Rivaroxaban falls short for cardiovascular prevention in advanced CKD

Clinical Takeaway: Low-dose rivaroxaban should not be added routinely to reduce cardiovascular risk in patients with stage four or five chronic kidney disease, including those receiving dialysis. In this trial, rivaroxaban failed to reduce major cardiovascular events and increased major bleeding risk.

Patients with advanced chronic kidney disease (CKD) face a high risk of cardiovascular events, yet they have largely been excluded from major antithrombotic trials. As a result, evidence to guide anticoagulant use in patients with advanced CKD has been limited.

The TRACK trial evaluated whether low-dose rivaroxaban (2.5 mg twice daily) could reduce cardiovascular events in patients with stage four or five CKD, including those receiving dialysis. The randomized, placebo-controlled study enrolled 1,458 patients across 12 countries and was stopped early after an interim analysis found little likelihood of demonstrating benefit.

Over a median follow-up of 1.7 years, rivaroxaban didn't reduce the risk of the primary composite outcome of cardiovascular death, myocardial infarction, stroke, or peripheral artery disease events compared with placebo. Rivaroxaban also failed to improve all-cause mortality or any individual component of the primary endpoint.

Safety outcomes favored placebo. Major bleeding occurred more frequently with rivaroxaban than with placebo, and intracranial bleeding was also numerically higher in the rivaroxaban group.

These results contrast with prior studies such as COMPASS and VOYAGER PAD, which demonstrated cardiovascular benefits of low-dose rivaroxaban in patients without advanced kidney disease. In TRACK, however, rivaroxaban increased bleeding without reducing cardiovascular events, suggesting that treatment strategies effective in other cardiovascular populations may not translate to patients with advanced CKD.

“Findings reported here have important clinical implications for treating cardiovascular risk in patients with advanced CKD,” the study authors wrote. “Clinical decisions regarding anticoagulation in people with advanced kidney disease should not be extrapolated from other cardiovascular populations. This trial underscores the need for dedicated cardiovascular outcome trials in people with advanced CKD.”

Source: Badve SV, et al. 2026 June 4. JAMA. Low-Dose Rivaroxaban and Cardiovascular Events in Advanced Kidney Disease (TRACK Randomized Clinical Trial)