NICE-4 Safety of Enoxaparin Therapy in Patients Undergoing PCI and Receiving Concomitant Abciximab Therapy
Enoxaparin has proven to have a more predictable dose response, superior efficacy, and safety when compared to UFH for both UA and PCI
Abciximab has demonstrated significant clinical benefit attributable to GP IIb/IIIa platelet inhibition in the aforementioned situations
The stage is set for integration of these two agents “upstream” or in the cardiac cath lab
NICE-4: Introduction
Open label, multicenter
857 patients
PCI with FDA approved device
Enoxaparin 0.75 mg/kg IV bolus; followed by abciximab 0.25 mg/kg IV bolus and 0.125 ?g/kg/min infusion (max: 10 ?g/kg/min) for 12 hours
Criteria for evaluation: major hemorrhage/ transfusion
NICE-4: Study Design
Preliminary
Patients (n) 310
Age (mean ? SD) 63 ? 11.0 (range 34-89)
Weight 88 ? 18.0 (range 42-166)
Male n (%) 221 (71%)
Hypertension 197 (64%)
Diabetes 71 (23%)
Current Smoker 67(22%)
PRIOR PCI 84 (27%)
CABG 59 (19%)
MI < 30 days 24 (8%)
CVA - TIA 9 (3%)
NICE-4: Patient Demographics
Preliminary
Enoxaparin Bolus
(mean ? SD) 66.8 ? 14.2 (range 32-137)
Abciximab bolus 21.8 ? 5.4 (range 8-67)
# Vessels PCI
? 2 52%
? 3 20%
% Stent 86%
% Balloon Only 12%
% Saphenous Vein Grafts 6%
NICE-4: Procedure Demographics
NICE-4: Clinical Outcomes (prelim.)
% Patients
NICE-4: Bleeding Events (prelim.)
% Patients
NICE-4: Conclusions
Safety and efficacy of other LMWH’s in combination with abciximab must be individually assessed
Combination therapy for PCI:
is safe (bleeding events/transfusions)
appears effective (ischemic outcomes)
may reduce frequency/severity of abciximab associated thrombocytopenia
may enhance antithrombotic efficacy of enoxaparin