A multicentre, prospective, randomised controlled trial to assess the safety and effectiveness of cooling as an adjunctive therapy to percutaneous intervention in patients with acute myocardial infarction: the COOL AMI EU Pivotal Trial
journal contributionposted on 2023-08-30, 18:37 authored by Marko Noc, Peep Laanmets, Aleksandar N. Neskovic, Mirko Petrovic, Bojan Stanetic, Daniel Aradi, Robert G. Kiss, Imre Ungi, Béla Merkely, Martin Hudec, Peter Blasko, Ivan Horvath, John R. Davies, Vladan Vukcevic, Michael Holzer, Bernhard Metzler, Adam Witkowsk, Andrejs Erglis, Misa Fister, Gergely Nagy, Josko Bulum, Istvan Edes, Beata Sredniawa, David Erlinge, Thomas R. Keeble
Background: Despite primary PCI (PPCI), STEMI can still result in large infarct size (IS). New technology with rapid intravascular cooling showed positive signal for reduction in IS in anterior STEMI. Aims: We investigated the effectiveness and safety of rapid systemic intravascular hypothermia as an adjunct to primary PCI (PPCI) in conscious patients with anterior ST-elevation myocardial infarction (STEMI) without cardiac arrest. Methods: Hypothermia was induced using ZOLL® Proteus™ Intravascular Cooling System. After randomization of 111 patients, 58 to hypothermia and 53 to control groups, the study was prematurely discontinued by the sponsor due to inconsistent patient logistics between the groups resulting in significantly longer total ischemic delay in hypothermia group (232 vs 188 minutes; p <0.001). Results: There were no differences in angiographic features and PPCI result between the groups. Intravascular temperature at wire crossing was 33.3+0.9°C. Infarct size/left ventricular mass (IS/LV) by cardiac magnetic resonance (CMR) at day 4-6 was 21.3% in hypothermia group and 20.0% in control group (p=0.540). Major adverse cardiac events (MACE) at 30 days were non significantly increased in hypothermia group (8.6% vs 1.9%; p=0.117) while cardiogenic shock (10.3% vs 0%; p=0.028) and paroxysmal atrial fibrillation (43.1% vs 3.8%; p<0.001) were significantly more frequent in hypothermia group. Conclusion: Intravascular ZOLL TM Proteus Cooling System reduced temperature to 33.3oC before PPCI in patients with anterior STEMI. Due to inconsistent patient logistics between the groups, this hypothermia protocol resulted in longer ischemic delay, did not reduce IS/LV mass and was associated with increased adverse events.