title: Comparison of radiofrequency catheter ablation of drivers and circumferential pulmonary vein isolation in atrial fibrillation: a noninferiority randomized multicenter RADAR-AF trial.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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 = 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.
  
  
  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 = 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.
  
  
  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 + HFSA offered no incremental value. (Radiofrequency Ablation of Drivers of Atrial Fibrillation [RADAR-AF]; NCT00674401).
authors.affiliation: Cardiology Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain. Electronic address: fatienzaf@secardiologia.es.
authors.forename: Felipe
authors.initials: F
authors.lastname: Atienza
authors.affiliation: Hospital Universitario Montepríncipe, Madrid, Spain.
authors.forename: Jesús
authors.initials: J
authors.lastname: Almendral
authors.affiliation: Hospital de Basurto, Bilbao, Spain.
authors.forename: José Miguel
authors.initials: JM
authors.lastname: Ormaetxe
authors.affiliation: Hospital Vall d'Hebron, Barcelona, Spain.
authors.forename: Angel
authors.initials: A
authors.lastname: Moya
authors.affiliation: Clinica San Sebastian, Bilbao, Spain.
authors.forename: Jesús Daniel
authors.initials: JD
authors.lastname: Martínez-Alday
authors.affiliation: Hospital Ramón y Cajal, Madrid, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Hernández-Madrid
authors.affiliation: Hospital Virgen de la Salud, Toledo, Spain.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Castellanos
authors.affiliation: Hospital Doce de Octubre, Madrid, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Arribas
authors.affiliation: Hospital Virgen de la Salud, Toledo, Spain.
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: Arias
authors.affiliation: Hospital Virgen de las Nieves, Granada, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Tercedor
authors.affiliation: Hospital La Paz, Madrid, Spain.
authors.forename: Rafael
authors.initials: R
authors.lastname: Peinado
authors.affiliation: Hospital de Basurto, Bilbao, Spain.
authors.forename: Maria Fe
authors.initials: MF
authors.lastname: Arcocha
authors.affiliation: Hospital Universitario Montepríncipe, Madrid, Spain.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Ortiz
authors.affiliation: Universidad Politécnica de Valencia, Valencia, Spain.
authors.forename: Nieves
authors.initials: N
authors.lastname: Martínez-Alzamora
authors.affiliation: Cardiology Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.
authors.forename: Angel
authors.initials: A
authors.lastname: Arenal
authors.affiliation: Cardiology Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Fernández-Avilés
authors.affiliation: University of Michigan, Ann Arbor, Michigan.
authors.forename: José
authors.initials: J
authors.lastname: Jalife
mesh_terms: D001281:Atrial Fibrillation / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D063868:Patient Outcome Assessment; D011446:Prospective Studies; D011667:Pulmonary Veins / Q000601:surgery*; D011788:Quality of Life; D012008:Recurrence; D019233:Retreatment; D016037:Single-Blind Method
keywords: dominant frequency mapping; high-frequency source ablation