RAPPORT
Trial question
What is the role of abciximab in patients with acute MI of < 12 hours duration undergoing PCI in the pre-drug eluting stent era?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 483
483 patients (133 female, 350 male).
Inclusion criteria: patients with acute MI of < 12 hours duration undergoing PCI in the pre-drug eluting stent era.
Key exclusion criteria: severe thrombocytopenia, baseline PT > 1.2 times control, ongoing internal bleeding or recent major surgery, previous stroke, or severe uncontrolled hypertension.
Interventions
N=241 abciximab (as a 0.25 mg/kg bolus followed by a 12-hour infusion of 0.125 mcg/kg/min, maximum, 10 mcg/min).
N=242 placebo (matching placebo).
Primary outcome
Death, reinfarction, or urgent target vessel revascularization at 6 months
11.6%
17.8%
17.8 %
13.4 %
8.9 %
4.5 %
0.0 %
Abciximab
Placebo
Significant
decrease ▼
NNT = 16
Significant decrease in death, reinfarction, or urgent target vessel revascularization at 6 months (11.6% vs. 17.8%; OR 0.61, 95% CI 0.36 to 1.02).
Secondary outcomes
No significant difference in death, reinfarction, or any target vessel revascularization at 6 months, by intention-to-treat analysis (28.2% vs. 28.1%; OR 1.01, 95% CI 0.68 to 1.5).
Safety outcomes
Significant differences in bleeding (16.6% vs. 9.5%, p = 0.02).
Conclusion
In patients with acute MI of < 12 hours duration undergoing PCI in the pre-drug eluting stent era, abciximab was superior to placebo with respect to death, reinfarction, or urgent target vessel revascularization at 6 months.
Reference
Brener SJ, Barr LA, Burchenal JE et al. Randomized, placebo-controlled trial of platelet glycoprotein IIb / IIIa blockade with primary angioplasty for acute myocardial infarction. ReoPro and Primary PTCA Organization and Randomized Trial (RAPPORT) Investigators. Circulation. 1998 Aug 25;98(8):734-41.
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