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Abstract: PO2115

Rivaroxaban Reduces Major Cardiovascular and Limb Events in Patients with CKD and Peripheral Artery Disease with Recent Lower Extremity Revascularization: Insights from VOYAGER PAD

Session Information

Category: Hypertension and CVD

  • 1402 Hypertension and CVD: Clinical, Outcomes, and Trials

Authors

  • Hsia, Judith, CPC Clinical Research, Aurora, Colorado, United States
  • Nehler, Mark R., University of Colorado Denver School of Medicine, Aurora, Colorado, United States
  • Anand, Sonia, McMaster University, Hamilton, Ontario, Canada
  • Patel, Manesh R., Duke University, Durham, North Carolina, United States
  • Hiatt, William R., University of Colorado Denver School of Medicine, Aurora, Colorado, United States
  • Debus, Sebastian, Universitatsklinikum Hamburg Eppendorf Universitares Herzzentrum Hamburg GmbH, Hamburg, Hamburg, Germany
  • Hess, Connie, University of Colorado Denver School of Medicine, Aurora, Colorado, United States
  • Capell, Warren H., University of Colorado Denver - Anschutz Medical Campus, Aurora, Colorado, United States
  • Diao, Lihong, CPC Clinical Research, Aurora, Colorado, United States
  • Berkowitz, Scott Darrell, Bayer Corp, Whippany, New Jersey, United States
  • Muehlhofer, Eva, Bayer AG, Leverkusen, Nordrhein-Westfalen, Germany
  • Haskell, Lloyd P., Janssen Global Services LLC, Raritan, New Jersey, United States
  • Bauersachs, Rupert M., Klinikum Darmstadt, Darmstadt, Hessen, Germany
  • Bonaca, Marc P., University of Colorado Denver School of Medicine, Aurora, Colorado, United States
Background

In the VOYAGER PAD trial, rivaroxaban reduced cardiovascular (CV) and limb ischemic events (HR 0.85 vs placebo, 95% CI 0.76-0.96; p=0.009) in peripheral arterial disease (PAD) patients following lower extremity revascularization (LER). This analysis examines the prespecified subgroup of VOYAGER PAD patients with CKD.

Methods

VOYAGER PAD (NCT02504216) randomized 6564 PAD patients following LER to rivaroxaban 2.5 mg twice daily or placebo on a background of aspirin 100 mg daily. The primary endpoint was a composite of acute limb ischemia, major amputation for vascular cause, myocardial infarction, ischemic stroke or CV death. Intention-to-treat analyses utilized Kaplan Meier estimates and Cox proportional-hazards models.

Results

Mean baseline eGFR was 75+23 ml/min/1.72m2 with 79, 20, 1 and <1% of patients with CKD stage <2, 3, 4 and 5 respectively. During 28-month median follow up, rates of major CV and limb events were higher among patients with more severe CKD (placebo group event rate: 7.4/100 patient-years for eGFR >60, 10.0 for eGFR 30-<60 and 9.8 for eGFR 15-<30). Rivaroxaban reduced primary endpoint events with no heterogeneity by eGFR above or below 60 (mostly CKD stage 3)(Figure). Acute limb ischemia and major amputation were significantly reduced among patients with eGFR>60 (HR 0.77, 95% CI 0.63, 0.94) and <60 (HR 0.55, 95% CI 0.36, 0.86). Major bleeding was infrequent with no heterogeneity by CKD category.

Conclusion

Rivaroxaban reduced CV and limb events in patients with CKD, PAD following LER, a particularly high-risk population.

Funding

  • Commercial Support – Bayer