Symptomatic Peripheral Arterial Occlusive Disease Research Articles

Antithrombotic Treatment Patterns of Patients with Symptomatic Peripheral Arterial Occlusive Disease in Germany: Evidence from Health Insurance Claims Data.

Objectives: Patients with peripheral arterial occlusive disease (PAOD) are at risk of worsening limb symptoms, major adverse cardiovascular events and exhibit an impaired life expectancy. There is a lack of evidence on the extent of pharmacological secondary prevention in PAOD patients. This study assesses treatment patterns of antithrombotic agents in symptomatic PAOD patients. Methods: This is a retrospective cohort study using data from the second largest insurance fund in Germany, BARMER. We included symptomatic PAOD patients undergoing in-hospital treatment with an index admission between 1 January 2010 and 31 December 2017. Outcomes were proportions of single antiplatelets (SAPT), dual antiplatelets (DAPT), vitamin-K antagonists (VKA), or direct oral anticoagulants (DOAC) in the 12 months prior and 6 months after the index hospitalization. Non-parametric cumulative incidence for competing risks was estimated to account for censoring and death after discharge from hospital stay. Patient flows were visualised by alluvial diagrams. All analyses were stratified by intermittent claudication (IC) and chronic limb-threatening ischaemia (CLTI). The protocol was registered to ClinicalTrials.gov (NCT03909022). Results: A total of 80,426 unique patient encounters were identified. Mean age was 72.7 (46.3% female). Amongst all patients, 25.6% were on SAPT, 4.1% on DAPT, 9.1% on VKA, 3.9% on DOAC, 3.9% on both antiplatelets and oral anticoagulation, and 53.3% without any antithrombotic therapy during the 12 months before index stay. The estimated cumulative incidence was 37.9% SAPT, 14.8% DAPT, 7.5% VKA, 4.3% DOAC, 7.4% both, and 28.1% without any antithrombotic therapy during the 6 months after index stay. The considerable increases in antiplatelet therapy were mainly driven by the group of patients without antithrombotics before index stay. As compared with IC, patients who suffered from CLTI received less often antiplatelets but more often anticoagulants both before and after index stay. Conclusions: Utilisation rates of antithrombotic therapy increased considerably after in-hospital treatment for PAOD. Yet, remarkably high rates of symptomatic patients without any blood-thinning therapy constitute a major concern with respect to adequate secondary prevention of PAOD patients.

The Impact of Chronic Kidney Disease on Mid-Term Outcomes after Revascularisation of Peripheral Arterial Occlusive Disease: Results from a Prospective Cohort Study.

Objective: The current study aimed to determine the relationship between chronic kidney disease (CKD) and major 12-month outcomes for patients with in-hospital treatment for symptomatic peripheral arterial occlusive disease (PAOD). Methods: An analysis of the prospective longitudinal multicentric cohort study with 12-month follow-up was conducted including patients who underwent endovascular or open surgery for symptomatic PAOD at 35 German vascular centres (initial study protocol: NCT03098290). Severity of CKD was grouped into four stages combining information about the estimated glomerular filtration rate (eGFR) at baseline and dialysis dependency. Outcomes included overall mortality as well as the two composite endpoints of amputation or death, and of major cardiovascular events (MACE). 12-month incidences and adjusted hazard ratios were estimated using the Kaplan–Meier function and Cox proportional hazard models. Results: A total of 4354 patients (32% female, 69 years mean age, 68% intermittent claudication, 69% percutaneous endovascular revascularisation) were included and followed for 244 days in median. Thereof, 22% had any CKD and 5% had end stage kidney disease (ESKD) at baseline. The 12-month overall mortality rate was 3.6% (95% CI 2.3–4.9) with 96 events in the entire cohort: 147 were amputated or died (5.3%, 95% CI 5.2–5.3), and 277 had a MACE (9.5%, 95% CI 9.4–9.5). When compared with patients without kidney disease, ESKD was significantly associated with overall mortality (HR 1.9; 95% CI 1.1–3.5), amputation or death (HR 2.4; 95% CI 1.4–4.1), and MACE (HR 2.0; 95% CI 1.3–3.2). Conclusions: In the current study on mid-term outcomes after invasive revascularisation for symptomatic PAOD, one out of five patients suffered from any CKD while those few with ESKD had twice the odds of death, of amputation or death, and of major adverse cardiovascular events after twelve months. These results emphasise that concomitant CKD and its impact on outcomes should be considered by severity while mild and moderate grades should not lead to ineffectual treatment strategies.

