Ablation was associated with a reduction in the composite endpoint of all-cause mortality, stroke, major bleeding, and cardiac arrest compared to medical therapy (HR 0.75; 95% CI 0.70-0.81; P<0.001).
Observational (n=183,760)
Does ablation reduce the composite of all-cause mortality, stroke, major bleeding, and cardiac arrest in patients with atrial fibrillation compared to medical therapy?
In a large real-world US cohort, AF ablation was associated with a 25% reduction in the composite of mortality, stroke, bleeding, and cardiac arrest compared to medical therapy, supporting the generalizability of the CABANA trial.
Effect estimate: HR 0.75 (95% CI 0.70-0.81)
p-value: p=<0.001
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 AND RESULTS: Using a large US administrative database, we identified 183 760 patients with atrial fibrillation (AF) treated with ablation 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.
Noseworthy et al. (2019) conducted an observational in Atrial fibrillation (n=183,760). Ablation vs. Medical therapy (antiarrhythmic or rate control drugs) was evaluated on Composite endpoint of all-cause mortality, stroke, major bleeding, and cardiac arrest (HR 0.75, 95% CI 0.70-0.81, p=<0.001). Ablation was associated with a reduction in the composite endpoint of all-cause mortality, stroke, major bleeding, and cardiac arrest compared to medical therapy (HR 0.75; 95% CI 0.70-0.81; P<0.001).