TY - JOUR JO - EuroIntervention TI - 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 AB - <p><u>Background:</u> 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.</p> <p><u>Aims:</u> 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.</p> <p><u>Methods:</u> Hypothermia was induced using ZOLL<sup>&reg;</sup> Proteus&trade; 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 &lt;0.001).</p> <p><u>Results:</u> There were no differences in angiographic features and PPCI result between the groups. Intravascular temperature at wire crossing was 33.3<u>+</u>0.9&deg;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&lt;0.001) were significantly more frequent in hypothermia group.</p> <p><u>Conclusion:</u> Intravascular ZOLL <sup>TM</sup> Proteus Cooling System reduced temperature to 33.3<sup>o</sup>C 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.</p> AU - Noc Marko AU - Laanmets Peep AU - Neskovic N. Aleksandar AU - Petrović Milovan AU - Stanetic Bojan AU - Aradi Daniel AU - Kiss G Robert AU - Ungi Imre AU - Merkely Béla AU - Hudec Martin AU - Blasko Peter AU - Horvath Ivan AU - Davies John AU - Vukcevic Vladan AU - Holzer Michael AU - Metzler Bernhard AU - Witkowski Adam AU - Erglis Andrejs AU - Fister Misa AU - Nagy Gergely AU - Bulum Josko AU - Édes István AU - Średniawa Beata AU - Erlinge David AU - Keeble Thomas R VL - IS - Y1 - 18/05/2021 Y1 - 2021 DOI - 10.4244/EIJ-D-21-00348 SP - KW - stemi KW - drug-eluting stent KW - mri PB - Europa Digital & Publishing UR - https://eurointervention.pcronline.com/article/a-multicentre-prospective-randomised-controlled-trial-to-assess-the-safety-and-effectiveness-ofcooling-as-an-adjunctive-therapy-to-percutaneous-intervention-in-patients-with-acute-myocardial-infarction-thecoolamieu-pivotal-trial SN - 1774-024X ER -