Nationwide Study of the Outcome of Treatment of Lower Extremity Atherosclerotic Lesions With Endovascular Surgery With or Without Drug Eluting Methods in Patients With Diabetes.

CLINICAL IMPACT: This retrospective observational registry trial combines national registries for vascular surgical procedures and diabetes mellitus to clarify results of drug eluting technology in treating diabetic subjects with intermittent claudication or chronic limb threatening ischemia compared to treatment of non-diabetic subjects. As earlier proposed and showed in this trial, there may be an implication for a beneficial treatment efficacy with drug eluting therapy in the diabetic population with PAD compared to the non-diabetic population. A finding worth further exploration.

Management of Acute Lower Limb Ischemia Without Surgical Revascularization - A Population-Based Study.

OBJECTIVES: To evaluate outcomes of management without surgical revascularization in patients with acute lower limb ischemia (ALI) in a population-based setting. DESIGN: Retrospective observational population-based study. MATERIALS: Patients from Malmö, Sweden, hospitalized for ALI between 2015 and 2018. METHODS: In-hospital, surgical, radiological, and autopsy registries were scrutinized for descriptive data on ALI patients managed by endovascular and open vascular surgery, conservative vascular therapy, primary major amputation, and palliative care. RESULTS: Among 161 patients, 73 (45.3%) did not undergo any operative revascularization. Conservative vascular therapy, primary amputation, and palliative care were conducted in 25 (15.5%), 26 (16.1%), and 22 (13.7%) patients, respectively. Conservatively treated patients had Rutherford class ≥ IIb ischemia and embolic occlusion in 33% and 68% of cases, respectively. Their median C-reactive protein level at admission was 7 mg/L (interquartile range 2 - 31 mg/L). Among conservatively treated patients, anticoagulation therapy in half to full dose was given to 22 (88%) patients for six weeks or longer, and analgesics in low or moderate doses were given to twelve (48%) patients at discharge. The major amputation rate at 1 year was 8% among conservatively treated patients, and four patients with foot embolization had not undergone amputation at 1 year. CONCLUSION: Patients selected for initial conservative therapy of ALI with anticoagulation alone may have a good outcome, even when admitted with Rutherford class IIb ischemia. A low C-reactive protein level at admission seems to be a favorable marker when choosing conservative therapy. A prospective, preferably multicenter, study with a predefined protocol in these conservatively treated patients is warranted to better define the dose and length of anticoagulation therapy.

Oxidative stress-related genetic variation and antioxidant vitamin intake in intact and ruptured abdominal aortic aneurysm: a Swedish population-based retrospective cohort study.

AIMS: The aim of this study is to investigate how genetic variations in genes related to oxidative stress, intake of antioxidant vitamins, and any potential interactions between these factors affect the incidence of intact abdominal aortic aneurysm (AAA) and its rupture (rAAA), accounting for sex differences where possible. METHODS AND RESULTS: The present retrospective cohort study (n = 25 252) uses baseline single-nucleotide polymorphisms (SNPs) and total antioxidant vitamin intake data from the large population-based, Malmö Diet and Cancer Study. Cumulative incidence of intact AAA was 1.6% and of rAAA 0.3% after a median follow-up of 24.3 years. A variant in NOX3 (rs3749930) was associated with higher rAAA risk in males [adjusted hazard ratio (aHR): 2.49; 95% confidence interval (CI): 1.36-4.35] and the overall population (aHR: 1.88; 95% CI: 1.05-3.37). Higher intakes of antioxidant vitamins, riboflavin, and folate were associated with 20% and 19% reduced intact AAA incidence, respectively. Interestingly, the inverse associations between riboflavin and vitamin D intake with intact AAA incidence were stronger in the individuals carrying the NOX3 variant as compared with the wild-type recessive genotype, i.e. by 60% and 66%, respectively (P for interaction < 0.05). Higher riboflavin intake was associated with a 33% male-specific intact AAA risk reduction, while higher intake of vitamin B12 intake was associated with 55% female-specific intact AAA risk increase; both these associations were significantly modified by sex (P for interaction < 0.05). CONCLUSIONS: Our findings highlight the role of oxidative stress genetic variations and antioxidant vitamin intake in AAA. Although a low AAA/rAAA sample size limited some analyses, especially in females, our findings highlight the need for future randomized controlled trials and mechanistic studies, to explore the potential benefits of antioxidant vitamins while accounting for genetic and sex differences.

