Complete Journal Club Article
Mercedes Ortiz, Alfonso Martín, Fernando Arribas, Blanca Coll-Vinent, Carmen del Arco, Rafael Peinado, Jesús Almendral. "Randomized Comparison of intravenous procainamide vs. intravenous amiodarone for the acute treatment of tolerated wide QRS tachycardia: the PROCAMIO study". European Heart Journal. 2017. 38(17):1329-1335.
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Clinical Question

  • Does the use of IV procainamide compared with IV amiodarone in patients with wide QRS tachycardia reduce major adverse cardiac events?


  • Procainamide therapy when compared with IV amiodarone for the treatment of acute sustained monomorphic wide QRS tachycardia was associated with less major cardiac adverse events (MACE) and a higher proportion of tachycardia termination within 40 minutes.

Major Points

  • The trials suggests and improved safety profile and efficacy of 10mg/kg IV procainamide over 20mins when compared to 5mg/kg IV amiodarone over the same period in the treatment of wide complex tachycardia.

Study Design

  • Multi-center, prospective, randomized controlled trial
  • Participants assigned in a 1:1 ratio through the use of sealed envelopes
  • Researchers were unblinded
  • Study Period
    • Drug Administered over 20 minutes
    • 20 minutes of monitoring
    • 24 hours of observation
  • To detect a absolute risk reduction of 15% from baseline, 302 patient are required


  • 26 Hospitals in Spain
  • Emergency and Cardiology Departments
  • Six year recruitment period

Inclusion Criteria

  • Adults with regular wide complex tachycardias
    • HR≥120, QRS≥120ms
  • "Good Hemodynamic tolerance"
    • Systolic BP≥90
    • No dyspnea at rest
    • No signs of peripheral hypoperfusion
    • Lack of severe angina
    • Age≥18

Exclusion Criteria

  • Treatment with IV procainamide or amiodarone in the previous 24 hours
  • Poor hemodynamic tolerance
  • Presence of irregular tachycardia
  • SVT as determined by physician
  • Contraindications to the drugs
  • Patient does not want to participate


  • Procainamide at 10mg/kg over 20 mins
  • Amiodarone at 5mg/kg over 20 mins


Primary Outcome

  • Compare the incidence of major cardiac adverse events (MACE) between both treatments
    • 9% vs 41%, Odds Ratio .1, 95% C.I. 0.03-0.6, p=.006
    • MACE
      • Clinical signs of hypoperfusion
      • Signs of Heart Failure
      • Severe Hypotension (≤70mmHg SBP if pre-treatment BP ≤100mmHg and ≤80mmHg if pre-treatment BP >100mmHg)
      • Tachycardia acceleration > 20bpm
      • Fast Polymorphic VT
    • Patients with MACE usually required cardioversion

Secondary Outcomes

  • compare the efficacy of both drugs in relation to the termination of tachycardia
    • 67% vs. 38% (OR 3.3, 95% C.I. 1.2-9.3, p=0.026)
  • compare the incidence of adverse events (other than MACE)
    • 24% vs. 48% (OR 0.34, 95% C.I. 0.12-1, p=0.052)
      • no significant difference

Subgroup analysis

  • Patients with structural heart disease
    • lower MACE and higher termination rate in procainamide group

Criticisms & Further Discussion


  • Multicenter,prospective, randomized and controlled


  • Sample size was too small
    • Needed 300+ participants for adequate power
  • Unblinded
  • No comparison with electrical cardioversion

External Links


See Also


  • This work was supported by Fundación para la Investigación Biomédica del Hospital Gregorio Marañón, Madrid, Spain; Instituto de Salud Carlos III (PI060675), Madrid, Spain; and the Arrhythmia Division of the Spanish Society of Cardiology, Madrid, Spain.
  • Conflict of interest: none to declared.