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Evidence has shown that patients with atrial fibrillation (AF) are at an increased risk of ischemic stroke and systemic embolism,1 and guidelines have long-supported the use of Vitamin K antagonists (VKA) as the gold standard for anticoagulation in this population.2,3 Patients with new onset AF or symptomatic AF are candidates for elective cardioversion to restore sinus rhythm. Results from observational studies suggest that patients who undergo elective cardioversion are at highest risk of stroke or thromboembolism within the first 72 hours after cardioversion and that a majority of these complications will occur within ten days following the procedure, making adequate peri-procedural anticoagulation crucial. In a post hoc analysis of the ROCKET-AF trial, there were no differences in long-term stroke rates or survival following cardioversion or ablation in patients treated with rivaroxaban versus VKA.4 Similarly, an analysis of patients who underwent cardioversion in the RE-LY trial demonstrated comparable frequencies of stroke and major bleed in patients receiving dabigatran compared to VKA.5 Although this data points toward safe use of novel oral anticoagulants for peri-procedural anticoagulation in elective cardioversion, prospective studies are lacking, and current guidelines still recommend the use of vitamin K antagonists for antithrombotic therapy in this setting.2

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The investigators of the non-blinded, randomized X-VERT study sought to evaluate the safety and efficacy of rivaroxaban compared to dose-adjusted vitamin K antagonists in patients who were scheduled to undergo elective cardioversion.6 Patients were eligible to participate in the study if the were ≥ 18 years of age, diagnosed with hemodynamically stable non-valvular AF, and scheduled to receive pharmacological or electrical cardioversion. Patients may have been previously on anticoagulation therapy with either VKA or a novel agent. Individuals were excluded from the study if they had a prosthetic heart valve, hemodynamically significant mitral valve stenosis, known left atrial thrombi, severe disabling stroke within the previous 3 months or any stroke or transient ischemic attack (TIA) up to 2 weeks or 3 days prior to randomization. Participants were randomized in a 2:1 ratio to receive rivaroxaban 20mg once daily (15mg in patients with CrCl 30-49 mL/min), warfarin or another VKA at the discretion of the investigator. Target INR range for the VKA group was 2-3. The primary efficacy outcome was the composite of stroke or TIA, myocardial infarction, and cardiovascular death and secondary efficacy outcomes included all-cause mortality, composite of stroke, TIA, peripheral embolism, myocardial infarction and all-cause mortality, and individual components of the primary efficacy endpoint. The primary safety outcome was major bleeding and the secondary safety outcome was all bleeding events.

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An estimated sample size of nearly 30,000 patients would be required to demonstrate non-inferiority of rivaroxaban to VKA, which was not feasible. Therefore, the investigators concluded a descriptive analysis comparing 1500 individuals would provide clinically useful information. A total of 1504 patients were randomized; 1002 to rivaroxaban and 502 to VKA. Patients were similar across both treatment ...

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