Editor's Choice – Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis

Behrendt, Christian‐Alexander; Sedrakyan, Art; Peters, Frederik; Kreutzburg, Thea; Schermerhorn, Marc L.; Bertges, Daniel J.; Larena-Avellaneda, A.; L’Hoest, Helmut; Kölbel, Tilo; Debus, Eike Sebastian

doi:10.1016/j.ejvs.2019.12.034

Cited by 103 publications

(35 citation statements)

References 33 publications

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“…The longitudinal data of Germany's second-largest insurance fund, BARMER, includes the outpatient and inpatient medical care provided to up to 9.4 million (from 2008 to 2020) German citizens (13.2% of Germany's population) involving more than 24 million hospitalizations between January 1, 2008, and May 31, 2020. The BARMER cohort is similar to Western European countries and has been widely used for research projects before [20,21]. A regular random sample validation of internal and external validity is performed by the Medical Service of the Health Funds (MDK) in Germany, and various peer-reviewed validation studies have been published before [22,23].…”

Section: Sample and Databasementioning

confidence: 99%

Temporal trends in the presentation of cardiovascular and cerebrovascular emergencies during the COVID-19 pandemic in Germany: an analysis of health insurance claims

et al. 2020

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Aims The first reports of declining hospital admissions for major cardiovascular emergencies during the COVID-19 pandemic attracted public attention. However, systematic evidence on this subject is sparse. We aimed to investigate the rate of emergent hospital admissions, subsequent invasive treatments and comorbidities during the COVID-19 pandemic in Germany. Methods and results This was a retrospective analysis of health insurance claims data from the second largest insurance fund in Germany, BARMER. Patients hospitalized for acute myocardial infarction, acute limb ischemia, aortic rupture, stroke or transient ischemic attack (TIA) between January 1, 2019, and May 31, 2020, were included. Admission rates per 100,000 insured, invasive treatments and comorbidities were compared from January-May 2019 (pre-COVID) to January-May 2020 (COVID). A total of 115,720 hospitalizations were included in the current analysis (51.3% females, mean age 72.9 years). Monthly admission rates declined from 78.6/100,000 insured (pre-COVID) to 70.6/100,000 (COVID). The lowest admission rate was observed in April 2020 (61.6/100,000). Administration rates for ST-segment elevation myocardial infarction (7.3-6.6), non-ST-segment elevation myocardial infarction (16.8-14.6), acute limb ischemia (5.1-4.6), stroke (35.0-32.5) and TIA (13.7-11.9) decreased from pre-COVID to COVID. Baseline comorbidities and the percentage of these patients treated with interventional or open-surgical procedures remained similar over time across all entities. In-hospital mortality in hospitalizations for stroke increased from pre-COVID to COVID (8.5-9.8%). Conclusions Admission rates for cardiovascular and cerebrovascular emergencies declined during the pandemic in Germany, while patients' comorbidities and treatment allocations remained unchanged. Further investigation is warranted to identify underlying reasons and potential implications on patients' outcomes. Moritz Seiffert and Fabian J. Brunner share the first authorship.

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Section: Sample and Databasementioning

confidence: 99%

Temporal trends in the presentation of cardiovascular and cerebrovascular emergencies during the COVID-19 pandemic in Germany: an analysis of health insurance claims

et al. 2020

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“…In a Germanywide propensity score-matched and adjusted analysis of the primary outcomes of 1) overall survival, 2) amputationfree survival and 3) freedom from major cardiovascular events, no evidence was found of increased complications in the femoropopliteal or crural artery in the paclitaxel group (37,914 and 14,738 pa- tients, respectively) after a 5-year followup period. Rather, an inverse association was discerned with improved outcomes following the index procedure, which could be confirmed in numerous sensitivity analyses [5,17].…”

Section: Real-world Evidence On Paclitaxel-coated Stents and Balloonsmentioning

confidence: 66%

“…In the BARMER cohort, which included almost 10% of insured persons in Germany and enables a patient-level evaluation, just 111 patients had received a coated stent and 138 patients a corresponding balloon by 2009. In 2018, the proportion of coated devices thus increased from 3% for the treatment of critical limb ischemia and 4% for the treatment of intermittent claudication (2010) to 39% and 48%, respectively [5,17]. A similar situation can be observed in practice patterns in the USA where around 50% of all procedures are today performed using coated stents or balloons [26].…”

Section: Real-world Evidence On Paclitaxel-coated Stents and Balloonsmentioning

confidence: 79%

“…The findings of the first meta-analysis by Katsanos et al were gradually confirmed in investigations by the FDA as well as in further meta-analyses that used patientlevel data along with additional data [32]. Meanwhile, an inverse association was observed in a number of real-world studies that used nonrandomized registry data and routinely collected data [5,7,20,37]. The two sides have responded with countless arguments in articles and at congresses without a conclusive outcome being reached [4].…”

Section: Introductionmentioning

confidence: 91%

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Randomized controlled trials and real-world evidence for market access and surveillance of high-risk products—The example of paclitaxel

et al. 2020

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In 2018 and 2020, two meta-analyses using summary-level data from randomized controlled trials reported worse mortality following the application of paclitaxel-coated stents and balloons in femoropopliteal and crural arteries. These results initiated a heated global discussion concerning the validity of this association, while various observational studies using clinical and administrative registries proved the safety of coated devices. This article aimed to summarize the development and adoption of paclitaxel-coated balloons and stents for the treatment of peripheral arterial occlusive disease in clinical practice, research, and practice guidelines. It especially focusses on the European Unionʼs medical device regulation, which has far-reaching implications for the market approval and monitoring of high-risk medical devices.

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“…Drawing on routinely collected data from BARMER, two comprehensive analyses of routinely collected data were conducted in parallel and independently of each other, taking very different methodological approaches. On the one hand, propensity score matching was implemented to compensate for the lack of randomizationatthe time ofthe intervention [13]. Onthe otherhand, information on multiple interventions per patient was used to model a possible dose-response relationship [21].…”

Section: Methodological Considerationsmentioning

confidence: 99%

Quality of care in surgical/interventional vascular medicine: what can routinely collected data from the insurance companies achieve?

et al. 2020

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The complexity and diversity of surgical/interventional vascular medicine necessitate innovative and pragmatic solutions for the valid measurement of the quality of care in the long term. The secondary utilization of routinely collected data from social insurance institutions has increasingly become the focus of interdisciplinary medicine over the years. Owing to their longitudinal linkage and pan-sector generation, routinely collected data make it possible to answer important questions and can complement quality development projects with primary registry data. Various guidelines exist for their usage, linkage, and reporting. Studies have shown good validity, especially for endpoints with major clinical relevance. The numerous advantages of routinely collected data face several challenges that require thorough plausibility and validity procedures and distinctive methodological expertise. This review presents a discussion of these advantages and challenges and provides recommendations for starting to use this increasingly important source of data.

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Editor's Choice – Long Term Survival after Femoropopliteal Artery Revascularisation with Paclitaxel Coated Devices: A Propensity Score Matched Cohort Analysis

Cited by 103 publications

References 33 publications

Temporal trends in the presentation of cardiovascular and cerebrovascular emergencies during the COVID-19 pandemic in Germany: an analysis of health insurance claims

Temporal trends in the presentation of cardiovascular and cerebrovascular emergencies during the COVID-19 pandemic in Germany: an analysis of health insurance claims

Randomized controlled trials and real-world evidence for market access and surveillance of high-risk products—The example of paclitaxel

Quality of care in surgical/interventional vascular medicine: what can routinely collected data from the insurance companies achieve?

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