Amiodarone, Lidocaine, or Placebo Study - ALPS

Apr 04, 2016
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Heart, Lung, and Blood Institute; and Canadian Institutes of Health Research.
Date Presented:
04/04/2016
Date Published:
04/04/2016
Original Posted Date:
04/04/2016
References

Description:

The goal of the trial was to compare the efficacy of amiodarone or lidocaine to placebo in patients with out-of-hospital cardiac arrest (OOHCA) and evidence of ventricular tachycardia (VT)/ventricular fibrillation (VF).

Contribution to the Literature: This study suggests that there is no significant difference in survival to hospital discharge or survival with favorable neurological outcomes among with patients with OOHCA due to VT/VF between amiodarone, lidocaine, or placebo.

Study Design

Patients with adult nontraumatic OOHCA and persistent or recurrent VT/VF after ≥1 shock were randomized in 1:1:1 fashion to either intravenous amiodarone (n = 974), lidocaine (n = 993), or placebo (n = 1,059). Advanced cardiac life support was performed according to prevailing practice. After arriving at the hospital, therapeutic hypothermia and coronary catheterization were also performed according to local practices.

  • Number screened: 37,889
  • Total number of enrollees: 4,653
  • Duration of follow-up: Hospital discharge
  • Mean patient age: 63 years
  • Percentage female: 20%

Other salient features/characteristics:

  • Cardiac arrest in public location: 30%
  • Bystander witnessed arrest: 66%; bystander cardiopulmonary resuscitation: 60%
  • Time from initial call to arrival of emergency medical service (EMS): 6 minutes

Inclusion criteria:

  • Age ≥18 years of age
  • Nontraumatic OOHCA and shock-refractory VF or pulseless VT
  • Intravenous or intraosseous vascular access

Exclusion criteria:

  • Open-label intravenous lidocaine or amiodarone during resuscitation

Principal Findings:

Primary outcome, survival to hospital discharge, for amiodarone vs. lidocaine vs. placebo: 24.4% vs. 23.7% vs. 21.0% (amiodarone vs. placebo, p = 0.08; lidocaine vs. placebo, p = 0.16)

Secondary outcomes (for amiodarone vs. lidocaine vs. placebo):

  • Survival with favorable neurological status: 18.8% vs. 17.5% vs. 16.6%, p = 0.19 and 0.59, respectively vs. placebo)
  • Return of spontaneous circulation at emergency department arrival: 35.9% vs. 39.9% vs. 34.6%
  • Number of EMS shocks: 5 vs. 5 vs. 6, p < 0.0001
  • Clinical seizure activity within 24 hours: 3.2% vs. 5.1% vs. 3.7%, p = 0.07
  • Temporary cardiac pacing within 24 hours: 4.9% vs. 3.2% vs. 2.7%, p = 0.02

Interpretation:

The results of this trial indicate that there was no significant difference in survival to hospital discharge or survival with favorable neurological outcomes among patients with OOHCA due to VT/VF between amiodarone, lidocaine, or placebo. The results were numerically lower in both active arms though, suggesting that either drug may not be a bad choice in these patients given the extremely grim overall prognosis, with a greater numerical benefit with amiodarone. Time to initiation of resuscitation is the most important parameter in patients with OOHCA.

References:

Kudenchuk PJ, Brown SP, Daya M, et al., on behalf of the Resuscitation Outcomes Consortium investigators. Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest. N Engl J Med 2016;Apr 4:[Epub ahead of print].

Editorial: Joglar JA, Page RL. Out-of-Hospital Cardiac Arrest — Are Drugs Ever the Answer? N Engl J Med 2016;Apr 4:[Epub ahead of print].

Presented by Dr. Peter J. Kudenchuk at the American College of Cardiology Annual Scientific Session, Chicago, IL, April 4, 2016.

Keywords: ACC Annual Scientific Session, Acute Coronary Syndrome, Advanced Cardiac Life Support, Amiodarone, Arrhythmias, Cardiac, Cardiopulmonary Resuscitation, Catheterization, Emergency Medical Services, Heart Arrest, Hypothermia, Induced, Lidocaine, Out-of-Hospital Cardiac Arrest, Secondary Prevention, Seizures, Tachycardia, Ventricular, Ventricular Fibrillation


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