Randomized trial of glucose-insulin-potassium infusion on 30 day mortality in patients with acute myocardial infarction treated with primary angioplasty - GIPS
Description:
Randomized trial comparing placebo to glucose-insulin-potassium infusion in patients treated with primary angioplasty for acute myocardial infarction.
Hypothesis:
High dose glucose-insulin-potassium infusion and optimal reperfusion will improve the prognosis of myocardial infarction in primary angioplasty patients.
Study Design
Patients Enrolled: 940
Mean Follow Up: 30 days
Mean Patient Age: Mean 61 years
Female: 23%
Patient Populations:
Acute ST segment elevation MI >30 minutes and <24 hours
840 of the 940 patients enrolled in this trial were to be in one of three prespecified subgroups:
1) Killip class 1
2) Patients without diabetes
3) Patients with successful reperfusion
Drug/Procedures Used:
Glucose 80 mmol in 500 cc + 20% glucose at a rate of 3 ml/kg bodyweight/hr over 8-12 hours + continuous IV insulin titrated with dose adjustment every hour.
Concomitant Medications:
ASA, heparin, GP IIb/IIIa (22-26%)
Principal Findings:
At 30 days, there was a nonsignificant trend toward a reduction in the combined endpoint in those treated with glucose-insulin-potassium infusion (8.0% v. 9.9%; p=0.08 [RR 0.68, 95%CI 0.44-1.05]). There were no significant differences in the individual components of the combined endpoint. In subgroup analysis, a significant reduction in the primary combined endpoint was noted in the patients without heart failure symptoms (Killip Class 1) (4.2% v.8.4%; p=0.01 [RR 0.47 (95% CI 0.27-0.83]). The benefit seemed to occur mainly within the first two days of therapy. Overall >90% underwent primary angioplasty. Stents were used in 56-58%. TIMI 3 flow was obtained in over 96% of both groups. Normal epicardial flow with normal myocardial perfusion was obtained in 83%.
Interpretation:
A beneficial effect of glucose-insulin-potassium infusion was noted in the subgroup of stable patients with acute ST elevation myocardial infarction. A higher incidence of pulmonary edema in part due to the requisite volume load makes the routine use of this infusion in all infarction patients unclear. The optimal indications, dosing, and duration of glucose-insulin-potassium infusion in patients with significant left ventricular function and the relative merits in diabetic patients remain to be determined.
References:
Presented by F. Zijlstra at the Annual Meeting of the European Society of Cardiology, August 31, 2002.
van der Horst IC, Zijlstra F, van 't Hof AW, et al. Glucose-insulin-potassium infusion inpatients treated with primary angioplasty for acute myocardial infarction: the glucose-insulin-potassium study: a randomized trial. J Am Coll Cardiol. 2003 Sep 3;42(5):784-91.
Keywords: Pulmonary Edema, Insulin, Myocardial Infarction, Potassium, Ventricular Function, Left, Heart Failure, Angioplasty, Diabetes Mellitus, Stents, Glucose
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