New sex-specific prognostic models successfully estimated the absolute bleeding harms of aspirin therapy among patients requiring primary prevention of CVD, according to research published in Annals of Internal Medicine.
“The decision to initiate aspirin therapy for the primary prevention of cardiovascular disease (CVD) requires careful consideration of both absolute benefits and harms,” Vanessa Selak, MBChB, PhD, from the University of Auckland, New Zealand, and colleagues wrote. “The most significant harm associated with aspirin is major bleeding.”
“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,” they added.
Selak conducted a prospective cohort study to develop sex-specific prognostic models for bleeding risk for individuals who may be candidates for aspirin for the primary prevention of CVD.
The researchers enrolled 385,191 individuals aged between 30 and 79 years. Participants had their CVD risk assessed between 2007 and 2016. Participants were excluded if they had indications for or contraindications to aspirin or were already receiving antiplatelet or anticoagulant therapy.
The predictors measured in the risk models included demographic characteristics, such as age, ethnicity and socioeconomic deprivation; clinical measurements, such as systolic BP and ratio of total HDL cholesterol; family history of premature CVD; medical history of smoking, diabetes, bleeding, peptic ulcer disease, cancer, chronic liver disease, chronic pancreatitis or alcohol-related conditions; and use of NSAIDs, corticosteroids and selective serotonin reuptake inhibitors.
Major bleeding events occurred in 4,442 patients. About 7% of these events resulted in death.
The median 5-year bleeding risk was 1% in women and 1.1% in men, according to the models. In both men and women, older age, smoking and diabetes were associated with a higher bleeding risk; however, other established CVD risk factors were not associated with bleeding risk.
These risk models could help identify patients who are more likely to benefit from aspirin for primary prevention than endure harm, according to the researchers.
“A tool, using the prognostic bleeding risk models described in this article, is under development,” Selak and colleagues wrote.
In a related editorial, Evelyn P. Whitlock, MD, MPH, from the Patient-Centered Outcomes Research Institute, and Eric S. Johnson, PhD, from the Center for Health Research at Kaiser Permanente Northwest, wrote that the analysis by Selak and colleagues provides significantly more evidence for individualized decision-making about aspirin use for primary prevention of CVD and offers the U.S. Preventive Services Task Force and others the opportunity to update their decision models.
“Such updates would allow incorporation of more robust, cohort-based estimates of the range and variability of major bleeding risks (for example, ‘other’ major bleeding events, as well as intracerebral and gastrointestinal events), including more precise case-fatality rates, than were available previously,” they wrote. – by Alaina Tedesco
Disclosures: Johnson reports receiving support from Novartis Pharma. Selak reports receiving grants from the Health Research Council of New Zealand. Whitlock reports that despite conducting prior work for the U.S. Preventive Services Task Force, she is not currently affiliated with the task force. Please see study for all other authors’ relevant financial disclosures.