VOYAGER-PAD Results Detail Benefits of Rivaroxaban Use in PAD Patients

New research suggests the use of rivaroxaban (Xarelto) at a dose of 2.5 mg twice a day plus aspirin could help to lower the incidence of a myriad of cardiac events, including myocardial infarction and major amputation, in patients with peripheral artery disease (PAD) after undergoing revascularization.

Results of the double-blind VOYAGER-PAD trial, which was presented at the American College of Cardiology’s Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC), found rivaroxaban plus aspirin was associated with a significantly lower incidence of a composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes than use of aspirin alone.

In an effort to determine whether rivaroxaban added to standard of care treatment could reduce the incidence of the aforementioned clinical events in PAD patients who had recently undergone revascularization, investigators conducted a randomized double-blind trial in 6564 patients. Using a 1:1 randomization method, investigators assigned 3286 patients to rivaroxaban and 3278 to placebo therapy.

With the previously mentioned composite used as the primary efficacy outcome, investigators observed events in 508 receiving rivaroxaban and in 584 receiving placebo. Using Kaplan-Meier estimates, results indicated an incidence of 17.3% and 19.9%, respectively, at 3 years (HR, 0.85, 95% CI, 0.76-0.98; P=.009).

Results pointed to an increased rate of TIMI major bleeding in the rivaroxaban group—occurring in just 2.65% (n=62) of those receiving rivaroxaban compared to 1.87% (n=44) in the placebo group (HR, 1.43, 95% CI, 0.97-2.10; P=.07). Investigators also noted an increase in ISTH major bleeding occurring in 5.94% (n=140) patients in the rivaroxaban group compared to (4.06%) (n=100) in the placebo group (HR, 1.42, 95% CI, 1.10-1.84; P=.007).

For more on what the results of VOYAGER-PAD tell us about the potential benefits and risks of rivaroxaban in patients with PAD who have undergone revascularization, HCPLive® conducted a special ACC House Call with principal investigator Marc Bonaca, MD, MPH, a cardiologist at Brigham and Women’s Hospital and executive director of CPC Clinical Research.

This study, “Rivaroxaban For Prevention Of Cardiovascular And Limb Events After Lower Extremity Revascularization: Primary Results Of The Voyager Pad Randomized Trial,” was presented at ACC.20/WCC.