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FINESSE: Study Design

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 1:1:1 N=3000. Double Blind Double Dummy. *Only 5U if ≥ 75yr. Placebo Placebo.

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FINESSE: Study Design

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  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 1:1:1 N=3000 Double Blind Double Dummy *Only 5U if ≥75yr Placebo Placebo Reteplase (5U+5U)* Abciximab Placebo Abciximab Transfer To Cath Lab ASA, unfractionated heparin 40U/kg (max 3000U) or enoxaparin (0.5 mg/kg IV + 0.3 mg/kg SC) – substudy only Abciximab Placebo Placebo Primary PCI with Abciximab Infusion (12 h) Follow up through 90 days and 1 year

  2. FINESSE Results: Primary and Secondary Endpoints * 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 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 p < 0.0001 p < 0.0001 61 % Percentage 25 % TIMI 2 TIMI 3 26 % 25 % 11 % 36 % 12 % 15 % 13 % Abciximab Facilitated PCI (n=809) Primary PCI (in lab Abciximab) (n=790) Reteplase/Abciximab Facilitated PCI (n=815) Ave Time from First Abciximab Bolus 74 min 76 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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