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With the post-LER PAD indication, rivaroxaban becomes the only anticoagulant in 2 decades to demonstrate safety and efficacy in the high-risk population.
Rivaroxaban (Xarelto) plus aspirin is newly indicated for use following lower-extremity revascularization in patients with symptomatic peripheral artery disease (PAD), according to a press statement from the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J).
The US Food and Drug Administration’s August 24th approval of the expanded label for the rivaroxaban vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) is based on data from the pivotal VOYAGER PAD study.
"For more than 20 years, many physicians have used dual antiplatelet therapy after lower extremity revascularization due to symptomatic PAD with limited data to support efficacy and safety in this setting,” said VOYAGER PAD lead author Marc P. Bonaca, MD, MPH, Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, in the J&J statement.
Bonaca adds that combined data from the VOYAGER PAD and COMPASS clinical studies demonstrate “the utility of dual pathway inhibition in targeting both platelets and thrombin in patients with PAD. These data provide a new mechanism of treatment using an evidence-based strategy for this vulnerable population.” The new indication, Bonaca suggests in the statement, “sets the stage to evolve the current standard of care for patients with PAD."
Rivaroxaban, a factor Xa inhibitor direct oral anticoagulant, is the only anticoagulant in 2 decades to demonstrate benefit in this vulnerable patient population--a group that remains at high risk for major thrombotic events, including acute limb ischemia and amputation—the most serious complication of PAD, according to the statement. Amputation, while preventable, has been increasing in the US and particularly in populations with limited access to care.
The international phase 3 VOYAGER PAD study included 6564 patients across 542 sites in 34 countries. Investigators randomized in a 1:1 ratio to rivaroxaban plus aspirin or aspirin alone. The trial met its primary efficacy and safety endpoints, demonstrating that use of rivaroxaban plus aspirin was superior to aspirin monotherapy for reducing risk of major adverse limb and cardiovascular events among patient with PAD and lower-extremity revascularization. No increase in major bleeding was observed in patients treated with the dual antiplatelet therapy vs aspirin therapy alone, according to the company statement.
"PAD is a serious condition that is too frequently missed or often not even discussed by patients and their doctors due to lack of awareness and other health conditions that often take priority,” said Ryan Gough, Executive Director of the Partnership to Advance Cardiovascular Health, a heart patient advocacy organization, in the press release. “It's important to understand the risk factors for PAD, including conditions such as diabetes, smoking and high blood pressure.
"There's been a long-standing need across the healthcare community for increased education around PAD and better access to screening and innovative treatments. This is especially critical for patients in underserved communities, who are often at even greater risk for serious complications like amputation."