PROCAMIO Trial
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.
PubMed Full text PDF
PubMed Full text PDF
Clinical Question
- Does the use of IV procainamide compared with IV amiodarone in patients with wide QRS tachycardia reduce major adverse cardiac events?
Conclusion
- 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
Setting
- 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
Interventions
- Procainamide at 10mg/kg over 20 mins
- Amiodarone at 5mg/kg over 20 mins
Outcomes
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
- 24% vs. 48% (OR 0.34, 95% C.I. 0.12-1, p=0.052)
Subgroup analysis
- Patients with structural heart disease
- lower MACE and higher termination rate in procainamide group
Criticisms & Further Discussion
Strengths
- Multicenter,prospective, randomized and controlled
Limitations
- Sample size was too small
- Needed 300+ participants for adequate power
- Unblinded
- No comparison with electrical cardioversion
External Links
See Also
Funding
- 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.