A randomized comparison of amiodarone and class IC antiarrhythmic drugs to treat atrial fibrillation in patients paced for sinus node disease: the Prevention Investigation and Treatment: A Group for Observation and Research on Atrial arrhythmias (PITAGORA) trial.
BACKGROUND
Rhythm control is an important goal in the treatment of recurrent atrial tachyarrhythmias (AT). The PITAGORA study was a randomized trial in patients paced for sinus node disease (SND), designed to test the noninferiority of class IC antiarrhythmic drugs (AADs) to amiodarone in terms of a primary end point composed of death, permanent AT, cardiovascular hospitalization, atrial cardioversion, or AAD change.


METHODS
Randomization was stratified to assign 2 patients to amiodarone and 2 patients to class IC AADs: propafenone or flecainide. One hundred seventy-six patients (46% men, 72 +/- 8 years) were enrolled. Device diagnostics continuously monitored AT recurrences and duration.


RESULTS
In a mean follow-up of 20 +/- 9 months, the primary end point occurred in 23 (30.7%) of 75 class IC patients and in 28 (40.0%) of 70 amiodarone patients. The absolute difference in the end point incidence (-9.3%; 95% CI between 3.7% and -22.3%) confirmed the noninferiority of class IC to amiodarone (P = .007). Kaplan-Meier 1-year freedom from AT episodes >10 minutes, 1 day, and 7 days was 40%, 73%, and 91% for amiodarone and 28%, 78%, and 86% for class IC AADs (P = nonsignificant).


CONCLUSIONS
In patients paced for SND and suffering from AT, class IC AADs proved not to be inferior to amiodarone in terms of the primary composite end point described or end points which were differently composed of mortality, efficacy, or AAD side effects. The AADs studied also showed similar results in terms of symptoms, quality of life, and freedom from AT recurrences.
Gulizia
Michele
M
Garibaldi-Nesima Hospital, Catania, Italy. michele.gulizia@tin.it
Mangiameli
Salvatore
S
Orazi
Serafino
S
Chiarandà
Giacomo
G
Piccione
Guglielmo
G
Di Giovanni
Nicolò
N
Colletti
Andrea
A
Pensabene
Orazio
O
Lisi
Francesco
F
Vasquez
Ludovico
L
Grammatico
Andrea
A
Boriani
Giuseppe
G
D000368:Aged; D000369:Aged, 80 and over; D000638:Amiodarone / Q000008:administration & dosage*; D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage*; D001146:Arrhythmia, Sinus / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000401:mortality / Q000517:prevention & control*; D002304:Cardiac Pacing, Artificial; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004562:Electrocardiography; D005260:Female; D005424:Flecainide / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011336:Probability; D011405:Propafenone / Q000008:administration & dosage; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D016037:Single-Blind Method; D013015:Sotalol / Q000008:administration & dosage; D018709:Statistics, Nonparametric; D015996:Survival Rate; D016896:Treatment Outcome
D000889:Anti-Arrhythmia Agents; D011405:Propafenone; D013015:Sotalol; D005424:Flecainide; D000638:Amiodarone