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The role of Glucagon-Like Peptide 1 Loading on periprocedural myocardial infarction During elective PCI (GOLD-PCI study): A randomized, placebo-controlled trial - 05/08/19

Doi : 10.1016/j.ahj.2019.05.013 
Joel P. Giblett, MD a, b, Sophie Clarke, PhD a, Tian Zhao, MA a, Liam M. McCormick, MD c, Denise M. Braganza, PhD a, Cameron G. Densem, MD a, Michael O'Sullivan, MD PhD a, David Adlam, PhD d, Sarah C. Clarke, MD a, Jo Steele e, Sarah Fielding, PhD e, Nick E.J. West, MD a, Sofia S. Villar, PhD e, f, Stephen P. Hoole, DM a, b,
a Department of Cardiology, Royal Papworth Hospital, Cambridge, United Kingdom 
b Department of Cardiovascular Medicine, University of Cambridge, United Kingdom 
c MonashHeart, Monash Medical Centre, Melbourne, Australia 
d Glenfield Hospital, Leicester, United Kingdom 
e Papworth Trials Unit Collaboration, Royal Papworth Hospital, Cambridge, United Kingdom 
f MRC Biostatistics Unit, University of Cambridge, United Kingdom 

Reprint requests: Dr Stephen Hoole, Department of Cardiology, Royal Papworth Hospital, Papworth Everard, Cambridge, CB23 3RE, United Kingdom.Department of Cardiology, Royal Papworth Hospital, Papworth EverardCambridgeCB23 3REUnited Kingdom

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 nonlethal 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 percutaneous coronary intervention (PCI)–associated myocardial infarction (PMI) during elective PCI.

Methods

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 cardiac troponin I (cTnI) was measured with a primary end point of PMI defined as rise ≫×5 upper limit of normal (280 ng/L). Secondary end points included cTnI rise and MACCE at 12 months.

Results

A total of 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) or in the secondary end points 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 NCT02127996

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 Disclosures: Sophie Clarke is an employee of Merck, Sharp, and Dohme. No other authors have any relevant disclosure or conflict of interest to declare


© 2019  Elsevier Inc. Tutti i diritti riservati.
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