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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).
J Am Coll Cardiol. 2014 Jan 27;
Authors: Erlinge D, Götberg M, Lang I, Holzer M, Noc M, Clemmensen P, Jensen U, Metzler B, James S, Bötker HE, Omerovic E, Engblom H, Carlsson M, Arheden H, Ostlund O, Wallentin L, Harnek J, Olivecrona GK
Abstract
BACKGROUND: Hypothermia has been reported to reduce infarct size (IS) in patients with ST segment elevation myocardial infarction (STEMI). We aimed to confirm the cardioprotective effects of hypothermia using a combination of cold saline and endovascular cooling.
METHODS: In a multi-center study, 120 patients with STEMI (<6 hours) planned to undergo percutaneous coronary intervention were randomized to hypothermia induced by rapid infusion of 600-2000 ml of cold saline and endovascular cooling or standard of care. Hypothermia was initiated before PCI and continued for 1 hr. after reperfusion. The primary endpoint was IS as % of myocardium at risk (IS/MaR), assessed by cardiac magnetic resonance imaging at 4±2 days.
RESULTS: Symptom to randomization was 129±56 vs. 132±64 minutes (mean±SD), hypothermia vs. control. Patients randomised to hypothermia achieved a core body temperature of 34.7°C before reperfusion with a 9 min longer door-to-balloon time. IS/MaR was not significantly reduced (hypothermia: 40.5, 29.3-57.8 vs. control: 46.6, 37.8-63.4 (%, interquartile range (IQR), 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 (0-4h) found reduction in IS/MaR of 33%, (p<0.05) and an absolute reduction of IS/left ventricular volume of 6.2%. (p=0.15).
CONCLUSION: Hypothermia induced by cold saline and endovascular cooling was feasible, safe, and rapidly reduced core temperature with minor reperfusion delay. The primary endpoint of IS/MaR was not significantly reduced. Lower incidence of heart failure and a possible effect among early anterior STEMI needs confirmation.
PMID: 24509284 [PubMed - as supplied by publisher]