Peripheral Arterial Disease Population Research Articles

Influenza vaccination coverage and determinants of vaccination in peripheral arterial disease patients.

Background: In the latest American Heart Association guidelines, influenza vaccination is recommended for patients with peripheral arterial disease (PAD). The vaccination coverage in this specific population is currently unknown. This study aims to determine the adherence to influenza vaccination in a PAD population and identify associated determinants. Patients and methods. Hospitalized patients and outpatients with PAD from two university departments of vascular medicine were prospectively included. A questionnaire was administered to collect sociodemographic data, cardiovascular risk factors, influenza vaccination status, history of cardiovascular disease, and perception and knowledge about vaccination. Logistic regression was conducted to assess vaccination determinants. Results: Over a six-month period, 494 patients were included (median age 69.5, IQR [63-77], 78% male). Overall, 60.1% were either vaccinated or intended to be (Group 1). Vaccination was associated with age (odds-ratio [OR]=1.055, 95% confidence intervals [95%CI]: 1.035-1.075, p<0.0001), abdominal aorta aneurysm (OR=0.390, 95%CI: 0.229-0.664, p=0.001), chronic obstructive pulmonary disease (OR=0.545, 95%CI: 0.367-0.810, p=0.003), chronic renal disease (OR=0.630, 95%CI: 0.400-0.993, p=0.046), and valvulopathy (OR=2.444, 95%CI: 1.122-5.326, p=0.025). Only 25.3% received vaccination information mainly from their general practitioners. Among patients against vaccination, 59.9% considered themselves not concerned about potential influenza consequences on their PAD, and 37.6% did not intend to change their decision. Conclusions: This study highlights the low adherence to influenza vaccination in the PAD population of 2 university hospital centers. Vaccination is often related to age, and there is a need for adapted information regarding influenza consequences on cardiovascular disease overall, particularly on PAD. Addressing common information and advice about vaccination will be a challenge.

Rationale and design for the randomized placebo-controlled double-blind trial studying the effect of single antiplatelet therapy (clopidogrel) versus dual antiplatelet therapy (clopidogrel/acetylsalicylic acid) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty (CLEAR-PATH)

RationaleAntiplatelet therapy (APT) is the standard of care after endovascular revascularization (EVR) in patients with peripheral artery disease (PAD). APT aims to prevent both major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Nonetheless, the rates of MACE and MALE after EVR remain high. In coronary artery and cerebrovascular disease, dual APT (DAPT)compared to acetylsalicylic acid alone has proven to reduce MACE without increasing the risk of major bleeding when applied for a restricted number of weeks. However, within the PAD population, insufficient data are available to understand the potential attributable effect of DAPT over single APT (SAPT). Therefore, prospective randomized studies in targeted study populations are warranted. Trial designCLEAR-PATH is a Dutch multicenter, double-blind, placebo-controlled, randomized trial comparing SAPT (clopidogrel 75mg plus placebo) with DAPT (clopidogrel 75mg plus acetylsalicylic acid 80mg) in patients with PAD undergoing EVR. CLEAR-PATH includes a time-to-event analysis with a follow-up of one year. The primary composite efficacy endpoint consists of all-cause mortality, nonfatal stroke, nonfatal myocardial infarction, severe limb ischemia, (indication for) re-intervention due to any symptomatic restenosis, re-occlusion, or due to acute limb ischemia, and major amputation. The primary safety endpoint contains major bleeding following the Thrombolysis In Myocardial Infarction classification. The enrolment started in August 2022. In total 450 primary efficacy outcome events are required which expectedly amounts to 1696 subjects. Recruitment will take approximately 36 months. ConclusionCLEAR-PATH will assess the efficacy and safety of DAPT compared to SAPT following EVR in PAD patients.

Correlation of Coronary Artery Disease in Patients with Peripheral Artery Disease: Cross-Sectional Study

