![]() Patients were followed for a median of 28 months. surgical) and use of clopidogrel, which was administered at the treating physician’s discretion. ![]() Patients were stratified by revascularization procedure type (endovascular vs. Patients were randomized in a 1:1 ratio and received either the XARELTO ® vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) (n=3,286) or aspirin alone (100 mg once daily) (n=3,278). The Phase 3 VOYAGER PAD study included 6,564 patients from 542 sites across 34 countries worldwide. XARELTO ® acts on a dual pathway inhibition (DPI) approach to target both clotting mechanisms, thrombin and platelet activation. The XARELTO ® vascular dose is the first and only approved anticoagulant for PAD. Food and Drug Administration (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. “At Janssen, we remain steadfast in our commitment to advance science that can transform cardiovascular care for all.” “These findings provide additional insights on the proven clinical utility of XARELTO ® for people living with PAD, particularly those who have undergone lower extremity revascularization,” said Avery Ince, M.D., Ph.D., Vice President, Medical Affairs, Cardiovascular & Metabolism, Janssen Scientific Affairs, LLC. 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. ![]() 2.10%, respectively, and 4.3% and 5.7% from 91 days to three years). 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. 1 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 (≤30 days HR=0.45 95% CI, 0.24–0.85) versus late (>90 days HR=0.75 95% CI 0.60-0.95). “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.”įollowing 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. Bonaca **, M.D., Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado. “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. These latest XARELTO ® data were presented at the American College of Cardiology’s 72nd Annual Scientific Session (ACC.23), hosted in New Orleans, Louisiana, March 4-6, 2023. 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). Lower extremity revascularization, also called peripheral revascularization, is a procedure that restores blood flow in blocked arteries or veins. TITUSVILLE, NJ, Ma– The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from a new prespecified analysis from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefits of the XARELTO ® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) over standard of care (aspirin alone), demonstrating consistent benefit at 30 days, 90 days and up to three years following LER in patients with PAD.
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