May 20, 2015
New Data on Bayer's Xarelto® Versus Vitamin K Antagonists in Patients Undergoing Catheter Ablation for Atrial Fibrillation
VENTURE-AF is the first prospective study of a novel oral anticoagulant in patients with atrial fibrillation undergoing catheter ablation / VENTURE-AF adds to findings from a subgroup analysis on catheter ablation of the pivotal Phase III ROCKET AF studyLeverkusen, Germany, May 20, 2015 - Bayer HealthCare and its development
partner Janssen Pharmaceuticals Inc. today announced results from the
VENTURE-AF trial. In this study, once-daily Xarelto® (rivaroxaban) was
investigated as an alternative to dose-adjusted Vitamin K Antagonists (VKAs) to
reduce the risk of blood clots in patients with non-valvular atrial
fibrillation (AF) undergoing catheter ablation. Results of the VENTURE-AF study
were presented today as a late breaking presentation at the Heart Rhythm
Society's 36th Annual Scientific Sessions, taking place from May 13-16 in
Boston, US and were published simultaneously in the European Heart Journal.
Catheter ablation is a technique routinely used in patients with AF in order to
restore normal heart rhythm. Bleeding and thromboembolic events are the most
common complication patients with AF face when undergoing catheter ablation.
Current AF Guidelines therefore recommend uninterrupted oral anticoagulation
for these patients before, during and after the procedure to reduce the risk of
bleeding and thromboembolic events.
VENTURE-AF was a randomised, open-label, comparative Phase IIIb exploratory
trial; the first prospective study of a novel oral anticoagulant in these
patients. 248 patients were randomised from 37 sites across five countries
(Belgium, France, Germany, UK and US). Patients with AF scheduled for catheter
ablation were randomly assigned in a 1:1 ratio to rivaroxaban 20 mg orally
once-daily or to dose-adjusted VKA (target INR 2.0-3.0). In patients treated
with rivaroxaban, there were no thromboembolic events. In those patients
receiving a VKA, two thromboembolic events (one vascular death and one
ischaemic stroke) occurred. There was one ISTH major bleeding event in the VKA
treatment arm versus none in the rivaroxaban treatment group. There were no
major bleeding events in either group using TIMI and GUSTO-defined scales. The
incidence of non-major bleeding events and procedure-attributable events was
low for both treatment arms.
"The VENTURE-AF study provides physicians additional insights for the clinical
management of patients with AF undergoing catheter ablation," said Dr Riccardo
Cappato, M.D., Arrhythmia and Electrophysiology Research Center, IRCCS
Humanitas Clinical Institute, Rozzano, Milan, Italy, Head of Second Arrhythmia
& EP Units, Cliniche Gavazzeni, Bergamo, Italy and Co-Principal Investigator of
the VENTURE-AF study. "Catheter ablation is frequently performed in patients
with AF and uninterrupted oral anticoagulation is important in these patients
to protect them from the consequences of potentially devastating blood clots."
"These study results further expand our understanding of Xarelto in the
management of blood clots and add to the findings of the pivotal ROCKET AF
study, investigating stroke prevention in patients with atrial fibrillation,"
said Dr Michael Devoy, Member of the Bayer HealthCare Executive Committee and
Chief Medical Officer of Bayer HealthCare. "The VENTURE-AF study is part of the
extensive ongoing evaluation of rivaroxaban in different settings and across
patient populations at risk of venous and arterial blood clots."
About Xarelto® (Rivaroxaban)
Rivaroxaban is the most broadly indicated novel oral anticoagulant and is
marketed under the brand name Xarelto®. Xarelto is approved for seven
indications, protecting patients across more venous and arterial thromboembolic
(VAT) conditions than any other novel oral anticoagulant:
- The prevention of stroke and systemic embolism in adult patients with
non-valvular atrial fibrillation (AF) with one or more risk factors
- The treatment of deep vein thrombosis (DVT) in adults
- The treatment of pulmonary embolism (PE) in adults
- The prevention of recurrent DVT and PE in adults
- The prevention of venous thromboembolism (VTE) in adult patients undergoing
elective hip replacement surgery
- The prevention of VTE in adult patients undergoing elective knee replacement
- The prevention of atherothrombotic events (cardiovascular death, myocardial
infarction or stroke) after an Acute Coronary Syndrome in adult patients with
elevated cardiac biomarkers and no prior stroke or transient ischaemic attack
(TIA) when co-administered with acetylsalicylic acid (ASA) alone or with ASA
plus clopidogrel or ticlopidine
Whilst licences may differ from country to country, across all indications
Xarelto is approved in more than 125 countries
Rivaroxaban was discovered by Bayer HealthCare, and is being jointly developed
with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S.
by Bayer HealthCare and in the U.S. by Janssen Pharmaceuticals, Inc. (a Johnson
& Johnson Company).
Anticoagulant medicines are potent therapies used to prevent or treat serious
illnesses and potentially life-threatening conditions. Before initiating
therapy with anticoagulant medicines, physicians should carefully assess the
benefit and risk for the individual patient.
Responsible use of Xarelto is a very high priority for Bayer, and the company
has developed a Prescribers Guide for physicians and a Xarelto Patient Card for
patients to support best practice.
To learn more, please visit https://prescribe.xarelto.com
To learn more about thrombosis, please visit www.thrombosisadviser.com
To learn more about Xarelto, please visit www.xarelto.com
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup
of Bayer AG with annual sales of around EUR 20.0 billion (2014), is one of the
world's leading, innovative companies in the healthcare and medical products
industry and is based in Leverkusen, Germany. The company combines the global
activities of the Animal Health, Consumer Care, Medical Care and
Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop,
manufacture and market products that will improve human and animal health
worldwide. Bayer HealthCare has a global workforce of 60,700 employees (Dec 31,
2014) and is represented in more than 100 countries. More information is
available at www.healthcare.bayer.com.