A Head-to-head Study Of Enoxaparin And Nadroparin In Patients With Acute Coronary Syndrom

Objective Anticoagulative and antithrombotic therapies are very important in acute coronary syndrom(ACS). Compared with unfractionated heparin , a body of evidence have indicated that low molecular weight heparin(LMWH) would have the equal or better curative effect on reducing the rate of major adverse cardiac events(MACE) in patients with ACS. Several studies on LMWH at present were limited to compare with UFH or placebo, lacking of "head-to-head" comparison between two or more kinds of LMWH. Therefore, the aims of present study are to compare the safety and efficacy of enoxaprin and nadroparin prospectively by "head-to-head" in high risk patients with ACS, and to analyse the co-efficiency between the level of anti-Xa activity and the rate of MACE.Methods 84 ACS patients were randomlized divided into enoxaprin group(n=44) and nadroparin group (n=40). After 300mg loading dose of aspirin and clopidogrel orally at admitted time, enoxaprin (1mg/kg) or nadroparin (0.1 ml/10kg) was injected respectivly, q12h. Anti-Xa activity was determined 4h after the first injection and was determined the same time once daily. Percutaneous coronary intervention (PCI) was underwent when LMWH was administrered at least 48 hours, and Anti-Xa activity was determinedpre-PCI or post-PCI respectively once again. Coronary angiograghy was performed within 8 hours after final LMWH injection. No additional UFH or LMWH was used during PCI. LMWH was administrered for 7days. Clinical follow-up was underwent, and serial indexes were recorded withing in-hospital and 30 days. Cardiac ischemic symptom, electro cardiogram, plasma myocardial enzyme, Tropnin-I, Anti-Xa activity were involved in the observation of in-hospital follow-up. Primary composite triple end point included cadiac death, myocardial infarction (or reinfarction), recurrent angina; secondary end point included major or minor hemorrhage were involved in the observation of in-hospital and 30 days follow-up.Results There was no difference in anti-Xa activity between enoxaprin group and nadroparin group, at 4h after the third injection. 88.1% of patients had >0.5IU/ml of anti-Xa activity, and become stable at 48h after injection. Anti-Xa activity at the time of catheterization was 0.767 ±0.16 IU/ml in the patients assigned to enoxaprin and 0.768 ±0.11 IU/ml in those assigned to nadroparin respectively, 93.3% of patients in two groups had anti-Xa activity at similar level of >0.5IU/ml, Anti-Xa activity was 0.794 ± 0.19 IU/ml in enoxaprin group and 0.768 ±0.11 IU/ml in nadroparin group respectively during PCI procedure. There was no significant difference in MACE, severe hemorrhage, everyday's anti-Xa activity and increase of anti-Xa activity between two groups (P>0.05) within 30 days. Anti-Xa activity was negative correlated to MACE and was positive correlated to severe hemorrhage.Conclusions Subcutaneous injection of enoxaprin or nadroparin seems to be safe and effective in ACS patients, the two LMWH are also safe and effective during PCI. LMWH could reduce the incidence of ischemic events in patients of ACS, especially in high risk ACS patients. Anti-Xa activity could estimate the rate of MACE in patients with ACS within 30 days.