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Open AccessOriginal communication

The prospective GermanVasc cohort study

Endovascular and open-surgical treatment of symptomatic peripheral artery disease

Published Online:July 19, 2021https://doi.org/10.1024/0301-1526/a000966

Abstract

Summary:Background: Previous observational studies reported a wide variation and possible room for improvement in the treatment of patients suffering from symptomatic peripheral artery disease (PAD). Yet, systematic assessment of everyday clinical practice is lacking. A General Data Protection Regulation (GDPR) compliant registry was developed and used to collect comprehensive data on clinical treatment and outcomes regarding PAD in Germany. Here, we report baseline characteristics of patients prospectively enrolled until the end of 2020. Methods: The GermanVasc registry study is a prospective longitudinal multicentre cohort study. Between 1st May 2018 and 31st December 2020, invasive endovascular, open-surgical, and hybrid revascularisations of patients suffering from chronic symptomatic PAD were prospectively included after explicit informed consent (NCT03098290). For ensuring high quality of the data, we performed comprehensive risk-based and random-sample external and internal validation. Results: In total, 5608 patients from 31 study centres were included (34% females, median 69 years). On-site monitoring visits were performed at least once in all centres. The proportion of chronic limb-threatening ischaemia was 30% and 13% were emergent admissions. 55% exhibited a previous revascularisation. Endovascular techniques made 69% among all documented invasive procedures (n=6449). Thirty-five percent were classified as patients with severe systemic disease, and 3% exhibited a constant threat to life according to the American Society of Anaesthesiologists classification. The risk profile comprised of 75% former or current smokers, 36% diabetes mellitus, and in 30% a current ischemic heart disease was present. At discharge, 93% of the patients received antiplatelets and 77% received statins. Conclusions: The GermanVasc registry study provides insights into real-world practice of treatment and outcomes of 5,608 patients with symptomatic PAD in Germany. The cohort covers a broader range of disease severity and types of interventions than usually found in trials. In future studies, comparative outcomes will be analysed in more detail.

References

  • 1 Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: A systematic review and analysis. Lancet. 2013;382:1329–40. First citation in articleCrossref Medline, Google Scholar

  • 2 Behrendt CA, Sigvant B, Kuchenbecker J, Grima MJ, Schermerhorn M, Thomson I, et al. International variations and gender disparities in the treatment of peripheral arterial occlusive disease – A report from VASCUNET and the International Consortium of Vascular Registries. Eur J Vasc Endovasc Surg. 2020;60:873–80. First citation in articleCrossref Medline, Google Scholar

  • 3 Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, et al. Editor’s Choice – 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018;55:305–68. First citation in articleCrossref Medline, Google Scholar

  • 4 Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: A report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines. Circulation. 2017;135:e726–79. First citation in articleCrossref Medline, Google Scholar

  • 5 Frank U, Nikol S, Belch J, Boc V, Brodmann M, Carpentier PH, et al. ESVM Guideline on peripheral arterial disease. VASA. 2019;48:1–79. First citation in articleLink, Google Scholar

  • 6 Menard MT, Farber A. The BEST-CLI trial: A multidisciplinary effort to assess whether surgical or endovascular therapy is better for patients with critical limb ischemia. Sem Vasc Surg. 2014;27:82–4. First citation in articleCrossref Medline, Google Scholar

  • 7 Hunt BD, Popplewell MA, Davies H, Meecham L, Jarrett H, Bate G, et al. BAlloon versus Stenting in severe Ischaemia of the Leg-3 (BASIL-3): Study protocol for a randomised controlled trial. Trials. 2017;18:224. First citation in articleCrossref Medline, Google Scholar

  • 8 Behrendt CA, Sedrakyan A, Peters F, Kreutzburg T, Schermerhorn M, Bertges DJ, et al. Editor’s Choice – Long term survival after femoropopliteal artery revascularisation with paclitaxel coated devices: A propensity score matched cohort analysis. Eur J Vasc Endovasc Surg. 2020;59:587–96. First citation in articleCrossref Medline, Google Scholar

  • 9 Behrendt CA, Peters F, Mani K. The swinging pendulum of evidence: Is there a reality behind results from randomised trials and real world data? Lessons learned from the paclitaxel debate. Eur J Vasc Endovasc Surg. 2020;59:510–1. First citation in articleCrossref Medline, Google Scholar

  • 10 Behrendt CA, Riess HC, Schwaneberg T, Heidemann F, Tsilimparis N, Larena-Avellaneda AA, et al. Complex endovascular treatment of intact aortic aneurysms: An analysis of health insurance claims data. Gefasschirurgie. 2018;23:32–8. First citation in articleCrossref Medline, Google Scholar

