Abstract 13428: The Long-term Therapy With Low-dose Aspirin Did Not Reduce Cardiovascular Events in Patients With Type 2 Diabetes in Primary Prevention Setting: 10-year Follow-up of a Randomized Controlled Trial

Abstract

Introduction: It takes long time to conclude efficacy and safety of an intervention on primary prevention of cardiovascular events. Up to date, there is no study to investigate the effect of the low-dose aspirin therapy on primary prevention of cardiovascular events in patients with diabetes with a follow-up period longer than 10 years. Hypothesis: The long-term therapy with low-dose aspirin prevents cardiovascular events in patients with diabetes and no pre-existing cardiovascular diseases. Methods: The Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD) trial was a randomized controlled trial to examine whether the low-dose aspirin therapy reduces cardiovascular events in 2,539 Japanese patients with type 2 diabetes. The original JPAD trial reported that the low-dose aspirin therapy did not reduce cardiovascular events for a median of 4.4 years. After the JPAD trial was completed in 2008, we followed the patients until July 2015. In this period, the low-dose aspirin therapy was decided by each physician. We analyzed the effect of low-dose aspirin on incidence of cardiovascular events, according to the per-protocol principle. Results: The median follow-up period was 10.3 years, and 2,160 (85 %) patients remained the original allocation. The low-dose aspirin therapy did not reduce cardiovascular events based on the per-protocol cohort (HR, 1.14; 95% CI, 0.91 - 1.42; Figure). Cox proportional hazard models showed similar results (HR, 1.04; 95% CI, 0.83 - 1.30), adjusting age, sex, HbA1c, eGFR, history of smoking, and presence of hypertension and dyslipidemia. There were 54 (5%) hemorrhagic events in the aspirin group, and 72 (6%) in the no aspirin group ( P = 0.5). Sensitivity analyses on the intention-to-treat cohort showed the similar results (HR, 1.01; 95% CI: 0.82 - 1.25). Conclusions: The low-dose aspirin therapy did not reduce cardiovascular events in patients with type 2 diabetes in primary prevention setting for 10-year follow-up.