Amiodarone, lidocaine, or placebo in out-of-hospital cardiac arrest

Resuscitation Outcomes Consortium Investigators

Research output: Contribution to journalArticle

125 Citations (Scopus)

Abstract

Background: Antiarrhythmic drugs are used commonly in out-of-hospital cardiac arrest for shock-refractory ventricular fibrillation or pulseless ventricular tachycardia, but without proven survival benefit. Methods: In this randomized, double-blind trial, we compared parenteral amiodarone, lidocaine, and saline placebo, along with standard care, in adults who had nontraumatic out-ofhospital cardiac arrest, shock-refractory ventricular fibrillation or pulseless ventricular tachycardia after at least one shock, and vascular access. Paramedics enrolled patients at 10 North American sites. The primary outcome was survival to hospital discharge; the secondary outcome was favorable neurologic function at discharge. The per-protocol (primary analysis) population included all randomly assigned participants who met eligibility criteria and received any dose of a trial drug and whose initial cardiac-arrest rhythm of ventricular fibrillation or pulseless ventricular tachycardia was refractory to shock. Results: In the per-protocol population, 3026 patients were randomly assigned to amiodarone (974), lidocaine (993), or placebo (1059); of those, 24.4%, 23.7%, and 21.0%, respectively, survived to hospital discharge. The difference in survival rate for amiodarone versus placebo was 3.2 percentage points (95% confidence interval [CI], -0.4 to 7.0; P = 0.08); for lidocaine versus placebo, 2.6 percentage points (95% CI, -1.0 to 6.3; P = 0.16); and for amiodarone versus lidocaine, 0.7 percentage points (95% CI, -3.2 to 4.7; P = 0.70). Neurologic outcome at discharge was similar in the three groups. There was heterogeneity of treatment effect with respect to whether the arrest was witnessed (P = 0.05); active drugs were associated with a survival rate that was significantly higher than the rate with placebo among patients with bystander-witnessed arrest but not among those with unwitnessed arrest. More amiodarone recipients required temporary cardiac pacing than did recipients of lidocaine or placebo. Conclusions: Overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo among patients with out-of-hospital cardiac arrest due to initial shock-refractory ventricular fibrillation or pulseless ventricular tachycardia.

Original languageEnglish (US)
Pages (from-to)1711-1722
Number of pages12
JournalNew England Journal of Medicine
Volume374
Issue number18
DOIs
StatePublished - May 5 2016

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Out-of-Hospital Cardiac Arrest
Amiodarone
Lidocaine
Placebos
Ventricular Fibrillation
Shock
Ventricular Tachycardia
Nervous System
Survival Rate
Confidence Intervals
Heart Arrest
Allied Health Personnel
Survival
Anti-Arrhythmia Agents
Pharmaceutical Preparations
Population
Blood Vessels

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Amiodarone, lidocaine, or placebo in out-of-hospital cardiac arrest. / Resuscitation Outcomes Consortium Investigators.

In: New England Journal of Medicine, Vol. 374, No. 18, 05.05.2016, p. 1711-1722.

Research output: Contribution to journalArticle

Resuscitation Outcomes Consortium Investigators 2016, 'Amiodarone, lidocaine, or placebo in out-of-hospital cardiac arrest', New England Journal of Medicine, vol. 374, no. 18, pp. 1711-1722. https://doi.org/10.1056/NEJMoa1514204
Resuscitation Outcomes Consortium Investigators. / Amiodarone, lidocaine, or placebo in out-of-hospital cardiac arrest. In: New England Journal of Medicine. 2016 ; Vol. 374, No. 18. pp. 1711-1722.
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T1 - Amiodarone, lidocaine, or placebo in out-of-hospital cardiac arrest

AU - Resuscitation Outcomes Consortium Investigators

AU - Kudenchuk, P. J.

AU - Brown, S. P.

AU - Daya, Mohamud Ramzan

AU - Rea, T.

AU - Nichol, G.

AU - Morrison, L. J.

AU - Leroux, B.

AU - Vaillancourt, C.

AU - Wittwer, L.

AU - Callaway, C. W.

AU - Christenson, J.

AU - Egan, D.

AU - Ornato, J. P.

AU - Weisfeldt, M. L.

AU - Stiell, I. G.

AU - Idris, A. H.

AU - Aufderheide, T. P.

AU - Dunford, J. V.

AU - Colella, M. R.

AU - Vilke, G. M.