Preoperative Factors Associated with Target Lesion Revascularization following Endovascular Therapy of the Superficial Femoral Artery.

Objectives: In patients with symptomatic peripheral arterial occlusive disease (PAOD), endovascular revascularization of the superficial femoral artery (SFA) is the most frequent intervention. A major drawback of endovascular procedures is clinically driven target lesion revascularization (CD-TLR), which may cause recurrence of symptoms, re-hospitalizations, and re-interventions. Outcome studies comparing endovascular modalities are heterogeneous and focus more on intraoperative rather than preoperative aspects. Studies have not examined potential risk factors in patients’ phenotype before an intervention to prevent CD-TLR. Design: Monocentric, retrospective cohort study of 781 patients with symptomatic PAOD referred to an endovascular intervention of the SFA between 2000 and 2018. Methods: The study aim was to identify risk factors and phenotypes leading to symptomatic PAOD in patients with de novo lesions of the SFA and ≥1 CD-TLR within 12 months post-index procedure. Two groups were differentiated: patients without CD-TLR and with ≥1 CD-TLR. Patient phenotype was compared for cardiovascular (CV) risk factors, age, gender, and renal function. Results: 662 patients (84.8%) (age 73.5 ± 11.2 years; 243 women (36.7%)) with no CD-TLR were compared to 119 patients (15.2%) with ≥1 CD-TLR (age 70.9 ± 12.4 years; 55 women (46.2%)). Women, as well as subjects with dyslipidemia, had each a 1.8-time higher odds ratio of receiving multiple interventions within one year than men or subjects without dyslipidemia. Older subjects (per decade) had a lower odds ratio (0.7) for multiple interventions. Subjects with an eGFR (estimated glomerular filtration rate) <30 mL/min had 3.8 times higher and subjects with eGFR ≥30 and <60 mL/min had a 2.4 higher odds ratio of receiving multiple interventions than subjects with eGFR values ≥90 mL/min. Conclusion: Our data indicate that younger women, patients with dyslipidemia, or those with renal insufficiency are at risk for recurrent midterm CD-TLR after endovascular therapy of the SFA.

MagicTouch PTA Sirolimus Coated Balloon for Femoropopliteal and Below the Knee Disease: Results From XTOSI Pilot Study Up To 12 Months

Introduction: Sirolimus coated balloon (SCB) is a promising treatment option to prevent restenosis for peripheral arterial occlusive disease (PAOD). This is a pilot first-in-human study of MagicTouch percutaneous transluminal angioplasty (PTA) SCB for treatment of PAOD for both femoropopliteal and below the knee arteries (BTK). Material and Methods: Xtreme Touch-Neo [MagicTouch PTA] Sirolimus Coated Balloon (XTOSI) pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAOD. Primary endpoint was defined as primary patency at 6 months (duplex ultrasound peak systolic velocity ratio ≤2.4). Secondary endpoints included clinically driven target lesion revascularization (CD-TLR), amputation free survival (AFS), all-cause mortality, and limb salvage success. Results: Fifty patients were recruited. The mean age was 67 (n=31 [62%] males). SCB was applied to femoropopliteal in 20 patients (40%) and BTK in 30 patients (60%). Majority of treatments (94%) were performed for limb salvage indications (Rutherford scores 5 or 6). This was a high risk cohort, in which 90% had diabetes, 36% had coronary artery disease, 20% had end stage renal failure, and American Society of Anaesthesiologists (ASA) score was 3 or more in 80%. Mean lesion length treated was 227±81 mm, of which 36% were total occlusions. Technical and device success were both 100%. At 30 days, mortality was 2% and major limb amputation was also 2%. Six-month primary patency was 80% (88.2% for femoropopliteal; 74% for BTK). At 12 months, freedom from CD-TLR was 89.7% (94.1% for femoropopliteal; 86.3% for BTK), AFS was 81.6% (90.0% for femoropopliteal; 75.9% for BTK), all-cause mortality was 14.3% (10.0% for femoropopliteal; 17.2% for BTK), and limb salvage success was 92.9% (94.4% for femoropopliteal; 91.7% for BTK). There was a statistically significant increase between baseline and 6-month toe pressures for both femoropopliteal (57.3±23.3 mm Hg vs 82.5±37.8 mm Hg; p<.001) and BTK lesions (52.8±19.2 mm Hg vs 70.7±37 mm Hg; p<.037). At 12 months, wound healing rate was 33/39 (84.6%). Conclusions: MagicTouch PTA SCB in the XTOSI study showed promising 6-month primary patency and encouraging 12-month freedom from CD-TLR, AFS, and limb salvage rates. No early safety concerns were raised. Randomized trials are needed to investigate the safety and efficacy of SCB for treatment of PAOD.

