VOYAGER PAD Analyses Evaluate Janssen’s Xarelto for Reducing Events After Lower Extremity Revascularization

April 1, 2022—The Janssen Pharmaceutical Companies of Johnson & Johnson announced data from new analyses from the phase 3 VOYAGER PAD clinical trial evaluating the Xarelto vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with peripheral artery disease (PAD) after lower extremity revascularization (LER).

According to the company, data from the two analyses demonstrate the role that the Xarelto vascular dose plays in PAD patients with and without chronic kidney disease (CKD) and in PAD patients with and without a history of statin therapy.

Janssen advised that the results were presented at ACC.22, the American College of Cardiology’s 71st annual scientific session held April 2-4 in Washington, DC.

In the VOYAGER PAD trial, the Xarelto vascular dose significantly reduced hospitalizations caused by thrombotic events in patients who underwent LER compared to patients who took aspirin alone (Kaplan-Meier estimate at 3 years, 8.7% vs 12.1%).

In an oral presentation delivered on April 3, the results of a VOYAGER PAD subgroup analysis of patients with and without CKD showed a consistent 4.7% absolute risk reduction in the subgroup with CKD with Xarelto plus aspirin compared to aspirin alone (Kaplan-Meier estimate at 3 years, 7.9% vs 12.6%).

“Patients with symptomatic PAD are already at a heightened risk of hospitalization following revascularization,” commented the study’s lead author Mark Svet, MD, in Janssen’s press release. “Previously reported primary data from the VOYAGER PAD clinical trial established the benefit of Xarelto plus aspirin in patients with PAD. Our research demonstrates the extension of this benefit to PAD patients with CKD in reducing rates of readmission following revascularization without increasing bleeding risk compared to those without CKD.” Dr. Svet is an internal medicine resident at University of Colorado Anschutz School of Medicine in Aurora, Colorado.

An additional VOYAGER PAD analysis presented in a moderated poster presentation on April 2 at ACC.22 evaluated PAD patients with and without a history of statin use.

Consistent with the overall VOYAGER PAD clinical trial results, the analysis showed that patients with PAD post-LER who received the Xarelto vascular dose and statin therapy had a 19% reduction in the primary endpoint composite of acute limb ischemia, major amputation for vascular cause, myocardial infarction, ischemic stroke, or cardiovascular death; a 26% reduction of major adverse limb events; and a 32% reduction of acute limb injury versus placebo and statin therapy.

Overall, it was found that with or without statin therapy, the Xarelto vascular dose consistently reduced the composite of major adverse cardiovascular events or major adverse limb events after revascularization for PAD.

The company noted that both analyses showed a numerical but not statistically significant increase in thrombolysis in myocardial infarction major bleeding in patients treated with Xarelto plus aspirin versus aspirin alone, consistent with the primary results of VOYAGER PAD, regardless of CKD at baseline or statin history. There was no increased intracerebral hemorrhage or fatal bleeding with Xarelto plus aspirin in PAD patients with or without CKD.

In August 2021, Janssen announced that the FDA approved an expanded PAD indication for the Xarelto vascular dose to include patients after recent LER due to symptomatic PAD. The Xarelto vascular dose uses a dual pathway inhibition approach to target both clotting mechanisms of thrombin and platelet activation.