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

NCT03909022 | Unknown

• 1 other identifier: GermanVasc2019_023
• Study Type: observational
• Target: 60,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Artery Disease; Intermittent Claudication; Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of participants deceased

  at 5 years after discharge

• Lower extremity amputation

  at 5 years after discharge

• Number of participants with a myocardial infarction

  at 5 years after discharge

• Number of participants with a stroke or transient ischaemic attack

  at 5 years after discharge

• Number of participants with a major bleeding

  at 5 years after discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• GermanVasc: collaborator
• MDEpiNet Chapter Germany: collaborator

Related Publications (4)

• 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.

  PMID: 35047784 BACKGROUND

• 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.

  PMID: 31926836 RESULT

• 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.

  PMID: 32669223 RESULT

• 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.

  PMID: 36143102 DERIVED

Related Links

• Website of the research group leading this project

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes; Pathologic Processes; Ischemia

Study Officials

• Christian-Alexander Behrendt, MD Dr.

  University Medical Center Hamburg-Eppendorf, Working Group GermanVasc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research Unit GermanVasc and Principal Investigator

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 9, 2019
• Study Start: January 1, 2008
• Primary Completion: March 31, 2021
• Study Completion: April 1, 2021
• Last Updated: April 14, 2020

Record last verified: 2020-04