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

Study Overview
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Brief Summary
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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.

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

Conditions
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Peripheral Artery Disease, Intermittent Claudication, Critical Limb Ischemia

Participation Criteria
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Eligibility Criteria
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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 At least 18 years of age Exclusion Criteria: Incomplete information on sex, age, date of hospital discharge Less than 5 years of insurance membership before index stay

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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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 |