X-VeRT: Rivaroxaban safe, effective in AF patients undergoing cardioversion

BARCELONA, Spain — Patients with nonvalvular atrial fibrillation undergoing elective cardioversion who were assigned once-daily oral rivaroxaban had a low and similar incidence of CV events and major bleeding compared with patients assigned a vitamin K antagonist, according to new findings from the X-VeRT trial.

Riccardo Cappato, MD, presented data from the randomized, prospective, phase 3b study, which was designed to examine the safety and efficacy of rivaroxaban (Xarelto, Janssen Pharmaceuticals) compared with a vitamin K antagonist (VKA). Researchers enrolled 1,504 patients with hemodynamically stable nonvalvular AF from 141 centers across 16 countries. Patients scheduled for cardioversion were randomly assigned once-daily rivaroxaban 20 mg (15 mg if creatinine clearance was 30-49 mL/min) or INR-adjusted VKA therapy, including warfarin.

Cappato reported that the primary efficacy outcome of stroke, transient ischemic attack, non-central nervous system systemic embolism, MI or CV death occurred in 0.51% of the rivaroxaban group vs. 1.02% of the VKA group. The primary safety outcome of major bleeding occurred in 0.61% of the rivaroxaban group vs. 0.81% of the VKA group, he said at ESC Congress.

The differences in the primary efficacy and safety outcomes were not significant, because X-VeRT was not designed to determine statistical significance, according to the researchers.

For this study, the decision regarding early or delayed cardioversion was made by the local investigator. The majority of patients underwent electrical cardioversion (97.6%).

In the early cardioversion group, the primary composite outcome occurred in 0.71% of the rivaroxaban group vs. 1.08% of the VKA group. In the delayed cardioversion group, the primary outcome occurred in 0.24% of the rivaroxaban group vs. 0.93% of the VKA group, according to Cappato, professor of electrophysiology and chief of the Arrhythmia and Electrophysiology Center, University of Milan, Italy.

Time between randomization and cardioversion was similar in both treatment groups in the early cardioversion group (median, 1 day). In the delayed cardioversion group, the wait for cardioversion was significantly shorter for patients assigned rivaroxaban compared with patients assigned VKA therapy (median, 22 days vs. 30 days; P<.001). This difference was related to the inability to achieve adequate anticoagulation prior to cardioversion in the VKA group, Cappato said.

The researchers reported no clinically important differences in the overall cumulative incidence of adverse events by treatment assignment or cardioversion strategy.

Although the data are preliminary, Cappato said this rivaroxaban treatment strategy “appears to be an effective and safe alternative to VKA, and allows prompt elective cardioversion in patients with AF.” – by Katie Kalvaitis

For more information:

Cappato R. Hot Line V. Coronary Artery Disease and Atrial Fibrillation. Presented at: the European Society of Cardiology Congress; Aug. 30-Sept. 3, 2014; Barcelona, Spain.

Disclosure: The trial was sponsored by Bayer HealthCare Pharmaceuticals and Janssen Scientific Affairs. Cappato reports financial relationships with several pharmaceutical companies, including Bayer HealthCare.