Dataset Information

A single-center pilot randomized controlled trial of atorvastatin loading for preventing ischemic brain damage after carotid artery stenting.

ABSTRACT:

Objective

Carotid artery stenting (CAS) performed perioperatively with high-dose atorvastatin may reduce the incidence of new ischemic brain lesions, but more high-level evidence is needed. Furthermore, the optimal dose and course of perioperative statin therapy remain uncertain.

Methods

A single-center, prospective, parallel controlled, pilot randomized clinical trial was conducted at Beijing Hospital. The study includes a total of 130 patients with CAS. The patients were randomly assigned to receive a high-dose of 80 mg/day atorvastatin (n = 65) or a standard-dose of 20 mg/day atorvastatin (n = 65) 3 days before and 3 days after planned CAS. The primary endpoint event was the cumulative incidence of silent new ischemic cerebral lesions (sNICL) on post-CAS cerebral diffusion-weighted magnetic resonance imaging (DW-MRI), transient ischemic attack (TIA), or ischemic stroke within 30 days after CAS.

Results

Among the 130 patients, 123 completed the study, of which 63 were in the high-dose group and 60 were in the standard-dose group. The incidence of major endpoint events was 69.8% (44 cases) and 78.3% (46 cases) in the high-dose and standard-dose groups, respectively. There was no significant difference between the two groups (HR, 0.705; 95% CI, 0.315-1.576; p = 0.393). According to the stratified analysis results, the sNICL incidence was significantly different between the two groups in the symptomatic patients (HR, 0.263; 95% CI, 0.70-0.984; p = 0.04).

Conclusion

Among patients with CAS, a periprocedural high-dose of atorvastatin did not reduce the rate of periprocedural ischemic brain damage. However, high-dose statins can reduce the incidence of sNICL after CAS in patients with symptomatic carotid stenosis.

Clinical trial registration

Clinicaltrials.gov, identifier NCT03079115.

SUBMITTER: Wang H

PROVIDER: S-EPMC9816409 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A single-center pilot randomized controlled trial of atorvastatin loading for preventing ischemic brain damage after carotid artery stenting.

Wang Haipeng H Wang Junjie J Qi Peng P Yang Ximeng X Chen Kunpeng K Hu Shen S Liu Erteng E Zhang Shun S Gao Qun Q Li Rui R Lu Jun J Deng Gang G Wang Daming D

Frontiers in aging neuroscience 20221223

<h4>Objective</h4>Carotid artery stenting (CAS) performed perioperatively with high-dose atorvastatin may reduce the incidence of new ischemic brain lesions, but more high-level evidence is needed. Furthermore, the optimal dose and course of perioperative statin therapy remain uncertain.<h4>Methods</h4>A single-center, prospective, parallel controlled, pilot randomized clinical trial was conducted at Beijing Hospital. The study includes a total of 130 patients with CAS. The patients were randoml ...[more]

PMID: 36620770

Similar Datasets

Project description:BackgroundBrain lesions on diffusion-weighted imaging (DWI) are frequently found after carotid artery stenting (CAS), but their clinical relevance remains unclear.ObjectivesThis study sought to investigate whether periprocedural ischemic DWI lesions after CAS or carotid endarterectomy (CEA) are associated with an increased risk of recurrent cerebrovascular events.MethodsIn the magnetic resonance imaging (MRI) substudy of ICSS (International Carotid Stenting Study), 231 patients with symptomatic carotid stenosis were randomized to undergo CAS (n=124) or CEA (n=107). MRIs were performed 1 to 7 days before and 1 to 3 days after treatment. The primary outcome event was stroke or transient ischemic attack in any territory occurring between the post-treatment MRI and the end of follow-up. Time to occurrence of the primary outcome event was compared between patients with (DWI+) and without (DWI-) new DWI lesions on the post-treatment scan in the CAS and CEA groups separately.ResultsMedian time of follow-up was 4.1 years (interquartile range: 3.0 to 5.2). In the CAS group, recurrent stroke or transient ischemic attack occurred more often among DWI+ patients (12 of 62) than among DWI- patients (6 of 62), with a cumulative 5-year incidence of 22.8% (standard error [SE]: 7.1%) and 8.8% (SE: 3.8%), respectively (unadjusted hazard ratio: 2.85; 95% confidence interval: 1.05 to 7.72; p=0.04). In DWI+ and DWI- patients, 8 and 2 events, respectively, occurred within 6 months after treatment. In the CEA group, there was no difference in recurrent cerebrovascular events between DWI+ and DWI- patients.ConclusionsIschemic brain lesions discovered on DWI after CAS seem to be a marker of increased risk for recurrent cerebrovascular events. Patients with periprocedural DWI lesions might benefit from more aggressive and prolonged antiplatelet therapy after CAS. (A Randomised Comparison of the Risks, Benefits and Cost Effectiveness of Primary Carotid Stenting With Carotid Endarterectomy: International Carotid Stenting Study; ISRCTN25337470).

