Glucose - Insulin - Potassium Study in Patients With ST Elevation Myocardial Infarction Without Signs of Heart Failure - GIPS II

Mar 09, 2005
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Date Presented:
01/01/2005
Date Published:
01/01/2006
Date Updated:
03/09/2005
Original Posted Date:
03/09/2005
References

Description:

The goal of the trial was to evaluate treatment with high-dose glucose/insulin/potassium (GIK) as an adjunct to reperfusion therapy compared with usual care among patients with ST elevation myocardial infarction (MI) without heart failure.

Hypothesis:

Adjunctive treatment with high-dose GIK will be associated with a reduction in mortality at 30 days compared with standard reperfusion therapy among patients with ST elevation MI without heart failure.

Study Design

Study Design:

Patients Enrolled: 731
Mean Follow Up: 30 days
Mean Patient Age: Mean age 62 years
Female: 27

Patient Populations:

Signs of heart failure (heart rate >90 bpm; systolic blood pressure <100 mm Hg with anterior infarction; Killip class ≥2), and disease with life expectancy <6 months

Primary Endpoints:

Mortality at 30 days

Secondary Endpoints:

Enzymatic infarct size, as assessed by peak creatine kinase; and left ventricular function

Drug/Procedures Used:

Patients were randomized to usual care (n=445) or high-dose GIK (n=444) in addition to standard care. The GIK infusion contained 20% glucose/80 mmol potassium/l and was given at a fixed rate of 2 ml/kg/h in addition to insulin (dose varied by glucose level). The insulin dose in normoglycemic patients was 5 U/h.

Principal Findings:

Baseline characteristics were well balanced between the treatment arms, with 94% of patients undergoing percutaneous coronary intervention (PCI). Anterior infarction was present more frequently in the GIK group than the usual care group (48% vs. 39%, p=0.01).

The trial was discontinued early at the recommendation of the steering board following the interim analysis, which showed futility. There was no difference in the primary endpoint of 30-day mortality (2.9% for GIK vs. 1.8% for usual care, p=0.27). There was also no difference in enzymatic infarct size (2008 U/l for GIK vs. 1932 U/l for usual care, p=0.57). In a subgroup analysis of anterior infarctions, there was also no difference in enzymatic infarct size (2343 U/l vs. 2118 U/l, respectively, p=0.32).

Interpretation:

Among patients with ST elevation MI without signs of heart failure, treatment with high-dose GIK in addition to standard therapy was not associated with a reduction in 30-day mortality compared with standard therapy.

Trials evaluating GIK as adjunctive therapy have shown mixed results. GIK was associated with a reduction in one-year mortality in the Diabetic Insulin-Glucose Infusion in Acute MI (DIGAMI) trial in patients with acute MI and elevated glucose. However, the recent 20,000 patient CREATE-ELCA trial showed no benefit associated with GIK as adjunctive therapy in acute MI. There was also no difference in the earlier GIPS I trial, which evaluated GIK in addition to primary PCI.

References:

Timmer JR et al. Glucose-insulin-potassium infusion in patients with acute myocardial infarction without signs of heart failure: the Glucose-Insulin-Potassium Study (GIPS)-II. J Am Coll Cardiol. 2006;47(8):1730-1.

Presented by Dr. Jorik Timmer at the March 2005 ACC Annual Scientific Session, Orlando, FL.

Keywords: Insulin, Myocardial Infarction, Potassium, Cardioplegic Solutions, Life Expectancy, Heart Failure, Blood Pressure, Medical Futility, Heart Rate, Diabetes Mellitus, Glucose, Percutaneous Coronary Intervention


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