Theresa I Shireman1, Kaijun Wang1, Jeffrey L Saver1, Mayank Goyal1, Alain Bonafé1, Hans-Christoph Diener1, Elad I Levy1, Vitor M Pereira1, Gregory W Albers1, Christophe Cognard1, Werner Hacke1, Olav Jansen1, Tudor G Jovin1, Heinrich P Mattle1, Raul G Nogueira1, Adnan H Siddiqui1, Dileep R Yavagal1, Thomas G Devlin1, Demetrius K Lopes1, Vivek K Reddy1, Richard du Mesnil de Rochemont1, Reza Jahan1, Katherine A Vilain1, John House1, Jin-Moo Lee1, David J Cohen2. 1. 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.). 2. 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.). dcohen@saint-lukes.org.
Abstract
BACKGROUND AND PURPOSE: Clinical trials have demonstrated improved 90-day outcomes for patients with acute ischemic stroke treated withstent 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.
RCT Entities:
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.
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