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
Post Views: 13
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
Post Views: 13