Aortic & peripheral vascular diseaseRandomised controlled trial
Rivaroxaban in Peripheral Artery Disease after Revascularization
- Randomised controlled trial
- double-blind
Authors' conclusion
In patients with peripheral artery disease who had undergone lower-extremity revascularization, rivaroxaban at a dose of 2.5 mg twice daily plus aspirin was associated with a significantly lower incidence of the composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes than aspirin alone. The incidence of TIMI major bleeding did not differ significantly between the groups. The incidence of ISTH major bleeding was significantly higher with rivaroxaban and aspirin than with aspirin alone.
Study context
- Population
- Patients with PAD who had undergone lower-extremity revascularization
- Participants
- 6,564 patients
- Comparison
- Rivaroxaban plus aspirin vs placebo plus aspirin
- Rivaroxabann = 3,286
- Placebon = 3,278reference
- Primary endpoint
- Composite of:
- Acute limb ischemia
- Major amputation for vascular causes
- MI
- Ischemic stroke
- CV death
- Follow-up
- 3 years
Primary result
As reported in the abstract
Hazard ratio
0.85
95% CI 0.76–0.96
P = 0.009
Events by treatment group
Safety
| Outcome | Rivaroxaban | Placebo | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| TIMI major bleeding (principal safety outcome) | 2.65% | 1.87% | 1.43 (0.97–2.10) | P = 0.07 | |
| ISTH major bleeding (secondary safety outcome) | 5.94% | 4.06% | 1.42 (1.10–1.84) | P = 0.007 | |
| 0.512Hazard ratio (log scale) |
Original publication
Summarised from the published abstract; every number is checked against it