Pub Date : 2025-05-07eCollection Date: 2025-01-01DOI: 10.2147/VHRM.S513926
Piotr Włodarczak, Mateusz Barycki, Szymon Włodarczak, Łukasz Furtan, Andrzej Giniewicz, Anita Chudaś, Waldemar Banasiak, Adrian Doroszko, Maciej Lesiak, Adrian Włodarczak, Piotr Rola
Purpose: Sex differences in the clinical course of coronary artery disease (CAD) particularly in Acute Coronary Syndrome (ACS), have been extensively hypothesized. Although coronary bifurcations account for approximately 20% of ACS cases, data concerning potential sex disparities in the outcomes of percutaneous interventions (PCI) remain scarce. Several data suggest the double kiss (DK) Culotte may provide advantages in bifurcation PCI. Therefore, we evaluate potential sex differences in relation to the Culotte technique.
Patients and methods: This study retrospectively analyzes sex disparities following PCI interventions in ACS patients using the DK-Culotte or Culotte technique for bifurcation lesions. The primary endpoint was Target Lesion Failure (TLF), a composite of cardiovascular death, target vessel myocardial infarction, or clinically driven target lesion revascularization (TLR). The secondary endpoint included major adverse cardiac events MACE (myocardial infarction, cardiac death, and target lesion revascularization).
Results: There were no significant differences between sexes regarding TLF (DK-Culotte: Females 10.3% vs Males 5.7%; p=0.401; Culotte: Females 16.2% vs Males 11.8%; p=0.481) or MACE (DK-Culotte: Females 13.8% vs Males 12.5%; p=0.771; Culotte: Females 24.3% vs Males 17.6%; p=0.370) after a 1-year follow-up for both bifurcation techniques.
Conclusion: The study found no significant differences in clinical outcomes between sexes following PCI for bifurcation lesions in the ACS cohort, regardless of whether the two-stent techniques (DK- Culotte or Culotte) were used.
{"title":"Sex Differences in Clinical Features and Outcomes in Patients with Acute Coronary Syndrome Treated with Bifurcation Stenting Using the Double-Kissing Culotte and Culotte Technique - 1-year Follow-up.","authors":"Piotr Włodarczak, Mateusz Barycki, Szymon Włodarczak, Łukasz Furtan, Andrzej Giniewicz, Anita Chudaś, Waldemar Banasiak, Adrian Doroszko, Maciej Lesiak, Adrian Włodarczak, Piotr Rola","doi":"10.2147/VHRM.S513926","DOIUrl":"https://doi.org/10.2147/VHRM.S513926","url":null,"abstract":"<p><strong>Purpose: </strong>Sex differences in the clinical course of coronary artery disease (CAD) particularly in Acute Coronary Syndrome (ACS), have been extensively hypothesized. Although coronary bifurcations account for approximately 20% of ACS cases, data concerning potential sex disparities in the outcomes of percutaneous interventions (PCI) remain scarce. Several data suggest the double kiss (DK) Culotte may provide advantages in bifurcation PCI. Therefore, we evaluate potential sex differences in relation to the Culotte technique.</p><p><strong>Patients and methods: </strong>This study retrospectively analyzes sex disparities following PCI interventions in ACS patients using the DK-Culotte or Culotte technique for bifurcation lesions. The primary endpoint was Target Lesion Failure (TLF), a composite of cardiovascular death, target vessel myocardial infarction, or clinically driven target lesion revascularization (TLR). The secondary endpoint included major adverse cardiac events MACE (myocardial infarction, cardiac death, and target lesion revascularization).</p><p><strong>Results: </strong>There were no significant differences between sexes regarding TLF (DK-Culotte: Females 10.3% vs Males 5.7%; p=0.401; Culotte: Females 16.2% vs Males 11.8%; p=0.481) or MACE (DK-Culotte: Females 13.8% vs Males 12.5%; p=0.771; Culotte: Females 24.3% vs Males 17.6%; p=0.370) after a 1-year follow-up for both bifurcation techniques.</p><p><strong>Conclusion: </strong>The study found no significant differences in clinical outcomes between sexes following PCI for bifurcation lesions in the ACS cohort, regardless of whether the two-stent techniques (DK- Culotte or Culotte) were used.</p>","PeriodicalId":23597,"journal":{"name":"Vascular Health and Risk Management","volume":"21 ","pages":"361-370"},"PeriodicalIF":2.6,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12067469/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144052122","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-05eCollection Date: 2025-01-01DOI: 10.2147/VHRM.S523798
Xueqing Wang, Sheng Zhang, Xinxin Wang, Xiaojun Shen, Lei Huang
Aim: The incidence of heart failure (HF) remains high throughout the world, posing a serious threat to human health, with inflammation being a pivotal factor in the entire pathophysiologic process. Systemic inflammatory response index (SIRI) and systemic immune inflammation index (SII) are novel indicators for poor prognosis of HF. This paper aimed to ascertain the connection between SIRI and mortality in critically ill HF patients and to compare the prognostic value with SII.
Methods: All data on HF patients were sourced from MIMIC-IV. Cox proportional hazards analysis, restricted cubic spline, and Kaplan-Meier survival analysis were utilized to determine the link between SIRI or SII and in-hospital mortality. Receiver operating characteristic curve, area under the curve (AUC), and Youden index were employed to compare the prognostic value of SIRI and SII. Subgroup analysis was conducted to confirm the predictive capability of SIRI on mortality. Propensity score matching was utilized to reveal the connection between SIRI and secondary outcomes.
Results: 754 patients were included and 45 patients (6.0%) died. There was a positive link between SIRI and in-hospital mortality in both unadjusted (p < 0.001) and adjusted models (p < 0.001 and p = 0.001, respectively), outperforming SII in all models (p > 0.05 in all models). SIRI had a higher AUC and Youden index than SII, indicating better prognostic power. In addition, hospital stay was shorter in the low SIRI group (p = 0.034).
