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- Daniela Iancu, Jennifer Collins, Behzad Farzin, Tim E Darsaut, Johanna Eneling, William Boisseau, Leonardo Olijnyk, Grégoire Boulouis, Chiraz Chaalala, Michel W Bojanowski, Alain Weill, Daniel Roy, and Jean Raymond.
- Department of Radiology, Service of Interventional Neuroradiology, Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada and CHUM Research Center (CRCHUM), Montreal, Quebec, Canada.
- World Neurosurg. 2022 Jul 1; 163: e413-e419.
ObjectivesThe Comprehensive Aneurysm Management (CAM) study is a pragmatic trial designed to manage unruptured intracranial aneurysm (UIA) patients within a care research framework.MethodsCAM is an all-inclusive study. Management options are allocated according to an algorithm combining pre-randomization and clinical judgment. Eligible patients are offered 1:1 randomized allocation of intervention versus conservative management and 1:1 randomization allocation of surgical versus endovascular treatment. Ineligible patients are registered. The primary outcome is survival without dependency (modified Rankin Scale score <3) at 10 years. All UIA patients at 1 center are reported.ResultsBetween February 2020 and July 2021, 403 UIA patients were recruited: 179 (44%) in one of the randomized controlled trials (RCTs) and 224 (56%) in one of the registries. Conservative management was recommended for 205 of 403 patients (51%); of 198 (49%) patients considered for curative treatment, 159 (80%) were randomly allocated conservative (n = 81) or curative treatment (n = 78). These patients were younger and had larger aneurysms than those in the observation registry (P = 0.004). In 39 of 198 patients (20%), conservative management was not considered reasonable (17 patients were recommended endovascular, 2 surgery, and 20 the RCT comparing endovascular with surgical treatment). In total, 70 patients were recruited in the RCT comparing surgery and endovascular treatment. After informed discussion at time of consent, 141 of 159 patients (89%) agreed with the randomly allocated management plan, while 11% crossed over to the alternative management option.ConclusionsCAM was successfully integrated into routine practice. Meaningful conclusions can be obtained if multiple centers actively participate in the trial.Copyright © 2022 Elsevier Inc. All rights reserved.
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