Dataset Information

Impact of statin pretreatment on the complications of carotid stenting in asymptomatic patients: observational study.

ABSTRACT:

Background

Carotid stenosis is a known risk factor for ischemic stroke, and carotid artery stenting is an effective preventive procedure. However, the stroke risk reduction for asymptomatic patients is small. Therefore, it is important to reduce the risk of complications, particularly in asymptomatic carotid stenosis. Statins are known to reduce the overall risk of periprocedural complications, although there is a lack of data focusing on asymptomatic patients. We aimed to investigate whether different doses of statin pretreatment can reduce periprocedural complications of carotid artery stenting (CAS) in patients with asymptomatic carotid artery stenosis.

Methods

Between July 2003 and June 2013, 276 consecutive patients received CAS for asymptomatic carotid stenosis. Periprocedural complications included the outcome of stroke, myocardial infarction, or death within 30?days of CAS. Statin pretreatment was categorized as no-statin (n?=?87, 31.5%), standard-dose (ResultsThe overall periprocedural complication rate was 3.3%. There was no significant difference in the risk of periprocedural complications between the three groups (no statin: n?=?3 [3.4%]; standard-dose: n?=?4 [2.9%]; high-dose n?=?2 [4.0%] p?=?0.923). The CA trend test did not demonstrate a trend in the proportion of periprocedural complications across increasing statin equivalent doses (p?=?0.919).

Conclusions

Statin pretreatment before CAS showed neither absolute nor dose-dependent effects against periprocedural complications in asymptomatic patients undergoing CAS.

SUBMITTER: Jang SH

PROVIDER: S-EPMC7883458 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Impact of statin pretreatment on the complications of carotid stenting in asymptomatic patients: observational study.

Jang Seong Hwa SH Kwon Doo Hyuk DH Han Moon-Ku MK Park Hyungjong H Sohn Sung-Il SI Choi Huimahn H Hong Jeong-Ho JH

BMC neurology 20210215 1

<h4>Background</h4>Carotid stenosis is a known risk factor for ischemic stroke, and carotid artery stenting is an effective preventive procedure. However, the stroke risk reduction for asymptomatic patients is small. Therefore, it is important to reduce the risk of complications, particularly in asymptomatic carotid stenosis. Statins are known to reduce the overall risk of periprocedural complications, although there is a lack of data focusing on asymptomatic patients. We aimed to investigate wh ...[more]

PMID: 33588788

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Project description:BACKGROUND:Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are alternative strategies for stroke prevention in patients with atherosclerotic carotid disease. CEA has been considered the first-line treatment for carotid stenosis worldwide, and the safety and efficacy of CAS compared to CEA remains in question. OBJECTIVE:The purpose of this study is to compare the practice and outcomes of CAS and CEA in a real-world setting within public university hospitals in Brazil. METHODS:This study will be a prospective 5-year analysis of treatment for atherosclerotic carotid stenosis with CEA and CAS performed at 5 centers affiliated with the Vascular Study Group at public university hospitals in Brazil. The indications for the procedures will be determined by each surgeon's individual discretion, in accordance with preoperative risk evaluation. The primary outcome measures will be (1) any in-hospital stroke or death, and (2) any per-procedural stroke, death, or myocardial infarction (MI). Patients undergoing CEA in conjunction with cardiac surgery will be excluded from the study. Multivariate logistic regression will be performed to identify predictors of stroke or death in patients undergoing CEA and CAS. All tests of significance will be performed at the .05 level. This study was approved by the Committee of Ethics in Research at the University Hospital of Ribeirao Preto Medical School, and in all other participating institutions linked to National Research System and National Board of Health in Brazil (Process 15695/2011). RESULTS:This study is currently in the recruitment phase, and the final patient is expected to be enrolled by the end of 2018. We hope to recruit approximately 800 patients to the study. Analyses will focus on primary end points for patients that are allocated to each treatment group. During the per-procedural period, the occurrence of the primary end point components (stroke, MI, or death) for CAS and CEA will be analyzed for symptomatic or asymptomatic subjects. CONCLUSIONS:The analyses of the primary endpoints (and all others variables of the study) are expected to be published in 2019 in a peer reviewed journal, and results will be presented at scientific meetings, with summary results published online. This study will obtain new data related to the quality of treatment for carotid disease in Brazil at the primary training centers of future vascular surgeons, but the initial data that will be obtained and published (with the outcomes and complications) are restricted to the first 30 days postprocedure. This time restriction limits the comparison of the results that relate to the main goal of treatment, which is to decrease the risk of stroke over 5 years. The purpose of the study group is to continue the monitoring of patient records, and evaluate the follow-up data in the 5 years following the initial evaluation. This study protocol will contribute very significantly to improving the care of patients with carotid disease, in addition to qualifying the level of assistance provided in public university hospitals in the state of São Paulo, Brazil. TRIAL REGISTRATION:Clinicaltrials.gov NCT02538276; https://www.clinicaltrials.gov/ct2/show/NCT02538276 (Archived by WebCite at http://www.webcitation.org/6m7APnFLD).

Project description:BackgroundAmong asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence.MethodsACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362.FindingsBetween Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86-1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91-1·32; p=0·21).InterpretationSerious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable.FundingUK Medical Research Council and Health Technology Assessment Programme.

Dataset Information

Impact of statin pretreatment on the complications of carotid stenting in asymptomatic patients: observational study.

Background

Methods

Conclusions

Publications

Impact of statin pretreatment on the complications of carotid stenting in asymptomatic patients: observational study.

Similar Datasets

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