AU - Brienza, A. M.

AU - Desvigne-Nickens, P.

AU - Gray, P. C.

AU - Gray, R.

AU - Seals, N.

AU - Straight, R.

AU - Dorian, P.

PY - 2016/5/5

Y1 - 2016/5/5

N2 - Background: Antiarrhythmic drugs are used commonly in out-of-hospital cardiac arrest for shock-refractory ventricular fibrillation or pulseless ventricular tachycardia, but without proven survival benefit. Methods: In this randomized, double-blind trial, we compared parenteral amiodarone, lidocaine, and saline placebo, along with standard care, in adults who had nontraumatic out-ofhospital cardiac arrest, shock-refractory ventricular fibrillation or pulseless ventricular tachycardia after at least one shock, and vascular access. Paramedics enrolled patients at 10 North American sites. The primary outcome was survival to hospital discharge; the secondary outcome was favorable neurologic function at discharge. The per-protocol (primary analysis) population included all randomly assigned participants who met eligibility criteria and received any dose of a trial drug and whose initial cardiac-arrest rhythm of ventricular fibrillation or pulseless ventricular tachycardia was refractory to shock. Results: In the per-protocol population, 3026 patients were randomly assigned to amiodarone (974), lidocaine (993), or placebo (1059); of those, 24.4%, 23.7%, and 21.0%, respectively, survived to hospital discharge. The difference in survival rate for amiodarone versus placebo was 3.2 percentage points (95% confidence interval [CI], -0.4 to 7.0; P = 0.08); for lidocaine versus placebo, 2.6 percentage points (95% CI, -1.0 to 6.3; P = 0.16); and for amiodarone versus lidocaine, 0.7 percentage points (95% CI, -3.2 to 4.7; P = 0.70). Neurologic outcome at discharge was similar in the three groups. There was heterogeneity of treatment effect with respect to whether the arrest was witnessed (P = 0.05); active drugs were associated with a survival rate that was significantly higher than the rate with placebo among patients with bystander-witnessed arrest but not among those with unwitnessed arrest. More amiodarone recipients required temporary cardiac pacing than did recipients of lidocaine or placebo. Conclusions: Overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo among patients with out-of-hospital cardiac arrest due to initial shock-refractory ventricular fibrillation or pulseless ventricular tachycardia.

AB - Background: Antiarrhythmic drugs are used commonly in out-of-hospital cardiac arrest for shock-refractory ventricular fibrillation or pulseless ventricular tachycardia, but without proven survival benefit. Methods: In this randomized, double-blind trial, we compared parenteral amiodarone, lidocaine, and saline placebo, along with standard care, in adults who had nontraumatic out-ofhospital cardiac arrest, shock-refractory ventricular fibrillation or pulseless ventricular tachycardia after at least one shock, and vascular access. Paramedics enrolled patients at 10 North American sites. The primary outcome was survival to hospital discharge; the secondary outcome was favorable neurologic function at discharge. The per-protocol (primary analysis) population included all randomly assigned participants who met eligibility criteria and received any dose of a trial drug and whose initial cardiac-arrest rhythm of ventricular fibrillation or pulseless ventricular tachycardia was refractory to shock. Results: In the per-protocol population, 3026 patients were randomly assigned to amiodarone (974), lidocaine (993), or placebo (1059); of those, 24.4%, 23.7%, and 21.0%, respectively, survived to hospital discharge. The difference in survival rate for amiodarone versus placebo was 3.2 percentage points (95% confidence interval [CI], -0.4 to 7.0; P = 0.08); for lidocaine versus placebo, 2.6 percentage points (95% CI, -1.0 to 6.3; P = 0.16); and for amiodarone versus lidocaine, 0.7 percentage points (95% CI, -3.2 to 4.7; P = 0.70). Neurologic outcome at discharge was similar in the three groups. There was heterogeneity of treatment effect with respect to whether the arrest was witnessed (P = 0.05); active drugs were associated with a survival rate that was significantly higher than the rate with placebo among patients with bystander-witnessed arrest but not among those with unwitnessed arrest. More amiodarone recipients required temporary cardiac pacing than did recipients of lidocaine or placebo. Conclusions: Overall, neither amiodarone nor lidocaine resulted in a significantly higher rate of survival or favorable neurologic outcome than the rate with placebo among patients with out-of-hospital cardiac arrest due to initial shock-refractory ventricular fibrillation or pulseless ventricular tachycardia.

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