asymptomatic carotid artery stenosis

  • 文章类型: Journal Article
    背景:确定影响灰度中位数(GSM)的临床因素并确定GSM诊断对区分有症状和无症状颈内动脉(ICA)狭窄的实用性。
    方法:本研究包括45例无症状的患者和40例有症状的ICA狭窄患者进行颈动脉内膜切除术(CEA)。使用用于GSM分析的计算机技术确定颈动脉斑块的回声。研究组在临床危险因素方面进行比较,共存的合并症,并使用药物治疗。
    结果:有症状组的平均GSM值显着低于无症状组(p<0.001)。无论是在单变量还是在多元回归分析中,在有症状的组中,GSM与D-二聚体和空腹血糖水平显着相关,并且倾向于与β-肾上腺素受体拮抗剂的使用相关。在无症状患者中,GSM与2级和3级高血压的存在有关,并倾向于与二甲双胍的使用相关,磺酰脲类,和他汀类药物。该组中GSM的独立因素仍然是3级高血压和他汀类药物治疗。受试者工作特征(ROC)分析显示,GSM区分症状性和无症状性ICA狭窄的敏感性和特异性分别为73%和80%。分别。
    结论:在有症状和无症状的CEA患者中,完全不同的临床参数可能会影响GSM,其临床特征在大多数比较参数方面相似。GSM可能是临床上用于区分有症状和无症状ICA狭窄的有用参数。
    BACKGROUND: The identification of clinical factors affecting the gray-scale median (GSM) and determination of GSM diagnostic utility for differentiating between symptomatic and asymptomatic internal carotid artery (ICA) stenosis.
    METHODS: This study included 45 patients with asymptomatic and 40 patients with symptomatic ICA stenosis undergoing carotid endarterectomy (CEA). Echolucency of carotid plaque was determined using computerized techniques for the GSM analysis. Study groups were compared in terms of clinical risk factors, coexisting comorbidities, and used pharmacotherapy.
    RESULTS: Mean GSM values in the symptomatic group were significantly lower than in the asymptomatic group (p < 0.001). Both in the univariate as well as in the multiple regression analysis, GSM was significantly correlated with D-dimers and fasting plasma glucose levels and tended to correlate with β-adrenoceptor antagonist use in the symptomatic group. In asymptomatic patients, GSM was associated with the presence of grade 2 and grade 3 hypertension, and tended to correlate with the use of metformin, sulfonylureas, and statin. Independent factors for GSM in this group remained as grade 3 hypertension and statin\'s therapy. The receiver operating characteristic (ROC) analysis revealed that GSM differentiated symptomatic from asymptomatic ICA stenosis with sensitivity and specificity of 73% and 80%, respectively.
    CONCLUSIONS: The completely diverse clinical parameters may affect GSM in symptomatic and asymptomatic patients undergoing CEA, whose clinical characteristics were similar in terms of most of the compared parameters. GSM may be a clinically useful parameter for differentiating between symptomatic and asymptomatic ICA stenosis.
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  • 文章类型: Journal Article
    本文旨在探讨无症状颈动脉狭窄患者围手术期缺血性卒中风险评估的进展。当前术前诊断算法中基于CTA或MR诊断成像的Willis环(CoW)形态学研究。功能性经颅多普勒(FTCD),近红外光谱(NIRS),在评估脑血管储备能力和侧支血管系统的背景下,讨论了光学相干断层扫描血管造影(OCTA)。尤其是CoW。这些非侵入性诊断工具提供对脑灌注状态的额外有价值的见解。他们支持生物医学建模作为预测颈动脉狭窄对脑灌注血流动力学变化的潜在影响的金标准。术中风险评估策略,包括选择性分流,重点探讨CoW变化及其对围手术期缺血性卒中和认知功能下降的影响。通过综合这些见解,本综述强调了非侵入性诊断方法通过降低围手术期缺血性神经系统事件的风险和预防进一步认知功能下降,支持临床决策并改善无症状患者结局的潜力.
