Results

The Cryoballoon meets the primary endpoints.1

The results of this landmark trial show that Cryoballoon ablation should be considered a gold standard for the treatment of paroxysmal atrial fibrillation (PAF). Click below for more details on the outcome of the FIRE AND ICE trial.

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Non-inferiority study design
Cryoballoon met the primary efficacy endpoint

Rigorous composite efficacy endpoint measured time to first documented:

  • Recurrent atrial rrhythmia(AF>30s/AT/AFL)
  • AAD Prescription
  • Repeat ablation
Primary Efficacy Endpoint Endpoint Table
In the Kaplan-Meier plot, Arctic Front Advance has the lowest failure rate, although the test across all four catheter types was not statistically significant (p=0.25)
Efficacy Performance by Catheter

SHORTER, MORE CONSISTENT*
PROCEDURE TIMES WITH CRYOBALLOON

Time Measurement Table * Standard deviations were smaller in the cryoballoon group for all three procedure time measures, indicating more consistent times with less variation from the mean.
** t-test
*** Protocol required 30 min. waiting period after last application to assess PV isolation

Primary Safety Endpoint Results:

  • RFC group = 51
  • Cryoballoon group = 40
    (HR = 0.78; 95% CI = 0.52–1.18; P = 0.24)
  • One-year Kaplan-Meier event rate estimates 10.2% Cryoballoon and 12.8% RFC

LOW OVERALL INCIDENCE OF
SERIOUS TREATMENT-RELATED ADVERSE EVENTS

Most Frequently Observed Chart * Includes vascular pseudoaneurysm, AV fistula, device-related infection, hematoma, puncture site hemorrhage, groin pain
** Adjudicated as serious (e.g., hospitalization) and causally related to the therapeutic intervention (e.g., ablation-induced or drug-induced)
*** 0.5% PNI ongoing after 3 months

Reference

  1. Kuck KH, et al. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016; 374(23): 2235-45.

© 2016 Medtronic