intermediate coronary lesions

  • 文章类型: Journal Article
    光学相干断层扫描(OCT)可以仔细表征冠状动脉斑块形态和管腔尺寸。我们试图评估OCT在预测血流储备分数(FFR)中的价值。
    我们执行了一个多中心,国际,对来自评估同一血管FFR和OCT的已发表研究的个体患者水平数据进行汇总分析.通过专用数据库收集接受相同冠状动脉FFR和OCT的稳定或不稳定患者的数据。预定义的OCT参数为最小管腔面积(MLA),狭窄面积百分比(%AS),和血栓或斑块破裂的存在。主要终点为FFR≤0.80。次要结果是基于阴性FFR(>0.80)的未进行血运重建的患者的主要不良心脏事件的发生率。
    共纳入489例患者的502个冠状动脉病变。在OCT-MLA和FFR值之间观察到显著的相关性(R=0.525;P<.001),以及OCT-%AS和FFR值之间(R=-0.482;P<.001)。在接收机工作特性分析中,MLA<2.0mm2显示出预测FFR≤0.80的良好判别力(AUC,0.80),而%AS>73%显示出中等判别力(AUC,0.73)。当考虑近端冠状动脉段时,预测FFR≤0.80的最佳OCT截止值为MLA<3.1mm2(AUC,0.82),和%AS>61%(AUC,0.84).FFR阴性未进行血运重建的患者,较低的MLA和较高的%AS的组合具有更差的结局趋势(这在局限于近端血管的分析中具有统计学显著性).
    OCT管腔测量(MLA,%AS)可以预测FFR,近端血管需要不同的截止。
    UNASSIGNED: Optical coherence tomography (OCT) allows to carefully characterize coronary plaque morphology and lumen dimensions. We sought to evaluate the value of OCT in predicting fractional flow reserve (FFR).
    UNASSIGNED: We performed a multicenter, international, pooled analysis of individual patient-level data from published studies assessing FFR and OCT on the same vessel. Data from stable or unstable patients who underwent both FFR and OCT of the same coronary artery were collected through a dedicated database. Predefined OCT parameters were minimum lumen area (MLA), percentage area stenosis (%AS), and presence of thrombus or plaque rupture. Primary end point was FFR ≤0.80. Secondary outcome was the incidence of major adverse cardiac events in patients not undergoing revascularization based on negative FFR (>0.80).
    UNASSIGNED: A total of 502 coronary lesions in 489 patients were included. A significant correlation was observed between OCT-MLA and FFR values (R = 0.525; P < .001), and between OCT-%AS and FFR values (R = -0.482; P < .001). In Receiver operating characteristic analysis, MLA <2.0 mm2 showed a good discriminative power to predict an FFR ≤0.80 (AUC, 0.80), whereas %AS >73% showed a moderate discriminative power (AUC, 0.73). When considering proximal coronary segments, the best OCT cutoff values predicting an FFR ≤0.80 were MLA <3.1 mm2 (AUC, 0.82), and %AS >61% (AUC, 0.84). In patients with a negative FFR not revascularized, the combination of lower MLA and higher %AS had a trend toward worse outcome (which was statistically significant in the analysis restricted to proximal vessels).
    UNASSIGNED: OCT lumen measures (MLA, %AS) may predict FFR, and different cutoffs are needed for proximal vessels.
