PROCAMIO
Trial question
What is the effect of intravenous procainamide versus amiodarone in patients with an acute episode of sustained monomorphic well-tolerated wide QRS tachycardia?
Study design
Multi-center
Open label
RCT
Population
74 patients.
Inclusion criteria: patients with regular wide QRS complex tachycardia that required medical attention.
Key exclusion criteria: treatment with either IV amiodarone or IV procainamide during the previous 24 hours; poor hemodynamic tolerance requiring urgent termination; VT.
Interventions
N=33 procainamide (IV infusion of a single dose of 10 mg/kg over 20 minutes).
N=29 amiodarone (IV infusion of a single dose of 5 mg/kg over 20 minutes).
Primary outcome
Major cardiac adverse events
9%
41%
41.0 %
30.8 %
20.5 %
10.3 %
0.0 %
Procainamide
Amiodarone
Significant
decrease ▼
NNT = 3
Significant decrease in major cardiac adverse events (9% vs. 41%; OR 0.1, 95% CI 0.03 to 0.6).
Secondary outcomes
Significant increase in tachycardia termination (67% vs. 38%; OR 3.3, 95% CI 1.2 to 9.3).
Borderline significant decrease in total adverse events (24% vs. 48%; OR 0.34, 95% CI 0.12 to 1).
No significant difference in adverse event (18% vs. 31%; OR 0.49, 95% CI 0.15 to 1.61).
Safety outcomes
No significant difference in total adverse effects in patients with structural heart disease.
Significant difference in major cardiac adverse events in patients with structural heart disease (11% vs. 43%).
Conclusion
In patients with regular wide QRS complex tachycardia that required medical attention, procainamide was superior to amiodarone with respect to major cardiac adverse events.
Reference
Mercedes Ortiz, Alfonso Martín, Fernando Arribas et al. Randomized comparison of intravenous procainamide vs. intravenous amiodarone for the acute treatment of tolerated wide QRS tachycardia: the PROCAMIO study. Eur Heart J. 2017 May 1;38(17):1329-1335.
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