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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.

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Presentation on theme: "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."— Presentation transcript:

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 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  g/kg/min for 24 hours followed by placebo for 24 hours –Abciximab 0.25 mg/kg bolus plus 0.125  g/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 GUSTO IVPURSUIT Females38%36% Diabetics22%23% Prior MI30%32% Preliminary Results of GUSTO IV presented at European Society of Cardiology August 2000

4 GUSTO IV: 30 Day Outcomes 1.1% higher risk of death / MI among patients treated with 48 hour infusion of abciximab did not reach statistical significance P = NS for all 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 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 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 GUSTO IV ACS Trial: Results in Troponin + 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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