Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany

Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany - A GermanVasc Study

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.

Study Overview

• Status: Unknown
• Conditions: Intermittent Claudication; Peripheral Artery Disease; Critical Limb Ischemia

• Study Type: Observational
• Enrollment (Anticipated): 60000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants receiving best-medical-treatment	Prevalence of the outpatient prescription of best medical treatment defined as picking up a medication at a pharmacy for a lipid-lowering, an antithrombotic, and an antihypertensive drug agent, within 12 months after index discharge for POAD according to information provided in health insurance claims data	at 12 months after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants deceased	Rate of all-cause mortality after index discharge for POAD according to information provided in health insurance claims	at 5 years after discharge
Lower extremity amputation	Rate of lower extremity amputation after index discharge for POAD according to information provided in health insurance claims	at 5 years after discharge
Number of participants with a myocardial infarction	Rate of myocardial infarction after index discharge for POAD according to information provided in health insurance claims	at 5 years after discharge
Number of participants with a stroke or transient ischaemic attack	Rate of stroke or TIA after index discharge for POAD according to information provided in health insurance claims	at 5 years after discharge
Number of participants with a major bleeding	Rate of major bleeding provided in health insurance claims	at 5 years after discharge

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: GermanVasc; MDEpiNet Chapter Germany
• Investigators: Principal Investigator: Christian-Alexander Behrendt, MD Dr., University Medical Center Hamburg-Eppendorf, Working Group GermanVasc

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Website of the research group leading this project

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2008
• Primary Completion (ANTICIPATED): March 31, 2021
• Study Completion (ANTICIPATED): April 1, 2021

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 7, 2019
• First Posted (ACTUAL): April 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 11, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Atherosclerosis; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease; Intermittent Claudication; Arterial Occlusive Diseases
• Other Study ID Numbers: GermanVasc2019_023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No