Quality of life measured in first-line therapy during the Cryo-FIRST study: a comparison between cryoballoon catheter ablation versus antiarrhythmic drug therapy

Abstract

Background By consensus statements, catheter ablation is a recommended treatment for patients with symptomatic drug-refractory paroxysmal atrial fibrillation (AF), as patients try to alleviate the burdensome AF symptoms that reduce the Quality of Life (QoL). Yet, first-line treatment of symptomatic patients via catheter ablation prior to initiation of antiarrhythmic drugs (AADs) is only a reasonable alternative (Class IIa). Clearly, more clinical data is necessary that compares catheter ablation to AAD therapy in treatment naïve patients. Purpose The Cryo-FIRST trial was designed to compare AAD treatment against pulmonary vein isolation (PVI) while using a cryoballoon catheter (Arctic Front Advance; Medtronic, Inc.). This current data analysis examines the QoL endpoints when comparing AADs to cryoballoon ablation in patients with symptomatic treatment naïve paroxysmal AF. Methods This randomized multicenter trial enrolled 220 patients from 18 sites in 9 countries (Europe, Australia, and Latin America) in a prospective open-blinded endpoint study design. Patients had not been administered a class I or III AAD for longer than 48 hours for inclusion into the study. Subjects were randomized (1:1) into a cohort that was administered AAD therapy or a cohort that received PVI via cryoablation. The prespecified QoL endpoint at 12 months was measured using the Atrial Fibrillation Effect on Quality of Life (AFEQT) scores, and QoL recordings were taken at baseline, 1, 3, 6, 9, and 12 months following the index treatment. Results Of the 218 patients randomized (age 52±13 years, 68% male) 86% completed the 12-month follow-up. Crossovers occurred in 9% of subjects (N=20), including: 1 subject in the cryoablation arm and 19 subjects in the AAD arm. At 12 months, 86.5% of the patients in the cryoablation arm and 70.4% of the patients in the AAD arm where without symptoms (EHRA score 1). The mean AFEQT summary score was more favorable in the catheter ablation group compared to the drug therapy group at 12 months (88.9 vs. 78.1 points, respectively). The adjusted difference was 9.9 points (95% CI: 5.5–14.2; P<0.0001). Conclusions Cryoballoon ablation resulted in a significant improvement in QoL at 12 months compared to AAD therapy in treatment naïve patients with first-line symptomatic paroxysmal AF. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic International Trading Sàrl

Catheter ablation superiority over the pharmacological treatments in atrial fibrillation: a dedicated review

“…Some trials [6,7,25] have attempted to investigate the effects of catheter ablation on naïve patients with paroxysmal AF, as compared to pharmacology therapy. Yet, even though there was significant [30,32] shows similar significant results as CABANA [29] with regard of QoL for patients who are refractory to antiarrhythmic medications, making these findings more robust. These findings show a superiority of catheter ablation over pharmacological therapy and can assist with decisionmaking for managing AF, see Table 1.…”

“…There was a significant improvement of QoL of catheter ablation over standard treatment (adjusted difference, 5.3 points [95% CI, 3.7–6.9]; p < .001; for AFEQT) and (adjusted difference, −1.7 points [95% CI, −2.3 to −1.2]; p < .001; for MAFSI frequency). Similarly, the Cryo-FIRST and CAPTAF trial [ 30 , 32 ] shows similar significant results as CABANA [ 29 ] with regard of QoL for patients who are refractory to antiarrhythmic medications, making these findings more robust. These findings show a superiority of catheter ablation over pharmacological therapy and can assist with decision-making for managing AF, see Table 1 .…”

Clinical outcomes following rhythm control for atrial fibrillation: is early better?

“…The recently presented Cryo-FIRST Cryoballoon Ablation Trial (NCT01803438) [49] among naïve patients with AF similarly showed a higher arrhythmia-free survival rate among patients after cryoballoon ablation as compared to the antiarrhythmic drugs therapy group (82.2% vs. 67.6%) during 12 months of follow-up [50]. In addition, an improvement in the quality of life was observed in the catheter ablation group; and 86.5% of the these patients were symptom-free vs. 70.4% of patients in the anti-arrhythmic drug group [51]. Of note, the results of ATTEST trial [52] support the notion of increased benefit with AF catheter ablation as compared to AAD therapy.…”

Novel scoring system derived from meta‐analysis and validated in cohort population for predicting 1‐year atrial fibrillation recurrence after cryoballoon catheter ablation: The HeLPS‐Cryo score

“…Moreover, first-line CBCA provided better benefits in reducing AF, improving quality of life, and relieving symptoms than AADs. [33][34][35] The high recurrence rate of AF following successful PVI remains the most crucial issue in CBCA. Most AF recurrences occur within the first year after CBCA.…”

“…Three major RCTs, such as Cryo‐FIRST, 12 STOP AF First, 13 and EARLY‐AF, 14 revealed the promising future of CBCA as the first‐line treatment for paroxysmal AF because it could reduce AF recurrence significantly compared to the AADs. Moreover, first‐line CBCA provided better benefits in reducing AF, improving quality of life, and relieving symptoms than AADs 33–35 …”