Low-dose rivaroxaban more harmful than beneficial in advanced CKD patients at high CV risk

The use of low-dose rivaroxaban among patients with advanced chronic kidney disease (CKD) and high cardiovascular (CV) risk does little to reduce the risk of adverse CV events and may even contribute to increased bleeding events, according to the TRACK randomized clinical trial.

Conducted at 90 centres across 12 countries, TRACK involved adults with CKD stage 4 or 5 and those with dialysis-dependent kidney failure. All participants had at least one risk factor for increased CV events (ie, age ≥65 years, coronary artery disease, nonhaemorrhagic/nonlacunar stroke, peripheral artery disease, diabetes).

A total of 1,458 participants (mean age 63.2 years, 29.6 percent female) were randomly assigned to receive rivaroxaban 2.5 mg twice daily (n=727) or placebo (n=731). The primary outcome was a composite of CV death, nonfatal myocardial infarction, stroke, or a peripheral artery disease event. The primary safety outcome was major bleeding.

Of the participants, 1,360 (93.3 percent) completed the study. Over a median follow-up of 1.7 years, the primary outcome occurred in 22.6 percent of patients in the low-dose rivaroxaban group and 20.7 percent of those in the placebo group. The corresponding incidence rates were 13 and 11.8 events per 100 person-years, (hazard ratio [HR], 1.09, 95 percent confidence interval [CI], 0.87–1.36; p=0.46).

Major bleeding occurred with greater frequency in the low-dose rivaroxaban group than in the placebo group (8.8 percent vs 6 percent), at 5.1 vs 3.4 events per 100 person-years (HR, 1.51, 95 percent CI, 1.02–2.22; p=0.04), respectively.