XARELTO® is the only Factor Xa inhibitor currently under investigation in patients with coronary and peripheral artery disease

Data from PIONEER AF-PCI examining the value of XARELTO® in patients with non-valvular atrial fibrillation following percutaneous coronary intervention with stenting among 25 studies being presented

TITUSVILLE, NJ, USA I August 21, 2017 I New data from the landmark Phase 3 COMPASS study evaluating the use of XARELTO® (rivaroxaban) in coronary and peripheral artery disease (CAD and PAD) are among the 25 presentations from Janssen Research & Development, LLC (Janssen) and its development partner Bayer to be featured at the ESC Congress 2017 in Barcelona, Spain. In addition to two late-breaking presentations from the COMPASS study, the companies will present sub-analyses from PIONEER AF-PCI, a study of XARELTO® in patients with non-valvular atrial fibrillation (NVAF) following percutaneous coronary intervention (PCI) with stenting.

Click to Tweet: @JanssenUS to present 25 studies at #ESCCongress addressing #CAD, #PAD, #AFib and #PCI #JanssenCV http://po.st/gbV8rG

Both COMPASS and PIONEER AF-PCI are part of the EXPLORER clinical research program for XARELTO®. Janssen announced earlier this year that COMPASS was being stopped early due to efficacy based on the recommendation of the study’s independent Data Monitoring Committee (DMC), as the primary efficacy endpoint had reached its pre-specified criteria for superiority.

“People living with CAD and/or PAD are at high risk for cardiovascular death, heart attack or stroke, and have limited treatment opportunities,” said James F. List, MD, PhD, Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen. “We are excited to share the results of the very important COMPASS study as they provide new insights into the prevention of cardiovascular events in patients treated with XARELTO®, the only Factor Xa inhibitor currently under investigation in this population.”

CAD and PAD affect 16.5 million and 10 million Americans, respectively. Globally, screening studies suggest approximately 20 percent of adults older than 55 years show evidence of PAD. Importantly, cardiovascular disease is estimated to account for one-third of deaths in people over age 35.

About COMPASS
COMPASS is a Phase 3 clinical study examining the use of XARELTO®, alone or in combination with aspirin, in the long-term prevention of major adverse cardiovascular (CV) events, including heart attack, stroke or CV-related death in people with CAD and/or PAD. A total of 27,395 patients with stable CAD and/or PAD from 33 countries were enrolled.

Both CAD and PAD are the result of atherosclerosis and occur when arteries become hardened or narrowed due to a buildup of cholesterol and plaque, limiting blood flow to parts of the body. When atherosclerosis occurs in the vessels that feed the heart, it is called CAD; it is called PAD when it occurs in other blood vessels in the body – most often in the legs, but also in the brain, arms and abdomen. People with CAD and/or PAD are at significant risk of experiencing a major CV event. While long-term aspirin helps prevent CV events, it is only modestly effective.

About PIONEER AF-PCI
Presented and published in 2016, the Phase 3b PIONEER AF-PCI study met its primary endpoint, showing XARELTO® significantly reduced the risk of bleeding compared to warfarin, the standard of care, in patients with NVAF who received background antiplatelet therapy following PCI with stenting. Although the study was not powered to make conclusions on efficacy, XARELTO® showed similar rates of major adverse CV events compared to warfarin. A separate post-hoc sub-analysis of PIONEER AF-PCI showed a reduction in the risk of re-hospitalization for XARELTO® compared to warfarin.

“As PIONEER AF-PCI addresses a common situation in clinical practice, we wanted to better understand the value of XARELTO® in these patients,” said Dr. List. “We look forward to sharing research on the number of clinically significant bleeding events, costs associated with re-hospitalization and the number of event-free days out of the hospital for patients both on XARELTO® and warfarin.”

About EXPLORER
The EXPLORER program is unmatched by any oral anticoagulant in the Factor Xa inhibitor class in its size, scope and ambition. A collaborative effort between Janssen and Bayer, EXPLORER seeks to generate important clinical evidence on the safety and efficacy of XARELTO® and its potential role in addressing critical unmet medical needs. A number of the studies, including COMPASS, are designed to seek additional indications or expand the label for XARELTO® to benefit more patients in need of additional therapies for their cardiovascular disease. By the time of its completion, more than 275,000 patients will have participated in the EXPLORER clinical development program, other completed and ongoing clinical trials, investigative registries and non-interventional studies.

Following is a list of abstracts to be presented at the ESC Congress 2017:

Abstract # Title Date/Time/Location
XARELTO®: Vascular Protection
1154 – 1155 Cardiovascular OutcoMes for People using Anticoagulation StrategieS (COMPASS) trial: primary results

Hot Line: Late-Breaking Clinical Trials 1

Sunday, August 27

11:36-11:51 a.m. CEST

Barcelona – Main Auditorium

1157 – 1158 Cardiovascular OutcoMes for People using Anticoagulation StrategieS (COMPASS) trial: results in patients with coronary artery disease and in patients with peripheral artery disease

Hot Line: Late-Breaking Clinical Trials 1

Sunday, August 27

11:54 a.m.-12:09 p.m. CEST

Barcelona – Main Auditorium

P4565

Rivaroxaban treatment strategies reduce not only the first bleeding event, but all (including multiple) bleeding events: a

PIONEER substudy

Poster Presentation

Monday, August 28

2:00-6:00 p.m. CEST

Poster Area

P6112

Effect of procedure and lesion characteristics on bleeding and ischemic outcomes among atrial fibrillation patients

undergoing percutaneous coronary intervention: results from the PIONEER AF-PCI trial

