Safety And Efficacy Of Fondaparinux Among Acute Coronary Syndrome Complicated With Diabetes Patients With Renal Insufficiency

Objective:To investigate the incidence of the bleeding complications and main adverse cardiovascular events (MACE) during48hours、the incidence of MACE during30days and180days in patients with acute coronary syndrome (ACS) complicated with diabetes mellitus (DM) undergoing percutaneous coronary intervention (PCI) treated by fondaparinux, to observe the efficacy and safety of fondaparinux in treatment of these patients and if the safety is influenced by the renal insufficiency.Methods:156patients who had ACS complicated with DM received PCI were selected in our study. All the enrolled patients were randomly divided into two groups, including fondaparinux group and enoxaparine group.The level of renal function in all enrolled patients was assessed by the glomerular filtration rate (GFR). The clinical bleeding events were assessed by the criteria of thrombolysis in myocardial infarction (TIMI), to investigate and record the situation about bleeding complications and MACE during48hours, to write down the situation about MACE during30days and180days according to the results of the regular follow-up by outpatient or phone given to the discharged patients.Results:(1) There was no statistically significant difference in the incidence of MACE between the two groups during48hours,30days and180days (48h:1.6%:5.1%, P=0.367;30d:6.4%:3.8%, P=0.717;180d:5.1%:2.6%, P=0.677).(2) The incidence of mild bleeding complications during48hours was significantly lower in fondaparinux group than that in enoxaparine group (P=0.008). There was no significantly difference in the incidence of small bleeding events (P>0.05) and no major bleeding complications in both groups.(3) Among the various subgroups with different renal function in the fondaparinux group, the incidence of hemorrhagic complications did not differ statistically significantly (P>0.05).Conclusion:(1) The patients of fondaparinux group have similar incidence of MACE with those of enoxaparine group during48hours^30days and180days after PCI, and fondaparinux has good efficacy in ACS patients complicated with DM undergoing PCI.(2) The incidence of bleedind complications in the patients of fondaparinux group was significantly lower than enoxaparine group, and fondaparinux has good safety in ACS patients complicated with DM undergoing PCI.(3) Among the various fondaparinux subgroups with different renal function, the incidence of hemorrhagic complications and MACE did not differ significantly, renal insufficiency do not affect the safety of the patients with ACS complicated with DM undergoing PCI and treatment of fondaparinux.