In patients with peripheral artery disease (PAD) who underwent a lower extremity revascularization (LER), rivaroxaban on top of aspirin significantly reduced the total event burden, according to new results of the VOYAGER PAD trial presented May 16 during ACC.21 and simultaneously published in the Journal of the American College of Cardiology.

The primary results from VOYAGER PAD, presented during ACC.20/WCC, showed that rivaroxaban 2.5 mg twice daily plus aspirin vs. placebo plus aspirin reduced first events by about 15%, with a number needed to treat to prevent a first event of 39 at three years in the 6,564 study patients. The median age of patients was 67 years and 26% were women. At baseline, 40% were diabetic, 60% had hyperlipidemia, and about 32% had coronary artery disease.

In this prespecified analysis, Rupert M. Bauersachs, MD, et al., explored the number of first and total events in the study population along with the types of events including all limb and cardiovascular events, and the efficacy of rivaroxaban on first and total events.

Over a median of 28 months after LER, there were 4,714 total first and subsequent vascular events, including 1,614 primary endpoint events and 3.100 vascular events. Primary endpoint events included acute limb ischemia, major amputation of a vascular cause, nonfatal myocardial infarction, nonfatal ischemic stroke and cardiovascular death. Vascular events included peripheral revascularization and venous thromboembolic event.

The results showed that rivaroxaban reduced total primary events by 14% (95% confidence interval [CI], 0.75-0.98; p=0.02) and total vascular events by 14% (95% CI, 0.79-0.95; p=0.003). For every 100 study participants, an estimated 4.4 primary endpoint events and 12.5 vascular events were prevented with rivaroxaban over three years. Of note, 60% of second events occurred in patients who had a first peripheral revascularization.

The authors note the "benefits must be weighed against bleeding risk." TIMI major bleeding was increased by 43% with rivaroxaban (62 vs. 44 events with placebo) and "ISTH major bleeding, a more sensitive measure, was similar in relative terms (42% increase)" but with 140 vs. 100, respectively.

"The current analysis demonstrates several novel findings. First, PAD patients undergoing LER are at an extremely high risk for limb and cardiovascular events with a significantly greater burden when considering total rather than first events. Second, the most significant burden of risk is driven by vascular limb outcomes with recurrent peripheral revascularization being a particularly frequent event. Finally, the magnitude of absolute benefit of rivaroxaban 2.5 mg twice daily plus aspirin versus aspirin alone in this population is even greater when considering total vascular events," the authors conclude.

Clinical Topics: Vascular Medicine

Keywords: ACC Annual Scientific Session, ACC21, Aneurysm, Ischemia

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