Rivaroxaban Plus Aspirin Reduces Acute Limb Ischemia After Lower Extremity Revascularization in PAD


Results of an analysis of the VOYAGER PAD clinical trial were presented at ACC.23.

Study findings presented at the American College of Cardiology 2023 Annual Scientific Sessions/World Congress of Cardiology (ACC.23) show that treatment with rivaroxaban (Xarelto) plus aspirin leads to a 33% reduction in acute limb ischemia after lower extremity revascularization in patients with peripheral artery disease (PAD), according to a press release from Janssen.1

The results of a prespecified analysis of data from the phase 3 VOYAGER PAD clinical trial (NCT02504216) also showed that the combination therapy provided a consistent benefit at 30 days, 90 days, and up to 3 years. Rivaroxaban plus aspirin also led to a 15% reduction in major adverse limb and cardiovascular events with or without dual antiplatelet therapy.

According to presenters, data showed a trend toward a greater benefit earlier in the course of treatment—that is, within 30 days or less—compared with later in the course of treatment (hazard ratio [HR], 0.45; 95% CI, 0.24-0.85 for ≤30 days vs HR, 0.75; 95% CI, 0.60-0.95). Hazard ratios for the rate of thrombolysis in myocardial infarction major bleeding from 0 to 90 days was 2.01 (range, 0.9-4.47) and 1.28 (range, 0.82-1.99) from 91 days to 3 years.

Patients with PAD are 4 times more likely to experience acute limb ischemia after lower extremity revascularization, which is associated with long hospitalization and high rates of amputation, disability, and/or death.

The rivaroxaban vascular dose—2.5 mg rivaroxaban twice daily plus aspirin 100 mg once daily—evaluated in the VOYAGER PAD study received an expanded indication for PAD in August 2021.2 Data from VOYAGER PAD were initially published in the New England Journal of Medicine in May 2020.3

VOYAGER PAD included a total of 6564 patients from 542 study sites in 34 coutries. Patients were randomly assigned 1:1 to receive either rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily or 100 mg aspirin once daily alone (n=3286 and n=3278, respectively). Participants were then stratified by revascularization procedure type—endovascular or surgical—and the use of clopidrogel before being followed for 28 months.

The study met its primary efficacy and principal safety endpoints, showing that the rivaroxaban vascular dose is “superior to aspirin alone in reducing the risk of major adverse limb and cardiovascular events (composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or cardiovascular death.”

“These data demonstrate an evolution in medical therapy [for] patients undergoing lower extremity revascularization 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,” said Marc P. Bonaca, MD, of the department of medicine, division of cardiovascular medicine at the University of Colorado Anschutz Medical Campus in Aurora, Colorado.1 “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 [dual antiplatelet therapy] is utilized.”

ACC.23 was held March 4 to 6, 2023 in New Orleans, Louisiana.

  1. New VOYAGER PAD analysis confirms consistent benefit of Xarelto (rivaroxaban) plus aspirin following lower extremity revascularization (LER). News release. Janssen. March 5, 2023. Accessed March 7, 2023. https://www.jnj.com/new-voyager-pad-analysis-confirms-consistent-benefit-of-xarelto-rivaroxaban-plus-aspirin-following-lower-extremity-revascularization-ler
  2. 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. Janssen. August 24, 2021. Accessed March 7, 2023. https://www.jnj.com/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
  3. Bonaca MP, Bauersachs RM, Anand SS, et al. Rivaroxaban in peripheral artery disease after revascularization. N Engl J Med. 2020;382(21):1994-2004. doi:10.1056/NEJMoa200052
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