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Europace Advance Access published online on February 21, 2006
Europace, doi:10.1093/europace/eul003
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© The European Society of Cardiology 2006. All rights reserved
Received November 18, 2004
Accepted November 22, 2005

Article

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 Gulizia 1 *, Salvatore Mangiameli 2, Giacomo Chiarandà 3, Vincenzo Spadola 4, Nicolò Di Giovanni 5, Andrea Colletti 6, Vincenzo Bulla 7, Antonio Circo 8, Orazio Pensabene 9, Ludovico Vasquez 10, Ignazio Vaccaro 11, Andrea Grammatico 12, and on behalf of PITAGORA Study Investigators

1 Cardiology Department, Garibaldi-Nesima Hospital, Via Palermo 636, Catania, 95122, Italy
2 Cardiology Department, Garibaldi Hospital, Catania, Italy
3 Cardiology Department, Muscatello Hospital, Siracusa, Italy
4 Cardiology Department, Civile Hospital, Ragusa, Italy
5 Cardiology Department, Abele Aiello Hospital, Mazzara del Vallo, Italy
6 Cardiology Department, Civili Riuniti Hospital, Sciacca, Italy
7 Cardiology Department, Cannizzaro Hospital, Catania, Italy
8 Cardiology Department, Vittorio Emanuele Hospital, Italy
9 Cardiology Department, Villa Sofia Hospital, Palermo, Italy
10 Cardiology Department, Civile Hospital, Milazzo, Italy
11 Cardiology Department, S.Giovanni di Dio Hospital, Agrigento, Italy
12 CNBD Department, Medtronic, Rome, Italy

* To whom correspondence should be addressed.
Michele Gulizia, E-mail: michele.gulizia{at}tin.it


  Abstract

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.

Keywords: Anti-arrhythmic drug therapy; Anti-tachycardia pacing; Sinus node disease; Atrial fibrillation.
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