Background Peripheral Artery Disease (PAD) and Coronary Artery Disease (CAD) represent two facets of atherosclerotic cardiovascular disease, significantly impacting global health. Despite their high morbidity and mortality rates, the epidemiological and clinical nexus between PAD and CAD remains underexplored. Understanding the interrelation of these conditions is paramount for optimizing diagnostic and therapeutic strategies. Objective This study aimed to delineate the incidence and clinical correlation of CAD in patients diagnosed with PAD, thereby providing insights into the epidemiological characteristics and enhancing the clinical management of these conditions. Methods A cross-sectional analysis was conducted at Afridi Medical Complex's departments of vascular surgery and cardiology from 2021 to 2023. One hundred PAD patients referred for peripheral angiography were enrolled. Demographic data, Ankle Brachial Index (ABI) readings, ejection fraction percentages, and the presence of multivessel disease were evaluated. Statistical analyses were performed using SPSS version 25, focusing on mean, median, range, and significance levels to elucidate the prevalence of CAD among PAD patients. Results The study revealed a median age of 58 years among participants, with a significant male predominance (84%). ABI analysis showed that 74% and 108% of patients had mild and moderate PAD severity, respectively. The incidence of CAD in the PAD population was 56%, with angiographic assessments indicating single, double, and triple vessel disease in 23.21%, 39.29%, and 37.5% of patients, respectively. Notably, diabetes and dyslipidemia were prominent predictors of CAD presence in PAD patients. Conclusion The high prevalence of CAD in PAD patients underscores the critical need for comprehensive cardiovascular risk assessment and suggests the potential benefit of routine coronary angiography in symptomatic PAD cases, particularly among those with diabetes and dyslipidemia. This study reinforces the intertwined nature of PAD and CAD, advocating for an integrated approach to the diagnosis and management of these atherosclerotic conditions.

Preclinical systolic dysfunction relating to ankle-brachial index among high-risk PAD population with preserved left ventricular ejection fraction

Peripheral artery disease (PAD) shares common clinical risk factors, for example, endothelial dysfunction, with preserved ejection fraction (LVEF) heart failure (HFpEF). Whether PAD is associated with preclinical systolic dysfunction and higher HF risk among individuals presenting preserved LVEF remains uncertain. We retrospectively included outpatients with at least one known or established cardiovascular (CV) risk factor with LVEF ≥ 50%. Patients were categorized into high risk and low risk of developing PAD (PAD vs Non-PAD) by ankle-brachial index (ABI) (≤ 0.90 or > 1.4) and further stratified based on their history of HFpEF (HFpEF vs. Non-HFpEF), resulting in the formation of four distinct strata. Preclinical systolic dysfunction was defined using dedicated speckle-tracking algorithm. A total of 2130 consecutive patients were enrolled in the study, with a median follow-up of 4.4 years. The analysis revealed a higher prevalence of high risk of developing PAD in patients with HFpEF compared to those without HFpEF (25.1% vs. 9.4%). Both high risk of developing PAD and HFpEF were independently associated with preclinical systolic dysfunction (global longitudinal strain, GLS ≥ − 18%) (odds ratio, OR: 1.38; 95% confidence interval, CI: 1.03–1.86). In comparison to patients at low risk of developing PAD without HFpEF (Non-PAD/Non-HFpEF group), those categorized as having a high risk of developing PAD with HFpEF (PAD/HFpEF group) exhibited the most impaired GLS and a heightened susceptibility to heart failure hospitalization (hazard ratio, HR: 6.51; 95% CI: 4.43–9.55), a twofold increased risk of all-cause mortality (HR: 2.01; 95% CI: 1.17–3.38), cardiovascular mortality (HR: 2.44; 95% CI: 1.08–5.51), and non-cardiovascular mortality (HR: 1.78; 95% CI: 0.82–3.84). A high risk of developing PAD was strongly linked to impaired preclinical systolic function and an increased likelihood for subsequent hospitalization for HF, all-cause mortality, CV mortality and non-CV mortality. There is a clear need for preventive strategies aimed at reducing hospitalizations for HF and mortality in this high-risk population.

Bleeding Risk Prediction in Patients Treated with Antithrombotic Drugs According to the Anatomic Site of Bleeding, Indication for Treatment, and Time Since Treatment Initiation.

Background Reasons for the relatively poor performance of bleeding prediction models are not well understood but may relate to differences in predictors for various anatomical sites of bleeding. Methods We pooled individual participant data from four randomized controlled trials of antithrombotic therapy in patients with coronary and peripheral artery diseases, embolic stroke of undetermined source (ESUS), or atrial fibrillation. We examined discrimination and calibration of models for any major bleeding, major gastrointestinal (GI) bleeding, and intracranial hemorrhage (ICH), according to the time since initiation of antithrombotic therapy, and indication for antithrombotic therapy. Results Of 57,813 patients included, 1,948 (3.37%) experienced major bleeding, including 717 (1.24%) major GI bleeding and 274 (0.47%) ICH. The model derived to predict major bleeding at 1 year from any site (c-index, 0.69, 95% confidence interval [CI], 0.68-0.71) performed similarly when applied to predict major GI bleeding (0.71, 0.69-0.74), but less well to predict ICH (0.64, 0.61-0.69). Models derived to predict GI bleeding (0.75, 0.74-0.78) and ICH (0.72, 0.70-0.79) performed better than the general major bleeding model. Discrimination declined over time since the initiation of antithrombotic treatment, stabilizing at approximately 2 years for any major bleeding and major GI bleeding and 1 year for ICH. Discrimination was best for the model predicting ICH in the ESUS population (0.82, 0.78-0.92) and worst for the model predicting any major bleeding in the coronary and peripheral artery disease population (0.66, 0.65-0.69). Conclusion Performance of risk prediction models for major bleeding is affected by site of bleeding, time since initiation of antithrombotic therapy, and indication for antithrombotic therapy.

