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Strategic target temperature management in myocardial infarction--a feasibility trial.

ABSTRACT: The purpose of this study was to demonstrate the feasibility of a combined cooling strategy started out of hospital as an adjunctive to percutaneous coronary intervention (PCI) in the treatment of ST-elevation acute coronary syndrome (STE-ACS).Non-randomised, single-centre feasibility trial.Department of emergency medicine of a tertiary-care facility, Medical University of Vienna, Vienna, Austria. In cooperation with the Municipal ambulance service of the city of Vienna.Consecutive patients with STE-ACS presenting to the emergency medical service within 6 h after symptom onset.Cooling was initiated with surface cooling pads in the out-of-hospital setting, followed by the administration of 1000-2000 mL of cold saline at hospital arrival and completed by endovascular cooling in the catheterisation laboratory.Feasibility of lowering core temperature below 35.0°C prior to immediately performed revascularisation. Safety and tolerability of the cooling procedure.In enrolled 19 patients (one woman, median age 51 years (IQR 45-59)), symptom onset to first medical contact (FMC) was 45 min (IQR 31-85). A core temperature below 35.0°C at reperfusion of the culprit lesion was achieved in 11 patients (78%) within 100 min (IQR 90-111) after FMC without any cooling-related serious adverse event. Temperature could be lowered from baseline 36.4°C (IQR 36.2-36.5°C) to 34.4°C (IQR 34.1-35.0°C) at the time of reperfusion.With limitations an immediate out-of-hospital therapeutic hypothermia strategy was feasible and safe in patients with STE-ACS undergoing primary PCI.http://www.clinicaltrials.gov/ct2/show/NCT01864343; clinical trials unique identifier: NCT01864343.

SUBMITTER: Testori C

PROVIDER: S-EPMC3812852 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Strategic target temperature management in myocardial infarction--a feasibility trial.

Testori Christoph C Sterz Fritz F Delle-Karth Georg G Malzer Reinhard R Holzer Michael M Stratil Peter P Stöckl Mathias M Weiser Christoph C van Tulder Raphael R Gangl Clemens C Sebald Dieter D Zajicek Andreas A Buchinger Angelika A Lang Irene I

Heart (British Cardiac Society) 20130924 22

<h4>Objective</h4>The purpose of this study was to demonstrate the feasibility of a combined cooling strategy started out of hospital as an adjunctive to percutaneous coronary intervention (PCI) in the treatment of ST-elevation acute coronary syndrome (STE-ACS).<h4>Design</h4>Non-randomised, single-centre feasibility trial.<h4>Setting</h4>Department of emergency medicine of a tertiary-care facility, Medical University of Vienna, Vienna, Austria. In cooperation with the Municipal ambulance servic ...[more]

PMID: 24064228

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Project description:BackgroundPatients with ST-elevation myocardial infarction (STEMI) not treated with primary or rescue percutaneous coronary intervention (PCI) are at risk for recurrent ischemia, especially when viability in the infarct-area is present. Therefore, an invasive strategy with PCI of the infarct-related coronary artery in patients with viability would reduce the occurrence of a composite end point of death, reinfarction, or unstable angina (UA).MethodsPatients admitted with an (sub)acute myocardial infarction, who were not treated by primary or rescue PCI, and who were stable during the first 48 hours after the acute event, were screened for the study. Eventually, we randomly assigned 216 patients with viability (demonstrated with low-dose dobutamine echocardiography) to an invasive or a conservative strategy. In the invasive strategy stenting of the infarct-related coronary artery was intended with abciximab as adjunct treatment. Seventy-five (75) patients without viability served as registry group. The primary endpoint was the composite of death from any cause, recurrent myocardial infarction (MI) and unstable angina at one year. As secondary endpoint the need for (repeat) revascularization procedures and anginal status were recorded.ResultsThe primary combined endpoint of death, recurrent MI and unstable angina was 7.5% (8/106) in the invasive group and 17.3% (19/110) in the conservative group (Hazard ratio 0.42; 95% confidence interval [CI] 0.18-0.96; p = 0.032). During follow up revascularization-procedures were performed in 6.6% (7/106) in the invasive group and 31.8% (35/110) in the conservative group (Hazard ratio 0.18; 95% CI 0.13-0.43; p < 0.0001). A low rate of recurrent ischemia was found in the non-viable group (5.4%) in comparison to the viable-conservative group (14.5%). (Hazard-ratio 0.35; 95% CI 0.17-1.00; p = 0.051).ConclusionWe demonstrated that after acute MI (treated with thrombolysis or without reperfusion therapy) patients with viability in the infarct-area benefit from a strategy of early in-hospital stenting of the infarct-related coronary artery. This treatment results in a long-term uneventful clinical course. The study confirmed the low risk of recurrent ischemia in patients without viability.Trial registrationClinicalTrials.gov: NCT00149591.

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Strategic target temperature management in myocardial infarction--a feasibility trial.

Publications

Strategic target temperature management in myocardial infarction--a feasibility trial.

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