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  • 文章类型: Journal Article
    背景:血流储备分数(FFR)是指导决定是否进行血管造影中间冠状动脉病变(AICL)的冠状动脉血运重建的金标准。光学相干断层扫描(OCT)可以仔细表征冠状动脉斑块形态和管腔尺寸。
    目标:我们寻求开发基于临床,血管造影和OCT变量预测FFR。
    方法:来自多中心的数据,国际,通过专用数据库收集来自评估同一目标AICL上FFR和OCT的已发表研究的个体患者水平数据的汇总分析,以训练(n=351)和验证(n=151)6个两类监督ML模型,采用25个临床模型,血管造影和OCT变量。
    结果:共纳入489例患者的502个冠状动脉病变。六个ML模型的AUC范围为0.71至0.78,而测量的F1评分为0.70至0.75。在检测FFR阳性或阴性的患者时,ML算法显示出中等的敏感性(范围:0.68-0.77)和特异性(范围:0.59-0.69)。在敏感性分析中,使用0.75作为FFR截止值,我们发现更高的AUC(0.78-0.86)和相似的F1评分(范围:0.63-0.76).具体来说,六个ML模型显示出更高的特异性(0.71-0.84),具有类似的灵敏度(0.58-0.80)相对于0.80截止。
    结论:ML算法来自临床,血管造影,OCT参数可以识别FFR阳性或阴性的患者。
    BACKGROUND: Fractional flow reserve (FFR) represents the gold standard in guiding the decision to proceed or not with coronary revascularization of angiographically intermediate coronary lesion (AICL). Optical coherence tomography (OCT) allows to carefully characterize coronary plaque morphology and lumen dimensions.
    OBJECTIVE: We sought to develop machine learning (ML) models based on clinical, angiographic and OCT variables for predicting FFR.
    METHODS: Data from a multicenter, international, pooled analysis of individual patient\'s level data from published studies assessing FFR and OCT on the same target AICL were collected through a dedicated database to train (n = 351) and validate (n = 151) six two-class supervised ML models employing 25 clinical, angiographic and OCT variables.
    RESULTS: A total of 502 coronary lesions in 489 patients were included. The AUC of the six ML models ranged from 0.71 to 0.78, whereas the measured F1 score was from 0.70 to 0.75. The ML algorithms showed moderate sensitivity (range: 0.68-0.77) and specificity (range: 0.59-0.69) in detecting patients with a positive or negative FFR. In the sensitivity analysis, using 0.75 as FFR cut-off, we found a higher AUC (0.78-0.86) and a similar F1 score (range: 0.63-0.76). Specifically, the six ML models showed a higher specificity (0.71-0.84), with a similar sensitivity (0.58-0.80) with respect to 0.80 cut-off.
    CONCLUSIONS: ML algorithms derived from clinical, angiographic, and OCT parameters can identify patients with a positive or negative FFR.
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  • 文章类型: Journal Article
    目的:评价参术冠心颗粒的临床疗效和安全性(,SGR)在治疗中度冠状动脉病变(ICL)患者中,并通过转录组测序方法研究潜在的机制。
    方法:采用ICL气虚痰瘀证患者,按随机数字发生器1:1随机比例随机分为病例组和对照组,评价临床疗效。
    结果:两组干预前后冠状动脉CT造影相关指标比较差异无统计学意义。通过基因芯片表达分析,最后得出结论,与SGR组和安慰剂组相比,有355个差异mRNA(190个上调基因和165个下调基因)。通过差异表达基因的蛋白质-蛋白质相互作用网络分析,最终获得10个hub基因:CACNA2D2、CACNA2D3、DNAJC6、FGF12、SGSM2、CACNA1G、LRP6,KIF25,OXTR,UPB1。
    结论:SGR联合西药治疗气虚痰瘀型ICL患者是安全的。提出了可能的作用机制及相关基因位点和通路。
    OBJECTIVE: To evaluate the clinical efficacy and safety of Shenzhu Guanxin recipe granules (, SGR) in treating patients with intermediate coronary lesions (ICL), and to investigate the potential mechanism though a transcriptome sequencing approach.
    METHODS: ICL patients with Qi deficiency and phlegm stasis were adopted and randomly assigned to a case group or a control by random number generator in a 1:1 randomization ratio to evaluate the clinical efficacy.
    RESULTS: There was no significant difference between the two groups in coronary computed tomography angiography related indexes in the two groups before and after intervention. Through the gene chip expression analysis, it is finally concluded that there are 355 differential mRNAs (190 up-regulated genes and 165 down regulated genes) when compared the SGR group and placebo group. Through protein-protein interaction network analysis of differentially expressed genes, 10 hub genes were finally obtained: CACNA2D2, CACNA2D3, DNAJC6, FGF12, SGSM2, CACNA1G, LRP6, KIF25, OXTR, UPB1.
    CONCLUSIONS: SGR combined with Western Medicine can be safely used to treat ICL patients with Qi deficiency and phlegm stasis. The possible mechanism of action and relevant gene loci and pathway were proposed.
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  • 文章类型: Journal Article
    指南建议使用充血(FFR)和非充血(iFR/RFR)方法评估冠状动脉疾病患者的冠状动脉狭窄。然而,在某些情况下,所获得的表明显著缺血的结果可能在这些方法之间有所不同。因此,我们试图找出这种差异的预测因素。收集了2020年至2021年间住院的所有连续慢性冠状动脉综合征患者的数据。对于279名患者(417条血管),FFR和iFR/RFR的结果均可用.FFR值≤0.80和iFR/RFR值≤0.89被认为是缺血阳性。在80例(19.2%)患者中观察到FFR和iFR/RFR测量不一致。心房颤动是总FFR和iFR/RFR不一致的唯一预测因子-OR(95CI)1.90(1.02-3.51);p=0.040。FFR阳性和iFR/RFR阴性的机会随着年龄的增加而独立降低-OR(95CI)0.96(0.93-0.99);p=0.024。相反,胰岛素治疗的糖尿病是FFR阴性和iFR/RFR阳性差异的预测因子-OR(95CI)4.61(1.38-15.40);p=0.013.在日常临床实践中,iFR/FFR与FFR良好相关。然而,这些方法之间的不一致是很常见的。医生应该意识到房颤患者出现这种不一致的风险,高龄,和胰岛素治疗的糖尿病。
    Guidelines recommend using hyperemic (FFR) and non-hyperemic (iFR/RFR) methods of evaluating coronary artery stenoses in patients with coronary artery disease. However, in some cases, achieved results indicating significant ischemia may differ between those methods. Thus, we sought to identify predictors of such a discrepancy. Data were collected on all consecutive patients with chronic coronary syndrome hospitalized between 2020 and 2021. For 279 patients (417 vessels), results for both FFR and iFR/RFR were available. Values of ≤0.80 for FFR and ≤0.89 for iFR/RFR were considered positive for ischemia. Discordant measurements of FFR and iFR/RFR were observed in 80 (19.2%) patients. Atrial fibrillation was the only predictor of the overall FFR and iFR/RFR discordance - OR (95%CI) 1.90 (1.02-3.51); p = 0.040. The chance of positive FFR and negative iFR/RFR decreased independently with age - OR (95%CI) 0.96 (0.93-0.99); p = 0.024. On the contrary, insulin-treated diabetes mellitus was the predictor of negative FFR and positive iFR/RFR discrepancy - OR (95%CI) 4.61 (1.38-15.40); p = 0.013. In everyday clinical practice, iFR/FFR correlates well with FFR. However, discordance between these methods is quite common. Physicians should be aware of the risk of such discordance in patients with atrial fibrillation, advanced age, and insulin-treated diabetes mellitus.
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  • 文章类型: Journal Article
    冠状动脉中度病变患者的最佳治疗策略,定义为50-70%的直径狭窄,对于心脏病学家来说仍然是一个巨大的挑战。识别预测主要不良心血管事件(MACE)风险的潜在生物标志物可能有助于风险分层和临床决策。
    本研究共纳入1,187例中度冠状动脉病变和可用N末端脑钠肽前体(NT-proBNP)水平的患者。获得基线NT-proBNP水平。主要终点定义为MACE,全因死亡和非致死性心肌梗死的复合终点.采用多因素Cox回归模型探讨NT-proBNP水平与MACE风险的关系。
    研究队列的平均年龄为59.2岁。在6.1年的中位随访期间,共有68例患者出现MACE。限制性三次样条分析描绘了基线NT-proBNP水平与MACE风险之间的线性关系。单变量和多变量分析均表明,NT-proBNP水平升高与MACE风险增加相关[每加倍调整风险比(HR):1.412,95%置信区间(CI):1.022-1.952,p=0.0365]。根据年龄,这种关联在有临床意义的亚组中保持一致,性别,体重指数(BMI),和糖尿病。
    在中度冠状动脉病变患者中,NT-proBNP水平升高与MACE风险增加相关,可作为危险分层和治疗决策指导的潜在生物标志物。
    UNASSIGNED: The optimal treatment strategy for patients with coronary intermediate lesions, defined as diameter stenosis of 50-70%, remains a great challenge for cardiologists. Identification of potential biomarkers predictive of major adverse cardiovascular events (MACEs) risk may assist in risk stratification and clinical decision.
    UNASSIGNED: A total of 1,187 patients with intermediate coronary lesions and available N-terminal pro-brain natriuretic peptide (NT-proBNP) levels were enrolled in the current study. A baseline NT-proBNP level was obtained. The primary endpoint was defined as MACEs, the composite endpoint of all-cause death and non-fatal myocardial infarction. A multivariate Cox regression model was used to explore the association between NT-proBNP level and MACE risk.
    UNASSIGNED: The mean age of the study cohort was 59.2 years. A total of 68 patients experienced MACE during a median follow-up of 6.1 years. Restricted cubic spline analysis delineated a linear relationship between the baseline NT-proBNP level and MACE risk. Both univariate and multivariate analyses demonstrated that an increased NT-proBNP level was associated with an increased risk of MACE [adjusted hazard ratio (HR) per doubling: 1.412, 95% confidence interval (CI): 1.022-1.952, p = 0.0365]. This association remains consistent in clinical meaningful subgroups according to age, sex, body mass index (BMI), and diabetes.
    UNASSIGNED: An increased NT-proBNP level is associated with an increased risk of MACE in patients with intermediate coronary lesions and may serve as the potential biomarker for risk stratification and treatment decision guidance.
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  • 文章类型: Journal Article
    UNASSIGNED: To analyze the gene expression profile of peripheral blood monocytes in different stages of coronary artery disease (CAD) by transcriptome sequencing, and to explore potential genes and pathway involved in CAD pathogenesis.
    UNASSIGNED: According to the screening of coronary angiography and quality control of blood samples, eight intermediate coronary lesion patients were selected, then eight patients with acute myocardial infarction, and eight patients with normal coronary angiography were matched by age and gender. Transcriptomics sequencing was conducted for the peripheral blood monocytes of these 24 samples by using the Illumina HiSeq high-throughput platform. Then, differentially expressed genes (DEGs) were analyzed. Gene Ontology (GO) functional annotation, Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway annotation, and protein-protein interaction (PPI) network were applied to annotate the potential functions of DEGs.
    UNASSIGNED: Compared with the normal coronary angiography group, we identified a total of 169 DEGs in the intermediate coronary lesion group, which were significantly enriched in 59 GO terms and 17 KEGG pathways. Compared with the normal coronary angiography group, we found a total of 2,028 DEGs, which were significantly enriched in 311 GO terms and 20 KEGG pathways in the acute myocardial infarction group. The cross-comparison between normal versus intermediate coronary lesion group, and normal versus acute myocardial infarction group included 98 differential genes with 65 up regulated and 33 down regulated genes, which were significantly enriched in 46 GO terms and 10 KEGG pathways. During the progression of CAD, there was a significant up-regulated expression of CSF3, IL-1A, CCR7, and IL-18, and down-regulated expression of MAPK14. Besides GO items such as inflammatory response was significantly enriched, KEGG analysis showed the most remarkable enrichments in IL-17 signaling pathway and cytokine-cytokine receptor interactions.
    UNASSIGNED: Transcriptomics profiles vary in patients with different severity of CAD. CSF3, IL-1A, CCR7, IL-18, and MAPK14, as well as IL-17 signaling pathway and cytokine and cytokine receptor interaction signaling pathway related with inflammatory response might be the potential biomarker and targets for the treatment of coronary artery disease.
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  • 文章类型: Journal Article
    Fractional flow reserve (FFR) is a proven technology for guiding percutaneous coronary intervention, but it is not reimbursed despite the fact that it frequently allows to defer revascularization. Our goal was to determine the economic benefit of FFR on intermediate lesions, as well as the clinical endpoints at 1 year follow up.
    Observational prospective study that included consecutive patients with intermediate lesions evaluated with FFR between April 2013 and March 2016. For the economic analysis we evaluated the specific resources used during the procedure. Clinical endpoints including cardiovascular death, target lesion revascularization and acute myocardial infarction, were followed up over a one-year period.
    FFR was performed on 222 lesions in 151 consecutive patients. FFR was positive in 26.1% of the assessed lesions. The estimated total cost using FFR was US$ 891,290.08 while cost estimate without FFR was US$ 1,557,352, meaning 43% in cost savings. There was one cardiovascular death and two readmissions during follow up in the positive FFR group.
    FFR guided revascularization on intermediate coronary lesions resulted in an economic benefit by reducing overall costs without harming clinical outcomes.
    La reserva de flujo fraccional (FFR) es una herramienta con evidencia demostrada para guiar las angioplastias coronarias. El reembolso por los sistemas de cobertura de salud es parcial o nulo a pesar de frecuentemente diferir la angioplastia. Nuestro objetivo fue determinar el beneficio económico de la utilización del FFR en la evaluación de lesiones intermedias, y evaluar asimismo puntos finales clínicos en el seguimiento a un año.
    Estudio observacional prospectivo que incluyó una cohorte de pacientes consecutivos con lesiones coronarias intermedias, evaluadas con FFR, entre abril de 2013 y marzo de 2016. Para el análisis económico se evaluaron los recursos específicos utilizados para la realización del procedimiento. Se analizaron puntos finales clínicos (muerte cardiovascular, revascularización de la arteria objetivo e infarto agudo de miocardio) durante la internación y en el seguimiento a un año.
    Se incluyeron 222 lesiones en 151 pacientes consecutivos. Se registró FFR positivo en el 26.1% de las lesiones evaluadas. Se estimó que sin la utilización de FFR, 126 pacientes hubieran sido tratados con angioplastia transluminal coronaria y 25 con cirugía de revascularización miocárdica. El costo estimado con la utilización de FFR fue US$ 891,290.08, mientras que sin el mismo hubiera sido de US$ 1,557,352. Esto implicó un ahorro del 43% de los gastos. Se observaron una muerte de origen cardiovascular y dos reinternaciones en el grupo FFR positivo en el seguimiento a un año.
    La revascularización de lesiones intermedias guiada por FFR resultó en un beneficio económico al reducir los costos generales sin resultar clínicamente perjudicial.
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  • 文章类型: Clinical Trial Protocol
    BACKGROUND: Coronary artery disease (CAD) is one of the most common types of the cardiovascular disease. Previous pilot trials have suggested that Traditional Chinese Medicine (TCM) has brought clinical benefits for patients with CAD. We will conduct this trial to determine the efficacy and safety of Shenzhu Guanxin Recipe Granules (SGR) for the treatment of patients with CAD.
    METHODS: This randomized controlled trial recruited 190 patients who were diagnosed with CAD by clinical manifestation and examination and in which coronary computed tomography angiography (CCTA) showed 50-70% stenosis, with soft or mixed plaque types. The included participants were randomly assigned to the case group and control group using a 1:1 allocation ratio; patients in the case group received SGR and usual care, and those in the control group received placebo (6 g/day for 6 months) and usual care. The endpoint of the study included Calcium Coverage Score (CCS), C-reactive protein (CRP) level, and the levels of blood lipids, tumor necrosis factor-α (TNF-α), interleukin-1 (IL-1), interleukin-6 (IL-6), and ATP-binding membrane cassette transporter A1 (ABCA1) were calculated before recruiting and at the sixth month. The indicators were Seattle Angina Questionnaire (SAQ) and TCM Syndrome Questionnaire scores at 0, 3, and 6 months.
