The role of glucagon-like peptide 1 loading on periprocedural myocardial infarction during elective PCI (GOLD-PCI study): A randomized, placebo-controlled trial

Abstract Background The incretin hormone Glucagon-like Peptide 1 (GLP-1) has been shown to protect against lethal ischemia–reperfusion injury in animal models, and against non-lethal ischemia reperfusion injury in humans. Furthermore, GLP-1 receptor agonists have been shown to reduce major adverse cardiovascular and cerebrovascular events (MACCE) in large scale studies. We sought to investigate whether GLP-1 reduced PCI-associated myocardial infarction (PMI) during elective percutaneous coronary intervention (PCI). Methods and Results The study was a randomized, double-blind controlled trial in which patients undergoing elective PCI received an intravenous infusion of either GLP-1 at 1.2 pmol/Kg/min or matched 0.9% saline placebo before and during the procedure. Randomization was performed in 1:1 fashion, with stratification for diabetes mellitus. Six-hour Troponin I (cTnI) was measured with a primary endpoint of PMI defined as rise > x5 ULN (280 ng/L). Secondary endpoints included cTnI rise and MACCE at 12-months. 192 patients were randomized with 152 (79%) male and a mean age of 68.1 ± 8.9 years. No significant differences in patient demographics were noted between the groups. There was no difference in the rate of PMI between GLP-1 and placebo (9 (9.8%) vs. 8 (8.3%), P  = 1.0), nor in the secondary endpoints of difference in median cTnI between groups (9.5 [0–88.5] vs. 20 [0–58.5] ng/L, P  = .25) and MACCE at 12-months ((7 (7.3%) vs. 9 (9.4%), P  = .61). Conclusions In this randomized, placebo controlled trial GLP-1 did not reduce the low incidence of PMI or abrogate biomarker rise during elective PCI, nor did it influence the 12-month MACCE rate which also remained low. Clinical trial registration Clinicaltrials.gov Number: NCT02127996 https://clinicaltrials.gov/ct2/show/NCT02127996