Safety and Effectiveness of Electrical and Pharmacological Cardioversion in Persistent Atrial Fibrillation. Part 2: Assessment of Safety
Aim. To compare safety of new class III antiarrhythmic drug Refralon with direct current cardioversion (DCC) in patients with persistent atrial fibrillation (AF). Material and methods. 60 patients with persistent AF were randomized to groups of DCC (n=30) and pharmacologic conversion (PCV; n=30). Th...
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| Format: | Article |
| Language: | English |
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Столичная издательская компания
2019-01-01
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| Series: | Рациональная фармакотерапия в кардиологии |
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| Online Access: | https://www.rpcardio.online/jour/article/view/1794 |
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| author | N. Yu. Mironov V. V. Vlodzyanovskiy Yu. A. Yuricheva S. F. Sokolov S. P. Golitsyn L. V. Rosenstraukh E. I. Chazov |
| author_facet | N. Yu. Mironov V. V. Vlodzyanovskiy Yu. A. Yuricheva S. F. Sokolov S. P. Golitsyn L. V. Rosenstraukh E. I. Chazov |
| author_sort | N. Yu. Mironov |
| collection | DOAJ |
| description | Aim. To compare safety of new class III antiarrhythmic drug Refralon with direct current cardioversion (DCC) in patients with persistent atrial fibrillation (AF). Material and methods. 60 patients with persistent AF were randomized to groups of DCC (n=30) and pharmacologic conversion (PCV; n=30). There were no significant differences in age, sex, AF duration, concomitant cardiovascular diseases, CHA2DS2-VASc score and echocardiographic parameters between the groups compared. Initial assessment excluded contraindications to restore sinus rhythm (SR). In DCC group two attempts using biphasic synchronized shocks of 150 J and 170 J were performed. In PCV group patients received up to three subsequent intravenous injections of Refralon 10 μg/kg (maximal dose 30 μg/kg). Results. There were no mortality, stroke, transient ischemic attack, ventricular arrhythmia, asystole longer than 3,0 sec (primary safety criteria) in both groups. Prolongation of QT interval longer than 500 ms observed in 1 of 30 patients (3,3%) in DCC group and in 7 of 30 patients (23,3%) in PCV group. 2 patients (one patient in each group; 3,3%) developed asymptomatic bradycardia after conversion to SR that resolved spontaneously within 30 minutes. 95% confidence interval (95%CI) for secondary safety criteria is [0,02-0,38] for QT prolongation and [-0,04-0,04] for bradycardia. Conclusion. Safety of PCV is noninferior to DCC in patients with persistent AF in terms of primary safety criteria and bradyarrhythmias. More frequent QT interval prolongation to values >500 ms observed in PCV group points to necessity of precautions with use of the drug. |
| format | Article |
| id | doaj-art-f47249aaf92d44f9aa129d5064c2d1e0 |
| institution | Kabale University |
| issn | 1819-6446 2225-3653 |
| language | English |
| publishDate | 2019-01-01 |
| publisher | Столичная издательская компания |
| record_format | Article |
| series | Рациональная фармакотерапия в кардиологии |
| spelling | doaj-art-f47249aaf92d44f9aa129d5064c2d1e02025-08-23T10:00:30ZengСтоличная издательская компанияРациональная фармакотерапия в кардиологии1819-64462225-36532019-01-0114682683010.20996/1819-6446-2018-14-6-826-8301545Safety and Effectiveness of Electrical and Pharmacological Cardioversion in Persistent Atrial Fibrillation. Part 2: Assessment of SafetyN. Yu. Mironov0V. V. Vlodzyanovskiy1Yu. A. Yuricheva2S. F. Sokolov3S. P. Golitsyn4L. V. Rosenstraukh5E. I. Chazov6National Medical Research Center of CardiologyNational Medical Research Center of CardiologyNational Medical Research Center of CardiologyNational Medical Research Center of CardiologyNational Medical Research Center of CardiologyNational Medical Research Center of CardiologyNational Medical Research Center of CardiologyAim. To compare safety of new class III antiarrhythmic drug Refralon with direct current cardioversion (DCC) in patients with persistent atrial fibrillation (AF). Material and methods. 60 patients with persistent AF were randomized to groups of DCC (n=30) and pharmacologic conversion (PCV; n=30). There were no significant differences in age, sex, AF duration, concomitant cardiovascular diseases, CHA2DS2-VASc score and echocardiographic parameters between the groups compared. Initial assessment excluded contraindications to restore sinus rhythm (SR). In DCC group two attempts using biphasic synchronized shocks of 150 J and 170 J were performed. In PCV group patients received up to three subsequent intravenous injections of Refralon 10 μg/kg (maximal dose 30 μg/kg). Results. There were no mortality, stroke, transient ischemic attack, ventricular arrhythmia, asystole longer than 3,0 sec (primary safety criteria) in both groups. Prolongation of QT interval longer than 500 ms observed in 1 of 30 patients (3,3%) in DCC group and in 7 of 30 patients (23,3%) in PCV group. 2 patients (one patient in each group; 3,3%) developed asymptomatic bradycardia after conversion to SR that resolved spontaneously within 30 minutes. 95% confidence interval (95%CI) for secondary safety criteria is [0,02-0,38] for QT prolongation and [-0,04-0,04] for bradycardia. Conclusion. Safety of PCV is noninferior to DCC in patients with persistent AF in terms of primary safety criteria and bradyarrhythmias. More frequent QT interval prolongation to values >500 ms observed in PCV group points to necessity of precautions with use of the drug.https://www.rpcardio.online/jour/article/view/1794atrial fibrillationdirect current cardioversionpharmacological cardioversioneffectivenesssafetyrefralon |
| spellingShingle | N. Yu. Mironov V. V. Vlodzyanovskiy Yu. A. Yuricheva S. F. Sokolov S. P. Golitsyn L. V. Rosenstraukh E. I. Chazov Safety and Effectiveness of Electrical and Pharmacological Cardioversion in Persistent Atrial Fibrillation. Part 2: Assessment of Safety Рациональная фармакотерапия в кардиологии atrial fibrillation direct current cardioversion pharmacological cardioversion effectiveness safety refralon |
| title | Safety and Effectiveness of Electrical and Pharmacological Cardioversion in Persistent Atrial Fibrillation. Part 2: Assessment of Safety |
| title_full | Safety and Effectiveness of Electrical and Pharmacological Cardioversion in Persistent Atrial Fibrillation. Part 2: Assessment of Safety |
| title_fullStr | Safety and Effectiveness of Electrical and Pharmacological Cardioversion in Persistent Atrial Fibrillation. Part 2: Assessment of Safety |
| title_full_unstemmed | Safety and Effectiveness of Electrical and Pharmacological Cardioversion in Persistent Atrial Fibrillation. Part 2: Assessment of Safety |
| title_short | Safety and Effectiveness of Electrical and Pharmacological Cardioversion in Persistent Atrial Fibrillation. Part 2: Assessment of Safety |
| title_sort | safety and effectiveness of electrical and pharmacological cardioversion in persistent atrial fibrillation part 2 assessment of safety |
| topic | atrial fibrillation direct current cardioversion pharmacological cardioversion effectiveness safety refralon |
| url | https://www.rpcardio.online/jour/article/view/1794 |
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