September 2, 2014 – Janssen Research & Development, LLC (Janssen) and its development partner, Bayer HealthCare, announced results from the X-VeRT trial, demonstrating once-daily rivaroxaban (Xarelto) may be an alternative to vitamin K antagonists (VKA) in treating and reducing the risk of blood clots in non-valvular atrial fibrillation (NVAF) patients undergoing elective cardioversion, a common medical procedure to reset the heartbeat back to a regular rhythm.
Cardioversion requires stable anticoagulation to help prevent life-threatening blood clots before, during and after the procedure. The X-VeRT trial is the first prospective study of any Factor Xa inhibitor in this high-risk patient population.
In this 1,504 patient Phase 3b exploratory trial, compared to VKA therapies such as warfarin, 0.51 percent of patients treated with rivaroxaban were observed to have a primary efficacy outcome of stroke, transient ischemic attack, peripheral embolism, myocardial infarction or cardiovascular death compared with 1.02 percent of patients treated with VKA. In addition, 0.61 percent of patients treated with rivaroxaban were also observed to have a major bleeding event compared with 0.81 percent for VKA. The differences in both the efficacy and safety primary endpoints were not statistically significant, as this trial was not designed to determine statistical significance.
Current European and American guidelines recommend at least three weeks of effective anticoagulation with a VKA (target International Normalized Ratio [INR] 2-3) prior to cardioversion and at least four weeks of anticoagulation after the procedure.
"The X-VeRT study results provide physicians with additional insights that may help them manage NVAF patients who are scheduled for cardioversion," said Riccardo Cappato, M.D., Professor of Electrophysiology and Chief of Arrhythmia and Electrophysiology Center, University of Milan, Irccs Policlinico San Donato, San Donato Milanese, Milan, Italy, and co-lead investigator of the X-VeRT study. "X-VeRT explores the potential advantage of using once-daily rivaroxaban as an alternative to VKA therapy to rapidly establish and maintain stable anticoagulation and avoid delays to cardioversion."
The X-VeRT study (eXplore the efficacy and safety of once-daily oral riVaroxaban for the prevention of cardiovascular events in patients with nonvalvular aTrial fibrillation scheduled for cardioversion) is part of the EXPLORER global cardiovascular research program for rivaroxaban. It includes 11 trials assessing the safety and efficacy of rivaroxaban in high-risk patient populations, including those with chronic heart failure, coronary artery disease, peripheral artery disease, acute coronary syndrome and embolic stroke of undetermined source. By the time of its completion, more than 275,000 patients will have participated in the XARELTO clinical development program, including completed and ongoing clinical trials, independent registries and non-interventional studies. More than 151,000 of those patients have been or will be part of controlled, randomized clinical trials.
"The results of the X-VeRT study build on the promising data first seen in a post-hoc analysis of the landmark ROCKET AF trial," said Anne Hermanowski Vosatka, M.D., Ph.D., FACC, vice president and compound development team Leader for rivaroxaban, Janssen. "Xarelto is the most studied and widely prescribed Factor Xa inhibitor in the world today. We remain committed to continuing to advance our understanding of how this medicine can address critical medical needs. Beyond X-VeRT, we have initiated 10 additional studies in high-risk patient populations, including acute coronary syndrome, embolic stroke of undetermined source, and peripheral artery disease."
"Patients on warfarin require significant preparation prior to having cardioversion, as they need to have their blood checked for three weeks prior to the procedure to determine if dose adjustments are needed to keep the medicine effective," said Andrea Natale, M.D., FACC, FHRS, FESC, executive medical director, Texas Cardiac Arrhythmia Institute at St. David's Medical Center. "The X-VeRT results indicate that rivaroxaban may offer a simpler process for clinicians because it does not require routine blood monitoring."
For more information: www.janssenrnd.com