August 21, 2017
Not intended for U.S. and UK Media

Two abstracts on Phase III COMPASS study with Bayer's Rivaroxaban accepted for presentation in Hot Line sessions at ESC Congress 2017

Results from COMPASS, the largest clinical study of rivaroxaban to date, will provide new insights into the management of patients with chronic coronary and peripheral artery disease / COMPASS study was stopped early because of overwhelming efficacy / A total of 17 rivaroxaban abstracts accepted for presentation covering both clinical and real-world studies in venous and arterial thromboembolism
Berlin, August 21, 2017 - Bayer AG and its development partner Janssen Research
& Development, LLC, announced today that two abstracts featuring new clinical
data from the Phase III COMPASS study(1) have been accepted for Hot Line
presentations at ESC Congress 2017. The congress will take place in Barcelona,
Spain from 26-30 August, 2017. The COMPASS study evaluated the efficacy and
safety of 2.5 and 5 mg vascular dose of rivaroxaban (Xarelto®) for the
prevention of major adverse cardiac events (MACE) including stroke,
cardiovascular death and heart attack in patients with chronic coronary artery
disease (CAD) and / or peripheral artery disease (PAD) including those with
prior heart conditions. In February this year, as part of a planned interim
analysis, the COMPASS study was found to have met its primary endpoint early
and was stopped because of overwhelming efficacy.

Cardiovascular disease, which includes CAD and PAD, is responsible for
approximately 17.7 million deaths per year(2). Specifically, CAD led to 8.8
million deaths in 2015(3), and around 202 million people worldwide are
estimated to be living with PAD(4). The current guideline-recommended
antithrombotic treatment for these patients is antiplatelet therapy, which is
generally not considered sufficient as event rates remain high(5).
Consequently, there is a need to improve outcomes by establishing new or add-on
treatments, which have the potential to reduce the risk of MACE in patients
with atherosclerotic disease. Rivaroxaban is the first and only non-vitamin K
antagonist oral anticoagulant (NOAC) investigated in these high-risk patient

Note: Per ESC Embargo Policy, all below mentioned abstracts are under embargo
until the time of presentation.

Full data from the Phase III COMPASS Study will be featured in the following
Hot Line presentations:
- Cardiovascular Outcomes for People using Anticoagulation Strategies (COMPASS)
trial: primary results
o Hot Line: Late Breaking Clinical Trials 1; Abstract number 1154
o Sunday 27 August, 11:36-11:51, Barcelona - Main Auditorium

- Cardiovascular Outcomes for People using Anticoagulation Strategies (COMPASS)
trial: Results in patients with Peripheral Artery Disease
o Hot Line: Late Breaking Clinical Trials 1; Abstract number 1157
o Sunday 27 August, 11:54-12:09, Barcelona - Main Auditorium

The COMPASS study was conducted in collaboration with the Population Health
Research Institute (PHRI) in Canada and enrolled 27,395 patients from more than
600 sites across more than 30 countries worldwide. In the study, patients were
randomized to receive either rivaroxaban 2.5 mg twice daily in addition to
aspirin 100 mg once daily, rivaroxaban 5 mg twice daily alone, or aspirin 100
mg once daily alone.

A further 15 abstracts on rivaroxaban have been accepted for presentation from
clinical trials, as well as real-world studies, in the areas of stroke
prevention and venous clot protection. This includes presentations from the
PIONEER AF-PCI study, and results from the real-world XANTUS study as follows:

- Rivaroxaban strategies improve the number of days patients remain out of the
hospital and event free: A PIONEER substudy
o Poster Session 4: Stroke Prevention; Abstract number P3590
o Monday 28 August, 08:30-12:30, Poster Area

- Safety analysis of rivaroxaban: a pooled analysis of the global XANTUS
programme (real-world, prospective, observational studies for stroke prevention
in patients with atrial fibrillation)
o Poster Session 4: Stroke Prevention; Abstract number P3592
o Monday 28 August, 08:30-12:30, Poster Area

Separately, 8 independent data presentations on the use of NOACs in real-world
settings have been accepted for presentation, including a Hot Line presentation
from the IMPACT-AF study and presentations from the GARFIELD-AF Registry,
including on the burden of atrial fibrillation across Europe.

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

- 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 about thrombosis, please visit
To learn more about Xarelto, please visit

(1) NCT01776424
(2) WHO Fact Sheet. Cardiovascular Diseases, 2017. [accessed 01 June 2017]
(3) WHO Fact Sheet. The Top 10 Causes of Death, 2017. [accessed 01 June 2017]
(4) Fowkes FG, Rudan D, Rudan I et al. Comparison of global estimates of
prevalence and risk factors for peripheral artery disease in 2000 and 2010: a
systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40
(5) Di Manno MND, Guida A, Camera M et al. Overcoming limitations of current
antiplatelet drugs: A concerted effort for more profitable strategies of
intervention. Annals of Medicine 2011 Nov; 43(7): 531-544.

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