ASPIRIN FOR PRIMARY PREVENTION IN HIGH-RISK TYPE 2 DIABETES: INSIGHTS FROM THE ACCORD TRIAL

Abstract

Therapeutic Area: ASCVD /CVD Risk Reduction Background: Aspirin is endorsed for preventing cardiovascular disease (CVD) in diabetes mellitus (DM) patients at elevated risk, balancing its benefits against the risk of bleeding; however, its efficacy for primary prevention in DM remains equivocal. This analysis aimed to assess the association of aspirin use for primary prevention with incident atherosclerotic cardiovascular disease (ASCVD) and mortality in high-risk Type 2 DM (T2DM) individuals from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Methods: We included participants in the ACCORD trial who were free of CVD at baseline. The ACCORD trial, conducted between 2001 and 2008, aimed to investigate whether intensive glycemic control, multi-drug lipid management, and intensive blood pressure control could prevent major CV events in adults with T2DM. We used multivariate Cox proportional hazard analysis to examine the association between aspirin use and the primary outcome composite of CV death, non‐fatal myocardial infarction (MI) or non‐fatal stroke) and all-cause mortality. Results: Eligible participants (n=6,330) were 62.8 ±5.9 years of age at baseline, 43.8% female, and 3,026 (47.8%) used aspirin. Over a median follow-up of 4.9 years (interquartile range 4.1–5.7 years), the number (%) of the primary outcome and all-cause mortality events in those who used aspirin (vs. those who did not), was 196 (6.5) vs. 229 (6.9) (p-value 0.471), 146 (4.8) vs. 147 (4.5) (p-value 0.477), respectively. The adjusted hazard ratios (HR) and the 95% confidence intervals associated with aspirin use for the primary outcome and all-cause mortality were 0.94 (0.77–1.14) and 1.08 (0.85–1.36), respectively (Table). A sensitivity analysis (n=2,742) limited to participants with data on consistent aspirin use throughout the trial confirmed these findings. Conclusions: Aspirin use was not associated with a reduced risk of CV events or mortality in high-risk T2DM patients, underscoring persistent uncertainties about its efficacy in primary prevention in this patient population.