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Predicting Bleeding Risk to Guide Aspirin Use for the Primary Prevention of Cardiovascular Disease: A Cohort Study
Vanessa Selak1, Rod Jackson1, Katrina Poppe1
1University of Auckland, Auckland, New Zealand (V.S., R.J., K.P., B.W., M.H., C.G., R.P., S.M., S.W.).
Insights
New bleeding risk models can now estimate aspirin
Area of Science:
- Cardiovascular Medicine and Epidemiology
- Clinical Risk Prediction Modeling
Background:
- Existing cardiovascular risk models effectively estimate aspirin's benefits for primary prevention.
- However, there is a lack of robust models to accurately predict the potential harms, specifically bleeding risks, associated with aspirin use.
Purpose of the Study:
- To develop and validate prognostic models for predicting major bleeding risk.
- These models are intended for individuals considering aspirin for primary cardiovascular disease (CVD) prevention.
Main Methods:
- A prospective cohort study involving 385,191 participants aged 30-79 years in New Zealand primary care.
- Cox proportional hazards models were developed for each sex, incorporating predictors such as demographics, clinical measurements, medical history, and medication use.
- Participants were followed for a median of 5 years, with major bleeding events as the primary outcome.
Main Results:
- The developed models demonstrated good calibration in predicting major bleeding risk.
- Median 5-year predicted bleeding risk was 1.0% for women and 1.1% for men.
- A total of 4,442 major bleeding events were recorded during 1,619,846 person-years of follow-up.
Conclusions:
- The study successfully developed prognostic bleeding risk models.
- These models provide a valuable tool for estimating the absolute bleeding harms of aspirin in primary CVD prevention.
- The models can aid clinicians and patients in making more informed decisions about aspirin therapy.
Background:
Many prognostic models for cardiovascular risk can be used to estimate aspirin's absolute benefits, but few bleeding risk models are available to estimate its likely harms.
Objective:
To develop prognostic bleeding risk models among persons in whom aspirin might be considered for the primary prevention of cardiovascular disease (CVD).
Design:
Prospective cohort study.
Setting:
New Zealand primary care.
Participants:
The study cohort comprised 385 191 persons aged 30 to 79 years whose CVD risk was assessed between 2007 and 2016. Those with indications for or contraindications to aspirin and those who were already receiving antiplatelet or anticoagulant therapy were excluded.
Measurements:
For each sex, Cox proportional hazards models were developed to predict major bleeding risk; participants were censored at the earliest of the date on which they first met an exclusion criterion, date of death, or study end date (30 June 2017). The main models included the following predictors: demographic characteristics (age, ethnicity, and socioeconomic deprivation), clinical measurements (systolic blood pressure and ratio of total-high-density lipoprotein cholesterol), family history of premature CVD, medical history (smoking, diabetes, bleeding, peptic ulcer disease, cancer, chronic liver disease, chronic pancreatitis, or alcohol-related conditions), and medication use (nonsteroidal anti-inflammatory agents, corticosteroids, and selective serotonin reuptake inhibitors).
Results:
During 1 619 846 person-years of follow-up, 4442 persons had major bleeding events (of which 313 [7%] were fatal). The main models predicted a median 5-year bleeding risk of 1.0% (interquartile range, 0.8% to 1.5%) in women and 1.1% (interquartile range, 0.7% to 1.6%) in men. Plots of predicted-against-observed event rates showed good calibration throughout the risk range.
Limitation:
Hemoglobin level, platelet count, and body mass index were excluded from the main models because of high numbers of missing values, and the models were not externally validated in non-New Zealand populations.
Conclusion:
Prognostic bleeding risk models were developed that can be used to estimate the absolute bleeding harms of aspirin among persons in whom aspirin is being considered for the primary prevention of CVD.
Primary Funding Source:
The Health Research Council of New Zealand.
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