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.

Differences in treatment strategies for LDL-cholesterol reduction in a university lipid clinic vs. standard care apart from the use of PCSK9 inhibitors.

BACKGROUND: Lipid-lowering therapy (LLT) in patients with cardiovascular disease (CVD) is insufficient despite clear guideline recommendations. Lipid clinics have specialized in patients with dyslipidemia, but the magnitude and reduction of low-density lipoprotein cholesterol (LDL-C) in lipid clinics has not yet been studied in depth. OBJECTIVE: To assess LDL-C reduction in very high-risk CVD patients achieved in a lipid clinic through different forms of LLT in comparison to standard care without the initiation of PSCK9 inhibitors. METHODS: Data from 96 lipid clinic patients were analyzed retrospectively and compared to 84 standard care patients. Very high-risk patients were defined according to the European Society of Cardiology (ESC). Different combinations of LLT focusing on statins and ezetimibe were investigated. Achievement of LDL-C treatment goals according to ESC guidelines as well as LDL-C reduction were assessed. RESULTS: Baseline and follow-up data of 180 very high-risk CVD patients (mean age 67.7 (±9.8) y; 60.6% male) were used. Achievement of the LDL-C goal in lipid clinic patients increased significantly from 14.6% at baseline to 41.7% at the latest visit (p<0.001) while standard care patients improved from 21.4% to 33.3% (p=0.08). The largest relative LDL-C reduction via an adjustment in LLT was achieved by initiation of high-intensity statins (50.8 ± 4.9%, n = 5, p < 0.05). CONCLUSION: Treatment in a lipid clinic leads to a superior LDL-C goal achievement in very high-risk CVD patients as compared to standard care with the highest reduction under LLT with high-intensity statins and ezetimibe. Referral algorithms have to be established for high-risk patients.

Income-Related Peripheral Artery Disease Treatment: A Nation-Wide Analysis from 2009-2018.

Economic status has a measurable and significant effect on cardiovascular health. Socioeconomic- and income-related disparities worsen cardiovascular risk factors. Peripheral artery disease (PAD) remains a major risk factor for morbidity and mortality. Not all patients benefit equally from recent advances in outpatient healthcare. The implementation of guideline recommendations regarding treatment is inadequate. Income-related disparities for PAD treatment are unknown. We aimed to analyse income-stratified PAD prevalence, outpatient treatment and pharmacotherapy. Associations of statutory health insurance physicians at the regional level, income-stratified PAD prevalence and differences in outpatient care and pharmacotherapy were analysed in 70.1 million statutorily insured patients/year between 2009 and 2018. Analysis was based on claims data (§295 of the social code (SGB V)) and drug-prescription data (§300 SGB V). The diagnosis of PAD was defined by ICD I70.2-9. Regional income data were derived from the German Census Bureau. PAD prevalence was higher in low-income than in high-income areas. Low-income patients more often presented to angiology outpatient care and more frequently received guideline recommended pharmacotherapy. High-income patients more often presented to outpatient vascular surgery. This was true for statins, antiplatelets, intermittent claudication and critical limb ischemia alike. These data indicate that PAD and income are associated. Regional income is related to insufficiencies in guideline-recommended treatment and contact to vascular specialists. Our results aim to encourage medical professionals to implement PAD guideline recommendations, especially in high-income areas. Further studies on associations between spatial-level income and healthcare in PAD are needed.

Mechanical atherothrombectomy improves endothelial function through plaque burden reduction in PAD.

Background: Endothelial dysfunction defines outcomes and serves as a surrogate parameter for the progression of cardiovascular disease. For symptomatic peripheral artery disease (PAD) endovascular treatment is the primary revascularization strategy, which affects endothelial function. Interventional mechanical atherothrombectomy (MATH) provides advantages when treating complex atherosclerotic and thrombotic lesions. We now aimed to determine the impact and mechanisms of MATH on endothelial function. Patients and methods: Endothelial function was determined using flow-mediated dilation (FMD) before and after lower limb intervention with a six-month follow-up in the target and control vessel in 15 PAD MATH+DCB treated patients and compared to 15 non-Math controls. In a further cohort of 20 patients the impact of MATH and DCB on vascular structure and virtual histology was assessed through intravascular ultrasound (IVUS) and compared to DCB treatment alone. Results: Improved endothelial function after 6 months was observed in both groups for the target and nontarget vessel. When comparing the changes from baseline endothelial function, treatment with MATH+DCB was superior to DCB treatment in the target vessel. IVUS revealed a greater improvement in luminal area and plaque burden reduction after MATH treatment. Virtual histology disclosed MATH-associated changes in plaque composition evidenced by alterations in fibrous volume and reductions in superficial calcium. Conclusions: We demonstrate an improved endothelial function after MATH treatment as compared to DCB treatment. The improved vessel function is evidenced by MATH-related plaque burden reduction, improved luminal gain and a decrease in superficial calcification. Clinicaltrials.gov: NCT04092972.

Gender Differences in Outpatient Peripheral Artery Disease Management in Germany: A Population Based Study 2009-2018.

