Bayer HealthCare announced today that new data from the clinical development programme for its oral anticoagulant Xarelto® (rivaroxaban) will be presented at the European Society of Cardiology (ESC) Congress 2012 in Munich, Germany, August 25-29, 2012. These data will provide further insights into the clinical utility of rivaroxaban for patients at risk of dangerous blood clots across multiple venous and arterial thromboembolic (VAT) conditions.
Rivaroxaban Oral and Poster Presentations in ACS
Oral Presentation Session: Clinical Trial and Registry Update II: Heart Failure & Coronary Heart Disease
Monday, August 27, 14:48-15:04
Munich - Central Village
Rivaroxaban in Patients with ST-Elevation Myocardial Infarction: Results from ATLAS ACS 2-TIMI 51
Poster Session 2: Controversial issues on thrombotic and antithrombotics treatment
Sunday, August 26, 14:00-18:00
Posters - Village 10
Concomitant administration of antiplatelet agents enhances the antithrombotic effects of rivaroxaban in vitro and in vivo (P1835)
Effect of rivaroxaban with or without acetylsalicylic acid on thrombus formation in an ex vivo perfusion chamber: an openlabel, randomized study in healthy subjects (P1833)
Full data from ATLAS ACS 2-TIMI 51 were presented at the American Heart Association (AHA) Scientific Sessions meeting in 2011 and were simultaneously published in the New England Journal of Medicine (NEJM). Subsequently, rivaroxaban has been submitted for marketing authorisation to reduce secondary cardiovascular events in patients with ACS in more than 40 countries, including Europe and the US.
Rivaroxaban Oral and Poster Presentations on Stroke Prevention in AF
Oral Presentation Session: New horizons of antithrombotic therapy in AF
Wednesday, August 29;
08:45-09:00 and 09:15-09:30
Brussels - Village 7
Inadequate anticoagulant therapy during end of study transition to open-label vitamin K antagonist therapy: experience in ROCKET AF
Relationship between centre time in therapeutic range and comparative treatment effect of rivaroxaban and warfarin: results from the ROCKET AF trial
Poster Session 1: AF: Antithrombotic treatment and beyond
Sunday, August 26; 08:30-12:30
Posters - Village 10
Independent predictors of mortality in patients with non-valvular atrial fibrillation: results from ROCKET AF (P571)
Full data from ROCKET AF were presented at the AHA Scientific Sessions meeting in 2010 and were published in the New England Journal of Medicine (NEJM) in September 2011. Subsequently, Xarelto received marketing approval in the EU and has now been approved for the prevention of stroke and systemic embolism in patients with non-valvular AF in more than 50 countries worldwide, including the U.S.
GARFIELD Registry Data to be Presented
Independently, the Thrombosis Research Institute (TRI) will present data from the ongoing Global Anticoagulant Registry in the FIELD (GARFIELD), providing real-world clinical insights into current anticoagulation therapies in AF management. The GARFIELD Registry is an academic research initiative, led by the TRI and a multi-disciplinary Steering Committee and supported by an unrestricted educational grant from Bayer Pharma AG.
Presentations from GARFIELD
Oral Presentation Session: Balancing stroke prevention versus bleeding risk in AF
Tuesday, August 28; 11:00-11:15
Tel Aviv - Village 7
Regional differences in the use of antithrombotic therapy for stroke prevention in atrial fibrillation: European and Asian insights from the Global Anticoagulant Registry in the FIELD (GARFIELD)
Oral Presentation Session: New horizons of antithrombotic therapy in AF
Wednesday, August 29; 08:30-08:45
Brussels - Village 7
Impact of renal function on use of antithrombotic therapy in atrial fibrillation: real-world perspective from the Global Anticoagulant Registry in the FIELD (GARFIELD)
Poster Session 1: AF: antithrombotic treatment and beyond
Sunday, August 26; 08:30-12:30
Posters - Village 10
Antithrombotic treatment patterns for stroke prevention in relation to age: insights from the Global Anticoagulant Registry in the FIELD (GARFIELD) (P557)
Gender differences in use of antithrombotic therapy in atrial fibrillation: real-world perspective from the Global Anticoagulant Registry in the FIELD (GARFIELD) (P578)
Patterns of antithrombotic therapy and type of atrial fibrillation: insights from the Global Anticoagulant Registry in the FIELD (GARFIELD) (P562)
Poster session 7: Critical role of comorbidities in coronary disease
Wednesday, August 29; 08:30-12:30
Posters - Village 10
Antithrombotic therapy for stroke prevention in patients with newly diagnosed atrial fibrillation and a history of acute coronary syndrome: the Global Anticoagulant Registry in the FIELD (GARFIELD) (P5748)
About the GARFIELD Registry
In August 2009, the Thrombosis Research Institute launched GARFIELD - the Global Anticoagulant Registry in the FIELD. This academic research initiative, led by a Global Steering Committee, was designed to enhance understanding of the burden of atrial fibrillation (AF) on a global scale. The data collected in the GARFIELD Registry will allow for important insights into how innovation in anticoagulation and AF management can best be used to reduce the clinical impact of AF for patients and the economic burden for healthcare systems.
The GARFIELD Registry is an observational, multicentre, international prospective study of men and women with newly diagnosed non-valvular AF and at least one additional, investigator determined risk factor for stroke. The aim is to enrol 55,000 patients at more than 1,000 randomly selected centres in up to 50 countries. Investigator sites are representative of national AF care settings and geographies.
About Xarelto® (Rivaroxaban)
Rivaroxaban is the most broadly indicated new oral anticoagulant and is marketed under the brand name Xarelto®. To date, Xarelto has been approved for use in the following indications across the venous arterial thromboembolic (VAT) space:
- The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors in more than 60 countries worldwide
- The treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults in more than 50 countries worldwide
- The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery in more than 120 countries worldwide
Since the first approval of Xarelto in 2008 in the orthopaedic setting, more than two million patients worldwide have received Xarelto in daily clinical practice in this indication alone.
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.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), 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 55,700 employees (Dec 31, 2011) and is represented in more than 100 countries.