Tim E Darsaut1, Hubert Desal2, Christophe Cognard3, Anne-Christine Januel3, Romain Bourcier2, Grégoire Boulouis4, Jai Jai Shiva Shankar5, J Max Findlay1, Jeremy L Rempel6, Robert Fahed7, Edoardo Boccardi8, Luca Valvassori8, Elsa Magro9, Jean-Christophe Gentric10, Michel W Bojanowski11, Chiraz Chaalala11, Daniela Iancu12, Daniel Roy12, Alain Weill12, Ange Diouf13, Guylaine Gevry12, Miguel Chagnon14, Jean Raymond15. 1. University of Alberta Hospital, Mackenzie Health Sciences Centre, Department of Surgery, Division Crosurgery, Edmonton, Alberta, Canada. 2. Service de Neuroradiologie Diagnostique et Interventionnelle du CHU de Nantes, Nantes, France. 3. Service de Neuroradiologie Diagnostique et Thérapeutique du CHU de Toulouse, Toulouse, France. 4. Service Imagerie Morphologique et Fonctionnelle, Hôpital Sainte-Anne, Paris, France. 5. Department of Radiology, University of Manitoba, Winnipeg, Manitoba, Canada. 6. Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada. 7. Department of Radiology, Service of Interventional Neuroradiology, University of Ottawa Hospitals, Civic Campus, Ottawa, Ontario, Canada. 8. Department of Neuroradiology, Metropolitan Hospital Niguarda, Milan, Italy. 9. Service de Neurochirurgie, CHU Cavale Blanche, INSERM UMR 1101 LaTIM, Brest, France. 10. Service de Radiologie, CHU Cavale Blanche, EA 3878 GETBO, Brest, France. 11. Department of Surgery, Service of Neurosurgery, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada. 12. Department of Radiology, Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada; CHUM Research Center, Montreal, Quebec, Canada. 13. Department of Radiology, Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada. 14. Department of Mathematics and Statistics, Université de Montréal, Montreal, Quebec, Canada. 15. Department of Radiology, Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada; CHUM Research Center, Montreal, Quebec, Canada. Electronic address: jean.raymond@umontreal.ca.
Abstract
BACKGROUND: In the absence of randomized evidence, the optimal management of patients with unruptured intracranial aneurysms (UIA) remains uncertain. METHODS:Comprehensive Aneurysm Management (CAM) is an all-inclusive care trial combined with a registry. Any patient with a UIA (no history of intracranial hemorrhage within the previous 30 days) can be recruited, and treatment allocation will follow an algorithm combining clinical judgment and randomization. Patients eligible for at least 2 management options will be randomly allocated 1:1 to conservative or curative treatment. Minimization will be used to balance risk factors, using aneurysm size (≥7 mm), location (anterior or posterior circulation), and age <60 years. RESULTS: The CAM primary outcome is survival without neurologic dependency (modified Rankin Scale [mRS] score <3) at 10 years. Secondary outcome measures include the incidence of subarachnoid hemorrhage during follow-up and related morbidity and mortality; morbidity and mortality related to endovascular treatment or surgical treatment of the UIA at 1 year; overall morbidity and mortality at 1, 5, and 10 years; when relevant, duration of hospitalization; and, when relevant, discharge to a location other than home. The primary hypothesis for patients randomly allocated to at least 2 options, 1 of which is conservative management, is that active UIA treatment will reduce the 10-year combined neurologic morbidity and mortality (mRS score >2) from 24% to 16%. At least 961 patients recruited from at least 20 centers over 4 years will be needed for the randomized portion of the study. CONCLUSIONS:Patients with unruptured intracranial aneurysms can be comprehensively managed within the context of an all-inclusive care trial.
RCT Entities:
BACKGROUND: In the absence of randomized evidence, the optimal management of patients with unruptured intracranial aneurysms (UIA) remains uncertain. METHODS: Comprehensive Aneurysm Management (CAM) is an all-inclusive care trial combined with a registry. Any patient with a UIA (no history of intracranial hemorrhage within the previous 30 days) can be recruited, and treatment allocation will follow an algorithm combining clinical judgment and randomization. Patients eligible for at least 2 management options will be randomly allocated 1:1 to conservative or curative treatment. Minimization will be used to balance risk factors, using aneurysm size (≥7 mm), location (anterior or posterior circulation), and age <60 years. RESULTS: The CAM primary outcome is survival without neurologic dependency (modified Rankin Scale [mRS] score <3) at 10 years. Secondary outcome measures include the incidence of subarachnoid hemorrhage during follow-up and related morbidity and mortality; morbidity and mortality related to endovascular treatment or surgical treatment of the UIA at 1 year; overall morbidity and mortality at 1, 5, and 10 years; when relevant, duration of hospitalization; and, when relevant, discharge to a location other than home. The primary hypothesis for patients randomly allocated to at least 2 options, 1 of which is conservative management, is that active UIA treatment will reduce the 10-year combined neurologic morbidity and mortality (mRS score >2) from 24% to 16%. At least 961 patients recruited from at least 20 centers over 4 years will be needed for the randomized portion of the study. CONCLUSIONS:Patients with unruptured intracranial aneurysms can be comprehensively managed within the context of an all-inclusive care trial.
Authors: P Lognon; F Gariel; G Marnat; J Darcourt; P Constant Dit Beaufils; J Burel; E Shotar; J F Hak; C Fauché; B Kerleroux; A Guédon; J Ognard; G Forestier; R Pop; C Paya; J B Veyrières; P Sporns; J B Girot; R Zannoni; F Zhu; A Crespy; V L'Allinec; D Mihoc; A Rouchaud; J C Gentric; W Ben Hassen; N Raynaud; B Testud; F Clarençon; B Kaczmarek; R Bourcier; G Bellanger; G Boulouis; Kevin Janot Journal: Neuroradiology Date: 2022-06-13 Impact factor: 2.804
Authors: J Raymond; D Iancu; W Boisseau; J D B Diestro; R Klink; M Chagnon; J Zehr; B Drake; H Lesiuk; A Weill; D Roy; M W Bojanowski; C Chaalala; J L Rempel; C O'Kelly; M M Chow; S Bracard; T E Darsaut Journal: AJNR Am J Neuroradiol Date: 2022-08-04 Impact factor: 4.966
Authors: Anass Benomar; Behzad Farzin; David Volders; Guylaine Gevry; Justine Zehr; Robert Fahed; William Boisseau; Jean-Christophe Gentric; Elsa Magro; Lorena Nico; Daniel Roy; Alain Weill; Charbel Mounayer; François Guilbert; Laurent Létourneau-Guillon; Gregory Jacquin; Chiraz Chaalala; Marc Kotowski; Thanh N Nguyen; David Kallmes; Phil White; Tim E Darsaut; Jean Raymond Journal: Neuroradiology Date: 2021-02-24 Impact factor: 2.804
Authors: A Benomar; B Farzin; G Gevry; W Boisseau; D Roy; A Weill; D Iancu; F Guilbert; L Létourneau-Guillon; G Jacquin; C Chaalala; M W Bojanowski; M Labidi; R Fahed; D Volders; T N Nguyen; J-C Gentric; E Magro; G Boulouis; G Forestier; J-F Hak; J S Ghostine; Z Kaderali; J J Shankar; M Kotowski; T E Darsaut; J Raymond Journal: AJNR Am J Neuroradiol Date: 2021-07-29 Impact factor: 4.966