Background: This study investigated the efficacy and the safety of the upstream glycoprotein (Gp) IIb/IIIa inhibitor (clotinab; ISU ABXIS, Seoul, Republic of Korea) under 600-mg clopidogrel pretreatment compared with provisional use in ST-elevation myocardial infarction (STEMI).
Methods and results: A total of 786 STEMI patients were randomized to upstream use in the emergency room (ER) (n = 392) or provisional use during percutaneous coronary intervention (PCI) (n = 394). All patients were prescribed 600-mg clopidogrel in the ER. The primary endpoint was the 30-day incidence of composite events including death, nonfatal myocardial infarction, target vessel revascularization, and stroke. There was no significant difference in the events that occurred in 40 patients (10.2%) in the upstream arm and 55 patients (14.0%) in the provisional arm during the 30 days (odds ratio 0.70, 95% confidence interval 0.45-1.08). Major bleeding was higher in the upstream arm (1.5% vs. 0%, P = 0.02). However, there was a significant reduction in 30-day composite events in the upstream arm in the high-risk population (Killip class ≥II or GRACE score >140).
Conclusions: The upstream use of clotinab under a 600-mg clopidogrel loading may not significantly reduce cardiac events following primary PCI but may improve the clinical outcome in high-risk patients.
Trial registration: ClinicalTrials.gov NCT00841438.