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001-es BibID:	BIBFORM126485
035-os BibID:	(Scopus)85113811297 (WoS)000690403600004
Első szerző:	Noc, Marko
Cím:	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 / Noc Marko, Laanmets Peep, Neskovic Aleksandar N., Petrovic Milovan, Stanetic Bojan, Aradi Daniel, Kiss Robert G., Ungi Imre, Merkely Béla, Hudec Martin, Blasko Peter, Horvath Ivan, Davies John R., Vukcevic Vladan, Holzer Michael, Metzler Bernhard, Witkowski Adam, Erglis Andrejs, Fister Misa, Nagy Gergely, Bulum Josko, Édes István, Peruga Jan Z., Sredniawa Beata, Erlinge David, Keeble Thomas R.
Dátum:	2021
ISSN:	1774-024X 1969-6213
Megjegyzések:	Background: Despite primary PCI (PPCI), ST-elevation myocardial infarction (STEMI) can still result in large infarct size (IS). New technology with rapid intravascular cooling showed positive signals for reduction in IS in anterior STEMI. Aims: We investigated the effectiveness and safety of rapid systemic intravascular hypothermia as an adjunct to PPCI in conscious patients, with anterior STEMI, without cardiac arrest. Methods: Hypothermia was induced using the ZOLL? Proteus? intravascular cooling system. After randomisation 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 ischaemic delay in the 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 (IS/LV) mass by cardiac magnetic resonance (CMR) at day 4-6 was 21.3% in the hypothermia group and 20.0% in the control group (p=0.540). Major adverse cardiac events at 30 days increased non-significantly in the 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 the hypothermia group. Conclusions: The ZOLL Proteus intravascular cooling system reduced temperature to 33.3?C before PPCI in patients with anterior STEMI. Due to inconsistent patient logistics between the groups, this hypothermia protocol resulted in a longer ischaemic delay, did not reduce IS/LV mass and was associated with increased adverse events. ? Europa Digital & Publishing 2021. All rights reserved.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Drug-eluting stent MRI STEMI
Megjelenés:	Eurointervention. - 17 : 6 (2021), p. 466-473. -
További szerzők:	Laanmets, Peep Neskovic, Aleksandar N. Petrovic, Milovan Stanetic, Bojan Aradi Dániel Kiss Róbert Gábor Ungi Imre Merkely Béla (1965-) (orvos) Hudec, Martin Blaskó Péter Horváth Iván Davies, John R. Vukcevic, Vladan Holzer, Michael Metzler, Bernhard Witkowski, Adam Erglis, Andrejs Fister, Misa Nagy Gergely György (1976-) (orvos) Bulum, Josko Édes István (1952-) (kardiológus) Peruga, Jan Z. Sredniawa, Beata Erlinge, David Keeble, Thomas R.
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