International Variations and Sex Disparities in the Treatment of Peripheral Arterial Occlusive Disease: A Report From VASCUNET and the International Consortium of Vascular Registries

The aim of this study was to determine sex-specific differences in the invasive treatment of symptomatic peripheral arterial occlusive disease (PAOD) between member states participating in the VASCUNET and International Consortium of Vascular Registries.

Sex Disparities in Long-Term Mortality after Paclitaxel Exposure in Patients with Peripheral Artery Disease: A Nationwide Claims-Based Cohort Study.

Background: Randomized controlled trials have reported excess mortality in patients treated with paclitaxel-coated devices versus uncoated devices, while observational studies have reported the opposite. This study aims to determine the underlying factors and cohort differences that may explain these opposite results, with specific focus on sex differences in treatment and outcomes. Methods: Multicenter health insurance claims data from a large insurance fund, BARMER, were studied. A homogeneous sample of patients with an index of endovascular revascularization for symptomatic peripheral arterial occlusive disease between 2013 and 2017 was included. Adjusted logistic regression and Cox regression models were used to determine the factors predicting allocation to paclitaxel-coated devices and sex-specific 5-year all-cause mortality, respectively. Results: In total, 13,204 patients (54% females, mean age 74 ± 11 years) were followed for a median of 3.5 years. Females were older (77 vs. 71 years), and had less frequent coronary artery disease (23% vs. 33%), dyslipidemia (44% vs. 50%), and diabetes (29% vs. 41%), as well as being less likely to have a history of smoking (10% vs. 15%) compared with males. Mortality differences were mostly attributable to the female subgroup who were revascularized above the knee (hazard ratio, HR 0.78, 95% CI: 0.64–0.95), while no statistically significant differences were observed in males. Conclusions: This study found that females treated above the knee benefited from paclitaxel-coated devices, while no differences were found in males. Ongoing and future registries and trials should take sex disparities into account.

The Association of Periodontitis and Peripheral Arterial Occlusive Disease in a Prospective Population-Based Cross-Sectional Cohort Study.

Objectives: Peripheral arterial occlusive disease (PAOD) and periodontitis are common chronic diseases, which together affect almost 1 billion people worldwide. There is growing evidence suggesting a relationship between chronic inflammatory conditions such as periodontitis and PAOD. This study aims to determine an association between both entities using high quality research data and multiple phenotypes derived from an epidemiological cohort study. Design: This population-based cross-sectional cohort study included data from 3271 participants aged between 45 and 74 years enrolled in the Hamburg City Health Study (NCT03934957). Material & Methods: An ankle-brachial-index below 0.9, color-coded ultrasound of the lower extremity arteries, and survey data was used to identify participants with either asymptomatic or symptomatic PAOD. Periodontitis data was collected at six sites per tooth and included the probing depth, gingival recession, clinical attachment loss, and bleeding on probing index. Multivariate analyses using logistic regression models were adjusted for variables including age, sex, smoking, education, diabetes, and hypertension. Results: The baseline characteristics differed widely between participants neither affected by periodontitis nor PAOD vs. the group where both PAOD and severe periodontitis were identified. A higher rate of males, higher age, lower education level, smoking, diabetes, and cardiovascular disease was observed in the group affected by both diseases. After adjusting, presence of severe periodontitis (odds ratio 1.265; 97.5% CI 1.006–1.591; p = 0.045) was independently associated with PAOD. Conclusion: In this cross-sectional analysis of a prospective cohort study, an independent association between periodontitis and PAOD was revealed. The results of the current study emphasize a potential for preventive medicine in an extremely sensitive target population. Future studies should determine the underlying factors modifying the relationship between both diseases.

