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
(2021) In EuroIntervention 17(6). p.466-473- Abstract
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... (More)
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.
(Less)
- author
- Noc, Marko
; Laanmets, Peep
; Neskovic, Aleksandar N.
; Petrović, 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
LU
; Bulum, Josko
; Edes, Istvan
; Peruga, Jan Z.
; Średniawa, Beata
; Erlinge, David
LU
and Keeble, Thomas R.
(Less) - organization
- publishing date
- 2021
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Drug-eluting stent, MRI, STEMI
- in
- EuroIntervention
- volume
- 17
- issue
- 6
- pages
- 8 pages
- publisher
- Société Europa Edition
- external identifiers
-
- scopus:85113811297
- pmid:34031023
- ISSN
- 1774-024X
- DOI
- 10.4244/EIJ-D-21-00348
- language
- English
- LU publication?
- yes
- id
- fdfc0a9f-c0cb-47a7-8f71-7964cbc58382
- date added to LUP
- 2022-01-04 12:54:33
- date last changed
- 2024-06-15 23:38:48
@article{fdfc0a9f-c0cb-47a7-8f71-7964cbc58382,
abstract = {{<p>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<sup>®</sup> 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.</p>}},
author = {{Noc, Marko and Laanmets, Peep and Neskovic, Aleksandar N. and Petrović, Milovan and Stanetic, Bojan and Aradi, Daniel and Kiss, Robert G. and Ungi, Imre and Merkely, Béla and Hudec, Martin and Blasko, Peter and Horvath, Ivan and Davies, John R. and Vukcevic, Vladan and Holzer, Michael and Metzler, Bernhard and Witkowski, Adam and Erglis, Andrejs and Fister, Misa and Nagy, Gergely and Bulum, Josko and Edes, Istvan and Peruga, Jan Z. and Średniawa, Beata and Erlinge, David and Keeble, Thomas R.}},
issn = {{1774-024X}},
keywords = {{Drug-eluting stent; MRI; STEMI}},
language = {{eng}},
number = {{6}},
pages = {{466--473}},
publisher = {{Société Europa Edition}},
series = {{EuroIntervention}},
title = {{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}},
url = {{http://dx.doi.org/10.4244/EIJ-D-21-00348}},
doi = {{10.4244/EIJ-D-21-00348}},
volume = {{17}},
year = {{2021}},
}