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Published on: August 11, 2015
Recruitment in a Pragmatic Randomized Trial on the Management of Unruptured Intracranial Aneurysms
Daniela Iancu1, Jennifer Collins1, Behzad Farzin1
1Department 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.
Insights
The Comprehensive Aneurysm Management (CAM) study successfully integrated unruptured intracranial aneurysm (UIA) patient management into routine practice. Further multi-center participation is crucial for obtaining meaningful clinical conclusions on UIA treatment effectiveness.
Area of Science:
- Neurosurgery
- Neurology
- Clinical Trials
Background:
- Unruptured intracranial aneurysms (UIAs) require careful management strategies.
- Pragmatic clinical trials are essential for evaluating real-world treatment effectiveness.
Purpose of the Study:
- To assess the integration of a pragmatic trial framework for managing UIA patients.
- To evaluate patient allocation to conservative versus interventional treatment pathways.
Main Methods:
- The Comprehensive Aneurysm Management (CAM) study employed an algorithm for patient management, combining clinical judgment with randomization.
- Eligible patients were randomized 1:1 to intervention vs. conservative management and surgical vs. endovascular treatment.
- Ineligible patients were registered, and outcomes were tracked for survival without dependency at 10 years.
Main Results:
- Between February 2020 and July 2021, 403 UIA patients were recruited, with 44% in randomized controlled trials (RCTs) and 56% in registries.
- Conservative management was recommended for 51% of patients; 49% were considered for curative treatment, with 80% randomized.
- Patient adherence to allocated management was high (89%), with 11% crossover.
Conclusions:
- The Comprehensive Aneurysm Management (CAM) study demonstrated successful integration into routine clinical practice.
- Active participation from multiple centers is vital for generating robust conclusions on UIA management.
Objectives:
The Comprehensive Aneurysm Management (CAM) study is a pragmatic trial designed to manage unruptured intracranial aneurysm (UIA) patients within a care research framework.
Methods:
CAM 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.
Results:
Between 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.
Conclusions:
CAM was successfully integrated into routine practice. Meaningful conclusions can be obtained if multiple centers actively participate in the trial.
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