Benefits of Integrating Technology into Home Exercise Therapy in Patients with Lower Extremity Peripheral Artery Disease.

(1) Background: Telerehabilitation is an approach that uses digital technology to provide remote medical recovery services. It can be an option for cardiovascular recovery at home in patients with peripheral arterial disease (PAD) of the lower limbs. (2) Methods: We performed literature research through two databases: PubMed and Embase. We included randomized controlled trials and cohort studies that evaluated the effectiveness of a technology-assisted home exercise intervention compared with conventional rehabilitation or the usual care in patients with PAD. We analyzed population, intervention, and outcome data. (3) Results: We identified 2468 studies. After rigorous screening, we included 25 articles in the review. The following results were evaluated: dissemination and acceptance of digital technologies among these people, functional capacity, exercise intensity, patient motivation, sex-specific response differences in mortality and clinical outcomes, quality of life assessment, and changes in values of inflammatory biomarkers. All of these were correlated with the type of intervention and the dose of the exercise. (4) Conclusions: Home-based exercise therapy supervised with the help of specific devices could be successfully implemented in the therapeutic management of the PAD population. Health specialists should take into account the clinical-paraclinical profile and the emotional status of the patients. Such individualized interventions could bring significant benefits for the people with this disease and for the healthcare system, including increasing exercise adherence, engagement, self-care capacity, life expectancy, and quality of life for these patients, as well as reducing their symptoms, cardiovascular complications, and hospitalizations.

Underutilization of guideline-recommended therapy in patients 80 years and older with peripheral artery diseases

Abstract Background Ageing is a major cardiovascular risk factor with detrimental pathophysiological changes that culminate in a high atherosclerotic burden. Peripheral artery disease (PAD) is a major manifestation of atherosclerosis with high mortality. Guideline-recommended treatment is essential, however implementation is inadequate. With an ageing society, age-related inequalities are important and have not been elucidated in a high-risk PAD population on a nation-wide scale. We sought to analyse the outpatient treatment structures and guideline adherence in treatment of PAD patients older than 80 year of age. Purpose Aim of the study was to identify age-based inequalities in outpatient treatment care and pharmacotherapy in PAD patients. Methods We analyzed age-related differences in prevalence, pharmacotherapy (statins, antiplatelets) and treatment by specialized outpatient care (angiology, vascular surgery, internal medicine, cardiology) in 17,633,970 patients with PAD and statutorily insurance presenting to outpatient care facilities in Germany between 2009 and 2018. The study is based on ambulatory claims data of the panel doctors’ services according to §295 SGB V and drug prescription data according to §300 SGB V, comprising 70.1 million patients per year. Diagnosis of PAD was defined upon medical diagnoses of PAD ICD. Statistical analysis was performed with chi-squared test for trend and two-way Anova. Results Of 17,633,970 PAD patients included, 28% were older than 80 years. PAD prevalence increased between 2008 and 2019 (1.85% vs 3.14%), with the proportion of the elderly increasing by a third (24.4% vs 31.2%). Octogenarians were undertreated regarding guideline-recommended statin pharmacotherapy compared to younger patients throughout the observed 10 year time frame (statins 2016: 46.5% vs 52.4%; antiplatelets 2016 30.6% vs 29.3%; p &amp;lt; 0.05). Furthermore, octogenarians received less specialized outpatient care (angiology: 6.4% vs 9.5%, vascular surgery: 8.1% vs 11.8%, cardiology: 25.2% vs 29.2%, p &amp;lt; 0.05). Conclusions Our results demonstrate that age-related differences in pharmacotherapy and specialized outpatient care of PAD patients are evident. While overall guideline-recommended outpatient treatment is low, patients 80 years and older are less likely to receive both, leaving age-related health inequalities a challenge of our future.

