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Hypothermia or Normothermia After Cardiac Arrest
Quick Takes
- Patients with coma after out-of-hospital cardiac arrest who were treated with hypothermia did not have a lower incidence of death at 6 months as compared to targeted normothermia.
- Furthermore, scores on the modified Rankin scale between the groups were similar, as were health-related quality of life scores.
- The large sample size, broad eligibility criteria, and numerous hospitals and countries represented in this trial increase the generalizability, and the study findings have implications for future clinical practice and standard of care regarding use of hypothermia.
Study Questions:
What are the beneficial and harmful effects of hypothermia as compared with normothermia in patients after cardiac arrest?
Methods:
The investigators conducted an open-label trial with blinded assessment of outcomes and randomly assigned 1,900 adults with coma who had had an out-of-hospital cardiac arrest of presumed cardiac or unknown cause to undergo targeted hypothermia at 33°C, followed by controlled rewarming, or targeted normothermia with early treatment of fever (body temperature, ≥37.8°C). The primary outcome was death from any cause at 6 months. Secondary outcomes included functional outcome at 6 months, as assessed with the modified Rankin scale. Prespecified subgroups were defined according to sex, age, initial cardiac rhythm, time to return of spontaneous circulation, and presence or absence of shock on admission. Prespecified adverse events were pneumonia, sepsis, bleeding, arrhythmia resulting in hemodynamic compromise, and skin complications related to the temperature management device.
Results:
A total of 1,850 patients were evaluated for the primary outcome. At 6 months, 465 of 925 patients (50%) in the hypothermia group had died, as compared with 446 of 925 (48%) in the normothermia group (relative risk with hypothermia, 1.04; 95% confidence interval [CI], 0.94-1.14; p = 0.37). Of the 1,747 patients in whom the functional outcome was assessed, 488 of 881 (55%) in the hypothermia group had moderately severe disability or worse (modified Rankin scale score ≥4), as compared with 479 of 866 (55%) in the normothermia group (relative risk with hypothermia, 1.00; 95% CI, 0.92-1.09). Outcomes were consistent in the prespecified subgroups. Arrhythmia resulting in hemodynamic compromise was more common in the hypothermia group than in the normothermia group (24% vs. 17%, p < 0.001). The incidence of other adverse events did not differ significantly between the two groups.
Conclusions:
The authors concluded that in patients with coma after out-of-hospital cardiac arrest, targeted hypothermia did not lead to a lower incidence of death by 6 months.
Perspective:
This study reports that patients with coma after out-of-hospital cardiac arrest who were treated with hypothermia did not have a lower incidence of death at 6 months as compared to targeted normothermia. Furthermore, scores on the modified Rankin scale between the groups were similar, as were health-related quality of life scores. The large sample size, broad eligibility criteria, and numerous hospitals and countries represented in this trial increase the generalizability, and the study findings have implications for future clinical practice and standard of care regarding use of hypothermia.
Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias
Keywords: Acute Coronary Syndrome, Arrhythmias, Cardiac, Body Temperature, Coma, Fever, Heart Arrest, Hemodynamics, Hypothermia, Out-of-Hospital Cardiac Arrest, Pneumonia, Quality of Life, Rewarming, Risk, Secondary Prevention, Sepsis, Standard of Care
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