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

Overview

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 (POAD) 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 POAD 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 POAD-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.

Full Title of Study: “Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany – A GermanVasc Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: March 31, 2021

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants receiving best-medical-treatment
    • Time Frame: at 12 months after discharge
    • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universitätsklinikum Hamburg-Eppendorf
  • Collaborator
    • GermanVasc
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christian Behrendt, Head of Research Unit GermanVasc and Principal Investigator – Universitätsklinikum Hamburg-Eppendorf
  • Overall Official(s)
    • Christian-Alexander Behrendt, MD Dr., Principal Investigator, University Medical Center Hamburg-Eppendorf, Working Group GermanVasc

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