Amiodarone, Lidocaine, or Placebo Study - ALPS
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.
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
- Age ≥18 years of age
- Nontraumatic OOHCA and shock-refractory VF or pulseless VT
- Intravenous or intraosseous vascular access
- Open-label intravenous lidocaine or amiodarone during resuscitation
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
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.
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.
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