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NICE-3 N ational I nvestigators C ollaborating on E noxaparin

NICE-3 N ational I nvestigators C ollaborating on E noxaparin. XXII nd Congress of the European Society of Cardiology August 30, 2000 Amsterdam, The Netherlands. NICE-3 Objectives.

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NICE-3 N ational I nvestigators C ollaborating on E noxaparin

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  1. NICE-3National Investigators Collaborating on Enoxaparin XXIInd Congress of the European Society of Cardiology August 30, 2000 Amsterdam, The Netherlands

  2. NICE-3 Objectives • To assess the safety profile (primarily with respect to bleeding) of enoxaparin and a IIb/IIIa antagonist (abciximab, eptifibatide or tirofiban) in patients with ACS • To assess the feasibility and safety of bringing patients to the cath laboratory on combination therapy (without the use of UFH)

  3. NICE-3Inclusion Criteria • Recent (w/in 24 hours) unprovoked or rest angina • Documented ischemic CAD • ECG changes • Abnormal biomarkers • Previously documented CAD • Patients on prior UFH could be included

  4. NICE-3Exclusion Criteria • Evolving Q-wave MI • Fibrinolytic Rx w/in 48 hours • Cardiogenic shock • Left main disease • Valvular disease • CABG w/in 2 mos.; revasc w/in 1 week • Thrombocytopenia

  5. All treated with Enoxaparin Eptifibatide (n=252) Abciximab (n=147) Tirofiban (n=217) NICE-3Protocol 661 patients enrolled 46 clinical sites in US/Canada Study Initiated January 2000 [Enoxaparin alone] (n=45) Enrollment Completed May 2000 If patients went to the cath lab, combination Rx continued; no UF heparin used If within 8 hrs of last enoxaparin, no additional Rx If > 8 hrs from last dose, 0.3 mg/kg enoxaparin iv All IIb/IIIa patients (n=616) In-hospital, 14-day, and 30-day follow-up Data available August 2000

  6. NICE-3Protocol • Primary Endpoint • Non-CABG major bleeding (TIMI criteria) during hospitalization • Secondary Endpoints • Minor bleeding (TIMI criteria) • Clinical efficacy • Composite of death, MI, ischemia-driven TVR

  7. NICE-3Sample Size • Primary Hypothesis • The 95% CI for major bleeding will not exceed the historical rate • Agents examined as a whole and separately • Example (Assuming major bleed rate of 2%): • A 200 patient sample size has a 95% CI of approx 0.1-3.9% • A 150 patient sample size has a 95% CI of approx0-4.2%

  8. NICE-3Demographics • Age 62.9 12.2 years • Weight 83.9 18.5 kg • M/F approx 2:1 • LOS 5.9  4.2 days • History • HTN 63.5% Prior PCI 30.7% • DM 30.0% Prior CABG 20.9% • Smoking 28.1% Prior MI 36.2% • CHF (on admin) 4.5%

  9. NICE-3Bleeding (%) Enoxaparin All IIb/IIIa (n=616) [Enoxaparin alone] (n=45) Tirofiban (n=217) Eptifibatide (n=252) Abciximab (n=147) All 27.9 Major 4.5 non-CABG 1.9 Minor 25.0 Xfusion 10.5 All 17.8 Major 6.7 non-CABG 4.4 Minor 13.3 Xfusion 8.9 All 27.2 Major 5.1 non-CABG 1.4 Minor 24.0 Xfusion 10.6 All 30.6 Major 4.4 non-CABG 3.2 Minor 27.2 Xfusion 10.3 All 24.5 Major 4.1 non-CABG 0.7 Minor 22.4 Xfusion 10.9

  10. NICE-3In-Hospital Clinical Outcomes (%) Enoxaparin All IIb/IIIa (n=616) [Enoxaparin alone] (n=45) Tirofiban (n=217) Eptifibatide (n=252) Abciximab (n=147) Death 0.3 MI 3.4 uTVR 2.1 D/MI/uTVR 5.7 D/MI 3.6 Death 0 MI 2.2 uTVR 2.2 D/MI/uTVR 4.4 D/MI 2.2 Death 0.5 MI 4.1 uTVR 3.2 D/MI/uTVR 7.8 D/MI 4.6 Death 0.4 MI 3.2 uTVR 2.0 D/MI/uTVR 5.2 D/MI 3.2 Death 0 MI 2.7 uTVR 0.7 D/MI/uTVR 3.4 D/MI 2.7

  11. NICE-330%  in Platelet Count 1.44%<100K 0<100K 0.85%<100K 0.86%<100K (n=138) (n=235) (n=208) (n=581) (n=38)

  12. NICE-3All Major Bleeding (%) 6 Abciximab Eptifibatide Tirofiban All IIb/IIIa 4.8 4.8 4 4.3 3.6 3.1 2 1.7 1 0.9 0 Patients not undergoing PCI or CABG Patients undergoing PCI

  13. NICE-3PCI Patients (n=292) Non-CABG Major Bleeding Tirofiban 0.9% Eptifibatide 2.4% Abciximab 0 All IIb/IIIa 1.0%

  14. NICE-3Conclusions • Combination of enoxaparin and IIb/IIIa • Does not result in excess major bleeding • Events (non-CABG) • Patients on combination Rx can safely undergo PCI • Clinical outcomes in NICE-3 were comparable to those noted in prior studies • Therefore, not necessary to use UFH in: • UA/NSTEMI patients undergoing coronary • intervention who are treated with enoxaparin and an IV IIb/IIIa antagonist

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