European Xarelto ( Rivaroxaban ) product information has now included guidance for use in patients with atrial fibrillation undergoing cardioversion.
The label update is based on findings from the X-VeRT study, the first prospective trial of a novel oral anticoagulant in 1,504 patients with atrial fibrillation undergoing cardioversion.
The results from X-VeRT showed that compared with the use of Vitamin K antagonist ( VKA ), Rivaroxaban, an oral factor Xa inhibitor, was associated with a numerical reduction in the risk of cardiovascular events of 50% in the composite primary efficacy outcome of stroke, transient ischaemic attack ( TIA ), peripheral embolism, myocardial infarction and cardiovascular death ( 0.5% vs 1.0%; risk reduction: 0.50; 95% confidence interval: 0.15-1.73 ), with a numerically lower risk of major bleeding of 24% in the primary safety outcome ( 0.6% vs 0.8%; risk reduction 0.76; 95% confidence interval: 0.21-2.67 ).
The practical advantage of using rivaroxaban was demonstrated by the shorter time to cardioversion compared to VKA, particularly in patients scheduled for delayed cardioversion.
The study, published in the European Heart Journal, was designed to supplement previous findings of Rivaroxaban from ROCKET AF and was not powered for statistical significance.
Cardioversion is a common medical procedure undertaken to restore the heartbeat from atrial fibrillation back to its regular sinus rhythm.
Without adequate anticoagulation, these patients are at risk of thromboembolic complications, with stroke rates of 5-7%.
Current guidelines recommend at least three weeks of effective anticoagulation with VKAs ( target INR 2.0-3.0 ) prior to cardioversion ( or less if a transesophageal echocardiogram has revealed no thrombus in the left atrium or left atrial appendage ) and four weeks of oral anticoagulation after the procedure.
X-VeRT was a prospective, randomised, open-label, parallel group phase IIIb study involving 1,504 patients with hemodynamically stable non-valvular atrial fibrillation of more than 48 hours or unknown duration, recruited from 16 countries.
Anticoagulation naïve or experienced patients scheduled for cardioversion were randomly assigned to Rivaroxaban 20 mg once daily ( 15 mg once daily if creatinine clearance was between 30 and 49 mL/min ) or INR-adjusted VKA therapy ( target INR 2.0-3.0 ) in a 2:1 ratio.
The decision regarding early cardioversion ( a goal of between 1–5 days of Rivaroxaban or usual VKA therapy before the procedure ) or delayed cardioversion ( Rivaroxaban or VKA for 3-8 weeks prior to the procedure ) was taken by the local investigator.
The X-VeRT study contributes to the extensive investigation program of Rivaroxaban. After its completion, the program will include more than 275,000 patients in clinical trials and real world settings. ( Xagena )
Source: Bayer, 2015