Low-dose rivaroxaban plus aspirin in older patients with peripheral artery disease undergoing acute limb revascularization: insights from the VOYAGER peripheral artery disease (PAD) trial
Authors' conclusion
Patients ≥75 years with PAD are at both heightened ischaemic and bleeding risk after LER. No excess harm with respect to major, intracranial or fatal bleeding was seen in older patients yet numerically greater absolute benefits were observed.
Study context
- Population
- Patients with PAD after lower extremity revascularization, analysed by age ≥75 years1,330 (20%) >75 years
- Participants
- 6,564 patients
- Comparison
- Rivaroxaban vs Placebo
- Primary endpoint
- Composite of:
- Acute limb ischaemia
- Major amputation
- MI
- Ischaemic stroke
- CV death
- Follow-up
- 3 years
Methodological detailspre-specified age cut-off of 75 years
- Pre-specified age cut-off of 75 years
Primary result
As reported in the abstract
Primary endpoint by age (subgroup analysis)
Efficacy of rivaroxaban consistent irrespective of age
P-interaction 0.83
3-year Kaplan-Meier incidence, elderly vs non-elderly
23.4% vs. 19.0%
Absolute risk reduction (primary endpoint)
3.8%
NNT (primary endpoint)
26
Safety
Events
| Outcome | Rivaroxaban | Placebo |
|---|---|---|
| Intracranial and fatal bleeding, patients >75 years | 2 | 8 |
Thrombolysis in myocardial infarction (TIMI) major bleeding by age · 3 years
- Safety consistent irrespective of age
- P-interaction 0.38
- 3-year Kaplan-Meier incidence, elderly vs non-elderly
- 3.5% vs. 1.5%
- Absolute risk increase
- 0.81%
- NNH
- 123
Intracranial and fatal bleeding, patients >75 years
- Not increased in patients >75 years
Original publication
Low-dose rivaroxaban plus aspirin in older patients with peripheral artery disease undergoing acute limb revascularization: insights from the VOYAGER PAD trial. Eur Heart J. Published 25 August 2021. doi:10.
Summarised from the published abstract; every number is checked against it