Patients with advanced chronic kidney disease (CKD stages 4 or 5, including those receiving dialysis) face a high risk of cardiovascular events, with up to 15% experiencing events each year. Since kidney dysfunction also carries an increased risk of bleeding, these patients have historically been excluded from major cardiovascular trials evaluating blood-thinning medications. As a result, the effectiveness and safety of anticoagulants in the advanced CKD and dialysis population remain unclear.
To address this gap, an international team of researchers, including CVC faculty member Dr. David Collister, undertook the TRACK (Treatment of Cardiovascular Disease With Low-Dose Rivaroxaban in Advanced Chronic Kidney Disease) randomized clinical trial. The study evaluated whether low-dose rivaroxaban, a direct-acting anticoagulant, could reduce major cardiovascular complications in adults with advanced CKD and elevated cardiovascular risk.
The study followed 1,458 patients across 90 international centres, randomly assigning them to receive either low-dose rivaroxaban (2.5 mg twice daily) or a placebo. The trial was terminated early after an interim analyses demonstrated a lack of efficacy with a concern for safety. Over a median 1.7-year follow-up period, major cardiovascular events, including myocardial infarctions, strokes, cardiovascular death, and peripheral artery disease events, occurred at similar rates between the rivaroxaban group (22.6%) and the placebo group (20.7%). The treatment was also found to increase harm, with major bleeding occurring in 8.8% of patients taking rivaroxaban compared to 6.0% receiving placebo.
These findings suggest that low-dose rivaroxaban should not be routinely used to reduce cardiovascular risk in patients with advanced CKD, as it offered no protection while elevating major bleeding risk. Researchers emphasize that the results must be interpreted with caution due to early trial termination, high rates of treatment dropouts, and a lack of representativeness with regards to patients from the United States and those that self-identify as Black, highlighting the ongoing need for further research in this area.
