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.

Background An increasing number of patients with a peripheral arterial occlusive disease were put on statins during the past years. This study assessed whether statin therapy was effective and safe for these new users. Methods and Results Using health insurance claims data from Germany’s second‐largest insurance fund, BARMER, we identified patients with peripheral arterial occlusive disease who had index revascularization between 2008 and 2018 without prior statin therapy. We compared patients with and without statin therapy in addition to antithrombotics during the first quarter after discharge (new users versus nonusers). Outcomes were all‐cause mortality, cardiovascular events, and incident major amputation for effectiveness and incident diabetes mellitus and incident myopathy for safety. Propensity score matching was used to balance the study groups. All analyses were stratified into patients with chronic limb‐threatening ischemia and intermittent claudication. A total of 22 208 patients (mean age 71.1 years and 50.3% women) were included in the study. In 10 922 matched patients, statin initiation was associated with lower all‐cause mortality (chronic limb‐threatening ischemia: hazard ratio [HR], 0.75 [95% CI, 0.68–0.84]; intermittent claudication: HR, 0.80 [95% CI, 0.70–0.92]), lower risk of major amputation in patients with chronic limb‐threatening ischemia (HR, 0.73; 95% CI, 0.58–0.93) and lower risk of cardiovascular events (hazard ratio, 0.80; 95% CI, 0.70–0.92) in patients with intermittent claudication during 5 years of follow‐up. Safety outcomes did not differ among the study groups. Conclusions Initiating statin therapy in patients with peripheral arterial occlusive disease after index revascularization is efficient and safe with an effect size comparable to earlier studies. Awareness campaigns for evidence‐based optimal pharmacological treatment among patients are recommended.

Objective: Previous studies have showed a potential disadvantage of female patients who underwent abdominal aortic aneurysm (AAA) repair. The current study aims to determine sex-specific perioperative and long-term outcomes using propensity score matched unselected nationwide health insurance claims data. Methods: Insurance claims from a large German fund were used, covering around 8% of the insured German population. Patients who underwent endovascular aortic repair (EVAR) for intact AAA from 1 January 2011 to 30 April 2017 were included in the cohort. A 1:2 female to male propensity score matching was applied to adjust for confounding variables. Perioperative and long-term outcomes after 5 years were determined using matching and regression methods. Results: Among a total of 3736 patients (19.3% females, mean 75 years) undergoing EVAR for intact AAA, we identified 1863 matched patients. Before matching, females were more likely to be previously diagnosed with hypothyroidism, electrolyte disorders, rheumatoid disorders, and depression, while males were more often diabetics. In the matched sample, 23.4% of the females and 25.8% of the males died during a median follow-up of 776 and 792 days, respectively. Perioperatively, females were more likely to exhibit acute limb ischemia (5.3% vs. 3.2%, p = 0.031) and major bleeding (22.0% vs. 15.9%, p = 0.001) before they were discharged to rehabilitation (5.5% vs. 1.5%, p < 0.001) when compared to males. No statistically significant difference in perioperative (odds ratio 1.12, 95% CI 0.54–2.16) or long-term mortality (hazard ratio 0.91, 95% CI 0.76–1.08) was observed between sexes. This was also true regarding aortic reintervention rates after 1 year (2.0% vs. 2.9%) and 5 years (10.9% vs. 8.1%). Conclusion: The current retrospective matched analysis of insurance claims revealed high early access-related morbidity in females when compared to their male counterparts. Short-term or long-term survival and reintervention outcomes were similar between sexes.

