OBJECTIVES: The cumulative experience gleaned from the NICE trials suggests that adjunctive enoxaparin therapy for percutaneous transluminal coronary angioplasty (PTCA), with or without concomitant abciximab therapy, is both safe and effective. However, no randomized studies have been conducted to compare the two strategies. The aim of this study was to evaluate the safety of combined enoxaparin-abciximab compared with standard therapy using unfractionated heparin and abciximab. PATIENTS AND METHOD:Ninety-nine patients undergoing PTCA were randomly assigned to receive either enoxaparin (enoxaparin group, 50 patients, 0.75 mg/kg) or unfractionated heparin (UH group, 49 patients, 70 U/kg) in an intravenous bolus. Both groups received standard abciximab treatment. The aPTT, creatine kinase (CPK), MB, troponin I, hemoglobin, and platelet count were determined 5 h and 17 h after PTCA. Endpoints were major bleeding and clinical or biochemical in-hospital events. RESULTS: There was less major bleeding in the enoxaparin group than in the UH group (1 vs 4) but the difference was not statistically significant. There were no significant differences in the frequency of in-hospital clinical events. There was a lower increase in aPTT at 5 h in the enoxaparin vs UH group (p = 0.02). It was impossible to remove the introducer in 7 of the UH group patients due to aPTT > 60 s as opposed to 1 patient in the enoxaparin group. Post-procedural CK elevation occurred in 8.0% of the enoxaparin group and in 6.1% of the UH group (p = NS). No thrombocytopenia was observed in either group. CONCLUSIONS: Combined enoxaparin-abciximab as an adjuvant therapy during PTCA was safe and associated with a low incidence of major bleeding, major ischemic in-hospital events, and post-procedural CPK elevation.
RCT Entities:
OBJECTIVES: The cumulative experience gleaned from the NICE trials suggests that adjunctive enoxaparin therapy for percutaneous transluminal coronary angioplasty (PTCA), with or without concomitant abciximab therapy, is both safe and effective. However, no randomized studies have been conducted to compare the two strategies. The aim of this study was to evaluate the safety of combined enoxaparin-abciximab compared with standard therapy using unfractionated heparin and abciximab. PATIENTS AND METHOD: Ninety-nine patients undergoing PTCA were randomly assigned to receive either enoxaparin (enoxaparin group, 50 patients, 0.75 mg/kg) or unfractionated heparin (UH group, 49 patients, 70 U/kg) in an intravenous bolus. Both groups received standard abciximab treatment. The aPTT, creatine kinase (CPK), MB, troponin I, hemoglobin, and platelet count were determined 5 h and 17 h after PTCA. Endpoints were major bleeding and clinical or biochemical in-hospital events. RESULTS: There was less major bleeding in the enoxaparin group than in the UH group (1 vs 4) but the difference was not statistically significant. There were no significant differences in the frequency of in-hospital clinical events. There was a lower increase in aPTT at 5 h in the enoxaparin vs UH group (p = 0.02). It was impossible to remove the introducer in 7 of the UH group patients due to aPTT > 60 s as opposed to 1 patient in the enoxaparin group. Post-procedural CK elevation occurred in 8.0% of the enoxaparin group and in 6.1% of the UH group (p = NS). No thrombocytopenia was observed in either group. CONCLUSIONS: Combined enoxaparin-abciximab as an adjuvant therapy during PTCA was safe and associated with a low incidence of major bleeding, major ischemic in-hospital events, and post-procedural CPK elevation.