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

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

• Registration Number: NCT03909022
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-01
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-07
• Study First Posted: 2019-04-09
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-11
• Last Update Posted: 2020-04-14
• Primary Completion: 2021-03-31
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60000

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants receiving best-medical-treatment	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 Outcome Measures

Name	Time	Method
Number of participants with a myocardial infarction	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 major bleeding	at 5 years after discharge	Rate of major bleeding provided in health insurance claims
Number of participants deceased	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	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 stroke or transient ischaemic attack	at 5 years after discharge	Rate of stroke or TIA after index discharge for POAD according to information provided in health insurance claims