The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced data from new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of the Xarelto (rivaroxaban) vascular dose (2.5mg twice daily plus aspirin 100mg once daily) in reducing severe vascular events in patients with PAD after lower-extremity revascularisation (LER).
Data from the two analyses demonstrate the role that the Xarelto vascular dose plays in PAD patients with and without CKD and in PAD patients with and without a history of statin therapy, a company press release reads. Results will be featured at the American College of Cardiology’s 71st Annual Scientific Session (ACC) 2022 (2–4 April, Washington DC, USA).
“At Janssen, we are continuing to invest in clinical research to help evolve the standard of care for people living with serious cardiovascular diseases, like PAD, an area of critical unmet need,” said James F List, global therapeutic area head, Cardiovascular, Metabolism, and Retina at Janssen Research & Development. “Our research continues to support the use of the Xarelto vascular dose and is a treatment option physicians should consider for patients with PAD or coronary artery disease.”
The Phase 3 VOYAGER PAD study included 6,564 patients from 542 sites across 34 countries worldwide. Patients were randomised in a 1:1 ratio and received either the Xarelto vascular dose (n=3,286) or aspirin alone (100 mg once daily; n=3,278). Patients were stratified by revascularisation procedure type (endovascular versus surgical) and use of clopidogrel, which was administered at the treating physician’s discretion. Patients were followed for a median of 28 months.
Janseen details that the VOYAGER PAD study met its primary efficacy and principal safety endpoints, demonstrating the Xarelto vascular dose was superior to aspirin alone in reducing the risk of major adverse limb and cardiovascular events by 15% in patients with symptomatic PAD after LER. The benefit of adding Xarelto to aspirin was apparent early, was consistent among major subgroups and continued to accrue over time.