A health insurance claims analysis on the effect of female sex on long-term outcomes after peripheral endovascular interventions for symptomatic peripheral arterial occlusive disease

ObjectiveSeveral reports have addressed sex disparities in peripheral arterial occlusive disease (PAOD) treatment with inconclusive or even conflicting results. However, most previous studies have neither been sufficiently stratified nor used matching or weighting methods to address severe confounding. In the present study, we aimed to determine the disparities between sexes after percutaneous endovascular revascularization (ER) for symptomatic PAOD. MethodsHealth insurance claims data from the second-largest insurance fund in Germany, BARMER, were used. A large cohort of patients who had undergone index percutaneous ER of symptomatic PAOD from January 1, 2010 to December 31, 2018 were included in the present study. The study cohort was stratified by the presence of intermittent claudication, ischemic rest pain, and wound healing disorders. Propensity score matching was used to adjust for confounding through differences in age, treated vessel region, comorbidities, and pharmacologic treatment. Sex-related differences regarding cardiovascular event-free survival, amputation-free survival, and overall survival within 5 years of surgery were determined using Kaplan-Meier time-to-event curves, log-rank test, and Cox regression analysis. ResultsIn the present study, 50,051 patients (47.2% women) were identified and used to compose a matched cohort of 35,232 patients. Among all strata, female patients exhibited lower mortality (hazard ratio [HR], 0.69-0.90), fewer amputations or death (HR, 0.70-0.89), and fewer cardiovascular events or death (HR, 0.78-0.91). The association between female sex and improved long-term outcomes was most pronounced for the patients with intermittent claudication. ConclusionsIn the present propensity score-matched analysis of health insurance claims, we observed superior cardiovascular event-free survival, amputation-free survival, and overall survival during 5 years of follow-up after percutaneous ER in women with symptomatic PAOD. Future studies should address sex disparities in the open surgical treatment of PAOD to illuminate whether the conflicting data from previous reports might have resulted from insufficient stratification of the studies.

Editor's Choice – The GermanVasc Score: A Pragmatic Risk Score Predicts Five Year Amputation Free Survival in Patients with Peripheral Arterial Occlusive Disease

ObjectivePatients with peripheral arterial occlusive disease (PAOD) face an increased risk of both lower limb amputation and death. To date, it has been challenging to predict the long term outcomes for PAOD. The aim was to develop a risk score to predict worse five year amputation free survival (AFS).MethodsIn this retrospective analysis of claims data, symptomatic PAOD patients were split into training and validation sets. Variables in the model were patient age and sex, Elixhauser comorbidities, and the 190 most common secondary diagnoses. Penalised Cox regression (least absolute shrinkage and selection operator [LASSO]) with tenfold cross validation for variable selection was performed and patients were categorised into five risk groups using the ten most important variables. All analyses were stratified by intermittent claudication (IC) and chronic limb threatening ischaemia (CLTI).ResultsIn total, 87 293 patients with PAOD (female 45.3%, mean age 71.4 ± 11.1 years) were included in the analysis. The most important variable predicting worse five year AFS was patient age >80 years. The GermanVasc score exhibited good predictive accuracy both for IC (c statistic = 0.70, 95% confidence interval [CI] 0.69–0.71) and CLTI (c statistic = 0.69, 95% CI 0.68–0.70) with adequate calibration due largely to alignment of observed and expected risk. Depending on the cumulative point score, the five year risk of amputation or death ranged from 9% (low risk) to 48% (high risk) for IC, and from 25% to 88% for CLTI.ConclusionThe GermanVasc score predicts worse five year AFS stratified for inpatients suffering from IC and CLTI, with good predictive accuracy. By separating low from high risk patients, the GermanVasc score may support patient centred consent. Patients with peripheral arterial occlusive disease (PAOD) face an increased risk of both lower limb amputation and death. To date, it has been challenging to predict the long term outcomes for PAOD. The aim was to develop a risk score to predict worse five year amputation free survival (AFS). In this retrospective analysis of claims data, symptomatic PAOD patients were split into training and validation sets. Variables in the model were patient age and sex, Elixhauser comorbidities, and the 190 most common secondary diagnoses. Penalised Cox regression (least absolute shrinkage and selection operator [LASSO]) with tenfold cross validation for variable selection was performed and patients were categorised into five risk groups using the ten most important variables. All analyses were stratified by intermittent claudication (IC) and chronic limb threatening ischaemia (CLTI). In total, 87 293 patients with PAOD (female 45.3%, mean age 71.4 ± 11.1 years) were included in the analysis. The most important variable predicting worse five year AFS was patient age >80 years. The GermanVasc score exhibited good predictive accuracy both for IC (c statistic = 0.70, 95% confidence interval [CI] 0.69–0.71) and CLTI (c statistic = 0.69, 95% CI 0.68–0.70) with adequate calibration due largely to alignment of observed and expected risk. Depending on the cumulative point score, the five year risk of amputation or death ranged from 9% (low risk) to 48% (high risk) for IC, and from 25% to 88% for CLTI. The GermanVasc score predicts worse five year AFS stratified for inpatients suffering from IC and CLTI, with good predictive accuracy. By separating low from high risk patients, the GermanVasc score may support patient centred consent.

