Nicolas Menjot de Champfleur1, Jeffrey L Saver2, Mayank Goyal2, Reza Jahan2, Hans-Christoph Diener2, Alain Bonafe2, Elad I Levy2, Vitor M Pereira2, Christophe Cognard2, Dileep R Yavagal2, Gregory W Albers2. 1. 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.). nicolasdechampfleur@orange.fr. 2. 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.).
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 (P=0.02), and therefore, the time from stroke onset to randomization was longer in the MRI group (P=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, P=0.02; CTP, P=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.
RCT Entities:
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 (P=0.02), and therefore, the time from stroke onset to randomization was longer in the MRI group (P=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, P=0.02; CTP, P=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.
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