Abciximab-Carbostent Evaluation - ACE

Apr 19, 2004
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Date Presented:
01/01/2002
Date Published:
01/01/2003
Date Updated:
04/19/2004
Original Posted Date:
04/19/2004
References

Description:

The goal of the trial was to evaluate the use of abciximab as adjunctive therapy to routine infarct-related artery (IRA) stenting compared with stenting alone in patients with acute myocardial infarction (MI).

Hypothesis:

Treatment with stenting plus adjunctive abciximab will be associated with a reduction in death, reinfarction, target vessel revascularization (TVR), or stroke at one month compared with stenting alone in patients with acute MI.

Study Design

Study Design:

Patients Screened: 485
Patients Enrolled: 400
Mean Follow Up: Six months
Mean Patient Age: Median 63-64 years
Female: 23

Patient Populations:

Chest pain persisting >30 minutes and associated with ST-segment elevation of ≥0.1 mV in ≥2 contiguous ECG leads, and admission either within six hours of symptom onset or between six and 24 hours if there was evidence of continuing ischemia

Exclusions:

Prior fibrinolytic or abciximab therapy, history of bleeding diathesis or allergy to the study drug, major surgery within 15 days, active bleeding, participation in another study, inability to obtain informed consent, IRA reference diameter <2.5 mm, previously stented IRA, <70% stenosis of the IRA associated with TIMI flow grade 3, and an inability to identify the IRA

Primary Endpoints:

Composite of death, reinfarction, TVR, or stroke at one month

Secondary Endpoints:

ST-segment reduction, postprocedural corrected TIMI frame count, infarct size at one month, death from any cause at six months, reinfarction at six months, six-month composite of death and reinfarction, TVR at six months, and angiographic restenosis of the IRA at six months

Drug/Procedures Used:

Following coronary angiography and evaluation of coronary anatomy, patients were randomized to stenting alone (n=200) or stenting plus abciximab (0.25 mg/kg bolus plus 12-hour infusion at 0.125 μg/kg/min; n=200). Stenting was to be performed with a carbofilm-coated tubular stent (Carbostent, SORIN, Saluggia, Italy).

Concomitant Medications:

Aspirin (325 mg orally or 250 mg intravenously), heparin (initial bolus of 70 U/kg plus additional boluses during the procedure to achieve an activated clotting time of 200-300 seconds in the abciximab arm and at least 300 seconds in the stenting alone arm), ticlopidine (500 mg/day for one month), or clopidogrel (75 mg/day for one month)

Principal Findings:

Crossover from the stenting alone arm to stenting plus abciximab occurred in 11% of patients. There was no difference in final thrombolysis in MI (TIMI) grade 3 flow (96% in stenting alone vs. 97% in stent + abciximab, p=0.719), TIMI frame count (25.00 frames vs. 27.17 frames, p=0.697), or final stenosis (median 10 in each arm, p=0.117).

Presence of peak creatine kinase (CK) ≥ median value occurred less frequently in the stent plus abciximab arm (45% vs. 57%, p=0.018). The frequency of ST-segment reduction of ≥50% by 30 minutes was higher in the stent plus abciximab arm (85% vs. 68%, p<0.001).

The primary composite endpoint at 30 days occurred less frequently in the stent plus abciximab arm (4.5% vs. 10.5%, p=0.023), driven by a reduction in reinfarction (0.5% vs. 4.5%, p=0.010), with no difference in death (3.5% vs. 4%, p=0.792), stroke (0% vs. 0.5%, p=0.317), or TVR (0.5% vs. 1.5%, p=0.315). At six months, the composite of death or MI was lower in the stent plus abciximab arm (5.5% vs. 13.5%, p=0.006), again driven by a reduction in reinfarction (1% vs. 5.5%, p=0.011), with no difference in mortality (4.5% vs. 8.0%, p=0.148).

At 1 year, the survival rate was significantly higher in the abciximab group vs the stent-alone group (95% vs 88%, p=0.017). There was no differences in the frequency of target vessel revascularization at 1 year (16.5% in the abciximab group, 17.5% in the stent-alone group) but reinfarction rates remained lower in the abciximab group (1% vs 6.0%).

Interpretation:

Among patients with acute MI, treatment with abciximab as adjunctive therapy to stenting was associated with a reduction in the primary endpoint of death, reinfarction, TVR, or stroke at one month compared with stenting alone. Results were in line with results seen in the ADMIRAL trial, which showed a reduction in the 30-day composite of death, MI, and urgent TVR associated with stenting plus abciximab, but differed from the CADILLAC trial, which did not show a difference in the composite of death, MI, ischemic-driven TVR, or stroke between the stent alone arm and the stent plus abciximab arm. The benefit in the ACE trial was maintained through 1 year, with differences in survival reaching statistical significance at 1 year.

References:

Antoniucci D, Rodriguez A, Hempel A, et al. A randomized trial comparing primary infarct artery stenting with or without abciximab in acute myocardial infarction. J Am Coll Cardiol 2003;42:1879-85.

Antoniucci D, et al. Abciximab-supported infarct artery stent implantation for acute myocardial infarction and long-term survival. Circulation. 2004;109:1704-1706.

Keywords: Stroke, Myocardial Infarction, Coronary Artery Disease, Creatine Kinase, Platelet Aggregation Inhibitors, Immunoglobulin Fab Fragments, Constriction, Pathologic, Electrocardiography, Stents, Coronary Angiography, Chest Pain, Survival Rate


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