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Safety and Effectiveness of Pharmacologic Conversion of Atrial Fibrillation and Flutter: Results of Multicenter Trial. Part I: Study Rationale, Design and Assessment of Effectiveness

https://doi.org/10.20996/1819-6446-2021-03-05

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Abstract

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.

About the Authors

N. Yu. Mironov
National Medical Research Center of Cardiology
Russian Federation

Nikolay Yu. Mironov - eLibrary SPIN 3542-5572

Moscow



Yu. A. Yuricheva
National Medical Research Center of Cardiology
Russian Federation

Yulia A. Yuriceva - eLibrary SPIN 8329-3595

Moscow



V. V. Vlodzyanovskiy
National Medical Research Center of Cardiology
Russian Federation

Vladislav V. Vlodzyanovskiy

Moscow



S. F. Sokolov
National Medical Research Center of Cardiology
Russian Federation

Sergey F. Sokolov - eLibrary SPIN 5551-8391

Moscow



Kh. M. Dzaurova
National Medical Research Center of Cardiology
Russian Federation

Khava M. Dzaurova

Moscow



S. P. Golitsyn
National Medical Research Center of Cardiology
Russian Federation

Sergey P. Golitsyn

Moscow



Yu. V. Shubik
National Medical Research Center of Cardiology
Russian Federation

Yuriy V. Shubik - eLibrary SPIN 6541-4328

Moscow



M. V. Berman
National Medical Research Center of Cardiology
Russian Federation

Mikhail V. Berman

Moscow



M. M. Medvedev
National Medical Research Center of Cardiology
Russian Federation

Mikhail M. Medvedev - eLibrary SPIN 4404-5907

Moscow



A. E. Rivin
National Medical Research Center of Cardiology
Russian Federation

Alexey E. Rivin - eLibrary SPIN 5218-7967

Moscow



D. S. Parkhomchuk
National Medical Research Center of Cardiology
Russian Federation

Demyan S. Parkhomchuk - eLibrary SPIN 4636-1536

Moscow



A. E. Barybin
National Medical Research Center of Cardiology
Russian Federation

Artyom E. Barybin

Moscow



D. А. Balandin
National Medical Research Center of Cardiology
Russian Federation

Dmitry A. Balandin

Moscow



R. E. Batalov
National Medical Research Center of Cardiology
Russian Federation

Roman E. Batalov -eLibrary SPIN 1371-4429

Moscow



D. S. Terekhov
National Medical Research Center of Cardiology
Russian Federation

Denis S. Terekhov - eLibrary SPIN 1638-6136

Moscow



I. V. Evstifeev
National Medical Research Center of Cardiology
Russian Federation

Ivan V. Evstifeev

Moscow



I. R. Kildeev
National Medical Research Center of Cardiology
Russian Federation

Ilham R. Kildeev

Moscow



O. V. Pyataeva
National Medical Research Center of Cardiology
Russian Federation

Olga V. Pyataeva - eLibrary SPIN 8357-9625

Moscow



S. A. Zenin
National Medical Research Center of Cardiology
Russian Federation

Sergey A. Zenin - eLibrary SPIN 4546-3790

Moscow



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For citation:


Mironov N.Yu., Yuricheva Yu.A., Vlodzyanovskiy V.V., Sokolov S.F., Dzaurova Kh.M., Golitsyn S.P., Shubik Yu.V., Berman M.V., Medvedev M.M., Rivin A.E., Parkhomchuk D.S., Barybin A.E., Balandin D.А., Batalov R.E., Terekhov D.S., Evstifeev I.V., Kildeev I.R., Pyataeva O.V., Zenin S.A. Safety and Effectiveness of Pharmacologic Conversion of Atrial Fibrillation and Flutter: Results of Multicenter Trial. Part I: Study Rationale, Design and Assessment of Effectiveness. Rational Pharmacotherapy in Cardiology. 2021;17(2):193-199. (In Russ.) https://doi.org/10.20996/1819-6446-2021-03-05

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ISSN 1819-6446 (Print)
ISSN 2225-3653 (Online)