New VOYAGER PAD data: Should patients with both PAD and CKD get rivaroxaban?

New findings from VOYAGER PAD indicate that patients with chronic kidney disease (CKD) and concomitant peripheral artery disease (PAD) showed a consistent 4.7% absolute risk reduction of hospitalisation after lower-extremity revascularisation when taking low-dose rivaroxaban plus aspirin compared with aspirin alone. Moreover, the risk of bleeding was not increased.

Internal medicine resident Dr Mark Svet (University of Colorado, CO, USA) presented the subgroup analysis of VOYAGER PAD (NCT02504216) participants with and without CKD [1,2]. VOYAGER PAD randomised 6,564 individuals to receive either the rivaroxaban vascular dose at 2.5 mg twice daily plus aspirin 100 mg once daily (n=3,286) or aspirin alone at 100 mg once daily (n=3,278), with a median follow-up of 28 months [3]. The primary efficacy and safety endpoints were met, which illustrated the superiority of rivaroxaban plus aspirin compared with aspirin alone in lowering the risk of major adverse limb and cardiovascular events by 15% among individuals with symptomatic PAD after revascularisation.

The new subgroup analysis presented at the ACC Scientific Session by Dr Svet stratified the VOYAGER PAD cohort by estimated glomerular filtration rate (eGFR) and showed a 4.7% absolute risk reduction in the subgroup with CKD, defined as eGFR<60 (n=1,327; 21% of all patients with eGFR at baseline) with rivaroxaban plus aspirin compared with aspirin alone (Kaplan-Meier estimate at 3 years: 7.9% vs 12.6%) [1,2].

"Patients with symptomatic PAD are already at a heightened risk of hospitalisation following revascularisation," said Dr Svet. "Previously reported primary data from the VOYAGER PAD clinical trial established the benefit of rivaroxaban plus aspirin in patients with PAD. Our research demonstrates the extension of this benefit to PAD patients with CKD in reducing rates of readmission following revascularisation without increasing bleeding risk compared with those without CKD."

Dr Svet concluded: “This data would hopefully encourage clinicians to not undertreat this patient population as while there is an increased risk of bleeding when using rivaroxaban, the net benefit was consistent across those who had or did not have CKD.”

1. 
   
   1. Svet M, et al. Rivaroxaban Reduces Hospitalizations For Thromboembolic Events In Patients With Peripheral Artery Disease After Revascularization In Those With And Without Chronic Kidney Disease. Abstract 906–06, ACC 2022, 2–4 April, Washington DC, USA.
   2. Svet M, et al. J Am Coll Cardiol. 2022;79(9Suppl):1739.
   3. Bonaca MP, et al. N Engl J Med 2020;382:1994–2004.

 

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Posted on 15 June, 202231 January, 2024