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

被引:154
作者
Atienza, Felipe [1 ]
Almendral, Jesus [2 ]
Miguel Ormaetxe, Jose [3 ]
Moya, Angel [4 ]
Daniel Martinez-Alday, Jesus [5 ]
Hernandez-Madrid, Antonio [6 ]
Castellanos, Eduardo [7 ]
Arribas, Fernando [8 ]
Angel Arias, Miguel [7 ]
Tercedor, Luis [9 ]
Peinado, Rafael [10 ]
Fe Arcocha, Maria [3 ]
Ortiz, Mercedes [2 ]
Martinez-Alzamora, Nieves [11 ]
Arenal, Angel [1 ]
Fernandez-Aviles, Francisco [1 ]
Jalife, Jose [12 ]
机构
[1] Hosp Gen Univ Gregorio Maranon, Inst Invest Sanitaria Gregorio Maranon, Dept Cardiol, Madrid 28007, Spain
[2] Hosp Univ Monteprincipe, Madrid, Spain
[3] Hosp Basurto, Bilbao, Spain
[4] Hosp Valle dHebron, Barcelona, Spain
[5] Clin San Sebastian, Bilbao, Spain
[6] Hosp Ramon & Cajal, E-28034 Madrid, Spain
[7] Hosp Virgen Salud, Toledo, Spain
[8] Hosp Doce Octubre, Madrid, Spain
[9] Hospital Virgen Nieves, Granada, Spain
[10] Hosp La Paz, Madrid, Spain
[11] Univ Politecn Valencia, E-46071 Valencia, Spain
[12] Univ Michigan, Ann Arbor, MI 48109 USA
关键词
dominant frequency mapping; high-frequency source ablation; SURGICAL ABLATION; ELECTROGRAMS; GRADIENT; SITES;
D O I
10.1016/j.jacc.2014.09.053
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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. (C) 2014 by the American College of Cardiology Foundation.
引用
收藏
页码:2455 / 2467
页数:13
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