Cryo-FIRST study: improved AF and QoL outcomes with cryoballoon versus drug therapy

The phase 4 Cryo-FIRST trial assessed the efficacy and safety of first-line cryoballoon ablation versus antiarrhythmic drugs in patients with paroxysmal atrial fibrillation (AF). The presented secondary efficacy outcomes of the trial suggest superiority of cryoballoon ablation in freedom of AF recurrence and quality of life (QoL) over 12 months compared with antiarrhythmic drugs [1,2].

The phase 4, international, multicentre Cryo-FIRST study (NCT01803438) evaluated the safety and efficacy of pulmonary vein isolation using a cryoballoon as first-line therapy in comparison with antiarrhythmic drugs (class I or II) in rhythm control-naïve patients with paroxysmal AF [2]. The main results, previously presented at the AHA Scientific Session 2020, demonstrated that first-line cryoballoon ablation is superior to antiarrhythmic drugs in the prevention of atrial arrhythmia recurrence over 12 months [3]. At the EHRA 2021, Dr Nikola Pavlović (University Hospital Sestre Milosrdnice, Croatia) focused on the secondary efficacy outcomes of AF recurrence and QoL [1].

The Cryo-FIRST study enrolled 218 treatment-naïve participants with paroxysmal AF (aged 18-75 years; 32% women) from 18 sites in 9 countries. The participants were randomised 1:1 to pulmonary vein isolation with a cryoballoon or antiarrhythmic drugs treatment. The primary endpoint of the study was ≥1 episode of recurrent atrial arrhythmia and the secondary endpoints included freedom from AF recurrence and QoL at 12 months. Participants were monitored by 7-day Holter at 1, 3, 6, 9, and 12 months of follow-up, and QoL was assessed using AFEQT and SF-36V2 questionnaires at baseline and at each follow-up.

Out of the 218 participants, 187 completed the 12-month follow-up. At 1 year, freedom from AF recurrence was significantly higher in participants treated with cryoballoon ablation (86.6%) than in antiarrhythmic drug-treated participants (75.5%; P=0.023). Similarly, the AFEQT summary score was 9.9 points higher in the cryoballoon ablation group compared with the drug-therapy group (95% CI 5.5-14.2; P<0.001). The SF-36 health domain scores were similar between the groups. However, Dr Pavlović pointed out that QoL assessment may have been impaired because the study was not blinded.

In conclusion, the efficacy of cryoballoon ablation showed superior results to antiarrhythmic drug-treatment in both presented endpoints, i.e. AF recurrence and QoL. The safety profile of both treatment regimens was similar.

1. 
   
   1. Pavlović N. Impact of initial rhythm control with cryoballoon ablation versus drug therapy on atrial fibrillation recurrence and quality of life: results from the Cryo-FIRST study. EHRA 2021 Congress, 23-25 April.
   2. Kuniss M, et al N Europace 2021.
   3. Velagic V, et Circulation. 2020;142:A13915.

 

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Posted on 16 June 202128 March 2024