Platelet Glycoprotein IIb/IIIa Inhibition With Coronary Stenting For Acute Myocardial Infarction - ADMIRAL

Jul 09, 2003
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Date Presented:
01/01/2001
Date Published:
01/01/2001
Date Updated:
07/09/2003
Original Posted Date:
07/09/2003
References

Description:

Platelet Glycoprotein IIb/IIIa Inhibition With Coronary Stenting For Acute Myocardial Infarction.

Hypothesis:

To compare the combination of primary stenting plus platelet glycoprotein IIb/IIIa receptor inhibition with primary stenting alone in patients with acute myocardial infarction (AMI).

Study Design

Study Design:

Patients Enrolled: 300

Patient Populations:

ST segment elevation MI

Primary Endpoints:

The primary end point was a 30-day composite of death, reinfarction or urgent revascularization of the target vessel.

Secondary Endpoints:

The secondary end point was a composite of death, reinfarction or any revascularization at 30 days and at 6 months.

Drug/Procedures Used:

300 patients with acute ST-segment elevation MI were randomized to abciximab plus stent implantation (149 patients) or to primary stenting alone (151 patients). Patients received either abciximab 0.25 mg/kg body weight followed by a 12 hours infusion of 0.125 mcg/kg/min or placebo. The study drug was administered immediately after randomization, in the mobile intensive care unit before arrival to the hospital, in the emergency department, in the intensive cardiac care unit or in the catheterization laboratory; in all cases, it was administered before sheath insertion and coronary angiography. Per study protocol, all patients underwent follow-up angiography 24 hours after the procedure and at 6 months. The primary end point was a 30-day composite of death, reinfarction or urgent revascularization of the target vessel. The secondary end point was a composite of death, reinfarction or any revascularization at 30 days and at 6 months.

Principal Findings:

Baseline TIMI grade 3 flow was significantly higher in the abciximab group than in the placebo group (16.8% vs. 5.4%, p=0.01), while TIMI grade 2 or 3 was, respectively, 25.8% in the abciximab group and 10.8% in the placebo group (p=0.006). TIMI grade 3 flow was also significantly higher in the abciximab group when compared to the placebo group after revascularization (95.1% vs. 86.7%, p=0.04) and at 6 months follow-up angiography (94.3% vs. 82.8%, p=0.04). At 30 days, the primary end point had occurred in 6% of patients in the abciximab group and 14.6% of those in the placebo group (= 2.01), while at 6 months, the corresponding rates were 7.4% and 15.9% (= 0.02), respectively. There was a trend toward lower 30-day and 6-month mortality in the abciximab group when compared with the placebo group (3.4% vs. 6.6% at 30 days, p=0.19; 3.4% vs. 7.3% at 6 months, p=0.13). When compared with stenting alone, the combination of abciximab and stenting results in higher acute and long-term coronary patency and in improved outcomes for patients presenting with acute myocardial infarction.

Interpretation:

Despite advancements in technology, mortality for acute ST segment elevation myocardial infarction in unselected patients continues to be high. However, as shown by this and other recent studies, combinations of pharmacological and mechanical interventions are emerging as a new standard in reperfusion therapy that may result in improved outcomes for patients with acute myocardial infarction.

References:

1. Montalescot G, Barragan P, Wittenberg O, et al for the ADMIRAL Investigators. N Engl J Med 2001;344:1895-903.

Keywords: Myocardial Infarction, Platelet Aggregation Inhibitors, Coronary Angiography, Catheterization, Body Weight, Coronary Disease, Immunoglobulin Fab Fragments, Platelet Membrane Glycoproteins, Stents


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