Comparison of Radiofrequency Catheter Ablation of Drivers and Circumferential Pulmonary Vein Isolation in Atrial Fibrillation: A Noninferiority Randomized Multicenter RADAR-AF Trial

• Published in: Journal of the American College of Cardiology Vol. 64; no. 23; pp. 2455 - 2467
• Main Authors: ATIENZA, Felipe, ALMENDRAL, Jesús, PEINADO, Rafael, ARCOCHA, Maria Fe, ORTIZ, Mercedes, MARTINEZ-ALZAMORA, Nieves, ARENAL, Angel, FERNANDEZ-AVILES, Francisco, JALIFE, José, ORMAETXE, José Miguel, MOYA, Angel, DANIEL MARTINEZ-ALDAY, Jesús, HERNANDEZ-MADRID, Antonio, CASTELLANOS, Eduardo, ARRIBAS, Fernando, ARIAS, Miguel Angel, TERCEDOR, Luis
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier 16-12-2014
• Subjects: Atrial Fibrillation - surgery; Biological and medical sciences; Cardiac dysrhythmias; Cardiology. Vascular system; Catheter Ablation - adverse effects; Combined Modality Therapy; Female; Heart; Humans; Male; Medical sciences; Middle Aged; Other treatments; Patient Outcome Assessment; Prospective Studies; Pulmonary Veins - surgery; Quality of Life; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Recurrence; Retreatment; Single-Blind Method; Treatment. General aspects; Tumors; Arrhythmia; Multicenter study; Atrial fibrillation; Instrumentation therapy; Catheter; Thermal ablation; Cardiovascular disease; Radiofrequency; Excitability disorder; Randomization; Pulmonary vessel; Heart disease; Blood vessel; Radar; Clinical trial; Isolation; Circulatory system; Cardiology; Non-inferiority trial; Comparative study; Pulmonary vein; high-frequency source ablation; dominant frequency mapping
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2014.09.053

Empiric circumferential pulmonary vein isolation (CPVI) has become the therapy of choice for drug-refractory atrial fibrillation (AF). Although results are suboptimal, it is unknown whether mechanistically-based strategies targeting AF drivers are superior.
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.
This prospective, multicenter, single-blinded study of 232 patients (age 53 ± 10 years, 186 males) randomized those with paroxysmal AF (n = 115) to CPVI or HFSA-only (noninferiority design) and those with persistent AF (n = 117) to CPVI or a combined ablation approach (CPVI + 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.
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 = 0.02). In persistent AF, there were no significant differences between treatment groups for primary and secondary endpoints, but CPVI + HFSA trended toward more serious adverse events.
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 + HFSA offered no incremental value. (Radiofrequency Ablation of Drivers of Atrial Fibrillation [RADAR-AF]; NCT00674401).