Voyager pad analyses demonstrates Benefit of XARELTO with aspirin across high-risk patient populations with peripheral artery disease

Janssen Pharmaceuticals announces data from two new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of XARELTO over standard of care. The data demonstrates the role of XARELTO® in treating both high-risk and fragile patients and those with and without comorbid coronary artery diseases.

“These analyses reinforce the consistency of the favorable benefit-risk profile of XARELTO® plus aspirin for patients with vascular disease, regardless of comorbidity. For example, patients categorized as ‘fragile’ are often undertreated due to concerns about benefit-risk, particularly with antithrombotic treatments,” said Marc P. Bonaca*, M.D., Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado. “We hope the ongoing wealth of data coming from VOYAGER PAD presented at AHA offers clinicians the information they need to support shared decision-making in prescribing XARELTO® plus aspirin as the standard of care for their PAD patients, including those who are high-risk or complex.”

Impact of XARELTO® plus Aspirin on Total Vascular Events in Fragile Patients with PAD

XARELTO® plus aspirin also reduced the occurrence of total vascular events in fragile patients over time, with an absolute rate of 82.1 events per 100 patients at three years compared to 99.3 events per 100 patients in those treated with placebo at three years. A similar benefit was also seen in non-fragile patients, with a rate of 70.4 events per 100 patients at three years in those treated with XARELTO® plus aspirin compared to 81.6 events per 100 patients in those treated with placebo at three years. Importantly, thrombolysis in myocardial infarction (TIMI) major bleeding was consistent in both the fragile and non-fragile treatment groups. XARELTO® plus aspirin demonstrated a consistent, numerical increase in TIMI major bleeding for both the fragile (HR 1.66; 95% CI 0.87-3.19) and the non-fragile (HR 1.37; 95% CI 0.83-2.24, p-interaction 0.65) patients.

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