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Evevident
Original paper
2020NEJMCardiology

VOYAGER PAD

Rivaroxaban in peripheral artery disease after revascularization

RCTPeripheral artery disease

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Overview

Low-dose rivaroxaban plus aspirin reduced limb and cardiovascular events after PAD revascularization.

Clinical takeaway

VOYAGER PAD supports dual-pathway inhibition after lower-extremity revascularization in selected PAD patients, balancing ischemic benefit against bleeding.

Key result

The composite of acute limb ischemia, major amputation, MI, ischemic stroke, or CV death was reduced; HR 0.85.

Practice impact

Consider rivaroxaban 2.5 mg twice daily plus aspirin after PAD revascularization when bleeding risk is acceptable.

Evidence

Study design

Randomized, double-blind, placebo-controlled trial.

Enrollment

6,564

Follow-up

Median 28 months.

Geography

Multinational

Clinical question

Does low-dose rivaroxaban plus aspirin reduce limb and cardiovascular events after lower-extremity revascularization for PAD?

Population

  • Patients with symptomatic lower-extremity PAD after surgical or endovascular revascularization.

Intervention

Rivaroxaban 2.5 mg twice daily plus aspirin.

Comparator

Placebo plus aspirin.

Primary outcome

Composite of acute limb ischemia, major vascular amputation, myocardial infarction, ischemic stroke, or cardiovascular death.

Rivaroxaban plus aspirin reduced major limb and cardiovascular events after PAD revascularization.

Hazard ratio / 0.85 / CI 95% CI 0.76-0.96 / p=0.009

Key results

  • Primary composite was reduced with rivaroxaban plus aspirin.
  • Acute limb ischemia was reduced.
  • ISTH major bleeding was increased.

Harms

  • ISTH major bleeding was increased.
  • Bleeding-risk selection is essential.

Clinical Use

When to cite

  • When choosing antithrombotic therapy after lower-extremity PAD revascularization.

Practice impact

  • Extended dual-pathway inhibition evidence into post-revascularization PAD care.

Applicability

  • Symptomatic PAD patients after lower-extremity revascularization with acceptable bleeding risk.

Limitations

  • Not for patients requiring full-dose anticoagulation or with high bleeding risk.
  • Requires coordination across vascular surgery, cardiology, and primary care.

Common misinterpretations

  • The trial used vascular-dose rivaroxaban, not full-dose AF/VTE anticoagulation.

Related evidence

COMPASS - Same Drug Class

Citation

Bonaca MP, Bauersachs RM, Anand SS, et al. Rivaroxaban in Peripheral Artery Disease after Revascularization. N Engl J Med. 2020;382(21):1994-2004. doi:10.1056/NEJMoa2000052