WHAT THIS PAPER ADDS In this retrospective cohort study of 14 738 patients and 6 568 propensity score matched patients with index revascularisation below the knee between 1 January 2010 and 31 December 2018, a reduction was observed in long term all cause mortality and the combined endpoints of amputation or death and cardiovascular event or death five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia. The study addressed a key question in vascular medicine and using long term real world evidence does not confirm the potential harm reported in randomised controlled trials. Objective: Endovascular revascularisation has become a standard approach for below knee lesions and paclitaxel coated devices have been widely used in patients with chronic limb threatening ischaemia. A recent metaanalysis reported higher mortality in paclitaxel coated devices compared with uncoated devices in femoropopliteal lesions. This study aimed to determine long term outcomes in below the knee interventions using paclitaxel coated devices in routine vascular care using a large and contemporary cohort. Methods: A large cohort was created using all inclusive health insurance claims data of patients covered by the second largest insurance fund in Germany. The cohort included patients with index revascularisation of arteries below the knee performed from 1 January 2010, to 31 December 2018. Only patients with first paclitaxel coated device exposure were included. The study cohort was stratified into balloon vs. stent treatment and patients with paclitaxel coated devices were matched with uncoated devices using propensity score. Outcomes were evaluated using the KaplaneMeier method and Cox regression. Results: There were 14 738 patients (mean age 77.6 years, 43.6% female) and 6 568 matched patients included in the study. Increasing use of paclitaxel coated devices was observed during the study period (6% in 2010 vs. 31% in 2018, p < .001), and a total of 2 611 (39.8%) deaths occurred within five years of follow up. In the propensity score matched Cox model, a paclitaxel related reduction of five year mortality (hazards ratio, HR 0.84, 95% confidence interval, CI 0.78e0.91), amputation or death (HR 0.87, 95% CI 0.81e0.94), and cardiovascular event or death (HR 0.86, 95% CI 0.80e0.92) were observed. Conclusion: In this propensity score matched cohort, reduced long term all cause mortality, reduced rates of amputation or death and cardiovascular event or death were observed at five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia.

Objective: This study aimed to determine predictors and outcomes associated with spinal cord ischemia (SCI) after elective fenestrated or branched endovascular aneurysm repair (F/BEVAR) of thoracoabdominal aortic aneurysm (TAAA), abdominal aortic aneurysm (AAA), or aortic dissection.Methods: Health insurance claims data of Germany's third largest insurance provider, DAK-Gesundheit, were used to investigate SCI in elective F/BEVAR performed between 2008 and 2017. The International Classification of Diseases and German Operation and Procedure Classification System were used. We stratified the results into F/BEVAR with one or two (AAA) vs three or more (TAAA) fenestrations or branches.Results: A total of 877 patients (18.9% female; 5.8% with SCI) matching the inclusion criteria were identified during the study period. SCI occurred more often after F/BEVAR of TAAA vs AAA (10.7% vs 3.0%; P < .001). SCI was associated with female sex in the AAA group (odds ratio, 3.87; 95% confidence interval [CI], 1.25-11.15; P ¼ .014) and with cardiac arrhythmias in the TAAA group (odds ratio, 2.98; 95% CI, 1.24-7.06; P ¼ .013). Compared with patients without SCI, SCI patients were more likely to suffer from drug use disorders (eg, opioids, cannabinoids, sedatives) in the TAAA group (17.6% vs 2.1%; P < .05). After F/BEVAR of TAAA, the occurrence of SCI was associated with higher 90-day mortality (14.7% vs 1.1%; P < .05), longer postoperative hospital stay (22 vs 9 days; P < .05), and severe adverse events, such as acute respiratory insufficiency (44.1% vs 12.7%), acute renal failure (35.3% vs 11.3%), and pneumonia (29.4% vs 4.9%; all P < .05). In adjusted analyses, SCI was associated with worse long-term survival after F/BEVAR for TAAA (hazard ratio, 2.54; 95% CI, 1.37-4.73; P < .003). Conclusions:Female AAA patients and TAAA patients with cardiac arrhythmias are at highest risk for development of SCI after F/BEVAR. The occurrence of this event was strongly associated with higher major complication rates and worse short-term and long-term survival. This emphasizes a need to further illuminate the value of spinal cord protection protocols in F/BEVAR.

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Objective: Several 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.Methods: Health 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.Results: In 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. Conclusions:In 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.

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 patients do not receive adequate pharmacological therapy after such interventions. Based on health insurance claims data, our study aims to assess (1) the extent of provision of pharmacological therapy after revascularisation and (2) related long-term outcomes for all patients and subgroups, that is, gender and disease severity.MethodsA retrospective observational population-based cohort study will be based on data from the second largest statutory health insurance fund in Germany (BARMER) covering about 13% of the insured population (~10 million patients). Study entry is the index revascularisation for symptomatic PAOD. Study variables will be analysed and compared among subgroups using parametric and non-parametric tests, generalised linear regression analysis and survival models.DiscussionThis study will provide a comprehensive insight in the extent and time trends of adequate provision of pharmacological therapy and long-term outcomes for patients with symptomatic PAOD. This may help to identify those patients benefiting most from improved pharmacological therapy for increasing the success of revascularisations in general.Trial registrationNCT03909022.