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A Pragmatic Randomized Trial Comparing Surgical Clipping and Endovascular Treatment of Unruptured Intracranial Aneurysms.
Darsaut, T E; Findlay, J M; Bojanowski, M W; Chalaala, C; Iancu, D; Roy, D; Weill, A; Boisseau, W; Diouf, A; Magro, E; Kotowski, M; Keough, M B; Estrade, L; Bricout, N; Lejeune, J-P; Chow, M M C; O'Kelly, C J; Rempel, J L; Ashforth, R A; Lesiuk, H; Sinclair, J; Erdenebold, U-E; Wong, J H; Scholtes, F; Martin, D; Otto, B; Bilocq, A; Truffer, E; Butcher, K; Fox, A J; Arthur, A S; Létourneau-Guillon, L; Guilbert, F; Chagnon, M; Zehr, J; Farzin, B; Gevry, G; Raymond, J.
Afiliação
  • Darsaut TE; From the Division of Neurosurgery (T.E.D., J.M.F., M.B.K., M.M.C.C., C.J.O.).
  • Findlay JM; From the Division of Neurosurgery (T.E.D., J.M.F., M.B.K., M.M.C.C., C.J.O.).
  • Bojanowski MW; Service of Neurosurgery (M.W.B., C.C.).
  • Chalaala C; Service of Neurosurgery (M.W.B., C.C.).
  • Iancu D; Department of Surgery, and Service of Neuroradiology (D.I., D.R., A.W., W.B., A.D., M.K., L.L.-G., F.G., J.R.), Department of Radiology, Centre Hospitalier de l'Université de Montréal, Montreal, Québec, Canada.
  • Roy D; Department of Surgery, and Service of Neuroradiology (D.I., D.R., A.W., W.B., A.D., M.K., L.L.-G., F.G., J.R.), Department of Radiology, Centre Hospitalier de l'Université de Montréal, Montreal, Québec, Canada.
  • Weill A; Department of Surgery, and Service of Neuroradiology (D.I., D.R., A.W., W.B., A.D., M.K., L.L.-G., F.G., J.R.), Department of Radiology, Centre Hospitalier de l'Université de Montréal, Montreal, Québec, Canada.
  • Boisseau W; Department of Surgery, and Service of Neuroradiology (D.I., D.R., A.W., W.B., A.D., M.K., L.L.-G., F.G., J.R.), Department of Radiology, Centre Hospitalier de l'Université de Montréal, Montreal, Québec, Canada.
  • Diouf A; Department of Surgery, and Service of Neuroradiology (D.I., D.R., A.W., W.B., A.D., M.K., L.L.-G., F.G., J.R.), Department of Radiology, Centre Hospitalier de l'Université de Montréal, Montreal, Québec, Canada.
  • Magro E; Service of Neurosurgery (E.M.), Centre Hospitalier Universitaire Cavale Blanche, Institut National de la Santé et de la Recherche Médicale Unité Mixte de Recherche 1101 LaTIM, Brest, France.
  • Kotowski M; Department of Surgery, and Service of Neuroradiology (D.I., D.R., A.W., W.B., A.D., M.K., L.L.-G., F.G., J.R.), Department of Radiology, Centre Hospitalier de l'Université de Montréal, Montreal, Québec, Canada.
  • Keough MB; From the Division of Neurosurgery (T.E.D., J.M.F., M.B.K., M.M.C.C., C.J.O.).
  • Estrade L; Interventional Neuroradiology (L.E., N.B.).
  • Bricout N; Interventional Neuroradiology (L.E., N.B.).
  • Lejeune JP; Service of Neurosurgery (J.-P.L.), Centre Hospitalier Universitaire de Lille, Lille, France.
  • Chow MMC; From the Division of Neurosurgery (T.E.D., J.M.F., M.B.K., M.M.C.C., C.J.O.).
  • O'Kelly CJ; From the Division of Neurosurgery (T.E.D., J.M.F., M.B.K., M.M.C.C., C.J.O.).
  • Rempel JL; Department of Surgery, and Department of Radiology and Diagnostic Imaging (J.L.R., R.A.A.), Mackenzie Health Sciences Centre, University of Alberta Hospital, Edmonton, Alberta, Canada.
  • Ashforth RA; Department of Surgery, and Department of Radiology and Diagnostic Imaging (J.L.R., R.A.A.), Mackenzie Health Sciences Centre, University of Alberta Hospital, Edmonton, Alberta, Canada.
  • Lesiuk H; Section of Neurosurgery (H.L., J.S.).
  • Sinclair J; Section of Neurosurgery (H.L., J.S.).
  • Erdenebold UE; Department of Surgery, and Department of Medical Imaging (U.-E.E.), Section of Interventional Neuroradiology, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.
  • Wong JH; Division of Neurosurgery (J.H.W.), Foothills Medical Centre, University of Calgary, Calgary, Alberta, Canada.
  • Scholtes F; Departments of Neurosurgery (F.S., D.M.).
  • Martin D; Departments of Neurosurgery (F.S., D.M.).
  • Otto B; Medical Physics (B.O.), Division of Medical Imaging, Centre Hospitalier Universitaire de Liège, Liège, Belgium.
  • Bilocq A; Service of Neurosurgery (A.B., E.T.), Centre Hospitalier Régional de Trois-Rivières, Trois-Rivières, Québec, Canada.
  • Truffer E; Service of Neurosurgery (A.B., E.T.), Centre Hospitalier Régional de Trois-Rivières, Trois-Rivières, Québec, Canada.
  • Butcher K; Clinical Neurosciences (K.B.), Prince of Wales Clinical School, University of New South Wales, Randwick, New South Wales, Australia.
  • Fox AJ; Department of Medical Imaging (A.J.F.), University of Toronto, Toronto, Ontario, Canada.
  • Arthur AS; Department of Neurosurgery (A.S.A.), University of Tennessee Health Science Center and Semmes-Murphey Clinic, Memphis, Tennessee.
  • Létourneau-Guillon L; Department of Surgery, and Service of Neuroradiology (D.I., D.R., A.W., W.B., A.D., M.K., L.L.-G., F.G., J.R.), Department of Radiology, Centre Hospitalier de l'Université de Montréal, Montreal, Québec, Canada.
  • Guilbert F; Department of Surgery, and Service of Neuroradiology (D.I., D.R., A.W., W.B., A.D., M.K., L.L.-G., F.G., J.R.), Department of Radiology, Centre Hospitalier de l'Université de Montréal, Montreal, Québec, Canada.
  • Chagnon M; Department of Mathematics and Statistics (M.C., J.Z.), Université de Montréal, Montréal, Québec, Canada.
  • Zehr J; Department of Mathematics and Statistics (M.C., J.Z.), Université de Montréal, Montréal, Québec, Canada.
  • Farzin B; Research Centre of the University of Montreal Hospital Centre (B.F., G.G., J.R.), Interventional Neuroradiology Research Laboratory, Montreal, Québec, Canada.
  • Gevry G; Research Centre of the University of Montreal Hospital Centre (B.F., G.G., J.R.), Interventional Neuroradiology Research Laboratory, Montreal, Québec, Canada.
  • Raymond J; Department of Surgery, and Service of Neuroradiology (D.I., D.R., A.W., W.B., A.D., M.K., L.L.-G., F.G., J.R.), Department of Radiology, Centre Hospitalier de l'Université de Montréal, Montreal, Québec, Canada jean.raymond@umontreal.ca.
AJNR Am J Neuroradiol ; 44(6): 634-640, 2023 06.
Article em En | MEDLINE | ID: mdl-37169541
ABSTRACT
BACKGROUND AND

