Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial

Abstract

Background: Abciximab reduces major adverse cardiac events in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI). Intracoronary abciximab bolus application results in high local drug concentrations and may be more effective than a standard intravenous bolus.

Methods and results: Patients undergoing primary PCI were randomized to either intracoronary (n=77) or intravenous (n=77) bolus abciximab administration with subsequent 12-hour intravenous infusion. The primary end point was infarct size and extent of microvascular obstruction as assessed by delayed enhancement magnetic resonance. Secondary end points were ST-segment resolution at 90 minutes, Thrombolysis in Myocardial Infarction flow and perfusion grades after PCI, and the occurrence of major adverse cardiac events within 30 days. The median infarct size was 15.1% (interquartile range, 6.1% to 25.2%) in the intracoronary versus 23.4% (interquartile range, 13.6% to 33.2%) in the intravenous group (P=0.01). Similarly, the extent of microvascular obstruction was significantly smaller in intracoronary compared with intravenous abciximab patients (P=0.01). Myocardial perfusion measured as early ST-segment resolution was significantly improved in intracoronary patients with an absolute ST-segment resolution of 77.8% (interquartile range, 66.7% to 100.0%) versus 70.0% (interquartile range, 45.2% to 83.5%; P=0.006). The Thrombolysis in Myocardial Infarction flow after PCI was not different between treatment groups (P=0.51), but there was a trend toward an improved perfusion grade (P=0.09). There also was a trend toward a lower major adverse cardiac event rate after intracoronary versus intravenous abciximab application (5.2% versus 15.6%; P=0.06; relative risk, 0.33; 95% CI, 0.09 to 1.05).

Conclusions: Intracoronary bolus administration of abciximab in primary PCI is superior to standard intravenous treatment with respect to infarct size, extent of microvascular obstruction, and perfusion.

Trial registration: ClinicalTrials.gov NCT00299377.