Safety and Efficacy of Intravenous Procainamide and Amiodarone in the Acute Treatment of Wide QRS Complex Monomorphic Tachycardias - PROCAMIO
The goal of the trial was to assess the safety and efficacy of intravenous procainamide compared with amiodarone in the acute treatment of wide QRS complex monomorphic tachycardias (presumably ventricular tachycardia [VT]) that were hemodynamically well tolerated.
Contribution to the Literature: The PROCAMIO study showed that procainamide is better tolerated and more efficacious acutely than amiodarone in the treatment of hemodynamically stable wide complex tachycardia (presumably VT).
Patients were randomized in a 1:1 open-label fashion to either intravenous procainamide (single dose 10 mg/kg over 20 minutes) (n = 33) or intravenous amiodarone (single dose 5 mg/kg over 20 minutes) (n = 29).
- Total number of enrollees: 62
- Duration of follow-up: 1 day
- Mean patient age: 65 years
- Age ≥18 years
- Regular wide QRS tachycardia requiring medical attention
- Rate ≥120 bpm
- Good hemodynamic tolerance (blood pressure >90, no dyspnea at rest or angina, no hypoperfusion)
- Treatment with either intravenous amiodarone or intravenous procainamide during the previous 24 hours
- Poor hemodynamic tolerance requiring urgent termination
- Presence of irregular tachycardia
- Tachycardia believed to be supraventricular tachycardia
- Contraindications to the drugs under study
Other salient features/characteristics:
- Known structural heart disease: 79% (50% of total with coronary artery disease)
- Mean left ventricular ejection fraction: 39%
- Mean heart rate: 178 bpm
- On beta-blockers: 34%
The primary outcome, major adverse cardiac events within 40 minutes of infusion initiation, for procainamide vs. amiodarone, was 9% vs. 41%, p = 0.006. Severe hypotension or symptoms requiring immediate direct current cardioversion (DCCV) occurred in 6.3% vs. 31.0%. Results were similar in patients with structural heart disease (n = 49).
Secondary outcomes for procainamide vs. amiodarone:
- Hypotension not requiring cessation of infusion or DCCV: 15.3% vs. 6.9%
- Tachycardia termination: 67% vs. 38%, p = 0.026
- Sinus bradycardia within 24 hours: 3.1%
The results of this trial indicate that procainamide is better tolerated and more efficacious acutely than amiodarone in the treatment of hemodynamically stable wide complex tachycardia (presumably VT), including in patients with structural heart disease. An important limitation of the current trial is the open-label nature of drug administration, especially since the primary outcome was subjectively assessed.
Ortiz M, Martín A, Arribas F, et al., on behalf of the PROCAMIO Study Investigators. Randomized Comparison of Intravenous Procainamide vs. Intravenous Amiodarone for the Acute Treatment of Tolerated Wide QRS Tachycardia: The PROCAMIO Study. Eur Heart J 2016;Jun 28:[Epub ahead of print].
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