Long term efficacy of abciximab bolus-only compared to abciximab bolus and infusion after transradial coronary stenting.

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.