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Publish Date : 04-Sep-2014

Bayer HealthCare today 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 today during the Hot Line Session at the ESC Congress 2014, and published simultaneously in the European Heart Journal.

Cardioversion is a common medical procedure undertaken in patients with atrial fibrillation in order to reset the heartbeat back to a regular sinus rhythm. Without adequate anticoagulation, these patients have a risk of thromboembolic complications with stroke rates of 5-7 per cent. 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 atrial or left atrial appendage) and four weeks of oral anticoagulation after the procedure. However, unstable INR levels often result in cancellation or postponement of cardioversion, underlining the need for stable, effective anticoagulation in these patients to help prevent life-threatening blood clots before, during and after the procedure.

“Until now, there has been a lack of dedicated clinical data to guide physicians on the practical use of novel oral anticoagulants in AF patients who are scheduled for cardioversion,” said Dr Riccardo Cappato, M.D., Arrhythmia and Electrophysiology Center, University of Milan, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy and Co-Principal Investigator of the X-VeRT study. “The results from the dedicated X-VeRT study indicate that once-daily rivaroxaban can provide effective blood clot protection for patients with atrial fibrillation before, during and after cardioversion, reducing the risk of unstable anticoagulation and allowing prompt elective cardioversion.”

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