    This review aims to explore advancements in perioperative ischemic stroke risk estimation for asymptomatic patients with significant carotid artery stenosis, focusing on Circle of Willis (CoW) morphology based on the CTA or MR diagnostic imaging in the current preoperative diagnostic algorithm. Functional transcranial Doppler (fTCD), near-infrared spectroscopy (NIRS), and optical coherence tomography angiography (OCTA) are discussed in the context of evaluating cerebrovascular reserve capacity and collateral vascular systems, particularly the CoW. These non-invasive diagnostic tools provide additional valuable insights into the cerebral perfusion status. They support biomedical modeling as the gold standard for the prediction of the potential impact of carotid artery stenosis on the hemodynamic changes of cerebral perfusion. Intraoperative risk assessment strategies, including selective shunting, are explored with a focus on CoW variations and their implications for perioperative ischemic stroke and cognitive function decline. By synthesizing these insights, this review underscores the potential of non-invasive diagnostic methods to support clinical decision making and improve asymptomatic patient outcomes by reducing the risk of perioperative ischemic neurological events and preventing further cognitive decline.
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  • 文章类型: Journal Article
    目的:我们旨在确定无症状颈动脉狭窄(ACS)引起的认知障碍是否与胆碱能高强度通路有关。
    方法:这项横断面研究纳入了中度至重度ACS患者,根据蒙特利尔认知评估(MoCA)评分将其分为轻度认知障碍(MCI)和正常认知组。胆碱能通路高强度量表(CHIPS),法泽卡斯,评估内侧颞叶萎缩(MTA)评分。采用SPSS软件进行统计分析。
    结果:共评估了117例ACS患者(70.89±8.81岁)和105例对照(67.87±9.49岁)(t=2.46,p=0.015)。ACS组显示中位简易精神状态检查(MMSE)评分(z=-2.41,p=0.016)和MoCA评分(z=-3.51,p<0.001)较差,CHIPS总分中位数(z=4.88,p<0.001)和平均Fazekas评分(t=2.39,p=0.018)明显更高。在相关性分析中,ACS组MoCA评分与CHIPS评分(ρ=-0.41,p<0.001)和Fazekas评分(ρ=-0.31,p<0.001)呈显著负相关。Logistic回归分析提示CHIPS评分是ACS患者MCI的危险因素(比值比[OR]=1.07,95%置信区间[CI]1.01-1.13和对照组(OR=1.09,95CI1.01-1.17),而MTA和Fazekas评分没有显示预测能力。受试者工作特征曲线显示ACS组CHIPS评分预测MCI的曲线下面积为0.71,但对照组只有0.57。
    结论:ACS患者的认知表现较差,CHIPS和Fazekas评分较高。CHIPS,但不是Fazekas,评分是认知障碍的危险因素,也是预测ACS患者MCI的有价值因素.
    We aimed to determine whether asymptomatic carotid artery stenosis (ACS) induced cognitive impairments were related to the cholinergic hyperintensity pathway.
    This cross-sectional study included patients with moderate-to-severe ACS, who were categorized into mild cognitive impairment (MCI) and normal cognition groups on the basis of Montreal Cognitive Assessment (MoCA) scores. The cholinergic pathway hyperintensity scale (CHIPS), Fazekas, and medial temporal atrophy (MTA) scores were assessed. SPSS software was used for statistical analyses.
    A total of 117 ACS patients (70.89 ± 8.81 years) and 105 controls (67.87 ± 9.49 years) were evaluated (t = 2.46, p = 0.015). The ACS group showed a worse median Mini-Mental Status Examination (MMSE) score (z = -2.41, p = 0.016) and MoCA score (z = -3.51, p < 0.001), and a significantly higher median total CHIPS score (z = 4.88, p < 0.001) and mean Fazekas score (t = 2.39, p = 0.018). In the correlation analysis, the MoCA score showed a significant negative correlation with the CHIPS score (ρ = -0.41, p < 0.001) and Fazekas score (ρ = -0.31, p < 0.001) in ACS group. Logistic regression analyses suggested that CHIPS scores were risk factors for MCI in patients with ACS (odds ratio [OR] = 1.07, 95% Confidence Interval [CI]1.01-1.13 and controls (OR = 1.09, 95%CI 1.01-1.17), while the MTA and Fazekas scores showed no predictive power. The receiver operating characteristic curve showed that the area under the curve of the CHIPS score for predicting MCI was 0.71 in ACS group, but was only 0.57 in controls.
