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A randomised trial of selective intracoronary hypothermia during primary PCI

Farissi, Mohamed El ; Pijls, Nico H.J. ; Good, Richard ; Engström, Thomas LU ; Keeble, Thomas R. ; Beleslin, Branko ; De Bruyne, Bernard ; Fröbert, Ole ; Erlinge, David LU orcid and Teeuwen, Koen , et al. (2024) In EuroIntervention 20(12). p.740-749
Abstract

BACKGROUND: While experimental data suggest that selective intracoronary hypothermia decreases infarct size, studies in patients with ST-elevation myocardial infarction (STEMI) are lacking. AIMS: We investigated the efficacy of selective intracoronary hypothermia during primary percutaneous coronary intervention (PCI) to decrease infarct size in patients with STEMI. METHODS: In this multicentre randomised controlled trial, 200 patients with large anterior wall STEMI were randomised 1:1 to selective intracoronary hypothermia during primary PCI or primary PCI alone. Using an over-the-wire balloon catheter for infusion of cold saline and a pressure-temperature wire to monitor the intracoronary temperature, the anterior myocardium distal to... (More)

BACKGROUND: While experimental data suggest that selective intracoronary hypothermia decreases infarct size, studies in patients with ST-elevation myocardial infarction (STEMI) are lacking. AIMS: We investigated the efficacy of selective intracoronary hypothermia during primary percutaneous coronary intervention (PCI) to decrease infarct size in patients with STEMI. METHODS: In this multicentre randomised controlled trial, 200 patients with large anterior wall STEMI were randomised 1:1 to selective intracoronary hypothermia during primary PCI or primary PCI alone. Using an over-the-wire balloon catheter for infusion of cold saline and a pressure-temperature wire to monitor the intracoronary temperature, the anterior myocardium distal to the occlusion was selectively cooled to 30-33°C for 7-10 minutes before reperfusion (occlusion phase), immediately followed by 10 minutes of cooling after reperfusion (reperfusion phase). The primary endpoint was infarct size as a percentage of left ventricular mass on cardiovascular magnetic resonance imaging after 3 months. RESULTS: Selective intracoronary hypothermia was performed in 94/100 patients randomised to cooling. Distal coronary temperature decreased by 6°C within 43 seconds (interquartile range [IQR] 18-113). The median duration of the occlusion phase and reperfusion phase were 8.2 minutes (IQR 7.2-9.0) and 9.1 minutes (IQR 8.2-10.0), respectively. The infarct size at 3 months was 23.1±12.5% in the selective intracoronary hypothermia group and 21.6±12.2% in the primary PCI alone group (p=0.43). The left ventricular ejection fraction at 3 months in each group were 49.1±10.2% and 50.1±10.4%, respectively (p=0.53). CONCLUSIONS: Selective intracoronary hypothermia during primary PCI in patients with anterior wall STEMI was feasible and safe but did not decrease infarct size compared with standard primary PCI.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
cooling, hypothermia, infarct size, MVO, myocardial reperfusion injury, STEMI
in
EuroIntervention
volume
20
issue
12
pages
740 - 749
publisher
Société Europa Edition
external identifiers
  • scopus:85196553658
  • pmid:38887884
ISSN
1774-024X
DOI
10.4244/EIJ-D-23-01042
language
English
LU publication?
yes
id
6d05d0f3-6aa4-4c98-9f70-a9c9b976ebfb
date added to LUP
2024-08-12 15:21:42
date last changed
2024-08-13 03:00:04
@article{6d05d0f3-6aa4-4c98-9f70-a9c9b976ebfb,
  abstract     = {{<p>BACKGROUND: While experimental data suggest that selective intracoronary hypothermia decreases infarct size, studies in patients with ST-elevation myocardial infarction (STEMI) are lacking. AIMS: We investigated the efficacy of selective intracoronary hypothermia during primary percutaneous coronary intervention (PCI) to decrease infarct size in patients with STEMI. METHODS: In this multicentre randomised controlled trial, 200 patients with large anterior wall STEMI were randomised 1:1 to selective intracoronary hypothermia during primary PCI or primary PCI alone. Using an over-the-wire balloon catheter for infusion of cold saline and a pressure-temperature wire to monitor the intracoronary temperature, the anterior myocardium distal to the occlusion was selectively cooled to 30-33°C for 7-10 minutes before reperfusion (occlusion phase), immediately followed by 10 minutes of cooling after reperfusion (reperfusion phase). The primary endpoint was infarct size as a percentage of left ventricular mass on cardiovascular magnetic resonance imaging after 3 months. RESULTS: Selective intracoronary hypothermia was performed in 94/100 patients randomised to cooling. Distal coronary temperature decreased by 6°C within 43 seconds (interquartile range [IQR] 18-113). The median duration of the occlusion phase and reperfusion phase were 8.2 minutes (IQR 7.2-9.0) and 9.1 minutes (IQR 8.2-10.0), respectively. The infarct size at 3 months was 23.1±12.5% in the selective intracoronary hypothermia group and 21.6±12.2% in the primary PCI alone group (p=0.43). The left ventricular ejection fraction at 3 months in each group were 49.1±10.2% and 50.1±10.4%, respectively (p=0.53). CONCLUSIONS: Selective intracoronary hypothermia during primary PCI in patients with anterior wall STEMI was feasible and safe but did not decrease infarct size compared with standard primary PCI.</p>}},
  author       = {{Farissi, Mohamed El and Pijls, Nico H.J. and Good, Richard and Engström, Thomas and Keeble, Thomas R. and Beleslin, Branko and De Bruyne, Bernard and Fröbert, Ole and Erlinge, David and Teeuwen, Koen and Eerdekens, Rob and Demandt, Jesse P.A. and Mangion, Kenneth and Lonborg, Jakob and Setz-Pels, Wikke and Karamasis, Grigoris and Wijnbergen, Inge and Vlaar, Pieter Jan and de Vos, Annemiek and Brueren, Guus R. and Oldroyd, Keith and Berry, Colin and Tonino, Pim A.L. and van’t Veer, Marcel and Otterspoor, Luuk C.}},
  issn         = {{1774-024X}},
  keywords     = {{cooling; hypothermia; infarct size; MVO; myocardial reperfusion injury; STEMI}},
  language     = {{eng}},
  number       = {{12}},
  pages        = {{740--749}},
  publisher    = {{Société Europa Edition}},
  series       = {{EuroIntervention}},
  title        = {{A randomised trial of selective intracoronary hypothermia during primary PCI}},
  url          = {{http://dx.doi.org/10.4244/EIJ-D-23-01042}},
  doi          = {{10.4244/EIJ-D-23-01042}},
  volume       = {{20}},
  year         = {{2024}},
}