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A Randomized Trial of Circumferential Pulmonary Vein Ablation Versus Antiarrhythmic Drug Therapy in Paroxysmal Atrial Fibrillation

The APAF Study

Carlo Pappone, MD, PhD, FACC^_*,_*, Giuseppe Augello, MD^_*, Simone Sala, MD^_*, Filippo Gugliotta, BEng^_*, Gabriele Vicedomini, MD^_*, Simone Gulletta, MD^_*, Gabriele Paglino, MD^_*, Patrizio Mazzone, MD^_*, Nicoleta Sora, MD^_*, Isabelle Greiss, MD^_*, Andreina Santagostino, MD^_*, Laura LiVolsi, MD^_*, Nicola Pappone, MD, Andrea Radinovic, MD^_*, Francesco Manguso, MD, PhD^_* and Vincenzo Santinelli, MD^_*

^_* Division of Cardiac Pacing and Electrophysiology, San Raffaele University Hospital, Milan, Italy
Salvatore Maugeri Foundation, IRCCS, Telese Terme, Italy.

View larger version (17K): [in this window] [in a new window] [Download PPT slide]   Figure 1 Study design. Enrolled patients were randomized to circumferential pulmonary vein ablation (CPVA) (n = 99) or antiarrhythmic drug therapy (ADT) (n = 99). After 4 weeks of antiarrhythmic therapy (run-in phase), patients proceeded to the randomized treatment (i.e., catheter ablation or solely continuing ADT). AAD = antiarrhythmic drug.

View larger version (103K): [in this window] [in a new window] [Download PPT slide]   Figure 2 Pre- and post-ablation bipolar voltage maps of the left atrium with either CARTO (A) or NavX systems (B) are shown.

View larger version (20K): [in this window] [in a new window] [Download PPT slide]   Figure 3 Flow of patients randomized to circumferential pulmonary vein ablation (CPVA) and antiarrhythmic drug therapy (ADT) groups. (A) After ablation, stable sinus rhythm (SR) was obtained in 85 patients of whom 82 stopped oral anticoagulant therapy (OAT). Of the 11 patients with recurrent atrial fibrillation (AF), 6 underwent a repeat procedure (REDO). Post-ablation atrial tachyarrhythmia (AT) developed in only 3 patients, and all had a successful re-do procedure. (B) Among patients randomized to ADT, 42 patients crossed over to CPVA of whom only 6 had AF recurrence. By study design, AF was considered under control if the patient had no more than 1 episode of AF in a 6-month period.

View larger version (41K): [in this window] [in a new window] [Download PPT slide]   Figure 4 Outcomes in the APAF (Ablation for Paroxysmal Atrial Fibrillation) trial. (A) By Kaplan-Meier analysis, 86% of patients randomized to circumferential pulmonary vein ablation (CPVA) needed only a single procedure and were atrial tachyarrhythmia (AT)-free at the end of follow-up as compared with the 22% of patients randomized to antiarrhythmic drug therapy (ADT) (p < 0.001) who did not require a second ADT and were AT-free at the end of follow-up; time 0 started at the end of the 6-week blanking period for both groups. (B and C) Monthly rhythm analysis in the NavX versus CARTO subgroups (95% and 87% at 1 year, respectively, p = 0.08) and in the 8-mm versus irrigated tip catheter groups (95% and 78% at 1 year, respectively, p = 0.03). (D) By monthly rhythm analysis that also took into account the outcome of the second procedure and for patients controlled with combined therapy in ADT group, 93% of CPVA patients were free from ATs as compared with the 35% in the ADT group. SR = sinus rhythm.