From the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at the University of California, Los Angeles (D.F.Y.-S., J.L.S.).
Department of Biomathematics, University of California, Los Angeles (J.G.).
Stroke. 2019 Sep;50(9):2433-2440. doi: 10.1161/STROKEAHA.118.023120. Epub 2019 Jul 17.
Background and Purpose- Quantifying the benefit magnitude of combined endovascular thrombectomy (EVT) and intravenous thrombolysis (IVT) versus nonreperfusion care in patients with acute ischemic stroke caused by large vessel occlusion would aid organization of regional stroke care systems. Methods- NINDS rt-PA Study (National Institute for Neurological Disorders and Stroke Recombinant Tissue Plasminogen Activator) and SWIFT PRIME trial (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment) patients were matched for prognosis (based on age and National Institutes of Health Stroke Scale) and definite/likely anterior circulation large vessel occlusion (based on National Institutes of Health Stroke Scale total score and item pattern), using optimal inverse variance matching, to determine comparative outcomes with nonreperfusion care alone, IVT alone, and IVT+EVT. Results- Matching yielded 240 patients, including 80 each treated with nonreperfusion care, IVT alone, and IVT+EVT, with, respectively, mean age 67.1, 67.1, and 66.9 and presenting deficit severity (National Institutes of Health Stroke Scale) mean 15.8, 15.9, and 15.9. Outcomes at 3 months for IVT+EVT versus nonreperfusion care included freedom from disability (modified Rankin Scale score, 0-1) 48.1% versus 21.3%, P=0.0004; functional independence (modified Rankin Scale score, 0-2) 62.9% versus 32.6, P=0.0001; and reduced disability over all 7 modified Rankin Scale levels, common odds ratio 3.34, P<0.0001. Outcomes for IVT alone versus nonreperfusion care included: freedom from disability 30.0% versus 21.3%, P=0.28 and reduced disability over all 7 modified Rankin Scale levels, common odds ratio 1.14, P=0.65. Compared with nonreperfusion care, the number needed to treat with EVT+IVT for 1 more patient to have reduced disability was 1.8. Conclusions- Matched patient analysis across randomized trials provides evidence that the strategy of combined IVT and mechanical thrombectomy is a highly beneficial treatment strategy for acute ischemic stroke caused by large vessel occlusion patients. A reasonable effect magnitude estimate is that, among every 100 patients treated, combined IVT+EVT reperfusion therapy, compared with no reperfusion therapy, reduces long-term disability in 57, including conferring functional independence upon 30.
背景与目的- 量化急性大血管闭塞性缺血性卒中患者接受血管内血栓切除术(EVT)联合静脉溶栓(IVT)与非再灌注治疗相比的获益程度,有助于组织区域性卒中治疗系统。方法- NINDS rt-PA 研究(美国国立卫生研究院神经疾病与卒中研究所重组组织型纤溶酶原激活剂)和 SWIFT PRIME 试验(Solitaire 与意图血管内血栓切除术作为主要血管内治疗)患者采用最佳逆方差匹配法进行预后(基于年龄和 NIHSS 评分)和明确/可能的前循环大血管闭塞(基于 NIHSS 总评分和项目模式)匹配,以确定单独非再灌注治疗、单独 IVT 和 IVT+EVT 的比较结果。结果- 匹配得到 240 例患者,分别接受非再灌注治疗、单独 IVT 和 IVT+EVT 治疗的患者各 80 例,平均年龄分别为 67.1、67.1 和 66.9,发病严重程度(NIHSS)分别为 15.8、15.9 和 15.9。3 个月时 IVT+EVT 与非再灌注治疗的结果包括无残疾(改良 Rankin 量表评分,0-1)48.1%与 21.3%,P=0.0004;功能独立(改良 Rankin 量表评分,0-2)62.9%与 32.6%,P=0.0001;以及所有 7 个改良 Rankin 量表水平的残疾程度降低,常见优势比 3.34,P<0.0001。单独 IVT 与非再灌注治疗的结果包括:无残疾 30.0%与 21.3%,P=0.28 和所有 7 个改良 Rankin 量表水平的残疾程度降低,常见优势比 1.14,P=0.65。与非再灌注治疗相比,每治疗 1 例患者使用 EVT+IVT 减少残疾的患者数量为 1.8。结论- 随机试验的匹配患者分析提供了证据,表明 IVT 联合机械血栓切除术的策略是急性大血管闭塞性缺血性卒中患者的一种非常有益的治疗策略。一个合理的效应量估计是,在每 100 例接受治疗的患者中,与不进行再灌注治疗相比,联合 IVT+EVT 再灌注治疗可使 57 例患者的长期残疾程度降低,其中 30 例患者可获得功能独立性。