VOYAGER PAD
Vascular Outcomes Study of ASA Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD
Patient / Population Intervention / Exposure Comparison Outcome
In 6,564 patients with peripheral artery disease after lower-extremity revascularisation, rivaroxaban 2.5 mg twice daily plus aspirin reduced acute limb ischaemia, major amputation, myocardial infarction, ischaemic stroke or cardiovascular death compared with aspirin alone.
N
6,564
Design
Double-blind RCT
Endpoint
Composite of acute limb ischaemia, major amputation, MI, ischaemic stroke or CV death
Relevance
2
Result17.3 % vs 19.9 % at 3 years (HR 0.85; 95 % CI 0.76–0.96; p=0.009). ISTH major bleeding 5.94 % vs 4.06 % (HR 1.42; 95 % CI 1.10–1.84).
Bonaca MP, Bauersachs RM, et al. N Engl J Med. 2020;382(21):1994-2004. 10.1056/NEJMoa2000052
Discussion & critique
The benefit is driven largely by acute limb ischaemia while major bleeding rises significantly, so selection by bleeding risk is essential. It is the only positive antithrombotic trial in the post-revascularisation PAD population and anchors dual-pathway inhibition in the guideline.