Conclusion: SIRI predicts in-hospital mortality in critically ill HF patients, and the prognostic power is superior to SII.
{"title":"Systemic Inflammatory Response Index Is a More Promising Prognostic Index Than Systemic Immune Inflammation Index in Critically Ill Heart Failure Patients: A Retrospective Cohort Analysis of the MIMIC-IV Database.","authors":"Xueqing Wang, Sheng Zhang, Xinxin Wang, Xiaojun Shen, Lei Huang","doi":"10.2147/VHRM.S523798","DOIUrl":"https://doi.org/10.2147/VHRM.S523798","url":null,"abstract":"<p><strong>Aim: </strong>The incidence of heart failure (HF) remains high throughout the world, posing a serious threat to human health, with inflammation being a pivotal factor in the entire pathophysiologic process. Systemic inflammatory response index (SIRI) and systemic immune inflammation index (SII) are novel indicators for poor prognosis of HF. This paper aimed to ascertain the connection between SIRI and mortality in critically ill HF patients and to compare the prognostic value with SII.</p><p><strong>Methods: </strong>All data on HF patients were sourced from MIMIC-IV. Cox proportional hazards analysis, restricted cubic spline, and Kaplan-Meier survival analysis were utilized to determine the link between SIRI or SII and in-hospital mortality. Receiver operating characteristic curve, area under the curve (AUC), and Youden index were employed to compare the prognostic value of SIRI and SII. Subgroup analysis was conducted to confirm the predictive capability of SIRI on mortality. Propensity score matching was utilized to reveal the connection between SIRI and secondary outcomes.</p><p><strong>Results: </strong>754 patients were included and 45 patients (6.0%) died. There was a positive link between SIRI and in-hospital mortality in both unadjusted (<i>p</i> < 0.001) and adjusted models (<i>p</i> < 0.001 and <i>p</i> = 0.001, respectively), outperforming SII in all models (<i>p</i> > 0.05 in all models). SIRI had a higher AUC and Youden index than SII, indicating better prognostic power. In addition, hospital stay was shorter in the low SIRI group (<i>p</i> = 0.034).</p><p><strong>Conclusion: </strong>SIRI predicts in-hospital mortality in critically ill HF patients, and the prognostic power is superior to SII.</p>","PeriodicalId":23597,"journal":{"name":"Vascular Health and Risk Management","volume":"21 ","pages":"345-360"},"PeriodicalIF":2.6,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12063699/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143984451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-30eCollection Date: 2025-01-01DOI: 10.2147/VHRM.S488465
Miguel Angel Flores Flores, Luis Antonio Flores Flores, Serafín Dernali Romero Yupanqui
Dyslipidemia is a condition characterized by excessive lipids in the blood plasma, including triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and decreased levels of high-density lipoprotein cholesterol (HDL-C), which is generated mostly due to obesity. This study aims to summarize research conducted on rats and humans regarding the potential of eight fruits in reducing dyslipidemia and their associated health benefits (eg, reduction of free radicals, hypoglycemic effects, weight reduction, lowering of blood pressure, and anti-inflammatory properties). The studied fruits include pomegranate, star fruit, Rosa roxburghii, pineapple, tree tomato, coffee, apple, and passion fruit. Various parts of these fruits, such as the root, leaves, stem, peel, and pulp, were analyzed for their effects. These fruits are edible, widely available, and cost-effective when purchased during the harvest season (Graphical abstract).
{"title":"Potential of Fruits to Improve Dyslipidemias: A Pilot Review.","authors":"Miguel Angel Flores Flores, Luis Antonio Flores Flores, Serafín Dernali Romero Yupanqui","doi":"10.2147/VHRM.S488465","DOIUrl":"https://doi.org/10.2147/VHRM.S488465","url":null,"abstract":"<p><p>Dyslipidemia is a condition characterized by excessive lipids in the blood plasma, including triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and decreased levels of high-density lipoprotein cholesterol (HDL-C), which is generated mostly due to obesity. This study aims to summarize research conducted on rats and humans regarding the potential of eight fruits in reducing dyslipidemia and their associated health benefits (eg, reduction of free radicals, hypoglycemic effects, weight reduction, lowering of blood pressure, and anti-inflammatory properties). The studied fruits include pomegranate, star fruit, Rosa roxburghii, pineapple, tree tomato, coffee, apple, and passion fruit. Various parts of these fruits, such as the root, leaves, stem, peel, and pulp, were analyzed for their effects. These fruits are edible, widely available, and cost-effective when purchased during the harvest season (Graphical abstract).</p>","PeriodicalId":23597,"journal":{"name":"Vascular Health and Risk Management","volume":"21 ","pages":"327-343"},"PeriodicalIF":2.6,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12050025/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143983829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-24eCollection Date: 2025-01-01DOI: 10.2147/VHRM.S506642
Yasuhiro Watanabe, Shoya Nonaka, Shuhei Yamaoka, Shoko Nakamura, Osamu Horikawa, Takashi Yamaguchi, Shuji Sato, Shunsuke Todani, Yuta Sugizaki, Takuro Ito, Hiroshi Mikamo, Mao Takahashi, Daiji Nagayama, Kazuhiro Shimizu, Atsuhito Saiki
Purpose: Pemafibrate is a novel selective peroxisome proliferator-activated receptor alpha modulator (SPPARMα) that improves lipid profile, but its effects on cardiovascular events remain unproven. This study examined changes in the cardio-ankle vascular index (CAVI), a marker of arterial stiffness, in high-risk patients with type 2 diabetes mellitus (T2DM) or ischemic heart disease (IHD) treated with pemafibrate.
