Abciximab during primary PTCA for acute MI did not reduce the 6-month primary endpoint of death, reinfarction, or any TVR compared to placebo (28.2% vs 28.1%, P=0.97), but increased major bleeding.
RCT (n=483)
double-blind
randomized
Does abciximab reduce the composite of death, reinfarction, or target vessel revascularization in patients with acute myocardial infarction undergoing primary PTCA?
Abciximab during primary PTCA for acute MI reduced early ischemic events and the need for bail-out stenting, but significantly increased major bleeding without improving the 6-month primary composite endpoint.
Absolute Event Rate: 28.2% vs 28.1%
p-value: p=0.97
BACKGROUND: The benefit of catheter-based reperfusion for acute myocardial infarction (MI) is limited by a 5% to 15% incidence of in-hospital major ischemic events, usually caused by infarct artery reocclusion, and a 20% to 40% need for repeat percutaneous or surgical revascularization. Platelets play a key role in the process of early infarct artery reocclusion, but inhibition of aggregation via the glycoprotein IIb/IIIa receptor has not been prospectively evaluated in the setting of acute MI. METHODS AND RESULTS: Patients with acute MI of <12 hours' duration were randomized, on a double-blind basis, to placebo or abciximab if they were deemed candidates for primary PTCA. The primary efficacy end point was death, reinfarction, or any (urgent or elective) target vessel revascularization (TVR) at 6 months by intention-to-treat (ITT) analysis. Other key prespecified end points were early (7 and 30 days) death, reinfarction, or urgent TVR. The baseline clinical and angiographic variables of the 483 (242 placebo and 241 abciximab) patients were balanced. There was no difference in the incidence of the primary 6-month end point (ITT analysis) in the 2 groups (28.1% and 28.2%, P=0.97, of the placebo and abciximab patients, respectively). However, abciximab significantly reduced the incidence of death, reinfarction, or urgent TVR at all time points assessed (9.9% versus 3.3%, P=0.003, at 7 days; 11.2% versus 5.8%, P=0.03, at 30 days; and 17.8% versus 11.6%, P=0.05, at 6 months). Analysis by actual treatment with PTCA and study drug demonstrated a considerable effect of abciximab with respect to death or reinfarction: 4.7% versus 1.4%, P=0.047, at 7 days; 5.8% versus 3.2%, P=0.20, at 30 days; and 12.0% versus 6.9%, P=0.07, at 6 months. The need for unplanned, "bail-out" stenting was reduced by 42% in the abciximab group (20.4% versus 11.9%, P=0.008). Major bleeding occurred significantly more frequently in the abciximab group (16.6% versus 9.5%, P=0.02), mostly at the arterial access site. There was no intracranial hemorrhage in either group. CONCLUSIONS: Aggressive platelet inhibition with abciximab during primary PTCA for acute MI yielded a substantial reduction in the acute (30-day) phase for death, reinfarction, and urgent target vessel revascularization. However, the bleeding rates were excessive, and the 6-month primary end point, which included elective revascularization, was not favorably affected.
Brener et al. (1998) conducted an RCT in acute myocardial infarction (n=483). abciximab vs. placebo was evaluated on death, reinfarction, or any (urgent or elective) target vessel revascularization (TVR) at 6 months (p=0.97). Abciximab during primary PTCA for acute MI did not reduce the 6-month primary endpoint of death, reinfarction, or any TVR compared to placebo (28.2% vs 28.1%, P=0.97), but increased major bleeding.