Question: In patients with acute myocardial infarction (MI), is abciximab plus stenting more effective than placebo plus stenting for reducing coronary events?
Design: Randomized (unclear allocation concealment*), blinded (clinicians, patients, and outcome assessors),* placebo-controlled trial with 6-month follow-up.
Setting: 26 centers in France.
Patients: 300 patients (mean age 61 y, 82% men) who were > 18 years of age, had had the first symptoms of MI within 12 hours before enrollment, and had ST-segment elevation of > 1 mm in ≥ 2 contiguous electrocardiographic leads. Exclusion criteria were bleeding diathesis; administration of thrombolytic agents for the current episode; neoplasm; recent stroke; uncontrolled hypertension; recent surgery; oral anticoagulant therapy; limited life expectancy; child-bearing potential; and known contraindications to aspirin, ticlopidine, or heparin. Follow-up was 100%.
Intervention: 149 patients were allocated to abciximab (bolus of 0.25 mg/kg of body weight, followed by a 12-hour infusion of 0.125 µg/kg per min) plus stenting (the treatment group); 151 patients were allocated to placebo plus stenting (the control group).
Main outcome measures: The main outcome was a composite of death, reinfarction, or urgent revascularization of the target vessel at 30 days. The major secondary outcome was a composite of death, reinfarction, or any revascularization at 30 days and at 6 months.
Main results: Analysis was by intention to treat. At 30 days, the incidence of the composite end point of death, reinfarction, or urgent target-vessel revascularization and the incidence of the composite end point of death, reinfarction, or any revascularization were lower in the treatment than in the control group (Table). At 6 months, the incidence of the composite end point of death, reinfarction, or any revascularization was lower in the treatment than in the control group (Table).
Conclusion: In patients with acute myocardial infarction, abciximab plus stenting was more effective than placebo plus stenting for reducing coronary events.
Abciximab plus stenting vs placebo plus stenting for acute myocardial infarction†
|Outcomes||Abciximab||Placebo||RRR (95% CI)||NNT (CI)|
|Composite 1‡ at 30 d||6%||15%||59% (15 to 80)||12 (7 to 59)|
|Composite 2‡ at 30 d||12%||21%||41% (1 to 65)||12 (6 to 1421)|
|Composite 2 at 6 mo||23%||34%||32% (3 to 53)||10 (5 to 135)|