The prospective GermanVasc cohort study

TY - JOUR

T1 - The prospective GermanVasc cohort study

T2 - Endovascular and open-surgical treatment of symptomatic peripheral artery disease

AU - Kotov, Artur

AU - Peters, Frederik

AU - Debus, Eike Sebastian

AU - Zeller, Thomas

AU - Heider, Peter

AU - Stavroulakis, Konstantinos

AU - Remig, Jürgen

AU - Gussmann, Andreas

AU - Hoffmann, Johannes

AU - Friedrich, Oliver

AU - Nolte, Thomas

AU - Behrendt, Christian Alexander

N1 - Publisher Copyright: © 2021 Hogrefe Verlag GmbH & Co. KG. All rights reserved.

PY - 2021/11

Y1 - 2021/11

N2 - 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.

AB - 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.

KW - bypass surgery

KW - chronic limb-threatening ischaemia

KW - endovascular techniques

KW - Health services research

KW - intermittent claudication

KW - peripheral artery disease

KW - Prospective Studies

KW - Endovascular Procedures/adverse effects

KW - Humans

KW - Risk Factors

KW - Male

KW - Treatment Outcome

KW - Peripheral Arterial Disease/diagnosis

KW - Ischemia

KW - Female

KW - Cohort Studies

UR - http://www.scopus.com/inward/record.url?scp=85110879912&partnerID=8YFLogxK

U2 - 10.1024/0301-1526/a000966

DO - 10.1024/0301-1526/a000966

M3 - SCORING: Journal article

C2 - 34279120

AN - SCOPUS:85110879912

VL - 50

SP - 446

EP - 452

JO - VASA

JF - VASA

SN - 0301-1526

IS - 6

ER -