Original Research

DOI: 10.4244/EIJ-D-23-01042

A randomised trial of selective intracoronary hypothermia during primary PCI

Mohamed El Farissi1, MD, PhD; Nico H.J. Pijls1, MD, PhD; Richard Good2, MD; Thomas Engström3, MD, PhD; Thomas R. Keeble4, MD; Branko Beleslin5, MD, PhD; Bernard De Bruyne6, MD, PhD; Ole Fröbert7, MD, PhD; David Erlinge8, MD, PhD; Koen Teeuwen1, MD, PhD; Rob Eerdekens1, MD; Jesse P.A. Demandt1, MD; Kenneth Mangion2, MD, PhD; Jakob Lonborg3, MD, PhD; Wikke Setz-Pels1, MD, PhD; Grigoris Karamasis4, MD; Inge Wijnbergen1, MD, PhD; Pieter Jan Vlaar1, MD, PhD; Annemiek de Vos1, MD; Guus R. Brueren1, MD, PhD; Keith Oldroyd2, MD, PhD; Colin Berry2, MD, PhD; Pim A.L. Tonino1, MD, PhD; Marcel van't Veer1, MSc, PhD; Luuk C. Otterspoor1, MD, PhD

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 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. (ClinicalTrials.gov: NCT03447834)

Sign in to read
the full article

Forgot your password?
No account yet?
Sign up for free!

Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com

Volume 20 Number 12
Jun 17, 2024
Volume 20 Number 12
View full issue


Key metrics

Suggested by Cory

CLINICAL RESEARCH

10.4244/EIJ-D-17-00240 Dec 8, 2017
Safety and feasibility of selective intracoronary hypothermia in acute myocardial infarction
Otterspoor L et al
free

10.4244/EIJV13I5A77 Aug 4, 2017
EuroPCR 2017, late-breaking clinical trials and EuroIntervention
Mylotte D and Byrne RA
free

10.4244/EIJV10STA2 Aug 19, 2014
STEMI: the EAPCI and Stent for Life Initiative
Windecker S
free
Trending articles
151.43

State-of-the-Art

10.4244/EIJ-D-22-00776 Apr 3, 2023
Computed tomographic angiography in coronary artery disease
Serruys PW et al
free
55.9

Clinical research

10.4244/EIJ-D-22-00621 Feb 20, 2023
Long-term changes in coronary physiology after aortic valve replacement
Sabbah M et al
free
54.9

Expert review

10.4244/EIJ-D-21-01010 Jun 24, 2022
Device-related thrombus following left atrial appendage occlusion
Simard T et al
free
43.75

Clinical Research

10.4244/EIJ-D-21-01091 Aug 5, 2022
Lifetime management of patients with symptomatic severe aortic stenosis: a computed tomography simulation study
Medranda G et al
free
39.95

Clinical research

10.4244/EIJ-D-22-00558 Feb 6, 2023
Permanent pacemaker implantation and left bundle branch block with self-expanding valves – a SCOPE 2 subanalysis
Pellegrini C et al
free
X

The Official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

EuroPCR EAPCI
PCR ESC
Impact factor: 7.6
2023 Journal Citation Reports®
Science Edition (Clarivate Analytics, 2024)
Online ISSN 1969-6213 - Print ISSN 1774-024X
© 2005-2024 Europa Group - All rights reserved