Statin treatment for unruptured intracranial aneurysms study: a study protocol for a double-blind, placebo-controlled trial

Li, Wenqiang; Zhang, Yisen; Tian, Zhongbin; Zhu, Wei; Liu, Jian; Yang, Xinjian; Tian, De-Cai

doi:10.1136/svn-2020-000353

Cited by 10 publications

(12 citation statements)

References 30 publications

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“…Alternatively, a retrospective cohort study examining 28,931 patients with unruptured cerebral aneurysms found no significant effect of statin use on likelihood of aneurysm rupture [ 70 ]. Currently, the Statin Treatment for UnruptureD Intracranial anEurysms (STUDIES) trial, a randomized, placebo-controlled trial to assess whether atorvastatin leads to significant changes in aneurysm vessel wall enhancement and inflammatory markers is ongoing [ 71 ].…”

Section: Treatment Of Unruptured Cerebral Aneurysms In the Elderlymentioning

confidence: 99%

Unruptured cerebral aneurysms in elderly patients: key challenges and management

et al. 2021

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Unruptured cerebral aneurysms are increasingly identified in elderly patients as the global life expectancy continues to rise and non-invasive vascular imaging becomes more prevalent. The optimal management of unruptured aneurysms in elderly patients remains controversial. Variability in life expectancy, comorbidities and rupture risk coupled with heterogenous endovascular and surgical treatments contribute to a paucity of clear guidelines, and current management is highly individualized. Elderly patients present unique considerations including frailty, cognitive dysfunction, vasculopathy, reduced life expectancy and overall worse prognosis in case of rupture which shape the risks and likelihood of success of endovascular and microsurgical treatment. In this review, we provide a comprehensive overview of unruptured cerebral aneurysms in the elderly, with a particular focus on the natural history, key challenges associated with advanced age, management and future innovations to further refine treatment. Key Messages The management of unruptured cerebral aneurysms in elderly patients remains controversial. Key challenges including frailty, cognitive dysfunction, reduced life expectancy, vasculopathy and poor prognosis with aneurysm rupture add complexity to endovascular and surgical decision making not encountered with younger demographics. A thorough understanding of available treatment options, likelihood of treatment success and associated risks weighed against the risk of aneurysm rupture informs patient discussion and management.

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Section: Treatment Of Unruptured Cerebral Aneurysms In the Elderlymentioning

confidence: 99%

Unruptured cerebral aneurysms in elderly patients: key challenges and management

et al. 2021

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“…Statins have recently gained traction as a possible therapeutic agent due to their pleiotropic effects on the aneurysm wall. 38 In our cohort study, oral atorvastatin is not associated with small UIA rupture, whereas oral atorvastatin is associated with a decreased growth rate. Uncontrolled hypertension and UIAs sized 5 to <7 mm are associated with UIA growth and rupture.…”

Section: Discussionmentioning

confidence: 55%

Atorvastatin and growth, rupture of small unruptured intracranial aneurysm: results of a prospective cohort study