Editor's Choice – International Variations and Sex Disparities in the Treatment of Peripheral Arterial Occlusive Disease: A Report from VASCUNET and the International Consortium of Vascular Registries

Objective:The aim of this study was to determine sex specific differences in the invasive treatment of symptomatic peripheral arterial occlusive disease (PAOD) between member states participating in the VASCUNET and International Consortium of Vascular Registries.Methods:Data on open surgical revascularisation and peripheral vascular intervention (PVI) of symptomatic PAOD from 2010 to 2017 were collected from population based administrative and registry data from 11 countries. Differences in age, sex, indication, and invasive treatment modality were analysed.Results:Data from 11 countries covering 671 million inhabitants and 1 164 497 hospitalisations (40% women, mean age 72 years, 49% with intermittent claudication, 54% treated with PVI) in Europe (including Russia), North America, Australia, and New Zealand were included. Patient selection and treatment modality varied widely for the proportion of female patients (23% in Portugal and 46% in Sweden), the proportion of patients with claudication (6% in Italy and 69% in Russia), patients’ mean age (70 years in the USA and 76 years in Italy), the proportion of octogenarians (8% in Russia and 33% in Sweden), and the proportion of PVI (24% in Russia and 88% in Italy). Numerous differences between females and males were observed in regard to patient age (72 vs. 70 years), the proportion of octogenarians (28% vs. 15%), proportion of patients with claudication (45% vs. 51%), proportion of PVI (57% vs. 51%), and length of hospital stay (7 days vs. 6 days).Conclusion:Remarkable differences regarding the proportion of peripheral vascular interventions, patients with claudication, and octogenarians were seen across countries and sexes. Future studies should address the underlying reasons for this, including the impact of national societal guidelines, reimbursement, and differences in health maintenance.

Optimal Pharmacological Treatment of Symptomatic Peripheral Arterial Occlusive Disease and Evidence of Female Patient Disadvantage: An Analysis of Health Insurance Claims Data

