[en] [en] 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.
Disciplines :
Neurology Surgery
Author, co-author :
Darsaut, T E ; From the Division of Neurosurgery (T.E.D., J.M.F., M.B.K., M.M.C.C., C.J.O
Findlay, J M ; From the Division of Neurosurgery (T.E.D., J.M.F., M.B.K., M.M.C.C., C.J.O
Bojanowski, M W ; 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, M B ; 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, J-P ; Service of Neurosurgery (J.-P.L.), Centre Hospitalier Universitaire de Lille, Lille, France
Chow, M M C ; From the Division of Neurosurgery (T.E.D., J.M.F., M.B.K., M.M.C.C., C.J.O
O'Kelly, C J ; From the Division of Neurosurgery (T.E.D., J.M.F., M.B.K., M.M.C.C., C.J.O
Rempel, J L ; 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, R A ; 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, U-E ; Department of Surgery, and Department of Medical Imaging (U.-E.E.), Section of Interventional Neuroradiology, Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada
Wong, J H ; Division of Neurosurgery (J.H.W.), Foothills Medical Centre, University of Calgary, Calgary, Alberta, Canada
Scholtes, Félix ; Université de Liège - ULiège > Département des sciences biomédicales et précliniques > Neuro-anatomie ; Centre Hospitalier Universitaire de Liège - CHU > > Service de neurochirurgie
Martin, Didier ; Université de Liège - ULiège > Département des sciences cliniques > Neurochirurgie
OTTO, Bernard ; Centre Hospitalier Universitaire de Liège - CHU > > Service médical de radiodiagnostic
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, A J ; Department of Medical Imaging (A.J.F.), University of Toronto, Toronto, Ontario, Canada
Arthur, A S ; 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 ; Research Centre of the University of Montreal Hospital Centre (B.F., G.G., J.R.), Interventional Neuroradiology Research Laboratory, Montreal, Québec, Canada
This report follows the CONsolidated Standards Of Reporting Trials (CONSORT) guidelines. CURES was an investigator-led, pragmatic, multicenter, randomized (1:1) parallel-group trial conducted in 5 Canadian and 2 European centers (Montreal, Edmonton, Ottawa, Trois-Rivi\u00E8res, and Calgary in Canada; and Li\u00E8ge, Belgium, and Lille, France). The trial, conceived as a pilot before a larger pivotal effort, was initially funded by the Canadian Institutes of Health Research (MOP 119554). The protocol, published in 2011,12 was approved by the local institutional review boards of all participating centers, and all patients provided written informed consent. Data capture and management were through secure servers in compliance with Good Clinical Practice requirements. The trial was monitored in Montreal, Canada. Electronic case report forms were simple, and data collection was kept to a minimum to facilitate completion by ordinary care personnel. Neuropsychological tests were not required by protocol. There were no preplanned interim efficacy analyses or stopping rules for safety or futility because both treatments were in common clinical use. The number of patients to be recruited was estimated to be 118 per group (with a statistical power of 0.80 and a 2-sided \u03B1 of .05), or 260 patients (to account for losses and cross-overs). The trial was launched in September 2010, but participation was below expectations. The Steering Committee decided to publish interim results in 2016 to encourage center participation and before re-submission for financial support.13 Further funding was declined in 2016, but the Steering Committee opted for trial continuation until the initiation of the Comprehensive Aneurysm Management (CAM) study on UIAs in 2020.14 The last patient was recruited in May 2020. In May 2021, after examination of the blinded 1-year outcome data, the Data Safety Monitoring Committee recommended trial continuation, but the Steering Committee decided to report the CURES trial.
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