Janssen’s Xarelto Demonstrates Consistent Benefits for PAD for Up to 3 Years

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The Janssen Pharmaceutical Companies of Johnson & Johnson announced data from a new prespecified analysis from the VOYAGER PAD (NCT02504216) phase 3 clinical trial, emphasizing the benefits of rivaroxaban’s (Xarelto) vascular dose, 2.5 mg twice a day, with aspirin 100 mg once a day, over aspirin alone, which is the standard of care.

The regimen demonstrated consistent benefits at 30 days, 90 days, and up to 3 years following lower extremity revascularization (LER) for patients with peripheral artery disease (PAD).

“These data demonstrate an evolution in the medical therapy of patients undergoing [LER] for symptomatic [PAD], where the addition of low dose rivaroxaban to antiplatelet therapy results in a 33% reduction in major adverse limb events both early and late and with a consistently favorable benefit risk,” Marc Bonaca, MD, from the Department of Medicine’s Division of Cardiovascular Medicine at the University of Colorado Anschutz Medical Campus, said in a statement. “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 [dual antiplatelet therapy (DAPT)] is utilized.”.

The phase 3 study included 6564 individuals from across 542 sites across 34 countries worldwide. They were randomized in a 1:1 ratio and received either the rivaroxaban vascular dose or aspirin alone,

Investigators found that rivaroxaban plus aspirin also resulted in a 15% reduction in major adverse cardiovascular and limb events, with or without DAPT.

When treated with rivaroxaban and aspirin, investigators observed a trend toward greater benefit earlier at 30 or less days compared with later at 90 or more days.

Rivaroxaban and aspirin were also more effective than antiplatelet therapy in preventing acute limb ischemia after LER at 1.02% and 2.10%, respectively, at 0 to 90 days and 4.3% and 5.7%, respectively, from 91 days to 3 years.

The hazard ratio rate for thrombolysis in myocardial infarction major bleeding at 0 to 90 days was HR 2.91 and HR 1.28 from 91 days up to 3 years, which investigators reported was not statistically significant.

“These findings provide additional insights on the proven clinical utility of [rivaroxaban] for [individuals] living with PAD, particularly those who have undergone lower extremity revascularization,” Avery Ince, MD, PhD, vice president of Medical Affairs in Cardiovascular & Metabolism at Janssen Scientific Affairs, LLC, said in the statement.

The latest data were presented at the American College of Cardiology’s 72nd Annual Scientific Session in New Orleans, Louisiana, which took place from March 4, 2023, through March 6, 2023.

In August 2021, the FDA approved an expanded PAD indication for the rivaroxaban vascular dose to include individuals following a recent LER due to symptomatic PAD. The rivaroxaban vascular dose is the only approved anticoagulant for PAD.

Rivaroxaban uses a dual pathway inhibition approach to target clotting, thrombin, and platelet activation.

LER is a procedure that respires blood flow to blocked arteries or veins.

Reference

New VOYAGER PAD analysis confirms consistent benefit of Xeralto (rivaroxaban) plus aspirin following lower extremity revascularization (LER). News release. Johnson & Johnson. March 5, 2023. Accessed March 14, 2023. https://www.jnj.com/new-voyager-pad-analysis-confirms-consistent-benefit-of-xarelto-rivaroxaban-plus-aspirin-following-lower-extremity-revascularization-ler