Abdominal aortic aneurysm (AAA) is an old age-related disease with lethal complication in the form of rupture (rAAA). Present study aimed to understand how genetic variations in oxidative stress­related genes and the intake of antioxidant vitamins influence the risk of AAA and rAAA. The study identified specific genetic differences associated with an increased risk of rAAA. Interestingly, higher intakes of riboflavin and folate were linked to a reduced risk of AAA. Interestingly, we observe that both genetics and sex modify the effect of vitamin intake on intact AAA risk, providing new insight into the individual differences in the benefits of vitamins. Although the low sample for rAAA and females limits some conclusions, the findings emphasize the need for future randomized controlled trials to explore the potential benefits of antioxidant vitamins while accounting for genetic and sex differences.

A population-based study on hyperinsulinaemia and arterial stiffness in men with and without abdominal aortic aneurysm.

Objectives: Patients with type 2 diabetes mellitus (DM) run lower risk for abdominal aortic aneurysm (AAA, aortic diameter ≥ 30 mm) and its complications. We aimed to evaluate associations between disturbances in glucose metabolism and arterial stiffness, AAA, and abdominal aortic diameter in 65-year-old men. Methods: Forty-eight 65-year-old men with screening-detected AAA and 115 men with normal abdominal aortic diameter underwent examination of glucose metabolism and arterial stiffness. Results: Men with AAA had higher BMI, waist-hip ratio (WHR), frequency of DM, haemoglobin A1c, smoking exposure, and plasma insulin levels at 0, 60 and 120 min during OGTT compared to those without. The increase in p-insulin (P < 0.001) after OGTT was also higher in men with AAA, adjusted for smoking, WHR, and nadir value of p-insulin. In analyses adjusted for smoking, use of lipid-lowering agents, and WHR, the increase in p-insulin at 2-hours (P = 0.006) after OGTT and p-homocysteine were associated with abdominal aortic diameter. There were no differences between groups in aortic stiffness or skin autofluorescence Advanced Glycation End products. Conclusion: In this population-based study hyperinsulinaemia as a marker of insulin resistance, but not hyperglycaemia or aortic stiffness, was associated with AAA and abdominal aortic diameter in 65-year-old men.

Patient Experiences after Open Trigger Finger Release in Patients with Type 1 and Type 2 Diabetes-A Retrospective Study Using Patient-reported Outcome Measures.

Trigger finger is overrepresented among patients with diabetes mellitus (DM). Whether DM affects the outcome after open trigger finger release (OTFR) in patients with DM is not known. Our aim was thus to explore outcomes after OTFR in patients with type 1 (T1D) and type 2 DM (T2D). Methods: Data included patient-reported outcome measures (PROMs) from all OTFRs performed between 2010 and 2020 registered in the Swedish national registry for hand surgery in individuals over 18 years cross-linked with the Swedish National Diabetes Register (NDR). PROMs included QuickDASH and HQ8, a questionnaire designed for national registry for hand surgery, preoperative and at 3 and 12 months postoperative. HQ8 included pain on load, pain on motion without load, and stiffness. Outcome was calculated using linear-mixed models and presented as means adjusted for age and stratified by sex. Results: In total, 6242 OTFRs were included, whereof 496 had T1D (332, 67% women) and 869 had T2D (451, 52% women). Women with T1D reported more symptoms of stiffness (P < 0.001), and women with T2D reported more pain on load (P < 0.05), motion without load (P < 0.01), and worse overall result at 3 months. At 12 months, however, no differences were found in any of the HQ-8 PROMs among men or women. Women with T2D had slightly higher QuickDASH scores at 3 and 12 months. Conclusion: Patients with T1D and T2D can expect the same results after OTFR as individuals without DM, although the improvement might take longer especially among women with T2D.

Glycemic control and outcome after carotid intervention in patients with T2D: A Swedish nationwide cohort study.

