TY - JOUR
T1 - Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation
T2 - A randomized controlled trial
AU - Wilber, David J.
AU - Pappone, Carlo
AU - Neuzil, Petr
AU - De Paola, Angelo
AU - Marchlinski, Frank
AU - Natale, Andrea
AU - Macle, Laurent
AU - Daoud, Emile G.
AU - Calkins, Hugh
AU - Hall, Burr
AU - Reddy, Vivek
AU - Augello, Giuseppe
AU - Reynolds, Matthew R.
AU - Vinekar, Chandan
AU - Liu, Christine Y.
AU - Berry, Scott M.
AU - Berry, Donald A.
PY - 2010/1/27
Y1 - 2010/1/27
N2 - Context: 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. Design, Setting, and Participants: 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. Intervention: Catheter ablation (n=106) or ADT (n=61), with assessment for effectiveness in a comparable 9-month follow-up period. Main Outcome Measures: 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. Conclusion: 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. Trial Registration: clinicaltrials.gov Identifier: NCT00116428.
AB - Context: 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. Design, Setting, and Participants: 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. Intervention: Catheter ablation (n=106) or ADT (n=61), with assessment for effectiveness in a comparable 9-month follow-up period. Main Outcome Measures: 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. Conclusion: 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. Trial Registration: clinicaltrials.gov Identifier: NCT00116428.
UR - http://www.scopus.com/inward/record.url?scp=75749090779&partnerID=8YFLogxK
U2 - 10.1001/jama.2009.2029
DO - 10.1001/jama.2009.2029
M3 - Article
C2 - 20103757
AN - SCOPUS:75749090779
SN - 0098-7484
VL - 303
SP - 333
EP - 340
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 4
ER -