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Randomized Controlled Trial
. 2019 Apr 2;321(13):1275-1285.
doi: 10.1001/jama.2019.0692.

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

Daniel B Mark  1 , Kevin J Anstrom  1 , Shubin Sheng  1 , Jonathan P Piccini  1 , Khaula N Baloch  1 , Kristi H Monahan  2 , Melanie R Daniels  1 , Tristram D Bahnson  1 , Jeanne E Poole  3 , Yves Rosenberg  4 , Kerry L Lee  1 , Douglas L Packer  2 ; CABANA Investigators
Affiliations
Randomized Controlled Trial

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

Daniel B Mark et al. JAMA. .

Erratum in

  • Error in the Results.
    [No authors listed] [No authors listed] JAMA. 2019 Jun 18;321(23):2370. doi: 10.1001/jama.2019.7682. JAMA. 2019. PMID: 31211327 Free PMC article. No abstract available.

Abstract

Importance: 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.

Objective: To determine whether catheter ablation is more beneficial than conventional drug therapy for improving QOL in patients with AF.

Design, setting, and participants: 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.

Interventions: 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).

Main outcomes and measures: 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).

Results: 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).

Conclusions and relevance: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT00911508.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Mark reported receiving grants from the National Institutes of Health (NIH) and Mayo Clinic during the conduct of the study; grants from Merck, Oxygen Therapeutics, Bristol-Myers Squibb, AstraZeneca, the University of Calgary, Eli Lilly & Company, AGA Medical, St Jude Medical, and Tufts University and personal fees from CeleCor and Novo Nordisk outside the submitted work. Dr Anstrom reported receiving grants from NIH during the conduct of the study. Dr Piccini reported receiving grants from ARCA biopharma, personal fees from Allergan, grants and personal fees from Abbott, grants from Boston Scientific, personal fees from Biotronik, grants from Gilead, personal fees from GlaxoSmithKline, grants from Janssen, personal fees from Medtronic, personal fees from Motif Bio, personal fees from Phillips, and personal fees from Sanofi outside the submitted work. Ms Monahan reported receiving grants from NIH, St Jude Foundation and Corporation, Biosense Webster Inc, Medtronic Inc, and Boston Scientific Corporation during the conduct of the study; providing consulting services to Biosense Webster Inc and providing consulting services to and receiving personal fees from Thermedical Inc outside the submitted work. Ms Daniels reported receiving grants from NIH and Mayo Clinic during the conduct of the study and personal fees from CeleCor outside the submitted work. Dr Bahnson reported receiving grants from NIH and Mayo Clinic during the conduct of the study; grants and personal fees and participating as a site primary investigator for a pivotal trial and receiving reimbursement from CardioFocus Inc, grants from Biosense Webster, grants from St Jude Medical, grants from Medtronic, and grants from Boston Scientific outside the submitted work; and a pending patent for a catheter/sheath for intracardiac imaging. Dr Poole reported receiving grants from Mayo Clinic during the conduct of the study and grants from AtriCure outside the submitted work. Dr Lee reported receiving grants from the National Heart, Lung, and Blood Institute (NHLBI) during the conduct of the study. Dr Packer reported receiving grants from NIH/NHLBI, St Jude Medical Corporation and Foundation, Biosense Webster Inc, Medtronic Inc, and Boston Scientific Corp during the conduct of the study; and receiving grants from Abbott, Biosense Webster Inc, Boston Scientific Corp, CardioFocus, Medtronic Inc, St Jude Medical, CardioInsight, NIH, Siemens, Thermedical, Endosense, Robertson Foundation, and Hansen Medical; serving on the advisory board without compensation for Abbott, Biosense Webster Inc, Boston Scientific Corp, CardioFocus, Medtronic Inc, St Jude Medical, Spectrum Dynamics, Siemens, Thermedical, Johnson & Johnson, and SigNum Preemptive Healthcare, Inc; speaking with honorarium from Biotronik and MediaSphere Medical, LLC; receiving royalties from Wiley & Sons, Oxford, and St Jude Medical; Dr Packer and Mayo Clinic jointly have equity in a privately held company, External Beam Ablation Medical Devices, outside the submitted work; Dr Packer has mapping technologies with royalties paid. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Patients Who Reported Being in Atrial Fibrillation Currently or Within the Past Month
Responses to the first item in the Atrial Fibrillation Effect on Quality of Life instrument.
Figure 2.
Figure 2.. Atrial Fibrillation Effect on Quality of Life (AFEQT) Summary Scores
Figure 3.
Figure 3.. Mayo Atrial Fibrillation–Specific Symptom Inventory (MAFSI) Frequency Scores
See this image and copyright information in PMC

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