Stroke Center EOC, Neurocenter of Southern Switzerland, Lugano (C.W.C.).
Stanford Stroke Center (M.M., S.K., M.G.L., G.W.A.), Stanford University School of Medicine, CA.
Stroke. 2021 Jan;52(1):313-316. doi: 10.1161/STROKEAHA.120.030816. Epub 2020 Nov 30.
Contrast-enhanced noninvasive angiography and perfusion imaging are recommended to identify eligible patients for endovascular therapy (EVT) in extended time windows (>6 hours or wake-up). If eligible, additional intraarterial contrast exposure will occur during EVT. We aimed to study the renal safety in the DEFUSE 3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke) population, selected with contrast-enhanced multimodal Imaging and randomized to EVT versus medical management.
In the randomized DEFUSE 3 trial population, we compared changes in serum creatinine between baseline (before randomization) and 24 hours later. The primary outcome was the relative change in creatinine level between baseline and 24 hours in the EVT versus medical arm. The secondary outcome was a comparison between computed tomography (CT) versus magnetic resonance imaging selection in the EVT arm. The safety outcome was a comparison of the proportion of patients with criteria for contrast-associated kidney injury in the EVT versus medical arm and a comparison between CT versus magnetic resonance imaging selection in the EVT arm.
In the DEFUSE 3 population (n=182, age 69±13, 51% female), mean creatinine decreased from a baseline of 0.98±0.33 mg/dL to 0.88±0.28 mg/dL at 24 hours (<0.001). There was no difference in change between treatment groups: relative to baseline, there was a 6.3% reduction in the EVT group versus 9.2% in the medical group, =0.294. Absolute decrease -0.08±0.18 in EVT versus -0.12±0.18 in medical, =0.135; Among patients treated with EVT, there was no difference in 24-hour creatinine level changes between patients who were selected with CT angiography/CT perfusion (-0.08±0.18) versus magnetic resonance imaging (-0.07±0.19), =0.808 or 6.8% reduction versus 4.8%, =0.696. In the EVT arm, contrast-associated kidney injury was encountered in 4 out of 91 (4.4%) versus 2/90 (2.2%) in the medical arm =0.682. In the EVT arm, contrast-associated kidney injury was evenly distributed between magnetic resonance imaging (1/22, 4.6%) versus CT 3 out of 69 (4.4%), =1.0.
Perfusion imaging before EVT was not associated with evidence of decline in renal function. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02586415.
对比增强的非侵入性血管造影和灌注成像被推荐用于识别血管内治疗（EVT）时间窗延长（>6 小时或苏醒后）的合格患者。如果合格，EVT 期间将额外进行动脉内对比剂暴露。我们旨在研究 DEFUSE 3（缺血性中风的影像学评估后血管内治疗）人群中的肾脏安全性，该人群通过对比增强多模态成像选择，并随机分为 EVT 与药物治疗组。
在随机化的 DEFUSE 3 试验人群中，我们比较了基线（随机化前）和 24 小时后血清肌酐的变化。主要结局是 EVT 与药物治疗组之间基线与 24 小时肌酐水平的相对变化。次要结局是比较 EVT 组中 CT 与磁共振成像的选择。安全性结局是比较 EVT 与药物治疗组中符合对比剂相关肾损伤标准的患者比例，并比较 EVT 组中 CT 与磁共振成像的选择。
在 DEFUSE 3 人群中（n=182，年龄 69±13，51%为女性），肌酐从基线时的 0.98±0.33mg/dL 平均下降至 0.88±0.28mg/dL（<0.001）。治疗组之间的变化没有差异：与基线相比，EVT 组降低 6.3%，药物治疗组降低 9.2%，=0.294。绝对下降-0.08±0.18 在 EVT 组与-0.12±0.18 在药物治疗组，=0.135；在接受 EVT 治疗的患者中，CT 血管造影/CT 灌注（-0.08±0.18）与磁共振成像（-0.07±0.19）选择的患者 24 小时肌酐水平变化无差异，=0.808 或 6.8%与 4.8%的减少，=0.696。在 EVT 组中，91 例患者中有 4 例（4.4%）发生对比剂相关肾损伤，90 例患者中有 2 例（2.2%）发生对比剂相关肾损伤，=0.682。在 EVT 组中，磁共振成像（1/22，4.6%）与 CT 各有 3 例（4.4%）发生对比剂相关肾损伤，=1.0。
EVT 前的灌注成像与肾功能下降无关。注册：网址：https://www.clinicaltrials.gov。唯一标识符：NCT02586415。