Abstract 16398: Impact of Low-Dose Rivaroxaban Plus Aspirin on Total Vascular Events in Fragile Patients With Peripheral Artery Disease: Insights From VOYAGER PAD

Background: Rivaroxaban 2.5 mg BID reduced major adverse limb events (MALE) and total vascular events in patients with symptomatic peripheral artery disease (PAD) after lower extremity revascularization (LER) in VOYAGER PAD. The safety and efficacy of rivaroxaban on MALE and total vascular events in fragile patients with PAD has not been described. Hypothesis and Methods: Patients were categorized as fragile based on prespecified criteria (age &gt; 75 years or weight ≤ 50 kg or baseline eGFR &lt; 50 mL/min). MALE was defined as composite of acute limb ischemia (ALI) and major amputation. Total vascular events include cardiovascular, MALE, peripheral revascularizations and venous thromboembolism events. Same-day vascular events are consolidated into a single event. The main safety outcome was TIMI major bleeding. Results: A total of 1,669 (25%) subjects of 6,564 randomized were categorized as fragile at baseline. Rivaroxaban reduced the risk of MALE particularly in fragile (HR 0.56; 95% CI 0.38 - 0.81) vs non-fragile patients (HR 0.82; 95% CI 0.67 - 1.00, p-interaction 0.07, figure upper panel) with the benefits in fragile patients driven by reduced ALI (HR 0.47; 95% CI 0.30 - 0.75). Rivaroxaban reduced the occurrence of total vascular events at 3 years in fragile patients with absolute rates of 82.1 events/100 patients on rivaroxaban vs 99.3 events/100 patients on placebo (HR 0.81; 95% CI 0.68 - 0.98). Similar benefit was seen in non-fragile patients 70.4 events/100 patients on rivaroxaban vs 81.6 events/100 patients on placebo, HR 0.90; 95% CI 0.81-1.00 (figure, lower panel). Rivaroxaban increased TIMI major bleeding similarly in fragile (HR 1.66; 95% CI 0.87 - 3.19) and non-fragile (HR 1.37; 95% CI 0.83 - 2.24, p-interaction 0.65). Conclusions: In a high-risk PAD population rivaroxaban reduces MALE and total vascular events and increases bleeding regardless of fragile status. These data may assist in personalization of antithrombotic therapy in this high-risk population.

Underutilization of guideline-recommended therapy in patients 80 years and older with peripheral artery diseases.

Background: Ageing is a major cardiovascular risk factor with detrimental changes that culminate in a high atherosclerotic burden. Peripheral artery disease (PAD) is a major manifestation of atherosclerosis with high mortality. Guideline-recommended treatment is essential, however implementation is inadequate. With an ageing society, age-related inequalities are important and have not been elucidated in a high-risk PAD population on a nation-wide scale. We sought to analyse outpatient treatment structures and guideline adherence in treatment of PAD patients older than 80 years. Patients and methods: The study is based on ambulatory claims data comprising 70.1 million statutorily insured patients per year in Germany from 2009 to 2018. We analysed age-related differences in prevalence, pharmacotherapy and specialized outpatient care in PAD patients. Results: Of 17,633,970 PAD patients included, 28% were older than 80 years. PAD prevalence increased between 2008 and 2018 (1.85% vs. 3.14%), with the proportion of older patients increasing by a third (24.4% vs. 31.2%). Octogenarians were undertreated regarding guideline-recommended statin pharmacotherapy compared to younger patients while antiplatelets were prescribed more often (statins 2016: 46.5% vs. 52.4%; antiplatelets 2016 30.6% vs. 29.3%; p<.05). Furthermore, octogenarians received less specialized outpatient care (angiology: 6.4% vs. 9.5%, vascular surgery: 8.1% vs. 11.8%, cardiology: 25.2% vs. 29.2%, p<.05). Conclusions: Our results demonstrate that age-related differences in pharmacotherapy and specialized outpatient care of PAD patients are evident. While overall guideline-recommended outpatient treatment is low, patients 80 years and older are less likely to receive both, leaving age-related health inequalities a challenge of our future.

Peripheral artery disease and extracorporeal membrane oxygenation: Examining a high-risk cohort over time.

