FDA Approves Expanded Indication for Rivaroxaban Plus Aspirin After Lower-Extremity Revascularization Due to Symptomatic PAD


Rivaroxaban is the first and only therapy indicated for both coronary artery disease and peripheral artery disease.

Officials with the FDA have approved an expanded indication for rivaroxaban (Xarelto; Janssen) plus aspirin for the treatment of patients following lower-extremity revascularization (LER) due to symptomatic peripheral artery disease (PAD).

According to a press release, rivaroxaban is the first and only therapy indicated for both coronary artery disease (CAD) and PAD. It is also the only anticoagulant in 20 years to show significant benefits in patients with PAD who are at high risk for major thrombotic events, including acute limb ischemia and amputation, Janssen stated in the release. PAD impacts 20 million individuals in the United States and is the leading cause of amputations, with these rates continuing to rise.

“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, in the press release. “It’s important to understand the risk factors for PAD, including conditions such as diabetes, smoking, and high blood pressure.”

Amputations are associated with high mortality rates, although they are largely preventable. In recent decades, the rate of amputations in the United States has been increasing and studies have shown that Black Americans are up to 4 times more likely to have an amputation as a result of PAD compared with white Americans, according to the press release.

“There’s been a long-standing need across the health care community for increased education around PAD and better access to screening and innovative treatments,” Gough said in the press release. “This is especially critical for patients in underserved communities, who are often at even greater risk for serious complications like amputation.”

Rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily has been approved based on data from the phase 3 VOYAGER PAD study, which included 6564 patients from 542 sites across 34 countries. Patients were randomized 1:1 to receive either rivaroxaban plus aspirin or aspirin alone and were stratified by revascularization procedure type and use of clopidogrel. Participants were followed for a median of 28 months.

The study met its primary efficacy and principal safety endpoints and demonstrated that rivaroxaban was superior to aspirin alone in reducing the risk of major adverse limb and cardiovascular events. Patients with symptomatic PAD following lower-extremity revascularization had a 15% lower risk of major adverse events and this benefit was apparent early in treatment.

The benefit was also consistent among major subgroups and continued to accrue over time. There was no significant increase in thrombolysis in myocardial infarction bleeding observed in patients treated with rivaroxaban compared to aspirin alone (2.65% vs 1.87%, respectively).

“We’re thrilled to bring Xarelto to even more patients with PAD who have been living for two decades without any new innovation in the antithrombotic space,” said James List, MD, PhD, global therapeutic area head of cardiovascular and metabolism at Janssen Research & Development, in the press release.


FDA approves expanded peripheral artery disease (PAD) indication for Xarelto (rivaroxaban) plus aspirin to include patients after lower-extremity revascularization (LER) due to symptomatic PAD. News release. PR Newswire; August 24, 2021. Accessed August 24, 2021. https://www.prnewswire.com/news-releases/fda-approves-expanded-peripheral-artery-disease-pad-indication-for-xarelto-rivaroxaban-plus-aspirin-to-include-patients-after-lower-extremity-revascularization-ler-due-to-symptomatic-pad-301361537.html

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