X-VeRT Study Results Presented as a Hot Line Session at the ESC Congress 2014 and Published in European Heart Journal
BARCELONA, Spain, September 2, 2014 – Janssen Research & Development, LLC (Janssen) and its development partner, Bayer HealthCare, announced today results from the X-VeRT trial, demonstrating once-daily XARELTO® (rivaroxaban) 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 XARELTO® were observed to have a primary efficacy outcome of stroke, transient ischemic attack (mini-stroke), peripheral embolism (a clot in blood vessels outside of the heart), myocardial infarction (heart attack) or cardiovascular death compared with 1.02 percent of patients treated with VKA. In addition, 0.61 percent of patients treated with XARELTO® 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 XARELTO®. 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, F.A.C.C., Vice President and Compound Development Team Leader for XARELTO®, 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., F.A.C.C., F.H.R.S., F.E.S.C., 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.”
About the X-VeRT Study
X-VeRT was a prospective, randomized, open-label, parallel group Phase 3b study involving 1,504 patients with hemodynamically stable non-valvular atrial fibrillation of > 48 hours or unknown duration, recruited from 16 countries worldwide. Patients scheduled for cardioversion were randomly assigned to rivaroxaban 20mg once-daily (15mg if creatinine clearance was between 30 and 49 mL/min) or INR-adjusted VKA therapy 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.
In NVAF patients, 0.51 percent of patients treated with XARELTO® were observed to have a primary efficacy outcome of stroke, transient ischemic attack (mini-stroke), peripheral embolism (a clot in blood vessels outside of the heart), myocardial infarction (heart attack) and cardiovascular death compared with 1.02 percent of patients treated with VKA. In addition, 0.61 percent of patients treated with XARELTO® 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.
About XARELTO® (rivaroxaban):
WHAT IS XARELTO®?
XARELTO® is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke.
XARELTO® is also a prescription medicine used to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again.
XARELTO® is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?
You may have a higher risk of bleeding if you take XARELTO® and take other medicines that increase your risk of bleeding, including:
Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.
Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding:
Spinal or epidural blood clots (hematoma): People who take a blood thinner medicine (anticoagulant) like XARELTO®, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:
If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weakness, (especially in your legs and feet), loss of control of the bowels or bladder (incontinence).
XARELTO® is not for patients with artificial heart valves.
WHO SHOULD NOT TAKE XARELTO®?
Do not take XARELTO® if you:
WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO®?
Before taking XARELTO®, tell your doctor if you:
Tell all of your doctors and dentists that you are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO® works. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about XARELTO®?”
Especially tell your doctor if you take:
Ask your doctor if you are not sure if your medicine is one listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
HOW SHOULD I TAKE XARELTO®?
Take XARELTO® exactly as prescribed by your doctor.
Do not change your dose or stop taking XARELTO® unless your doctor tells you to.
If you take XARELTO® for:
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?
Please see “What is the most important information I should know about XARELTO®?”
Tell your doctor if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
Please click here for full Prescribing Information, including Boxed Warnings, and Medication Guide.
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