Patients and methods: In this single-center, prospective, observational study, 95 patients with T2DM and/or IHD, who had hypertriglyceridemia (≥150 mg/dL) and started pemafibrate (0.2 mg/day) were analyzed. CAVI was measured at baseline and after 24 weeks of treatment as an indicator of arterial stiffness, along with comprehensive assessment of lipid parameters including triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), non-HDL-C, and apolipoproteins.
Results: No significant change in CAVI was observed after 24 weeks of treatment (median [interquartile range (IQR)]; baseline vs 24 weeks: CAVI 9.4 [8.8-10.6] vs 9.6 [8.9-10.8], p=0.715). However, pemafibrate significantly reduced triglycerides (233 mg/dL [171-329] to 143 mg/dL [111-187], p<0.001), apolipoprotein C-II (8.1 mg/dL [6.1-10.2] to 6.3 mg/dL [5.3-8.3], p<0.001), apolipoprotein C-III (15.3 mg/dL [12.2-18.3] to 11.6 mg/dL [9.3-14.2], p<0.001) and liver enzymes; and increased HDL-C (45 mg/dL [39-52] to 50 mg/dL [40-60], p<0.001), LDL-C (92 mg/dL [70-111] to 103 mg/dL [79-128], p<0.001), apolipoprotein A-I and apolipoprotein A-II (both p<0.05). Calculated small dense low-density lipoprotein cholesterol also decreased significantly (40 mg/dL [31-49] to 36 mg/dL [28-45], p=0.002).
Conclusion: While pemafibrate improves lipid profile and liver enzymes, its short-term impact on vascular stiffness, as measured by CAVI, appears limited. Extended follow-up studies are needed to clarify its cardiovascular benefits in high-risk patients.
{"title":"Effects of Pemafibrate on Cardio-Ankle Vascular Index (CAVI) in Patients with Type 2 Diabetes or Ischemic Heart Disease: A 24-Week Observational Study.","authors":"Yasuhiro Watanabe, Shoya Nonaka, Shuhei Yamaoka, Shoko Nakamura, Osamu Horikawa, Takashi Yamaguchi, Shuji Sato, Shunsuke Todani, Yuta Sugizaki, Takuro Ito, Hiroshi Mikamo, Mao Takahashi, Daiji Nagayama, Kazuhiro Shimizu, Atsuhito Saiki","doi":"10.2147/VHRM.S506642","DOIUrl":"10.2147/VHRM.S506642","url":null,"abstract":"<p><strong>Purpose: </strong>Pemafibrate is a novel selective peroxisome proliferator-activated receptor alpha modulator (SPPARMα) that improves lipid profile, but its effects on cardiovascular events remain unproven. This study examined changes in the cardio-ankle vascular index (CAVI), a marker of arterial stiffness, in high-risk patients with type 2 diabetes mellitus (T2DM) or ischemic heart disease (IHD) treated with pemafibrate.</p><p><strong>Patients and methods: </strong>In this single-center, prospective, observational study, 95 patients with T2DM and/or IHD, who had hypertriglyceridemia (≥150 mg/dL) and started pemafibrate (0.2 mg/day) were analyzed. CAVI was measured at baseline and after 24 weeks of treatment as an indicator of arterial stiffness, along with comprehensive assessment of lipid parameters including triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), non-HDL-C, and apolipoproteins.</p><p><strong>Results: </strong>No significant change in CAVI was observed after 24 weeks of treatment (median [interquartile range (IQR)]; baseline vs 24 weeks: CAVI 9.4 [8.8-10.6] vs 9.6 [8.9-10.8], p=0.715). However, pemafibrate significantly reduced triglycerides (233 mg/dL [171-329] to 143 mg/dL [111-187], p<0.001), apolipoprotein C-II (8.1 mg/dL [6.1-10.2] to 6.3 mg/dL [5.3-8.3], p<0.001), apolipoprotein C-III (15.3 mg/dL [12.2-18.3] to 11.6 mg/dL [9.3-14.2], p<0.001) and liver enzymes; and increased HDL-C (45 mg/dL [39-52] to 50 mg/dL [40-60], p<0.001), LDL-C (92 mg/dL [70-111] to 103 mg/dL [79-128], p<0.001), apolipoprotein A-I and apolipoprotein A-II (both p<0.05). Calculated small dense low-density lipoprotein cholesterol also decreased significantly (40 mg/dL [31-49] to 36 mg/dL [28-45], p=0.002).</p><p><strong>Conclusion: </strong>While pemafibrate improves lipid profile and liver enzymes, its short-term impact on vascular stiffness, as measured by CAVI, appears limited. Extended follow-up studies are needed to clarify its cardiovascular benefits in high-risk patients.</p>","PeriodicalId":23597,"journal":{"name":"Vascular Health and Risk Management","volume":"21 ","pages":"293-304"},"PeriodicalIF":2.6,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12036687/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144015773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-24eCollection Date: 2025-01-01DOI: 10.2147/VHRM.S507783
Rafał Wyderka, Bogusława Ołpińska, Dorota Diakowska, Anna Leśków, Łukasz Osuch, Michał Borger, Barbara Brzezińska, Maria Łoboz-Rudnicka, Joanna Jaroch
Background: Despite a growing evidence from the animal models of the cardioprotective function of the apelinergic system in the setting of myocardial infarction, little is known on the role of apelinergic system in the development of post- infarction adverse left ventricle remodeling in humans.
Methods: The study group consisted of 49 patients with first-time ST-segment elevation myocardial infarction of anterior wall treated invasively. Echocardiography was performed on index hospitalization and on one-year check-up, with categorizing the study population into group with adverse LV remodeling defined as an increase of LV end diastolic volume by >20% (n = 12) and the group without adverse remodeling (n = 29). ELA, AP-17, AP-13 and APJ receptor levels were measured on one-year follow-up.
