ELISA II Trial
Presented at
The European Society of Cardiology
Hot Line Session 2005
Presented by Dr. Saman Rasoul
ELISA II Trial
Dual anti-platelet strategy with aspirin and high-dose clopidogrel (600 mg load)
n=166
ELISA II Trial
Presented at ESC 2005
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
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
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
Angiography with or without revascularization (24-48 hrs)
ELISA II Trial: Baseline Characteristics
Median time to angiography
Presented at ESC 2005
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
ELISA II Trial: Primary Endpoint
Analysis of infarct size when assessed by LDHQ p=0.36
Presented at ESC 2005
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
ELISA II Trial: Secondary Endpoint
Analysis of initial TIMI grade 3 flow at angiography (%) p=0.002
Presented at ESC 2005
The secondary endpoint of initial TIMI grade 3 flow at angiography was higher in the triple therapy group (47% vs 67%)
ELISA II Trial: MI Free Survival at 30 days
Analysis of survival free from myocardial infarction at 30 days (%)
p=0.098
Presented at ESC 2005
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
ELISA II Trial: Bleeding
Analysis of bleeding (%)
Presented at ESC 2005
No significant difference among bleeding existed between the two treatment groups
There were no strokes in either of the two treatment groups
p = NS
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