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Reopro And Primary PTCA Organization and Randomized Trial - RAPPORT
Description:
Abciximab vs placebo in conjunction with primary PTCA for acute ST elevation MI.
Hypothesis:
To evaluate whether platelet IIb/IIIa receptor blockade with abciximab reduces ischemic events in acute MI patients undergoing primary angioplasty.
Study Design
Study Design:
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)
Female: 28%
Mean Ejection Fraction: Not evaluated
Patient Populations:
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.
Exclusions:
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.
Primary Endpoints:
6 month incidence of death, MI, and any target vessel revascularization (TVR).
Secondary Endpoints:
Major bleeding (intracranial hemorrhage or >5g% adjusted decline in hemoglobin)
Drug/Procedures Used:
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.
Principal Findings:
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.
Interpretation:
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.
References:
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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