Clinical Trials

Date: 2014-09-02

Type of information: Presentation of results at a congress

phase: 3b

Announcement: presentation of results at the European Society of Cardiology (ESC) Congress 2014

Company: Bayer Healthcare (Germany)

Product: Xarelto® (rivaroxaban)

Action mechanism: anticoagulant agent/oral direct Factor Xa inhibitor

Disease:

patients with non-valvular atrial fibrillation undergoing cardioversion

Therapeutic area: Cardiovascular diseases

Country:

Trial details:

X-VeRT was a prospective, randomized, open-label, parallel group Phase IIIb study involving 1,504 patients with hemodynamically stable non-valvular atrial fibrillation of > 48 hours or unknown duration, recruited from 16 countries worldwide. Anticoagulation naïve or experienced patients scheduled for cardioversion were randomly assigned to rivaroxaban 20mg once daily (15mg 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. AF patients on rivaroxaban demonstrated a numerically lower risk of cardiovascular events (0.51% vs. 1.02%) compared to VKA, as well as a reassuring bleeding profile with a low major bleeding incidence risk (0.61% vs. 0.8%). Overall, the mean time between randomization and cardioversion was shorter in patients assigned to rivaroxaban (early: 1.8±1.6 days; delayed: 24.6±5.6 days) than in those assigned to VKA treatment (2.1±3.0 days; 33.7±13.1 days). The positive rivaroxaban findings were consistent in both early and delayed cardioversion strategies. These results were not statistically significant, as the trial was not powered accordingly.

Latest news:

• On September 2, 2014, Bayer HealthCare announced results from the X-VeRT study demonstrating that once-daily Xarelto® (rivaroxaban) is an effective and well-tolerated alternative to dose-adjusted vitamin K antagonists (VKAs) such as warfarin in patients with non-valvular atrial fibrillation undergoing cardioversion. X-VeRT, the first prospective trial of a novel oral anticoagulant, showed that compared with the use of VKA, rivaroxaban was associated with a numerical reduction in the risk of cardiovascular events of 50 per cent in the composite primary efficacy outcome of stroke, transient ischemic attack, peripheral embolism, myocardial infarction and cardiovascular death, with a numerically lower risk of major bleeding of 24 per cent in the primary safety outcome. The practical advantage of using rivaroxaban was demonstrated by the shorter time to cardioversion compared to VKA. The study was designed to support previous findings of rivaroxaban in the setting of cardioversion from ROCKET AF and was not powered for statistical significance. These data were presented during the Hot Line Session at the ESC Congress 2014, and published simultaneously in the European Heart Journal. The X-VeRT study contributes to the extensive ongoing evaluation of rivaroxaban that will include more than 275,000 patients in both clinical trials and real world settings.