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Integrilin in Acute Myocardial Infarction - INTAMI
Description:
The goal of the trial was to evaluate adjunctive therapy with the glycoprotein IIb/IIIa inhibitor eptifibatide administered early in the emergency department compared with late, optional administration in the catheterization laboratory among patients with acute ST elevation myocardial infarction (MI) undergoing primary percutaneous coronary intervention (PCI).
Study Design
Study Design:
Patients Enrolled: 102
Mean Follow Up: 30 days
Mean Patient Age: Mean age 61 years
Female: 27
Patient Populations:
Age >18 years, presented with acute ST elevation MI, and scheduled for primary PCI within 12 hours
Exclusions:
Fibrinolytic therapy within 24 hours prior to randomization, oral anticoagulation with an international normalized ratio >2, platelets <100,000 or known hemorrhagic diathesis, stroke or transient ischemic attack within 30 days, evidence of an active gastrointestinal or urogenital bleeding, major surgery within six weeks, history of allergic reaction to eptifibatide, severe renal or hepatic insufficiency, contraindication to coronary angiography, or severe concomitant disease with life expectation <1 year
Primary Endpoints:
TIMI flow grade 3 in the infarct-related artery prior to PCI
Secondary Endpoints:
TIMI flow post-PCI, ST resolution at 60 minutes after PCI, all-cause death, reinfarction, urgent revascularization, stroke, and severe bleeding complications
Drug/Procedures Used:
Patients with ST elevation MI were randomized to administration of eptifibatide early in the emergency department (n=53) or optional administration at the time of the PCI (n=49). Eptifibatide was dosed at two 180 µg/kg boluses followed by an infusion of 2.0 µg/kg/min for 12-24 hours.
Concomitant Medications:
All patients received aspirin (50 mg IV) and heparin (5000 U IV bolus + 1000 U/h infusion to target activated partial thromboplastin time 50-70 seconds). Clopidogrel was given after PCI with stent (300 mg loading dose and 75 mg daily for at least 30 days).
Principal Findings:
Baseline characteristics were similar among the two treatment groups, with the exception of prior PCI (4% for early eptifibatide group vs. 18% for late/no eptifibatide group, p=0.02). The left anterior descending artery was the infarct-related artery in 36% of patients. Median time from first eptifibatide bolus to angiography in the early group was 45 minutes.
TIMI grade 3 flow at the time of angiography was higher in the early eptifibatide group compared with the late/no eptifibatide group (34.0% vs. 10.2%, p=0.01). Patency (TIMI flow grade 2 or 3) trended higher in the early group (41.6% vs. 32.6%, p=0.06). TIMI myocardial perfusion grade 3 occurred more frequently in the early eptifibatide group (28.3% vs. 8.2%, p=0.01). Presence of visible thrombus trended lower in the early group (57.7% vs. 70.8%, p=0.1).
PCI was performed in 87% of the early group and 94% of the late/no group. Among the late/no group, 86% of patients received eptifibatide. There was no difference in post-PCI TIMI flow grade 3 (86.5% for early vs. 83% for late/no) or TIMI myocardial perfusion grade 3 (51.9% for early vs. 42.5% for late/no, p=0.42).
ST resolution did not differ between the groups (median 76.7% in early group vs. 75.3% in late/no group, p=0.9). There was no difference in clinical events or bleeding by 30 days.
Interpretation:
Among patients with acute ST elevation MI undergoing primary PCI, early administration of eptifibatide in the emergency department was associated with improvements in TIMI flow grade 3 and TIMI myocardial perfusion grade 3 compared with late or no administration of eptifibatide. Results of the present trial are similar to those of the TIGER-PA and On-TIME studies, which evaluated early administration of another glycoprotein IIb/IIIa inhibitor, tirofiban.
While the trial enrolled only 102 patients, there was no evidence of increased bleeding in the early versus late/no eptifibatide groups. The larger, ongoing TITAN-TIMI 34 trial of early emergency department eptifibatide administration compared with later catheterization laboratory administration will provide a larger sample size to more fully evaluate these findings.
References:
Zeymer U, Zahn R, Schiele R, et al. Early eptifibatide improves TIMI 3 patency before primary percutaneous coronary intervention for acute ST elevation myocardial infarction: results of the randomized integrilin in acute myocardial infarction (INTAMI) pilot trial. Eur Heart J 2005;26:1971–1977.
Keywords: Myocardial Infarction, Platelet Aggregation Inhibitors, Thrombosis, Peptides, Catheterization, Coronary Disease, Tyrosine, Percutaneous Coronary Intervention, Platelet Glycoprotein GPIIb-IIIa Complex
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