Peripheral artery disease (PAD) affects an estimated 200 million people globally. It causes leg pain, trouble walking, and impaired circulation. People with peripheral artery disease (PAD) are at an extremely high risk of catastrophic consequences, such as acute limb ischemia, which can result in limb amputation or death if not treated promptly.
Rupert Bauersachs, MD, director of vascular medicine at the Darmstadt Clinic in Germany, conducted the VOYAGER PAD trial in which the effectiveness of rivaroxaban in reducing ischemic events in PAD patients was evaluated. Bauersachs said, “To our knowledge, this is the first time that the addition of low-dose rivaroxaban to aspirin has been clearly shown to reduce the occurrence of both first and total adverse events in patients with PAD who have undergone lower extremity revascularization but remain at high risk for a heart attack, stroke or recurrent arterial blockage in a limb.”
VOYAGER PAD was a randomized, double-blind, worldwide trial that enrolled 6,564 patients with PAD who had had lower extremity revascularization from 34 countries. The study population had an average age of 67, with 74% of them being men. In addition to daily aspirin, patients were randomly allocated to receive rivaroxaban or a placebo. The study’s primary outcome was timed to the first occurrence of acute arterial blockage in the leg, heart attack, leg amputation owing to blood vessel disease, stroke, or death from cardiovascular causes. After patients had revascularization, the study's median follow-up period was 28 months.
During the study period, the 6,564 participants had a total of 4,714 vascular events, with 2,301 of them having at least one vascular event. The rivaroxaban group had 342 fewer adverse events than the placebo group. In addition, patients who received rivaroxaban had a 15% statistically significant reduction in the probability of a first major adverse event when compared to those who got the placebo.
Despite significant utilization of background medical therapy, about 2–3 out of every 6 patients with PAD suffered a vascular incident during the three-year follow-up period.
The VOYAGER PAD study found a statistically significant reduction in the occurrence of ischemic events among PAD patients who were given rivaroxaban in addition to low-dose aspirin.