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

Abstract

Aims: We aimed to investigate the rapid induction of therapeutic hypothermia using the ZOLL Proteus Intravascular Temperature Management System in patients with anterior ST-elevation myocardial infarction (STEMI) without cardiac arrest. Methods and results: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. Intravascular temperature at coronary guidewire crossing after 20.5 minutes of endovascular cooling decreased to 33.6°C (range 31.9-35.5°C). There was a 17-minute (95% CI: 4.6-29.8 min) cooling-related delay to reperfusion. 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.Conclusions: We rapidly and safely cooled patients with anterior STEMI to 33.6°C at the time of coronary guidewire crossing. This is ≥1.1°C lower than in previous cooling studies. Except for self-terminating atrial fibrillation, there was no excess of adverse events and no clinically important cooling-related delay to reperfusion. A statistically non-significant numerical 7.1% absolute and 30% relative reduction in infarct size warrants a pivotal trial powered for efficacy. ClinicalTrials.

Effects of endovascular cooling on infarct size in ST‐segment elevation myocardial infarction: A patient‐level pooled analysis from randomized trials

“…The results in this study reinforce the value of achieving sufficient cooling prior to reperfusion, and support efforts to improve the technology to cool faster and more effectively. To this end, the recently reported COOL AMI EU pilot study, which used a more powerful cooling system in patients with anterior STEMI, showed an absolute 7% (relative 30%) decrease in infarct size in the per protocol population, warranting the value in performing a fully powered randomized control trial to confirm this signal …”

“…To this end, the recently reported COOL AMI EU pilot study, which used a more powerful cooling system in patients with anterior STEMI, showed an absolute 7% (relative 30%) decrease in infarct size in the per protocol population, warranting the value in performing a fully powered randomized control trial to confirm this signal. 18…”

Coronary microvascular obstruction (the no-reflow phenomenon) during percutaneous coronary interventions in patients with myocardial infarction

“…Еще одним вариантом кардиопротекции является ишемическое коронарное посткондиционирование, суть которого заключается в проведении серии циклических раздуваний баллона в просвете КА непосредственно после имплантации стента и восстановления [28] • Минимально инвазивная стратегия у избранных пациентов (П М) [32,33] • Ишемическое посткондиционирование (П М К) [34,35] • Механическая тромбэктомия (П М) [2] • Эксенатид, лираглутид (П) [36] • Оксид азота (П) [37] • Блокаторы кальциевых каналов (П М) [38] • Предсердный натрийуретический пептид (П) [36] • Гипотермия (П) [28] • Аденозин (П М) [39] • Прерывистая окклюзия коронарного синуса (П) [40] • Эксенатид, лираглутид (П) [36] • Предсердный натрийуретический пептид (П) [36] • Гипотермия (П) [28] • Аденозин (П М) [39] • Цилостазол (П) [42] Не рекомендовано…”

Cardiogenic Causes of Fever

“…There have been no systematic studies on the administration of antipyretics to patients who have suffered myocardial infarction. In contrast, several studies have investigated the induction of therapeutic hypothermia before or during a percutaneous coronary intervention with the aim of limiting infarct size (16,19,20). However, none of these studies has yet demonstrated convincingly that induction of mild hypothermia during a myocardial infarction is of any benefit to the patient (21,22).…”