AIMS: To investigate the association between glycemic control and outcome in people with type 2 diabetes (T2D) after carotid intervention due to carotid stenosis. METHODS: Observational nationwide population-based cohort study using inverse probability treatment weighting (IPTW) and Cox regressions with covariates, that is, 4 stepwise models, investigating the relationship between terciles of glycated hemoglobin (HbA1c) levels and stroke or death. RESULTS: 1115 subjects with T2D undergoing carotid intervention were included during Jan 1st 2009 to Dec 31st 2015. Divided into terciles, with a mean HbA1c level of 44 (tercile 1), 53 (tercile 2), and 72 (tercile 3) mmol/mol. By using IPTW and Cox regression, each model was stepwise introduced for the investigating of relative risks, that is, hazard ratios (HRs) with associated 95% confidence intervals (CI). There was a significant increased risk for stroke or death, in every model observed for tercile 3, compared to tercile 1: HR for model 4: 1.35 (95% CI 1.02-1.78). No difference for stroke or death within 30 days was observed between the groups. CONCLUSION: Poor glycemic control in people with T2D after carotid intervention is associated with an increased long-term risk for stroke or death.

Associations between physical activity and autonomic function during deep breathing test: the Swedish CArdioPulmonary bioImage Study (SCAPIS).

PURPOSE: The deep breathing test (DBT) is a sensitive test of cardiovagal function. The aim of this study was to explore associations between physical activity and sedentary time, measured by accelerometer, and autonomic function, using DBT. METHODS: In the Swedish Cardio-Pulmonary bioImage Study, men and women aged 50-64 were randomly invited from the general population. A total of 4325 subjects who underwent DBT and assessment of physical activity and sedentary time by accelerometery were included. ECG files from 1-min DBT were used to calculate measures of respiratory sinus arrhythmia [RSA; expiration-inspiration (E-I) difference and E/I ratio], heart rate variability [HRV; root mean square of successive differences (RMSSD), standard deviation of heart rates and mean circular resultant]. Low RSA and HRV was defined as the lowest 10% in the population. RESULTS: For accelerometer-assessed physical activity, there were significant associations between high percentage of sedentary time and low E/I (p < 0.01), and low RMSSD (p < 0.01) in an age- and sex-adjusted model, and between percentage of sedentary time and low RMSSD (p = 0.04) in a risk factor-adjusted model. Low RMSSD was less common in those with a high percentage of moderate to vigorous physical activity (p = 0.04, after risk-factor adjustment). These associations became non-significant when further adjusting for heart rate. CONCLUSION: We report associations between degree of physical activity and indices of autonomic dysfunction in a large population. The relationships were no longer significant after adjustments for heart rate, indicating that the relationship between physical activity and cardiovagal function partly is accounted for by reduced heart rate.

Characterization of the Mitochondrial Genetic Landscape in Abdominal Aortic Aneurysm.

Background Abdominal aortic aneurysm (AAA) is a vascular disease with a mortality rate of >80% if ruptured. Mitochondrial dysfunction has been previously implicated in AAA pathogenesis. In this study, we aimed to characterize the mitochondrial genetic landscape in AAA. Methods and Results Whole mitochondrial genome sequencing and bioinformatics analysis were performed in comorbidity matched 48 cases without AAA and 48 cases with AAA, objectively diagnosed, and selected from a cohort of 65-year-old men recruited for a screening program. We identified differential mutational landscapes in men with and without AAA, with errors in mitochondrial DNA replication or repair as potential sources. Heteroplasmic insertions and overall heteroplasmy of structural rearrangements were significantly elevated in AAA cases. Three heteroplasmic variants were associated with risk factors of AAA: leukocyte concentration, plasma glucose, and cholesterol levels, respectively. Interestingly, mutations were more prevalent in regulatory part of the mitochondria, the displacement loop region, in AAA as compared with controls (P value <0.05), especially in the conserved and critical mitochondrial extended termination-associated sequence region. Moreover, we report a novel 24 bp mitochondrial DNA duplication present exclusively in cases with AAA (4%) and 75% of the unmatched AAA biopsies. Finally, the haplogroup cluster JTU was overrepresented in AAA and significantly associated with a positive family history of AAA (odds ratio, 2.9 [95% CI, 1.1-8.1]). Conclusions This is the first study investigating the mitochondrial genome in AAA, where important genetic alterations and haplogroups associated with AAA and clinical risk factors were identified. Our findings have the potential to fill in gaps in the missing genetic information on AAA.

Randomized clinical Trial Comparing drug Eluting Stent Zilver PTX® Versus Bare Metal Stent Zilver Flex® for Treatment of Lesions in Femoral and Popliteal Arteries in Chronic Limb Threatening Ischemia.

