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Published on: September 25, 2016
Trial of Thrombectomy for Stroke with a Large Infarct of Unrestricted Size
Vincent Costalat1, Tudor G Jovin1, J F Albucher1
1From the Department of Neuroradiology, Hôpital Gui de Chauliac, Montpellier (V.C.), the Departments of Neurology (J.F. Albucher) and Neuroradiology (C. Cognard), Hôpital Pierre Paul Riquet, and Toulouse Clinical Investigations Centers 1436 (J.F. Albucher, C. Cognard), Toulouse, the Departments of Neurology (H.H.) and Neuroradiology (N.N.), Hôpital Salengro, and the Department of Biostatistics, Centre Hospitalier Universitaire (CHU) Lille (A.D., J.L.), Lille, the Department of Neuroradiology, Hôpital central, L'unité d'Imagerie Adaptative Diagnostique et Interventionnelle, INSERM Unité 1254 (B. Gory), and the Department of Neurology, Hôpital central, Centre d'investigation clinique Plurithématique 1433, INSERM Unité 1116 (S.R.), Nancy, the Departments of Neuroradiology (G.M.) and Neurology (I.S.), Hôpital Pellegrin, Bordeaux, the Department of Neuroradiology, Hôpital Foch, Suresnes (F.D.M.), the Departments of Neurology (M.A.) and Neuroradiology (G.B.), Hôpital Bretonneau, Tours, the Departments of Neurology (M.O.) and Neuroradiology (M.P.), Hôpital Fondation Adolphe de Rothschild, the Departments of Neurology (G.T.) and Neuroradiology (O.N.), Groupe Hospitalier Universitaire Paris, Centre Hospitalier Sainte-Anne, INSERM Unité 1266, the Departments of Neuroradiology (F.C.) and Neurology (S.A.), Hôpital La Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris (AP-HP), the Departments of Neuroradiology (L. Spelle) and Neurology (C.D.), Hôpital Bicêtre, AP-HP, the Departments of Neurology (M. Mazighi) and Neuroradiology (E.H.), Hôpital Lariboisière AP-HP, and INSERM Unité 1266 (C.A.), Paris, the Department of Neuroradiology, Nantes Université, CHU Nantes (R.B.), INSERM Unité Mixte de Recherche 1087, Centre National de la Recherche Scientifique, University of Nantes, L'institut du Thorax (R.B.), and Clinique Neurologique, Hôpital G.R. Laennec CHU Nantes (B. Guillon), Nantes, the Departments of Neurology (S.G.) and Neuroradiology (A.P.-P.), CHU d'Angers, Angers, the Departments of Neuroradiology (O.F.E.) and Neurology (T.-H.C.), Hospices Civils de Lyon, Groupement Hospitalier Est Hôpital Pierre Wertheimer, Lyon, the Departments of Neuroradiology (S.V.) and Neurology (M.L.), CHU Poitiers, Site de La Milétrie, Poitiers, the Stroke Unit (L. Suissa) and the Department of Neuroradiology (H.B.), Assistance Publique-Hôpitaux de Marseille, Hôpital de la Timone, Marseille, the Departments of Neuroradiology (J.-C.G.) and Neurology (S.T.), Centre Hospitalier Régional Universitaire (CHRU) Brest, Hôpital de la Cavale Blanche, Brest, the Departments of Neurology (C.L.) and Neuroradiology (C. Chivot), CHU Amiens-Picardie, Amiens, the Departments of Neurology (F.M.-M.) and Neuroradiology (C.M.), CHU Limoges, Dupuytren, Limoges, the Departments of Neurology (O.O.-W.) and Neuroradiology (C.P.), CHU Rouen, Rouen, the Departments of Neurology (V.W.) and Neuroradiology (R.P.), CHRU Strasbourg, Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre, Strasbourg, the Departments of Neurology (A.F.) and Neuroradiology (E.C.), CHU Clermont-Ferrand, Hôpital Gabriel Montpied, Clermont-Ferrand, the Departments of Neuroradiology (F.R.) and Neurology (Y.B.), CHU Dijon-Bourgogne, Hôpital François Mitterrand, Dijon, and the Department of Neurology, Hôpital Foch, Suresnes (B.L.), and the Department of Neurology, Hôpital Gui de Chauliac, Montpellier (C.A.) - all in France; Cooper Neurological Institute and Cooper Medical School of Rowan University, Camden, NJ (T.G.J.); the Department of Neurology, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat (P.C.), and the Department of Neurology, Hospital Clínic de Barcelona (A.R.), Barcelona, the Department of Radiology, Hospital Universitario Central de Asturias, Oviedo (E.L.-C., P.V.), the Department of Neurology Hospital Germans Trias i Pujol, Badalona (M. Millán), Hospital Clínico Universitario de Valladolid, Valladolid (J.F. Arenillas), and the Department of Neurology, Hospital Universitario Cruces, Baracaldo (M.M.F.) - all in Spain; and the Department of Neurology, University of Southern California (N.S.), and the Department of Neurology, UCLA (D.S.L.) - both in Los Angeles.
Background:
The use of thrombectomy in patients with acute stroke and a large infarct of unrestricted size has not been well studied.
Methods:
We assigned, in a 1:1 ratio, patients with proximal cerebral vessel occlusion in the anterior circulation and a large infarct (as defined by an Alberta Stroke Program Early Computed Tomographic Score of ≤5; values range from 0 to 10) detected on magnetic resonance imaging or computed tomography within 6.5 hours after symptom onset to undergo endovascular thrombectomy and receive medical care (thrombectomy group) or to receive medical care alone (control group). The primary outcome was the score on the modified Rankin scale at 90 days (scores range from 0 to 6, with higher scores indicating greater disability). The primary safety outcome was death from any cause at 90 days, and an ancillary safety outcome was symptomatic intracerebral hemorrhage.
Results:
A total of 333 patients were assigned to either the thrombectomy group (166 patients) or the control group (167 patients); 9 were excluded from the analysis because of consent withdrawal or legal reasons. The trial was stopped early because results of similar trials favored thrombectomy. Approximately 35% of the patients received thrombolysis therapy. The median modified Rankin scale score at 90 days was 4 in the thrombectomy group and 6 in the control group (generalized odds ratio, 1.63; 95% confidence interval [CI], 1.29 to 2.06; P<0.001). Death from any cause at 90 days occurred in 36.1% of the patients in the thrombectomy group and in 55.5% of those in the control group (adjusted relative risk, 0.65; 95% CI, 0.50 to 0.84), and the percentage of patients with symptomatic intracerebral hemorrhage was 9.6% and 5.7%, respectively (adjusted relative risk, 1.73; 95% CI, 0.78 to 4.68). Eleven procedure-related complications occurred in the thrombectomy group.
Conclusions:
In patients with acute stroke and a large infarct of unrestricted size, thrombectomy plus medical care resulted in better functional outcomes and lower mortality than medical care alone but led to a higher incidence of symptomatic intracerebral hemorrhage. (Funded by Montpellier University Hospital; LASTE ClinicalTrials.gov number, NCT03811769.).
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