Key result
Abciximab bolus-only was associated with a similar 3-year incidence of MACE compared to bolus plus infusion (14% vs 17%, P=0.38) after uncomplicated transradial coronary stenting.
Why the study?
Does abciximab bolus-only prevent major adverse cardiovascular events compared to bolus plus infusion in patients undergoing uncomplicated transradial coronary stenting?
RCT (n=1,348)
Does abciximab bolus-only prevent major adverse cardiovascular events compared to bolus plus infusion in patients undergoing uncomplicated transradial coronary stenting?
Absolute Event Rate: 14% vs 17%
p-value: p=0.38
In patients undergoing uncomplicated transradial stenting, an abciximab bolus-only strategy provides similar 3-year clinical outcomes compared to a standard bolus plus 12-hour infusion.
Supports bolus-only abciximab after uncomplicated transradial stenting; extends RCT evidence for simplified GPIIb/IIIa regimens.
BACKGROUND: No data are available on the long term efficacy of abciximab bolus-only with aspirin and clopidogrel pretreatment and systematic coronary stenting. Our objective was to evaluate the 3-year clinical outcomes in the EASY trial. METHODS: After a bolus of abciximab (0.25 mg/kg) and uncomplicated transradial coronary stenting, 1,005 patients were randomized either to same-day home discharge and no infusion (bolus-only group, n = 504) or to overnight hospitalization and 12 hours abciximab infusion (bolus + infusion group, n = 501). In contrast, 343 patients were not randomized after stenting for safety reasons and received abciximab bolus and infusion (not-randomized group). The rate of major adverse cardiovascular events (MACE), including death, myocardial infarction (MI) and target vessel revascularization (TVR) after percutaneous coronary intervention (PCI) was evaluated. RESULTS: Up to 3 years, the incidence of MACE remained similar in the two randomized groups, 14% in bolus-only vs. 17% in bolus + infusion (P = 0.38). Similar efficacy was observed in subgroups analysis including higher-risk patients such as those with diabetes, unstable angina or non-ST elevation MI. Conversely, the incidence of MACE remained significantly higher in patients not-randomized post-PCI at all time intervals (P < 0.0001). The difference in outcomes between randomized and not-randomized patients was mostly accounted by the higher rates of MI, TVR as survival rate remained similar. CONCLUSION: In patients pretreated with aspirin and clopidogrel and undergoing uncomplicated coronary artery stenting, abciximab bolus-only was associated with similar outcomes compared with bolus followed by infusion, up to 3 years after PCI. Conversely, patients with suboptimal results or clinical complications during PCI remained at higher risk of late revascularization or MI.
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Bagur et al. (2009) conducted an RCT in Transradial coronary stenting (n=1,348). Abciximab bolus-only vs. Abciximab bolus + 12 hours infusion was evaluated on Major adverse cardiovascular events (MACE), including death, myocardial infarction (MI) and target vessel revascularization (TVR) (p=0.38). Abciximab bolus-only was associated with a similar 3-year incidence of MACE compared to bolus plus infusion (14% vs 17%, P=0.38) after uncomplicated transradial coronary stenting.
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