Key result
Adjunctive abciximab shows no benefit over placebo for 3-year all-cause mortality in STEMI.
Why the study?
Does abciximab plus stenting reduce mortality and ischemic events in patients with STEMI compared to placebo plus stenting?
RCT (n=300)
double-blind
randomized
Does abciximab plus stenting reduce mortality and ischemic events in patients with STEMI compared to placebo plus stenting?
Absolute Risk Reduction: 3.1
Absolute Event Rate: 9.1% vs 12.2%
Absolute Risk Reduction: 3.1%
p-value: p=0.36
Adjunctive abciximab to primary stenting for STEMI maintains the absolute risk reductions of hard clinical outcomes up to 3 years, with a significant reduction in recurrent ischaemia.
No significant 3-year mortality benefit with adjunctive abciximab in STEMI stenting; extends prior RCT follow-up without confirming sustained efficacy.
AIMS: The Abciximab Before Direct Angioplasty and Stenting in Myocardial Infarction Regarding Acute and Long-term Follow-up (ADMIRAL) study demonstrated that early inhibition of the platelet glycoprotein IIb/IIIa (GP IIb/IIIa) receptor with abciximab led to improved coronary patency, left ventricular function, and clinical outcomes. The current long-term follow-up study evaluated the durability of the positive outcomes. METHODS AND RESULTS: The randomized double-blind ADMIRAL trial enrolled 300 patients who received either abciximab plus stenting or placebo plus stenting for the treatment of ST-elevation myocardial infarction (STEMI). Abciximab (bolus of 0.25 mg/kg body weight, followed by 12 h infusion of 0.125 microg/kg per min) was administered to 149 patients, whereas 151 patients received placebo. Long-term follow-up was conducted in a blinded manner by either patient chart review or telephone interview. Long-term follow-up data were obtained on 288 patients (96%). After 3 years, using an intent-to-treat analysis, the outcome of all-cause mortality occurred in 9.1% of abciximab-treated patients when compared with 12.2% of placebo patients, absolute and relative risk reductions of 3.1 and 25%, respectively (P=0.36). Parallel Kaplan-Meier curves were observed for the cumulative incidence of death or re-infarction, which was reduced from 16.9% in the placebo group to 11.8% in the abciximab group, absolute and relative risk reductions of 5.1 and 30%, respectively (P=0.20). Rates of recurrent ischaemia were significantly reduced from 21.7 to 11.5% (P=0.05). CONCLUSION: Adjunctive abciximab to primary stenting for STEMI elicits favourable clinical outcomes with the same absolute risk reductions of hard clinical outcomes from 30 days up to 3 years of follow-up.
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A 2005 study conducted an RCT in ST-elevation myocardial infarction (STEMI) (n=300). abciximab vs. placebo was evaluated on all-cause mortality (ARR 3.1%, p=0.36). Adjunctive abciximab plus stenting for STEMI resulted in a non-significant reduction in 3-year all-cause mortality compared to placebo (9.1% vs 12.2%; P=0.36).
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