Randomized comparison of intravenous procainamide vs. intravenous amiodarone for the acute treatment of tolerated wide QRS tachycardia: the PROCAMIO study

Intravenous procainamide and amiodarone are drugs of choice for well-tolerated ventricular tachycardia. However, the choice between them, even according to Guidelines, is unclear. We performed a multicentre randomized open-labelled study to determine the safety and efficacy of intravenous procainami...

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Bibliographic Details
Published in:European heart journal 2017-05, Vol.38 (17), p.1329-1335
Main Authors: Ortiz, Mercedes, Martín, Alfonso, Arribas, Fernando, Coll-Vinent, Blanca, Del Arco, Carmen, Peinado, Rafael, Almendral, Jesús
Format: Article
Language:English
Subjects:
Aged
Amiodarone - administration & dosage
Amiodarone - adverse effects
Anti-Arrhythmia Agents - administration & dosage
Anti-Arrhythmia Agents - adverse effects
Cardiomyopathies - complications
Clinical Research
Drug Administration Schedule
Female
Humans
Infusions, Intravenous
Male
Middle Aged
Patient Selection
Procainamide - administration & dosage
Procainamide - adverse effects
Tachycardia, Ventricular - drug therapy
Treatment Outcome
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Summary:Intravenous procainamide and amiodarone are drugs of choice for well-tolerated ventricular tachycardia. However, the choice between them, even according to Guidelines, is unclear. We performed a multicentre randomized open-labelled study to determine the safety and efficacy of intravenous procainamide and amiodarone for the acute treatment of tolerated wide QRS complex (probably ventricular) tachycardia. Patients were randomly assigned to receive intravenous procainamide (10 mg/kg/20 min) or amiodarone (5 mg/kg/20 min). The primary endpoint was the incidence of major predefined cardiac adverse events within 40 min after infusion initiation. Of 74 patients included, 62 could be analysed. The primary endpoint occurred in 3 of 33 (9%) procainamide and 12 of 29 (41%) amiodarone patients (odd ratio, OR = 0.1; 95% confidence interval, CI 0.03-0.6; P = 0.006). Tachycardia terminated within 40 min in 22 (67%) procainamide and 11 (38%) amiodarone patients (OR = 3.3; 95% CI 1.2-9.3; P = 0.026). In the following 24 h, adverse events occurred in 18% procainamide and 31% amiodarone patients (OR: 0.49; 95% CI: 0.15-1.61; P: 0.24). Among 49 patients with structural heart disease, the primary endpoint was less common in procainamide patients (3 [11%] vs. 10 [43%]; OR: 0.17; 95% CI: 0.04-0.73, P = 0.017). This study compares for the first time in a randomized design intravenous procainamide and amiodarone for the treatment of the acute episode of sustained monomorphic well-tolerated (probably) ventricular tachycardia. Procainamide therapy was associated with less major cardiac adverse events and a higher proportion of tachycardia termination within 40 min.
ISSN:0195-668X
1522-9645
DOI:10.1093/eurheartj/ehw230