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Effects of endovascular cooling on infarct size in ST‐segment elevation myocardial infarction: A pa 时间:2018-09-18 08:27 来源:未知作者:admin 点击: 次 Abstract:Objectives This study sought to examine the relationship between temperature at reperfusion and infarct size.Background Hypothermia consistently reduces infarct size when administered prior to reperfusion in animal studies, however, clinical results have been inconsistent.Methods We performed a patient‐level pooled analysis from six randomized control trials of endovascular cooling during primary percutaneous coronary intervention (PCI) for ST‐segment elevation myocardial infarction (STEMI) in 629 patients in which infarct size was assessed within 1 month after randomization by either single‐photon emission computed tomography (SPECT) or cardiac magnetic resonance imaging (cMR).Results In anterior infarct patients, after controlling for variability between studies, mean infarct size in controls was 21.3 (95%CI 17.4‐25.3) and in patients with hypothermia <35°C it was 14.8 (95%CI 10.1‐19.6), which was a statistically significant absolute reduction of 6.5%, or a 30% relative reduction in infarct size (P = 0.03). There was no significant difference in infarct size in anterior ≥35°C, or inferior infarct patients. There was no difference in the incidence of death, ventricular arrhythmias, or re‐infarction due to stent thrombosis between hypothermia and control patients.Conclusions The present study, drawn from a patient‐level pooled analysis of six randomized trials of endovascular cooling during primary PCI in STEMI, showed a significant reduction in infarct size in patients with anterior STEMI who were cooled to <35°C at the time of reperfusion. The results support the need for trials in patients with anterior STEMI using more powerful cooling devices to optimize the delivery of hypothermia prior to reperfusion.
1 INTRODUCTION
Prompt reperfusion remains the most effective treatment to date for preservation of myocardium following acute coronary occlusion. However, large infarctions still occur despite timely reperfusion, due to reperfusion injury.1 Numerous treatments have been studied to reduce reperfusion injury, with little success to date.2 Hypothermia has shown the ability to consistently reduce infarct size when administered prior to reperfusion in preclinical studies.3-6 Results from clinical trials, however, have been inconsistent.7-11 One major difference between preclinical and clinical trials is the lack of achievement of an effective degree of cooling prior to reperfusion in patients, as occurred in experimental studies.12 In the clinical trials to date, a suggestion has been made that patients that achieved a core body temperature less than 35°C prior to reperfusion showed smaller infarcts, at least in those with anterior infarction.8 However, sample sizes were not sufficient to confirm these findings in individual clinical studies. We therefore performed a patient‐level pooled analysis from six randomized trials of endovascular cooling during primary PCI for STEMI in 629 patients, to examine the relationship between temperature at reperfusion and infarct size.
2 METHODS
2.1 Study population
This study is a patient‐level pooled analysis of six hypothermia trials using endovascular cooling in which infarct size (IS) was assessed by either cardiac magnetic resonance (cMR) or technetium (Tc)‐99m sestamibi single‐photon emission computed tomography (SPECT) within 1 month after reperfusion at a core laboratory. Adverse events were followed through 30 days.
2.2 Studies and characteristics
The randomized trials included in the pooled analysis were: COOL MI Pilot,8 in which patients presenting with anterior or inferior STEMI within 6 h of symptom onset were randomized to primary PCI and cooling to a target temperature of 33°C using an endovascular cooling catheter (Radiant Medical Inc., Redwood City, CA) versus PCI alone. Target temperature was maintained for 3 h post PCI; COOL‐MI Pivotal,7 in which patients presenting with anterior or inferior STEMI within 6 h of symptom onset were randomized to primary PCI and cooling to a target temperature of 33°C using an endovascular cooling catheter (Radiant Medical Inc.) versus PCI alone. Target temperature was maintained for 3 h post PCI; COOL MI II, in which patients presenting with anterior STEMI within 6 h of symptom onset were randomized to primary PCI and cooling to a target temperature of 32°C using an endovascular cooling catheter (Radiant Medical Inc.) versus PCI alone. Target temperature was maintained for 3 h post PCI; ICE‐IT,9 in which patients presenting with anterior or inferior STEMI within 6 h of symptom onset were randomized to primary PCI and cooling to a target temperature of 33°C using an endovascular cooling catheter (Innercool Therapies Inc., San Diego, CA) versus PCI alone. Target temperature was maintained for 6 h post PCI; RAPID MI‐ICE,10 in which patients presenting with anterior or inferior STEMI within 6 h of symptom onset were randomized to primary PCI and cooling to a target temperature of 33°C using an endovascular cooling catheter (Innercool Therapies Inc.) and cold saline infusion versus PCI alone. Target temperature was maintained for 3 h post PCI; and CHILL‐MI,11 in which patients presenting with anterior or inferior STEMI within 6 h of symptom onset were randomized to primary PCI and cooling to a target temperature of 33°C using an endovascular cooling catheter (Innercool Therapies Inc.) and cold saline infusion versus PCI alone. Target temperature was maintained for 1 h post PCI.