Aortic & peripheral vascular diseaseSecondary analysis
Low-Dose Rivaroxaban Plus Aspirin in Fragile Patients After Lower Extremity Revascularization
- Secondary analysis of the VOYAGER peripheral artery disease (PAD) randomised trial
- prespecified subgroup (fragile criteria)
Authors' conclusion
Rivaroxaban reduces ischemic risk and increases bleeding regardless of frailty status.
Study context
- Population
- Symptomatic PAD after lower extremity revascularization; fragile = age >75 years, weight ≤50 kg, or baseline eGFR <50 mL/min/1.73 m²1,674 fragile
- Participants
- 6,564 participants
- Comparison
- Rivaroxaban 2.5 mg plus aspirin vs placebo, by frailty status
- Primary endpoint
- Composite of:
- Acute limb ischemia
- Major amputation of vascular etiology
- MI
- Ischemic stroke
- CV death
Primary result
As reported in the abstract
Primary efficacy outcome by frailty status
Rivaroxaban vs PlaceboHazard ratio (95% CI)
fragile
0.93(0.75–1.15)
nonfragile
0.83(0.72–0.97)
- Effect not modified by frailty status
- P for interaction = 0.37
Further findings
| Outcome | HR (95% CI) | |
|---|---|---|
| Risk in fragile vs nonfragile patients (placebo) — Fragile vs Nonfragile · primary outcome · placebo arm only | 1.34 (1.12–1.61) | |
| Risk in fragile vs nonfragile patients (placebo) — Fragile vs Nonfragile · TIMI major bleeding · placebo arm only | 1.57 (0.83–2.96) | |
| 0.20.5125Hazard ratio (log scale) |
Safety
| Outcome | HR (95% CI) | |
|---|---|---|
| TIMI major bleeding by frailty status — Rivaroxaban vs Placebo · fragile | 1.54 (0.82–2.91) | |
| TIMI major bleeding by frailty status — Rivaroxaban vs Placebo · nonfragile | 1.37 (0.84–2.23) | |
| 0.20.5125Hazard ratio (log scale) |
- TIMI major bleeding by frailty status: interaction P = 0.65
Original publication
Low-Dose Rivaroxaban Plus Aspirin in Fragile Patients After Lower Extremity Revascularization. J Am Coll Cardiol. Published 27 August 2024. doi:10.1016/j.jacc.2024.05.060
Summarised from the published abstract; every number is checked against it