Poster Presentation

Tuesday, August 29

2:00-6:00 p.m. CEST

Poster Area

2872 Association between sociodemographic factors and choice of direct oral anticoagulants versus warfarin in atrial fibrillation: a population based cross-sectional study using Swedish Registers

Rapid Fire Abstract

Monday, August 28

8:30-8:39 a.m. CEST

Agora 2 – Agora

P2642 Effect of rivaroxaban on coagulation and inflammation biomarkers: results from an X-VeRT substudy

Poster Presentation

Sunday, August 27

2:00-6:00 p.m. CEST

Poster Area

XARELTO®: Venous Protection
P1617 Clinical and economic outcomes in low-risk pulmonary embolism patients treated with rivaroxaban vs. standard of care

Poster Presentation

Sunday, August 27

8:30 a.m.-12:30 p.m. CEST

Poster Area

P4925 Recurrent venous thromboembolism and major bleeding in patients treated with rivaroxaban or warfarin for venous thromboembolism in routine practice

Poster Presentation

Tuesday, August 29

10:05-10:55 a.m. CEST

Moderated Poster Station – Poster Area

XARELTO®: Stroke Prevention
P3592 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)

Poster Presentation

Monday, August 28

8:30 a.m.-12:30 p.m. CEST

Poster Area

P3622 Timing of trial stoppage for non-inferiority trials and interpretation: lessons from ROCKET AF

Poster Presentation

Monday, August 28

8:30 a.m.-12:30 p.m. CEST

Poster Area

XARELTO®: Value
P3590 Rivaroxaban strategies improve the number of days patients remain out of the hospital and event free: A PIONEER sub-study

Poster Presentation

Monday, August 28

8:30 a.m.-12:30 p.m. CEST

Poster Area

P4569

Rivaroxaban treatment strategies reduce costs associated with rehospitalizations due to bleeding and cardiovascular events:

results from the PIONEER AF-PCI trial

Poster Presentation

Monday, August 28

2:00-6:00 p.m. CEST

Poster Area

Independent Studies/Registries
P1078 Short and intermediate term all-cause mortality among newly-diagnosed heart failure patients in the U.S. Medicare population

Poster Presentation

Sunday, August 27

10:05-10:55 a.m. CEST

Moderated Poster Station – Poster Area

P3237

One-year clinical outcomes and management of patients with ischaemic vs non-ischaemic cardiomyopathy and newly

diagnosed atrial fibrillation: results from GARFIELD-AF

Poster Presentation

Monday, August 28

8:30 a.m.-12:30 p.m. CEST

Best Poster Screen – Poster Area

P3609 Which definition of hypertension best defines thromboembolic risk in patients with atrial fibrillation? Data from the GARFIELD-AF registry

Poster Presentation

Monday, August 28

8:30 a.m.-12:30 p.m. CEST

Poster Area

P3581 Real-world effectiveness of stroke prevention in patients with non-valvular atrial fibrillation treated with rivaroxaban vs. phenprocoumon in Germany – insights from the RELOAD study

Poster Presentation

Monday, August 28

8:30 a.m.-12:30 p.m. CEST

Poster Area

P3600 Characteristics of 15 mg once-daily rivaroxaban patients from the RELOAD study

Poster Presentation

Monday, August 28

8:30 a.m.-12:30 p.m. CEST

Poster Area

P3569 Impact of body mass index in newly diagnosed atrial fibrillation in the GARFIELD-AF registry

Poster Presentation

Monday, August 28

8:30 a.m.-12:30 p.m. CEST

Poster Area

3058 – 3059 An international multicenter clustered randomized trial to IMProve treatment with oral AntiCoagulanTs in Atrial Fibrillation

Hot Line: Late-Breaking Clinical Trials 2

Monday, August 28

11:36-11:51 a.m. CEST

Barcelona – Main Auditorium

P4603 The burden of atrial fibrillation in the more populated European countries: perspectives from the GARFIELD-AF registry

Poster Presentation

Monday, August 28

2:00-6:00 p.m. CEST

Poster Area

P4594 Global healthcare resource use in 39,670 patients with AF: perspectives from GARFIELD-AF

Poster Presentation

Monday, August 28

2:00-6:00 p.m. CEST

Poster Area

P4602

Similar clinical outcomes of asymptomatic and symptomatic patients with newly diagnosed atrial fibrillation: results from

GARFIELD-AF

Poster Presentation

Monday, August 28

2:00-6:00 p.m. CEST

Poster Area

P4601 Differences in two-year outcomes according to type of atrial fibrillation: results from the GARFIELD-AF registry

Poster Presentation

Monday, August 28

2:00-6:00 p.m. CEST

Poster Area

P4608 Benefits of active involvement of community pharmacists in know your pulse awareness campaign

Poster Presentation

Monday, August 28

2:00-6:00 p.m. CEST

Poster Area

P4893 A scheme based on ICD-10 diagnoses and drug prescriptions to stage chronic kidney disease severity in healthcare administrative records

Poster Presentation

Tuesday, August 29

10:05-10:55 a.m. CEST

Moderated Poster Station – Poster Area

WHAT IS XARELTO®?

XARELTO® is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke.

XARELTO® is also a prescription medicine used to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again.

XARELTO® is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.

About the Janssen Pharmaceutical Companies 
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at @JanssenUS.

SOURCE: Janssen