Amine Boussofara1,2, Lobna Laroussi3,4,5, Hela Baccouche2,6, Emna Bennour1,2, Sami Kasbaoui1,2, Hbib Triki1,2, Ibn El Haj Zied2,7, Ikram Kammoun1,2, Afef Ben Halima1,2, Faouzi Addad1,2, Sonia Marrakchi1,2, Neila Ben Romdhane2,6, Salem Kachboura1,2. 1. Department of Cardiology, Abderrahmen Mami Hospital, Tunis, Tunisia. 2. Faculty of Medicine of Tunis- Tunis University El Manar, Tunis, Tunisia. 3. Department of Cardiology, Abderrahmen Mami Hospital, Tunis, Tunisia. lobna_laroussi@hotmail.com. 4. Faculty of Medicine of Tunis- Tunis University El Manar, Tunis, Tunisia. lobna_laroussi@hotmail.com. 5. , Residence Diar Ons apartment B 2 1, Riadh El Andalos, 2058, Ariana, Tunisia. lobna_laroussi@hotmail.com. 6. Department of Hematology, Rabta Hospital, Tunis, Tunisia. 7. Taher Maamouri Hospital, Nabeul, Tunisia.
Abstract
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.
RCT Entities:
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 diabeticpatients 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 diabeticpatients 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 diabeticpatients. However, no thrombin generation normalization was reported.
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