ROC-ALPS (amiodarone)
Trial question
What is the role of amiodarone in patients with out-of-hospital cardiac arrest due to initial shock-refractory VF or pulseless VT?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 2033
2033 patients (426 female, 1606 male)
Inclusion criteria: adult patients who had nontraumatic out-of-hospital cardiac arrest, shock-refractory VF or pulseless VT after at least one shock, and vascular access
Key exclusion criteria: receipt of open-label IV lidocaine or amiodarone during resuscitation; known hypersensitivity to study drugs
Interventions
N=974 amiodarone (a dose of 450 mg in amiodarone kit)
N=1059 placebo (normal saline kit)
Primary outcome
Survival to hospital discharge
24.4
21
24.4 %
18.3 %
12.2 %
6.1 %
0.0 %
Amiodarone
Placebo
No significant
difference ↔
No significant difference in survival to hospital discharge (24.4% vs. 21%; AD 3.2%, 95% CI -0.4 to 7)
Secondary outcomes
No significant difference in mRS score ≤ 3 (18.8% vs. 16.6%; AD 2.2%, 95% CI -1.1 to 5.6)
No significant difference in return of spontaneous circulation at emergency department arrival (35.9% vs. 34.6%; AD 1.4%, 95% CI -2.8 to 5.5)
Significant increase in hospital admission (45.7% vs. 39.7%; AD 6%, 95% CI 1.7 to 10.3)
Safety outcomes
No significant difference in drug-related adverse events or serious adverse events.
Significant difference in temporary cardiac pacing (4.9% vs. 2.7%).
Conclusion
In adult patients who had nontraumatic out-of-hospital cardiac arrest, shock-refractory VF or pulseless VT after at least one shock, and vascular access, amiodarone was not superior to placebo with respect to survival to hospital discharge.
Reference
Peter J Kudenchuk, Siobhan P Brown, Mohamud Daya et al. Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Cardiac Arrest. N Engl J Med. 2016 May 5;374(18):1711-22.
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