OBJECTIVE: Drug eluting stents (DES) might improve the results of stenting in the femoropopliteal (FP) segment, but randomized data between DES and BMS in the treatment of patients with chronic limb threatening ischemia (CLTI) is lacking. The aim of this study was to perform a randomized comparison, between DES and bare metal stent (BMS) implantation in a subgroup of CLTI patients with lesions in the superficial femoral artery (SFA) and the P1-P2 portion of the popliteal artery. METHODS: Patients presenting with CLTI scheduled for endovascular treatment of FP lesions were randomly assigned by blinded envelopes 1:1 in a single blinded, parallel group design to DES or BMS after lesion crossing. Primary endpoints were target lesion revascularization (TLR) at 12 and 24 months and primary patency at 12 and 24 months. Secondary endpoints were technical success (TS), clinical success, secondary patency at 12 and 24 months, limb salvage, serious adverse events (SAE) at 24 month and survival at five years. RESULTS: A total of 48 CLTI patients and 49 limbs, were enrolled, 22 in the BMS group and 27 in the DES group. Demographics, comorbidities, and Rutherford class were similar in both treatment arms. The overall rate of total occlusions was 96% and the corresponding overall median lesion length was 240 mm. No patients were lost to follow up. No significant differences were detected between groups regarding TLR and primary patency. The overall primary patency at 12 and 24 months was 42.9% and 36.7% respectively and the overall freedom from TLR was 67.3% and 61.2% respectively. The results in the two groups were also similar regarding secondary outcomes. CONCLUSIONS: This single centre, randomized study could not demonstrate superiority of DES compared to BMS when treating long FP lesions in patients with CLTI but was limited by insufficient patient inclusion.

Long Term Results of a Randomised Trial of Stenting of the Superficial Femoral Artery for Intermittent Claudication.

OBJECTIVE: Primary stenting of the superficial femoral artery (SFA) in intermittent claudication (IC) has been shown to increase health related quality of life (HRQoL) after 12 and 24 months. An extended follow up of HRQoL 36 and 60 months after randomisation is presented. METHODS: A multicentre randomised controlled trial was conducted at seven vascular clinics in Sweden between 2010 and 2020. One hundred patients randomised to either primary stenting and best medical treatment (BMT; n = 48) or BMT alone (n = 52) were followed for 60 months. HRQoL, assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 36 and 60 months after randomisation, was the primary outcome. Walking Impairment Questionnaire (WIQ) score, re-interventions, progression to chronic limb threatening ischaemia (CLTI), amputation, and death were secondary outcomes. RESULTS: At the 36 month follow up, the stent group (n = 32) had statistically significantly better scores in the SF-36 domain "Role Physical" (p = .023) and the Physical Component Summary (p = .032) compared with the control group (n = 30); however, there was no statistically significant difference in EQ5D scores (p = .52). WIQ was statistically significantly better in the stent group compared with the control group (p = .029) at 36 months. At the 60 month follow up, no statistically significant difference in HRQoL was seen between patients in the stent (n = 31) and control groups (n = 32). Crossover from the control group to the stent group was 25% at 60 months. There were no differences in progression to CLTI, amputation (2.1% vs. 1.9%), or mortality (14.6% vs. 15.4%) between groups. CONCLUSION: In patients with IC caused by isolated SFA lesions, primary stenting conferred benefits to HRQoL until 36 months from treatment vs. BMT alone, but these benefits were no longer detectable at 60 months, where a high crossover rate affected the power of the final analysis.

Abdominal aortic aneurysm growth rates are not correlated to body surface area in screened men.

