EBM Focus articles provide concise summaries of clinical trials most likely to inform clinical practice curated by the DynaMed® editorial team.
Three trials published in the last year (ASPREE, ASCEND, and ARRIVE) have brought into question the net benefit of aspirin therapy for primary prevention of cardiovascular disease (CVD). Risk stratification tools could help personalize the discussion about the benefits and harms of aspirin therapy with patients.
A recent study out of New Zealand utilized a previously validated risk calculator (PREDICT) linked to electronic primary care practice management systems to estimate the absolute CVD and bleeding event risks for over 245,000 adults aged 30-79 years. Participants with another indication for aspirin therapy, chronic kidney disease, diabetic nephropathy, atrial fibrillation, or antithrombotic therapy use in the past six months were excluded.
After calculating the CVD risk, the authors combined this with the relative effect of aspirin therapy as predicted from the updated systematic review to estimate the benefit of aspirin therapy over a five-year period (hazard ratio [HR] 0.89 for CVD events) and harms (HR 1.43 for major bleeding events). The difference in the final estimate of harm was then subtracted from the estimate of benefit, yielding a net effect. In an analysis assuming one CVD event (death or hospitalization from CVD event) was equivalent to one major bleeding event (death or hospitalization from bleeding), 2.5 percent of women and 12.1 percent of men were classified as benefiting from aspirin therapy over five years. Importantly, death or hospitalization due to hemorrhagic stroke was included in both analyses. Substantial benefit, defined as a difference in net effect of five events per 1,000 persons treated for five years, would be gained by 0.2 percent of women and 2 percent of men. Participants with diabetes, tobacco use, or antihypertensive use were more likely to benefit from aspirin, while those with alcohol use or cancer were more likely to be harmed. Net benefit also differed among different ethnicities and socioeconomic strata.
This study lays out a personalized approach to aspirin for primary prevention. Not only does the model include patient-specific data, but the risk calculator can account for patient preferences -- perhaps some patients are more fearful of major bleeding than of a major CVD event. One limitation of this analysis was the failure to analyze mortality outcomes separately, given that death from either cardiovascular causes or bleeding should count more than other events that someone may recover from. These adjustments are easily made if the risk calculator is designed properly. While clinicians and patients often view the electronic medical record as a barrier to care, putting these big datasets to use may help us provide more personalized medicine.
For more information, see the topic: Aspirin for Primary Prevention of Cardiovascular Disease in DynaMed.
