Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial.
BACKGROUND
Antiarrhythmic drugs are commonly used for prevention of recurrent atrial fibrillation (AF) despite inconsistent efficacy and frequent adverse effects. Catheter ablation has been proposed as an alternative treatment for paroxysmal AF.


OBJECTIVE
To determine the efficacy of catheter ablation compared with antiarrhythmic drug therapy (ADT) in treating symptomatic paroxysmal AF.


METHODS
A prospective, multicenter, randomized (2:1), unblinded, Bayesian-designed study conducted at 19 hospitals of 167 patients who did not respond to at least 1 antiarrhythmic drug and who experienced at least 3 AF episodes within 6 months before randomization. Enrollment occurred between October 25, 2004, and October 11, 2007, with the last follow-up on January 19, 2009.


METHODS
Catheter ablation (n = 106) or ADT (n = 61), with assessment for effectiveness in a comparable 9-month follow-up period.


METHODS
Time to protocol-defined treatment failure. The proportion of patients who experienced major treatment-related adverse events within 30 days of catheter ablation or ADT was also reported.


RESULTS
At the end of the 9-month effectiveness evaluation period, 66% of patients in the catheter ablation group remained free from protocol-defined treatment failure compared with 16% of patients treated with ADT. The hazard ratio of catheter ablation to ADT was 0.30 (95% confidence interval, 0.19-0.47; P < .001). Major 30-day treatment-related adverse events occurred in 5 of 57 patients (8.8%) treated with ADT and 5 of 103 patients (4.9%) treated with catheter ablation. Mean quality of life scores improved significantly in patients treated by catheter ablation compared with ADT at 3 months; improvement was maintained during the course of the study.


CONCLUSIONS
Among patients with paroxysmal AF who had not responded to at least 1 antiarrhythmic drug, the use of catheter ablation compared with ADT resulted in a longer time to treatment failure during the 9-month follow-up period.


BACKGROUND
clinicaltrials.gov Identifier: NCT00116428.
Wilber
David J
DJ
Cardiovascular Institute, Department of Medicine, Loyola University Medical Center, 2160 S First Ave, Bldg 110, Room 6232, Maywood, IL 60153, USA. dwilber@lumc.edu
Pappone
Carlo
C
Neuzil
Petr
P
De Paola
Angelo
A
Marchlinski
Frank
F
Natale
Andrea
A
Macle
Laurent
L
Daoud
Emile G
EG
Calkins
Hugh
H
Hall
Burr
B
Reddy
Vivek
V
Augello
Giuseppe
G
Reynolds
Matthew R
MR
Vinekar
Chandan
C
Liu
Christine Y
CY
Berry
Scott M
SM
Berry
Donald A
DA
D000889:Anti-Arrhythmia Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D017211:Treatment Failure
D000889:Anti-Arrhythmia Agents