN)用于神经保护的安全性、可行性和初步疗效。这是一项前瞻性随机对照研究。符合条件的患者随机接受 800μg GTN 或相同体积的生理盐水通过导管再通后。主要结局是症状性颅内出血(sICH),次要结局包括死亡率、功能结局、梗死体积、并发症和血液硝酸盐指数(NO)。共纳入 40 例患者并随机分组,无失访患者。GTN 组和对照组 sICH 比例无显著差异。此外,死亡率或神经恶化率和其他并发症发生率无显著差异。90 天时功能独立的结果和影像学结果有良好的趋势,但无统计学意义,GTN 组的最终梗死体积减少(75.0%比 65.0%;33.2 比 38.9ml)。此外,GTN 给药后 2 小时 GTN 组血液 NO 浓度明显高于对照组(26.2 比 18.0μmol/l,p<0.05)。AGAIN 研究表明,血管内治疗后动脉内给予 GTN 安全可行,GTN 可在 2 小时内成功升高对照组的 NO 水平。需要进行更大样本量的多中心随机对照试验来确定 GTN 的新辅助疗效。