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See the latest evidence on how first-line cryoablation improves AF patients outcomes.
Catheter Cryoablation versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation (Cryo-FIRST) is a 1:1 randomised control trial designed to compare the safety and efficacy of antiarrhythmic drug (AAD) therapy against cryoballoon pulmonary vein isolation (PVI) as a first-line therapy in treatment naïve patients with paroxysmal AF (PAF).
Study Size: 220 patients enrolled by 18 hospitals.
Primary Endpoint: Freedom from any atrial arrhythmia >30 seconds after blanking
Principal Investigators: Gian Battista Chierchia (BE), Malte Kuniss (DE)
Watch Prof. G.B. Chierchia present Cryo-FIRST trial results: - (09:43)
First-line Cryoballoon ablation vs. antiarrhythmic drugs for paroxysmal AF
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Watch Dr. M. Kuniss present:
Watch Dr. A. Metzner discuss:
The STOP AF First Trial (NCT03118518) was an FDA-regulated, prospective, multicentre randomised study designed to evaluate the safety and effectiveness of the Medtronic cryoablation system as an initial first-line treatment in patients with symptomatic paroxysmal atrial fibrillation (PAF). Patients were randomised (1:1) to antiarrhythmic drug therapy (class I or III) or pulmonary vein isolation with the Arctic Front Advance ™ Cryoablation catheter.
Study Size: 225 patients enrolled by 24 hospitals (U.S.)
Primary Safety Endpoint:
Primary Efficacy Endpoint:
Treatment success at 12 months.
Treatment failure included:
Principal Investigator: Oussama Wazni
Early Aggressive Invasive Intervention for Atrial Fibrillation (EARLY AF, NCT02825979) is a multicentre, randomized, controlled trial comparing the safety and efficacy of Arctic Front AdvanceTM Cryoablation with antiarrhythmic drug (AAD) therapy as a first line therapy. Clinical efficacy was assessed by an insertable cardiac monitor (ICM).
Study Size: 303 patients enrolled by 18 hospitals in Canada
Watch Prof. J. Andrade present the key findings from EARLY-AF
Panel Discussion on the Cryo-FIRST, STOP AF First, and EARLY-AF trial findings - (18:49)
Watch Prof. J. Camm, Prof. J. Andrad, Dr. O. Wazni, and Dr. N. Pavlović discuss the Cryo-FIRST, STOP AF First, and EARLY-AF trial findings
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Watch Prof. J. Camm, Prof. J. Andrade, Dr. O. Wazni, and Dr. N. Pavlović discuss the Cryo-FIRST, STOP AF First, and EARLY-AF trial findings
AF is progressive is nature, with longer diagnosis-to-ablation times associated with markers of atrial remodelling2.
For patients with symptomatic paroxysmal AF, antiarrhythmic drugs (AAD) are often prescribed as the first-line therapy. However, these drugs fail to prevent AF recurrence in up to 50% of patients3. Some of these patients go on to receive catheter ablation.
Importantly, prior studies suggest that a shorter diagnosis to ablation time is associated with lower rates of atrial arrythmia recurrence, repeat procedures, and cardiovascular hospitalisation4-7. These observations paired with evidence that catheter ablation can halt AF progression more effectively than AAD therapy7 has sparked debate around the optimal first line therapy for symptomatic AF patients.
The positive results from the Cryo-FIRST study demonstrate Cryoballoon ablation is safe and superior to AAD therapy in reducing AF recurrence in this first line patient population1.
The 2020 ESC Guidelines for the Diagnosis and Management of Atrial Fibrillation recommend catheter ablation for AF symptom improvement (class I, level A), targeting pulmonary vein isolation (class I, level A)6.
AF Catheter Ablation as a First-line Therapy:
2020 ESC GUIDELINES HIGHLIGHTS
Watch Prof. G. Hindricks explain key updates made to the ESC Guidelines for AF Management
2020 ESC Guidelines Highlights
Watch Prof. G. Hindricks explain key updates made to the ESC Guidelines for AF Management.
Please refer to the following link for additional guidance on which patients to refer for catheter ablation: 2020 ESC Guidelines on AF Management
Hermida et al., Cryoballoon catheter ablation versus antiarrhythmic drugs as a first-line therapy for patients with paroxysmal atrial fibrillation: Rationale and design of the international Cryo-FIRST study. Am Heart J. 2020 Apr;222:64-72
Kuniss et al. Presented at the German Cardiac Society conference DGK 2020.
Chierchia, GB., et al. Quality of Life Measured in First-Line Therapy During the Cryo-FIRST Study: A Comparison Between Cryoballoon Catheter Ablation Versus Antiarrhythmic Drug Therapy. Poster presented at the 2020 ESC Congress – The Digital Experience.
Wazni et al. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. New England Journal of Medecine. 2020.
Andrade, J. et al. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. New England Journal of Medecine. 2020.
Hindricks, G., et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). European Heart Journal. 2020. 00, 1-126.