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

Peters, Frederik; Kreutzburg, Thea; Kuchenbecker, Jenny; Debus, Sebastian; Marschall, Ursula; L’Hoest, Helmut; Behrendt, Christian‐Alexander

doi:10.1136/bmjsit-2019-000020

Cited by 9 publications

(7 citation statements)

References 29 publications

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“…34 More details about the broader study of which this analysis is part and the German healthcare system are available in a corresponding study protocol (clinicaltrials.gov NCT03909022). 35…”

Section: Discussionmentioning

confidence: 99%

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

Peters

Kreutzburg

Rieß

et al. 2020

European Journal of Vascular and Endovascular Surgery

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WHAT THIS PAPER ADDS In 2018, women are still disadvantaged in terms of optimal pharmacological treatment for peripheral arterial occlusive disease after hospital discharge. Although presenting at older age and with more severe symptoms, women have a lower prescription prevalence of optimal pharmacological treatment, particularly with respect to lipid lowering drugs. The sex prescription gap did not narrow over time, despite an overall upward trend in prescription prevalence for both women and men. Objective: 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). Methods: 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. Results: 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. Conclusion: 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.

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Section: Discussionmentioning

confidence: 99%

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

Peters

Kreutzburg

Rieß

et al. 2020

European Journal of Vascular and Endovascular Surgery

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“…For identifying medical prescriptions, the German version of the international Anatomical Therapeutic Chemical (ATC) classification was used. The study protocol was published a priori on 24 December 2020 (clinicaltrials.gov NCT04683458) (accessed on 1 June 2021) [21].…”

Section: Barmer Cohortmentioning

confidence: 99%

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

Behrendt

Sedrakyan

Κατσάνος

et al. 2021

JCM

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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.

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“…Further details regarding this cohort can be found in a published study protocol on optimal pharmacological treatment and the ongoing claims study (clinicaltrials.gov NCT03909022). 23 The precise analyses in this paper were not pre-specified.…”

Section: Barmer Cohortmentioning

confidence: 99%

Long Term Outcomes After Revascularisations Below the Knee with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis

Heidemann

Peters

Kuchenbecker

et al. 2020

European Journal of Vascular and Endovascular Surgery

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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.

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

Cited by 9 publications

References 29 publications

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

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

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

Long Term Outcomes After Revascularisations Below the Knee with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis

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