Project description:BackgroundCarotid artery stenting (CAS) is a common treatment for carotid artery stenosis, but it can lead to new ischemic brain lesions on diffusion-weighted images (DWI) during the perioperative period. Identifying these lesions early is crucial to preventing recurrent ischemic strokes.MethodsThis retrospective study included 47 patients who underwent CAS. Preoperative carotid PET/MR examinations and postoperative brain MRI were performed. Clinicians identified the responsible carotid artery based on symptoms and records. Vessel morphology, plaque characteristics, and inflammatory uptake were analyzed. The standardized uptake value and tissue-to-background ratio quantified 18F-fluorodeoxyglucose(18F-FDG) uptake. The symptomatic carotid atheroma inflammation lumen-stenosis(SCAIL) score assessed stenosis severity and inflammation. The primary outcome was the presence of new ischemic lesions on DWI.ResultsAmong the 47 patients (mean age, 65 ± 7 years; 44 males), 30 (63.8%) exhibited new ischemic lesions. These patients had a higher prevalence of AHA type VI plaques (50.0% vs. 17.6%, p = 0.028), higher PET uptake (43.3% vs. 11.8%, p = 0.026), and higher SCAIL scores (63.3% vs. 23.5%, p = 0.009). The most common distribution pattern of new ischemic lesions was located in the mixed (in and beyond of the treated artery) territory (36.2%). Of the 30 participants with new ischemic lesions, 15 (50%) had lesions located in both peripheral brain areas and deep brain areas. In the adjusted model, high PET uptake and SCAIL scores were independently associated with new ischemic lesions (aOR = 7.26, 95% CI: 1.22, 73.59; p = 0.049 and aOR = 7.06 [95% CI: 1.50, 44.18]; p = 0.020).ConclusionCarotid PET/MR-related indicators can effectively predict the risk of new ischemic lesions on DWI during the perioperative period after carotid artery stenting, providing important references for early identification of high-risk patients for recurrent ischemic stroke. Further large-scale randomized controlled studies are necessary to validate the clinical application value of these indicators.

Project description:Background: The occurrence of ischemic lesions is common in patients receiving carotid artery stenting (CAS), and most of them are clinically silent. However, few studies have directly addressed the cognitive sequelae of these procedure-related silent ischemic lesions (SILs). Objective: In this study, we attempted to investigate the effects of SILs on cognition using a comprehensive battery of neuropsychological tests. Method: Eighty-five patients with unilateral carotid stenosis and 25 age-matched healthy volunteers participated in this study. Brain MRI was performed within 1 week before and 1 week after CAS to monitor the occurrence of post-CAS SILs. A comprehensive battery tapping reading ability, verbal and non-verbal memory, visuospatial function, manual dexterity, executive function, and processing speed was administered 1 week before and 6 months after CAS. To control for practice effects on repeated cognitive testing, the reliable change index (RCI) derived from the healthy volunteers was used to determine the cognitive changes in patients with carotid stenosis. Results: Among the 85 patients with carotid stenosis, 21 patients received medical treatment (MED group), and procedure-related SILs were noted in 17 patients (SIL+ group) but not observed in 47 patients (SIL- group) after undergoing CAS. Two-way (group × phase) ANOVA revealed that the volunteer group showed improved scores in most cognitive tests while only limited improvement was noted in the SIL- group. The MED and control groups tended to show improvement in the follow-up cognitive testing than the SIL+ group. However, most of the cognitive changes for each patient group did not exceed the upper or lower limits (z = ±1.0) of the RCI. Conclusions: Although the occurrence of procedure-related SILs is common in patients undergoing CAS, their impacts on cognitive changes after CAS may be limited. The practice effect should be taken into consideration when interpreting cognitive changes following CAS.

Dataset Information

A single-center pilot randomized controlled trial of atorvastatin loading for preventing ischemic brain damage after carotid artery stenting.

Objective

Methods

Results

Conclusion

Clinical trial registration

Publications

A single-center pilot randomized controlled trial of atorvastatin loading for preventing ischemic brain damage after carotid artery stenting.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets