Peripheral Arterial Revascularization Research Articles

Educational attainment and cardiovascular outcomes in prostate cancer: observations from 3700 men in 6 countries in the RADICAL PC study

Abstract Background Educational attainment has been associated with improved cardiovascular outcomes in individuals with or at high risk for cardiovascular disease (CVD). There is little information on the relationship between education and CVD outcomes in individuals with cancer. Also, we have limited understanding of what mediates the relationship between education and these outcomes. Purpose To evaluate the relationship between educational attainment in patients with PC and CVD event (CVE) or all-cause mortality. Methods We prospectively studied 3,778 men with PC from 55 sites in 7 countries (median age 69 years), 46% on ADT. Inclusion criteria were one of: PC diagnosed in the past 12 months; started ADT within the past 6 months; or plan to start ADT in the next month. Educational attainment was classified as those who attained primary school education vs. those who attained high school education vs. those who attained greater than high school education. Participants were followed for a median of 2.5 years from enrolment to document CVE: myocardial infarction, angina, stroke, cerebrovascular disease, peripheral arterial disease, arterial revascularization, heart failure, venous thromboembolism, and atrial fibrillation. The primary outcome for this analysis was CVE or death. All outcomes were evaluated by Cox proportional hazards models adjusted sequentially for age, race, physical activity levels, tobacco use, and alcohol use. Results Among 3,778 participants, 726 (19%) achieved primary school education, 1,001 (27%) high school, and 2,051 (54%) greater than high school education. On univariate analysis, as compared with participants with greater than high school education, those with high school education and primary school education had respective HR (95% CI) of 1.33 (1.05-1.69) and 2.19 (1.71-2.83). Adding age, race, tobacco, and alcohol use to the Cox model progressively attenuated the association between education and the primary outcome. Eventually, after adjustment for these characteristics and physical activity levels, the relationship between education and the primary outcome was no longer significant (Table). Conclusion This finding suggests that patterns of tobacco and alcohol use and physical activity, which are modifiable behaviors, account for the relationship between education and death or CVE in patients with prostate cancer.Table

Mammographic breast density and cardiovascular disease in women. A literature review

The world is searching for new simple and economically available gender-specific markers to improve cardiovascular risk stratification in women. The aim of this review was to analyze the association of mammographic density (MD) with cardiovascular disease (CVD). In low MD, i.e., high relative mammary gland fat content, there is a higher incidence of the main risk factors for CVD: hypertension, hyperlipidemia, hyperglycemia, excess body weight, as well as an increase in the volume of fat depots, visceral and ectopic fat. Low MD is associated with a higher 10-year risk of adverse cardiovascular events such as coronary artery disease, stroke, peripheral arterial disease, revascularization, and heart failure, and may serve as a predictor of their development. Including MD in the Framingham Risk Score model improves its accuracy. Identification of low MD, as a marker of high cardiovascular risk, allows the use of mammography for early detection and prevention of the two most dangerous diseases among the female population — breast cancer and CVD.

In-silico trial emulation to predict the cardiovascular protection of new lipid-lowering drugs: an illustration through the design of the SIRIUS programme.

Inclisiran, an siRNA targeting hepatic PCSK9 mRNA, administered twice-yearly (after initial and 3-month doses), substantially and sustainably reduced LDL-cholesterol (LDL-C) in Phase III trials. Whether lowering LDL-C with inclisiran translates into a reduced risk of major adverse cardiovascular events (MACE) is not yet established. In-silico trials applying a disease computational model to virtual patients receiving new treatments allow to emulate large scale long-term clinical trials. The SIRIUS in-silico trial programme aims to predict the efficacy of inclisiran on CV events in individuals with established atherosclerotic cardiovascular disease (ASCVD). A knowledge-based mechanistic model of ASCVD was built, calibrated, and validated to conduct the SIRIUS programme (NCT05974345) aiming to predict the effect of inclisiran on CV outcomes. The SIRIUS Virtual Population included patients with established ASCVD (previous myocardial infarction (MI), previous ischemic stroke (IS), previous symptomatic lower limb peripheral arterial disease (PAD) defined as either intermittent claudication with ankle-brachial index <0.85, prior peripheral arterial revascularization procedure, or vascular amputation) and fasting LDL-C ≥ 70 mg/dL, despite stable (≥4 weeks) well-tolerated lipid-lowering therapies.SIRIUS is an in-silico multi-arm trial programme. It follows an idealized crossover design where each virtual patient is its own control, comparing inclisiran to (i) placebo as adjunct to high-intensity statin therapy with or without ezetimibe, (ii) ezetimibe as adjunct to high-intensity statin therapy, (iii) evolocumab as adjunct to high-intensity statin therapy and ezetimibe.The co-primary efficacy outcomes are based on the time to the first occurrence of any component of 3P-MACE (composite of CV death, nonfatal MI, or nonfatal IS) and time to occurrence of CV death over 5 years. The SIRIUS in-silico trial programme will provide early insights regarding potential effect of inclisiran on MACE in ASCVD patients, several years before the availability of the results from ongoing CV outcomes trials (ORION-4 and VICTORION-2-P). Clinicaltrials.gov identifier: NCT05974345.

Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial.

INCORPORATE trial was designed to evaluate whether default coronary-angiography (CA) and ischemia-targeted revascularization is superior compared to a conservative approach for patients with treated critical limb ischemia (CLI). Registered at clinicaltrials.gov (NCT03712644) on October 19, 2018. Severe peripheral artery disease is associated with increased cardiovascular risk and poor outcomes. INCORPORATE was an open-label, prospective 1:1 randomized multicentric trial that recruited patients who had undergone successful CLI treatment. Patients were randomized to either a conservative or invasive approach regarding potential coronary artery disease (CAD). The conservative group received optimal medical therapy alone, while the invasive group had routine CA and fractional flow reserve-guided revascularization. The primary endpoint was myocardial infarction (MI) and 12-month mortality. Due to COVID-19 pandemic burdens, recruitment was halted prematurely. One hundred eighty-five patients were enrolled. Baseline cardiac symptoms were scarce with 92% being asymptomatic. Eighty-nine patients were randomized to the invasive approach of whom 73 underwent CA. Thirty-four percent had functional single-vessel disease, 26% had functional multi-vessel disease, and 90% achieved complete revascularization. Conservative and invasive groups had similar incidences of death and MI at 1year (11% vs 10%; hazard ratio 1.21 [0.49-2.98]). Major adverse cardiac and cerebrovascular events (MACCE) trended for hazard in the Conservative group (20 vs 10%; hazard ratio 1.94 [0.90-4.19]). In the per-protocol analysis, the primary endpoint remained insignificantly different (11% vs 7%; hazard ratio 2.01 [0.72-5.57]), but the conservative approach had a higher MACCE risk (20% vs 7%; hazard ratio 2.88 [1.24-6.68]). This trial found no significant difference in the primary endpoint but observed a trend of higher MACCE in the conservative arm.

Machine learning model for cardiovascular disease prediction in patients with chronic kidney disease.

Cardiovascular disease (CVD) is the leading cause of death in patients with chronic kidney disease (CKD). This study aimed to develop CVD risk prediction models using machine learning to support clinical decision making and improve patient prognosis. Electronic medical records from patients with CKD at a single center from 2015 to 2020 were used to develop machine learning models for the prediction of CVD. Least absolute shrinkage and selection operator (LASSO) regression was used to select important features predicting the risk of developing CVD. Seven machine learning classification algorithms were used to build models, which were evaluated by receiver operating characteristic curves, accuracy, sensitivity, specificity, and F1-score, and Shapley Additive explanations was used to interpret the model results. CVD was defined as composite cardiovascular events including coronary heart disease (coronary artery disease, myocardial infarction, angina pectoris, and coronary artery revascularization), cerebrovascular disease (hemorrhagic stroke and ischemic stroke), deaths from all causes (cardiovascular deaths, non-cardiovascular deaths, unknown cause of death), congestive heart failure, and peripheral artery disease (aortic aneurysm, aortic or other peripheral arterial revascularization). A cardiovascular event was a composite outcome of multiple cardiovascular events, as determined by reviewing medical records. This study included 8,894 patients with CKD, with a composite CVD event incidence of 25.9%; a total of 2,304 patients reached this outcome. LASSO regression identified eight important features for predicting the risk of CKD developing into CVD: age, history of hypertension, sex, antiplatelet drugs, high-density lipoprotein, sodium ions, 24-h urinary protein, and estimated glomerular filtration rate. The model developed using Extreme Gradient Boosting in the test set had an area under the curve of 0.89, outperforming the other models, indicating that it had the best CVD predictive performance. This study established a CVD risk prediction model for patients with CKD, based on routine clinical diagnostic and treatment data, with good predictive accuracy. This model is expected to provide a scientific basis for the management and treatment of patients with CKD.

Patency and Survival in Patients Undergoing Revascularization for Peripheral Arterial Disease

Aim: Peripheral arterial disease is a progressive, and chronic disease caused by atherosclerosis, and characterized by narrowing, or occlusion of the arterial structures of the lower extremities, which can lead to high morbidity and mortality. The aim of this study is to investigate the short and medium-term patency, and survival outcomes of different peripheral arterial revascularization techniques. Material and Methods: Patients undergoing revascularization for lower extremity arterial disease between January 2015 and August 2019 were retrospectively analyzed. Patients were divided into three groups according to the type of revascularization: endovascular, surgical, or hybrid. Major amputation, occlusion, and death were the primary endpoints. Expected primary patency and overall survival rates were estimated using Kaplan-Meier analyses. Results: The study included 285 patients and 338 revascularization procedures. There was no difference in primary outcome between treatment groups (p=0.080). Improvement in Rutherford category was observed in 57.1% of patients after revascularization. There was no difference between the groups in terms of change in Rutherford category (p=0.230). Expected primary patency rates were significantly lower in patients with chronic limb-threatening ischemia, and in patients with chronic renal failure (respectively; p

Access Site Complication Rates Following Peripheral Artery Revascularization in patients With End-Stage Renal Disease: A Comparison of Vascular Closure Devices and Manual Compression.

Manual compression (MC) or vascular closure devices (VCDs) are used to achieve hemostasis after percutaneous transluminal angioplasty (PTA). However, limited data on the comparative safety and effectiveness of VCDs vs MC in patients with end-stage renal disease (ESRD) undergoing PTA are available. Accordingly, this study compared the safety and effectiveness of VCD and MC in patients with ESRD undergoing PTA. This single-center retrospective cohort study included the data of patients with ESRD undergoing peripheral intervention at Chang Gung Memorial Hospital, Taiwan, from January 1, 2019, to June 30, 2022. The patients were divided into VCD and MC groups. The primary endpoint was a composite of puncture site complications, including acute limb ischemia, marked hematoma, pseudoaneurysm, and puncture site bleeding requiring blood transfusion. We included 264 patients with ESRD undergoing PTA, of whom 60 received a VCD and 204 received MC. The incidence of puncture site complications was 3.3% in the VCD group and 4.4% in the MC group (hazard ratio: .75; 95% confidence interval: .16-3.56L P = 1.000), indicating no significant between-group difference. VCDs and MC had comparable safety and effectiveness for hemostasis in patients with ESRD undergoing peripheral intervention.

АНТИНОЦИЦЕПТИВНОЕ И РЕПАРАТИВНОЕ ДЕЙСТВИЕ МЕЗЕНХИМАЛЬНЫХ СТВОЛОВЫХ КЛЕТОК ЖИРОВОЙ ТКАНИ ПРИ ЭКСПЕРИМЕНТАЛЬНОЙ ИШЕМИИ КОНЕЧНОСТИ

Background. Transplantation of adipose-derived mesenchymal stem cells (ADMSCs) appears to be a promising method for relieving pain in peripheral arterial diseases and revascularization of an ischemic limb. Objective. To study the effect of various modes of local administration of ADMSCs on nociceptive reactions, gait parameters, and soft tissue histostructure of the ischemic limb in rats. Material and methods. Experimental limb ischemia was induced in Wistar rats by transection of the common femoral artery with preliminary bilateral ligation. On the 7th day of the experiment, allogeneic ADMSCs were transplanted to the corresponding groups of animals in the amount of 1×106 cells/kg (single and double administration). An assessment of nociceptive reactions to a mechanical stimulus, gait parameters, as well as the histostructure of the soft tissues in the rat hind limb with ischemia was carried out. Results. Transplantation of ADMSCs at a dose of 1×106 cells/kg into the area of the hind limb ischemia, regardless of the multiplicity, weakened mechanical hyperalgesia, produced a protective effect on the myelin sheaths of nerve fibers, and contributed to the restoration of gait parameters. A single transplantation of ADMSCs proved to be more effective in terms of anti-inflammatory and anti-ischemic effects on the tissues of the ipsilateral limb. Conclusions. Local allogeneic transplantation of ADMSCs effectively attenuated mechanical hyperalgesia and gait disturbances caused by arterial transection, and prevented thinning of the myelin sheath of nerves in the area of vessel damage.

The association of lipoprotein(a) with patient characteristics and mortality in a primary prevention cohort: data from our clinic database

Abstract Background Lipoprotein(a) [Lp(a)] has emerged as a causal risk factor for development of cardiovascular (CVD) and valvular heart disease. However, not much is known about the gender differences and Lp(a). The aim of our study was to investigate gender differences in clinical and laboratory characteristics of primary prevention patients with elevated Lp(a) and to study the associations between Lp(a) and all-cause mortality by gender. Method We analyzed data obtained from the Preventive Cardiology Information System (PreCis), a database of clinical and laboratory information on 8,136 consecutive primary prevention patients seen at our clinic preventive cardiology clinic from 1999-2018. Primary prevention was defined as having no history of coronary artery disease (CAD), coronary and peripheral arterial revascularization, nor atherosclerosis. Data regarding mortality were gathered from a combination of sources including the Social Security Death Index (SSDI), the Ohio State Department of Health Vital Statistics, and electronic medical record. All-cause mortality was assessed using time to event analyses, and adjusted Cox proportional hazards models. All statistical analyses were conducted using SAS version 9.4. Result In the overall cohort (n=8,136), 57% were female at a median age of 54 years and 43% were male at a median age of 52 years. Median Lp(a) was 24 (IQR 8-63) mg/dL in females and 18.6 (IQR 7-51) mg/dL in males. The proportion of females increased with increasing Lp(a) values from 54% with Lp(a) &amp;lt;30 mg/dL to 69% with Lp(a) ≥90mg/dL. Female patients with Lp(a) ≥50 mg/dL were significantly more likely to have dyslipidemia (40.5% vs 34.1%; p&amp;gt;0.001) and hypertension (27.3% vs 23.3%; p&amp;gt;0.001) compared to &amp;lt;50 mg/dL. There was a trend toward increased all-cause mortality in elevated Lp(a) group among female patients (&amp;lt;50 mg/dL vs ≥50 mg/dL; (HR (95%CI): 1.22 (0.98-1.52); p=0.083). Conclusion In this primary prevention population, a higher proportion of females had elevated Lp(a) than males. Females with elevated Lp(a) presented with more comorbidities and a trend towards increased all-cause mortality. These findings suggest a gender difference in the distribution of Lp(a) and all-cause mortality in the primary prevention setting, which warrants further investigation.

Influence of Lp(a) and systemic inflammation on all-cause mortality in a primary prevention population: data from our clinic database

Abstract Background Epidemiological, pathophysiological, and genetic studies have established Lp(a) as a causal risk factor for development of cardiovascular (CVD) and valvular heart disease. However, there is controversy about how inflammation can modulate Lp(a) risk and major adverse cardiovascular events. We aim to investigate the influence of elevated Lp(a) and systemic inflammation on all-cause mortality in a primary prevention setting. Method We analyzed data obtained from the Preventive Cardiology Information System (PreCis), a database of clinical and laboratory information on 8,136 primary prevention patients seen at our clinic preventive cardiology clinic between 1st Jan 1999-12th Dec 2018. Primary prevention was defined as having no history of coronary artery disease (CAD), coronary and peripheral arterial revascularization, nor atherosclerosis. Lp(a) ≥50 mg/dL was considered as clinically elevated. The association between Lp(a) and the demographic and clinical variables of interest was examined using the student’s t-test or Chi-squared test. All-cause mortality was assessed using Kaplan-Meier estimates, and adjusted Cox proportional hazards models. All statistical analyses were conducted using SAS version 9.4. Result In the overall primary prevention population (n=8,136), the median age was 54 years, with 56.9% women and 84.8% being Caucasian. In this cohort, 21% had hypertension, and 5.5% had diabetes. The median Lp(a) was 21 mg/dL (interquartile interval 7-57 mg/dL). Lp(a) was ≥50 mg/dL in 29% of the population. Of those with elevated Lp(a) (n=2,368), 1,751 (73.9%) patients had hsCRP drawn. In this group, 782 patients (44.7%) had hsCRP &amp;lt;2 mg/L and 969 (55.3%) had hsCRP ≥2 mg/L. The all-cause mortality rate in individuals with elevated Lp(a) and hsCRP ≥2mg/L was 9.2% compared to 4.2% in those with elevated Lp(a) and hsCRP &amp;lt;2mg/L. In a multivariable Cox proportional hazard regression model adjusted for age and gender, in patients with elevated Lp(a), hsCRP ≥2 mg/L was significantly associated with all-cause mortality (HR 2.35, 95% CI (1.57-3.53), p&amp;gt;0.001) (Figure 1). Conclusion In a primary prevention population without established atherosclerosis, elevated Lp(a), increased systemic inflammation was associated with increased all-cause mortality. This finding supports the need for risk classification and targeted primary prevention management of higher risk patients with elevated Lp(a).

Androgen deprivation therapy for prostate cancer, measures of adiposity and strength, and adverse cardiovascular outcomes: observations from 3000 men in 5 countries in the RADICAL PC study

Abstract Background Androgen deprivation therapy (ADT) is prescribed to nearly half of patients with prostate cancer (PC). ADT is associated with weight gain, reduced muscle strength and increased cardiovascular (CV) risk. However, no PC study has examined the relationship between these physical characteristics, their change with ADT and cardiovascular outcomes. Purpose In men with PC: To compare 1-year changes in physical measures in those receiving versus not receiving ADT To evaluate the relationship between physical measures and adverse CV outcomes Methods We prospectively studied 3080 men with PC from 37 sites in 5 countries (mean age 68 years), 41% on ADT. Inclusion criteria were one of: PC diagnosed in the past 12 months; started ADT within the past 6 months; or plan to start ADT in the next month. Weight, waist and hip circumference, handgrip strength and get-up-and-go time were recorded at baseline and 1 year. Change in measurements were adjusted for age, education, race, tobacco and alcohol use, baseline cardiovascular disease and renal function. Participants were followed for a median 3 years from enrolment to document adverse CV outcomes associated with adiposity: myocardial infarction, angina, stroke, cerebrovascular disease, peripheral arterial disease, arterial revascularization, heart failure, venous thromboembolism and atrial fibrillation. The relationship between baseline physical measures and outcomes was evaluated by Cox proportional hazards models adjusted for age, diabetes, hypertension, total cholesterol, tobacco use and physical activity levels. Results Changes in physical measures are displayed in Table. ADT recipients gained 5x more weight than non-recipients. Weight gain was distributed evenly between waist and hips, resulting in no difference in waist:hip ratio. Muscle strength decreased in both groups but with 43% larger decrease among ADT recipients. The ratio of strength to body weight fell twice as much in ADT recipients as non-recipients. Gait speed slowed by 13% after 12 months’ ADT. We observed 144 adverse CV events. There was a continuous relationship between handgrip strength and CV events. Each quartile reduction in strength was associated with adjusted hazard ratio (95% CI) 1.24 (1.01-1.52). There was no detectable association between other physical measures and CV events. Conclusion ADT use is associated with increased adiposity and reduced muscle strength. Low muscle strength, reflected by low handgrip strength is a better predictor of adverse CV outcomes than increased adiposity. These findings may explain help the association between ADT use and adverse CV outcomes.Table

Abstract 12428: Small Apolipoprotein(a) Isoform Size is a Predictor of Postoperative Patency Following Peripheral Arterial Revascularization

Introduction: High Lp(a) is associated with adverse limb events in patients undergoing lower extremity (LE) revascularization. Lp(a) levels are genetically pre-determined, with LPA gene encoding for two apo(a) isoforms whose variations in size are driven by the number of kringle IV type 2 repeats. We examined the role of apo(a) size in LE revascularization outcomes. Methods: 25 subjects with symptomatic PAD, Rutherford stage 4 or less underwent open or endovascular LE revascularization (age 66.7±9.7 years; F=12, M=13; Black=8, Hispanic=5, and White=12). Pre- and post-operative medical history, self-reported symptoms, ABIs, and LE ultrasounds were obtained. Plasma Lp(a), apoB100, lipid panel, and pro-inflammatory markers (IL-6, IL-18, hsCRP, TNFa) were assayed preoperatively. Isoform size was estimated using gel electrophoresis and weighted isoform size ( wIS ) calculated based on % isoform expression. Firth logistic regression was used to examine the relationship between wIS and procedural outcomes: symptoms (better/worse), patency of treated lesion(s) in the postoperative period (&lt;1 month), change in ABI, and re-intervention &lt;6 months. We controlled for age, sex, smoking, statin and antiplatelet use. Results: Median plasma Lp(a) level was 108 (44, 301) nmol/L. The mean apoB100 level was 168.0±65.8 mg/dl. As expected, plasma Lp(a) levels were inversely correlated with wIS (R2 = 0.20; p=0.00001). Interestingly, plasma Lp(a) levels and w IS were not associated with any of the measured plasma pro-inflammatory markers. However, small apo(a) wIS was associated with occlusion of the treated lesion(s) in the postoperative period [OR=2.32 (95% CI 1.08 to 4.9, p= 0.03)]. The relationship of small apo(a) wIS with re-intervention was not as strong [OR=1.59 (95% CI 0.97 to 2.62), p=0.07)]. We observed no association between wIS with patient reported symptoms or change in ABI. Conclusions: Subjects with small apo(a) isoform sizes undergoing peripheral arterial revascularization may be more likely to experience occlusion in the perioperative period and/or require re-intervention. Further studies identifying the mechanism and possible relationship of these findings to detrimental long-term peripheral vascular outcomes are warranted.

Echogenicity of carotid atherosclerotic plaques as a predictor of adverse cardiovascular events in patients aged 40–64: prospective study

INTRODUCTION: Noninvasive assessment of carotid atherosclerotic plaque (CAP) morphology represents a promising direction, allowing to optimize not only cardiovascular event risk assessment, but also the selection of patients for carotid revascularization. Determination of CAP echogenicity by means of GSM-analysis can be used as part of multiparametric assessment of CAP instability and prediction of adverse cardiovascular events.OBJECTIVE: To assess the predictive value of echogenicity of carotid atherosclerotic plaques in relation to the development of adverse cardiovascular events in patients 40–64 years old.MATERIALS AND METHODS: The study included 191 patients with carotid atherosclerosis aged 40–64 years. All patients underwent duplex scanning of the arteries of the carotid basin with determination of the echogenicity of carotid ASBs. The combined end point (CEP) consisted of the following possible events: nonfatal myocardial infarction or unstable angina, nonfatal stroke, coronary revascularization or peripheral artery revascularization, and death from cardiovascular causes. Data on the onset of CVD were collected during follow-up visits and using medical information systems. Statistics: Data were analyzed using MedCalc software (version 20.216). Frequencies and percentages were used to describe nominal data, and medians and quartiles were used for quantitative data. The Kaplan-Meier survival analysis method was used to estimate the probability of events constituting the combined endpoint. Cox regression analysis was used to estimate the risk of the event and the influence of independent variables on the risk.RESULTS: By correlation analysis, carotid AP echogenicity (GSM) was inversely correlated with BMI (r=-0,355; p&lt;0,0001), waist circumference (r=-0.37; p&lt;0.0001), triglyceride levels (r=-0.163; p=0.027), uric acid (r=-0.188; p=0.028). The duration of the follow-up period was 15.1 (12.2; 22.9) months. Events constituting CEP occurred in 15 (7.85%) patients: nonfatal myocardial infarction in 2 (1.05%) patients, nonfatal stroke in 2 (1.05%) patients, myocardial revascularization in 6 (3.14%) patients, unstable angina in 5 (2.61%) patients. The presence of carotid AP with echogenicity ≤39 conventional units allowed predicting the development of events constituting CEP with sensitivity of 53.3% and specificity of 80.7%. Kaplan-Meier survivalanalysis revealed that cumulative survival of patients with carotid AP with echogenicity ≤39 conventional units was statistically significantly lower compared to patients with carotid ASB with echogenicity &gt;39 conventional units.DISCUSSION: It should be noted that in the presented study, decreased echogenicity of carotid AP was associated with the risk of adverse cardiovascular events only in the simple and sex- and age-adjusted models, but not in the full-adjusted model. It is likely that this may be due to the fact that the echogenicity of CAP is closely related to the cumulative burden of cardiovascular risk factors, which has been shown in earlier studies including. Probably, combined assessment of carotid atherosclerosis burden and morphological features of CAP may be the most promising approach to obtain additional prognostic information in patients with carotid atherosclerosis.CONCLUSION: Among patients with carotid atherosclerosis 40–64 years old, the presence of ACS with echogenicity ≤39 conventional units was associated with a 3.44 (95% CI 1.19–9.91) fold increase in the relative risk of events constituting the combined endpoint after adjusting for sex and age.

TCT-211 Intentional Coronary Revascularization Versus Conservative Therapy in Patients, Who Underwent Successful Peripheral Artery Revascularization due to Critical Limb Ischemia: The INCORPORATE Randomized Clinical Trial

TCT-211 Intentional Coronary Revascularization Versus Conservative Therapy in Patients, Who Underwent Successful Peripheral Artery Revascularization due to Critical Limb Ischemia: The INCORPORATE Randomized Clinical Trial

Machine Learning Models Predict the Need of Amputation and/or Peripheral Artery Revascularization in Hypertensive Patients Within 7-Years Follow-Up.

Lower extremity amputation and requirement of peripheral artery revascularization are common outcomes of undiagnosed peripheral artery disease patients. In the current work, prediction models for the need of amputation or peripheral revascularization focused on hypertensive patients within seven years follow up are employed. We applied machine learning (ML) models using classifiers such as Extreme Gradient Boost (XGBoost), Random Forest (RF) and Adaptive Boost (AdaBoost), that will allow clinicians to identify the patients at risk of these two endpoints using simple clinical data. We used the non-interventional cohort of the getABI study in the primary care setting, selecting 4,191 hypertensive patients out of 6,474 patients with age over 65 years old and followed up for vascular events or death up to 7 years. During this follow up period, 150 patients underwent either amputation or peripheral revascularization or both. Accuracy, Specificity, Sensitivity and Area under the receiver operating characteristic curve (AUC) were estimated for each machine learning model. The results demonstrate Random Forest as the most accurate model for the prediction of the composite endpoint in hypertensive patients within 7 years follow-up, achieving 73.27 % accuracy.Clinical Relevance-This study assists clinicians to better predict and treat these serious outcomes, amputation and peripheral revascularization in hypertensive patients.

Pitavastatin to Prevent Cardiovascular Disease in HIV Infection

BackgroundThe risk of cardiovascular disease is increased among persons with human immunodeficiency virus (HIV) infection, so data regarding primary prevention strategies in this population are needed.MethodsIn this phase 3 trial, we randomly assigned 7769 participants with HIV infection with a low-to-moderate risk of cardiovascular disease who were receiving antiretroviral therapy to receive daily pitavastatin calcium (at a dose of 4 mg) or placebo. The primary outcome was the occurrence of a major adverse cardiovascular event, which was defined as a composite of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, transient ischemic attack, peripheral arterial ischemia, revascularization, or death from an undetermined cause.ResultsThe median age of the participants was 50 years (interquartile range, 45 to 55); the median CD4 count was 621 cells per cubic millimeter (interquartile range, 448 to 827), and the HIV RNA value was below quantification in 5250 of 5997 participants (87.5%) with available data. The trial was stopped early for efficacy after a median follow-up of 5.1 years (interquartile range, 4.3 to 5.9). The incidence of a major adverse cardiovascular event was 4.81 per 1000 person-years in the pitavastatin group and 7.32 per 1000 person-years in the placebo group (hazard ratio, 0.65; 95% confidence interval [CI], 0.48 to 0.90; P=0.002). Muscle-related symptoms occurred in 91 participants (2.3%) in the pitavastatin group and in 53 (1.4%) in the placebo group; diabetes mellitus occurred in 206 participants (5.3%) and in 155 (4.0%), respectively.ConclusionsParticipants with HIV infection who received pitavastatin had a lower risk of a major adverse cardiovascular event than those who received placebo over a median follow-up of 5.1 years. (Funded by the National Institutes of Health and others; REPRIEVE ClinicalTrials.gov number, NCT02344290.)

Outcomes of Omniflow® II prosthesis used for revascularization in the femoral tract both in infected and non-infected setting.

Evidence regarding the outcomes of Omniflow® II prosthesis in peripheral arterial revascularization at different anatomical sites and for different indications is scarce. Therefore, the aim of this study was to evaluate the outcomes of the Omniflow® II used at various positions within the femoral tract both in infected and non-infected setting. Patients who underwent reconstructive lower leg vascular surgery with implantation of an Omniflow® II from 2014 until 2021 at five medical centers were retrospectively included (N.=142). Patients were subdivided into the following categories: femoro-femoral crossover (N.=19), femoral interposition (N.=18), femoro-popliteal (above-the-knee [N.=25; AK] or below-the-knee [N.=47; BK]), and femoro-crural bypass grafts (N.=33). Primary outcome was primary patency and secondary outcomes included primary assisted patency, secondary patency, major amputation, vascular graft infection, and mortality. Outcomes were compared according to different subgroups and the surgical setting (infected versus non-infected). The median follow-up was 35.0 (17.5-54.3) months. Three years primary patency of 58% was observed for femoro-femoral crossover bypass, 75% for femoral interposition graft, 44% for femoro-popliteal above-the-knee bypass, 42% for femoro-popliteal below-the-knee bypass, and 27% in the femoro-crural position (P=0.006). Freedom from major amputation at three years were 84% for femoro-femoral crossover bypass, 88% for femoral interposition bypass, 90% for femoro-popliteal AK bypass, 83% for femoro-popliteal BK bypass, and 50% for femoro-crural bypass (P<0.001). This study demonstrates the safety and feasibility of the use of Omniflow® II for femoro-femoral crossover-, femoral interposition-, and femoro-popliteal (AK and BK) bypass. Omniflow® II seems to be less suitable for femoro-crural bypass with a significantly lower patency compared to other positions.

In Situ Fenestrated Thoracic Endovascular Repair Using the Upstream Peripheral Go BackTM Re-Entry Catheter

Purpose: The aim is to present a case of in situ fenestrated thoracic endovascular repair, using a re-entry peripheral catheter, needing urgent repair due to recurrent episodes of hemoptysis because of an aorto-bronchial fistula after previous thoracic endovascular aortic repair (TEVAR). Technique: A 74-year-old male with a previous TEVAR presented with hemoptysis, fever, and cachexia. An aorto-bronchial fistula and type Ia endoleak were depicted on computed tomography angiography (CTA). Due to the patient’s frail general condition, a proximal TEVAR extension was planned, prior to thoracotomy for debridement, and long-term antibiotics. An in situ fenestrated TEVAR was performed to provide proximal sealing and revascularize the left common carotid and subclavian arteries. For fenestration creation, an Upstream Peripheral Go Back catheter (Bentley, Hechingen, Germany) was used. The Go Back catheter has been approved as a re-entry tool for complex peripheral arterial revascularization. In this case, both fenestrations were successfully created. Proximal seal and target vessel patency were confirmed on CTA. Thoracotomy confirmed aortic exclusion. A wedge lobectomy was performed in combination with pediculated omentectomy to exclude the exposed endograft. Conclusion: In urgent cases, where custom-made thoracic devices are unavailable, in situ fenestrations with the Go Back catheter are an alternative to laser fenestrations. Clinical Impact Fenestrations are often required in acute TEVAR to achieve a proximal seal in the arch. In situ fenestrations with the Go Back catheter are an alternative to laser fenestrations and PMEGs in this setting.

Revascularization of Peripheral Arteries in Patients with Intermittent Claudication Decreases Inflammatory Biomarkers.

Patients with intermittent claudication have significantly higher levels of inflammatory biomarkers, particularly interleukins, which is also a consequence of exercise limitation. Physical activity, which is one of the preventive measures against atherosclerosis, is associated with a decrease in inflammatory biomarkers. Therefore, in our study, we investigated the effects of revascularization of peripheral arteries in patients with intermittent claudication on functional capacity and levels of inflammatory markers. The study included 26 patients with intermittent claudication who underwent percutaneous transluminal angioplasty (PTA). Before the procedure and 2-4 months after successful revascularization, the ankle-brachial index (ABI), functional capacity using the treadmill test, and the walking impairment questionnaire (WIQ) were determined. Inflammatory biomarkers were also measured before and after procedures. Successful revascularization was associated with an increase in intermittent claudication: 120 (20-315) versus 300 (100-1000 m), P < 0.001. Treadmill testing showed a significant increase in initial and maximal walking distance. After revascularization, ABI increased significantly (0.55 vs 0.82, P < 0.003). Improvement in functional performance was also demonstrated by WIQ. Two to three months after revascularization, some inflammatory biomarkers decreased significantly: fibrinogen, interleukin-6 (IL-6), and interleukin-8 (IL-8). The high-sensitivity C-reactive protein (hsCRP) and tumor necrosis factor-alpha (TNFα) also did not decrease significantly. The levels of some inflammatory markers: IL-6, TNFα, and fibrinogen were significantly related to the improvement in patients' functional capacity. The results of our study show that successful revascularization of the lower limb arteries not only improves the functional capacity of patients with intermittent claudication, but also reduces the systemic inflammatory response and may have a preventive effect on local and concomitant other atherosclerotic diseases.

Diabetic retinopathy predicts cardiovascular disease independently of subclinical atherosclerosis in individuals with type 2 diabetes: A prospective cohort study

Diabetic retinopathy (DR) and preclinical atherosclerosis are associated with higher cardiovascular risk. However, no studies have investigated the predictive role of DR and preclinical atherosclerosis jointly on cardiovascular events in subjects with type 2 diabetes (T2D). We aimed to assess the contribution of DR and subclinical atherosclerosis on the risk of adverse cardiovascular events in subjects with T2D without previous cardiovascular disease (CVD). We included two prospective cohorts of subjects with T2D from the same geographical area. Assessment of subclinical atherosclerosis was performed by carotid ultrasound. An ophthalmologist classified DR according to standard criteria. Cardiovascular outcomes considered for analysis were the following: ischemic heart disease, stroke, heart failure, peripheral artery disease, revascularization procedures, and cardiovascular mortality. Bivariable and multivariable predictive models were performed. From a total of 374 subjects with T2D 44 developed cardiovascular events during the 7.1 years of follow-up. Diabetes duration, total cholesterol, and glycated hemoglobin (HbA1c) at baseline were higher in subjects who developed cardiovascular outcomes (p < 0.001, p = 0.026, and p = 0.040, respectively). Compared with subjects without events, those developing cardiovascular events had higher prevalence of retinopathy (65.9% vs. 38.8%, p = 0.001; respectively) and more than mild retinopathy (43.2% vs. 31.8%, p = 0.002; respectively). Furthermore, all-cause mortality was higher in subjects with MACE than those without events (13.6% vs. 3.3%, p = 0.009; respectively). The multivariable analyses showed that HbA1c and the presence of DR at baseline were predictive of cardiovascular outcomes (p = 0.045 and p = 0.023, respectively). However, the burden of subclinical atherosclerosis was not (p = 0.783 and p = 0.071, respectively). DR is a strong predictor of cardiovascular events in T2D individuals at primary CVD prevention, even after accounting for the presence of preclinical carotid atherosclerosis. These results may help to individualize CVD prevention strategies in T2D.