FDA Approves Rivaroxaban for Post-LER Patients with Peripheral Artery Disease


The newest indication for the anticoagulant is based on phase 3 VOYAGER PAD findings showing benefit in reduced risk of major cardiovascular events among post-revascularization patients with PAD.


The US Food and Drug Administration (FDA) has approved an expanded indication for rivaroxaban (XARELTO) vascular dose for the treatment of patients following recent lower-extremity revascularization (LER) due to peripheral artery disease (PAD).

The indication, granted for 2.5 mg twice-daily rivaroxaban in combination with 100 mg once-daily aspirin, broadens the availability of the anticoagulant therapy for patients in the coronary artery disease (CAD) and PAD spectrum. For this use in post-LER patients, rivaroxaban may help reduce PAD patient risk of amputation—as evidenced by supporting phase 3 data.

The FDA granted the expanded indication on the basis of findings from the VOYAGER PAD trial. The analysis showed rivaroxaban plus aspirin significantly lowered the composite outcome incidence of composite acute limb ischemia, vascular-related major amputation, myocardial infarction, ischemic stroke, and cardiovascular-related death among treated patients with PAD who had undergone revascularization, versus placebo.

The May 2020 findings also showed the rate of major bleeding per Thrombolysis in Myocardial Infarction (TIMI) did not significantly differ between patients treated with rivaroxaban or placebo, while a greater incidence of bleeding per International Society on Thrombosis and Haemostasis (ISTH) was observed in patients treated with rivaroxaban.

In an episode of the HCPLive podcast series Heart Trials discussing the VOYAGER PAD findings, Manesh Patel, MD, professor of Medicine and chief of the Division of Clinical Pharmacology and Division of Cardiology at the Duke University School of Medicine, discussed the importance of the trial and the precedent it set for reducing PAD-related adverse outcomes.

“There’s always got to be a therapy that’s the first therapy to show it’s reduced something, and it sets the bar for other studies,” Patel explained. “Once you have something that works, you can now demand other stuff has to work like it.”

In another episode of Heart Trials, study author Marc Bonaca, MD, MPH, of CPC Clinical Research reviewed new VOYAGER PAD subgroup analysis which showed rivaroxaban plus aspirin’s benefit in significantly reducing amputation risk among 1533 trial participants with critical limb ischemia, with or without diabetes.

The findings, presented at the American Diabetes Association (ADA) 2021 Scientific Sessions this June, helped evidence a `beneficial agent for patients with PAD and comorbid disease.

“The risk in this population is really daunting,” Bonaca said. “I mean, there’s an extremely high event rate, there’s a huge unmet need, and the efficacy of rivaroxaban is consistent and really associated with very large absolute risk reductions.”

In a statement accompanying the approval, James List, MD, PhD, Global Therapeutic Area Head of Cardiovascular and Metabolism at Janssen Research & Development, emphasized the potentially transformative care provided by rivaroxaban in patients with PAD.

“We're thrilled to bring XARELTO® to even more patients with PAD who have been living for 2 decades without any new innovation in the antithrombotic space," List said.

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