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.
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 efficacybased 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.
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.”
Filed Under: Drug Discovery