PolarX vs Arctic Front for Cryoballoon Ablation of Paroxysmal AF: The Randomized COMPARE CRYO Study

Reichlin, T; Kueffer, T; Knecht, S; Madaffari, A; Badertscher, P; Maurhofer, J; Krisai, P; Jufer, C; Asatryan, B; Heg, D; Servatius, H; Tanner, H; Kühne, M; Roten, L; Sticherling, C

doi:10.1016/j.jacep.2024.03.021

Arrhythmias & electrophysiology

PolarX vs Arctic Front for Cryoballoon Ablation of Paroxysmal Atrial Fibrillation (AF): The Randomized COMPARE CRYO Study

JACC Clin ElectrophysiolPublished 15 May 2024Randomised controlled trial

Primary resultResultHazard ratio 0.85 95% CI 0.56–1.30

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Authors' conclusion

In this randomized controlled trial using implantable cardiac monitors for continuous rhythm monitoring, the novel PolarX cryoballoon was noninferior compared with the Arctic Front cryoballoon regarding efficacy. However, the PolarX balloon resulted in significantly more phrenic nerve palsies.

Study context

Population: Patients with symptomatic paroxysmal AF; all received an implantable cardiac monitor
Participants: 201 patients

Comparison: PolarX vs Arctic Front cryoballoon for pulmonary vein isolation
PolarXn = 99
Arctic Frontn = 102reference
Primary endpoint: First recurrence of atrial tachyarrhythmia (AF, atrial flutter or AT)
Follow-up: Between days 91 and 365

Methodological detailsnon-inferiority, 2 centres

Non-inferiority
2 centres

Primary result

As reported in the abstract

1 year

Hazard ratio

0.85

95% CI 0.56–1.30

P = 0.03 for noninferiority

Events by treatment group

PolarX41.6%41

Arctic Front47.1%48 of 102

PolarX vs Arctic Front

HR 0.85 (95% CI 0.56–1.30); P = 0.03 for noninferiority

Safety

Outcome	PolarX	Arctic Front	P value
Procedural safety composite (tamponade, phrenic nerve palsy >24 h, vascular complications, stroke/TIA, atrioesophageal fistula or death) · up to 30 days	5%		P = 0.03
Phrenic nerve palsies lasting >24 h	n = 5	Not reported in the abstract		Arctic Front: not reported in the abstract

Procedural safety composite (tamponade, phrenic nerve palsy >24 h, vascular complications, stroke/TIA, atrioesophageal fistula or death) · up to 30 days

No safety endpoints occurred in the Arctic Front group

Original publication

PolarX vs Arctic Front for Cryoballoon Ablation of Paroxysmal AF: The Randomized COMPARE CRYO Study. JACC Clin Electrophysiol. Published 15 May 2024. doi:10.1016/j.jacep.2024.03.021

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Summarised from the published abstract; every number is checked against it