Why the study?
Does prophylactic antiarrhythmic drug therapy prevent atrial tachyarrhythmia recurrence in adults with paroxysmal atrial fibrillation post-pulmonary vein isolation?
RCT (n=243)
Open-label
randomized by envelopes
No
Does prophylactic antiarrhythmic drug therapy prevent atrial tachyarrhythmia recurrence in adults with paroxysmal atrial fibrillation post-pulmonary vein isolation?
Prophylactic antiarrhythmic therapy with propafenone, verapamil, or sotalol showed minimal incremental benefit over no antiarrhythmic therapy in preventing recurrence after pulmonary vein isolation.
Prophylactic AADs add no benefit after PVI; challenges routine use and confirms observation-only strategy suffices in paroxysmal AF.
Aim . To study a complex approach in observation and medication monotherapy with assessment of its effectiveness and safety, with the following antiarrhythmic drugs (AAD): IC class propafenon, III class sotalol, IV class verapamil, — comparing to the controls without AAD, for prevention of atrial fibrillation (AF) recurrent, as atrial tachyarrhythmia (AT) in postoperation period of catheter isolation of the pulmonary veins ostia (PV). Material and methods. The study PRUF is prospective, comparison, open-label, randomized, with control group. Males and females included, at the age ≥25 y., having symptomatic paroxysmal AF without organic pathology of the heart. 243 patients were randomized to 4 groups according the drugs studied and invasive management group with achieved successful isolation of the PV ostia, confirmed during operation. There were no significant differences in baseline characteristics: sex, age, duration of AF, main disease and comorbidities, echocardiography parameters and concomitant therapy. Follow-up lasted for 365 days. Results. PRUF study provided the following results: in group 1 (verapamil) effectiveness after first operation was 65,5% (n=40), in group 2 (propafenon) — 70,96% (n=44), in group 3 (sotalol) — 65% (n=39) and the controls (no AAD) — 65% (n=39), respectively. Main results of the study will be presented in further publications. Conclusion . First time, the assessment of efficacy and safety provided, of different AAD classes for prevention of AF and AT episodes in earlier and later post-operation periods of catheter PV ostia, with implanted subcutaneous cardio monitor for symptomatic and asymptomatic AT, and traditional 24-hour monitoring system by Holter.
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Тарасов et al. (2016) conducted an RCT in Symptomatic paroxysmal atrial fibrillation (n=243). Propafenone vs. No antiarrhythmic drugs was evaluated on Effectiveness after first operation (absence of recurrence).
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