Author + information
- Received July 16, 2014
- Revision received August 31, 2014
- Accepted September 5, 2014
- Published online December 16, 2014.
- Felipe Atienza, MD, PhD∗∗ (, )
- Jesús Almendral, MD, PhD†,
- José Miguel Ormaetxe, MD, PhD‡,
- Ángel Moya, MD§,
- Jesús Daniel Martínez-Alday, MD, PhD‖,
- Antonio Hernández-Madrid, MD, PhD¶,
- Eduardo Castellanos, MD#,
- Fernando Arribas, MD, PhD∗∗,
- Miguel Ángel Arias, MD, PhD#,
- Luis Tercedor, MD††,
- Rafael Peinado, MD, PhD‡‡,
- Maria Fe Arcocha, MD‡,
- Mercedes Ortiz, PhD†,
- Nieves Martínez-Alzamora, PhD§§,
- Ángel Arenal, MD, PhD∗,
- Francisco Fernández-Avilés, MD, PhD∗,
- José Jalife, MD‖‖,
- RADAR-AF Investigators
- ∗Cardiology Department, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain
- †Hospital Universitario Montepríncipe, Madrid, Spain
- ‡Hospital de Basurto, Bilbao, Spain
- §Hospital Vall d’Hebron, Barcelona, Spain
- ‖Clinica San Sebastian, Bilbao, Spain
- ¶Hospital Ramón y Cajal, Madrid, Spain
- #Hospital Virgen de la Salud, Toledo, Spain
- ∗∗Hospital Doce de Octubre, Madrid, Spain
- ††Hospital Virgen de las Nieves, Granada, Spain
- ‡‡Hospital La Paz, Madrid, Spain
- §§Universidad Politécnica de Valencia, Valencia, Spain
- ‖‖University of Michigan, Ann Arbor, Michigan
- ↵∗Reprint requests and correspondence:
Dr. Felipe Atienza, Hospital General Universitario Gregorio Marañón, Cardiology Department, C/ Dr Esquerdo, 46, 28007 Madrid, Spain.
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.
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 = 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)
This study was funded by the Centro Nacional de Investigaciones Cardiovasculares and by an unrestricted research grant from St. Jude Medical. Dr. Atienza has received research grants from St. Jude Medical; and is on the advisory board of Medtronic, Inc. Dr. Jalife is on the scientific advisory board of Topera, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 16, 2014.
- Revision received August 31, 2014.
- Accepted September 5, 2014.
- American College of Cardiology Foundation