New VOYAGER PAD analysis confirms consistent benefit of Xarelto plus aspirin following lower extremity revascularization.- Janssen Pharmaceuticals

Lower extremity revascularization , also called peripheral revascularization, is a procedure that restores blood flow in blocked arteries or veins. This analysis of the VOYAGER PAD study showed Xarelto plus aspirin resulted in a 33 percent reduction in acute limb ischemia and a 15 percent reduction in major adverse limb and cardiovascular events, with or without dual antiplatelet therapy (DAPT). These latest Xarelto data were presented at the American College of Cardiology’s 72nd Annual Scientific Session (ACC.23), hosted in New Orleans, Louisiana.

“These data demonstrate an evolution in the medical therapy of patients undergoing lower extremity revascularization for symptomatic peripheral artery disease, where the addition of low dose rivaroxaban to antiplatelet therapy results in a 33 percent reduction in major adverse limb events both early and late and with a consistently favorable benefit risk,” said Marc P. Bonaca M.D., Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado. “We hope these data assist clinicians in understanding how to implement antithrombotic therapy in practice and overall support initiation of rivaroxaban in the first days after revascularization regardless of whether or not DAPT is utilized.”

Following LER, patients with PAD are four times more likely to experience acute limb ischemia, or a rapid decrease in lower limb blood flow, which is often associated with long hospitalizations and high incidences of amputation, disability, and death unless appropriate treatment is given. Those treated with Xarelto plus aspirin after LER saw a 33 percent reduction in acute limb ischemia, with a trend toward greater benefit observed early ( less than 30 days HR=0.45; 95% CI, 0.24–0.85) versus late ( greater than 90 days HR=0.75; 95% CI 0.60-0.95). Xarelto plus aspirin was more effective than antiplatelet therapy alone in preventing acute limb ischemia after LER (Kaplan-Meier estimate from 0 to 90 days 1.02% vs. 2.10%, respectively, and 4.3% and 5.7% from 91 days to three years). The hazard ratio for the rate of thrombolysis in myocardial infarction (TIMI) major bleeding at 0 to 90 days was HR 2.01 (range 0.9-4.47) and from days 91 up to three years was HR 1.28 (range 0.82-1.99), neither of which were statistically significant.

In August 2021, the FDA approved an expanded PAD indication for the Xarelto vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following a recent LER due to symptomatic PAD. The Xarelto vascular dose is the first and only approved anticoagulant for PAD. Xarelto acts on a dual pathway inhibition (DPI) approach to target both clotting mechanisms, thrombin and platelet activation..