Kidney Week

Abstract: FR-OR113

Effects of Low-Dose Rivaroxaban on Cardiovascular Events in Patients with Advanced Kidney Disease According to Baseline Aspirin Use: A Prespecified Subgroup Analysis of the TRACK Trial

Session Information

• Late-Breaking Research Orals: AKI, CKD, CKM, and More
  October 23, 2026 | Location: Four Seasons Ballroom 2, Convention Center
  Abstract Time: 05:30 PM - 05:42 PM

Category: Cardiovascular-Kidney-Metabolic Health

• 602 Cardiovascular-Kidney-Metabolic Health: Clinical

Authors

• Jha, Vivekanand, The George Institute for Global Health, Sydney, New South Wales, Australia

Vivekanand Jha, MD

• Perkovic, Vlado, University of New South Wales Medicine & Health, Sydney, New South Wales, Australia

Vlado Perkovic, MBBS, PhD, FASN

• Ramachandran, Raja, Postgraduate Institute of Medical Education and Research, Chandigarh, India

Raja Ramachandran, MD, MBBS

• Rathore, Vinay, All India Institute of Medical Sciences, Raipur, India

Vinay Rathore, MD, MBBS

• Mushahar, Lily, Hospital Tuanku Ja'afar Seremban, Seremban, Negeri Sembilan, Malaysia

Lily Mushahar, MD

• Menne, Jan, KRH Klinikum Siloah, Hanover, NDS, Germany

Jan Menne, MD

• De Vriese, An S., AZ Sint-Jan Brugge AV, Bruges, Flanders, Belgium

An S. De Vriese, MD, PhD

• Rossignol, Patrick, Clinical Investigation Center-INSERM-CHU of Nancy, Nancy, France

Patrick Rossignol, MD

• Skhiri, Habib, Monastir Hospital, Monastir, Tunisia

Habib Skhiri, PhD

• Walsh, Michael, McMaster University, Hamilton, Ontario, Canada

Michael Walsh, MD, PhD

• Collister, David Thomas Barker, University of Alberta, Edmonton, Alberta, Canada

David Thomas Barker Collister, MD, PhD

• Liew, Adrian, Mount Elizabeth Novena Hospital, Singapore, Singapore

Adrian Liew, MD, MBBS, FASN

• Billot, Laurent, The George Institute for Global Health, Sydney, New South Wales, Australia

Laurent Billot, MS

• Ha, Jeffrey Tsun Kit, The George Institute for Global Health, Sydney, New South Wales, Australia

Jeffrey Tsun Kit Ha, MBBS, PhD

• Eikelboom, John, McMaster University, Hamilton, Ontario, Canada

John Eikelboom, MBBS

• Jardine, Meg, University of Sydney, Sydney, New South Wales, Australia

Meg Jardine, MBBS, PhD

• Wong, Muh Geot, University of Sydney, Sydney, New South Wales, Australia

Muh Geot Wong, MBBS, PhD

• Gallagher, Martin P., University of New South Wales Medicine & Health, Sydney, New South Wales, Australia

Martin P. Gallagher, MBBS, PhD

• Badve, Sunil, The George Institute for Global Health, Sydney, New South Wales, Australia

Sunil Badve, MD, MBBS, PhD, FASN

Group or Team Name

• for the TRACK Trial Investigators

Background

The TRACK trial evaluated the effects of low-dose rivaroxaban (2.5 mg twice daily) on major adverse cardiovascular and major bleeding events in patients with advanced kidney disease. The objective of this prespecified analysis was to assess whether the effects of low-dose rivaroxaban differed by aspirin use at baseline.

Methods

In the TRACK trial, 1458 patients with chronic kidney disease (CKD) stage 4 or 5 or dialysis-dependent kidney failure, and at least one cardiovascular risk were randomly assigned to low-dose rivaroxaban or placebo. The primary efficacy end point was a composite of cardiovascular death, nonfatal myocardial infarction, stroke, or peripheral artery disease event. The primary safety end point was major bleeding. Baseline aspirin use was a covariate in balancing study treatment allocation and a prespecified subgroup for analysis.

Results

At baseline, 677 (46.4%) patients were using aspirin. Patients using aspirin at baseline were older, and more likely to have dialysis-dependent kidney failure and established cardiovascular disease and treated with a lipid-lowering medication. The risk of primary outcome did not differ significantly between the randomized groups in patients using aspirin at baseline (hazard ratio [HR] 1.06, 95% CI 0.77-1.46) and in those not using aspirin at baseline (HR 1.11, 95% CI 0.81-1.53; P_interaction=0.837). Compared with placebo, low-dose rivaroxaban similarly increased the risk of major bleeding in patients using aspirin at baseline (hazard ratio [HR] 1.43, 95% CI 0.83-2.46) and in those not using aspirin at baseline (HR 1.60, 95% CI 0.91-2.79; P_interaction=0.780).

Conclusion

In patients with advanced kidney disease and high cardiovascular risk, low-dose rivaroxaban did not reduce the risk of major adverse cardiovascular event irrespective of the use of aspirin. The increased major bleeding risk was consistent in patients with or without aspirin.

Acknowledgment

Supported by research grants from the National Health and Medical Research Council of Australia (2018/GNT1162375), the French Ministry of Health Programme Hospitalier de Recherche Clinique (Projet PHRC-19-0112) and Deutsche Forschungsgemeinschaft, Germany (Project number 506165771). Rivaroxaban 2.5 mg tablets and placebo tablets were provided by Bayer AG, Germany free of cost through the Investigator Initiated Research Support Scheme.

Funding

• Government Support - Non-U.S.