BACKGROUND: Screening for abdominal aortic aneurysm (AAA) in 65-year-old males reduces aneurysm related mortality. Infrarenal aortic diameter (IAD) has been shown to correlate to body surface area (BSA) which could influence diagnostic criteria for AAA. This study investigates whether AAA growth rates are also dependent on BSA, as that might have potential effects on surveillance of small AAAs. METHODS: We conducted a retrospective, single center cohort study of 301 men with screening detected AAA between 2010-2017 with surveillance to 2021. AAA growth rates were analyzed in relation to the subject's BSA, smoking habits, and diabetic disease using a linear mixed-effects model. All men were offered smoking cessation program, optimized medical treatment, and advice on physical activity. RESULTS: The screening program included 28,784 men. Of the 22,819 (79%) attending the examinations, 374 men (1.6%) were found to have an AAA out of which 301 men had undergone two or more examinations during surveillance and were included with a median follow-up of 1846 days (IQR: 1 399). Mean unadjusted AAA growth rate was 1.60 mm/year (95% CI: 1.41-1.80). Diabetes mellitus had a statistically significant negative impact, smoking had a statistically significant positive impact on AAA growth rates whereas no correlation between AAA growth rate and BSA could be found. CONCLUSIONS: Body surface area could not be found to have a statistically significant correlation to AAA growth rates. The impact of smoking and diabetes on AAA growth rates remains similar to previously reported.

Obesity is associated with coronary artery stenosis independently of metabolic risk factors: The population-based SCAPIS study.

BACKGROUND AND AIMS: Previous studies reported divergent results on whether metabolically healthy obesity is associated with increased coronary artery calcium and carotid plaques. We investigated this in a cross-sectional fashion in a large, well-defined, middle-aged population using coronary CT angiography (CCTA) and carotid ultrasound. METHODS: In the SCAPIS study (50-65 years, 51% female), CCTA and carotid artery ultrasound were performed in 23,674 individuals without clinical atherosclerotic disease. These subjects were divided into six groups according to BMI (normal weight, overweight, obese) and the presence of metabolic syndrome (MetS) according to the NCEP consensus criteria. RESULTS: The severity of coronary artery stenosis was increased in individuals with obesity without MetS compared to normal-weight individuals without MetS (OR 1.47, 95%CI 1.34-1.62; p < 0.0001), even after adjusting for non-HDL-cholesterol and several lifestyle factors. Such difference was not observed for the presence of carotid artery plaques (OR 0.94, 95%CI 0.87-1.02; p = 0.11). Obese or overweight individuals without any MetS criteria (except the waist criterion) showed significantly more pronounced stenosis in the coronary arteries as compared to the normal-weight individuals, while one criterion was needed to show increased plaque prevalence in the carotid arteries. High blood pressure was the most important single criterion for increased atherosclerosis in this respect. CONCLUSIONS: Individuals with obesity without MetS showed increased severity of coronary artery stenosis, but no increased occurrence of carotid artery plaques compared to normal-weight individuals without MetS, further emphasizing that obesity is not a benign condition even in the absence of MetS.

High HbA1c Levels Are Associated With Development of Trigger Finger in Type 1 and Type 2 Diabetes: An Observational Register-Based Study From Sweden.

OBJECTIVE: Trigger finger (TF) is a hand disorder causing the fingers to painfully lock in flexion. Diabetes is a known risk factor; however, whether strict glycemic control effectively lowers risk of TF is unknown. Our aim was to examine whether high HbA1c was associated with increased risk of TF among individuals with diabetes. RESEARCH DESIGN AND METHODS: The Swedish National Diabetes Register (NDR) was cross-linked with the health care register of the Region of Skåne in southern Sweden. In total, 9,682 individuals with type 1 diabetes (T1D) and 85,755 individuals with type 2 diabetes (T2D) aged ≥18 years were included from 2004 to 2019. Associations between HbA1c and TF were calculated with sex-stratified, multivariate logistic regression models with 95% CIs, with adjustment for age, duration of diabetes, BMI, and systolic blood pressure. RESULTS: In total, 486 women and 271 men with T1D and 1,143 women and 1,009 men with T2D were diagnosed with TF. Increased levels of HbA1c were associated with TF among individuals with T1D (women OR 1.26 [95% CI 1.1-1.4], P = 0.001, and men 1.4 [1.2-1.7], P < 0.001) and T2D (women 1.14 [95% CI 1.2-1.2], P < 0.001, and men 1.12 [95% CI 1.0-1.2], P = 0.003). CONCLUSIONS: Hyperglycemia increases the risk of developing TF among individuals with T1D and T2D. Optimal treatment of diabetes seems to be of importance for prevention of diabetic hand complications such as TF.

[The quest for protective mechanisms against cardiovascular disease]. / Kardiovaskulära händelser ­ varför drabbas inte alla?

