INTERBLEED: Design of an International Study of Risk Factors for Gastrointestinal Bleeding and Cardiovascular Events After Gastrointestinal Bleeding
Jacqueline Bosch, PhD,
Paul Moayyedi, MD, PhD,
Marco Alings, MD, PhD,
Alvaro Avezum, Jr., MD, PhD,
Shrikant I. Bangdiwala, PhD,
Alan Barkun, MD, CM, MSc,
Federico Cassella, MD,
Aloisio Marchi da Rocha, MD, PhD,
Irfan Duzen, MD,
Robert Enns, MD,
Nauzer Forbes, MD, MSc,
Leah Hamilton, MSc,
Shofiqul Islam, PhD,
Mustafa Kilickap, MD, MSc,
Paul Kruger, MBBS,
Yan Liang, MD,
Jose C. Nicolau, MD,
Rafael Nunes, MD, PhD,
Martin O’Donnell, MD, PhD,
Gustavo Oliveira, MD, PhD,
Alejandro Rey, MD,
Yihong Sun, MD,
Thomas Vanassche, MD,
Peter Verhamme, MD,
Michael Walsh, MD, PhD,
Zhenyu Wang, MD,
Cynthia Wu, MD,
Li Zhao, MD,
Jun Zhu, MD,
John W. Eikelboom, MBBS
Affiliations
Jacqueline Bosch, PhD
Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada; Corresponding author: Dr Jacqueline Bosch, Population Health Research Institute, 20 Copeland Ave, Hamilton L8L 2X2, Canada. Tel.: +1-905-317-9161.
Paul Moayyedi, MD, PhD
Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada
Marco Alings, MD, PhD
Amphia Ziekenhuis, Breda, The Netherlands
Alvaro Avezum, Jr., MD, PhD
International Research Centre, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil
Shrikant I. Bangdiwala, PhD
Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada
Alan Barkun, MD, CM, MSc
Research Institute of the McGill University Health Centre/Institut de recherche du Centre universitaire de santé McGill, Montreal, Quebec, Canada
Federico Cassella, MD
Fundación Sanatorio Güemes, Buenos Aires, Argentina
Aloisio Marchi da Rocha, MD, PhD
Sociedade Campineira de Educação e Instrução, São Paulo, Brazil
Irfan Duzen, MD
Gaziantep Üniversitesi Tıp Fakültesi Şahinbey Eğitim ve Araştırma Hastanesi, Gaziantep, Turkey
Robert Enns, MD
University of British Columbia, Vancouver, British Columbia, Canada
Nauzer Forbes, MD, MSc
Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada
Leah Hamilton, MSc
Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada
Shofiqul Islam, PhD
Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada
Mustafa Kilickap, MD, MSc
Cardiology Department, Ankara University School of Medicine, Ankara, Turkey
Paul Kruger, MBBS
Fiona Stanley Hospital, Perth, Western Australia, Austrailia
Yan Liang, MD
Emergency Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
Jose C. Nicolau, MD
Instituto do Coração do Hospital das Clincias da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
Rafael Nunes, MD, PhD
Clinical Cardiology and Cardio-Oncology, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil
Martin O’Donnell, MD, PhD
College of Medicine, Nursing and Health Sciences, University of Galway, Galway, Ireland
Gustavo Oliveira, MD, PhD
International Research Centre, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil
Alejandro Rey, MD
Medicina Interna, Centro de Educación Médica e Investigaciones Clínicas (CEMIC), Buenos Aires, Argentina
Yihong Sun, MD
China-Japan Friendship Hospital, Beijing, China
Thomas Vanassche, MD
KU Leuven Department of Cardiovascular Sciences, Leuven, Belgium
Peter Verhamme, MD
KU Leuven Department of Cardiovascular Sciences, Leuven, Belgium
Michael Walsh, MD, PhD
Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
Zhenyu Wang, MD
Beijing Traditional Chinese Medicine Hospital, Beijing, China
Cynthia Wu, MD
Research Transition Facility, University of Alberta, Edmonton, Alberta, Canada
Li Zhao, MD
Fu Xing Hospital, Beijing, China
Jun Zhu, MD
Emergency Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
John W. Eikelboom, MBBS
Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada
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. Résumé: Contexte: L’hémorragie est l’effet indésirable le plus fréquent chez les patients atteints de maladies cardiovasculaires (CV) qui reçoivent un traitement antithrombotique, et elle survient le plus souvent dans le tractus gastro-intestinal (GI). Les cliniciens considèrent souvent l’hémorragie comme une simple manifestation indésirable réversible par un traitement antithrombotique efficace, mais une morbidité et une mortalité considérables y sont associées, probablement en raison d’un risque accru d’événements CV. Une réduction du fardeau de l’hémorragie nécessite une connaissance des facteurs de risque potentiellement modifiables tant de l’hémorragie que des événements indésirables qui surviennent après l’hémorragie. Méthodologie: INTERBLEED est une étude internationale, observationnelle et multicentrique à deux volets; le premier volet est une étude cas-témoins incidents visant à examiner les facteurs de risque d’hémorragie GI, alors que le second volet est une étude de cohorte prospective visant à examiner les facteurs de risque d’événements CV après une hémorragie GI. Les cas sont des patients atteints de maladies CV qui consultent les services hospitaliers pour une hémorragie GI ou qui présentent une hémorragie GI en cours d’hospitalisation. Les témoins sont des patients atteints de maladies CV, mais sans antécédents d’hémorragie GI. Un questionnaire est utilisé pour obtenir des renseignements détaillés au sujet de facteurs de risque connus et potentiels d’hémorragie GI et d’événements CV et d’autres résultats de santé après une hémorragie. Des mesures cardiovasculaires et anthropométriques ainsi que des évaluations fonctionnelles et cognitives sont réalisées, et les participants sont revus après trois mois et 12 mois. Résultats: En date du 1er avril 2022, l’étude est en cours dans 10 pays et 31 établissements de santé; 2 407 cas et 1 478 témoins ont été recrutés. Conclusions: La connaissance des facteurs de risque d’hémorragie, ainsi que des facteurs de risque d’événements CV et de déclin fonctionnel à la suite d’une hémorragie, aidera à mettre en place des stratégies pour prévenir les hémorragies et les complications qui peuvent en découler.
