November 07, 2016
Not intended for U.S. and UK Media - American Heart Association (AHA) Scientific Sessions 2016:

PIONEER AF-PCI Study with Bayer's Xarelto® Accepted as Late-Breaking Clinical Trial Presentation at AHA 2016

Per the AHA Embargo Policy, all abstracts will become available on the AHA Scientific Sessions 2016 website in the afternoon of Friday, November 11th. They are under embargo until the time of the scientific presentation or the start of the AHA/ASA news conference in which they are featured. Late-Breaking Clinical Trials are under embargo until the beginning of the overall late-breaking plenary session in which the study will be presented.

Berlin, Germany, November 7, 2016
- Bayer AG announced today that results from the Phase IIIb PIONEER AF-PCI study with the oral Factor Xa inhibitor Xarelto® (rivaroxaban) will be presented as part of a Late-Breaking Clinical Trial Session at the upcoming American Heart Association (AHA) Scientific Sessions 2016 in New Orleans, LA, USA, 12-16 November 2016.

Late-Breaking Clinical Trial Presentation on Xarelto:
An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin K antagonist treatment strategy in subjects with atrial fibrillation who undergo percutaneous coronary intervention
o Late-Breaking Clinical Trial: LBCT.02 - Pioneering the Future of HeART Interventions
o Monday 14 November, 11:15-11:27, Main Event 1

PIONEER AF-PCI is the first randomized trial of a non-vitamin K antagonist oral anticoagulant (NOAC) in this patient population. Latest Guideline and consensus / position paper recommendations for these patients are limited and rely on retrospective, non-randomized observational data, therefore the best possible treatment strategy for patients with atrial fibrillation undergoing PCI with stent placement is currently uncertain.

Additionally, a total of 16 abstracts were accepted as oral and poster presentations providing new clinical and real-world insights on rivaroxaban in venous and arterial blood clot management across a broad range of patients. Notable presentations include:


- Outcomes after ablation and cardioversion in patients with non-valvular atrial fibrillation: Results from the XANTUS study
o Oral Session: ST.AOS.580 - Cardiovascular Stroke
o Sunday 13 November, 18:30-18:40, Room 348-349

- Adherence to QD vs. BID medications in NVAF patients is associated with reduced risk of ischemic stroke: A modeling study using RCT and claims data
o Oral Session: ST.AOS.479.N - Stroke Council Award & Lecture and Oral Abstracts
o Monday 14 November, 09:30-09:40, Room 348-349

- Evaluation of the incidence of major bleeding in a heterogeneous population of 51,842 rivaroxaban users with nonvalvular atrial fibrillation
o Poster Session: QU.APS.P199 - Patient Centered Outcomes Research in Atrial Fibrillation and Anticoagulation
o Monday 14 November, 14:00-15:15, Science and Technology Hall, Population Science Section

- Risk of ischemic stroke in newly diagnosed heart failure patients
o Poster Session: HF.APS.P117 - Risk Assessment in Heart Failure: Models and More
o Monday 14 November, 14:00-15:15, Science and Technology Hall, Clinical Science Section

Separately, real-world data from an independent Danish Nationwide Cohort Study will provide further insights on the effectiveness and safety of reduced-dose non-vitamin K antagonist oral anticoagulants in patients with AF in everyday clinical practice:
- Comparative Effectiveness and Safety of Reduced Dose Non-vitamin K Antagonist Oral Anticoagulants Versus Warfarin: A Nationwide Cohort Study
o Oral Session: ST.AOS.580 - Cardiovascular Stroke
o Sunday 13 November, 17:30-17:40, Room 348-349

About Xarelto® (Rivaroxaban)
Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant (NOAC) 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 NOAC:


- 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 pulmonary embolism (PE) in adults


- The treatment of deep vein thrombosis (DVT) in adults


- The prevention of recurrent PE and DVT 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 surgery


- 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 130 countries.

Rivaroxaban was discovered by Bayer, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer and in the U.S. by Janssen Pharmaceuticals, Inc. (Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson).

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 prescribe.xarelto.com
To learn more about thrombosis, please visit www.thrombosisadviser.com To learn more about Xarelto, please visit www.xarelto.com

Bayer: Science For A Better Life

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2015, the Group employed around 117,000 people and had sales of EUR 46.3 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.3 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.com.
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This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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