    Patients with ACS showed poorer cognitive performance and higher CHIPS and Fazekas scores. CHIPS, but not Fazekas, scores were risk factors for cognitive impairment and were a valuable factor to predict MCI in patients with ACS.
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  • 文章类型: Journal Article
    循环microRNAs(miRNAs)被广泛认为是诊断人类疾病的有希望的新型生物标志物。这项研究调查了miR-532-5p对无症状颈动脉狭窄(CAS)患者的临床价值,并检测了其对未来脑缺血事件(CIE)发生的预测价值。
    使用qRT-PCR测量miR-532-5p的血清表达。进行受试者工作特征(ROC)分析以评估miR-532-5p在无症状CAS患者中的诊断价值。并计算曲线下面积(AUC)。使用Kaplan-Meier方法和Cox回归分析评估miR-532-5p对CIE发生的预测价值。
    与健康对照相比,在CAS患者中miR-532-5p的血清表达被鉴定为显著降低。AUC为0.903的ROC曲线表明无症状CAS患者中血清miR-532-5p表达的高诊断准确性。正如Kaplan-Meier分析结果表明的那样,在miR-532-5p低表达的病例中观察到更多的E事件。miR-532-5p低和颈动脉狭窄程度高是无症状CAS患者发生CIE的独立因素。
    该研究表明miR-532-5p对无症状CAS患者的早期诊断具有潜在的临床价值。MiR-532-5p可能对无症状CAS患者未来E的风险具有预测价值。
    UNASSIGNED: Circulating microRNAs (miRNAs) are widely identified as promising and novel biomarkers for the diagnosis of human diseases. This study investigated the clinical value of miR-532-5p for asymptomatic carotid artery stenosis (CAS) patients and detected its predictive value for the occurrence of future cerebral ischaemic events (CIE).
    UNASSIGNED: Serum expression of miR-532-5p was measured using qRT-PCR. A receiver operating characteristic (ROC) analysis was performed to evaluate the diagnostic value of miR-532-5p in asymptomatic CAS patients, and the area under the curve (AUC) was calculated. The predictive value of miR-532-5p for the occurrence of CIE was evaluated by using Kaplan-Meier methods and Cox regression analysis.
    UNASSIGNED: Serum expression of miR-532-5p was identified to be significantly decreased in CAS patients compared with healthy controls. The ROC curve with an AUC of 0.903 indicated high diagnostic accuracy of serum miR-532-5p expression in asymptomatic CAS patients. As Kaplan-Meier analysis results suggested, more CIE events were observed in cases with low miR-532-5p expression. Low miR-532-5p and high degree of carotid stenosis were independent factors for the occurrence of CIE in asymptomatic CAS patients.
    UNASSIGNED: The study suggests the potential clinical value of miR-532-5p for the early diagnosis of asymptomatic CAS patients. MiR-532-5p might have predictive value for the risk of future CIE in asymptomatic CAS patients.
