卒中介入管理III期试验的12个月临床及生活质量结果
Twelve-Month Clinical and Quality-of-Life Outcomes in the Interventional Management of Stroke III Trial.
作者信息
Palesch Yuko Y, Yeatts Sharon D, Tomsick Thomas A, Foster Lydia D, Demchuk Andrew M, Khatri Pooja, Hill Michael D, Jauch Edward C, Jovin Tudor G, Yan Bernard, von Kummer Rüdiger, Molina Carlos A, Goyal Mayank, Schonewille Wouter J, Mazighi Mikael, Engelter Stefan T, Anderson Craig, Spilker Judith, Carrozzella Janice, Ryckborst Karla J, Janis L Scott, Simpson Annie, Simpson Kit N, Broderick Joseph P
机构信息
From the Departments of Neurology and Rehabilitation Medicine and Radiology, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, Cincinnati (J.P.B., P.K., J.S., J.C., T.A.T.); Department of Public Health Sciences (Y.Y.P., S.D.Y., L.D.F., A.S., K.N.S.) and Division of Emergency Medicine (E.C.J.), Medical University of South Carolina, Charleston; Calgary Stroke Program, Seaman Family MR Research Centre, Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada (A.M.D., M.D.H., M.G., K.J.R.); Stroke Institute, University of Pittsburgh Medical Center, Pittsburgh (T.G.J.); Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia (B.Y.); Department of Neuroradiology, Dresden University Stroke Center, University Hospital, Dresden, Germany (R.v.K.); Neurovascular Unit, Department of Neurology, Hospital Universitari Vall d'Hebron, Barcelona (C.A.M.); Department of Neurology, University Medical Center Utrecht and the Rudolph Magnus Institute of Neurosciences, Utrecht, the Netherlands, and the St. Antonius Hospital, Nieuwegein, the Netherlands (W.J.S.); Department of Neurology and Stroke Center, Lariboisière Hospital, Paris (M.M.); Department of Neurology, Basel University Hospital, Basel, Switzerland (S.T.E.); George Institute for Global Health, Royal Prince Alfred Hospital, University of Sydney, Sydney (C.A.); and National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (L.S.J.).
出版信息
Stroke. 2015 May;46(5):1321-7. doi: 10.1161/STROKEAHA.115.009180. Epub 2015 Apr 9.
BACKGROUND AND PURPOSE
Randomized trials have indicated a benefit for endovascular therapy in appropriately selected stroke patients at 3 months, but data regarding outcomes at 12 months are currently lacking.
METHODS
We compared functional and quality-of-life outcomes at 12 months overall and by stroke severity in stroke patients treated with intravenous tissue-type plasminogen activator followed by endovascular treatment as compared with intravenous tissue-type plasminogen activator alone in the Interventional Management of Stroke III Trial. The key outcome measures were a modified Rankin Scale score ≤2 (functional independence) and the Euro-QoL EQ-5D, a health-related quality-of-life measure.
RESULTS
656 subjects with moderate-to-severe stroke (National Institutes of Health Stroke Scale ≥8) were enrolled at 58 centers in the United States (41 sites), Canada (7), Australia (4), and Europe (6). There was an interaction between treatment group and stroke severity in the repeated measures analysis of modified Rankin Scale ≤2 outcome (P=0.039). In the 204 participants with severe stroke (National Institutes of Health Stroke Scale ≥20), a greater proportion of the endovascular group had a modified Rankin Scale ≤2 (32.5%) at 12 months as compared with the intravenous tissue-type plasminogen activator group (18.6%, P=0.037); no difference was seen for the 452 participants with moderately severe strokes (55.6% versus 57.7%). In participants with severe stroke, the endovascular group had 35.2 (95% confidence interval: 2.1, 73.3) more quality-adjusted-days over 12 months as compared with intravenous tissue-type plasminogen activator alone.
CONCLUSIONS
Endovascular therapy improves functional outcome and health-related quality-of-life at 12 months after severe ischemic stroke.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00359424.
背景与目的
随机试验表明，对于经适当选择的中风患者，血管内治疗在3个月时具有益处，但目前缺乏12个月时预后的数据。
方法
在卒中干预管理III试验中，我们比较了接受静脉注射组织型纤溶酶原激活剂后再进行血管内治疗的中风患者与仅接受静脉注射组织型纤溶酶原激活剂的中风患者在12个月时的总体功能和生活质量预后，并按中风严重程度进行了比较。关键预后指标为改良Rankin量表评分≤2（功能独立）和欧洲五维度健康量表（Euro-QoL EQ-5D），这是一种与健康相关的生活质量指标。
结果
656例中重度中风患者（美国国立卫生研究院卒中量表≥8）在美国（41个地点）、加拿大（7个）、澳大利亚（4个）和欧洲（6个）的58个中心入组。在改良Rankin量表≤2预后的重复测量分析中，治疗组与中风严重程度之间存在交互作用（P=0.039）。在204例严重中风患者（美国国立卫生研究院卒中量表≥20）中，与静脉注射组织型纤溶酶原激活剂组相比，血管内治疗组在12个月时改良Rankin量表≤2的比例更高（32.5%对18.6%，P=0.037）；452例中度严重中风患者中未见差异（55.6%对57.7%）。在严重中风患者中，与仅接受静脉注射组织型纤溶酶原激活剂相比，血管内治疗组在12个月内的质量调整生命天数多35.2天（95%置信区间：2.1，73.3）。
结论
血管内治疗可改善严重缺血性中风后12个月的功能预后和与健康相关的生活质量。
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