Aortic & peripheral vascular disease
Rivaroxaban Plus Aspirin Versus Aspirin Alone After Endovascular Revascularization for Symptomatic PAD: Insights From VOYAGER PAD
Authors' conclusion
Rivaroxaban added to aspirin or dual antiplatelet therapy after LER for peripheral artery disease reduces ischemic risk and increases major bleeding without an increased risk of intracranial or fatal bleeding. These benefits are consistent in those treated with endovascular and surgical approaches with significant benefits for major adverse limb events.
Study context
- Population
- Patients with symptomatic PAD after lower extremity revascularization (LER); subgroup undergoing endovascular LER4,379 endovascular LER
- Participants
- 6,564 patients
- Comparison
- Rivaroxaban 2.5 mg BID plus aspirin vs placebo plus aspirin, by endovascular vs surgical LER
- Primary endpoint
- Composite of:
- Acute limb ischemia
- Major amputation of vascular pathogenesis
- MI
- Ischemic stroke
- CV death
- Follow-up
- 3-year follow-up
Methodological detailsdouble-blind, placebo-controlled
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Primary outcome, by LER type (subgroup) · 3 years
Rivaroxaban vs PlaceboHazard ratio (95% CI)
Endovascular LER
0.89(0.76–1.03)
Surgical LER
0.81(0.67–0.98)
Further findings
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| Primary outcome, overall trial · 3 years | 0.85 (0.76–0.96) | ||
| Acute limb ischemia or major amputation of vascular pathogenesis (endovascular)Absolute risk reduction 1.0% at 6 months and 2.0% at 3 years | 0.70 (0.54–0.90) | P = 0.005 | |
| Mortality (endovascular)Isolated to specific regions | 1.24 (1.02–1.52) | ||
| 0.512Hazard ratio (log scale) |
- Primary outcome, overall trial: absolute risk reduction 0.92% at 6 months and 1.04% at 3 years
Duration of concomitant DAPT with clopidogrel (endovascular)
- Median duration
- 31 days (IQR 30-58)
- Consistent benefit for rivaroxaban regardless of background clopidogrel
Safety
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| TIMI major bleeding (endovascular) · 3 yearsAbsolute risk increase 0.9% at 3 years | 1.66 (1.06–2.59) | ||
| Intracranial or fatal bleeding (endovascular) | 0.86 (0.40–1.87) | P = 0.71 | |
| 0.20.5125Hazard ratio (log scale) |
Original publication
Rivaroxaban Plus Aspirin Versus Aspirin Alone After Endovascular Revascularization for Symptomatic PAD: Insights From VOYAGER PAD. Circulation. Published 18 October 2023. doi:10.
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