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Europace Advance Access originally published online on February 21, 2006
Europace 2006 8(4):302-305; doi:10.1093/europace/eul003
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© The European Society of Cardiology 2006. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

ATRIAL FIBRILLATION

Design and rationale of a randomized study to compare amiodarone and Class IC anti-arrhythmic drugs in terms of atrial fibrillation treatment efficacy in patients paced for sinus node disease: the PITAGORA trial

Michele Gulizia1,* {dagger}, Salvatore Mangiameli2, Giacomo Chiarandà3, Vincenzo Spadola4, Nicolò Di Giovanni5, Andrea Colletti6, Vincenzo Bulla7, Antonio Circo8, Orazio Pensabene9, Ludovico Vasquez10, Ignazio Vaccaro11, Andrea Grammatico12 on behalf of PITAGORA Study Investigators

1 Cardiology DepartmentGaribaldi-Nesima HospitalVia Palermo 636, Catania, 95122 Italy; 2 Cardiology DepartmentGaribaldi HospitalCatania Italy; 3 Cardiology DepartmentMuscatello HospitalSiracusa Italy; 4 Cardiology DepartmentCivile HospitalRagusa Italy; 5 Cardiology DepartmentAbele Aiello HospitalMazzara del Vallo Italy; 6 Cardiology DepartmentCivili Riuniti HospitalSciacca Italy; 7 Cardiology DepartmentCannizzaro HospitalCatania Italy; 8 Cardiology DepartmentVittorio Emanuele Hospital Italy; 9 Cardiology DepartmentVilla Sofia HospitalPalermo Italy; 10 Cardiology DepartmentCivile HospitalMilazzo Italy; 11 Cardiology DepartmentS.Giovanni di Dio HospitalAgrigento Italy; 12 CNBD Department, Medtronic, Rome Italy

Aims Many sinus node disease (SND) patients suffer from atrial fibrillation (AF). Anti-arrhythmic drugs (AADs) are the therapeutic mainstay for AF prophylaxis. The PITAGORA trial has a multicentre, prospective, randomized, single blind design to compare amiodarone with Class IC AADs in patients who have an AF history and are paced for SND.

Methods and results Starting from January 2001, 176 patients received a Medtronic AT500 pacemaker. AADs were randomly assigned with a 3 : 2 ratio between Class III and Class IC. Randomization was stratified in order to assign two patients to amiodarone and one patient to sotalol every three Class III AAD patients. After a 5-month observational period, Ramp or Burst+ ATP therapies were enabled in a randomized way, maintained for 4 months, and then crossed over. Total follow-up period is 21 months. The primary long-term objective is to show the non-inferiority of IC AADs compared with amiodarone in terms of time to first occurrence of a composite endpoint (death, atrial cardioversion, hospitalizations due to AF or heart failure, or change of AADs). Data will be analysed on an intention-to-treat basis. The primary short-term objective is to compare Ramp vs. Burst+ efficacy in terminating atrial tachyarrhythmias treated by the device. Secondary endpoints are major clinical events, medication toxicity, symptoms, AF burden, and quality-of-life.

Conclusion Given the high morbidity and healthcare costs associated with AF, new therapeutic strategies are needed. The results of the PITAGORA trial may help in guiding AADs therapy and ATP programming in SND patients suffering from AF.

Key Words: Anti-arrhythmic drug therapy, Anti-tachycardia pacing, Sinus node disease, Atrial fibrillation

* Corresponding author. Tel:+39 0 95 7594728; fax:+39 0 95 7120662. E-mail address: michele.gulizia{at}tin.it


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