Introduction and methods

Reductions in Total Ischemic Events with Rivaroxaban in Patients with Symptomatic Pad after Revascularization: The VOYAGER PAD Trial

Presented at ACC.21 by Prof. Rupert Bauersachs, MD (Darmstadt, Germany)

Patients with peripheral artery disease (PAD) undergoing peripheral revascularization are at high risk of major adverse limb events (MALE) and vascular events. The results from VOYAGER PAD were presented last year at ACC.20 and demonstrated that rivaroxaban 2.5 mg twice daily with aspirin versus aspirin alone reduced first events by 15% in patients with PAD undergoing peripheral revascularization (HR 0.85, 95%CI 0.76-0.96, P=0.0085). The results on the effect of rivaroxaban on total (first and potentially subsequent) events in VOYAGER PAD were presented this year at ACC.21.

VOYAGER PAD was a double-blind, placebo-controlled trial in 6564 patients with symptomatic lower extremity PAD undergoing peripheral revascularization. Patients were randomized 1:1 to receive rivaroxaban 2.5 mg twice daily or placebo on a background of aspirin 100 mg daily. The primary endpoint was time to first acute limb ischemia, major amputation of a vascular cause, MI, ischemic stroke, or CV death. The objective of the current prespecified analysis was to investigate the number of first and total events in PAD patients undergoing peripheral revascularization, and to evaluate the efficacy of rivaroxaban on first and total events. Another prespecified endpoint was total (first and subsequent) vascular events, including recurrent primary endpoint events as well as other vascular events. Median follow up was 28 months.

Main results

• In 6564 patients, 1092 first primary endpoints events and 522 subsequent primary endpoint events occurred (1614 total primary endpoint events). 4714 Total vascular events occurred during follow-up.
• There were 61 fewer first vascular events and 342 fewer total vascular events in the rivaroxaban group compared with the placebo group.
• Rivaroxaban significantly reduced total primary endpoint events (HR 0.68, 95%CI 0.75-0.98, P=0.02) and total vascular events (HR 0.86, 95%CI 0.79-0.95, P=0.003), compared to placebo. An estimated 4.4 total primary endpoint events and 12.5 total vascular events per 100 participants were avoided with rivaroxaban during follow-up.

Conclusion

Rivaroxaban 2.5 mg twice daily with aspirin versus aspirin alone reduced first and subsequent adverse limb and CV events. Prof. Bauersachs said that rivaroxaban 2.5 mg twice daily with aspirin should be considered as adjunctive therapy after lower extremity revascularization to reduce first and subsequent adverse outcomes.

-Our coverage of ACC.21 is based on the information provided during the congress –

The results from this study were simultaneously published in J Am Coll Cardiol.