Results: Patients with adverse LV remodeling presented significantly higher plasma level of apelin-13 (85.63 [75.43-96.13] vs 65.43 [57.35-69.35], p = 0.001) and apelin-17 (69.36 [42.61-77.04] vs 30.04 [25.97-41.95], p = 0.004). In a univariable logistic regression analysis, higher LVEDV and LVEDV1, higher LVESV and LVESVi, lower LVEF, higher WMSI score, higher SYNTAX score, higher levels of hs-CRP during index hospitalization and higher levels of AP-13 and AP-17 on the one-year check-up were associated with adverse LV remodeling. In multivariable logistic regression analysis, only AP-17 level was independently associated with adverse LV remodeling (p = 0.050).
Conclusion: Apelinergic system may be involved in the development of post- infarction adverse left ventricle remodeling.
背景:尽管越来越多的动物模型证据表明,在心肌梗死的情况下,乙酰胆碱能系统具有心脏保护功能,但对乙酰胆碱能系统在人类梗死后不良左心室重构中的作用知之甚少。方法:研究组49例经有创治疗的首次st段抬高型前壁心肌梗死患者。在指数住院和一年体检时进行超声心动图检查,将研究人群分为左室不良重构组(定义为左室舒张末期容积增加bbb20 %)和无不良重构组(n = 29)。随访1年,测量ELA、AP-17、AP-13和APJ受体水平。结果:不良左室重构患者血浆apelin-13水平(85.63 [75.43-96.13]vs 65.43 [57.35-69.35], p = 0.001)和apelin-17水平(69.36 [42.61-77.04]vs 30.04 [25.97-41.95], p = 0.004)显著升高。在单变量logistic回归分析中,较高的LVEDV和LVEDV1、较高的LVESV和LVESVi、较低的LVEF、较高的WMSI评分、较高的SYNTAX评分、住院期间较高的hs-CRP水平以及一年体检时较高的AP-13和AP-17水平与不良左室重构相关。在多变量logistic回归分析中,只有AP-17水平与左室不良重构独立相关(p = 0.050)。结论:乙酰胆碱能系统可能参与了梗死后不良左心室重构的发生。
{"title":"Apelinergic System in the Left Ventricle Adverse Remodeling After Myocardial Infarction: A Preliminary Study.","authors":"Rafał Wyderka, Bogusława Ołpińska, Dorota Diakowska, Anna Leśków, Łukasz Osuch, Michał Borger, Barbara Brzezińska, Maria Łoboz-Rudnicka, Joanna Jaroch","doi":"10.2147/VHRM.S507783","DOIUrl":"https://doi.org/10.2147/VHRM.S507783","url":null,"abstract":"<p><strong>Background: </strong>Despite a growing evidence from the animal models of the cardioprotective function of the apelinergic system in the setting of myocardial infarction, little is known on the role of apelinergic system in the development of post- infarction adverse left ventricle remodeling in humans.</p><p><strong>Methods: </strong>The study group consisted of 49 patients with first-time ST-segment elevation myocardial infarction of anterior wall treated invasively. Echocardiography was performed on index hospitalization and on one-year check-up, with categorizing the study population into group with adverse LV remodeling defined as an increase of LV end diastolic volume by >20% (n = 12) and the group without adverse remodeling (n = 29). ELA, AP-17, AP-13 and APJ receptor levels were measured on one-year follow-up.</p><p><strong>Results: </strong>Patients with adverse LV remodeling presented significantly higher plasma level of apelin-13 (85.63 [75.43-96.13] vs 65.43 [57.35-69.35], p = 0.001) and apelin-17 (69.36 [42.61-77.04] vs 30.04 [25.97-41.95], p = 0.004). In a univariable logistic regression analysis, higher LVEDV and LVEDV1, higher LVESV and LVESVi, lower LVEF, higher WMSI score, higher SYNTAX score, higher levels of hs-CRP during index hospitalization and higher levels of AP-13 and AP-17 on the one-year check-up were associated with adverse LV remodeling. In multivariable logistic regression analysis, only AP-17 level was independently associated with adverse LV remodeling (p = 0.050).</p><p><strong>Conclusion: </strong>Apelinergic system may be involved in the development of post- infarction adverse left ventricle remodeling.</p>","PeriodicalId":23597,"journal":{"name":"Vascular Health and Risk Management","volume":"21 ","pages":"279-291"},"PeriodicalIF":2.6,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12036603/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144039834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-24eCollection Date: 2025-01-01DOI: 10.2147/VHRM.S507356
Konstantinos Vasileiadis, Christina Antza, Anastasia Malliora, Victoria Potoupni, Vasilios Kotsis
Objective: Hypertension significantly impacts cardiovascular health, leading to arterial stiffness and myocardial dysfunction. Pulse wave velocity (PWV) is a recognized measure of arterial stiffness, while cardiac magnetic resonance imaging (MRI) is the gold standard for assessing myocardial structure and function. The aim of the present study is to investigate the relationship between arterial stiffness, ambulatory blood pressure monitoring (ABPM), and cardiac MRI findings in untreated hypertensive individuals.
Methods: This cross-sectional study included 22 untreated hypertensive participants referred to the Hypertension ABPM Center of Excellence at Aristotle University of Thessaloniki. Participants underwent carotid-femoral PWV measurement and 24-hour ABPM. Cardiac function and structure were evaluated through cardiac MRI. Statistical analyses included Mann-Whitney and Kruskal-Wallis tests, with logistic regression for associations between c-f PWV and cardiac abnormalities. A significance threshold of p<0.05 was applied.
Results: The study population had increased office and 24-hour ABPM values. Cardiac MRI revealed systolic LV dysfunction in 31.8% and diastolic LV dysfunction in 63.6% of participants. Myocardial fibrosis was present in 50% of the participants. Elevated PWV was significantly associated with LV systolic dysfunction (p=0.003), LV diastolic dysfunction (p=0.002), myocardial stiffness (p<0.001), and myocardial fibrosis (p = 0.004). Additionally, aortic valve velocity was significantly associated with increased arterial stiffness (p=0.006). Post-hoc analysis of fibrosis showed significant differences (p=0.007 for minimal vs no fibrosis; p=0.011 for severe vs no fibrosis).
