David Erlinge1, Matthias Götberg2, Irene Lang3, Michael Holzer3, Marko Noc4, Peter Clemmensen5, Ulf Jensen6, Bernhard Metzler7, Stefan James8, Hans Erik Bötker9, Elmir Omerovic9, Henrik Engblom10, Marcus Carlsson10, Håkan Arheden10, Ollie Ostlund11, Lars Wallentin8, Jan Harnek2, Göran K Olivecrona2. 1. Department of Cardiology, Lund University, Lund, Sweden. Electronic address: david.erlinge@med.lu.se. 2. Department of Cardiology, Lund University, Lund, Sweden. 3. Department of Cardiology and the Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria. 4. Center for Intensive Internal Medicine, Ljubljana, Slovenia. 5. Department of Cardiology, Rigshospitalet, Copenhagen, Denmark. 6. Cardiology Unit, Department of Medicine, Karolinska University Hospital, Stockholm, Sweden. 7. Department of Cardiology, Medical University of Innsbruck, Innsbruck, Austria. 8. Uppsala Clinical Research Center, Uppsala, Sweden; Department of Medical Sciences, Uppsala University, Uppsala, Sweden. 9. Department of Cardiology, Sahlgrenska University, Gothenburg, Sweden. 10. Department of Clinical Physiology, Lund University, Lund, Sweden. 11. Uppsala Clinical Research Center, Uppsala, Sweden.
Abstract
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).
RCT Entities:
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).
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