In spite of a major risk factor burden or existing co-morbidities certain individuals seem to escape or substantially delay major clinical cardiovascular (CV) events. Besides random variation of disease onset and manifestations it is therefore likely that protective mechanisms exist to postpone or prevent disease. Such processes could involve genetic predisposition, metabolic traits, lifestyle, or other unknown factors. Definition, mapping, and characterization of true protective mechanisms for CV disease by use of omics and biomarkers together with questionnaire data, as well as cardiovascular and metabolic phenotyping in subjects "escaping" a high expected CV risk, might enable identification of potential new drug targets associated with CV protection.

Circulating Biomarkers in Lower Extremity Artery Disease.

Lower extremity artery disease (LEAD), a chronic condition with disturbed lower extremity circulation due to narrowing of the arteries, is predominantly caused by atherosclerosis and is associated with the presence of cardiovascular risk factors and an increased risk of cardiovascular events. LEAD is prevalent among older individuals and predicted to rise with the ageing population. In progressive disease, the patient experiences symptoms of ischaemia when walking and, in advanced critical limb-threatening ischaemia, even at rest. However, LEAD is asymptomatic in most patients, delaying diagnosis and treatment. In this setting, circulating biomarkers may facilitate earlier diagnosis in selected individuals. This review provides a broad overview of the circulating biomarkers investigated to date in relation to LEAD and discusses their usefulness in clinical practice.

Novel cardiovascular biomarkers associated with peripheral arterial disease in men screened for abdominal aortic aneurysm.

Background: Peripheral arterial disease (PAD) is a common atherosclerotic disease with severity ranging from asymptomatic to chronic limb threatening ischemia. The aim of the present cross-sectional study was to identify novel biomarkers associated with PAD. Patients and methods: Levels of 91 cardiovascular specific proteins in plasma samples were measured by the Proseek Multiplex CVD III96x96 panel from a cohort consisting of 267 65-year-old men recruited from a screening program for abdominal aortic aneurysm (AAA) Levels of protein biomarkers were compared in men with and without PAD (defined as an ankle brachial index of <0.9) and their diagnostic potential was calculated by receiver-operating characteristic analysis. Results: The prevalence of PAD was 14.2% (38/267). After adjustment for multiple comparisons, levels of the following 11 biomarkers remained significantly higher (p<0.0001) in patients with PAD: secretoglobin family 3A member 2, osteoprotegerin, urokinase-type plasminogen activator surface receptor, serum macrophage chemokine ligand 16, matrix metalloproteinase 9, p-selectin, growth differentiation factor 15, elafin, cystatin B, trefoil factor 3, and fatty acid-binding protein 4. Multivariable logistic regression analysis (adjusted for smoking, use of antihypertensive and lipid-lowering medication, and metformin) showed that 11 biomarkers were significantly associated with higher risk of PAD with odds ratios ranging from 1.6 to 2.4. Area under curve calculated by receiver operating characteristic curve analysis (diagnostic value) for each protein biomarker ranged from 0.63 to 0.74. Conclusions: We have identified multiple proteins with a potential to be diagnostic biomarkers for PAD, and further research is warranted to clarify their potential predictive and prognostic value.

Drug-eluting balloon (DEB) versus plain old balloon angioplasty (POBA) in the treatment of failing dialysis access: A prospective randomized trial.

OBJECTIVE: To compare the efficacy of angioplasty using drug-eluting balloons (DEB) compared with plain old balloon angioplasty (POBA) to reduce the rate of restenosis. METHODS: This prospective, single-centre, single-blinded, 1:1 randomized, clinical trial enrolled patients that had primary or restenotic lesions in native upper extremity arteriovenous (AV) fistulas or at the graft-venous anastomosis. Patients were randomized to angioplasty with a POBA or a DEB. The primary effectiveness endpoints were freedom from target lesion revascularization (TLR) and functional status of access circuit at 12 months. RESULTS: A total of 42 (28 male, 14 female; age range, 42-83 years) patients were enrolled. Patients were followed for 12 months. No significant differences were detected between the POBA and DEB groups regarding total number of TLR procedures (31 versus 36, respectively), freedom from TLR (3 versus 4, respectively) and functional status of the access circuit at 12 months (14 of 20 patients [70%] versus 17 of 22 patients [77%], respectively). CONCLUSION: This clinical trial did not demonstrate any significant differences between DEB angioplasty and standard balloon angioplasty when treating dysfunctional haemodialysis access.