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)

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Volume 20 Number 12
Jun 17, 2024
Volume 20 Number 12
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