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