[Does intracoronary abciximab improve the outcome of percutaneous coronary interventions? A randomized controlled trial].

INTRODUCTION AND OBJECTIVES It has been clearly demonstrated that abciximab is useful in percutaneous coronary interventions. However, it is not known if intracoronary administration of the initial abciximab bolus improves outcome. Moreover, there may be safety concerns. METHODS The study was a single-center prospective randomized trial that included all patients undergoing coronary angioplasty involving the use of abciximab. Patients were randomized to either intracoronary or intravenous administration of the abciximab bolus. The primary endpoint was the incidence of major adverse cardiac events (i.e., death, myocardial infarction, or the need for revascularization); secondary endpoints were hemorrhagic complications and the troponin-I level. RESULTS The study included 137 patients; 72 received an intracoronary abciximab bolus and 65, an intravenous bolus. Clinical characteristics and baseline angiographic findings were similar in the two groups. All patients underwent coronary stent implantation. No difference was observed between the intracoronary bolus group and the intravenous bolus group in type of stent used (drug eluting stent 47.2% vs 50.8%, respectively), total stent length, or final TIMI flow grade (3 vs 2.97, respectively). The intervention success rates were also similar (98.5% vs. 99%, respectively). No complication associated with the administration route was reported. However, the level of the myocardial injury marker troponin I increased significantly in the intravenous bolus group. Clinical follow-up at 1 year did not reveal any difference in the incidence of major adverse cardiac events: 8.5% in the intracoronary bolus group versus 6.2% in the intravenous bolus group. CONCLUSIONS Intracoronary administration of an abciximab bolus did not appear to be less safe or effective than intravenous administration. Less post-procedural myocardial damage was observed in the intracoronary bolus group.