Conclusion: The study confirms a significant correlation between increased arterial stiffness, systolic ABPM-derived systolic blood pressure, and cardiac MRI dysfunction in untreated hypertensive individuals. These findings highlight the importance of arterial stiffness evaluation as a diagnostic tool for early detection of myocardial dysfunction, allowing for timely intervention and targeted treatment strategies to mitigate heart damage.
{"title":"Arterial Stiffness: A Strong Determinant of Abnormal Cardiac Magnetic Resonance Imaging in an Untreated Hypertensive Population.","authors":"Konstantinos Vasileiadis, Christina Antza, Anastasia Malliora, Victoria Potoupni, Vasilios Kotsis","doi":"10.2147/VHRM.S507356","DOIUrl":"https://doi.org/10.2147/VHRM.S507356","url":null,"abstract":"<p><strong>Objective: </strong>Hypertension significantly impacts cardiovascular health, leading to arterial stiffness and myocardial dysfunction. Pulse wave velocity (PWV) is a recognized measure of arterial stiffness, while cardiac magnetic resonance imaging (MRI) is the gold standard for assessing myocardial structure and function. The aim of the present study is to investigate the relationship between arterial stiffness, ambulatory blood pressure monitoring (ABPM), and cardiac MRI findings in untreated hypertensive individuals.</p><p><strong>Methods: </strong>This cross-sectional study included 22 untreated hypertensive participants referred to the Hypertension ABPM Center of Excellence at Aristotle University of Thessaloniki. Participants underwent carotid-femoral PWV measurement and 24-hour ABPM. Cardiac function and structure were evaluated through cardiac MRI. Statistical analyses included Mann-Whitney and Kruskal-Wallis tests, with logistic regression for associations between c-f PWV and cardiac abnormalities. A significance threshold of p<0.05 was applied.</p><p><strong>Results: </strong>The study population had increased office and 24-hour ABPM values. Cardiac MRI revealed systolic LV dysfunction in 31.8% and diastolic LV dysfunction in 63.6% of participants. Myocardial fibrosis was present in 50% of the participants. Elevated PWV was significantly associated with LV systolic dysfunction (p=0.003), LV diastolic dysfunction (p=0.002), myocardial stiffness (p<0.001), and myocardial fibrosis (p = 0.004). Additionally, aortic valve velocity was significantly associated with increased arterial stiffness (p=0.006). Post-hoc analysis of fibrosis showed significant differences (p=0.007 for minimal vs no fibrosis; p=0.011 for severe vs no fibrosis).</p><p><strong>Conclusion: </strong>The study confirms a significant correlation between increased arterial stiffness, systolic ABPM-derived systolic blood pressure, and cardiac MRI dysfunction in untreated hypertensive individuals. These findings highlight the importance of arterial stiffness evaluation as a diagnostic tool for early detection of myocardial dysfunction, allowing for timely intervention and targeted treatment strategies to mitigate heart damage.</p>","PeriodicalId":23597,"journal":{"name":"Vascular Health and Risk Management","volume":"21 ","pages":"269-278"},"PeriodicalIF":2.6,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12036619/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144001818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Purpose: This study aimed to investigate the current practices of VTE prophylaxis in patients undergoing abdominal-pelvic surgery (PAS) and to identify the factors that influence surgeons' practice of VTE prophylaxis.
Patients and methods: This two-phase explanatory sequential mixed-method study used chart audits followed by semi-structured interviews based on the theoretical domain framework (TDF). During Phase I, quantitative data from 240 medical records of patients with PAS in April 2023 were audited to measure adherence rates to the standard thromboprophylaxis guidelines. In Phase II, in-depth interviews with 16 surgeons were conducted and analyzed using thematic content analysis based on the TDF framework to understand the determinants of thromboprophylaxis in patients with PAS.
Results: Audits of 240 medical records of patients showed the rate of appropriate prophylactic methods was low (11.7%). For patients on anticoagulant prophylaxis, adherence rates regarding drug selection and dosage were high (100% and 89.3%, respectively), whereas adherence rates regarding time of initiation and length of prophylaxis were low (50% and 28.6%, respectively). A qualitative analysis identified 12 theoretical domains relevant to thromboprophylaxis practices among surgeons. The most encountered barriers included concerns about bleeding risk, resource issues, low beliefs about preventive benefits for certain patients with PAS, inadequate knowledge and training, and a lack of protocol and policy. The most encountered enablers included positive beliefs in prophylaxis benefits, mandatory policy and computerized supportive tools, thromboprophylaxis set as patient safety goals, leadership and multidisciplinary working, and training.
Conclusion: Significant quality gaps were present in VTE prevention practice for abdominal-pelvic surgical patients, and multiple coexisting factors prevented the full adoption of practice standards. The implementation of an anticoagulation stewardship program is essential for addressing practical issues.