Optimal pharmacological treatment (OPT) for peripheral arterial occlusive disease (PAOD) includes prescription of lipid lowering drugs, antithrombotics, and antihypertensives to symptomatic patients affected by intermittent claudication or chronic limb threatening ischaemia. This study sought to determine sex disparities and time trends in prescription of OPT in this population (clinicaltrials.gov NCT03909022). Using data from the second largest insurance fund in Germany, BARMER, data on patients with an index admission for symptomatic PAOD between 1 January 2010 and 30 June 2018 with follow up until the end of 2018 were analysed. Sex disparities in post-discharge prescription status six months after index admission were tested and adjusted for patient and healthcare variables using bivariable tests and logistic regression analysis. Time trends in the prescription prevalence of OPT were analysed and tested. There were 83 867 patients (mean age 71.9 years and 45.8% women) eligible for inclusion in the study. When compared with men, women had lower rates of prior outpatient care for PAOD (39.8% vs. 47.0%), were admitted more often with ischaemic rest pain (13.9% vs. 10.4%) and were older (74 vs. 70 y). After discharge, women had a lower rate of prescriptions for lipid lowering drugs (52.4% vs. 59.9%), while they received antihypertensive drugs more often (86.7% vs. 84.1%). We found evidence for a lower prescription prevalence of OPT in females (37.0% vs. 42.7%). Differences in patient and healthcare variables (e.g. demographics, comorbidities, prior treatment) between women and men explained 56% of this gap. The sex prescription gap did not narrow over time despite an overall upward trend in prescription prevalence for both women and men. Although presenting older and with more severe symptoms at the index admission for PAOD, women have a lower prescription prevalence of OPT compared with men, particularly with respect to lipid lowering drugs.

Editor's Choice – Optimal Pharmacological Treatment of Symptomatic Peripheral Arterial Occlusive Disease and Evidence of Female Patient Disadvantage: An Analysis of Health Insurance Claims Data

Optimal pharmacological treatment (OPT) for peripheral arterial occlusive disease (PAOD) includes prescription of lipid lowering drugs, antithrombotics, and antihypertensives to symptomatic patients affected by intermittent claudication or chronic limb threatening ischaemia. This study sought to determine sex disparities and time trends in prescription of OPT in this population (clinicaltrials.gov NCT03909022). Using data from the second largest insurance fund in Germany, BARMER, data on patients with an index admission for symptomatic PAOD between 1 January 2010 and 30 June 2018 with follow up until the end of 2018 were analysed. Sex disparities in post-discharge prescription status six months after index admission were tested and adjusted for patient and healthcare variables using bivariable tests and logistic regression analysis. Time trends in the prescription prevalence of OPT were analysed and tested. There were 83867 patients (mean age 71.9 years and 45.8% women) eligible for inclusion in the study. When compared with men, women had lower rates of prior outpatient care for PAOD (39.8% vs. 47.0%), were admitted more often with ischaemic rest pain (13.9% vs. 10.4%) and were older (74 vs. 70 y). After discharge, women had a lower rate of prescriptions for lipid lowering drugs (52.4% vs. 59.9%), while they received antihypertensive drugs more often (86.7% vs. 84.1%). We found evidence for a lower prescription prevalence of OPT in females (37.0% vs. 42.7%). Differences in patient and healthcare variables (e.g. demographics, comorbidities, prior treatment) between women and men explained 56% of this gap. The sex prescription gap did not narrow over time despite an overall upward trend in prescription prevalence for both women and men. Although presenting older and with more severe symptoms at the index admission for PAOD, women have a lower prescription prevalence of OPT compared with men, particularly with respect to lipid lowering drugs.

A retrospective cohort study on the provision and outcomes of pharmacological therapy after revascularisation for peripheral arterial occlusive disease: a study protocol

BackgroundSymptomatic peripheral arterial occlusive disease (PAOD) involves highly complex and costly revascularisations for preventing adverse limb events and impaired survival. Contrary to recommendations from valid guidelines, a large group of...

The Braden Scale as a Predictor for Perioperative and Long Term Outcomes After Revascularization of Symptomatic Peripheral Arterial Occlusive Disease

The Braden Scale as a Predictor for Perioperative and Long Term Outcomes After Revascularization of Symptomatic Peripheral Arterial Occlusive Disease

Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany

Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany

Interventional angiology : Endovascular treatment of chronic and acute limb ischemia

The development of new technologies and techniques has significantly advanced the field of endovascular peripheral interventions for chronic and acute limb ischemia over the last 20years. Nowadays, the majority of patients with symptomatic peripheral arterial occlusive disease can be treated percutaneously using an endovascular first approach as aminimally invasive alternative to classical bypass surgery. Balloon angioplasty and stent implantation are the mainstays of endovascular interventions. For reconstruction of complex aortoiliac occlusions covered stents are frequently used. Patency rates after femoropopliteal interventions have been improved by the introduction of drug-eluting balloon and stent technologies. Advances in material and access techniques now enable the successful endovascular treatment of more complex infrapopliteal stenoses and occlusions.

