Recruitment in a Pragmatic Randomized Trial on the Management of Unruptured Intracranial Aneurysms

Iancu, Daniela; Collins, Jennifer B.; Farzin, Behzad; Darsaut, T.E.; Eneling, Johanna; Boisseau, William; Olijnyk, Leonardo Desessards; Boulouis, Grégoire; Chaalala, Chiraz; Bojanowski, Michel W.; Weill, Alain; Roy, Daniel; Raymond, Jean

doi:10.1016/j.wneu.2022.03.142

Cited by 5 publications

(4 citation statements)

References 18 publications

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“…These questions are now being addressed by the CAM study. 14,34 The limitations to this study include the relatively small number of patients, slowly accrued during .10 years. Indications, techniques, and treatments may have substantially changed across time.…”

Section: Discussionmentioning

confidence: 99%

A Pragmatic Randomized Trial Comparing Surgical Clipping and Endovascular Treatment of Unruptured Intracranial Aneurysms

Darsaut¹,

Findlay²,

Bojanowski³

et al. 2023

AJNR Am J Neuroradiol

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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 ¼ .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.

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Section: Discussionmentioning

confidence: 99%

A Pragmatic Randomized Trial Comparing Surgical Clipping and Endovascular Treatment of Unruptured Intracranial Aneurysms

Darsaut¹,

Findlay²,

Bojanowski³

et al. 2023

AJNR Am J Neuroradiol

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“…With 403 patients included up till July 2021, the trial was able to randomize patients with UIA into subgroups of conservative versus endovascular management, conservative versus surgical management, and surgical versus endovascular management. 28 As the trial is underway, the group recommends individualized decision-making for the treatment of UIA, with consideration of current aneurysm data and incorporation of physician discretion based on clinical and radiographic criteria.…”

Section: Ia Treatmentmentioning

confidence: 99%

ARISE I Consensus Review on the Management of Intracranial Aneurysms

Tjoumakaris,

Hanel,

Mocco

et al. 2024

Stroke

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BACKGROUND: Intracranial aneurysms (IAs) remain a challenging neurological diagnosis associated with significant morbidity and mortality. There is a plethora of microsurgical and endovascular techniques for the treatment of both ruptured and unruptured aneurysms. There is no definitive consensus as to the best treatment option for this cerebrovascular pathology. The Aneurysm, Arteriovenous Malformation, and Chronic Subdural Hematoma Roundtable Discussion With Industry and Stroke Experts discussed best practices and the most promising approaches to improve the management of brain aneurysms. METHODS: A group of experts from academia, industry, and federal regulators convened to discuss updated clinical trials, scientific research on preclinical system models, management options, screening and monitoring, and promising novel device technologies, aiming to improve the outcomes of patients with IA. RESULTS: Aneurysm, Arteriovenous Malformation, and Chronic Subdural Hematoma Roundtable Discussion With Industry and Stroke Experts suggested the incorporation of artificial intelligence to capture sequential aneurysm growth, identify predictors of rupture, and predict the risk of rupture to guide treatment options. The consensus strongly recommended nationwide systemic data collection of unruptured IA radiographic images for the analysis and development of machine learning algorithms for rupture risk. The consensus supported centers of excellence for preclinical multicenter trials in areas such as genetics, cellular composition, and radiogenomics. Optical coherence tomography and magnetic resonance imaging contrast–enhanced 3T vessel wall imaging are promising technologies; however, more data are needed to define their role in IA management. Ruptured aneurysms are best managed at large volume centers, which should include comprehensive patient management with expertise in microsurgery, endovascular surgery, neurology, and neurocritical care. CONCLUSIONS: Clinical and preclinical studies and scientific research on IA should engage high-volume centers and be conducted in multicenter collaborative efforts. The future of IA diagnosis and monitoring could be enhanced by the incorporation of artificial intelligence and national radiographic and biologic registries. A collaborative effort between academic centers, government regulators, and the device industry is paramount for the adequate management of IA and the advancement of the field.

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“…The study proposes systematic randomization of consecutive patients with unruptured intracranial aneurysm between curative versus conservative management, and endovascular versus surgical treatment, with a prospective registry arm. 45 The CURES (Collaborative UnRuptured Endovascular versus Surgery) trial is another pragmatic randomized trial comparing the results of surgical clipping and endovascular treatment of unruptured intracranial aneurysm. Interim analysis demonstrated no difference in morbidity between surgical clipping or endovascular coiling at 1 year.…”

Section: Durability Of Aneurysm Treatmentmentioning

confidence: 99%

“…The CAM (Comprehensive Aneurysm Management) study is an ongoing pragmatic trial to manage patients with unruptured intracranial aneurysm into a paradigm of a care trial. The study proposes systematic randomization of consecutive patients with unruptured intracranial aneurysm between curative versus conservative management, and endovascular versus surgical treatment, with a prospective registry arm 45 . The CURES (Collaborative UnRuptured Endovascular versus Surgery) trial is another pragmatic randomized trial comparing the results of surgical clipping and endovascular treatment of unruptured intracranial aneurysm.…”

Section: Cerebral Aneurysmsmentioning

confidence: 99%

Management of Unruptured Intracranial Aneurysms and Brain Arteriovenous Malformations

Nguyen¹

2023

CONTINUUM: Lifelong Learning in Neurology

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OBJECTIVEManaging a patient with an unruptured brain aneurysm or brain arteriovenous malformation (AVM) can lead to uncertainty about preventive treatment. While the bleeding risks are low, the morbidity or mortality associated with a hemorrhagic event is not insignificant. The objective of this article is to review the natural history of these vascular entities, the risk factors for hemorrhage, preventive treatment options, and the risks of treatment.LATEST DEVELOPMENTSRandomized trials to inform preventive treatment strategies for unruptured intracranial aneurysms and brain AVMs are ongoing. Higher angiographic obliteration rates of unruptured intracranial aneurysms have been reported with the flow-diversion technique compared with alternative standard techniques. One randomized trial for unruptured brain AVMs showed a higher rate of morbidity and mortality in patients who underwent interventional treatment compared with observation.ESSENTIAL POINTSThe decision to treat a patient with a brain aneurysm should consider patient factors, the patient’s life expectancy, aneurysm anatomical factors, and treatment risks. Patients with unruptured brain AVMs should be observed in light of recent clinical trial data or enrolled in an ongoing clinical trial.

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Recruitment in a Pragmatic Randomized Trial on the Management of Unruptured Intracranial Aneurysms

Cited by 5 publications

References 18 publications

A Pragmatic Randomized Trial Comparing Surgical Clipping and Endovascular Treatment of Unruptured Intracranial Aneurysms

A Pragmatic Randomized Trial Comparing Surgical Clipping and Endovascular Treatment of Unruptured Intracranial Aneurysms

ARISE I Consensus Review on the Management of Intracranial Aneurysms

Management of Unruptured Intracranial Aneurysms and Brain Arteriovenous Malformations

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