{"title":"A Call to Action for Anticoagulation Stewardship to Address Suboptimal Thromboprophylaxis Practices for at-Risk Non-Orthopedic Surgical Patients in Vietnam: An Explanatory Sequential Mixed-Methods Study.","authors":"Thuy Thi Thu Nguyen, Huyen Thanh Tong, Huong Thi Lien Nguyen, Trung Duc Nguyen","doi":"10.2147/VHRM.S505100","DOIUrl":"https://doi.org/10.2147/VHRM.S505100","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to investigate the current practices of VTE prophylaxis in patients undergoing abdominal-pelvic surgery (PAS) and to identify the factors that influence surgeons' practice of VTE prophylaxis.</p><p><strong>Patients and methods: </strong>This two-phase explanatory sequential mixed-method study used chart audits followed by semi-structured interviews based on the theoretical domain framework (TDF). During Phase I, quantitative data from 240 medical records of patients with PAS in April 2023 were audited to measure adherence rates to the standard thromboprophylaxis guidelines. In Phase II, in-depth interviews with 16 surgeons were conducted and analyzed using thematic content analysis based on the TDF framework to understand the determinants of thromboprophylaxis in patients with PAS.</p><p><strong>Results: </strong>Audits of 240 medical records of patients showed the rate of appropriate prophylactic methods was low (11.7%). For patients on anticoagulant prophylaxis, adherence rates regarding drug selection and dosage were high (100% and 89.3%, respectively), whereas adherence rates regarding time of initiation and length of prophylaxis were low (50% and 28.6%, respectively). A qualitative analysis identified 12 theoretical domains relevant to thromboprophylaxis practices among surgeons. The most encountered barriers included concerns about bleeding risk, resource issues, low beliefs about preventive benefits for certain patients with PAS, inadequate knowledge and training, and a lack of protocol and policy. The most encountered enablers included positive beliefs in prophylaxis benefits, mandatory policy and computerized supportive tools, thromboprophylaxis set as patient safety goals, leadership and multidisciplinary working, and training.</p><p><strong>Conclusion: </strong>Significant quality gaps were present in VTE prevention practice for abdominal-pelvic surgical patients, and multiple coexisting factors prevented the full adoption of practice standards. The implementation of an anticoagulation stewardship program is essential for addressing practical issues.</p>","PeriodicalId":23597,"journal":{"name":"Vascular Health and Risk Management","volume":"21 ","pages":"305-326"},"PeriodicalIF":2.6,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12036610/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144001882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-21eCollection Date: 2025-01-01DOI: 10.2147/VHRM.S511689
Huihui Ma, Fengcheng Xu, Lei Liu, Caixia Pan, Rong Luo, Mingjiang Liu, Tianhu Liu, Yan Shu, Xiaoping Li
Objective: There is a significant difference in prognosis among patients with hypertrophic cardiomyopathy (HCM) across different age groups and gender groups. This study aims to explore the risk of sudden cardiac death (SCD) in various age groups and genders.
Methods: A cohort of 2781 patients with HCM, initially evaluated between 1996 and 2023, were followed for a median of 4.54 years. The patients were divided into three age groups: youth group (aged ≤ 40 years), middle-aged group (aged between 40 and 60 years), and elderly group (aged ≥60 years). The outcome event was (SCD). Kaplan-Meier survival curves and Cox regression analysis were employed to compare outcomes across different age groups for both genders. Additionally, restricted cubic splines (RCS) were utilized to evaluate the potential relationship between age and prognosis within different gender categories.
Results: A total of 128 patients (4.6%) experienced SCD. In the whole population, significant age differences were observed in the Kaplan-Meier survival curves for SCD (log-rank P<0.0001). Significant age differences in SCD were also noted in both genders (log-rank P<0.0001). In multivariate Cox regression analysis, age was an independent predictor of SCD in the whole population [HR: 0.983; 95% CI: 0.972-0.994; P=0.003] and female patients [HR: 0.963; 95% CI: 0.947-0.98; P<0.001]. However, it was not significant in male patients [HR: 0.995; 95% CI: 0.98-1.01; P=0.538].
Conclusion: In patients with HCM, age was an independent predictor of SCD both the whole population and female patients. Compared to young patients, the risk of SCD is reduced by 71.4% in middle-aged patients and by 43.5% in elderly patients across the whole population. Among male patients, the risk of SCD decreases by 68.5% in middle-aged patients and by 10.7% in elderly patients. In female patients, the risk of SCD is reduced by 77.8% in middle-aged patients and by 75.3% in elderly patients.
{"title":"Age and Sex Differences in the Risk of Sudden Cardiac Death in Patients with Hypertrophic Cardiomyopathy: A Multi-Centre Cohort Study.","authors":"Huihui Ma, Fengcheng Xu, Lei Liu, Caixia Pan, Rong Luo, Mingjiang Liu, Tianhu Liu, Yan Shu, Xiaoping Li","doi":"10.2147/VHRM.S511689","DOIUrl":"10.2147/VHRM.S511689","url":null,"abstract":"<p><strong>Objective: </strong>There is a significant difference in prognosis among patients with hypertrophic cardiomyopathy (HCM) across different age groups and gender groups. This study aims to explore the risk of sudden cardiac death (SCD) in various age groups and genders.</p><p><strong>Methods: </strong>A cohort of 2781 patients with HCM, initially evaluated between 1996 and 2023, were followed for a median of 4.54 years. The patients were divided into three age groups: youth group (aged ≤ 40 years), middle-aged group (aged between 40 and 60 years), and elderly group (aged ≥60 years). The outcome event was (SCD). Kaplan-Meier survival curves and Cox regression analysis were employed to compare outcomes across different age groups for both genders. Additionally, restricted cubic splines (RCS) were utilized to evaluate the potential relationship between age and prognosis within different gender categories.</p><p><strong>Results: </strong>A total of 128 patients (4.6%) experienced SCD. In the whole population, significant age differences were observed in the Kaplan-Meier survival curves for SCD (log-rank P<0.0001). Significant age differences in SCD were also noted in both genders (log-rank P<0.0001). In multivariate Cox regression analysis, age was an independent predictor of SCD in the whole population [HR: 0.983; 95% CI: 0.972-0.994; P=0.003] and female patients [HR: 0.963; 95% CI: 0.947-0.98; P<0.001]. However, it was not significant in male patients [HR: 0.995; 95% CI: 0.98-1.01; P=0.538].</p><p><strong>Conclusion: </strong>In patients with HCM, age was an independent predictor of SCD both the whole population and female patients. Compared to young patients, the risk of SCD is reduced by 71.4% in middle-aged patients and by 43.5% in elderly patients across the whole population. Among male patients, the risk of SCD decreases by 68.5% in middle-aged patients and by 10.7% in elderly patients. In female patients, the risk of SCD is reduced by 77.8% in middle-aged patients and by 75.3% in elderly patients.</p>","PeriodicalId":23597,"journal":{"name":"Vascular Health and Risk Management","volume":"21 ","pages":"251-267"},"PeriodicalIF":2.6,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12024479/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144036772","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-11eCollection Date: 2025-01-01DOI: 10.2147/VHRM.S497866
Emil Karonen, Frida Eek, Isabel Drake, Talha Butt, Hanne Krage Carlsen, Björn Eliasson, Anders Gottsäter, Stefan Acosta
Introduction: Acute lower limb ischemia (ALI) is a life and limb threatening event often affecting patients with type 2 diabetes mellitus (T2DM). Little is known about how T2DM affects the risk of adverse events in patients revascularized for ALI. This study aimed to investigate if there were differences in major outcomes between ALI patients with and without T2DM.
