COOL AMI EU pilot trial: a multicentre, prospective, randomised controlled trial to assess cooling as an adjunctive therapy to percutaneous intervention in patients with acute myocardial infarction
Selected in EuroIntervention by S. Brugaletta
Noc M, Erlinge D, Neskovic AN, Kafedzic S, Merkely B, Zima E, Fister M, Petrović M, Čanković M, Veress G, Laanmets P, Pern T, Vukcevic V, Dedovic V, Średniawa B, Świątkowski A, Keeble TR, Davies JR, Warenits AM, Olivecrona G, Peruga JZ, Ciszewski M, Horvath I, Edes I, Nagy GG, Aradi D, Holzer M.
EuroIntervention. 2017 Aug 4;13(5):e531-e539
LinkRead the abstract
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Why this study - the rationale/objective?
Experimental studies in different animal species have shown that mild hypothermia, induced before reperfusion of acute coronary occlusion, reduces infarct size (IS). Cooling prior to reperfusion therefore appeared a promising adjunct to primary percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) to reduce IS further and thereby improve clinical outcome. Its benefits, however, are contrasting in various studies, probably due to heterogenous patients included. The aim of the present study was to test Cooling in a specific population of patients with anterior STEMI within six hours of symptom onset.
How was it executed – the methodology?
This is a multicentre, prospective, interventional, randomised controlled, two-arm pilot trial performed at 16 sites in eight countries. IS by RMN at 30 day was primary endpoint.
What is the main result?
- A total of 50 patients were randomised.
- 22 patients (88%; 95% confidence interval [CI]: 69-97%) in the hypothermia group and 23 patients (92%; 95% CI: 74-99) in the control group completed cardiac magnetic resonance imaging at four to six days and 30-day follow-up.
- In “per protocol” analysis, median infarct size/left ventricular mass was 16.7% in the hypothermia group versus 23.8% in the control group (absolute reduction 7.1%, relative reduction 30%; p=0.31) and median left ventricular ejection fraction (LVEF) was 42% in the hypothermia group and 40% in the control group (absolute reduction 2.4%, relative reduction 6%; p=0.36). Except for self-terminating paroxysmal atrial fibrillation (32% versus 8%; p=0.074), there was no excess of adverse events in the hypothermia group.
Critical reading and the relevance for clinical practice
The topic of the present study is of great interest, as the cardiology community is wondering about the value of cooling devices in STEMI patients. The guidelines for using such devices are different not only between countries but also within a same country.
What is missing is its clinical value. The present study tested a specific protocol identifying a specific population and used a new device which allows cooling in conscious patients. Although primary endpoint was not powered, it provides important information to be used in future powered trials.
How many of you have cooling devices available in your practice? and in which clinical situation do you use it?