Cardiometabolic & kidneyRandomised controlled trial
Low-Dose Rivaroxaban and Cardiovascular Events in Advanced Kidney Disease
- Randomised controlled trial
- double-blind
- placebo-controlled
- 90 centres in 12 countries
- stopped early for lack of efficacy
Authors' conclusion
In patients with advanced CKD at high cardiovascular risk, low-dose rivaroxaban did not reduce the risk of a composite cardiovascular outcome. Major bleeding rates were significantly higher in the low-dose rivaroxaban group compared with the placebo group.
Study context
- Population
- Adults with chronic kidney disease (CKD) stage 4 or 5 or dialysis-dependent kidney failure, with CAD, nonhemorrhagic nonlacunar stroke, PAD, diabetes or age ≥65 years1,360 (93.3%) completed follow-up
- Participants
- 1,458 adults
- Comparison
- Low-dose rivaroxaban vs placebo
- Primary endpoint
- Composite of:
- CV death
- Nonfatal MI
- Stroke
- PAD event
- Follow-up
- Median 1.7 years
Primary result
As reported in the abstract
Hazard ratio
1.09
95% CI 0.87–1.36
P = 0.46
Events by treatment group
Low-dose rivaroxaban vs Placebo
HR 1.09 (95% CI 0.87–1.36); P = 0.46
Safety
| Outcome | Low-dose rivaroxaban | Placebo | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Major bleeding (primary safety outcome) | 8.8% | 6.0% | 1.51 (1.02–2.22) | P = 0.04 | |
| Rate | 5.1 events per 100 person-years | 3.4 events per 100 person-years | |||
| 0.512Hazard ratio (log scale) |
Original publication
Low-Dose Rivaroxaban and Cardiovascular Events in Advanced Kidney Disease. JAMA. Published 28 July 2026. doi:10.1001/jama.2026.9379
Summarised from the published abstract; every number is checked against it