TRACK was the first dedicated placebo-controlled trial to test an anticoagulant for protection from hard cardiovascular outcomes in patients with advanced CKD at high cardiovascular risk.In this population, historically excluded from landmark studies, low-dose rivaroxaban did not reduce the risk of a composite cardiovascular outcome and, in fact, increased major bleeding.Results are a departure from low-dose rivaroxaban's benefit in broader populations, including patients with mild to moderate CKD.
An established blood thinner regimen failed to extend its cardioprotective benefits to patients with advanced chronic kidney disease (CKD), according to the international TRACK trial.
In this placebo-controlled study of patients with advanced CKD and cardiovascular risk factors and/or cardiovascular disease, low-dose rivaroxaban (Xarelto) was no help for reducing the composite of cardiovascular death, nonfatal myocardial infarction, stroke, or peripheral artery disease events during a median 1.7 years (22.6% vs 20.7% with placebo; HR 1.09, 95% CI 0.87-1.36).
What's more, the primary safety outcome, major bleeding, put rivaroxaban users at a significant disadvantage (8.8% vs 6.0%; HR 1.51, 95% CI 1.02-2.22), reported study investigators led by Sunil Badve, PhD, of the University of New South Wales Sydney in Australia.
