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GUSTO IV ACS: Trial Design

GUSTO IV ACS: Trial Design. Abciximab versus placebo in very high-risk patients with non-ST elevation acute coronary syndromes: ST ¯ > 0.5 mm or elevated troponin I Medical management for at least 60 hours If a patient underwent PCI within 30 days, abciximab permitted in all patients

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GUSTO IV ACS: Trial Design

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  1. GUSTO IV ACS: Trial Design • Abciximab versus placebo in very high-risk patients with non-ST elevation acute coronary syndromes: • ST¯ > 0.5 mm or • elevated troponin I • Medical management for at least 60 hours • If a patient underwent PCI within 30 days, abciximab permitted in all patients • Primary Endpoint: 30 day death / MI Preliminary Results of GUSTO IV presented at European Society of Cardiology August 2000

  2. GUSTO IV ACS Trial: Therapies • Randomized to receive either: • Placebo for 48 hours • Abciximab 0.25 mg/kg bolus plus 0.125 mg/kg/min for 24 hours followed by placebo for 24 hours • Abciximab 0.25 mg/kg bolus plus 0.125 mg/kg/min for 48 hours. • All patients received aspirin and heparin • Over 900 patients received dalteparin instead of heparin in a substudy. • PCI was not allowed until 60 hours post-randomization. • CABG surgery to be delayed until 72 hours post-randomization. Preliminary Results of GUSTO IV presented at European Society of Cardiology August 2000

  3. GUSTO IV: Baseline Demographics Preliminary Results of GUSTO IV presented at European Society of Cardiology August 2000

  4. GUSTO IV: 30 Day Outcomes P = NS for all • 1.1% higher risk of death / MI among patients treated with 48 hour infusion of abciximab did not reach statistical significance Preliminary Results of GUSTO IV presented at European Society of Cardiology August 2000

  5. GUSTO IV: Bleeding Risk * P < 0.05 Preliminary Results of GUSTO IV presented at European Society of Cardiology August 2000

  6. GUSTO IV ACS Trial: Results in Troponin + Patients • Troponin-positive patients were a subgroup with particular benefit in previous 2b/3a trials • They represent a higher-risk group • Troponin results were obtained from bedside assays • No benefit observed among these high risk patients Preliminary Results of GUSTO IV presented at European Society of Cardiology August 2000

  7. GUSTO IV ACS Trial: Discussion of Negative Trial Results • Fewer interventions than in previous trials of GP 2b/3a inhibitors • Fewer than 5% of patients underwent PCI during intervention • The maintenance dose of abciximab may have been insufficient

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