Noc, Marko, Erlinge, David, Neskovic, Aleksandar, Kafedzic, Srdjan, Merkely, Béla, Zima, Endre, Fister, Misa, Petrović, Milovan, Čanković, Milenko, Veress, Gábor, Laanmets, Peep, Pern, Teele, Vukcevic, Vladan, Dedovic, Vladimir, Średniawa, Beata, Świątkowski, Andrzej, Keeble, Thomas R., Davies, John R., Warenits, Alexandra-Maria, Olivecrona, Göran, Peruga, Jan, Ciszewski, Michal, Horvath, Ivan, Edes, Istvan, Nagy, Gergely, Aradi, Daniel and Holzer, Michael (2017) 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. EuroIntervention, 13 (5). e531-e539. ISSN 1969-6213
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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.gov Identifier: NCT02509832
Item Type: | Journal Article |
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Faculty: | ARCHIVED Faculty of Medical Science (until September 2018) |
Depositing User: | Ian Walker |
Date Deposited: | 02 Feb 2018 15:10 |
Last Modified: | 09 Sep 2021 16:11 |
URI: | https://arro.anglia.ac.uk/id/eprint/702700 |
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