Methods: Between 2010 and 2014, 615 patients underwent revascularization for ALI, according to the Swedish Vascular Registry (SWEDVASC). Using the National Diabetes Registry (NDR), 245 (39.8%) of the patients were identified as having T2DM. Uni- and multivariable Cox or logistic regression analyses were performed to evaluate risk differences for major amputation, mortality, major adverse cardiovascular events (MACE), and fasciotomy between patients with and without T2DM.
Results: The rates of major amputation and mortality at one year were 32.7% and 21.6% in the T2DM group, compared to 21.9% and 31.9% in the non-DM group, respectively, resulting in a hazard ratio (HR) of 1.52 (95% confidence interval [CI] 1.12-2.07) for major amputation and HR of 0.64 (95% CI 0.46-0.88) for mortality. At one year, the HR for major amputation was 1.45 (95% CI 0.99-2.11), HR for mortality 0.92 (95% CI 0.61-1.39), HR for combined major amputation/mortality 1.27 (95% CI 0.94-1.72), and HR for MACE 1.24 (95% CI 0.92-1.67) for those with T2DM compared to those without in the multivariable Cox-regression analyses. The multivariable logistic regression analysis showed significantly lower odds of fasciotomy, OR 0.1 (95% CI 0.01-0.51) in the T2DM-group.
Conclusion: T2DM was not significantly associated with higher hazard of major amputation, mortality, combined major amputation/mortality, or MACE after revascularization for ALI, compared to patients without T2DM. Patients with T2DM had significantly lower odds of fasciotomy.
急性下肢缺血(Acute lower limb ischemia, ALI)是2型糖尿病(T2DM)患者常发生的危及生命和肢体的事件。对于T2DM如何影响ALI患者血运重建术中不良事件的风险知之甚少。本研究旨在探讨ALI患者合并和不合并T2DM的主要结局是否存在差异。方法:根据瑞典血管登记处(SWEDVASC)的数据,2010年至2014年间,615例ALI患者接受了血运重建术。使用国家糖尿病登记处(NDR), 245例(39.8%)患者被确定为T2DM。采用单变量和多变量Cox或logistic回归分析来评估T2DM患者和非T2DM患者主要截肢、死亡率、主要不良心血管事件(MACE)和筋膜切开术的风险差异。结果:T2DM组1年主要截肢率和死亡率分别为32.7%和21.6%,非dm组分别为21.9%和31.9%,导致主要截肢的风险比(HR)为1.52(95%可信区间[CI] 1.12-2.07),死亡率的风险比(HR)为0.64(95%可信区间[CI] 0.46-0.88)。在多变量cox回归分析中,1年时,T2DM患者与非T2DM患者相比,主要截肢的HR为1.45 (95% CI 0.99-2.11),死亡率HR为0.92 (95% CI 0.61-1.39),合并主要截肢/死亡率HR为1.27 (95% CI 0.94-1.72), MACE HR为1.24 (95% CI 0.92-1.67)。多变量logistic回归分析显示,t2dm组筋膜切开术的几率显著降低,OR为0.1 (95% CI 0.01-0.51)。结论:与非T2DM患者相比,T2DM与ALI大截肢、死亡率、合并大截肢/死亡率或血管重建术后MACE的高风险无显著相关。T2DM患者行筋膜切开术的几率明显较低。
{"title":"Comparison of Outcomes After Revascularization for Acute Lower Limb Ischemia in Patients with and without Type 2 Diabetes Mellitus - A Nationwide Registry Study.","authors":"Emil Karonen, Frida Eek, Isabel Drake, Talha Butt, Hanne Krage Carlsen, Björn Eliasson, Anders Gottsäter, Stefan Acosta","doi":"10.2147/VHRM.S497866","DOIUrl":"https://doi.org/10.2147/VHRM.S497866","url":null,"abstract":"<p><strong>Introduction: </strong>Acute lower limb ischemia (ALI) is a life and limb threatening event often affecting patients with type 2 diabetes mellitus (T2DM). Little is known about how T2DM affects the risk of adverse events in patients revascularized for ALI. This study aimed to investigate if there were differences in major outcomes between ALI patients with and without T2DM.</p><p><strong>Methods: </strong>Between 2010 and 2014, 615 patients underwent revascularization for ALI, according to the Swedish Vascular Registry (SWEDVASC). Using the National Diabetes Registry (NDR), 245 (39.8%) of the patients were identified as having T2DM. Uni- and multivariable Cox or logistic regression analyses were performed to evaluate risk differences for major amputation, mortality, major adverse cardiovascular events (MACE), and fasciotomy between patients with and without T2DM.</p><p><strong>Results: </strong>The rates of major amputation and mortality at one year were 32.7% and 21.6% in the T2DM group, compared to 21.9% and 31.9% in the non-DM group, respectively, resulting in a hazard ratio (HR) of 1.52 (95% confidence interval [CI] 1.12-2.07) for major amputation and HR of 0.64 (95% CI 0.46-0.88) for mortality. At one year, the HR for major amputation was 1.45 (95% CI 0.99-2.11), HR for mortality 0.92 (95% CI 0.61-1.39), HR for combined major amputation/mortality 1.27 (95% CI 0.94-1.72), and HR for MACE 1.24 (95% CI 0.92-1.67) for those with T2DM compared to those without in the multivariable Cox-regression analyses. The multivariable logistic regression analysis showed significantly lower odds of fasciotomy, OR 0.1 (95% CI 0.01-0.51) in the T2DM-group.</p><p><strong>Conclusion: </strong>T2DM was not significantly associated with higher hazard of major amputation, mortality, combined major amputation/mortality, or MACE after revascularization for ALI, compared to patients without T2DM. Patients with T2DM had significantly lower odds of fasciotomy.</p>","PeriodicalId":23597,"journal":{"name":"Vascular Health and Risk Management","volume":"21 ","pages":"229-238"},"PeriodicalIF":2.6,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11998955/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143983534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-10eCollection Date: 2025-01-01DOI: 10.2147/VHRM.S510121
Paolo Sbarzaglia, Mattia Galli, Elena Tenti, Diego Sangiorgi, Maria Letizia Lunetto, Paolo Russo, Armando Liso, Vincenzo Pernice, Antonio Micari, Fausto Castriota
Background: The clinical performance of drug-coated balloons (DCBs) for the treatment of femoro-popliteal lesions may depend on the specific device used. There is limited evidence on the clinical safety and efficacy of the paclitaxel-coated device Stellarex® for the treatment of long (>180 mm) femoro-popliteal lesions.
