Цель. Сравнить эффективность и безопасность медикаментозной кардиоверсии новым антиаритмическим препаратом Рефралон с электрической кардиоверсией у больных с персистирующей фибрилляцией предсердий (ФП) Материал и методы. 60 больных с персистирующей формой ФП были рандомизированы в группы электрической (ЭКВ; n=30) и медикаментозной кардиоверсии (МКВ; n=30). Статистически значимые различия по основным клиническим характеристикам между группами отсутствовали. После предварительного обследования, исключившего противопоказания, в условиях блока интенсивной терапии проводилась попытка восстановления синусового ритма (СР). В группе ЭКВ применяли бифазные синхронизированные разряды 150 Дж и 170 Дж. В группе МКВ производилось внутривенное введение Рефралона в дозе 10 мкг/кг, в случае сохранения ФП введение повторяли через 15 мин (максимальная доза составляла 30 мкг/кг). Наблюдение за больными продолжали в течение 24 ч. Результаты. Восстановление СР (первичный критерий эффективности) отмечено у 27 из 30 больных (90%) в группе ЭКВ и у 28 из 30 больных (93,3%) в группе МКВ; 95% доверительный интервал (ДИ) составил [-0,1-0,16]. В группе ЭКВ после восстановления СР у одного больного отмечен рецидив ФП. В группе МКВ рецидивы ФП не отмечались. Таким образом, в группе ЭКВ через 24 ч СР сохранялся у 26 из 30 больных (86,7%); в группе МКВ-у 28 из 30 больных (93,3%). При этом 95%ДИ для вторичного критерия эффективности (сохранение СР через 24 ч) составил [-0,07-0,19]. Заключение. МКВ с использованием Рефралона в дозах от 10 до 30 мкг/кг по первичным и вторичным критериям эффективности не уступает ЭКВ, которая на протяжении длительного времени считалась «методом выбора» в восстановлении СР у больных персистирующей ФП.
Aim. We aimed to assess safety and effectiveness of class III antiarrhythmic drug Refralon for conversion of atrial fibrillation (AFib) and flutter (AFl) in post-registration trial and to compare data of primary center (National medical research center in cardiology) with data of other hospitals.Material and Methods. We performed retrospective cohort study in 727 patients (451 enrolled in primary center and 276 enrolled in other hospitals) admitted between June 24, 2014 and June 24, 2019. Refralon was administered for conversion of AFib and AFl in intense care units in escalating doses (10-30 micrograms/kg) intravenously.Results. Conversion of AFib and AFl into sinus rhythm was achieved in 53,6% after administration of 10 mcg/kg dose, in 73% after administration of 20 mcg/kg dose and in 91,6% after administration of Refralon in dose up to 30 mcg/kg. No mortality and no major adverse cardiac events registered in our study. Asystole >3.0 sec observed in 5% (35 of 727) of patients): in 5% (24 of 451) of patients enrolled in primary center and in 4% (11 of 276) of patients enrolled in other hospitals; 95% confidence interval (CI) [-0.09; 0.113]. Asystole> 5.0 s observed in 1.7% of patients who further required non-urgent implantation of a permanent pacemaker due to manifestations of sinus node dysfunction. Cardiac conduction disturbances (exclusively sinus bradycardia) were registered in 7% (53 of 727) patients: in 8% (37 of 451) of patients enrolled in primary center and in 6% (17 of 276) of patients enrolled in other hospitals; 95% CI: [-0.1; 0.15]. Only 0.14% of patients had symptomatic sinus bradycardia that resolved after atropine injection. Ventricular arrhythmias (exclusively Torsade de pointes tachycardia in excessive QT interval prolongation) were registered in 1.7% (12 of 727) patients: in 2% (9 of 451) of patients in primary center and in 1% (3 of 276) of patients of other hospitals; 95% CI: [-0.06; 0.08]. QTc interval prolongation to values >500 ms documented in 19% (138 of 727) of patients: in 21% (95 of 451) of patients in primary center and in 16% (43 of 276) of patients in other hospitals; 95% CI: [-0.13; 0.24].Conclusion: In post-registration multicenter trial Refralon demonstrated good safety profile in conversion of AFib and AFl. Potential risk of TdP tachycardia mandates precautions with the use of the drug. In other hospitals Refralon did not demonstrate lower safety than in primary medical center.
