A Clinical Research About The Effects Of Fondaparinux In Patients With Acute Coronary Syndrome

Objective:To compare the application efficacy and safety of fondaparinux with that of low molecular weight heparin (LMWH) in ACS. Use CRUSADE scoring to rank bleeding risk and to identify fondaparinux beneficial population.Method:860patients with ACS were enrolled according to Guidelines for the diagnosis and treatment of Patients with ACS made by ESC in2007. All the patients were randomly divided into experimental group (430cases) and control group (430cases). All patients received antiplatelet agents aspirin and clopidogrel and Anticoagulants, nitrate esters, B receptor inhibitor, ACEI or ARB and statins were given in2groups. Both the two groups were checked blood clotting before anticoagulation and re-checked after2days’treatment. Besides the basic treatment,1mg/kg enoxaparine was administrated to the control group subcutaneously every12hours for5-8days, The treatment group were given fondaparinux2.5mg per day subcutaneously for5-8days. PCI patients, unfractionated heparin was given in the surgery. Occurrences were observed for30days.1. Compare the incidence of major adverse cardiac events and bleeding events during7days and30days.2. Ranking patients in each group to5subgroups: extremely high risk group, high risk group,mediate high risk group, low risk group, extremely low risk group according to the CRUSADE bleeding risk scoring, compare incidence of MACE and bleeding events of the subgroups in two groups during7、30days.3. Compare the change of the two groups PT、APTT.Results:1. Incidence of major adverse cardiac events in experimental group and control group during7days, were4.2%,4.7%(HR,0.896;95%CI,0.467-1.718; P=0.74); Incidence of bleeding in experimental group and control group were1.9%,5.8%(HR,0.080;95%CI,0.035-0.182; P=0.003). The incidence of the major adverse cardiac events at30days in fondaparinux group was obviously lower than that in LMWH group (6.5%vs11.9%, HR,0.518;95%CI,0.320-0.838; P=0.007); The incidence of the bleeding events at30days in fondaparinux group was obviously lower than that in LMWH group (3.3%vs7.4%, HR,0.419;95%CI,0.220-0.796; P=0.006).2. Compare5subgroups according to CRUSADE bleeding risk scoring, in 7days, there was significant difference within extremely high risk subgroup (p<0.05). In high,mediate high, low and extremely low subgroups, no differences in bleeding were found(p>0.05); there was insignificant difference within5subgroups in major adverse cardiac events(p>0.05).in30days, there was significant difference within extremely high risk subgroup and high risk subgroup (p<0.05); In mediate high, low and extremely low subgroups, no differences in bleeding were found(p>0.05); Significant difference in major adverse cardiac events were found(p<0.05) in extremely high risk subgroup; other subgroups have no difference.3Before anticoagulant treatment, PT value between the experimental group and control group had no significant difference (P=0.068), and APTT value between the experimental group and control group had no significant difference (P=0.215). In the experimental group, PT value on3rd day of anticoagulant treatment, compared with it on admission, was statistically significant (P=0.000), and so was APTT value (P=0.000). In the control group, PT value on3rd day of anticoagulant treatment, compared with it on admission, had no significant difference (P=0.844), and so did APTT value (P=0.174). On3rd day of anticoagulant treatment,PT value between the experimental group and control group was statistically significant (P=0.008), and APTT value between the experimental group and control group was statistically significant (P=0.029).Conclusion:1. The incidence of the recurrence of major adverse cardiac events in fondaparinux group was obviously lower than that in enoxaparin group.2. The incidence of the recurrence of bleeding events in fondaparinux group was obviously lower than that in enoxaparin group.3. fondaparinux can function as a safer drug for acute bleeding for ACS patients, especially significant for the high risk and extremely high risk population according to the CRUSADE bleeding risk scoring.4. Fondaparinux has some influence on PT and APTT.