TY - JOUR
T1 - Effect of Catheter Ablation vs Medical Therapy on Quality of Life among Patients with Atrial Fibrillation
T2 - The CABANA Randomized Clinical Trial
AU - Mark, Daniel B.
AU - Anstrom, Kevin J.
AU - Sheng, Shubin
AU - Piccini, Jonathan P.
AU - Baloch, Khaula N.
AU - Monahan, Kristi H.
AU - Daniels, Melanie R.
AU - Bahnson, Tristram D.
AU - Poole, Jeanne E.
AU - Rosenberg, Yves
AU - Lee, Kerry L.
AU - Packer, Douglas L.
N1 - Funding Information:
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
Funding Information:
U01HL89709, U01HL089786, U01HL089907 and U01HL089645 from the National Heart, Lung, and Blood Institute, St Jude Foundation and Corporation, Biosense Webster Inc, Medtronic Inc, Boston Scientific Corporation, and Mayo Clinic.
Publisher Copyright:
© 2019 American Medical Association. All rights reserved.
PY - 2019/4/2
Y1 - 2019/4/2
N2 - 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.
AB - 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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U2 - 10.1001/jama.2019.0692
DO - 10.1001/jama.2019.0692
M3 - Article
C2 - 30874716
AN - SCOPUS:85063004118
VL - 321
SP - 1275
EP - 1285
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
SN - 0002-9955
IS - 13
ER -