Document Detail


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.
MedLine Citation:
PMID:  16627459     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Michele Gulizia; Salvatore Mangiameli; Giacomo Chiarandà; Vincenzo Spadola; Nicolò Di Giovanni; Andrea Colletti; Vincenzo Bulla; Antonio Circo; Orazio Pensabene; Ludovico Vasquez; Ignazio Vaccaro; Andrea Grammatico;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2006-02-21
Journal Detail:
Title:  Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology     Volume:  8     ISSN:  1099-5129     ISO Abbreviation:  Europace     Publication Date:  2006 Apr 
Date Detail:
Created Date:  2006-04-21     Completed Date:  2006-09-28     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  100883649     Medline TA:  Europace     Country:  England    
Other Details:
Languages:  eng     Pagination:  302-5     Citation Subset:  IM    
Affiliation:
Cardiology Department, Garibaldi-Nesima Hospital, Via Palermo 636, Catania, 95122, Italy. michele.gulizia@tin.it
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MeSH Terms
Descriptor/Qualifier:
Amiodarone / therapeutic use*
Anti-Arrhythmia Agents / therapeutic use*
Arrhythmia, Sinus / therapy*
Atrial Fibrillation / drug therapy*
Cardiac Pacing, Artificial*
Female
Humans
Italy
Male
Prospective Studies
Questionnaires
Research Design
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anti-Arrhythmia Agents; 1951-25-3/Amiodarone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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