Comparison of Radiofrequency Catheter Ablation of Drivers versus Circunferencial Pulmonary Vein Isolation in Patients with Atrial Fibrillation. A Noninferiority Randomized Clinical Trial

Abstract

BACKGROUND Empiric circumferential pulmonary vein isolation (CPVI) has become the therapy of choice for drugrefractory atrial fibrillation (AF). Although results are suboptimal, it is unknown whether mechanistically-based strategies targeting AF drivers are superior. OBJECTIVES This study sought to determine the efficacy and safety of localized high-frequency source ablation (HFSA) compared with CPVI in patients with drug-refractory AF. METHODS This prospective, multicenter, single-blinded study of 232 patients (age 53 10 years, 186 males) randomized those with paroxysmal AF (n ¼ 115) to CPVI or HFSA-only (noninferiority design) and those with persistent AF (n ¼ 117) to CPVI or a combined ablation approach (CPVI þ HFSA, superiority design). The primary endpoint was freedom from AF at 6 months post-first ablation procedure. Secondary endpoints included freedom from atrial tachyarrhythmias (AT) at 6 and 12 months, periprocedural complications, overall adverse events, and quality of life. RESULTS In paroxysmal AF, HFSA failed to achieve noninferiority at 6 months after a single procedure but, after redo procedures, was noninferior to CPVI at 12 months for freedom from AF and AF/AT. Serious adverse events were significantly reduced in the HFSA group versus CPVI patients (p ¼ 0.02). In persistent AF, there were no significant differences between treatment groups for primary and secondary endpoints, but CPVI þ HFSA trended toward more serious adverse events. CONCLUSIONS In paroxysmal AF, HFSA failed to achieve noninferiority at 6 months but was noninferior to CPVI at 1 year in achieving freedom of AF/AT and a lower incidence of severe adverse events. In persistent AF, CPVI þ HFSA offered no incremental value. (Radiofrequency Ablation of Drivers of Atrial Fibrillation [RADAR-AF]; NCT00674401) (J Am Coll Cardiol 2014;64:2455–67).