Clinical Research
Acute Coronary Syndromes
Rapid Endovascular Catheter Core Cooling Combined With Cold Saline as an Adjunct to Percutaneous Coronary Intervention for the Treatment of Acute Myocardial Infarction: The CHILL-MI Trial: A Randomized Controlled Study of the Use of Central Venous Catheter Core Cooling Combined With Cold Saline as an Adjunct to Percutaneous Coronary Intervention for the Treatment of Acute Myocardial Infarction

https://doi.org/10.1016/j.jacc.2013.12.027Get rights and content
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Objectives

The aim of this study was to confirm the cardioprotective effects of hypothermia using a combination of cold saline and endovascular cooling.

Background

Hypothermia has been reported to reduce infarct size (IS) in patients with ST-segment elevation myocardial infarctions.

Methods

In a multicenter study, 120 patients with ST-segment elevation myocardial infarctions (<6 h) scheduled to undergo percutaneous coronary intervention were randomized to hypothermia induced by the rapid infusion of 600 to 2,000 ml cold saline and endovascular cooling or standard of care. Hypothermia was initiated before percutaneous coronary intervention and continued for 1 h after reperfusion. The primary end point was IS as a percent of myocardium at risk (MaR), assessed by cardiac magnetic resonance imaging at 4 ± 2 days.

Results

Mean times from symptom onset to randomization were 129 ± 56 min in patients receiving hypothermia and 132 ± 64 min in controls. Patients randomized to hypothermia achieved a core body temperature of 34.7°C before reperfusion, with a 9-min longer door-to-balloon time. Median IS/MaR was not significantly reduced (hypothermia: 40.5% [interquartile range: 29.3% to 57.8%; control: 46.6% [interquartile range: 37.8% to 63.4%]; relative reduction 13%; p = 0.15). The incidence of heart failure was lower with hypothermia at 45 ± 15 days (3% vs. 14%, p < 0.05), with no mortality. Exploratory analysis of early anterior infarctions (0 to 4 h) found a reduction in IS/MaR of 33% (p < 0.05) and an absolute reduction of IS/left ventricular volume of 6.2% (p = 0.15).

Conclusions

Hypothermia induced by cold saline and endovascular cooling was feasible and safe, and it rapidly reduced core temperature with minor reperfusion delay. The primary end point of IS/MaR was not significantly reduced. Lower incidence of heart failure and a possible effect in patients with early anterior ST-segment elevation myocardial infarctions need confirmation. (Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute Myocardial Infarction [CHILL-MI]; NCT01379261)

Key Words

cardioprotection
hypothermia
STEMI

Abbreviations and Acronyms

AMI
acute myocardial infarction
CMR
cardiac magnetic resonance
IQR
interquartile range
IS
infarct size
MaR
myocardium at risk
PCI
percutaneous coronary intervention
STEMI
ST-segment elevation myocardial infarction
TIMI
Thrombolysis In Myocardial Infarction
UCR
Uppsala Clinical Research Center

Cited by (0)

This study was funded by Philips Healthcare (San Diego, California). Dr. Erlinge has received speaker's honoraria from Philips and ZOLL. Dr. Götberg has received consulting honoraria from Medtronic and Volcano. Dr. Lang has received honoraria from Actelion, Bayer, United Therapeutics, AstraZeneca, AOP Orphan, Pfizer, and GlaxoSmithKline; and research support from Actelion, Bayer, and United Therapeutics. Dr. Holzer has received travel grants for scientific conferences and honoraria for lectures from EMCOOLS and ZOLL; and has provided consultancy for Leerink Swann. Dr. Noc has received speaker honoraria from AstraZeneca, Lilly, and Krka. Dr. Clemmensen has research contracts with Philips and UCI; and has received speaker's fees from Philips. Dr. Wallentin has received research grants, consultancy fees, lecture fees, honoraria, and travel support from AstraZeneca, Bristol-Myers Squibb/Pfizer, and GlaxoSmithKline; research grants, consultancy fees, lecture fees, and honoraria from Boehringer-Ingelheim; research grants and consultancy fees from Merck & Company; and consultancy fees from Abbott, Regado Biosciences, and Athera Biotechnologies. Dr. Harnek has received consulting honoraria from Boston Scientific and EPS Vascular. Dr. Olivecrona is a proctor for Edwards Lifesciences; and has received lecture honoraria from AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.