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Randomized Controlled Trial
. 2024 Jun 17;20(12):e740-e749.
doi: 10.4244/EIJ-D-23-01042.

A randomised trial of selective intracoronary hypothermia during primary PCI

Mohamed El Farissi  1 , Nico H J Pijls  1 , Richard Good  2 , Thomas Engström  3 , Thomas R Keeble  4 , Branko Beleslin  5 , Bernard De Bruyne  6 , Ole Fröbert  7 , David Erlinge  8 , Koen Teeuwen  1 , Rob Eerdekens  1 , Jesse P A Demandt  1 , Kenneth Mangion  2 , Jakob Lonborg  3 , Wikke Setz-Pels  1 , Grigoris Karamasis  4 , Inge Wijnbergen  1 , Pieter Jan Vlaar  1 , Annemiek de Vos  1 , Guus R Brueren  1 , Keith Oldroyd  2 , Colin Berry  2 , Pim A L Tonino  1 , Marcel Van't Veer  1 , Luuk C Otterspoor  1
Affiliations
Randomized Controlled Trial

A randomised trial of selective intracoronary hypothermia during primary PCI

Mohamed El Farissi et al. EuroIntervention. .

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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Conflict of interest statement

N.H.J. Pijls reports personal fees from Abbott and OpSens; holding equity in Philips, ASML, HeartFlow, and GE HealthCare; and institutional research grants from Abbott and Hexacath. T. Engström reports personal fees from Abbott and Bayer, outside the submitted work. T.R. Keeble reports grants from Abbott, ZOLL Medical, and AstraZeneca, outside the submitted work. B. De Bruyne receives grant support from Abbott, Boston Scientific, Biotronik AG, and St. Jude Medical; and receives consulting fees from St. Jude Medical, OpSens, and Boston Scientific, outside of the submitted work; he is a shareholder for Siemens, GE HealthCare, Bayer, Philips, HeartFlow, Edwards Lifesciences, and Celyad. G. Karamasis reports personal fees from Abbott, outside the submitted work. K. Oldroyd reports employee fees from Biosensors International, outside the submitted work. C. Berry reports grants from Abbott, AstraZeneca, Boehringer Ingelheim, Coroventis, GSK, HeartFlow, Medyria, Neovasc, Novartis, Siemens Healthcare, and Menarini, outside the submitted work; and is supported by research funding from the British Heart Foundation (RE/18/6134217). The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1. Composite tracing of all patients showing aortic pressure (red), distal coronary pressure (green) and intracoronary temperature (blue) during treatment with selective intracoronary hypothermia.
Tracings are displayed as means with 95% confidence intervals (shading). Time in minutes is indicated on the horizontal axis with the number of patients participating at that timepoint written below. A) The procedure consisted of two parts: the occlusion phase with the inflated balloon and infusion of saline at room temperature, immediately followed by the reperfusion phase with the deflated balloon (allowing reperfusion) and infusion of saline at 4°C. B) Intracoronary temperature is expressed as °C relative to body temperature.
Central illustration
Central illustration. Selective intracoronary hypothermia during primary PCI in patients with anterior wall STEMI.
A) A schematic overview of the instrumentation for selective intracoronary hypothermia is shown. The close-up shows the positioning of the balloon within the occlusion after removal of the regular guidewire in order to enable saline infusion through the central lumen of the over-the-wire balloon. The sensor-tipped pressure temperature wire is indicated in red. B) The occlusion phase (balloon inflated) and the reperfusion phase (balloon deflated) are shown with the associated saline temperatures. OTWB: over-the-wire balloon
See this image and copyright information in PMC

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