Wang

Weng

et al. 2021

Ther Adv Neurol Disord

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Background and aims: The role of statins in unruptured intracranial aneurysm (UIA) growth and rupture remains ambiguous. This study sought to determine whether atorvastatin is associated with aneurysm growth and rupture in patients harboring UIA <7 mm. Methods: This prospective, multicenter cohort study consecutively enrolled patients with concurrent UIA <7 mm and ischemic cerebrovascular disease from four hospitals between 2016 and 2019. Baseline and follow-up patient information was recorded. Because of the strong anti-inflammatory effect of aspirin, patients using aspirin were excluded. Patients taking atorvastatin 20 mg daily were atorvastatin users. The primary and exploratory endpoints were aneurysm rupture and growth, respectively. Results: Among the 1087 enrolled patients, 489 (45.0%) took atorvastatin, and 598 (55%) took no atorvastatin. After a mean follow-up duration of 33.0 ± 12.5 months, six (1.2%) and five (0.8%) aneurysms ruptured in atorvastatin and non-atorvastatin groups, respectively. In the adjusted multivariate Cox analysis, UIA sized 5 to <7 mm, current smoker, and uncontrolled hypertension were associated with aneurysm rupture, whereas atorvastatin [adjusted hazard ratio (HR) 1.495, 95% confidence interval (CI) 0.417–5.356, p = 0.537] was not. Of 159 patients who had follow-up imaging, 34 (21.4%) took atorvastatin and 125 (78.6%) took no atorvastatin. Aneurysm growth occurred in five (14.7%) and 21 (16.8%) patients in atorvastatin and non-atorvastatin groups (mean follow-up: 20.2 ± 12.9 months), respectively. In the adjusted multivariate Cox analysis, UIAs sized 5 to <7 mm and uncontrolled hypertension were associated with a high growth rate; atorvastatin (adjusted HR 0.151, 95% CI 0.031–0.729, p = 0.019) was associated with a reduced growth rate. Conclusions: We conclude atorvastatin use is associated with a reduced risk of UIA growth, whereas atorvastatin is not associated with UIA rupture. The trial registry name: The Clinic Benefit and Risk of Oral Aspirin for Unruptured Intracranial Aneurysm Combined With Cerebral Ischemia Clinical Trial Registration-URL: http://www.clinicaltrials.gov Unique identifier: NCT02846259

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“…To our knowledge, this is the first conservative treatment study to completely exclude the effects of intervention, while previous studies have focused on reducing the recurrence of UIVBDAs after the intervention. This study is based on our previous research26 27 and the known effects of statins in regulating inflammation and promoting angiogenesis in chronic subdural haematoma 15…”

Section: Discussionmentioning

confidence: 99%

Atorvastatin for unruptured intracranial vertebrobasilar dissecting aneurysm (ATREAT-VBD): protocol for a randomised, double-blind, blank-controlled trial

et al. 2022

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IntroductionVertebrobasilar dissecting aneurysms (VBDAs) are associated with serious complications and a poor prognosis. It is believed that inflammation of the aneurysm wall may be the main cause of rupture or deterioration. Atorvastatin has been shown to inhibit inflammation and may be a suitable drug candidate. Here, we report a clinical research study protocol to investigate whether atorvastatin inhibits inflammation of the aneurysm wall, as measured by signal index enhancement.Methods and analysisWe have designed a single-centre, randomised, double-blind, blank-controlled clinical trial. 40 patients with non-ruptured VBDAs with enhancement aneurysm walls will be enrolled in Beijing Tiantan Hospital. Eligible patients will be randomly divided into two treatment groups, at a ratio of 1:1, to receive atorvastatin 20 mg orally for 6 months or no treatment. The primary assessment outcome will be the change in aneurysm wall enhancement, as measured by the signal index during the 6-month treatment period. The secondary assessment outcomes will be the aneurysm morphology (intramural haematoma, dissection valve and false lumen) and changes in the concentrations of inflammatory factors, including C reactive protein, tumour necrosis factor-α, interleukin (IL)-1β and IL-6.Ethics and disseminationThe protocol has been approved by the medical ethics committee of the Beijing Tiantan Hospital at which the work will be conducted (Approval No. KY 2019-024-02). Written informed consent will be obtained from all participants. Findings from the study will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT04943783.

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Statin treatment for unruptured intracranial aneurysms study: a study protocol for a double-blind, placebo-controlled trial

Cited by 10 publications

References 30 publications

Unruptured cerebral aneurysms in elderly patients: key challenges and management

Unruptured cerebral aneurysms in elderly patients: key challenges and management

Atorvastatin and growth, rupture of small unruptured intracranial aneurysm: results of a prospective cohort study

Atorvastatin for unruptured intracranial vertebrobasilar dissecting aneurysm (ATREAT-VBD): protocol for a randomised, double-blind, blank-controlled trial

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