TY - JOUR
T1 - Atrial fibrillation ablation in practice
T2 - Assessing CABANA generalizability
AU - Noseworthy, Peter A.
AU - Gersh, Bernard J.
AU - Kent, David M.
AU - Piccini, Jonathan P.
AU - Packer, Douglas L.
AU - Shah, Nilay D.
AU - Yao, Xiaoxi
N1 - Funding Information:
National Institutes of Health, National Heart, Lung, and Blood Institute (NIH R21 HL140205 'Pairing Observational and Patient-level Clinical Trial Data to Assess Cardiovascular Risk Reduction with Catheter Ablation for Atrial Fibrillation') to P.A.N. and X.Y. and Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery to P.A.N., N.D.S., and X.Y.
Funding Information:
from Johnson & Johnson, Medtronic, and Sanofi; D.L.P. reports grants from NIH, St. Jude Medical Foundation and Corporation, Biosense Webster, Inc., Medtronic Corp., and Boston Scientific Corp., during the conduct of the study; other from Abbott, Aperture Diagnostics, Biosense Webster, Inc., Boston Scientific Corp., CardioFocus, Medtronic, Inc., St. Jude Medical, Spectrum Dynamics, and MediaSphere Medical; grants from Abbott, Biosense Webster, Boston Scientific, and CardioInsight; grants and other from Medtronic, Inc., grants from NIH, grants and other from St. Jude Medical, grants and other from Siemens, grants and other from Thermedical, other from Other, other from Wiley & Sons, other from Oxford, other from St. Jude Medical, outside the submitted work. No other potential conflict of interest relevant to this article was reported.
Publisher Copyright:
© The Author(s) 2018.
PY - 2019/4/1
Y1 - 2019/4/1
N2 - Aims The Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial aimed to assess the impact of ablation on morbidity and mortality. This observational study was conducted in parallel to CABANA to assess trial generalizability. Methods Using a large US administrative database, we identified 183 760 patients with atrial fibrillation (AF) treated with ablation and results or medical therapy (antiarrhythmic or rate control drugs) between 1 August 2009 and 30 April 2016 (CABANA enrolment period). Propensity score weighting was used to balance patients treated with ablation (N= 12 032) or medical therapy alone (N= 171 728) on 90 dimensions. Ablation was associated with a reduction in the composite endpoint of all-cause mortality, stroke, major bleeding, and cardiac arrest [hazard ratio (HR) 0.75, 95% confidence interval (CI) 0.70-0.81; P < 0.001]. The majority of patients (73.8%) were potentially trial eligible; among whom the risk reduction associated with ablation was greatest (HR 0.70, 95% CI 0.63-0.77; P < 0.001). Among the 3.8% of patients who failed to meet the inclusion criterion, i.e. patients under 65 years without stroke risk factors, the event rates were low and there was no significant relationship with ablation (HR 0.67, 95% CI 0.29-1.56; P = 0.35). Among the 22.4% patients who met at least one of the trial exclusion criteria, there was a lesser but statistically significant reduction associated with ablation (HR 0.85, 95% CI 0.75-0.95; P = 0.01). Conclusion In routine clinical care, ablation was associated with a reduction in the primary CABANA composite endpoint of all-cause mortality, stroke, major bleeding, and cardiac arrest, particularly in patients who were eligible for the trial. All rights reserved.
AB - Aims The Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial aimed to assess the impact of ablation on morbidity and mortality. This observational study was conducted in parallel to CABANA to assess trial generalizability. Methods Using a large US administrative database, we identified 183 760 patients with atrial fibrillation (AF) treated with ablation and results or medical therapy (antiarrhythmic or rate control drugs) between 1 August 2009 and 30 April 2016 (CABANA enrolment period). Propensity score weighting was used to balance patients treated with ablation (N= 12 032) or medical therapy alone (N= 171 728) on 90 dimensions. Ablation was associated with a reduction in the composite endpoint of all-cause mortality, stroke, major bleeding, and cardiac arrest [hazard ratio (HR) 0.75, 95% confidence interval (CI) 0.70-0.81; P < 0.001]. The majority of patients (73.8%) were potentially trial eligible; among whom the risk reduction associated with ablation was greatest (HR 0.70, 95% CI 0.63-0.77; P < 0.001). Among the 3.8% of patients who failed to meet the inclusion criterion, i.e. patients under 65 years without stroke risk factors, the event rates were low and there was no significant relationship with ablation (HR 0.67, 95% CI 0.29-1.56; P = 0.35). Among the 22.4% patients who met at least one of the trial exclusion criteria, there was a lesser but statistically significant reduction associated with ablation (HR 0.85, 95% CI 0.75-0.95; P = 0.01). Conclusion In routine clinical care, ablation was associated with a reduction in the primary CABANA composite endpoint of all-cause mortality, stroke, major bleeding, and cardiac arrest, particularly in patients who were eligible for the trial. All rights reserved.
KW - Ablation
KW - Atrial fibrillation
KW - Mortality
KW - Stroke
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U2 - 10.1093/eurheartj/ehz085
DO - 10.1093/eurheartj/ehz085
M3 - Article
C2 - 30875424
AN - SCOPUS:85062996363
VL - 40
SP - 1257
EP - 1264
JO - European Heart Journal
JF - European Heart Journal
SN - 0195-668X
IS - 16
ER -