    CONCLUSIONS: This clinical trial may provide reliable evidence regarding the clinical effectiveness and safety of SGR therapy for patients with CAD diagnosed by clinical manifestation and examination, in which CCTA showed 50-70% stenosis, with soft or mixed plaque types.
    BACKGROUND: ClinicalTrials.gov, ID: ChiCTR1900020501 . The trial was registered on 25 December 2018.
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  • 文章类型: Journal Article
    OBJECTIVE: To establish whether frequency-domain optical coherence tomography (FD-OCT) is safe and effective in the evaluation and treatment of angiographically-intermediate coronary lesions (ICL).
    METHODS: Sixty-four patients with 2-dimensional quantitative coronary angiography (2D-QCA) demonstrating ICL were included. OCT imaging was performed. According to predetermined OCT criteria, patients were assigned to either of 2 groups: OCT-guided percutaneous coronary intervention (PCI) or OCT-guided optimal medical therapy (OMT). The primary efficacy endpoint was to demonstrate the superiority and higher accuracy of FD-OCT compared to 2D-QCA in evaluating stenosis severity in patients with ICL. The primary safety endpoint was the incidence of 30-d major adverse cardiac events (MACE). Secondary endpoints included MACE at 12 mo and other clinical events.
    RESULTS: Analysis of the primary efficacy endpoint demonstrates that 2D-QCA overestimates the stenosis severity of ICL in both the OCT-guided PCI and OMT groups, proving FD-OCT to be superior to and more precise than 2D-QCA in treating this subset of lesions. The primary safety endpoint was fully met with the incidence of 30-d MACE being nil in both the OCT-guided PCI and OCT-guided OMT groups. Incidences of secondary endpoints were found to be low in both arms, the only exception being the relatively high incidence of recurrent episodes of angina which was, however, very similar in the 2 groups.
    CONCLUSIONS: FD-OCT is safe and effective in the evaluation and treatment of ICL. Larger studies are needed to firmly establish the efficacy and safety of FD-OCT in treating ICL across all coronary artery disease population subgroups.
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  • 文章类型: Journal Article
    The decision-making process of patients with angiographically-intermediate coronary lesions (ICL) is clinically challenging and may benefit from adjunctive invasive techniques. Fractional-flow-reserve (FFR) represents the gold standard to evaluate ICL but frequency-domain optical-coherence-tomography (OCT) is a novel, promising, high resolution coronary imaging technique, which allows physiopathologic assessment of coronary plaque. We investigated the possible relation between OCT and FFR in selected ICL patients.
    Stable or unstable patients with ICL who underwent both FFR and OCT assessment at two large tertiary centers were retrospectively enrolled. FFR was performed according to standard methodology. OCT images were (on blind to clinical and FFR results) analyzed to assess minimal lumen area (MLA), percentage area stenosis (AS), thrombus and plaque ulceration.
    Forty patients were identified (62±10years, 93% symptomatic, 35% acute presentation, 93% left-anterior-descending artery ICL). Percentage diameter stenosis at quantitative coronary angiography was 40±12% and FFR was 0.85±0.07. MLA (p=0.009), AS (p<0.001) and plaque ulceration (p=0.02) were significantly associated with FFR values. An integrated assessment of AS (≥ or <70%), MLA (≥ or <2.5mm2) and presence or absence of thrombus and plaque ulceration was found to have the potential to accurately (sensitivity 91%, specificity 93%) predict FFR results.
    In patients with ICL, a combination of different OCT parameters may help predict FFR results. These findings suggest that only a comprehensive assessment of lesion features by OCT can allow an accurate prediction of lesion severity assessed by FFR.
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