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ELISA II Trial

ELISA II Trial. ELISA II Trial. Presented at The European Society of Cardiology Hot Line Session 2005 Presented by Dr. Saman Rasoul. ELISA II Trial.

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ELISA II Trial

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  1. ELISA II Trial ELISA II Trial Presented at The European Society of Cardiology Hot Line Session 2005 Presented by Dr. Saman Rasoul

  2. ELISA II Trial 328 patients with non-ST elevation MI; ischemic chest pain at rest within 24 hrs; and either positive biomarkers (CKMB or troponin) or an abnormal ECG (ST depression >0.1 mV in >2 leads or transient ST elevation) 29% female, mean age 63 years, mean follow-up 30 days Low-molecular weight heparin, beta-blocker, and statin therapy were administered to all patients Triple anti-platelet strategy with aspirin, standard-dose clopidogrel (300mg load), and tirofiban (10 μg/kg bolus followed by 0.15 μg/kg infusion) n=162 Dual anti-platelet strategy with aspirin and high-dose clopidogrel (600 mg load) n=166 Angiography with or without revascularization (24-48 hrs) • Primary Endpoint: Infarct size as assessed by LDHQ at 48 hours and as assessed by peak CK • Secondary Endpoint: Initial TIMI flow grade of the culprit artery Presented at ESC 2005

  3. ELISA II Trial: Baseline Characteristics Median time to angiography • In the dual therapy group, median time to angiography was 26 hours. In the triple therapy group, median time to angiography was 30 hrs. • 81% of enrolled patients had a positive troponin and 62% had ST depression • PCI was performed in ~60% of patients Presented at ESC 2005

  4. ELISA II Trial: Primary Endpoint Analysis of infarct size when assessed by LDHQ p=0.36 • The primary endpoint of infarct size did not differ between the dual therapy group and the triple therapy group when assessed by LDHQ (p=0.36) or peak CK (p=NS) 392 331 Presented at ESC 2005

  5. ELISA II Trial: Secondary Endpoint Analysis of initial TIMI grade 3 flow at angiography (%) p=0.002 • The secondary endpoint of initial TIMI grade 3 flow at angiography was higher in the triple therapy group (47% vs 67%) Presented at ESC 2005

  6. ELISA II Trial: MI Free Survival at 30 days Analysis of survival free from myocardial infarction at 30 days (%) p=0.098 • A trend toward higher rates of survival free from myocardial infarction at 30 days were observed in the triple therapy group • These results were driven almost exclusively by myocardial infarction (56% MI rate in the dual therapy group vs 46% MI rate in the triple therapy group) • Mortality rate of 1% in each group Presented at ESC 2005

  7. ELISA II Trial: Bleeding Analysis of bleeding (%) p = NS • No significant difference among bleeding existed between the two treatment groups • There were no strokes in either of the two treatment groups Presented at ESC 2005

  8. ELISA II Trial Summary • Among patients with non-ST elevation MI undergoing angiography with or without revascularization, use of a triple anti-platelet regimen of aspirin, 300mg clopidogrel, and tirofiban was not associated with a difference in the primary endpoint of enzymatic infarct size compared with a dual anti-platelet regimen of aspirin and a 600 mg loading dose of clopidogrel. • The secondary endpoint of TIMI grade 3 flow was improved among the triple therapy treatment group. • A favorable trend toward lower rates of MI through 30 days was observed in the triple therapy group. • Further investigation of the clinical benefit of triple therapy is warranted (upcoming ISAR-REACT 2). Presented at ESC 2005

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