Aims: In patients with atrial fibrillation, catheter ablation and cardioversion carry a risk of peri-procedural thromboembolic events; current guidelines recommend anticoagulation in these settings. This study aimed to report the baseline demographics and clinical characteristics of patients enrolled in the prospective, observational XANTUS study who underwent catheter ablation or cardioversion, and adverse outcomes with each of these procedures in patients treated with rivaroxaban.
Methods and results: Data collected included information on catheter ablation and cardioversion, and adverse outcomes occurring within 30 days of these procedures: incidence of treatment-emergent adjudicated symptomatic thromboembolic events and major bleeding; and cardiovascular and all-cause death. Incidence of these adverse outcomes at 42 days after cardioversion was also analysed. Patients undergoing either procedure had significantly lower mean CHA2DS2-VASc and HAS-BLED scores than those who did not, and were more frequently hospitalized at study baseline. Within a period of 30 days after intervention, symptomatic thromboembolic events were reported in 1.2% and 0.6% of patients undergoing ablation or cardioversion, respectively; major bleeding events were reported in 2.9% and 0.4% of patients undergoing ablation or cardioversion, respectively. No patients died within 30 days of intervention. Incidence of symptomatic thromboembolic and major bleeding events remained low at 42 days after cardioversion.
Conclusion: Similar to the results of prospective and non-interventional studies, the low rates of symptomatic thromboembolic events and major bleeding in patients with atrial fibrillation undergoing ablation or cardioversion and treated with rivaroxaban in XANTUS suggest that its use is associated with an acceptable benefit-risk profile in this setting.
Trial registration number: Clinicaltrials.gov: NCT01606995.