Xarelto significantly reduced major CV events in stable CAD/PAD patients

Results from the pivotal Phase III COMPASS study found that the Xarelto (rivaroxaban) vascular dose (2.5mg twice daily) plus aspirin 100mg once daily significantly reduced the risk of major cardiovascular (CV) events defined as CV death, heart attack or stroke by 24% in patients with stable coronary and/or peripheral artery disease (CAD/PAD) compared to aspirin alone.

This finding was driven by a robust 42% reduction in any stroke and 22% reduction in CV death. The risk of major bleeding was significantly higher in patients taking the Xarelto/aspirin regimen compared to aspirin alone, with no significant increase in fatal or intracranial bleeds. Findings from this global, randomized, superiority study were announced by Germany’s Bayer (BAYN: DE) and partner Janssen Research & Development, a unit of US healthcare giant Johnson & Johnson (NYSE: JNJ), during a Hot Line session at the European Society of Cardiology (ESC) Congress 2017 being held in Barcelona, Spain, and simultaneously published in The New England Journal of Medicine.

The COMPASS study is the largest clinical study of rivaroxaban to date. The study was stopped approximately one year ahead of schedule due to overwhelming efficacy and Bayer, Janssen and the Population Health Research Institute (PHRI) are working towards offering rivaroxaban to study participants in an open-label extension trial. Rivaroxaban is the only non-vitamin K antagonist oral anticoagulant (NOAC) investigated in secondary prevention for cardiovascular disease in stable / chronic CAD or PAD patients.