View source for PROCAMIO Trial

{{JC info
| title= Randomized Comparison of intravenous procainamide vs. intravenous amiodarone for the acute treatment of tolerated wide QRS tachycardia: the PROCAMIO study
| abbreviation= PROCAMIO Study
| expansion=
| published= 28 June 2016
| author= Mercedes Ortiz, Alfonso Martín, Fernando Arribas, Blanca Coll-Vinent, Carmen del Arco, Rafael Peinado, Jesús Almendral
| journal= European Heart Journal
| year= 2017
| volume= 38
| issue= 17
| pages= 1329-1335
| pmid= 
| fulltexturl= https://academic.oup.com/eurheartj/article/38/17/1329/3056919/Randomized-comparison-of-intravenous-procainamide
| pdfurl= https://academic.oup.com/eurheartj/article-pdf/38/17/1329/14018200/ehw230.pdf
| status=Complete
}}

==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

===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==
[http://rebelem.com/rebelcast-procamio/ RebelEM:Procamio]

==See Also==
*[[Tachycardia (wide)]]
*[[Procainamide]]
*[[Amiodarone]]

==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.

==References==
<references/>

[[Category:EBQ]]