Abstract
Background: The role of aspirin in primary prevention of ASCVD amongst high-risk individuals with diabetes mellitus remains unclear. We investigated aspirin use with and without statin and its association with future ASCVD events in a cohort of real-world primary prevention patients with diabetes mellitus. Methods: Primary prevention patients with diabetes were stratified based on HbA1c levels (6.5-7%, 7-9%, >9%) and 10-year ASCVD risk (High-risk [≥20%]). Aspirin use was defined as no use, seldom used (<30% of the time), sometimes used (≥30% - < 70% of the time), and often used (≥70% of the time). Cox regression assessed HRs of myocardial infarction (MI), stroke, and mortality with aspirin use. Results: Of 79, 597 patients with diabetes, 44.6% were classified as high-risk. These patients showed highest utilization of aspirin (45.7%) and statin (44.9%). Compared to high-risk patients with diabetes and an HbA1c of >9% on both a statin and an aspirin, those on statin alone had higher risk of MI [HR MI 1.74 (1.44-2.212), p <0.001], ischemic stroke [HR STROKE 2.52 (1.92-3.29), p <0.001], and mortality [HR 1.67 (1.27-2.19), p <0.001] (Table). Aspirin use alone was associated with higher risk of MI [HR 3.11 (2.42-4.00), p <0.001], ischemic stroke [HR 3.12 (2.08-4.67), p <0.001], and mortality [HR 3.77 (2.71-5.23), p < 0.0004] in the high-risk population with HbA1c >9% (Table). At all A1c levels, patients on no statin or aspirin were at significantly higher risk for MI, stroke, and mortality (Table). In high-risk patients with an HbA1c >9%, ASA use ≥ 70% resulted in significantly lower risk of MI [HR 0.58 (0.49-0.69), p<0.001)], ischemic stroke [HR 0.36 (0.28-0.46), p<0.001] and mortality [HR 0.52 (0.42-0.66), p<0.001]. Conclusion: Low dose aspirin may play a role in prevention of ASCVD events in high-risk patients with diabetes. Future studies can clarify the risk-benefit ratio of using aspirin with statin in patients with poor glycemic control for primary prevention of ASCVD events.
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