This research focuses on patients with heart-related diseases who are often prescribed blood-thinning drugs to help prevent future heart problems. Even with the best care and treatment, some people remain at high risk for more heart problems. In these cases, additional blood-thinning drugs may help reduce this risk. However, these drugs come with a catch: they can increase the chance of bleeding. Therefore, physicians are advised that blood thinnersshould only be used for patients who are not at a high risk of bleeding. To check this, there are certain criteria in prevention guidelines, such as old age, previous bleedings or problems with the liver or kidneys. But it's not clear how likely these patients are to experience bleeding.
This study aims to find out how many patients with heart disease meet the criteria for high bleeding risk and to assess their actual chances of bleeding.
Antithrombotic therapy is one of the secondary prevention pillars in patients with established cardiovascular disease. Intensification of antithrombotic treatment can be considered in patients with a high residual cardiovascular event risk, as is stated in the 2021 ESC guideline on CVD prevention. Given the possible harm of bleeding complications inflicted by antithrombotics, ESC guidelines on chronic coronary syndromes (2019) and peripheral artery disease (2017) advise that this intensified treatment should only be considered in patients without a high risk of bleeding. HBR criteria are listed in these documents to identify patients at high bleeding risk: history of intracerebral haemorrhage or ischemic stroke, history of other intracranial pathology, recent gastrointestinal bleeding or anaemia due to possible gastrointestinal blood loss, other gastrointestinal pathology associated with increased bleeding risk, liver failure, bleeding diathesis or coagulopathy, extreme old age or frailty or renal failure requiring dialysis or with estimated glomerular filtration rate (eGFR) <15 mL/min. These criteria correspond to exclusion criteria of trials on intensification of antithrombotic therapy, but the actual bleeding risk of patients meeting these criteria is unknown. This is of importance for shared decision making, since an increase in bleeding risk may be acceptable where there is very high residual risk of an ischemic cardiovascular event. The goal of this study is to describe the prevalence of the HBR criteria and the actual major bleeding risk among individuals meeting these criteria. Prevalence of HBR criteria will be described for a cohort of patients with established CVD, and Hospital Episode Statistics (HES) admission and Office for National Statistics (ONS) mortality data will be used to assess and compare incidence rates of bleeding events adjusted for non-bleeding deaths, for patients meeting and not meeting any HBR criterion and individual HBR criteria.
Clinically relevant bleeding classified as Bleeding Academic Research Consortium bleeding types 2-5; major bleeding events requiring hospital admission or resulting in death; non-bleeding death.
Kausik Ray - Chief Investigator - Imperial College London
Maria Castelijns - Corresponding Applicant - Imperial College London
Ailsa McKay - Collaborator - Imperial College London
Frank Visseren - Collaborator - Utrecht University
Laura Gunn - Collaborator - Imperial College London
Steven Hageman - Collaborator - Imperial College London
HES Admitted Patient Care;ONS Death Registration Data