title: 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.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Cardiology Department, Garibaldi-Nesima Hospital, Via Palermo 636, Catania, 95122, Italy. michele.gulizia@tin.it
authors.forename: Michele
authors.initials: M
authors.lastname: Gulizia
authors.forename: Salvatore
authors.initials: S
authors.lastname: Mangiameli
authors.forename: Giacomo
authors.initials: G
authors.lastname: Chiarandà
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Spadola
authors.forename: Nicolò
authors.initials: N
authors.lastname: Di Giovanni
authors.forename: Andrea
authors.initials: A
authors.lastname: Colletti
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Bulla
authors.forename: Antonio
authors.initials: A
authors.lastname: Circo
authors.forename: Orazio
authors.initials: O
authors.lastname: Pensabene
authors.forename: Ludovico
authors.initials: L
authors.lastname: Vasquez
authors.forename: Ignazio
authors.initials: I
authors.lastname: Vaccaro
authors.forename: Andrea
authors.initials: A
authors.lastname: Grammatico
mesh_terms: D000638:Amiodarone / Q000627:therapeutic use*; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D001146:Arrhythmia, Sinus / Q000628:therapy*; D001281:Atrial Fibrillation / Q000188:drug therapy*; D002304:Cardiac Pacing, Artificial; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D011446:Prospective Studies; D012107:Research Design; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000889:Anti-Arrhythmia Agents; D000638:Amiodarone