Clinical trial NCT03909022: Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany
Official title: Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany - A GermanVasc Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Artery Disease
Intermittent Claudication
Critical Limb Ischemia
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: GermanVasc
name: MDEpiNet Chapter Germany
First posted: 2019-04-09
Enrollment: 60000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients older than 18 years of age. Treated in outpatient or inpatient facilities for symptomatic peripheral arterial occlussive disease.

Brief summary: This proposed study will be conducted to support real-world-evidence on the extent of best medical treatment for secondary prevention of patients with symptomatic peripheral arterial occlusive disease (PAOD) for prevention of worsening limb symptoms or of major adverse cardiovascular events. The overall objective of this study is to gain a better understanding of patient characteristics, treatment patterns and outcomes in PAOD patients. For this purpose the investigators will analyze a patient population hospitalized either with intermittent claudication (IC) or chronic limb-threatening ischaemia (CLTI) while taking prior PAOD-related diagnoses in the outpatient setting into account. In detail, we study differentials according to age, calendar time, sex, disease severity and hospital procedure. Data were extracted from available German health insurance claims.


Eligibility criteria: 1. First clinical diagnosis of symptomatic peripheral arterial occlusive disease (according to Fontaine classification, stages II, III and IV) after at least 5 years without such clinical diagnosis
2. At least 18 years of age

   Exclusion Criteria:
3. Incomplete information on sex, age, date of hospital discharge
4. Less than 5 years of insurance membership before index stay

Primary outcomes:
measure: Number of participants receiving best-medical-treatment
timeFrame: at 12 months after discharge
Secondary outcomes:
measure: Number of participants deceased
timeFrame: at 5 years after discharge
measure: Lower extremity amputation
timeFrame: at 5 years after discharge
measure: Number of participants with a myocardial infarction
timeFrame: at 5 years after discharge
measure: Number of participants with a stroke or transient ischaemic attack
timeFrame: at 5 years after discharge
measure: Number of participants with a major bleeding
timeFrame: at 5 years after discharge
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf, Working Group GermanVasc
name: Christian-Alexander Behrendt, MD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peters F, Kreutzburg T, Kuchenbecker J, Debus S, Marschall U, L'Hoest H, Behrendt CA. A retrospective cohort study on the provision and outcomes of pharmacological therapy after revascularisation for peripheral arterial occlusive disease: a study protocol. BMJ Surg Interv Health Technol. 2020 Jan 27;2(1):e000020. doi: 10.1136/bmjsit-2019-000020. eCollection 2020.
citation: Behrendt CA, Sedrakyan A, Peters F, Kreutzburg T, Schermerhorn M, Bertges DJ, Larena-Avellaneda A, L'Hoest H, Kolbel T, Debus ES. 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 Apr;59(4):587-596. doi: 10.1016/j.ejvs.2019.12.034. Epub 2020 Jan 8.
citation: Peters F, Kreutzburg T, Riess HC, Heidemann F, Marschall U, L'Hoest H, Debus ES, Sedrakyan A, Behrendt CA. 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. Eur J Vasc Endovasc Surg. 2020 Sep;60(3):421-429. doi: 10.1016/j.ejvs.2020.05.001. Epub 2020 Jul 12.
citation: Peters F, Kuchenbecker J, Acar L, Marschall U, L'Hoest H, Lareyre F, Spanos K, Behrendt CA. Antithrombotic Treatment Patterns of Patients with Symptomatic Peripheral Arterial Occlusive Disease in Germany: Evidence from Health Insurance Claims Data. J Clin Med. 2022 Sep 16;11(18):5455. doi: 10.3390/jcm11185455.