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  • 文章类型: Journal Article
    颈内动脉狭窄(ICAS)可导致中风和认知功能下降。相关的血液动力学损伤,在血管区域之间的各个分水岭区域(iWSA)中最明显,可以通过血流动力学-氧合敏感的MRI进行评估,并可能有助于检测受影响严重的患者。我们旨在通过随机森林机器学习来识别最敏感的参数和感兴趣的体积(VOI),以预测高级ICAS。我们假设在正确分类的患者中,考虑iWSA的预测能力增加,认知能力下降。
    24例患者无症状,单边,高度颈动脉狭窄和24名年龄匹配的健康对照者接受了包括假连续动脉自旋标记(pCASL)的MRI,屏气功能磁共振成像(BH-fMRI),动态磁化率对比(DSC),T2和T2*映射,MPRAGE和FLAIR。八个灌注的定量图,获得氧合和微血管参数。计算了两个半球和半球间差异的iWSA内部和外部的各个参数的平均值,这些参数分为灰色(GM)和白质(WM),导致96个特征。随机森林分类器在整个GM/WMVOI上进行了训练,考虑iWSA和附加功能选择的VOI,分别。
    按递减顺序最敏感的特征是峰值时间(TTP),脑血流量(CBF)和脑血管反应性(CVR),所有这些都在iWSA内部。与整个GM/WMVOIs相比,应用iWSA结合特征选择产生的接收器工作特征曲线下面积(AUC)明显更高(AUC:0.84vs.0.90,p=0.039)。正确预测的患者的认知表现要比经常错误分类的患者差(Trail-making-testB:152.5svs.94.4s,p=0.034)。
    在多参数MRI数据上训练的随机森林分类器允许识别最相关的参数和VOI以预测ICAS,这可以改善个性化治疗。
    UNASSIGNED: Internal carotid artery stenosis (ICAS) can cause stroke and cognitive decline. Associated hemodynamic impairments, which are most pronounced within individual watershed areas (iWSA) between vascular territories, can be assessed with hemodynamic-oxygenation-sensitive MRI and may help to detect severely affected patients. We aimed to identify the most sensitive parameters and volumes of interest (VOI) to predict high-grade ICAS with random forest machine learning. We hypothesized an increased predictive ability considering iWSAs and a decreased cognitive performance in correctly classified patients.
    UNASSIGNED: Twenty-four patients with asymptomatic, unilateral, high-grade carotid artery stenosis and 24 age-matched healthy controls underwent MRI comprising pseudo-continuous arterial spin labeling (pCASL), breath-holding functional MRI (BH-fMRI), dynamic susceptibility contrast (DSC), T2 and T2* mapping, MPRAGE and FLAIR. Quantitative maps of eight perfusion, oxygenation and microvascular parameters were obtained. Mean values of respective parameters within and outside of iWSAs split into gray (GM) and white matter (WM) were calculated for both hemispheres and for interhemispheric differences resulting in 96 features. Random forest classifiers were trained on whole GM/WM VOIs, VOIs considering iWSAs and with additional feature selection, respectively.
    UNASSIGNED: The most sensitive features in decreasing order were time-to-peak (TTP), cerebral blood flow (CBF) and cerebral vascular reactivity (CVR), all of these inside of iWSAs. Applying iWSAs combined with feature selection yielded significantly higher receiver operating characteristics areas under the curve (AUC) than whole GM/WM VOIs (AUC: 0.84 vs. 0.90, p = 0.039). Correctly predicted patients presented with worse cognitive performances than frequently misclassified patients (Trail-making-test B: 152.5s vs. 94.4s, p = 0.034).
    UNASSIGNED: Random forest classifiers trained on multiparametric MRI data allow identification of the most relevant parameters and VOIs to predict ICAS, which may improve personalized treatments.
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  • 文章类型: Journal Article
    本研究的目的是评估性别对接受颈动脉支架置入术(CAS)的无症状患者的影响。
    一项回顾性观察研究于2006年1月至2020年12月进行。共有438例无症状颈动脉狭窄>70%的连续患者接受了经股动脉CAS,并分为男性(M)和女性(F)。围手术期30天结果为:卒中,死亡,心肌梗死(MI)。随访结果为:死亡率和卒中发生率(主要),再狭窄发生率(FFR)和再干预率(次要)。随访数据分别在1年、5年和10年进行分析。数据采用χ2检验和Fisher精确检验分析,随访结果采用Kaplan-Meier曲线分析。使用对数秩检验来确定组间的差异,并进行单因素分析以确定危险因素和术中细节与死亡率和再狭窄率之间的关联。
