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Effect of Catheter Ablation vs Medical Therapy on Quality of Life Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial
Journal article   Open access   Peer reviewed

Effect of Catheter Ablation vs Medical Therapy on Quality of Life Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial

Daniel B Mark, Kevin J Anstrom, Shubin Sheng, Jonathan P Piccini, Khaula N Baloch, Kristi H Monahan, Melanie R Daniels, Tristram D Bahnson, Jeanne E Poole, Yves Rosenberg, …
JAMA : the journal of the American Medical Association, v 321(13), pp 1275-1285
02 Apr 2019
DOI: https://doi.org/10.1001/jama.2019.0692
PMID: 30874716
Featured in Collection :   UN Sustainable Development Goals @ Drexel
url
https://jamanetwork.com/journals/jama/articlepdf/2728675/jama_mark_2019_oi_190009.pdfView
Published, Version of Record (VoR) Open
url
https://doi.org/10.1001/jama.2019.0692View
Published, Version of Record (VoR) Open

Abstract

Aged Anti-Arrhythmia Agents - therapeutic use Atrial Fibrillation - complications Atrial Fibrillation - drug therapy Atrial Fibrillation - surgery Bias Catheter Ablation Female Follow-Up Studies Humans Intention to Treat Analysis Male Middle Aged Quality of Life Surveys and Questionnaires ESI Highly Cited Paper (Incites)
Catheter ablation is more effective than drug therapy in restoring sinus rhythm in patients with atrial fibrillation (AF), but its incremental effect on long-term quality of life (QOL) is uncertain. To determine whether catheter ablation is more beneficial than conventional drug therapy for improving QOL in patients with AF. An open-label randomized clinical trial of catheter ablation vs drug therapy in 2204 symptomatic patients with AF older than 65 years or 65 years or younger with at least 1 risk factor for stroke. Patients were enrolled from November 2009 to April 2016 from 126 centers in 10 countries. Follow-up ended in December 2017. Pulmonary vein isolation, with additional ablation procedures at the discretion of the investigators, for the catheter ablation group (n = 1108) and standard rhythm and/or rate-control drugs selected and managed by investigators for the drug therapy group (n = 1096). Prespecified co-primary QOL end points at 12 months, including the Atrial Fibrillation Effect on Quality of Life (AFEQT) summary score (range, 0-100; 0 indicates complete disability and 100 indicates no disability; patient-level clinically important difference, ≥5 points) and the Mayo AF-Specific Symptom Inventory (MAFSI) frequency score (range, 0-40; 0 indicates no symptoms and 40 indicates the most severe symptoms; patient-level clinically important difference, ≤-1.6 points) and severity score (range, 0-30; 0 indicates no symptoms and 30 indicates the most severe symptoms; patient-level clinically important difference, ≤-1.3 points). Among 2204 randomized patients (median age, 68 years; 1385 patients [63%] were men, 946 [43%] had paroxysmal AF, and 1256 [57%] had persistent AF), the median follow-up was 48.5 months, and 1968 (89%) completed the trial. The mean AFEQT summary score was more favorable in the catheter ablation group than the drug therapy group at 12 months (86.4 points vs 80.9 points) (adjusted difference, 5.3 points [95% CI, 3.7-6.9]; P < .001). The mean MAFSI frequency score was more favorable for the catheter ablation group than the drug therapy group at 12 months (6.4 points vs 8.1 points) (adjusted difference, -1.7 points [95% CI, -2.3 to -1.2]; P < .001) and the mean MAFSI severity score was more favorable for the catheter ablation group than the drug therapy group at 12 months (5.0 points vs 6.5 points) (adjusted difference, -1.5 points [95% CI, -2.0 to -1.1]; P < .001). Among patients with symptomatic atrial fibrillation, catheter ablation, compared with medical therapy, led to clinically important and significant improvements in quality of life at 12 months. These findings can help guide decisions regarding management of atrial fibrillation. ClinicalTrials.gov Identifier: NCT00911508.

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Collaboration types
Domestic collaboration
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Web of Science research areas
Cardiac & Cardiovascular Systems
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