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a resource-intensive approach for the management of refractory cardiogenic shock. Within this population exists a substantial cohort of patients with peripheral artery disease (PAD), which independently increases the risk of complications and all-cause mortality. We studied 10-year national trends of the impact of PAD among VA-ECMO recipients to better understand the prevalence of PAD and implications on outcomes in this vulnerable population. This 10-year retrospective, propensity score-matched study identified all adult patients (≥18) who underwent VA-ECMO between 2009 and 2018, from a large US database (National Inpatient Sample). Patients with an ICD diagnosis of PAD were identified. The primary endpoints of in-hospital mortality, bleeding complications and major limb loss (above- or below-knee amputation) were compared between patients with PAD to those without. A total of 6768 patients were identified, of which 342 (5.3%) had PAD. The median age at admission was significantly higher in PAD patients [64years vs. 55years; p < .01], as was male gender [71% vs. 64%; p < .01]. Patients with PAD had higher rates of smoking (38.9% vs. 23.3%), hypertension (71.1% vs. 50%), diabetes (37.4% vs. 27.0%), chronic kidney disease (30.1% vs. 18.0%), coronary artery disease (76.0% vs. 35.0%) and dyslipidemia (76.0% vs. 35.0); all p < .01. After propensity-matching 2:1 for comorbidities, PAD patients were found to have significantly greater overall complications, including in-hospital mortality, bleeding, surgical wound infections, pseudoaneurysms, and major adverse limb events [71.9% vs. 63.9%; p < .01]. Subgroup analysis revealed greater in-hospital mortality [62.2% vs. 55.3%; p < .05], major amputations [4.1% vs. 0.3%; p < .01] and blood transfusions [32.2% vs. 26.2%; p < .05] in PAD patients. Over 2014-2018, the non-PAD group demonstrated statistically discernable trends in a 51.1% decrease in overall complications and a 28.1% increase in survival to discharge (all p < .01). Over the same time period the PAD cohort experienced a modest, nonsignificant, decrease in complications [7.0%, p = .40] and a decrease in those surviving to discharge [47.1% vs. 40.5%, p = .91]. Patients with PAD on VA-ECMO are sicker at baseline and experience significantly greater major amputations and higher in-hospital mortality. They have not benefitted from the considerable decrease in complication rates and increase in survival to discharge over time as compared to their non-PAD counterparts. These findings demonstrate the substantial frailty of the PAD population within an already high-risk cohort, and highlight the need for better procedural approaches and innovative technologies.

Effects of SGLT2 inhibitors and GLP1-receptor agonists on cardiovascular and limb events in peripheral artery disease: A review.

Peripheral artery disease (PAD) and diabetes mellitus are two overwhelming health problems associated with major cardiovascular (CV) and limb events, in addition to increased mortality, despite advances in medical therapies including statins and renin-angiotensin system inhibitors. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1-receptor agonists (GLP1-RA) are two new antihyperglycemic drug classes that have been associated with a significant reduction of major adverse cardiovascular events (MACE) in patients with type 2 diabetes (T2D) and CV risk. Whereas most studies had enrolled patients with T2D and concurrent CV disease (CVD), patients with PAD were obviously underrepresented. Furthermore, there was a signal of increased risk of amputation in one of the main trials with canagliflozin. We aim to provide a general review of the current literature and summarize societal guideline recommendations addressing the role of SGLT2i and GLP1-RA drugs in patients with CVD focusing on the PAD population when data are available. Endpoints of interest were MACE and, when available, major adverse limb events (MALE).

Praliciguat Promotes Ischemic Leg Reperfusion in Leptin Receptor-Deficient Mice.

Lower-limb peripheral artery disease is one of the major complications of diabetes. Peripheral artery disease is associated with poor limb and cardiovascular prognoses, along with a dramatic decrease in life expectancy. Despite major medical advances in the treatment of diabetes, a substantial therapeutic gap remains in the peripheral artery disease population. Praliciguat is an orally available sGC (soluble guanylate cyclase) stimulator that has been reported both preclinically and in early stage clinical trials to have favorable effects in metabolic and hemodynamic outcomes, suggesting that it may have a potential beneficial effect in peripheral artery disease. We evaluated the effect of praliciguat on hind limb ischemia recovery in a mouse model of type 2 diabetes. Hind limb ischemia was induced in leptin receptor-deficient (Leprdb/db) mice by ligation and excision of the left femoral artery. Praliciguat (10 mg/kg/day) was administered in the diet starting 3 days before surgery. Twenty-eight days after surgery, ischemic foot perfusion and function parameters were better in praliciguat-treated mice than in vehicle controls. Improved ischemic foot perfusion was not associated with either improved traditional cardiovascular risk factors (ie, weight, glycemia) or increased angiogenesis. However, treatment with praliciguat significantly increased arteriole diameter, decreased ICAM1 (intercellular adhesion molecule 1) expression, and prevented the accumulation of oxidative proangiogenic and proinflammatory muscle fibers. While investigating the mechanism underlying the beneficial effects of praliciguat therapy, we found that praliciguat significantly downregulated Myh2 and Cxcl12 mRNA expression in cultured myoblasts and that conditioned medium form praliciguat-treated myoblast decreased ICAM1 mRNA expression in endothelial cells. These results suggest that praliciguat therapy may decrease ICAM1 expression in endothelial cells by downregulating Cxcl12 in myocytes. Our results demonstrated that praliciguat promotes blood flow recovery in the ischemic muscle of mice with type 2 diabetes, at least in part by increasing arteriole diameter and by downregulating ICAM1 expression.