    总共进行了462个手术(M:n=321,69.4%),其中24个CAS为双侧(5.5%)。平均年龄为71.9±7.6岁(M:72.1±7.8;F:71.7±7.3)。围手术期结果为:卒中发生率2.2%(n=10;M:n=5,1.6%;F:n=5,3.5%;p=0.176),死亡率0.6%(M:n=3,p=0.334),卒中/死亡率为2.8%(n=13;M:n=8,2.5%;F:n=5,3.5%;p=0.528);没有记录到心脏事件(MI)。3名男性(0.9%)发现非致残(轻微)中风,据报道,有7例患者(1.7%)发生了致残(严重)中风,其中5例为缺血性事件(M:n=2,0.6%;F:n=3,2.2%),2例为脑出血(F:1.3%,p=0.046)。平均随访时间为73.66±40.83个月(M:72.66;F:76.01;p=0.246)。总生存率为96.1%(95%置信区间[CI]:93-98),81.8%(95%CI:77-86),在1年、5年和10年时为45.5%(95%CI:38-53),分别(p=0.236)。总卒中发生率为0.3%(卒中自由[FFS]:99.7%;95%CI:98-100),0.9%(FFS:99%;95%CI:98-100),和4.3%(FFS:95.7%;95%CI:89-98;M:n=6;F:n=2;p=0.774)。5年和10年卒中相关死亡率分别为0.7%(FFS:99.3%;95%CI:97-100)和2.9%(FFS:97.1%;95%CI:91-99),分别,组间无差异(M:n=4;F:n=2;p=0.763)。总体FFR率为97.4%(95%CI:95-99),93.4%(95%CI:90-96),和89.5%(95%CI:84-93;p=0.322)。两次严重症状性再狭窄(>70%,M)需要新的血管内血运重建。
    在短期和长期随访中,性别变量不影响无症状患者的CAS结果,尽管女性表现出最严重的围手术期主要中风的发生率。当仔细选择患者时,可以安全地建议颈动脉支架置入术。
    结论:性别变量被认为是影响经股颈动脉支架置入术(CAS)结果的重要因素。文献数据形成对比,即使不同的论文主要报道CAS与女性患者的最差结局相关.我们的研究表明,在短期和长期随访中,性别变量不会影响无症状患者的CAS结果,尽管女性的围手术期主要卒中发生率最差。当应用仔细的患者选择时,可以安全地提出CAS。
    UNASSIGNED: Aim of the study was to evaluate the influence of sex in asymptomatic patients undergoing carotid artery stenting (CAS).
    UNASSIGNED: A retrospective observational study was conducted from January 2006 to December 2020. A total of 438 consecutive patients with asymptomatic carotid artery stenosis >70% underwent transfemoral CAS and were stratified in males (M) and females (F). Periprocedural 30-day outcomes were: stroke, death, and myocardial infarction (MI). Follow-up outcomes were: death and stroke rates (primary) and freedom from restenosis (FFR) and reintervention rates (secondary). Follow-up data were analyzed at 1, 5, and 10 years. Data were analyzed with χ2 test and Fisher\'s exact test and follow-up outcomes with Kaplan-Meier curves. The log-rank test was used to determine differences between the groups and univariate analysis to identify the association between risk factors and intraoperative details with mortality and restenosis rates.
    UNASSIGNED: A total of 462 procedures were performed (M: n=321, 69.4%), in which 24 CAS were bilateral (5.5%). Mean age was 71.9±7.6 years (M: 72.1±7.8; F: 71.7±7.3). Periprocedural outcomes were: stroke rate 2.2% (n=10; M: n=5, 1.6%; F: n=5, 3.5%; p=0.176), mortality rate 0.6% (M: n=3, p=0.334), and stroke/death rate 2.8% (n=13; M: n=8, 2.5%; F: n=5, 3.5%; p=0.528); no cardiac events (MI) were recorded. A not-disabling (minor) stroke was detected in 3 males (0.9%), while a disabling (major) stroke was reported in 7 patients (1.7%) of whom 5 were ischemic events (M: n=2, 0.6%; F: n=3, 2.2%) and 2 were cerebral hemorrhages (F: 1.3%, p=0.046). Mean follow-up was 73.66±40.83 months (M: 72.66; F: 76.01; p=0.246). Overall survival rate was 96.1% (95% confidence interval [CI]: 93-98), 81.8% (95% CI: 77-86), and 45.5% (95% CI: 38-53) at 1, 5, and 10 years, respectively (p=0.236). The overall stroke rate was 0.3% (freedom from stroke [FFS]: 99.7%; 95% CI: 98-100), 0.9% (FFS: 99%; 95% CI: 98-100), and 4.3% (FFS: 95.7%; 95% CI: 89-98; M: n=6; F: n=2; p=0.774). Stroke-related mortality rate was 0.7% (FFS: 99.3%; 95% CI: 97-100) and 2.9% (FFS: 97.1%; 95% CI: 91-99) at 5 and 10 years, respectively, without differences between the groups (M: n=4; F: n=2; p=0.763). Overall FFR rate was 97.4% (95% CI: 95-99), 93.4% (95% CI: 90-96), and 89.5% (95% CI: 84-93; p=0.322). Two severe symptomatic restenosis (>70%, M) required a new endovascular revascularization.