Aim. We aimed to assess safety and effectiveness of class III antiarrhythmic drug Refralon for conversion of atrial fibrillation (AFib) and flutter (AFl) in post-registration trial and to compare data of primary center (National medical research center in cardiology) with data of other hospitals.Material and Methods. We performed retrospective cohort study in 727 patients (451 enrolled in primary center and 276 enrolled in other hospitals) admitted between June 24, 2014 and June 24, 2019. Refralon was administered for conversion of AFib and AFl in intense care units in escalating doses (10-30 mcg/kg) intravenously. Primary endpoints: restoration of sinus rhythm (SR) within 24 hours after the start of infusion of the study drug in a total dose of up to 30 pg / kg; registration of SR on an electrocardiogram (ECG) 24 hours after the start of the study drug infusion. Secondary endpoints: restoration of SR after infusion of the study drug at a dose of 10 pg / kg; restoration of SR after infusion of the studied drug in a total dose of up to 20 pg / kg; no recurrence of AFib/AFl after restoration of AFl within 24 hours of observation after the start of the study drug infusion.Results. Conversion to SR was achieved in 53,6% (391 of 727) after administration of 10 mcg/kg dose, in 73% (531 of 727) after administration of 20 mcg/kg dose and in 91,6% (666 of 727) after administration in dose up to 30 mcg/kg. SR was restored in 89% (402 of 451) of patients in primary center, and in 96% (264 of 276) of patients in other hospitals; 95% confidence interval (CI): (-0,1;-0,03). SR preserved 24 hours after conversion in 98% (650 of 666) successfully converted patients. In primary center SR preserved in 97% (390 of 402) successfully converted patients. In other hospitals - in 98,5% (260 of 264) successfully converted patients. 95 CI: (-0,09;0,06).Conclusion: In post-registration multicenter trial Refralon demonstrated high effectiveness in conversion of AFib and AFl to SR. In other hospitals Refralon did not demonstrate lower effectiveness than in primary medical center.
Introduction: Niferidil is a new Russian class III antiarrhythmic drug, which in clinical trials has shown a high efficiency of restoration of sinus rhythm (SR) in persistent AF (87%), not inferior to electrical cardioversion. Currently, a three-stage scheme of drug administration is used (10 μg / kg - 10 μg / kg - 10 μg / kg). In a number of patients, SR is restored before the end of the first dose of the drug, which indicates the effectiveness of an even lower dose (5 μg / kg) of the drug, which has not been studied in clinical trials. Objective: To evaluate the effectiveness and safety of the modified protocol of niferidil administration in patients with paroxysmal AF. Methods: Included 87 patients with paroxysmal, 42 of them were men, mean age 63 [57;70]. After exclusion of contraindications, all patients received niferidil according to the following scheme. The initial dose of niferidil was 5 μg/kg of body weight, if AF did not terminate after 15 minutes (min.), niferidil was additionally administered at a dose of 5 μg/kg (total dose of 10 μg/kg). If SR was not restored patients received subsequent injections of niferidil 10 μg/kg, each after 15 min. (maximal total dose of 30 μg/kg). Injections were discontinued in case of SR restoration, QTc>500ms or proarrhythmia. All patients underwent continuous ECG monitoring within 24 hours to assess effectiveness and safety of niferidil. Results: SR was restored in 81 out of 87 patients (cumulative effectiveness of niferidil in doses up to 30 μg / kg was 93,1 %. 49,4 % of them restored SR after administration of 5 μg/kg dose, 66 (77 %) - after 10 μg/kg dose, 77 (88,5 %) - after 20 μg/kg dose, 81 (93,1 %) - after 30 μg/kg dose. In none of the cases was there any development of life-threatening ventricular arrhythmias. Prolongation of the QTc>500 ms was recorded in 14 patients (16%). Bradyarrhythmias after SR recovery were reported in 6 patients (6,8 %). In all cases sinus bradycardia was asymptomatic. Conclusions: The modified protocol of cardioversion allows SR to be restored in a significant number of AF patient’s lower doses of niferidil. The drug is highly effective in the treatment of paroxysmal AF, while in almost half of the cases, SR is restored after the administration after drug dose - 5 μg / kg. None of the patients developed Torsades de pointes.
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.
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