Jovin Tudor G, Desai Shashvat M, Aghaebrahim Amin, Ducruet Andrew F, Giurgiutiu Dan-Victor, Gross Bradley A, Hammer Maxim, Jankowitz Brian T, Jumaa Mouhammad A, Kenmuir Cynthia, Linares Guillermo, Reddy Vivek, Rocha Marcelo, Starr Matthew, Totoraitis Viktoria, Wechsler Lawrence, Zaidi Syed, Jadhav Ashutosh P
Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.
Department of Neurosurgery, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.
Front Neurol. 2020 Sep 24;11:1047. doi: 10.3389/fneur.2020.01047. eCollection 2020.
The practice of endovascular therapy has evolved dramatically over the last 10 years with randomized clinical trials investigating the benefit of thrombectomy in select patient populations based on time of presentation, imaging criteria, and procedural technique. We sought to understand the benefit of thrombectomy in patients treated within the context of a clinical trial at a single academic center. Patient-level data recorded in case forms and core-lab adjudicated data were analyzed from patients enrolled in RCTs investigating the benefit of endovascular thrombectomy over medical management (IMSIII, MR RESCUE, ESCAPE, SWIFT PRIME, and DAWN) between 2007 and 2017 at a single academic referral center. A total of 134 patients (intervention group, = 81; medical group, = 53) were identified across five clinical trials (IMSIII, = 46; MR RESCUE, = 4; ESCAPE, = 24; SWIFT PRIME, = 14; DAWN, = 46). There were no significant differences between the treatment arm and control arm in terms of age, gender, baseline NIHSS, ASPECTS, and site of occlusion. Rates of good outcome were superior in the intervention group with early neurological recovery (NIHSS of 0-1 or increase NIHSS of 8 points at 24 h) at a higher rate of 49% vs. 17% ( = <0.001) and higher rates of functional independence (90 day mRS 0-2 of 53% vs. 26%, = 0.002). In multivariate logistic regression analysis, lower NIHSS and younger age were predictors of good outcome. There were comparable rates of good outcome irrespective of clinical trial, imaging selection criteria (CTP vs. MRI), early vs. late time window (0-6 h vs. 6-24 h) and procedural technique (Merci vs. Solitaire/Trevo device). There were no differences in rates of sICH, PH-2 or mortality in the intervention group vs. medical group. At a large academic center, the benefit of endovascular therapy over medical therapy is observed irrespective of clinical trial design, patient selection or procedural technique.
在过去10年中，血管内治疗实践发生了巨大变化，随机临床试验根据就诊时间、影像学标准和手术技术，研究了血栓切除术在特定患者群体中的益处。我们试图了解在单一学术中心进行的一项临床试验背景下接受治疗的患者中血栓切除术的益处。分析了2007年至2017年期间在单一学术转诊中心参加随机对照试验（RCT）的患者的病例表格中记录的患者水平数据和核心实验室判定数据，这些试验研究了血管内血栓切除术相对于药物治疗（IMSIII、MR RESCUE、ESCAPE、SWIFT PRIME和DAWN）的益处。在五项临床试验（IMSIII，n = 46；MR RESCUE，n = 4；ESCAPE，n = 24；SWIFT PRIME，n = 14；DAWN，n = 46）中总共确定了134例患者（干预组，n = 81；药物组，n = 53）。治疗组和对照组在年龄、性别、基线美国国立卫生研究院卒中量表（NIHSS）评分、脑梗死溶栓治疗（ASPECTS）评分和闭塞部位方面无显著差异。干预组早期神经功能恢复（24小时时NIHSS评分为0 - 1或NIHSS评分增加8分）的良好结局率更高，为49%，而药物组为17%（P = <0.001），且功能独立率更高（90天改良Rankin量表[mRS]评分为0 - 2的比例为53%对26%，P = 0.002）。在多因素逻辑回归分析中，较低的NIHSS评分和较年轻的年龄是良好结局的预测因素。无论临床试验、影像学选择标准（CTP与MRI）、早期与晚期时间窗（0 - 6小时与6 - 24小时）以及手术技术（Merci与Solitaire/Trevo装置）如何，良好结局率相当。干预组与药物组在症状性颅内出血（sICH）、PH - 2或死亡率方面无差异。在大型学术中心，无论临床试验设计、患者选择或手术技术如何，血管内治疗相对于药物治疗均有益处。
