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INTERBLEED: Design of an International Study of Risk Factors for Gastrointestinal Bleeding and Cardiovascular Events
Jacqueline Bosch1,2, Paul Moayyedi1, Marco Alings3
1Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
Insights
Gastrointestinal (GI) bleeding is a common, serious complication for cardiovascular disease patients on antithrombotic therapy. Understanding modifiable risk factors for bleeding and its consequences is crucial for developing prevention strategies.
Area of Science:
- Cardiology
- Gastroenterology
- Clinical Research
Background:
- Gastrointestinal (GI) bleeding is the most frequent adverse event in patients with cardiovascular (CV) disease on antithrombotic therapy.
- Bleeding, often dismissed as reversible, significantly increases morbidity, mortality, and future CV event risk.
- Identifying modifiable risk factors for GI bleeding and subsequent adverse outcomes is essential for effective management.
Purpose of the Study:
- To investigate the risk factors associated with GI bleeding in patients with CV disease.
- To examine the risk factors for CV events and functional decline following GI bleeding.
- To inform the development of strategies for preventing bleeding and its complications.
Main Methods:
- The INTERBLEED study is an international, multicentre, observational study.
- It comprises an incident case-control study for GI bleeding risk factors and a prospective cohort study for post-GI bleeding CV event risk factors.
- Data collection includes questionnaires, clinical measurements, functional/cognitive assessments, with 3- and 12-month follow-ups.
Main Results:
- As of April 1, 2022, the study is active in 10 countries across 31 centres.
- The study has enrolled 2407 cases and 1478 controls.
- Ongoing data collection aims to identify key risk factors.
Conclusions:
- Understanding the risk factors for GI bleeding in CV patients is critical.
- Identifying factors that predict CV events and functional decline post-bleeding is necessary.
- This knowledge will guide the development of preventative measures and improve patient outcomes.
Background:
Bleeding is the most common adverse event in those with cardiovascular (CV) disease receiving antithrombotic therapy, and it most commonly occurs in the gastrointestinal (GI) tract. Clinicians often dismiss bleeding as an adverse event that is reversible with effective antithrombotic therapy, but bleeding is associated with substantial morbidity and mortality, most likely mediated through an increased risk of CV events. Reducing the burden of bleeding requires knowledge of the potentially modifiable risk factors for bleeding and the potentially modifiable risk factors for adverse outcomes after bleeding.
Methods:
INTERBLEED is an international, multicentre, 2-component, observational study, with an incident case-control study examining the risk factors for GI bleeding, and a prospective cohort study of risk factors for CV events after GI bleeding. Cases either have CV disease and present to the hospital with GI bleeding or develop GI bleeding during hospitalization. Controls have CV disease, but no history of GI bleeding. We use a questionnaire to obtain detailed information on known and potential risk factors for GI bleeding and for CV events and outcomes after bleeding. We obtain CV and anthropometric measurements, perform functional and cognitive assessments, and follow participants at 3 months and 12 months.
Results:
As of April 1, 2022, the study is ongoing in 10 countries at 31 centres and has recruited 2407 cases and 1478 controls.
Conclusions:
Knowledge of risk factors for bleeding, and risk factors for CV events and functional decline after bleeding, will help develop strategies to prevent bleeding and subsequent complications.
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