Radiofrequency Catheter Ablation of Drivers vs. Circumferential Pulmonary Vein Isolation in Patients With Atrial Fibrillation - RADAR-AF

Description:

The goal of the trial was to evaluate treatment with high-frequency source ablation compared with circumferential pulmonary vein isolation among patients with symptomatic drug-refractory atrial fibrillation (AF).

Contribution to the Literature: The RADAR-AF trial showed that high-frequency source ablation plus circumferential pulmonary vein isolation was not superior to circumferential pulmonary vein isolation alone.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Patients with symptomatic drug-resistant AF (paroxysmal or persistent)

    Number of enrollees: 232 patients
    Duration of follow-up: 12 months
    Mean patient age: 53 years
    Percentage female: 16%

Primary Endpoints:

  • Freedom from AF at 6 and 12 months

Secondary Endpoints:

  • Serious adverse events

Drug/Procedures Used:

Patients with symptomatic paroxysmal drug-refractory AF were randomized to high-frequency source ablation (n = 56) versus circumferential pulmonary vein isolation alone (n = 59).

Patients with symptomatic persistent drug-refractory AF were randomized to high-frequency source ablation plus circumferential pulmonary vein isolation (n = 59) versus circumferential pulmonary vein isolation alone (n = 58).

Principal Findings:

Overall, 232 patients were randomized. The mean age was 53 years, 16% were women, and 3% had diabetes. In the paroxysmal group, the duration of AF was approximately 6 years, whereas in the persistent group, the duration was approximately 3 years.

Among the paroxysmal AF cohort:
- Freedom from AF at 6 months: 73% vs. 83% (p for noninferiority = 0.23), respectively, for high-frequency source ablation vs. circumferential pulmonary vein isolation
- Freedom from AF at 12 months: 69% vs. 69% (p for noninferiority = 0.04), respectively
- Serious adverse events: 9% vs. 24% (p for superiority = 0.03), respectively

Among the persistent AF cohort:
- Freedom from AF at 6 months: 61% vs. 60% (p for superiority = 0.94), respectively, for high-frequency source ablation plus circumferential pulmonary vein isolation vs. circumferential pulmonary vein isolation alone
- Freedom from AF at 12 months: 52% vs. 39% (p for superiority = 0.15), respectively
- Serious adverse events: 24% vs. 10% (p for superiority = 0.05), respectively

Interpretation:

Among patients with paroxysmal AF, high-frequency source ablation was not noninferior to circumferential pulmonary vein isolation in freedom from AF at 6 months. However, high-frequency source ablation was noninferior in regard to freedom from AF at 12 months, and was associated with a lower incidence of serious adverse events.

Among patients with persistent AF, high-frequency source ablation plus circumferential pulmonary vein isolation was not superior to circumferential pulmonary vein isolation alone in freedom from AF at 6 and 12 months. Moreover, this therapy was associated with an increase in serious adverse events.

References:

Atienza F, Almendral J, Ormaetxe JM, et al. Comparison of radiofrequency catheter ablation of drivers and circumferential pulmonary vein isolation in atrial fibrillation: a noninferiority randomized multicenter RADAR-AF trial. J Am Coll Cardiol 2014;64:2455-67.

Presented by Dr. Felipe Atienza at the American Heart Association Scientific Sessions, Dallas, TX, November 19, 2013.

Keywords: Follow-Up Studies, Pulmonary Veins, Electrophysiologic Techniques, Cardiac, Catheter Ablation, Diabetes Mellitus


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