Limitations
bleeding, ASCVD
MINOR, BLEEDING, ASCVD
This study has limitations. First, formulation of aspirin was participant determined, and participants reported only at baseline, with only 70.1% of the participants reporting the formulation of the aspirin they were using. The determination of whether a participant took the reported medication or was adherent to it was not captured after baseline. This assumption of which formulation of medication the participants were taking is an act of trust, as patients could have switched during the study on their own or with the advice of their physician. This would lead to a false conclusion if a large number of participants switched formulations of medication during the study. Second, the use of enteric-coated aspirin was not part of the randomization stratification; thus the data must be treated as though from an observational study. Because the participants decided which formulation of aspirin they would use, there may be unknown confounders leading to the choice of aspirin formulation used by the participant. For instance, a well-known leading brand of aspirin has a large number of their aspirin products, particularly cardiovascular products, packaged with the phrase “safety coating” included. However, adjustments were applied to the data to attempt to control for known confounders although unknown confounders may still affect the results. Third, there are no pharmacokinetic or pharmacodynamic data demonstrating whether enteric coating had any association with serum aspirin levels or platelet inhibition. Fourth, we did not collect detailed data on bleeding outcomes. It is unknown whether minor GI tract or other bleeding was reduced by either enteric coating or the dose of aspirin consumed. Finally, despite attempts to enroll a diverse population of patients with ASCVD, the enrollment of women and historically underrepresented minority groups lagged, so generalizability of the results remains questionable.