ALPS
Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest
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Overview
In shock-refractory VF or pulseless VT, neither amiodarone nor lidocaine improved survival to discharge or neurologic outcome versus placebo.
Clinical takeaway
ALPS found no overall survival or neurologic benefit of amiodarone or lidocaine over placebo in shock-refractory VF or pulseless VT.
Key result
In the per-protocol population, survival to discharge was 24.4% with amiodarone, 23.7% with lidocaine, and 21.0% with placebo (amiodarone vs placebo p=0.08).
Practice impact
Do not expect amiodarone or lidocaine to improve discharge survival in shock-refractory VF or pulseless VT; the two drugs performed similarly.
Evidence
Study design
Randomized, double-blind trial comparing parenteral amiodarone, lidocaine, and saline placebo, given with standard care, in shock-refractory out-of-hospital cardiac arrest.
Enrollment
3,026
Follow-up
Survival and neurologic function assessed at hospital discharge.
Geography
North America
Clinical question
Do amiodarone or lidocaine improve survival to hospital discharge compared with placebo in shock-refractory ventricular fibrillation or pulseless ventricular tachycardia?
Population
- Adults with nontraumatic out-of-hospital cardiac arrest, shock-refractory ventricular fibrillation or pulseless ventricular tachycardia after at least one shock, and vascular access.
Intervention
Parenteral amiodarone or lidocaine plus standard care.
Comparator
Saline placebo plus standard care.
Primary outcome
Survival to hospital discharge.
In the per-protocol population, neither amiodarone nor lidocaine significantly increased survival to hospital discharge compared with placebo.
Risk difference / 3.2 / 95% CI -0.4 to 7.0 / p=0.08
Key results
- In the per-protocol primary-analysis population (3026 patients: 974 amiodarone, 993 lidocaine, 1059 placebo), survival to hospital discharge was 24.4% with amiodarone, 23.7% with lidocaine, and 21.0% with placebo.
- In that per-protocol population, the survival difference for amiodarone versus placebo was 3.2 percentage points (95% 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).
- Neurologic outcome at discharge was similar in the three per-protocol groups.
- Active drugs were associated with higher survival than placebo among patients with bystander-witnessed arrest but not among those with unwitnessed arrest.
Harms
- More amiodarone recipients required temporary cardiac pacing than did recipients of lidocaine or placebo.
Clinical Use
Practice impact
- Do not expect amiodarone or lidocaine to improve survival to discharge in shock-refractory VF or pulseless VT; if an antiarrhythmic is used, the two drugs performed similarly.
Applicability
- Most applicable to adults with nontraumatic out-of-hospital cardiac arrest and shock-refractory ventricular fibrillation or pulseless ventricular tachycardia who have vascular access.
Limitations
- The primary analysis was per-protocol among patients who received any dose of a trial drug and had shock-refractory ventricular fibrillation or pulseless ventricular tachycardia.
- Overall differences versus placebo were not statistically significant.
- The abstract does not report drug doses.
Common misinterpretations
- A negative overall survival result does not mean these drugs never terminate ventricular fibrillation; the primary outcome was survival to discharge.
- The witnessed-arrest subgroup finding is not a license to treat only witnessed arrests.
Related evidence
Citation
Kudenchuk PJ, Brown SP, Daya M, et al. Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest. N Engl J Med. 2016;374(18):1711-1722. doi:10.1056/NEJMoa1514204
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.
- PMID
- 27043165