Data from a new prespecified analysis of the phase III VOYAGER PAD clinical trial show that low-dose rivaroxaban plus aspirin resulted in a 33% reduction in acute limb ischemia and a 15% reduction in major adverse limb and cardiovascular events, with or without dual antiplatelet therapy (DAPT).
The data were presented at the American College of Cardiology’s 72nd annual scientific session (ACC.23), hosted in New Orleans, Louisiana, March 4–6.
The new findings reinforce the benefits of the Xarelto (rivaroxaban; Janssen Pharmaceutical Companies of Johnson & Johnson) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) over standard of care (aspirin alone), demonstrating consistent benefit at 30 days, 90 days and up to three years following lower extremity revascularization in patients with peripheral arterial disease (PAD).
“These data demonstrate an evolution in the medical therapy of patients undergoing lower extremity revascularization for symptomatic [PAD],” said lead study author of the VOYAGER PAD analysis, Marc P. Bonaca, MD, of the University of Colorado Anschutz Medical Campus in Aurora, Colorado. “We hope these data assist clinicians in understanding how to implement antithrombotic therapy in practice and overall support initiation of rivaroxaban in the first days after revascularization regardless of whether or not DAPT is utilized.”
Those treated with Xarelto plus aspirin after lower extremity revascularization saw a 33% reduction in acute limb ischemia, with a trend toward greater benefit observed early (≤30 days hazard ratio [HR]=0.45; 95% confidence interval [CI] 0.24–0.85) vs. late (>90 days HR=0.75; 95% CI 0.60–0.95).
Xarelto plus aspirin was more effective than antiplatelet therapy alone in preventing acute limb ischemia after lower extremity revascularization (Kaplan-Meier estimate from 0 to 90 days 1.02% vs. 2.10%, respectively, and 4.3% and 5.7% from 91 days to three years). The hazard ratio for the rate of thrombolysis in myocardial infarction (TIMI) major bleeding at 0 to 90 days was HR 2.01 (range 0.9–4.47) and from days 91 up to three years was HR 1.28 (range 0.82–1.99), neither of which were statistically significant.
Janssen Pharmaceutical Companies of Johnson & Johnson note in a press release announcing the new results that the Xarelto vascular dose is the first and only approved anticoagulant for PAD.