Gender variation in symptomatic peripheral arterial occlusive disease among type-2 diabetic patients.

Purpose:Little is known about the existence of potential gender disparities in peripheral arterial occlusive disease. To our knowledge, this is the first study to analyze differences attributed to gender in type-2 diabetic patients with symptomatic peripheral arterial occlusive disease, with regard to clinical presentations, risk factors and anatomical distributions of atherosclerosis.Patients and methods:This study was conducted at King Abdullah University Hospital, Jordan. Medical records of all diabetic (type-2) patients who presented with symptomatic peripheral arterial occlusive disease in the period from January 2012 and November 2017 were reviewed, data were collected retrospectively. In all, 364 patients (282 males and 82 females) were involved. Criteria for diagnosis include the following Ankle-Brachial Index ⩽ 0.9 and intermittent claudication or critical limb ischemia. Risk factors for atherosclerosis (age, smoking and hypertension) and computed tomography-angiogram findings were analyzed using Statistical Package for the Social Sciences. p < 0.05 was considered statistically significant.Results:The mean age was higher in females than males (67.61 vs 62.61 years; p = 0.001). Females had greater prevalence of uncontrolled diabetes compared to males (HbA1c 9.07 in females vs 8.51 in males; p = 0.03). High density lipoprotein was higher in females than males (1.02 vs 0.935; p = 0.009). Females presented more with critical limb ischemia than intermittent claudication in comparison with males (p = 0.017). Involvement of superficial femoral artery, deep femoral artery and peroneal artery in hemodynamic relevant atherosclerotic lesion was significantly higher in females than males (p < 0.05). However, involvement of common iliac artery with hemodynamic relevant atherosclerotic lesion was significantly higher in males than females (p = 0.003).Conclusions:Clinical presentation, risk factors and anatomical distributions of atherosclerosis among type-2 diabetic patients with symptomatic peripheral arterial occlusive disease are different between males and females. When compared to males, female patients presented more with critical limb ischemia than intermittent claudication. Females showed higher age at presentation, poor control of diabetes mellitus and higher level of high density lipoprotein. Involvement of superficial femoral artery, deep femoral artery and peroneal artery in hemodynamic relevant atherosclerotic lesion were significantly higher in females than males. In contrast, common iliac artery involvement with hemodynamic relevant atherosclerotic lesion was significantly higher in males than females.

Randomized comparison of femoropopliteal artery drug-eluting balloons and drug-eluting stents (FOREST trial): Study protocol for a randomized controlled trial

The optimal endovascular treatment for femoropopliteal arterial occlusive disease has yet to be assessed. Patency rates after uncoated balloon angioplasty are disappointing. Although stents have better outcomes, they also have limitations. Intra-arterial stenting may lead to stent thrombosis and flow pattern disruption, which may result in stent fracture or in-stent restenosis. In the past decade, drug-eluting balloons (DEBs) and drug-eluting stents (DESs) have been introduced, and both have been proven to possess antirestenotic features compared with conventional techniques. The objective of this study is to perform a noninferiority analysis of DEBs with provisional bare-metal stenting and primary stenting with DESs in the treatment of femoropopliteal arterial occlusive disease. If DEB with provisional bare-metal stenting proves to be noninferior to primary stenting with DESs, DEBs may be the favorable technique because the postoperative long-term limitations of stents will be restricted. This is a prospective, randomized, controlled, single-blind, multicenter trial. The study population consists of volunteers aged ≥18 years, with chronic, symptomatic peripheral arterial occlusive disease (Rutherford-Baker classification 2 to 5) caused by de novo stenotic or occlusive atherosclerotic lesions of the superficial femoral artery or of the popliteal artery (only segment P1). Subjects will be treated with a DEB and provisional bare-metal stenting (if a stenosis >30% or a flow-limiting dissection persists after prolonged inflation with an uncoated balloon) or with primary stenting with a DES. The study will include 254 patients (ratio 1:1). The primary end point is 2-year freedom from binary restenosis, defined as a lumen diameter reduction of <50% assessed by duplex ultrasound imaging (peak systolic velocity ratio <2.5). Secondary end points are technical success, target lesion revascularization, target vessel revascularization, improvement in ankle-brachial index, improvement in Rutherford classification, amputation rate, and mortality rate.

