Low-doses aspirin in the primary prevention of cardiovascular disease in patients with diabetes: Meta-analysis stratified by baseline cardiovascular risk

Abstract

Background and aim: The aim of this meta-analysis was to analyze the risks and benefits of low-dose aspirin in patients with T2D without cardiovascular conditions according to the baseline cardiovascular risk.

Methods: We performed a meta-analysis including randomized clinical trials that evaluated the use of low-dose aspirin (75-100 mg/day) versus placebo/usual care in patients with T2D. Studies were classified as low, moderate and high risk based on the number of events in the placebo/control arms or by cardiovascular risk score when reported. The incidence of MACE, cardiovascular mortality and bleeding were evaluated.

Results: Ten eligible trials (34069 patients) were considered eligible for the analyses. According to the stratified analysis, low-dose aspirin use was associated with reduced risk for MACE in the moderate/high-risk group (OR: 0.88; 95% CI, 0.80-0.97; I² = 0%) but not in the low-risk group (OR: 0.89; 95% CI, 0.77-1.01; I² = 0%). Likewise, low-dose aspirin use was associated with more bleeding in the low-risk group, showing a non-significant trend in the moderate/high-risk group. There was no reduction in cardiovascular mortality in either group. Beyond the different findings in each stratum, the differences between the subgroups were not statistically significant.

Conclusion: This study showed that low-dose aspirin in patients with T2D reduces MACE and increases bleeding. Based on the within-subgroups results, the baseline cardiovascular risk does not modify the effect of aspirin therapy. However, few studies were included and the comparison between subgroups showed a trend in favor to the highest risk group, these results should be confirmed in future studies.

Keywords: Aspirin; Cardiovascular risk; Major cardiovascular events; Type 2 diabetes.