Abstract 15676: Sex Differences in Leg Microvascular Arteriolar Function in Patients With Limb Ischemia

Introduction: There are known sex differences in peripheral artery disease (PAD) symptom presentation with women manifesting atypical symptoms and a higher vascular burden. Women are also more prone to periprocedural complications possibly due to sex-specific endothelial dysfunction and microvascular impairment. There is a critical need to understand sex specific differences in microvascular function to improve outcomes for women with PAD. Hypothesis: Lower limb arteriolar flow induced dilation (FID) will be significantly reduced in women, compared to men. Methods: Combined muscle and fat tissue were obtained from the affected leg in patients undergoing revascularization due to PAD. Arterioles were dissected, cannulated, and suspended in a physiological chamber at a stable intraluminal pressure. FID was assessed at increasing intraluminal pressure gradients. A subsample of vessels underwent arteriolar dilation with ACh with and without L-NAME, and SNP. Results: We quantified arteriolar FID in 24 arterioles (7=not viable) from 18 patients undergoing revascularization due to PAD (age 60.2 + 7.4, 44%=F, 61%=Black). Heterogeneity was observed in FID with significantly reduced response observed in women. FID in women at 60 cmH 2 O was 24.7 + 20.5%, compared to 52.6 + 28.0% in men, p=.05, and AUC was 69.0 + 66.8 in women, compared to 147.6 + 82.0 in men (p=.07). Findings were similar in both muscle and adipose arterioles. Vessels treated with Ach responded similar to FID. Vessels treated with L-NAME and SNP showed variable blunted response. Conclusions: Women had more impairment in arteriolar function compared to men, providing insight into sex dimorphism in the PAD population. Findings indicated that FID in arterioles is mostly nitric oxide dependent, although patient and sex specific changes in vascular smooth muscle signaling/function are present. This study support the need to develop microvascular and sex specific interventions for patients with PAD.

Cancer should not contravene the revascularization of chronic limb-threatening ischaemia.

This study aimed to examine the frequency of cancer among patients with chronic limb-threatening ischaemia (CLTI) due to peripheral artery disease (PAD) and to determine how active cancer affected outcomes after open or endovascular revascularization. In addition, we aimed to investigate all-cause mortality and cause of death in the PAD population. Observational single-centre cohort study based on a retrospective analysis of prospectively entered registry data. All consecutive patients treated for CLTI due to PAD at a single university centre between the 1st of January 2011 and the 31st of December 2015 were included. Data from the Danish Vascular Registry (Karbase) regarding demographics, surgical procedure, and complications were linked with data from the Danish Cancer Registry and Cause of Death Registry. The primary endpoint was major amputation-free survival. Secondary endpoints were postoperative complications within 30 days, cancer-free survival, all-cause mortality and cause of death in the cohort. Major amputation-free survival, cancer-free survival and mortality were described with Kaplan-Meier (KM) survival estimates. We included 920 patients, of which 116 (13%) were in the active cancer group at the time of revascularization. There was no difference in amputation-free survival between those with cancer (86.8% 1-year KM estimate) and those without cancer (85.2% 1-year KM estimate) (p = 0.50). Likewise, we found no difference in 30-day postoperative complication rate. The risk of developing cancer in the included CLTI cohort was similar to the age-matched background population (6.1% vs 6.4%) (p = 0.69). All-cause mortality was higher in CLTI patients with cancer, mainly due to cancer, compared with CLTI patients without cancer who mainly died from cardiovascular disease. Three-year KM survival estimates were 48.3% (95% CI 40.0%-58.3%) and 64.4% (95% CI 61.2%-67.8%) (p = 0.014) for cancer and non-cancer patients, respectively. Although cancer in patients with CLTI is related to higher medium- to long-term mortality, active cancer per se should not contravene revascularization, as postoperative complications and risk of amputation are not overrepresented.