PURPOSE:

Surgical clipping and endovascular treatment are commonly used in patients with unruptured intracranial aneurysms. We compared the safety and efficacy of the 2 treatments in a randomized trial. MATERIALS AND

METHODS:

Clipping or endovascular treatments were randomly allocated to patients with one or more 3- to 25-mm unruptured intracranial aneurysms judged treatable both ways by participating physicians. The study hypothesized that clipping would decrease the incidence of treatment failure from 13% to 4%, a composite primary outcome defined as failure of aneurysm occlusion, intracranial hemorrhage during follow-up, or residual aneurysms at 1 year, as adjudicated by a core lab. Safety outcomes included new neurologic deficits following treatment, hospitalization of >5 days, and overall morbidity and mortality (mRS > 2) at 1 year. There was no blinding.

RESULTS:

Two hundred ninety-one patients were enrolled from 2010 to 2020 in 7 centers. The 1-year primary outcome, ascertainable in 290/291 (99%) patients, was reached in 13/142 (9%; 95% CI, 5%-15%) patients allocated to surgery and in 28/148 (19%; 95% CI, 13%-26%) patients allocated to endovascular treatments (relative risk 2.07; 95% CI, 1.12-3.83; P = .021). Morbidity and mortality (mRS >2) at 1 year occurred in 3/143 and 3/148 (2%; 95% CI, 1%-6%) patients allocated to surgery and endovascular treatments, respectively. Neurologic deficits (32/143, 22%; 95% CI, 16%-30% versus 19/148, 12%; 95% CI, 8%-19%; relative risk 1.74; 95% CI, 1.04-2.92; P = .04) and hospitalizations beyond 5 days (69/143, 48%; 95% CI, 40%-56% versus 12/148, 8%; 95% CI, 5%-14%; relative risk 0.18; 95% CI, 0.11-0.31; P < .001) were more frequent after surgery.

CONCLUSIONS:

Surgical clipping is more effective than endovascular treatment of unruptured intracranial aneurysms in terms of the frequency of the primary outcome of treatment failure. Results were mainly driven by angiographic results at 1 year.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Etiology_studies Limite: Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article
Texto completo
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PubMed Links
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials / Etiology_studies Limite: Humans Idioma: En Ano de publicação: 2023 Tipo de documento: Article