From the Department of Neuroradiology (J.F., M.B., H.K., S.G.), University Hospital Hamburg-Eppendorf, Germany.
Department of Neurology (G.T.), University Hospital Hamburg-Eppendorf, Germany.
Stroke. 2019 May;50(5):1275-1278. doi: 10.1161/STROKEAHA.119.024858.
Background and Purpose- Using a novel study design with virtual comparators based on predictive modeling, we investigated whether next-generation mechanical thrombectomy devices improve outcomes in patients with ischemic stroke. We hypothesized that this new study design shows that a next-generation mechanical thrombectomy system is superior to intravenous tPA (tissue-type plasminogen activator) therapy (IVT) alone. Methods- ERASER (Eric Acute Stroke Recanalization) was an investigator-initiated, prospective, multicenter, single-arm (virtual 2-arm) study that evaluated the effectiveness of a new recanalization device together with a specific intermediate catheter (Embolus Retriever with Interlinked Cages/SOFIA, Microvention) in stroke patients with internal carotid artery or middle cerebral artery occlusions. The primary end point was the volume of saved tissue. Volume of saved tissue was defined as the difference of actual infarct volume and brain volume predicted to develop infarction using a machine learning model based on data from intravenous tPA therapy patients. Results- Eighty-one patients were enrolled. The median patient age was 71 years (interquartile range, 61-77). National Institutes of Health Stroke Scale score was 14 (interquartile range, 12-18). The actual infarct volume was smaller than predicted by the intravenous tPA therapy model, with a median volume of saved tissue of 50 mL (interquartile range, 19-103; P<0.0001). Good clinical outcome (modified Rankin Scale, 0-2 at 90 days) was observed in 48 out of 69 (70%). The recanalization rate (Thrombolysis in Cerebral Infarction 2b/3) was 95%. Conclusions- ERASER is the first mechanical thrombectomy study with a primary end point based on predictive analytics enabling intraindividual virtual comparisons. The next-generation mechanical thrombectomy method resulted in smaller infarcts than predicted after intravenous tPA therapy alone and showed a high rate of good clinical outcome. The novel study design with virtual comparisons is promising for further application and testing in the neurovascular arena. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT02534701.
背景与目的- 使用基于预测模型的新型虚拟对照研究设计，我们研究了新一代机械取栓装置是否能改善缺血性脑卒中患者的预后。我们假设这种新的研究设计表明，新一代机械取栓系统优于单独的静脉内组织型纤溶酶原激活剂（tPA）治疗（IVT）。方法- ERASER（Eric Acute Stroke Recanalization）是一项由研究者发起的、前瞻性的、多中心的单臂（虚拟双臂）研究，评估了一种新的再通装置与特定中间导管（带互连笼的 Embolus Retriever/ SOFIA，Microvention）联合用于伴有颈内动脉或大脑中动脉闭塞的脑卒中患者的有效性。主要终点是保存组织的体积。保存组织的体积定义为使用基于静脉内 tPA 治疗患者数据的机器学习模型预测发生梗死的脑容积与实际梗死容积之间的差异。结果- 共纳入 81 例患者。患者中位年龄为 71 岁（四分位间距，61-77）。国立卫生研究院卒中量表评分为 14 分（四分位间距，12-18）。实际梗死体积小于静脉内 tPA 治疗模型预测的体积，保存组织的中位数为 50 mL（四分位间距，19-103；P<0.0001）。90 天时，69 例患者中有 48 例（70%）获得良好的临床转归（改良 Rankin 量表评分 0-2）。再通率（血栓切除术溶栓分级 2b/3）为 95%。结论- ERASER 是首个基于预测分析的以主要终点为基础的机械取栓研究，可进行个体内虚拟对照。与单独静脉内 tPA 治疗相比，新一代机械取栓方法导致的梗死体积更小，且临床转归良好的比例较高。这种基于虚拟对照的新型研究设计在神经血管领域具有广阔的应用和测试前景。临床试验注册- URL：https://www.clinicaltrials.gov. 唯一标识符：NCT02534701。
