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Solitaire支架取栓术治疗急性缺血性卒中的成本效益:SWIFT-PRIME试验(以取栓术为急性缺血性卒中主要血管内治疗手段的Solitaire)结果

Cost-Effectiveness of Solitaire Stent Retriever Thrombectomy for Acute Ischemic Stroke: Results From the SWIFT-PRIME Trial (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke).

作者信息

Shireman Theresa I, Wang Kaijun, Saver Jeffrey L, Goyal Mayank, Bonafé Alain, Diener Hans-Christoph, Levy Elad I, Pereira Vitor M, Albers Gregory W, Cognard Christophe, Hacke Werner, Jansen Olav, Jovin Tudor G, Mattle Heinrich P, Nogueira Raul G, Siddiqui Adnan H, Yavagal Dileep R, Devlin Thomas G, Lopes Demetrius K, Reddy Vivek K, du Mesnil de Rochemont Richard, Jahan Reza, Vilain Katherine A, House John, Lee Jin-Moo, Cohen David J

机构信息

From the Center for Gerontology and Health Care Research, Brown University School of Public Health, Providence, RI (T.I.S.); Department of Cardiovascular Research (K.W., K.A.V., J.H.) and Department of Cardiology (D.J.C.), Saint Luke's Mid America Heart Institute, Kansas City, MO; Department of Neurology and Comprehensive Stroke Center (J.L.S.) and Division of Interventional Neuroradiology (R.J.), University of California Los Angeles; Departments of Radiology and Clinical Neurosciences, University of Calgary, Alberta, Canada (M.G.); Department of Neuroradiology, Hôpital Gui-de-Chauliac, Montpellier, France (A.B.); Department of Neurology, University Hospital of University Duisburg-Essen, Germany (H.-C.D.); Department of Neurosurgery, State University of New York at Buffalo (E.I.L.); Division of Neuroradiology and Division of Neurosurgery, Department of Medical Imaging and Department of Surgery, Toronto Western Hospital, University Health Network, University of Toronto, Ontario, Canada (V.M.P.); Department of Neurology and Neurological Sciences, Stanford University School of Medicine, CA (G.W.A.); Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Toulouse, France (C.C.); Department of Neurology, University of Heidelberg, Germany (W.H.); Department of Radiology and Neuroradiology, Christian-Albrechts-University Kiel, Germany (O.J.); Department of Neurology, University of Pittsburgh Medical Center, PA (T.G.J., V.K.R.); Department of Neurology, Inselspital, University of Bern, Switzerland (H.P.M.); Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Department of Neurology, Emory University School of Medicine, Atlanta, GA (R.G.N.); Department of Neurosurgery, Toshiba Stroke and Vascular Research Center, University at Buffalo State University of New York at Buffalo (A.H.S.); Department of Neurology and Neurosurgery, University of Miami Miller School of Medicine, Jackson Memorial Hospital, FL (D.R.Y.); Division of Neurology, Erlanger Hospital at University of Tennessee, Chattanooga (T.G.D.); Department of Neurosurgery, Rush University Medical Center, Chicago, IL (D.K.L.); Institute of Neuroradiology, Klinikum der Goethe-Universität, Frankfurt, Germany (R.d.M.d.R.); Department of Neurology, Washington University in Saint Louis, MO (J.-M.L.); and Department of Medicine, University of Missouri-Kansas City School of Medicine (D.J.C.).

出版信息

Stroke. 2017 Feb;48(2):379-387. doi: 10.1161/STROKEAHA.116.014735. Epub 2016 Dec 27.

Abstract

BACKGROUND AND PURPOSE

Clinical trials have demonstrated improved 90-day outcomes for patients with acute ischemic stroke treated with stent retriever thrombectomy plus tissue-type plasminogen activator (SST+tPA) compared with tPA. Previous studies suggested that this strategy may be cost-effective, but models were derived from pooled data and older assumptions.

METHODS

In this prospective economic substudy conducted alongside the SWIFT-PRIME trial (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke), in-trial costs were measured for patients using detailed medical resource utilization and hospital billing data. Utility weights were assessed at 30 and 90 days using the EuroQol-5 dimension questionnaire. Post-trial costs and life-expectancy were estimated for each surviving patient using a model based on trial data and inputs derived from a contemporary cohort of ischemic stroke survivors.

RESULTS

Index hospitalization costs were $17 183 per patient higher for SST+tPA than for tPA ($45 761 versus $28 578; P<0.001), driven by initial procedure costs. Between discharge and 90 days, costs were $4904 per patient lower for SST+tPA than for tPA ($11 270 versus $16 174; P=0.014); total 90-day costs remained higher with SST+tPA ($57 031 versus $44 752; P<0.001). Higher utility values for SST+tPA led to higher in-trial quality-adjusted life years (0.131 versus 0.105; P=0.005). In lifetime projections, SST+tPA was associated with substantial gains in quality-adjusted life years (6.79 versus 5.05), cost savings of $23 203 per patient and was economically dominant when compared with tPA in 90% of bootstrap replicates.

CONCLUSIONS

Among patients with acute ischemic stroke enrolled in the SWIFT-PRIME trial, SST increased initial treatment costs, but was projected to improve quality-adjusted life-expectancy and reduce healthcare costs over a lifetime horizon compared with tPA.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT01657461.

摘要

背景与目的

临床试验表明,与单纯使用组织型纤溶酶原激活剂(tPA)治疗相比,使用支架取栓联合组织型纤溶酶原激活剂(SST+tPA)治疗急性缺血性卒中患者可改善90天预后情况。此前研究表明该策略可能具有成本效益,但相关模型源自汇总数据及陈旧假设。

方法

在这项与SWIFT-PRIME试验(以血栓切除术为主要血管内治疗手段治疗急性缺血性卒中的Solitaire试验)同期开展的前瞻性经济子研究中,利用详细医疗资源利用情况及医院计费数据来衡量患者的试验期间成本。使用欧洲五维健康量表问卷在30天和90天时评估效用权重。利用基于试验数据及来自当代缺血性卒中幸存者队列的数据输入构建的模型,对每位存活患者的试验后成本及预期寿命进行估算。

结果

由于初始手术成本,SST+tPA组每位患者的首次住院成本比tPA组高17,183美元(45,761美元对28,578美元;P<0.001)。出院至90天期间,SST+tPA组每位患者的成本比tPA组低4904美元(11,270美元对16,174美元;P=0.014);SST+tPA组90天总成本仍更高(57,031美元对44,752美元;P<0.001)。SST+tPA组更高的效用值导致试验期间质量调整生命年更高(0.131对0,105;P=0.005)。在终生预测中,SST+tPA与质量调整生命年大幅增加相关(6.79对5.05),每位患者可节省成本23,203美元,并且在9次重复抽样中有90%的情况下与tPA相比具有经济优势。

结论

在SWIFT-PRIME试验纳入的急性缺血性卒中患者中,SST增加了初始治疗成本,但与tPA相比,预计在终生范围内可改善质量调整预期寿命并降低医疗成本。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT01657461。

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