Résumé
Background: The ideal management of patients with newly diagnosed symptomatic atrial fibrillation (AF) remains unknown. Current practice guidelines recommend a trial of antiarrhythmic drugs (AAD) prior to considering an invasive ablation procedure. However, earlier ablation offers an opportunity to halt the progressive patho-anatomical changes associated with AF, as well as impart other important clinical benefits. Objective: The aim of this study is to determine the optimal initial management strategy for patients with newly diagnosed, symptomatic atrial fibrillation. Methods/Design: The EARLY-AF study (ClinicalTrials.gov NCT02825979) is a prospective, open label, multicenter, randomized trial with a blinded assessment of outcomes. A total of 298 patients will be randomized in a 1:1 fashion to first-line AAD therapy, or first-line cryoballoon-based pulmonary vein isolation. Patients with symptomatic treatment naïve AF will be included. Arrhythmia outcomes will be assessed by implantable cardiac monitor (ICM). The primary outcome is time to first recurrence of AF, atrial flutter, or atrial tachycardia (AF/AFL/AT) between days 91 and 365 following AAD initiation or AF ablation. Secondary outcomes include arrhythmia burden, quality of life, and healthcare utilization. Discussion: The EARLY-AF study is a randomized trial designed to evaluate the optimal first management approach for patients with AF. We hypothesize that catheter ablation will be superior to drug therapy in prevention of AF recurrence.
| Langue d'origine | English |
|---|---|
| Pages (de-à) | 94-104 |
| Nombre de pages | 11 |
| Journal | American Heart Journal |
| Volume | 206 |
| DOI | |
| Statut de publication | Published - déc. 2018 |
| Publié à l'externe | Oui |
Note bibliographique
Funding Information:Dr. Andrade reports grants and personal fees from Medtronic, grants from Baylis, personal fees from Biosense-Webster; Dr. Champagne has nothing to disclose; Dr. Deyell reports grants from Biosense-Webster; Dr. Essebag reports personal fees from Biosense, Abbott, and Medtronic; Dr. Lauck has nothing to disclose; Dr. Morillo personal fees from Abbott (SJM), Boston Scientific, Bayer, Daiichi Sankyo, Medtronic, grants from Bayer, Pfizer; Dr. Sapp reports grants from Biosense-Webster, personal fees from Biosense-Webster, grants from Abbott (SJM), personal fees from Abbott, personal fees from Medtronic Inc.; Dr. Skanes reports grants from Medtronic and Biosense-Webster; Dr. Wells has nothing to disclose; Dr. Verma reports grants and personal fees from Medtronic, Bayer, and Biosense-Webster.
Funding Information:
Funding source: The EARLY-AF study was funded by a peer-reviewed grant from the Canadian Arrhythmia Network [grant number SRG-15-P15-001], with additional financial support from Medtronic. Drs. Andrade and Deyell are supported by Michael Smith Foundation for Health Research Career Scholar Awards. Dr. Essebag is supported by a Clinical Research Scholar Award from Fonds de recherché du Quebec-Santé (FRQS). All authors are Investigators of the Cardiac Arrhythmia Network of Canada (CANet), a Networks of Centres of Excellence.
Publisher Copyright:
© 2018 Elsevier Inc.
ASJC Scopus Subject Areas
- Cardiology and Cardiovascular Medicine