  • 11 Behrendt CA, Schwaneberg T, Hischke S, Muller T, Petersen T, Marschall U, et al. Data privacy compliant validation of health insurance claims data: The IDOMENEO approach. Gesundheitswesen. 2020;82:S94–100. First citation in articleCrossref Medline, Google Scholar

  • 12 Behrendt CA, Bjorck M, Schwaneberg T, Debus ES, Cronenwett J, Sigvant B, et al. Editor’s Choice – Recommendations for registry data collection for revascularisations of acute limb ischaemia: A Delphi consensus from the international consortium of vascular registries. Eur J Vasc Endovasc Surg. 2019;57:816–21. First citation in articleCrossref Medline, Google Scholar

  • 13 Behrendt CA, Bertges D, Eldrup N, Beck AW, Mani K, Venermo M, et al. International consortium of vascular registries consensus recommendations for peripheral revascularisation registry data collection. Eur J Vasc Endovasc Surg. 2018;56:217–37. First citation in articleCrossref Medline, Google Scholar

  • 14 Riess HC, Debus ES, Schwaneberg T, Hischke S, Maier J, Bublitz M, et al. Indicators of outcome quality in peripheral arterial disease revascularisations – a Delphi expert consensus. VASA. 2018;47:491–7. First citation in articleLink, Google Scholar

  • 15 Petersen T, Blochberger M, Mueller T, Federrath H. [Sichere und datenschutzgerechte Umsetzung medizinischer Register]. DuD. 2019;43:507–12. First citation in articleCrossref, Google Scholar

  • 16 Bavendiek K, Mueller T, Wittner F, Schwaneberg T, Behrendt CA, Schulz W, et al. Automatically proving purpose limitation in software architectures. In: Dhillon GKarlsson FHedström KZúquete Aeds.. ICT Systems Security and Privacy Protection. SEC 2019. IFIP Advances in Information and Communication Technology. Vol. 562. Cham: Springer; 2019. 345–58. First citation in articleCrossref, Google Scholar

  • 17 von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: Guidelines for reporting observational studies. J Clin Epidemiol. 2008;61:344–9. First citation in articleCrossref Medline, Google Scholar

  • 18 Gray WK, Day J, Horrocks M. Outcomes for angioplasty and bypass lower limb revascularisation procedures for limb salvage in England: Findings from the getting it right first time programme. Eur J Vasc Endovasc Surg. 2020;60:711–9. First citation in articleCrossref Medline, Google Scholar

  • 19 Behrendt CA, Lyons O. Is England getting it right yet? Potential lessons for Europe. Eur J Vasc Endovasc Surg. 2020;60:720. First citation in articleCrossref Medline, Google Scholar

  • 20 Kreutzburg T, Peters F, Riess HC, Hischke S, Marschall U, Kriston L, et al. Editor’s Choice – Comorbidity patterns among patients with peripheral arterial occlusive disease in Germany: A trend analysis of health insurance claims data. Eur J Vasc Endovasc Surg. 2020;59:59–66. First citation in articleCrossref Medline, Google Scholar

  • 21 Malyar N, Stausberg J, Langhoff R, Tatò F, Kalka C, Ito WD, et al. Demographic and procedural characteristics in the RECording COurses of vasculaR Diseases (RECCORD) registry – the first 1000 patients. VASA. 2020;49:382–8. First citation in articleLink, Google Scholar

  • 22 Behrendt CA, Kolbel T, Schwaneberg T, Diener H, Hohnhold R, Debus ES, et al. Multidisciplinary team decision is rare and decreasing in percutaneous vascular interventions despite positive impact on in-hospital outcomes. VASA. 2019;48:262–9. First citation in articleLink, Google Scholar

  • 23 Bisdas T, Borowski M, Torsello G. First-Line Treatments in Patients With Critical Limb Ischemia Collaborators. Current practice of first-line treatment strategies in patients with critical limb ischemia. J Vasc Surg. 2015;62:965–73.e3. First citation in articleCrossref Medline, Google Scholar

  • 24 Docherty AB, Harrison EM, Green CA, Hardwick HE, Pius R, Norman L, et al. Features of 20133 UK patients in hospital with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol: Prospective observational cohort study. BMJ. 2020;369: m1985. First citation in articleCrossref Medline, Google Scholar

  • 25 Janssen F, El Gewily S, Bardoutsos A. Smoking epidemic in Europe in the 21st century. Tob Control. 2020. Online ahead of print. First citation in articleCrossref Medline, Google Scholar

  • 26 Rentería E, Jha P, Forman D, Soerjomataram I. The impact of cigarette smoking on life expectancy between 1980 and 2010: A global perspective. Tob Control. 2016;25:551–7. First citation in articleCrossref Medline, Google Scholar