Reopro And Primary PTCA Organization and Randomized Trial - RAPPORT
Abciximab vs placebo in conjunction with primary PTCA for acute ST elevation MI.
To evaluate whether platelet IIb/IIIa receptor blockade with abciximab reduces ischemic events in acute MI patients undergoing primary angioplasty.
Patients Screened: Not reported
Patients Enrolled: 483
NYHA Class: Not reported
Mean Follow Up: 6 months
Mean Patient Age: 52-71 years (average 61 years)
Mean Ejection Fraction: Not evaluated
12 hours or less from onset of symptoms with ischemic chest pain lasting >20 minutes and with significant ST elevation in at least two contiguous leads or new left bundle branch block.
Severe thrombocytopenia, baseline PT >1.2 time control, ongoing internal bleeding or recent major surgery, previous stroke, severe uncontrolled hypertension, PTCA of infarct-related artery in prior 3 months, cardiogenic shock or prolonged resuscitation, vasculitis, and prior abciximab or thrombolytic therapy.
6 month incidence of death, MI, and any target vessel revascularization (TVR).
Major bleeding (intracranial hemorrhage or >5g% adjusted decline in hemoglobin)
Abciximab 0.25 mg/kg bolus then 0.125 μg/kg/min (maximum 10 μg/min) for 12 hours. All patients received aspirin and heparin 100 U/kg bolus before PTCA (with extra boluses if needed to keep ACT >300 seconds). Stenting permitted for residual dissection with >50% restenosis and for abrupt or threatened closure.
No difference was observed between the two groups in incidence of 6-month primary end point (28.1% vs. 28.2%). However, the abciximab group sustained lower rates of death, MI, and URGENT target vessel revascularization at 7 days (3.3% vs. 9.9%; p = 0.003), 30 days (5.8% vs. 11.2%; p = 0.03), and 6 months (11.6% vs. 17.8%; p = 0.05). The abciximab group had 42% less bailout stenting (11.9% vs. 20.4%; p = 0.008). The abciximab had increased major bleeding (16.6% vs. 9.5%, p = 0.02), primarily at the arterial access site. On treatment analysis showed that abciximab was associated with decreased death and MI at 7 days (1.4% vs. 4.7%; p = 0.047) with a trend at 6 months (6.9% vs. 12%; p = 0.07). Of note, this was a low-risk population (30-day mortality rates ~2%) which may have attenuated the impact of abciximab.
While abciximab administered during primary PTCA for acute MI did not significantly reduce the incidence of death, MI, and any target vessel revascularization (TVR), it was associated with a significant reduction in the early (7 day) occurrence of death, MI, and urgent TVR.
Circulation 1998;98:734–741. Related trial: ADMIRAL (N Engl J Med 2001;344:1895-1903)
Keywords: Platelet Aggregation Inhibitors, Chest Pain, Heparin, Bundle-Branch Block, Coronary Disease, Blood Platelets, Immunoglobulin Fab Fragments, Angioplasty, Stents
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