Cardiovascular or renal disease (CVRD) complication and mortality incidence for type 2 diabetics with a single or without CVRD comorbidity: a 5-year SNDS nationwide claims database cohort study

Abstract Background Myocardial infarction (MI), stroke, peripheral arterial disease (PAD), heart failure (HF) and chronic kidney disease (CKD) are common cardiovascular renal disease (CVRD) complications for type 2 diabetes (T2D). However, for those with a single CVRD comorbidity, the incidence of a new CVRD complication and death is not well known. Purpose To assess the 5-year CVRD complication and mortality incidence for T2D patients with a single CVRD comorbidity or without CVRD at baseline. Methods A cohort study of all T2D patients with a single CVRD or without CVRD (disease-free) at baseline (January 1st, 2014) identified and followed-up for 5 years within the French SNDS nationwide claims database. Incidence rates were estimated for 5 years and the risk of all-cause death was compared to the disease-free population using Cox proportional hazards risk model: hazard ratio (HR) with [95% confidence interval]. Results From about 2 million T2D patients without cancer or transplantation at baseline, 76.5% were disease-free, 7.9% with a single CVRD and the others having several CVRD comorbidities history. Five-year CVRD complication and mortality incidence rates for 1,000 patient-years are presented in the table. CKD and HF were the most frequent CVRD complications for the disease-free and all CVRD comorbid populations, far ahead of MI, stroke and PAD, except PAD complication for PAD population and to a lesser degree stroke complication for stroke population. The incidence rate of all-cause death was the highest for HF+CKD patients, followed by HF patients, then PAD, stroke and CKD patients. Compared to disease-free patients with same sex and age, the HR of death was 4.3 [4.2–4.5] higher for HF+CKD patients, 2.7 [2.7–2.8], 2.1 [2.0–2.1], 2.1 [2.0–2.1], 1.9 [1.9–1.9] and 1.4 [1.3–1.4] for HF, CKD, PAD, stroke and MI patients, respectively. Conclusions While MI, stroke and PAD comorbidities remain major risks of complications for T2D patients, HF and CKD nowadays represent a clearly higher risk of CVRD complications and death, that needs improved preventive strategies. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Study performed with unconditional funding from AstraZeneca

Peripheral arterial disease and hypertension.

Hypertension (HTN) is a well known risk factor for atherosclerosis and peripheral arterial disease (PAD). PAD affects more than 250 million people globally and is associated with worse clinical outcomes. Although multiple studies have been performed to evaluate treatment of HTN in patients with PAD, blood pressure management in this high-risk cohort remains poor. There has been conflicting evidence regarding blood pressure goals in PAD with some recent studies showing adverse outcomes with low blood pressure in this patient population. Current guidelines, however, continue to recommend treatment goals in PAD patients similar to patients without PAD. To date, no single antihypertensive drug class has shown a clear benefit in PAD population over other antihypertensive drug classes. Prospective randomized trials enrolling PAD patients are required that can shed light on optimum blood pressure target and also distinguish between different antihypertensive drugs in terms of reducing adverse outcomes.

Sex-Specific Differences in Cardiovascular Risk, Risk Factors and Risk Management in the Peripheral Arterial Disease Population.

Cardiovascular disease (CVD) is the leading cause of mortality in women worldwide but has been primarily recognised as a man’s disease. The major components of CVD are ischaemic heart disease (IHD), stroke and peripheral arterial disease (PAD). Compared with IHD or stroke, individuals with PAD are at significantly greater risk of major cardiovascular events. Despite this, they are less likely to receive preventative treatment than those with IHD. Women are at least as affected by PAD as men, but major sex-specific knowledge gaps exist in the understanding of relevant CVD risk factors and efficacy of treatment. This prompted the American Heart Association to issue a “call to action” for PAD in women, in 2012. Despite this, PAD and CVD risk in women continues to be under-recognised, leading to a loss of opportunity to moderate and prevent CVD morbidity. This review outlines current evidence regarding cardiovascular risk in women and men with PAD, the relative significance of traditional and non-traditional risk factors and sex differences in cardiovascular risk management.