Treatment Evaluation of Flow-Limiting Stenoses of the Superficial Femoral and Popliteal Artery by Parametric Color-Coding Analysis of Digital Subtraction Angiography Series.

To evaluate the hemodynamic effect of percutaneous transluminal intervention (PTI) on stenosis of the superficial femoral (SFA) and popliteal arteries (PA) using time-density curves (TDCs) derived from digital subtraction angiography (DSA) series in correlation with ultrasound peak systolic velocity ratio (PSVR) and ankle brachial index (ABI). DSA series of SFA or PA of patients with symptomatic peripheral arterial occlusive disease was obtained with a flat-panel angiography system with intention-to-treat. In DSA series acquired before and after PTI, TDCs were analyzed proximal and distal of each stenosis using parametric color coding (PCC). For correlation, ABI and PSVR measurements pre- and post-PTI were recorded for all patients. In total, 25 stenoses of the SFA or PA were treated by PTI in 22 patients (17 male, 5 female, mean age 68 years). After treatment, peak-to-peak (PTP) times between TDCs proximal and distal to the treated vessel segment decreased statistically significantly (p=0.01) on average from PTP=1.9±1.7s to mean PTP=1±1s. ABI and PSVR also changed statistically significantly after treatment (pretreatment ABI=0.7±0.2, PSVR=4.2±1.9; post-ABI=0.9±0.2, PSVR=1.3±0.4, both p<0.05). Correlation parameters did not show a strong correlation between change in TDC and clinical parameters ABI and PSVR. Using PCC for analyzing contrast medium dynamics in DSA series is clinically useful for evaluating stenoses of the SFA and PA and for immediate treatment control after PTA. Case series, IV.

Dual-Energy CTA in Patients with Symptomatic Peripheral Arterial Occlusive Disease: Study of Diagnostic Accuracy and Impeding Factors.

Purpose The purpose of this study was to assess the diagnostic performance of dual-energy CT angiography (DE-CTA) in patients with symptomatic peripheral artery occlusive disease (PAOD) and to identify factors that impede its diagnostic accuracy. Materials and Methods Dual-source DE-CTA scans of the lower extremities of 94 patients were retrospectively compared to the diagnostic reference standard, digital subtraction angiography (DSA). Two independent observers assessed PAOD incidence, image quality, artifacts, and diagnostic accuracy of DE-CTA in 1014 arterial segments on axial, combined 80/140 kVp reconstructions and on 3 D maximum intensity projections (MIP) after automated bone and plaque removal. The impact of calcifications, image quality, and image artifacts on the diagnostic accuracy was evaluated using Fisher's exact test. Furthermore, interobserver agreement was analyzed. Results Two observers achieved sensitivities of 98.0 % and 93.9 %, respectively, and specificities of 75.0 % and 66.7 %, respectively, for detecting stenoses of > 50 % of the lower extremity arteries. Calcifications impeded specificity, e. g. from 81.2 % to 46.2 % for reader 1 (p < 0.001). Specificity increased with higher image quality, e. g. from 70.0 % to 76.4 % for reader 1 (p < 0.001). Artifacts decreased the specificity of reader 2 (p < 0.001). The overall interobserver agreement ranged between moderate and substantial for stenosis detection and calcified plaques. Conclusion DE-CTA is accurate in the detection of arterial stenoses of > 50 % in symptomatic PAOD patients. Calcified atherosclerotic plaques, image quality, and artifacts may impede specificity. Key Points: · Sensitivities of DE-CTA were 98.0 and 93.9 %, specificities 75.0 % and 66.7 %.. · Interobserver agreement was moderate to substantial for stenosis and plaque detection.. · Calcified atherosclerotic plaques, image quality, and artifacts may impede specificity.. Citation Format · Klink T, Wilhelm T, Roth C et al. Dual-Energy CTA in Patients with Symptomatic Peripheral Arterial Occlusive Disease: Study of Diagnostic Accuracy and Impeding Factors. Fortschr Röntgenstr 2017; 189: 441 - 452.