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SVS-VESS Scientific Session @ VAM: Session 2a

VESS16 - Trends in Rivaroxaban Use for Symptomatic Peripheral Artery Disease Before and After FDA Approval

Wednesday, June 10, 2026
3:57 PM - 4:05 PM ET
Location: Hynes CC, Third Level, Room 304

    Submitting & Presenting Author(s)

  • Y. Andrew Wu, MD

    Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, The Johns Hopkins School of Medicine, Baltimore, MD
    Baltimore, Maryland

    • Co-Author(s)

  • Chen Dun, PhD, MS

    PhD candidate in Biomedical Informatics and Data Science
    Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, The Johns Hopkins School of Medicine, Baltimore, MD
    Baltimore, Maryland

  • MW

    Midori White

    General Surgery Resident Physician
    Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, The Johns Hopkins School of Medicine, Baltimore, MD

  • JS

    Jamie Schwartz

    Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, The Johns Hopkins School of Medicine, Baltimore, MD

  • JS

    Jung-Im Shin

    Welch Center for Prevention, Epidemiology and Clinical Research, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD

  • MS

    Maya Salameh

    Johns Hopkins Center for Vascular Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland

  • Christopher J. Abularrage, MD

    Professor of Surgery
    Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, The Johns Hopkins School of Medicine, Baltimore, MD
    Baltimore, Maryland

    • Senior Author(s)

  • Caitlin W. Hicks, MD, MS (she/her/hers)

    Associate Professor, Vascular Surgery
    Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, The Johns Hopkins School of Medicine, Baltimore, MD
    Baltimore, Maryland

Objectives: The VOYAGER PAD Trial, published in 2020, showed that low-dose rivaroxaban plus aspirin reduces major adverse cardiovascular events in patients with symptomatic peripheral artery disease (PAD) undergoing lower-extremity revascularization. In August 2021, the FDA approved rivaroxaban for patients with PAD undergoing intervention, and the 2024 ACC/AHA Guidelines now recommends rivaroxaban (Class 1A) for the treatment of revascularized PAD. However, limited data exist on rivaroxaban prescribing trends. We aimed to characterize temporal trends in the rates of new rivaroxaban prescriptions for symptomatic PAD patients.

Methods: Using the Medicare Part D database (January 2017–December 2022), we identified patients with symptomatic PAD (defined as claudication or chronic limb-threatening ischemia [CLTI]) who underwent lower-extremity revascularization. Patients with anticoagulation prescriptions in the 90 days preceding the procedure were excluded. We assessed the rate of new rivaroxaban prescriptions filled within 30 days after the procedure and performed an interrupted time-series analysis anchored to the FDA approval date in August 2021 to evaluate changes in rivaroxaban prescribing rates before vs. after approval. We performed a sensitivity analysis expanding rivaroxaban to any of available direct oral anticoagulants (DOACs).

Results: We identified 189,257 patients with PAD who underwent lower extremity revascularization (median age 74.4 years; 56.3% male; 65.7% with CLTI). Among these, 2.3% (median age 73.8 years; 57.5% male; 67.6% with CLTI) received a rivaroxaban prescription within 30 days after the procedure. Monthly rivaroxaban prescription rates increased both before and after FDA approval. Prior to approval, rates increased from 13.5 to 36.9 prescriptions per 1,000 patients (January 2017–July 2021), and after approval rates increased from 31.9 to 45.1 prescriptions per 1,000 patients (September 2021–December 2022). Interrupted time-series analysis showed a significant monthly increase in rivaroxaban prescriptions before FDA approval in both claudication patients (IRR 1.023; 95%CI 1.019–1.027; P< 0.001) and CLTI patients (IRR 1.027; 95%CI 1.024–1.030; P< 0.001; Figure). After FDA approval, monthly rivaroxaban prescribing continued to rise but was no longer statistically significant (claudication: IRR 1.008; 95%CI 0.987–1.030; P=0.5; CLTI: IRR 1.011; 95%CI 0.998–1.024; P=0.1; Figure). Temporal trends in prescriptions of all available DOACs were similar.

Conclusions: Despite level 1 evidence, FDA approval, and guideline endorsement, rivaroxaban is prescribed to only a small fraction of PAD patients undergoing revascularization. The slow uptake of DOAC prescribing as secondary prevention therapy for symptomatic PAD highlights the need for continued efforts to promote evidence-based practice and improve guideline-concordant care in this high-risk population.