Methods: This is a single arm, prospective, open label, observational study including symptomatic patients with long femoro-popliteal lesions undergoing endovascular revascularization with Stellarex® DCB. The primary endpoints were the safety and efficacy of the DCB over time. Secondary endpoints were represented by functional outcomes.
Results: Ninety-five patients (median age 72, lesion length 250 mm) were included. At 6 months after the procedure, 61% of patients were asymptomatic as defined by the Rutherford classification, decreasing over time (57% at 12 months, 56% at 24 months, 44% at 36 months). Walking Impairment Questionnaire showed a remarkable improvement at 6 months, with a decreasing trend over time. When single components were analysed, better performances were observed for distance and climbing scores throughout the study period, while speed returned to baseline levels after 24 months. EQ5D Questionnaire showed a statistically significant improvement throughout the study period (with a decreasing trend over time, as seen for Rutherford classification and Walking Impairment Questionnaire). During the 36-months follow-up, 9% of patients died, with previous limb amputation being an independent predictor of mortality (HR = 7.4, p = 0.013). One-year primary patency was 76.5%, with no significant difference compared to the reference rate of 80% (p = 0.810). Primary patency defined as PSVR ≤2.4 (peak systolic velocity ratio) was maintained over time (median survival time free from PSVR >2.4 was not assessable as it exceeded the 36 months of follow-up).
Conclusion: In our sample, Stellarex showed to be safe and effective and it was associated with an event rate comparable to other devices reported in literature.
{"title":"Safety and Efficacy of a Paclitaxel-Coated Balloon for the Treatment of Symptomatic Patients with Long Superficial Femoral Artery Disease.","authors":"Paolo Sbarzaglia, Mattia Galli, Elena Tenti, Diego Sangiorgi, Maria Letizia Lunetto, Paolo Russo, Armando Liso, Vincenzo Pernice, Antonio Micari, Fausto Castriota","doi":"10.2147/VHRM.S510121","DOIUrl":"https://doi.org/10.2147/VHRM.S510121","url":null,"abstract":"<p><strong>Background: </strong>The clinical performance of drug-coated balloons (DCBs) for the treatment of femoro-popliteal lesions may depend on the specific device used. There is limited evidence on the clinical safety and efficacy of the paclitaxel-coated device Stellarex<sup>®</sup> for the treatment of long (>180 mm) femoro-popliteal lesions.</p><p><strong>Methods: </strong>This is a single arm, prospective, open label, observational study including symptomatic patients with long femoro-popliteal lesions undergoing endovascular revascularization with Stellarex<sup>®</sup> DCB. The primary endpoints were the safety and efficacy of the DCB over time. Secondary endpoints were represented by functional outcomes.</p><p><strong>Results: </strong>Ninety-five patients (median age 72, lesion length 250 mm) were included. At 6 months after the procedure, 61% of patients were asymptomatic as defined by the Rutherford classification, decreasing over time (57% at 12 months, 56% at 24 months, 44% at 36 months). Walking Impairment Questionnaire showed a remarkable improvement at 6 months, with a decreasing trend over time. When single components were analysed, better performances were observed for distance and climbing scores throughout the study period, while speed returned to baseline levels after 24 months. EQ5D Questionnaire showed a statistically significant improvement throughout the study period (with a decreasing trend over time, as seen for Rutherford classification and Walking Impairment Questionnaire). During the 36-months follow-up, 9% of patients died, with previous limb amputation being an independent predictor of mortality (HR = 7.4, p = 0.013). One-year primary patency was 76.5%, with no significant difference compared to the reference rate of 80% (p = 0.810). Primary patency defined as PSVR ≤2.4 (peak systolic velocity ratio) was maintained over time (median survival time free from PSVR >2.4 was not assessable as it exceeded the 36 months of follow-up).</p><p><strong>Conclusion: </strong>In our sample, Stellarex showed to be safe and effective and it was associated with an event rate comparable to other devices reported in literature.</p>","PeriodicalId":23597,"journal":{"name":"Vascular Health and Risk Management","volume":"21 ","pages":"239-250"},"PeriodicalIF":2.6,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11995917/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144048977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}