NICE-4 Safety of Enoxaparin Therapy in Patients Undergoing PCI and Receiving Concomitant Abciximab Therapy

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NICE-4Safety of Enoxaparin Therapy in Patients
Undergoing PCI and Receiving Concomitant
Abciximab Therapy
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NICE-4 Introduction

• 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

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NICE-4 Study Design

• 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

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NICE-4 Patient Demographics
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 lt 30 days 24
(8) CVA - TIA 9 (3)
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NICE-4 Procedure 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
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NICE-4 Clinical Outcomes (prelim.)
Patients
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NICE-4 Bleeding Events (prelim.)
Patients
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NICE-4 Conclusions

• Safety and efficacy of other LMWHs 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