Safety of Selective Intracoronary Hypothermia During Primary Percutaneous Coronary Intervention in Patients With Anterior STEMI

Abstract

Objectives: The aim of this study was to determine the safety of selective intracoronary hypothermia during primary percutaneous coronary intervention (PPCI) in patients with anterior ST-segment elevation myocardial infarction (STEMI).

Background: Selective intracoronary hypothermia is a novel treatment designed to reduce myocardial reperfusion injury and is currently being investigated in the ongoing randomized controlled EURO-ICE (European Intracoronary Cooling Evaluation in Patients With ST-Elevation Myocardial Infarction) trial (NCT03447834). Data on the safety of such a procedure during PPCI are still limited.

Methods: The first 50 patients with anterior STEMI treated with selective intracoronary hypothermia during PPCI were included in this analysis and compared for safety with the first 50 patients randomized to the control group undergoing standard PPCI. In-hospital mortality, occurrence of rhythm or conduction disturbances, stent thrombosis, onset of heart failure during the procedure, and subsequent hospital admission were assessed.

Results: In-hospital mortality was 0%. One patient in both groups developed cardiogenic shock. Atrial fibrillation occurred in 0 and 3 patients (P = 0.24), and ventricular fibrillation occurred in 5 and 3 patients (P = 0.72) in the intracoronary hypothermia group and control group, respectively. Stent thrombosis occurred in 2 patients in the intracoronary hypothermia group; 1 instance was intraprocedural, and the other occurred following interruption of dual-antiplatelet therapy consequent to an intracranial hemorrhage 6 days after enrollment. No stent thrombosis was observed in the control group (P = 0.50).

Conclusions: Selective intracoronary hypothermia during PPCI in patients with anterior STEMI can be implemented within the routine of PPCI and seems to be safe. The final safety results will be reported at the end of the trial.

Keywords: STEMI; infarct size; myocardial reperfusion injury; procedural safety; selective intracoronary hypothermia.

Conflict of interest statement

Funding Support and Author Disclosures Dr Engstrøm has received personal fees from Abbott and Bayer, outside the submitted work. Dr Oldroyd has received employee fees from Biosensors International, outside the submitted work. Dr Karamasis has received personal fees from Abbott Vascular, outside the submitted work. Dr Keeble has received grants from Abbott Vascular, Zoll, and AstraZeneca, outside the submitted work. Dr De Bruyne has received grant support from Abbott, Boston Scientific, Biotronik, and St. Jude Medical; has received consulting fees from St. Jude Medical, Opsens, and Boston Scientific, outside the submitted work; and is a shareholder in Siemens, GE, Bayer, Philips, HeartFlow, Edwards Lifesciences, and Ceyliad. Dr Berry has received grants from Abbott Vascular, AstraZeneca, Boehringer Ingelheim, Coroventis, GlaxoSmithKline, 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). Dr Pijls has received personal fees from Abbott and Opsens; holds equity in Philips, ASML, HeartFlow and GE Healthcare; and has received institutional research grants from Abbott and Hexacath. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.