Aortic & peripheral vascular diseaseRandomised controlled trial
Low-Dose Rivaroxaban Plus Aspirin in Patients With PAD Undergoing Lower Extremity Revascularization With and Without History of Prior Limb Revascularization: Insight From the VOYAGER-PAD Trial
- randomized trial
- placebo-controlled
Authors' conclusion
Patients with PAD with prior LER are at particularly high risk of MALE relative to those presenting without prior LER. Rivaroxaban reduces the risk of major adverse cardiovascular events and MALE after LER for symptomatic PAD with a greater relative benefit in those with prior LER.
Study context
- Population
- Patients with symptomatic PAD undergoing lower extremity revascularization (LER), with and without history of prior LER2,336 (35.5%) with a prior history of LER
- Participants
- 6,564 patients
- Comparison
- rivaroxaban 2.5 mg twice daily vs placebo on a background of aspirin 100 mg daily, by history of prior LER
- prior LERn = 2,336
- Primary endpoint
- Composite of:
- Acute limb ischemia
- Major amputation of a vascular cause
- Myocardial infarction
- Ischemic stroke
- Cardiovascular death
Primary result
As reported in the abstract
rivaroxaban vs placeboHazard ratio (95% CI)
with prior LER
0.73(0.60–0.88)
without prior LER
0.94(0.81–1.10)
Further findings
| Outcome | rivaroxaban | placebo | prior LER | without prior LER | HR (95% CI) | |
|---|---|---|---|---|---|---|
| MALE · 3-year Kaplan-Meier cumulative rates | Not reported in the abstract | Not reported in the abstract | 12.9% | 8.0% | 1.58 (1.25–1.99) | |
| 0.512Hazard ratio (log scale) |
Safety
| Outcome | HR (95% CI) | |
|---|---|---|
| Thrombolysis in Myocardial Infarction major bleeding — rivaroxaban vs placebo · prior LER | 1.08 (0.62–1.89) | |
| Thrombolysis in Myocardial Infarction major bleeding — rivaroxaban vs placebo · no prior LER | 1.88 (1.09–3.25) | |
| 0.20.5125Hazard ratio (log scale) |
- Thrombolysis in Myocardial Infarction major bleeding: P interaction =0.16
Original publication
Low-Dose Rivaroxaban Plus Aspirin in Patients With PAD Undergoing Lower Extremity Revascularization With and Without History of Prior Limb Revascularization: Insight From the VOYAGER-PAD Trial. Circ Cardiovasc Interv. Published 27 February 2026. doi:10.1161/circinterventions.125.015229
Summarised from the published abstract; every number is checked against it