A combination of low-dose rivaroxaban and aspirin may greatly benefit patients with peripheral artery disease (PAD) as new trial results show that it can decrease major adverse limb events (MALE).
Results from the randomized, double-blind COMPASS trial found that patients with PAD who took rivaroxaban 2.5 mg twice daily and aspirin experienced a lower incidence of MALE events, amputations, peripheral vascular interventions, and total peripheral vascular hospitalizations compared to taking aspirin alone. The study was published in the New England Journal of Medicine and presented at the 2018 American College of Cardiology conference in Orlando, Florida.
“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,” Peter DiBattiste, MD, global development head and co-leader of the Cardiovascular & Metabolism Therapeutic Area at Janssen Research & Development, said in a press release.
Aspirin. (Source: Creative Commons)
Researchers in the COMPASS trial analyzed 5,551 patients with PAD “of the lower extremities” and followed them for 21 months. They gave patients 2.5 mg of rivaroxaban plus aspirin, examined the incidence of MALE, and compared them to patients with coronary artery disease or PAD who only took aspirin. The researchers stated that MALE is “defined as severe limb ischemia”, which can lead to major adverse cardiovascular events (MACE), total amputation, and mortality.
What they found was that the combination of low-dose rivaroxaban and aspirin lowered the incidence of MALE events by 49% (95% CI: 17-69%), peripheral vascular interventions by 29% (95% CI: 9-46%), all peripheral vascular hospitalizations by 28% (95% CI: 8-44%), and amputations by 55% (95% CI: 8-78%) compared to aspirin alone.
According to the study, 109 patients suffered from MALE events. Predictors of MALE included severe intermittent claudication at baseline, prior foot or limb amputation, history of peripheral bypass surgery, and randomization to aspirin therapy during the trial. The researchers stated that MALE was associated with a 4-fold increase in death and a 6-fold increase in MACE or total vascular amputation compared to patients with PAD who did not suffer from a MALE event.
Because of these results, the researchers said that “preventing MALE in patients with PAD is of major clinical importance.”
Due to the trial’s efficacy, the COMPASS study was stopped about a year early, according to a press release. In December 2017, Janssen submitted a supplemental new drug application of two new rivaroxaban vascular indications to the U.S. Food and Drug Administration based on the results. The supplement included reducing the risk of major cardiovascular events in patients with chronic CAD and PAD and reducing the risk of acute limb ischemia in patients with PAD.