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A challenge to the metabolic approach to myocardial ischaemia
Carl S Apstein1, Lionel H Opie
1Cardiac Muscle Research Laboratory, Boston University School of Medicine, Boston, MA, USA.
Abstract:
The negative results of glucose-insulin-potassium (GIK) in the very large CREATE-ECLA trial that studied 20,201 patients with ST-elevation acute myocardial infarction (AMI), are disappointing and warrant thorough evaluation. We attempt to put the new data into perspective and uncover the serious flaws in the trial design, otherwise the whole metabolic concept will be disparaged. The crucial issue, developed from basic science data, is that GIK should be initiated very early, before, or at the time of reperfusion. Another problem with CREATE-ECLA is that the mortality in Killip class 1 reperfused patients was 7.1%, much higher than that of a recent Dutch study in which mortality was only 1.2%. Nonetheless, there was a strong trend towards a lower mortality in the sub-groups that received the best reperfusion therapy in CREATE-ECLA, as well as in the first of two rather small Dutch GIK trials. In the future, the ideal protocol to test would be if GIK were given in the ambulance as the patient is being transported to a specialized centre of percutaneous coronary intervention (PCI), with the aim of expanding the time window between pain onset and actual PCI.
Insights
Glucose-insulin-potassium (GIK) therapy for acute myocardial infarction (AMI) may be effective if initiated very early, before reperfusion. The CREATE-ECLA trial
Area of Science:
- Cardiology
- Metabolic interventions
- Clinical trials
Background:
- Glucose-insulin-potassium (GIK) therapy is a metabolic intervention for acute myocardial infarction (AMI).
- The large CREATE-ECLA trial yielded disappointing negative results for GIK in AMI patients.
- Previous studies and basic science suggest early GIK administration is crucial.
Purpose of the Study:
- To evaluate the negative results of the CREATE-ECLA trial regarding GIK therapy in AMI.
- To identify potential flaws in the trial design and re-evaluate the metabolic concept of GIK.
- To provide perspective on GIK's role in AMI management.
Main Methods:
- Analysis of data from the CREATE-ECLA trial (20,201 patients with ST-elevation AMI).
- Comparison of mortality rates between CREATE-ECLA and other relevant studies (e.g., Dutch GIK trials).
- Evaluation of GIK timing relative to reperfusion therapy.
Main Results:
- The CREATE-ECLA trial showed negative results for GIK in AMI.
- Mortality in Killip class 1 reperfused patients in CREATE-ECLA (7.1%) was higher than in a Dutch study (1.2%).
- A trend towards lower mortality was observed in subgroups with optimal reperfusion in CREATE-ECLA and in a Dutch GIK trial.
Conclusions:
- The timing of GIK initiation, ideally before or at reperfusion, is critical for efficacy.
- Flaws in trial design may have contributed to the negative outcomes in CREATE-ECLA.
- Future research should investigate pre-hospital GIK administration to optimize the treatment window for AMI patients undergoing percutaneous coronary intervention (PCI).
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