This double-blind RCT evaluated whether rivaroxaban 2.5 mg twice daily vs. placebo reduces major cardiovascular events in 1,458 adults with CKD stage 4–5 or dialysis-dependent kidney failure who had ≥1 high-risk feature (CAD, stroke, PAD, diabetes, or age ≥65). Median follow-up was 1.7 years across 90 centers in 12 countries.
Low-dose rivaroxaban did **not** reduce the composite of cardiovascular death, nonfatal MI, stroke, or PAD event vs. placebo (22.6% vs. 20.7%; HR 1.09 [95% CI 0.87–1.36]; P = .46). Major bleeding was significantly higher with rivaroxaban (8.8% vs. 6.0%; HR 1.51 [95% CI 1.02–2.22]; P = .04).
- Trial stopped early for lack of efficacy, which limits power to detect modest benefit or harm in subgroups. - Median follow-up of only 1.7 years may be insufficient to capture longer-term effects. - Only 29.6% female enrollment limits generalizability across sexes.
Do **not** use low-dose rivaroxaban (2.5 mg BID) to lower cardiovascular risk in patients with advanced CKD or dialysis — it offers no benefit and significantly increases major bleeding. Clinicians should seek alternative strategies for cardiovascular risk reduction in this population.