OR72. The relationship between diabetes mellitus and homocysteine level in peripheral arterial disease population in mataram city

Abstract Background Peripheral Arterial Disease (PAD) is partial or total blockage of blood vessel caused by occlusive atherosclerosis especially in lower extremity. Hyperhomocysteinemia had been used as a biomarker of cardiovascular disease such atherosclerosis formation process. Previous study have reported higher incidence of homocysteine level in patient with Diabetes Mellitus (DM) type 2. However, data on homocysteine level in PAD patient with DM type 2 is limited. Therefore, this study aim to investigate the comparation between DM and homocysteine level in PAD patient in Mataram City. Methods and Results This study is a cross sectional study conducted at Siti Hajar Islamic Hospital in Mataram City. The sample was patients with PAD with an ankle brachial index score &amp;lt;0.90 and DM type 2. The outcome of this study was homocysteine level on DM PAD patient and non-DM PAD patient. Data analysis using the unpaired T test. fifty-two PAD patients in this study, with 75% female (39) and average age of 57.4 years old in this research. The average homocysteine level in PAD patient with DM (5.7±0.9 µmol/L) was significantly higher than those in non-DM PAD patient (4.8±1.0 µmol/L) (p = 0.001). We found that history of hypertension was significantly higher in non-DM PAD patient and ankle brachial index score was significantly lower in DM PAD patient (p = 0.049). Conclusion There is a significant differences of homocysteine level within DM patient compared to non-DM patient.

Abstract 11854: Longitudinal Improvement in Patient Reported Outcome Measures Following Supervised Exercise Therapy for Symptomatic Peripheral Artery Disease

Background: Symptomatic peripheral artery disease (PAD) is associated with severe morbidity and poor quality of life. Although data suggest that supervised exercise therapy (SET) may improve symptoms, few studies have evaluated longitudinal changes in patient reported outcomes among a real-world PAD population. Methods: Consecutive patients with symptomatic PAD treated at a single tertiary care center and referred for SET were enrolled. Patient reported outcomes were assessed at baseline and at 30 days, 6-months, and 1-year post-treatment through an electronic survey. The primary outcome was the change in the Peripheral Artery Questionnaire (PAQ) summary score from baseline to each time point. A change in PAQ summary score of &gt;8 has been established as clinically meaningful improvement. Results: Twenty-nine patients enrolled in the study received SET who had a mean baseline PAQ score 46.9±16.5. Following treatment, the mean PAQ score at 30 days, 6 months and 1 year were 61.0 ±20.7, 70.4 ±16.2 and 67.0 ±13.9, respectively (Figure 1), corresponding to a 14.1 point, 23.5 point and 20.1 point improvement in PAQ score. Conclusion: In this real-world assessment of patient reported outcomes following SET for the management of symptomatic PAD, treatment demonstrated consistent long-term improvement in patient reported outcomes as measured by the PAQ. Future work assessing the long-term durability of these changes is ongoing.

Structured pain-free exercise progressively improves ankle-brachial index and walking ability in patients with claudication and compressible arteries: an observational study

In patients with peripheral artery disease (PAD), supervised exercise at near-moderate pain improves walking ability but not ankle-brachial index (ABI) values. In a retrospective observational study, we determined vascular and functional effects of a 6-month structured pain-free exercise program in patients with claudication and compressible vessels. Four-hundred and fifty-nine consecutive patients were studied. Segmental limb pressures were measured and ABI calculated during circa-monthly hospital visits. The 6-min (6MWD) and the pain-free walking distance (PFWD) during the 6-min walking test were determined. Two daily 8-min sessions of slow–moderate in-home walking at increasing metronome-paced speed were prescribed. After excluding patients with unmeasurable ABI or incompletion of the program, 239 patients were studied. Safe and satisfactory (88%) execution of the prescribed training sessions was reported. During the visits, bilateral ABI improved (+ 0.07; p < 0.001) as well as the segmental pressures in the more impaired limb, with changes already significant after 5 weeks of slow walking. Both systolic and diastolic blood pressure decreased overtime (F = 46.52; p < 0.001; F = 5.52; p < 0.001, respectively). 6MWD and PFWD improved (41[0‒73]m p < 0.001 and 107[42‒190]m p < 0.001, respectively) with associated decrease of walking heart rate (F = 15.91; p < 0.001) and Physiological Cost Index (F = 235.93; p < 0.001). The variations of most parameters at different visits correlated to the training load calculated. In a regression model, the PFWD variations directly correlated with rate sessions completed, training load and ABI change and inversely with the baseline value (R2 = 0.27; p < 0.001). In the PAD population studied, moderate pain-free exercise improved ABI with associated progressive functional and cardiovascular changes occurring regardless of subjects characteristics.