FDA Approves Rivaroxaban for Use After Lower Extremity Revascularization in Peripheral Artery Disease

Announced on August 24, rivaroxaban (Xarelto) has received its ninth indication from the US FDA. This time, the FDA has approved a label expansion to include patients with symptomatic peripheral artery disease who have undergone lower extremity revascularization.

Rivaroxaban (Xarelto) plus aspirin is now indicated for use following lower extremity in revascularization in patients with symptomatic peripheral artery disease (PAD), according to a release from the Janssen Pharmaceutical Companies of Johnson & Johnson.

Announced on August 24, the US Food and Drug Administration’s approved the expanded label for rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily is based on data from the landmark 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. Now, the VOYAGER PAD and COMPASS clinical studies have demonstrated 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," said Marc P. Bonaca, MD, MPH, Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, in the aforementioned release. "This FDA approval of rivaroxaban plus aspirin is a major advancement for PAD management and sets the stage to evolve the current standard of care for patients with PAD."

The expanded indication from the US FDA marks the ninth indication for rivaroxaban in the US, which Janssen claims is the most of any direct oral anticoagulant. Although rates of have decreased in recent years, amputation remains among the most serious complications of PAD and has been associated with marked increases in mortality risk. With approval based on results of the VOYAGER PAD study, the latest indication expands the potential patient population for the DOAC.

The phase 3 VOYAGER PAD study included more than 6500 patients rolled across 542 sites in 34 countries. In the trial, participants were randomized in a 1:1 ratio to rivaroxaban plus aspirin or aspirin alone. The trial met its primary efficacy and safety endpoints and demonstrated 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. In the aforementioned release, Johnson & Johnson highlighted to observed safety profile from VOYAGER PAD by noting there was no increase in major bleeding observed in patients treated with rivaroxaban plus aspirin compared to aspirin monotherapy.

"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. It's important to understand the risk factors for PAD, including conditions such as diabetes, smoking and high blood pressure," said Ryan Gough, Executive Director of the Partnership to Advance Cardiovascular Health, a heart patient advocacy organization. "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."