The Janssen Pharmaceutical Companies has reported that the latest data from the Phase III VOYAGER PAD trial showed Xarelto (rivaroxaban) plus aspirin lowered severe vascular events in peripheral artery disease (PAD) patients.
The study enrolled 6,564 subjects at 542 sites in 34 countries globally. Participants were randomly given either a 2.5mg dose of Xarelto twice daily plus aspirin 100mg once daily or aspirin alone.
Subjects were differentiated based on the revascularisation procedure type – endovascular versus surgical, and the usage of clopidogrel. They were followed up for a median of 28 months.
Participants already had lower-extremity revascularisation (LER).
According to the primary data from the trial, Xarelto plus aspirin provided a 15% reduction in first events in PAD patients after LER.
Furthermore, the analysis demonstrated an increased burden of ensuing events while showing a 14% drop in primary endpoint events as well as total vascular events for a median time of 2.5 years.
On analysing thrombotic events that arose after the first event, Xarelto plus aspirin was found to lower total primary endpoint events and total vascular events versus aspirin alone.
Total primary endpoint events were acute limb ischemia, non-fatal myocardial infarction, major amputation due to vascular causes, non-fatal ischemic stroke, or death related to vascular causes.
Meanwhile, total vascular events included these primary endpoints and resulting peripheral revascularisations of the index and contralateral leg, as well as venous thromboembolic events.
In addition, no significant hike in Thrombolysis in Myocardial Infarction major bleeding was noted in the trial in subjects who received the combination treatment.
Janssen Research & Development Cardiovascular & Metabolism global therapeutic area head James List said: “The VOYAGER PAD trial is the first and only study of antithrombotic therapy in the past 20 years to demonstrate a significant benefit in patients with peripheral artery disease after lower-extremity revascularisation.
“With these new data, we now have a full picture of evidence demonstrating the potential of Xarelto in treating patients through various stages of peripheral artery disease, chronic, symptomatic, those requiring revascularisation, and beyond.”
At present, Xarelto is approved for use along with aspirin to lower the risk of major cardiovascular events in chronic coronary artery disease or PAD patients.
In February this year, Janssen reported that the Phase III ACIS study of Erleada and Zytiga combination in patients with metastatic castration-resistant prostate cancer met the primary endpoint.