The Janssen Pharmaceutical Companies of Johnson & Johnson has reported that two new analyses from the Phase 3 VOYAGER PAD clinical trial have reinforced the benefit of Xarelto (rivaroxaban) Plus Aspirin in high-risk and complex patient populations with peripheral artery disease (PAD).

The late-stage trial randomised 6,564 patients in a 1:1 ratio and received either Xarelto (rivaroxaban or Aspirin alone, the standard of care).

The results from the two analyses demonstrate the role of Xarelto in the treatment of both high-risk and fragile patients and those with and without comorbid coronary artery diseases (CAD).

VOYAGER PAD study met its primary efficacy and principal safety endpoints.

The combination consistently lowered major adverse limb events (MALE) and major cardiovascular events (MACE) in complex patients with PAD.

According to the findings, Xarelto plus Aspirin was found superior to Aspirin alone in reducing the risk of major adverse limb and cardiovascular events.

It lowered the risk by 15% in patients with symptomatic PAD after lower-extremity revascularisation, Janssen Pharmaceutical said.

The advantages of taking Aspirin with Xarelto were seen early on, were consistent for major subgroups, and grew over time.

When the combination was administered to patients for myocardial infarction (TIMI) major bleeding, there was no statistically significant increase in thrombolysis as compared to Aspirin alone.

Janssen Scientific Affairs cardiovascular & metabolism medical affairs VP Avery Ince said: “At Janssen, we work tirelessly to bring the latest research and clinical practice insights to healthcare providers and their patients to help improve cardiovascular care for all.

“These new findings continue to support the use of Xarelto with its positive benefit-risk profile in many types of patients, including those who are high-risk and considered harder to treat.”

In 2021, the US Food and Drug Administration (FDA) authorised an expanded PAD indication for Xarelto plus Aspirin to include patients following a recent LER due to symptomatic PAD.