    UNASSIGNED: The sex variable does not influence outcomes of CAS in asymptomatic patients at short- and long-term follow-up, although females show a worst incidence of periprocedural major strokes. Carotid artery stenting may be safely proposed when a careful patient selection is applied.
    CONCLUSIONS: The sex variable has been advocated as a considerable factor that could influence the outcomes of transfemoral carotid artery stenting (CAS). Literature data are contrasting, even if different papers mainly reported that CAS is associated to worst outcomes in female patients. Our study shows that the sex-variable does not influence outcomes of CAS in asymptomatic patients at short and long-term follow-up, although females had a worst incidence of periprocedural major strokes. CAS may be safely proposed when a careful patient selection is applied.
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    暂无摘要。
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  • 文章类型: Journal Article
    BACKGROUND: Psychological factors like anxiety and depression are recognised to play a causal role in the development of cardiovascular disease and they may also influence outcome after vascular surgery procedures. The aim of this study was to investigate the association of anxiety and depression with postoperative outcome following elective carotid surgery.
    METHODS: Single centre prospective observational study of patients treated for asymptomatic carotid artery stenosis at an academic vascular surgery centre. Preoperative anxiety and depression were evaluated using self-reporting questionnaires: Spielberger State-Trait Anxiety Inventory (STAI-S/-T) and Hospital Anxiety and Depression Scale (HADS-A/-D). Postoperative morbidity and mortality were assessed with the primary composite endpoint of stroke, myocardial infarction (MI) and death. Standard reporting guidelines for carotid disease were applied.
    RESULTS: From June 2012 to November 2015, 393 carotid endarterectomies (CEA) were performed at our institution. Out of those, 98 asymptomatic patients were available for analysis (78% male; median age, 71.1 years). Median scores of self-reporting questionnaires did not differ from published data of the general population (STAI-T, trait component, median, 36; IQR, 31-42.75; STAI-S, state component, median, 38; IQR, 32-43; HADS-A median, 6; IQR, 3-8; HADS-D median, 4; IQR, 2-7). Cardiovascular risk factors were similar in anxious and non-anxious patients. The composite endpoint of stroke, MI and death occurred significantly more often in patients presenting with a preoperative HADS-A score higher than 6 (10.5%, 95% CI, 3-25; p =.020).
    CONCLUSIONS: The present study indicates that preoperative anxiety is associated with the occurrence of intra- and postoperative neurological events in patients undergoing CEA. Patients who had a preoperative HADS-A score of 6 or less had a very low probability of experiencing these complications.
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  • 文章类型: Journal Article
    Atherosclerosis is the main cause of carotid artery stenosis (CAS) which mostly occurs in the elderly. In this paper, the expression level of miR-375-3p in asymptomatic CAS patients and its diagnostic value for asymptomatic CAS were investigated, and the effects of miR-375-3p on the cell proliferation and migration of vascular smooth muscle cells (VSMCs) was further explored.
    98 healthy subjects and 101 asymptomatic CAS patients were participated in this study. qRT-PCR was used to measure the expression level of serum miR-375-3p, and the ROC curve was established to evaluate the predictive value of miR-375-3p for asymptomatic CAS. After transfection with miR-375-3p mimic or inhibitor in vitro, cell proliferation and migration were detected by CCK-8 assay, colony formation assay, and Transwell assay, respectively. The levels of TNF-α, IL-1β, IL-6 were detected by ELISA. Western blot was used to detect the protein expression of XIAP. Finally, luciferase reporter gene assay was applied to assess the interaction of miR-375-3p with target genes.
