• (GIPS)-III trial

    Glycometabolic Interventions in Patients presenting with ST-segment Elevation Myocardial Infarction (GIPS)-III trial Chris P.H. Lexis, Iwan C.C. van der Horst (P.I.), Erik Lipsic, Jan G.P. Tijssen, Pim van der Harst, Dirk J. van Veldhuisen and the GIPS-III Investigators Chris P.H. Lexis has no conflicts of interest Grant 95103007 from ZonMw The Netherlands Organization for Health Research and Development, The Hague, the Netherlands Myocardial infarction in the western world 1 in every 7 people dies from consequences of MI Late or early 1-year mortality 10 – 15% Left ventricular dysfunction after MI in 30 – 50% of patients heart failure in 20 – 40% the strongest predictor of outcome after STEMI Steg PG, et al. ESC Guidelines for the management of STEMI. Eur Heart J, 2012. Metformin The most widely used oral antihyperglycemic drug In top 20 prescription drugs Metformin in patients with diabetes (UKPDS)- 36% reduction of all cause mortality 42% diabetes related death 32% any diabetes related endpoint UK Prospective Diabetes Study (UKPDS) Group. Lancet, 1998. The DIGAMI 2 trial (n=1253) in patients with DM and MI Metformin HR 0.65 (0.47–0.90) for death Mellbin L, et al. Diabetologia, 2011. Animal experimental (rats) of myocardial infarction Yin MM, et al. Am J Physiol Heart Circ Physiol, 2011; Lexis CP, et al. Cardiovasc Drug Ther, 2012. Animal experimental (rats) of myocardial infarction Yin MM, et al. Am J Physiol Heart Circ Physiol, 2011; Lexis CP, et al. Cardiovasc Drug Ther, 2012. To study the effect of metformin on left ventricular function in patients without DM presenting with STEMI GIPS-III trial Double blind Randomized 1-1 Placebo controlled Parallel group Intervention Metformin 500 mg twice daily vs placebo twice daily Started immediately after PCI Continued for 4 months Lexis CP, et al. Cardiovasc Drug Ther, 2012. Primary endpoint Left ventricular ejection fraction (LVEF) 4 months after myocardial infarction Measured by 3.0 Tesla MRI Independent core laboratory Blinded to allocation Secondary endpoints Concentration of NT-proBNP at 4 months Clinical events Safety parameters Glycometabolic state Based on LVEF by MRI 80% power to detect a difference in LVEF 3% (SD 9%) 141 patients with evaluable MRI per group Allow for 25% dropout Total sample size 380 patients Statistical Analyses according to a predefined Statistical Analysis Plan Inclusion criteria Patients aged >18 years with STEMI Primary PCI with = 1 stent of 3.0 mm in diameter TIMI flow grade post PCI = 2 Key exclusion criteria Diabetes Prior MI Need for cardiothoracic surgery Contraindication for MRI Severe renal impairment 1473 patients via STEMI protocol Randomized (n=380) Metformin (n=191) Placebo (n=189) MRI at 4 months (n=136) MRI at 4 months (n=139) LVEF with MRI (n=136) 1043 not eligible 149 prior MI 131 CI for MRI 130 no STEMI 128 diabetes 113 CABG 392 other 50 eligible 37 declined 13 different trial 21 refused MRI 17 claustrophobic 17 contraindication 14 refused MRI 19 claustrophobic 16 contraindication 1 withdrew consent LVEF with MRI (n=135) 54.8 ± 7.9 54.8 ± 7.9 53.1 ± 9.0 54.8 ± 7.9 54.8 ± 7.9 53.1 ± 9.0 54.8 ± 7.9 54.8 ± 7.9 In patients without diabetes, metformin 500mg 2dd, started directly after PCI and continued for 4 months does not preserve left ventricular ejection fraction after STEMI as compared to placebo In patients without diabetes, metformin 500mg 2dd, started directly after PCI and continued for 4 months does not preserve left ventricular ejection fraction after STEMI as compared to placebo Metformin is safe to use after STEMI In patients without diabetes, metformin 500mg 2dd, started directly after PCI and continued for 4 months does not preserve left ventricular ejection fraction after STEMI as compared to placebo Metformin is safe to use after STEMI The current results do not support the use of metformin in this setting

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