Peter A Noseworthy1, Holly K Van Houten2, Bernard J Gersh3, Douglas L Packer3, Paul A Friedman3, Nilay D Shah4, Shannon M Dunlay3, Konstantinos C Siontis3, Jonathan P Piccini5, Xiaoxi Yao6. 1. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota. 2. Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota. 3. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota. 4. Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota; Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota; OptumLabs, Cambridge, Massachusetts. 5. Duke Center for Atrial Fibrillation, Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. 6. Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota; Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota. Electronic address: yao.xiaoxi@mayo.edu.
Abstract
BACKGROUND: In the Catheter Ablation for Atrial Fibrillation with Heart Failure (CASTLE-AF) trial, catheter ablation reduced the risk of death and heart failure (HF) hospitalization in patients with atrial fibrillation and HF by 40%. OBJECTIVES: The study aimed to assess the generalizability of CASTLE-AF to routine clinical practice. METHODS: Using a large US administrative database, we identified 289,831 patients with atrial fibrillation and HF treated with ablation (n = 7465) or medical therapy alone (n = 282,366) from January 1, 2008, through August 31, 2018. Patients were divided into 3 groups on the basis of trial eligibility: (1) eligible for CASTLE-AF, (2) failing to meet the inclusion criteria, and (3) meeting at least 1 of the exclusion criteria. Propensity score overlap weighting was used to balance ablated and drug-treated patients on 90 baseline characteristics. Cox proportional hazards regression was used to compare ablation with medical therapy for the primary outcome of a composite end point of all-cause mortality and HF hospitalization. RESULTS: Only 7.8% of patients would have been eligible for the trial; 91.0% failed to meet the trial inclusion criteria; and 15.5% met the exclusion criteria. Ablation was associated with a lower risk of the primary outcome in the overall cohort (hazard ratio [HR] 0.81; 95% confidence interval [CI] 0.76-0.87; P < .001), in the trial-eligible cohort (HR 0.82; 95% CI 0.70-0.96; P = .01), and in patients who failed to meet inclusion criteria (HR 0.79; 95% CI 0.73-0.86; P < .001) but not in patients who met the exclusion criteria (HR 0.97; 95% CI 0.81-1.17). The relative risk reduction was consistent regardless of whether patients had HF with reduced left ventricular ejection fraction. CONCLUSION: The benefit associated with ablation appears to be more modest in practice than that reported in the CASTLE-AF trial.
BACKGROUND: In the Catheter Ablation for Atrial Fibrillation with Heart Failure (CASTLE-AF) trial, catheter ablation reduced the risk of death and heart failure (HF) hospitalization in patients with atrial fibrillation and HF by 40%. OBJECTIVES: The study aimed to assess the generalizability of CASTLE-AF to routine clinical practice. METHODS: Using a large US administrative database, we identified 289,831 patients with atrial fibrillation and HF treated with ablation (n = 7465) or medical therapy alone (n = 282,366) from January 1, 2008, through August 31, 2018. Patients were divided into 3 groups on the basis of trial eligibility: (1) eligible for CASTLE-AF, (2) failing to meet the inclusion criteria, and (3) meeting at least 1 of the exclusion criteria. Propensity score overlap weighting was used to balance ablated and drug-treated patients on 90 baseline characteristics. Cox proportional hazards regression was used to compare ablation with medical therapy for the primary outcome of a composite end point of all-cause mortality and HF hospitalization. RESULTS: Only 7.8% of patients would have been eligible for the trial; 91.0% failed to meet the trial inclusion criteria; and 15.5% met the exclusion criteria. Ablation was associated with a lower risk of the primary outcome in the overall cohort (hazard ratio [HR] 0.81; 95% confidence interval [CI] 0.76-0.87; P < .001), in the trial-eligible cohort (HR 0.82; 95% CI 0.70-0.96; P = .01), and in patients who failed to meet inclusion criteria (HR 0.79; 95% CI 0.73-0.86; P < .001) but not in patients who met the exclusion criteria (HR 0.97; 95% CI 0.81-1.17). The relative risk reduction was consistent regardless of whether patients had HF with reduced left ventricular ejection fraction. CONCLUSION: The benefit associated with ablation appears to be more modest in practice than that reported in the CASTLE-AF trial.
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