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在SWIFT PRIME试验(以Solitaire FR取栓术作为急性缺血性卒中主要血管内治疗手段)中,磁共振成像与计算机断层扫描灌注成像选择的患者中,支架取栓术的疗效对比

Efficacy of Stent-Retriever Thrombectomy in Magnetic Resonance Imaging Versus Computed Tomographic Perfusion-Selected Patients in SWIFT PRIME Trial (Solitaire FR With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke).

作者信息

Menjot de Champfleur Nicolas, Saver Jeffrey L, Goyal Mayank, Jahan Reza, Diener Hans-Christoph, Bonafe Alain, Levy Elad I, Pereira Vitor M, Cognard Christophe, Yavagal Dileep R, Albers Gregory W

机构信息

From the Stanford Stroke Center, Department of Neurology and Neurological Sciences, Stanford University School of Medicine, CA (G.W.A.); Department of Radiology (M.G.) and Department of Clinical Neurosciences (M.G.), University of Calgary, Alberta, Canada; Division of Interventional Neuroradiology (R.J.) and Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine (J.L.S.), University of California Los Angeles; Department of Neuroradiology, Hôpital Gui de Chauliac, Montpellier, France (A.B., N.M.d.C.); 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 (V.M.P.) and Department of Surgery (V.M.P.), Toronto Western Hospital, University Health Network, University of Toronto, Ontario, Canada; Department of Diagnostic and Therapeutic Neuroradiology, University Hospital of Toulouse, France (C.C.); and Department of Neurology and Neurosurgery, University of Miami Miller School of Medicine, FL (D.R.Y.).

出版信息

Stroke. 2017 Jun;48(6):1560-1566. doi: 10.1161/STROKEAHA.117.016669. Epub 2017 May 2.

Abstract

BACKGROUND AND PURPOSE

The majority of patients enrolled in SWIFT PRIME trial (Solitaire FR With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke) had computed tomographic perfusion (CTP) imaging before randomization; 34 patients were randomized after magnetic resonance imaging (MRI).

METHODS

Patients with middle cerebral artery and distal carotid occlusions were randomized to treatment with tPA (tissue-type plasminogen activator) alone or tPA+stentriever thrombectomy. The primary outcome was the distribution of the modified Rankin Scale score at 90 days. Patients with the target mismatch profile for enrollment were identified on MRI and CTP.

RESULTS

MRI selection was performed in 34 patients; CTP in 139 patients. Baseline National Institutes of Health Stroke Scale score was 17 in both groups. Target mismatch profile was present in 95% (MRI) versus 83% (CTP). A higher percentage of the MRI group was transferred from an outside hospital (=0.02), and therefore, the time from stroke onset to randomization was longer in the MRI group (=0.003). Time from emergency room arrival to randomization did not differ in CTP versus MRI-selected patients. Baseline ischemic core volumes were similar in both groups. Reperfusion rates (>90%/TICI [Thrombolysis in Cerebral Infarction] score 3) did not differ in the stentriever-treated patients in the MRI versus CTP groups. The primary efficacy analysis (90-day mRS score) demonstrated a statistically significant benefit in both subgroups (MRI, =0.02; CTP, =0.01). Infarct growth was reduced in the stentriever-treated group in both MRI and CTP groups.

CONCLUSIONS

Time to randomization was significantly longer in MRI-selected patients; however, site arrival to randomization times were not prolonged, and the benefits of endovascular therapy were similar.

CLINICAL TRIAL REGISTRATION

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

摘要

背景与目的

参加SWIFT PRIME试验(以Solitaire FR血栓切除术作为急性缺血性卒中主要血管内治疗手段)的大多数患者在随机分组前接受了计算机断层扫描灌注(CTP)成像检查;34例患者在磁共振成像(MRI)检查后进行了随机分组。

方法

大脑中动脉和颈内动脉远端闭塞的患者被随机分为单纯接受组织型纤溶酶原激活剂(tPA)治疗或tPA联合支架取栓治疗。主要结局为90天时改良Rankin量表评分的分布情况。通过MRI和CTP确定符合入组标准的目标不匹配特征的患者。

结果

34例患者进行了MRI检查;139例患者进行了CTP检查。两组患者的基线美国国立卫生研究院卒中量表评分为17分。目标不匹配特征在MRI组中的比例为95%,在CTP组中的比例为83%。MRI组中更高比例的患者从外院转入(P=0.02),因此,MRI组从卒中发作到随机分组的时间更长(P=0.003)。CTP检查与MRI检查选择的患者从急诊室到随机分组的时间无差异。两组患者的基线缺血核心体积相似。MRI组和CTP组接受支架取栓治疗的患者再灌注率(>90%/脑梗死溶栓[TICI]评分3分)无差异。主要疗效分析(90天改良Rankin量表评分)显示,两个亚组均有统计学意义的获益(MRI组,P=0.02;CTP组,P=0.01)。MRI组和CTP组中,接受支架取栓治疗的患者梗死灶增长均减少。

结论

MRI检查选择的患者随机分组时间显著更长;然而,从到达研究地点到随机分组的时间并未延长,血管内治疗的获益相似。

临床试验注册

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

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