Bendszus Martin, Thomalla Götz, Knauth Michael, Hacke Werner, Bonekamp Susanne, Fiehler Jens
Neuroradiology, University of Heidelberg, Heidelberg, Germany.
Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
Int J Stroke. 2015 Aug;10(6):950-5. doi: 10.1111/ijs.12527. Epub 2015 Jun 4.
A relevant proportion of patients with acute ischemic stroke are ineligible for intravenous thrombolysis with recombinant tissue plasminogen activator. Mechanical thrombectomy offers a treatment alternative for these patients; however, only few data are available on its safety and efficacy.
AIMS AND/OR HYPOTHESIS: The aim of this study was to compare safety and efficacy of stent retrievers as device class with best medical care alone in acute stroke patients with large intracranial vessel occlusion in the anterior circulation who are not eligible for intravenous thrombolysis with recombinant tissue plasminogen activator up to eight-hours of symptom onset.
'Thrombectomy in patients ineligible for iv tPA' is a prospective, open-label, blinded end-point, binational (Germany and Austria), two-arm, randomized, controlled, post-market study.
STUDY OUTCOME(S): Primary end-point is the modified Rankin Score shift analysis 90 days (±14) after stroke. Secondary end-points are excellent neurological outcomes (modified Rankin Score ≤ 1), good neurological outcomes (modified Rankin Score ≤ 2 or National Institutes of Health Stroke Scale improvement ≥ 10), difference between predicted infarct volume and actual core infarct volume (computed tomography or magnetic resonance imaging) at 30 (±6) h post-ictus, successful recanalization (thrombolysis in cerebral infarction score 2b or 3), functional health status 90 (±14) days after stroke (European Quality of Life-5 Dimensions) as well as common safety end-points (adverse event, serious adverse event, symptomatic intracranial haemorrhage at 30 (±6) h, death, or dependency).
Whether mechanical thrombectomy in patients with acute ischemic stroke who are not eligible for intravenous thrombolysis with recombinant tissue plasminogen activator improves clinical outcomes is unclear. 'Thrombectomy in patients ineligible for iv tPA' may change clinical practice by providing evidence of an effective and safe treatment for such patients.
相当一部分急性缺血性中风患者不符合使用重组组织型纤溶酶原激活剂进行静脉溶栓的条件。机械取栓术为这些患者提供了一种治疗选择；然而，关于其安全性和有效性的数据却很少。
目的和/或假设：本研究的目的是比较支架取栓器作为一种器械类型与单纯最佳药物治疗对急性中风且前循环大颅内血管闭塞、症状发作8小时内不符合使用重组组织型纤溶酶原激活剂进行静脉溶栓条件的患者的安全性和有效性。
“不符合静脉注射tPA条件患者的取栓术”是一项前瞻性、开放标签、双盲终点、双边（德国和奥地利）、双臂、随机、对照的上市后研究。
主要终点是中风后90天（±14天）的改良Rankin量表评分变化分析。次要终点包括良好的神经功能结局（改良Rankin量表评分≤1）、较好的神经功能结局（改良Rankin量表评分≤2或美国国立卫生研究院卒中量表改善≥10）、发病后30（±6）小时时预测梗死体积与实际核心梗死体积之间的差异（计算机断层扫描或磁共振成像）、成功再通（脑梗死溶栓评分2b或3）、中风后90（±14）天的功能健康状况（欧洲生活质量-5维度）以及常见的安全性终点（不良事件、严重不良事件、30（±6）小时时的症状性颅内出血、死亡或依赖）。
对于不符合使用重组组织型纤溶酶原激活剂进行静脉溶栓条件的急性缺血性中风患者，机械取栓术是否能改善临床结局尚不清楚。“不符合静脉注射tPA条件患者的取栓术”可能会通过为这类患者提供有效且安全治疗的证据来改变临床实践。