    The expression level of serum miR-375-3p in asymptomatic CAS patients was significantly higher than that in healthy controls, and the AUC value of ROC curve was 0.888. The sensitivity and specificity were 80.2 and 86.7%, respectively, indicating that miR-375-3p had high diagnostic value for asymptomatic CAS. In vitro cell experiments showed that up-regulation of miR-375-3p significantly promoted the proliferation and migration of VSMCs, and also promoted the generation of inflammatory factors and phenotypic transformation of VSMCs. Luciferase reporter gene assay confirmed that XIAP was a target gene of miR-375-3p and was negatively regulated by miR-375-3p.
    In this study, miR-375-3p may have a clinical diagnostic value for asymptomatic CAS patients which need further validation. Increased miR-375-3p levels in CAS may be associated with increased proliferation and migration of VSMCs via downregulation of the apoptosis inducing gene XIAP.
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  • 文章类型: Journal Article
    BACKGROUND: Asymptomatic carotid artery stenosis (ACS) can be treated with carotid endarterectomy (CEA), carotid artery stenting (CAS), or best medical treatment (BMT) only. For all treatment options, optimization of vascular risk factors such as arterial hypertension, hyperlipidemia, smoking, obesity, and insufficient physical activity is essential. Data on adherence to BMT and lifestyle modification in patients with ACS are sparse. The subject of this investigation is the implementation and quality of risk factor adjustment in the context of a randomized controlled trial.
    METHODS: A total of 513 patients in the prematurely terminated, randomized, controlled, multicenter SPACE-2 trial (ISRCTN 78592017) were analyzed within one year after randomization into 3 groups (CEA, CAS, and BMT only) for implementation of prespecified BMT recommendations and lifestyle modifications. Measurement time points were the screening visit and visits after one month (D30), 6 months (M6), and one year (A1). Differences between groups and follow-up visits (FUVs) relative to the screening visit were investigated.
    RESULTS: For all FUVs, a significant increase in statin medication (91% at A1; p < 0.0001) was demonstrated to be associated with a significant decrease (p < 0.01) in cholesterol levels (median 167 mg/dl at A1) and LDL cholesterol levels (median 93 mg/dl at A1). The lowest cholesterol levels were achieved by patients in the BMT group. Seventy-eight percent of all patients reached predefined target cholesterol levels (< 200 mg/dl), with significantly better rates in the BMT group (p = 0.036 at D30). Furthermore, a significant decrease in arterial blood pressure at all FUVs (p < 0.05) was associated with a significant increase in antihypertensive medication (96% at A1, p < 0.0001). However, only 28% of patients achieved the predefined treatment goal of a systolic blood pressure of ≤ 130 mmHg. Forty-two of a total of 100 smokers at the screening visit quit smoking within one year, resulting in a significant increase in nonsmokers at all FUVs (p < 0.0001). Recommended HbA1c levels (< 7%) were achieved in 82% without significant changes after one year. Only 7% of obese (BMI > 25) patients achieved sufficient weight reduction after one year without significant changes at all FUVs (median BMI 27 at A1; p = 0.1201). The BMT group showed significantly (p = 0.024) higher rates of adequate physical activity than the intervention groups. Furthermore, after one year, the BMT group showed a comparatively significantly better implementation of risk factor modification (77%; p = 0.027) according to the treating physician.
    CONCLUSIONS: SPACE-2 demonstrated sustained improvement in the noninterventional management of vascular risk factors in patients treated in a clinical trial by general practitioners, internists and neurologists. The best implemented treatment targets were a reduction in cholesterol and HbA1c levels. In this context, a significant increase in statin use was demonstrated. Blood pressure control missed its target but was significantly reduced by intensification of antihypertensive medication. Patients on BMT only had better adjusted lipid parameters and were more physically active. However, all groups failed to achieve sufficient weight reduction. Due to insufficient patient recruitment, the results must be interpreted cautiously.
    BACKGROUND: ISRCTN Registry, ISRCTN78592017, Registered 16 June 2007, https://www.isrctn.com/search?q=78592017 .
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