Rivaroxaban vs Vitamin K Antagonists for Cardioversion in AF
Rivaroxaban vs Vitamin K Antagonists for Cardioversion in AF
Aims X-VeRT is the first prospective randomized trial of a novel oral anticoagulant in patients with atrial fibrillation undergoing elective cardioversion.
Methods and results We assigned 1504 patients to rivaroxaban (20 mg once daily, 15 mg if creatinine clearance was between 30 and 49 mL/min) or dose-adjusted vitamin K antagonists (VKAs) in a 2:1 ratio. Investigators selected either an early (target period of 1–5 days after randomization) or delayed (3–8 weeks) cardioversion strategy. The primary efficacy outcome was the composite of stroke, transient ischaemic attack, peripheral embolism, myocardial infarction, and cardiovascular death. The primary safety outcome was major bleeding. The primary efficacy outcome occurred in 5 (two strokes) of 978 patients (0.51%) in the rivaroxaban group and in 5 (two strokes) of 492 patients (1.02%) in the VKA group [risk ratio 0.50; 95% confidence interval (CI) 0.15–1.73]. In the rivaroxaban group, four patients experienced primary efficacy events following early cardioversion (0.71%) and one following delayed cardioversion (0.24%). In the VKA group, three patients had primary efficacy events following early cardioversion (1.08%) and two following delayed cardioversion (0.93%). Rivaroxaban was associated with a significantly shorter time to cardioversion compared with VKAs (P < 0.001). Major bleeding occurred in six patients (0.6%) in the rivaroxaban group and four patients (0.8%) in the VKA group (risk ratio 0.76; 95% CI 0.21–2.67).
Conclusion Oral rivaroxaban appears to be an effective and safe alternative to VKAs and may allow prompt cardioversion.
Atrial fibrillation (AF) is the most frequently encountered sustained cardiac arrhythmia, with a prevalence of about 1% in the general population. In symptomatic patients, pharmacological or electrical cardioversion can be used to rapidly restore sinus rhythm. However, there is a peri-procedural risk of thromboembolic events associated with cardioversion, with stroke rates between 5 and 7% in non-anticoagulated patients. Vitamin K antagonist (VKA) therapy, although never validated in controlled clinical trials, reduces the peri-procedural incidence of thromboembolic events to between 0.5 and 1.6%. Current European Society of Cardiology and American Heart Association/American College of Cardiology/Heart Rhythm Society guidelines recommend at least 3 weeks of effective anticoagulation before cardioversion, followed by at least 4 weeks of anticoagulation after the procedure. The use of transesophageal echocardiography to rule out left atrial (LA) thrombus plus heparin and VKA treatment immediately before, during, and for at least 4 more weeks after cardioversion is effective to expedite cardioversion.
Novel oral anticoagulants are alternatives to VKAs for long-term stroke prevention in patients with non-valvular AF. In addition, recent post hoc analyses have found dabigatran, rivaroxaban, and apixaban to be as safe and effective as VKA treatment in the setting of cardioversion when the pre-cardioversion anticoagulation time period is long. This study was designed to explore prospectively the efficacy and safety of once-daily rivaroxaban compared with dose-adjusted VKA treatment (with or without heparin), in anticoagulation-naïve or -experienced patients undergoing elective cardioversion.
Abstract and Introduction
Abstract
Aims X-VeRT is the first prospective randomized trial of a novel oral anticoagulant in patients with atrial fibrillation undergoing elective cardioversion.
Methods and results We assigned 1504 patients to rivaroxaban (20 mg once daily, 15 mg if creatinine clearance was between 30 and 49 mL/min) or dose-adjusted vitamin K antagonists (VKAs) in a 2:1 ratio. Investigators selected either an early (target period of 1–5 days after randomization) or delayed (3–8 weeks) cardioversion strategy. The primary efficacy outcome was the composite of stroke, transient ischaemic attack, peripheral embolism, myocardial infarction, and cardiovascular death. The primary safety outcome was major bleeding. The primary efficacy outcome occurred in 5 (two strokes) of 978 patients (0.51%) in the rivaroxaban group and in 5 (two strokes) of 492 patients (1.02%) in the VKA group [risk ratio 0.50; 95% confidence interval (CI) 0.15–1.73]. In the rivaroxaban group, four patients experienced primary efficacy events following early cardioversion (0.71%) and one following delayed cardioversion (0.24%). In the VKA group, three patients had primary efficacy events following early cardioversion (1.08%) and two following delayed cardioversion (0.93%). Rivaroxaban was associated with a significantly shorter time to cardioversion compared with VKAs (P < 0.001). Major bleeding occurred in six patients (0.6%) in the rivaroxaban group and four patients (0.8%) in the VKA group (risk ratio 0.76; 95% CI 0.21–2.67).
Conclusion Oral rivaroxaban appears to be an effective and safe alternative to VKAs and may allow prompt cardioversion.
Introduction
Atrial fibrillation (AF) is the most frequently encountered sustained cardiac arrhythmia, with a prevalence of about 1% in the general population. In symptomatic patients, pharmacological or electrical cardioversion can be used to rapidly restore sinus rhythm. However, there is a peri-procedural risk of thromboembolic events associated with cardioversion, with stroke rates between 5 and 7% in non-anticoagulated patients. Vitamin K antagonist (VKA) therapy, although never validated in controlled clinical trials, reduces the peri-procedural incidence of thromboembolic events to between 0.5 and 1.6%. Current European Society of Cardiology and American Heart Association/American College of Cardiology/Heart Rhythm Society guidelines recommend at least 3 weeks of effective anticoagulation before cardioversion, followed by at least 4 weeks of anticoagulation after the procedure. The use of transesophageal echocardiography to rule out left atrial (LA) thrombus plus heparin and VKA treatment immediately before, during, and for at least 4 more weeks after cardioversion is effective to expedite cardioversion.
Novel oral anticoagulants are alternatives to VKAs for long-term stroke prevention in patients with non-valvular AF. In addition, recent post hoc analyses have found dabigatran, rivaroxaban, and apixaban to be as safe and effective as VKA treatment in the setting of cardioversion when the pre-cardioversion anticoagulation time period is long. This study was designed to explore prospectively the efficacy and safety of once-daily rivaroxaban compared with dose-adjusted VKA treatment (with or without heparin), in anticoagulation-naïve or -experienced patients undergoing elective cardioversion.
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