Remote Ischemic Perconditioning as an Adjunct Therapy to Thrombolysis in Patients With Acute Ischemic Stroke A Randomized Trial
Remote Ischemic Perconditioning as an Adjunct Therapy to Thrombolysis in Patients With Acute Ischemic Stroke A Randomized Trial
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DOI：
10.1161/strokeaha.113.001346
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发表时间：
2014-01-01
期刊：
影响因子：
8.3
通讯作者：
Andersen, Grethe
中科院分区：
文献类型：
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作者：
Hougaard, Kristina Dupont;Hjort, Niels;Andersen, Grethe
背景与目的远程缺血预处理对急性脑缺血模型具有神经保护作用。我们测试的效果院前rPerC作为一种辅助治疗与静脉阿替普酶在急性缺血性stroke.Methods开放标签的盲法结果的概念验证研究院前，护理人员管理的rPerC在1：1的比例在连续的疑似急性中风患者。在神经系统检查和MRI后，纳入了接受阿替普酶治疗的证实卒中的患者，并在24小时和1个月时接受MRI检查，3个月后进行临床复查。主要终点是半影挽救，定义为体积的灌注扩散不匹配不进展梗死后1 month.Results四百四十三例患者随机后，临时同意，247接受rPerC和196接受标准治疗。非卒中诊断的患者（n=105）被排除在进一步检查之外。其余患者为短暂性脑缺血发作（n=58）、急性缺血性卒中（n=240）或出血性卒中（n=37）。与对照组相比，干预组的短暂性脑缺血发作更频繁（P=0.006），入院时美国国立卫生研究院卒中量表评分更低（P=0.016）。两组之间的半暗带挽救、1个月时的最终梗死面积、基线与1个月之间的梗死增长以及3个月后的临床结局均无差异。调整后的基线灌注和扩散病变的严重程度，voxelwise分析表明，rPerC降低组织梗死的风险（P=0.0003）。结论虽然总体结果是中性的，组织生存分析表明，院前rPerC可能有立即的神经保护作用。未来的临床试验应考虑此类即时效应及其持续时间。临床试验注册URL：http://www.clinicaltrials.gov。唯一标识符：NCT 00975962。
Background and Purpose Remote ischemic preconditioning is neuroprotective in models of acute cerebral ischemia. We tested the effect of prehospital rPerC as an adjunct to treatment with intravenous alteplase in patients with acute ischemic stroke.Methods Open-label blinded outcome proof-of-concept study of prehospital, paramedic-administered rPerC at a 1:1 ratio in consecutive patients with suspected acute stroke. After neurological examination and MRI, patients with verified stroke receiving alteplase treatment were included and received MRI at 24 hours and 1 month and clinical re-examination after 3 months. The primary end point was penumbral salvage, defined as the volume of the perfusion-diffusion mismatch not progressing to infarction after 1 month.Results Four hundred forty-three patients were randomized after provisional consent, 247 received rPerC and 196 received standard treatment. Patients with a nonstroke diagnosis (n=105) were excluded from further examinations. The remaining patients had transient ischemic attack (n=58), acute ischemic stroke (n=240), or hemorrhagic stroke (n=37). Transient ischemic attack was more frequent (P=0.006), and National Institutes of Health Stroke Scale score on admission was lower (P=0.016) in the intervention group compared with controls. Penumbral salvage, final infarct size at 1 month, infarct growth between baseline and 1 month, and clinical outcome after 3 months did not differ among groups. After adjustment for baseline perfusion and diffusion lesion severity, voxelwise analysis showed that rPerC reduced tissue risk of infarction (P=0.0003).Conclusions Although the overall results were neutral, a tissue survival analysis suggests that prehospital rPerC may have immediate neuroprotective effects. Future clinical trials should take such immediate effects, and their duration, into account.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00975962.