The Xarelto booth at the 2018 American College of Cardiology meeting.
March 14, 2018 — A late-breaking analysis of the landmark COMPASS study presented at the American College of Cardiology (ACC) 2018 meeting this week showed rivaroxaban (Xarelto) combined with aspirin, compared to aspirin alone, significantly lowered the incidence of major adverse limb events (MALE) in people with peripheral artery disease (PAD).
The combination of the anticoagulant and aspirin showed a 43 percent reduction in MALE events, which resulted in fewer amputations, death and hospitalizations (HR=0.57; 95% CI, 0.37 to 0.88; p=0.01).
Additionally, COMPASS researchers confirmed the importance of preventing MALE in patients with PAD, noting the correlation between MALE and amputations, death and hospitalizations. Of note, MALE was associated with a three-fold increase in death and a 200-fold increase in amputation.
The COMPASS PAD analysis also identified several factors that were predictors of MALE in patients: prior revascularization (peripheral surgery or angioplasty), prior limb amputation, critical limb ischemia or randomization to aspirin therapy in the trial.
"This analysis reinforces the potential clinical benefit of Xarelto in this population and may offer additional insight into how physicians manage patients with PAD in the future,” said Dr. Peter DiBattiste, global development head, cardiovascular, Janssen Research and Development.
PAD affects 10 million Americans and can signal that a more serious cardiovascular (CV) event, like heart attack or stroke, may occur. Untreated PAD may also lead to MALE, or severe limb ischemia, where blockage in the arteries of the lower extremities markedly reduces blood-flow.
Rivaroxaban is the only factor Xa inhibitor to be investigated in PAD and coronary artery disease (CAD).
The COMPASS study was stopped about a year ahead of schedule due to efficacy, and primary results were published in The New England Journal of Medicine and presented at the 2017 ESC Congress.
In December 2017, Janssen submitted a supplemental new drug application (sNDA) to the FDA for two new rivaroxaban vascular indications based on COMPASS. These include reducing the risk of major CV events such as CV death, heart attack or stroke in patients with chronic CAD and/or PAD, and for reducing the risk of acute limb ischemia in patients with PAD.
Rivaroxaban is used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. It is also a prescribed to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least six months. It also has an indication 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.
For more information on late-breakering news at ACC.18, find links to stories at ACC 2018 Late-Breaking Trials.
407-16 - High Mortality after Major Adverse Limb Events in Peripheral Artery Disease: Results from the COMPASS trial. ACC 2018 featured clinical research. Presented March 11, 2018. http://www.abstractsonline.com/pp8/#!/4496/presentation/41771