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FINESSE: Study Design Acute ST Elevation MI (or New LBBB) within 6h pain onset Presenting at Hub or Spoke with estimated time to Cath between 1 and 4 hours.

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Presentation on theme: "FINESSE: Study Design Acute ST Elevation MI (or New LBBB) within 6h pain onset Presenting at Hub or Spoke with estimated time to Cath between 1 and 4 hours."— Presentation transcript:

1 FINESSE: Study Design Acute ST Elevation MI (or New LBBB) within 6h pain onset Presenting at Hub or Spoke with estimated time to Cath between 1 and 4 hours Randomize 1:1: N=3000 Double Blind Double Dummy *Only 5U if ≥75yr Placebo Placebo Placebo Abciximab Reteplase (5U+5U)* Abciximab Transfer To Cath Lab ASA, unfractionated heparin 40U/kg (max 3000U) or enoxaparin (0.5 mg/kg IV mg/kg SC) – substudy only Abciximab Placebo Placebo Primary PCI with Abciximab Infusion (12 h) Follow up through 90 days and 1 year 1

2 FINESSE Results: Primary and Secondary Endpoints
Primary PCI (%) Abciximab- facilitated (%) Combination (abciximab/ reteplase)- facilitated (%) Combination- facilitated vs primary PCI (P) Combination- facilitated vs abciximab- facilitated (P) Primary end point * 10.7 10.5 9.8 NS All-cause mortality 4.5 5.5 5.2 Complications of MI 8.9 7.5 7.4 CHF requiring hospital/ ED visit 2.2 2.9 1.9 Death * All cause mortality; rehospitalization or ED treatment for CHF; resuscitated ventricular fibrillation occurring > 48 hours after randomization; cardiogenic shock ED=emergency department Ellis S. European Society of Cardiology Congress 2007; September 3, 2007; Vienna, Austria

3 FINESSE Results: Safety (Bleeding) Endpoints
Primary PCI (%) Abciximab-facilitated (%) Combination (abciximab/ reteplase)- facilitated (%) Combination- facilitated vs primary PCI (P) Combination- facilitated vs abciximab- facilitated (P) TIMI major bleeding 2.6 4.1 4.8 0.025 NS TIMI minor bleeding 4.3 6.0 9.7 <0.001 0.006 TIMI major or minor bleeding 6.9 10.1 14.5 0.008 Ellis S. European Society of Cardiology Congress 2007; September 3, 2007; Vienna, Austria

4 TIMI Flow in IRA Pre-PCI % Subjects with TIMI 2/3 (Patency) Pre-PCI
61 % Percentage 25 % TIMI 2 TIMI 3 25 % 26 % 11 % 36 % 12 % 15 % 13 % Primary PCI (in lab Abciximab) (n=790) Abciximab Facilitated PCI (n=809) Reteplase/Abciximab Facilitated PCI (n=815) Ave Time from First Abciximab Bolus min min to Angiogram in Facilitated Groups: Modified ITT Population with Index PCI: ITT, PCI and any dose of study drug (active or placebo); Investigator assessment


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