Adjunctive abciximab during primary PCI significantly reduced the 30-day composite of death, MI, ischemia-driven TVR, or disabling stroke compared to no abciximab (4.6% vs 7.0%; RR 0.65; P=0.01).
RCT (n=2,082)
Open-label
2x2 factorial
Does abciximab treatment reduce the composite of death, MI, ischemia-driven TVR, or disabling stroke in patients undergoing primary PCI for acute MI?
Adjunctive abciximab during primary PCI for acute MI improves 30-day event-free survival primarily by reducing early ischemia-driven TVR, but does not provide sustained benefit at 1 year.
Relative Risk: 0.65 (95% CI 0.46–0.93)
Absolute Event Rate: 4.6% vs 7%
p-value: p=0.01
BACKGROUND: Trials of platelet glycoprotein IIb/IIIa inhibitors as adjuncts to primary percutaneous coronary intervention for acute myocardial infarction (MI) have shown improved early clinical and angiographic outcomes with treatment. However, variations in trial designs, modest sample sizes, and limited long-term follow-up have precluded these studies from being definitive. METHODS AND RESULTS: As a prespecified secondary analysis of the CADILLAC trial, we compared early and late outcomes by abciximab assignment among 2082 patients randomized in an open-label, 2x2 factorial-design trial of primary stenting versus angioplasty and abciximab treatment (n=1052) versus no abciximab treatment (n=1030). Baseline characteristics were balanced between groups. Abciximab treatment was associated with a significant reduction in the composite end point of death, MI, ischemia-driven target-vessel revascularization (TVR), or disabling stroke at 30 days (4.6% versus 7.0%; relative risk, 0.65; 95% CI, 0.46 to 0.93; P=0.01). Subacute thrombosis also was significantly reduced with abciximab treatment. At 12 months, however, rates of the composite end point did not differ significantly (18.4% for controls versus 16.9% for abciximab-treated patients; relative risk, 0.92; 95% CI, 0.76 to 1.10; P=0.29), reflecting a decrease in the relative difference in TVR rates (ie, no effect of abciximab on reducing restenosis). In an angiographic substudy (n=656), myocardial salvage, restenosis, and infarct-artery reocclusion at 7 months were unaffected by abciximab treatment. There was no significant interaction between stenting and abciximab treatment. CONCLUSIONS: Adjunctive abciximab treatment during primary percutaneous coronary intervention significantly enhanced 30-day event-free survival, predominantly by reducing ischemia-driven TVR. Abciximab treatment did not affect the composite end point at 1 year, reflecting a lack of effect on restenosis.
Tcheng et al. (2003) conducted an RCT in Acute myocardial infarction (n=2,082). Abciximab vs. No abciximab treatment was evaluated on Composite of death, MI, ischemia-driven target-vessel revascularization (TVR), or disabling stroke at 30 days (RR 0.65, 95% CI 0.46 to 0.93, p=0.01). Adjunctive abciximab during primary PCI significantly reduced the 30-day composite of death, MI, ischemia-driven TVR, or disabling stroke compared to no abciximab (4.6% vs 7.0%; RR 0.65; P=0.01).