ELISA II Trial

ELISA II TrialELISA II Trial

Presented atPresented atThe European Society of Cardiology The European Society of Cardiology

Hot Line Session 2005Hot Line Session 2005

Presented by Dr. Saman RasoulPresented by Dr. Saman Rasoul


www. Clinical trial results.org

Dual anti-platelet strategy with aspirin and high-dose

clopidogrel (600 mg load)

n=166


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 CharacteristicsELISA II Trial: Baseline Characteristics

2630

0

10

20

30

40

Median time to angiography

Hou

rs

Dual therapy Triple therapy

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


ELISA II Trial: Primary EndpointELISA II Trial: Primary Endpoint

0

100

200

300

400

Infarct size


LDH

Q

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)

392392 331331


ELISA II Trial: Secondary EndpointELISA II Trial: Secondary Endpoint

47%

67%

0%

20%

40%

60%

80%

Initial TFG 3 at angiography


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%)


ELISA II Trial: MI Free Survival at 30 daysELISA II Trial: MI Free Survival at 30 days

43%

54%

0%

20%

40%

60%


Analysis of survival free from myocardial infarction at 30 days (%) p=0.098


• A trend toward higher rates of A trend toward higher rates of survival free from myocardial survival free from myocardial infarction at 30 days were infarction at 30 days were observed in the triple therapy observed in the triple therapy groupgroup

• These results were driven These results were driven almost exclusively by almost exclusively by myocardial infarction (56% MI myocardial infarction (56% MI rate in the dual therapy group rate in the dual therapy group vs 46% MI rate in the triple vs 46% MI rate in the triple therapy group)therapy group)

• Mortality rate of 1% in each Mortality rate of 1% in each groupgroup


ELISA II Trial: BleedingELISA II Trial: Bleeding

10%12%

0%

5%

10%

15%

Bleeding


Analysis of bleeding (%)


• No significant difference No significant difference among bleeding existed among bleeding existed between the two treatment between the two treatment groupsgroups

• There were no strokes in either There were no strokes in either of the two treatment groupsof the two treatment groups

p = NS


ELISA II Trial SummaryELISA 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).


ELISA II Trial

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