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P5: Plenary Session 5

RS19 - Antiproliferative Endovascular Drug Technology is Associated with Fewer Major Reinterventions After Femoropopliteal Interventions for Chronic Limb Threatening Ischemia

Friday, June 6, 2025
9:00 AM – 9:07 AM CT
Location: Morial CC, First Floor, Great Hall A

    Submitting & Presenting Author(s)

  • Jeffrey J. Siracuse, MD, MBA

    Professor of Surgery and Radiology, Chief of Vascular and Endovascular Surgery
    Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian & Avedisian School of Medicine, Boston, MA, USA
    Boston, Massachusetts

    Slides

    • Co-Author(s)

  • JK

    John A. Kaufman

    Professor
    Dotter Department of Interventional Radiology
    Lake Oswego, Oregon

  • AF

    Alik Farber, MD, MBA

    Professor of Surgery
    Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University Chobanian & Avedisian School of Medicine, Boston, MA, USA
    Boston, Massachusetts

  • Matthew T. Menard, MD

    Professor of Surgery
    Division of Vascular and Endovascular Surgery, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
    Lincoln, Massachusetts

  • KR

    Kenneth Rosenfield

    Section Head for Vascular Medicine and Intervention
    Massachusetts General Hospital, Harvard Medical School, Boston, MA
    Boston, Massachusetts

  • GD

    Gheorghe Doros

    Professor of Biostatistics
    Boston University, School of Public Health, Boston, MA USA

  • Andres Schanzer, MD (he/him/his)

    Professor
    UMass Chan Medical School
    Worcester, Massachusetts

  • RP

    Richard J. Powell, MD

    Director Heart and Vascular Center
    Dartmouth-Hitchcock Medical Center
    Hanover, New Hampshire

  • Michael S. Conte, MD

    Professor and Chief
    Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA, USA
    San Francisco, California

  • MS

    Michael B. Strong

    Senior National Trial Manager
    Division of Vascular and Endovascular Surgery, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
    Boston, Massachusetts

  • Maarit Venermo, MD, PhD

    Professor of Vascular Surgery
    Department of Vascular Surgery, University of Helsinki; Helsinki University Hospital, Helsinki, Finland
    Helsinki University
    Helsinki

  • AB

    Andrew Barleben

    • Senior Author(s)

  • Michael D. Dake, MD

    Senior Vice President for Health
    University of Arizona Health Sciences, Tucson, AZ
    Tucson, Arizona

Objectives: Conflicting data exist regarding the benefits of paclitaxel (ENDO-Drug) in endovascular interventions for patients with chronic limb-threatening ischemia (CLTI). This analysis aims to evaluate the effect of paclitaxel therapy in the Best Endovascular versus Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.

Methods: The as treated dataset from BEST-CLI Trial, a prospective randomized trial comparing surgical and endovascular revascularization for infrainguinal CLTI, was used to assess the association of ENDO-Drug (drug coated balloon or drug eluting stent) use and 3-year outcomes after initial technical success in the femoropopliteal (FP) segment. ENDO-Drug was compared with ENDO-No Drug procedures. Outcomes evaluated included Major Adverse Limb Events (MALE)/death, above ankle amputations, major reinterventions (new bypass, interposition graft, thrombectomy, or thrombolysis), minor reintervention, and death.

Results: There were 341 FP endovascular procedures (186 ENDO-Drug, 155 without (ENDO-No Drug) performed; the majority were for tissue loss (66.3%). On Kaplan-Meier unadjusted analysis, at 3 years ENDO-Drug was associated with fewer major reinterventions (16.7% vs. 29.7%, P=.026), but similar minor reinterventions (40.8% vs. 44.7%, P=.95), MALE/death (42.4% vs. 44.5%, P=.12), above ankle amputation (11.3% vs 10.3%, P=.52), and death (21.5% vs 25%, P=.77). On risk adjusted analysis, ENDO-Drug was associated with fewer major reinterventions (HR 0.57, 95% CI 0.31 – 0,91, P=.02) and lower mortality (HR 0.53, 95% CI 0.31 – 0.91, P=.02). Results were similar when excluding failures within 30 days (Table).
When taking into account any adjunct infrapopliteal (IP) interventions, there were 668 FP with or without infrapopliteal (IP) endovascular interventions (377 ENDO-Drug, 291 ENDO-No Drug) performed. On risk adjusted analysis, there were no differences in outcomes overall and after excluding those with failure within 30 days (Table).

Conclusions: In patients with CLTI and FP disease treated using endovascular therapy, ENDO-Drug was associated with fewer major reinterventions, without higher mortality. Endovascular interventions with drug technology should routinely be used for FP interventions.