OBJECTIVE: Peripheral artery disease (PAD) is a major risk factor for morbidity and death. Despite clear guideline recommendations regarding outpatient treatment and pharmacotherapy, implementation is inadequate. Gender differences are becoming increasingly important, especially in patients with atherosclerosis. METHODS: Gender stratified PAD prevalence and differences in treatment by specialised outpatient care and pharmacotherapy were analysed in 70.1 million statutorily insured patients/year in Germany between 2009 and 2018. This was based on claims data according to §295 of the social code (SGB V) and drug prescription data according to §300 SGB V. Diagnosis of PAD was defined according to ICD I70.2-9 coding. Statistical analysis was performed with the chi square test for trend and two way ANOVA. RESULTS: In total, 17 633 970 patients with PAD were identified, of whom 47% were female. Prevalence of PAD in Germany increased between 2009 and 2018 and was higher in male patients. Only a minority of 37.1% presented to a vascular specialist. Interestingly, female patients were both less likely to present to a vascular specialist and to receive guideline recommended pharmacotherapy. Overall prescription rates of statins and antiplatelet drugs increased between 2009 and 2018, however. PAD stages were stratified by intermittent claudication (IC) and chronic limb threatening ischaemia (CLTI). In CLTI even fewer patients received a statin, with the gender gap increasing. CONCLUSION: The results demonstrate gender based differences in pharmacotherapy and specialised outpatient care of patients with PAD. While overall outpatient treatment by vascular specialists and guideline recommended medical therapy of PAD are low, women and patients with CLTI remain undertreated.

Peripheral artery disease in Germany (2009-2018): Prevalence, frequency of specialized ambulatory care and use of guideline-recommended therapy - A population-based study.

BACKGROUND: Peripheral artery disease (PAD) patients have high morbidity and mortality rates, demonstrating a need for improved treatment strategies. While underuse and undertreatment have been reported, there is no clear picture of patterns in population-level disease prevalence, prescription of guideline-recommended pharmacotherapy, or frequency of contact with dedicated specialists. We present population-level data on changes in prevalence, care and treatment of PAD from 2009 to 2018 in Germany. METHODS: We analyzed the ambulatory claims data for all statutorily insured patients comprising 70.1 million patients each year and 87% of the German population. Prevalence was assessed by documentation of PAD and stratified by age and sex within the 10-year study timeframe. In addition, current ambulatory care, stratified by vascular specialists (vascular surgeons or angiologists), internists, cardiologists and primary care physicians, were examined. FINDINGS: Prevalence increased from 1·85% in 2009 to 3·14% in 2018, affecting 2·3 million patients in 2018 and more males (55%) than females (45%). A low level of visits to vascular specialists, with 11·1% receiving care from vascular surgeons and 8·1% from angiologists, was shown. Moreover, analysis of guideline-recommended prescriptions revealed increasing, but still insufficient, prescription frequencies among PAD patients between 2009 and 2016, from 42·6% to 56% for statins and from 40·2% to 48·0% for antiplatelets. INTERPRETATION: Our results show that the prevalence of PAD in Germany, as assessed by outpatient PAD documentation, is increasing and PAD patients are underutilizing specialized vascular care; moreover, the prescription frequency of guideline-recommended therapies remains low. There is a clear need to improve the referral and treatment algorithms in the high-risk PAD population. FUNDING: None.

The impact of percutaneous peripheral interventions on endothelial function.

Background: Treatment of symptomatic peripheral artery disease (PAD) through endovascular interventions is the primary revascularization strategy. Interventions restore perfusion but may cause severe injury to the vascular endothelium, which regulates vascular tone. Endothelial dysfunction is involved in the progression of cardiovascular disease, with higher incidences of vascular events. We aimed to determine the impact of percutaneous interventions on change in endothelial function. Patients and methods: Endothelial function was determined using flow-mediated dilation (FMD) before, the day after lower limb intervention with paclitaxel-coated balloons or stent guided interventions and after a six-month follow-up in the target limb, control limb and the systemic circulation in 42 PAD patients aged 70.2±9 years and 66% men. Additionally, macro- and microvascular function were assessed. Results: In PAD patients aged 70.2±9 years and 66% men, we observed an immediate enhancement of macro-, microvascular and endothelial function after endovascular treatment (FMD of superficial femoral artery (SFA) 3.7±0.2% to 4.1±0.1%, n=42, p=0.02), a sustained long-term improvement after 6-months (FMD SFA 3.7±0.2% to 4.2±0.1%, n=42, p=0.01), and moreover an improved systemic endothelial function (FMD brachial artery 4.3±0.1% to 4.7±0.2, n=42, p=0.01) following peripheral interventions. Subgroup analysis however revealed that following paclitaxel-based percutaneous intervention, the paclitaxel dosage applied was inversely related to the chronic improvement in local endothelial function (r=-0.6, n=22, p=0.005) without evidence for systemic effects (r=-0.25, p=0.27). Conclusions: We demonstrate an improved local and systemic endothelial function after treatment of atherosclerotic peripheral disease with a distinguished response after endovascular intervention with higher dosage of applied paclitaxel restraining the benefits. Further studies have to determine the optimal interventional strategy with respect to different treatment modalities to maintain vessel functions.