ImpaCt of aspirin regimen on THrombin generation in diabEtic patients with acute coronary syndrome: CARTHaGE-ACS trial

Background Diabetes is associated with a high rate of events after acute coronary syndrome. It was recently reported that once-daily aspirin might not provide stable biological efficacy in patients with diabetes. Aims We sought to compare the biological efficacy of aspirin given once a day versus aspirin divided twice per day in a population of diabetic patients with non-ST elevation acute coronary syndrome (NSTE-ACS) as assessed by the thrombin generation test. Methods We performed an open-label single-blind randomized study including 59 consecutive diabetic patients admitted for NSTE-ACS. Patients were randomly treated with aspirin 100 mg once a day (GA100; n = 20), aspirin 160 mg once a day (GA160; n = 19) or aspirin 100 mg twice a day (G2A100; n = 20). The primary endpoint was endogenous thrombin potential (ETP) at discharge and after 6 months. Results The mean age of our patients was 61.5 ± 9 years, and 73% were male. The baseline characteristics were comparable between the three groups. In the GA100 group, there was no significant effect on ETP variation at 6 months (1150.46 ± 504.84 vs. 1087.63 ± 454.18; p = 0.794). An increase in aspirin dose with a second daily administration of 100 mg was associated with a significant reduction in ETP at 6 months (1004.87 ± 196.2 vs. 1233.63 ± 333.5; p = 0.003). A nonsignificant decrease in ETP was seen in the GA160 group (from 1173.8 ± 388.07 to 1053.64 ± 269.93 at 6 months, p = 0.117). Conclusion Only the twice-daily aspirin regimen led to better control of hypercoagulability in NSTE-ACS diabetic patients. However, no thrombin generation normalization was reported.