CREATE-ECLA - GIK Trial No improvement in 30-day mortality with high-dose Glucose-Insulin-Potassium (GIK) infusion Presented at: American Heart Association Scientific Sessions 2004 Presented by: Dr. S.R. Mehta
CREATE-ECLA - GIK 20,195 patients with acute ST-segment-elevation MI presenting within 12 hours of symptom onset 77.8% male, mean age 58.6 9% received PCI, 74% thrombolytic therapy 97% Aspirin, 72% ACE inhibitors, 70% beta-blockers, 68% lipid-lowering therapy Also randomized to reviparin or placebo – results presented separately • GIK • Infusion of high-dose GIK (25% glucose, 50 units/L insulin, and 80 mEq/L KCI) for 24 hours at 1.5 mL/kg per hour • n=10,088 Mean onset-to-treatment = 4.6 hr • Usual Care • n=10,107 Mean onset-to-treatment = 4.7 hr Primary Endpoint: 30 day mortality Secondary Endpoints: 30 day cardiac arrest, cardiogenic shock, reinfarction, Safety Endpoints: Pulmonary edema, Heart failure, Killip class > 1, Hyperkalemia, Significant phlebitis, Hypoglycemia Presented at AHA 2004
CREATE-ECLA – GIK: Primary endpoint 30 DAY MORTALITY p = 0.45 • No difference in 30-day mortality between the GIK and control groups % Presented at AHA 2004
CREATE-ECLA –GIK: Secondary endpoint No difference in the secondary endpoints of cardiac arrest, cardiogenic shock or reinfarction between the two groups p=0.38 p=0.81 p=0.51 % Presented at AHA 2004
CREATE-ECLA – GIK: Ischemia Recurrent Ischemia at 7 days p = 0.004 • GIK was associated with a significant reduction in recurrent ischemia at 7 days. The reduction remained significant at 30 days (p=0.036) • Recurrent ischemia was neither a primary nor secondary endpoint % Presented at AHA 2004
CREATE-ECLA –GIK: Safety endpoints No difference in incidence of pulmonary edema, heart failure or worse Killip class between the two groups p=0.88 p=0.92 p=0.42 % Presented at AHA 2004
CREATE-ECLA –GIK: Safety endpoints p=0.0006 p=<0.0001 p=<0.0001 % Presented at AHA 2004
CREATE-ECLA –GIK: Summary • Among acute MI patients presenting within 12 hours of onset of symptoms, treatment with a high-dose glucose-insulin-potassium infusion was not associated with a difference in the primary endpoint of 30-day mortality compared with control. • In addition, the two groups showed no difference in the secondary endpoints of cardiac arrest, cardiogenic shock, and reinfarction at 30 days. • GIK was associated with a reduction in recurrent ischemia at 7 and 30 days, but an increase in hyperkalemia, phlebitis and hypoglycemia. • These findings differ from a previous meta-analysis of 16 smaller studies, which suggested a reduction in mortality with GIK.