Drug-Eluting Stent Versus Drug-Coated Balloon Revascularization in Patients With Femoropopliteal Arterial Disease

Yvonne Bausback1, Tim Wittig1, Andrej Schmidt1

  • 1Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany.

Insights

Drug-eluting stents (DES) and drug-coated balloons (DCB) showed similar 12-month patency in femoropopliteal interventions. However, DES demonstrated a trend toward better patency at 36 months compared to DCB with bailout stenting.

Area of Science:

  • Cardiovascular Interventions
  • Peripheral Artery Disease Treatment
  • Vascular Surgery

Background:

  • Drug-eluting stents (DES) and drug-coated balloons (DCB) are used for femoropopliteal interventions.
  • Previous studies suggest superior patency rates for both DES and DCB compared to standard balloon angioplasty.
  • Head-to-head comparisons between DES and DCB in this context are limited.

Purpose of the Study:

  • To compare the effectiveness and safety of DES versus DCB in treating femoropopliteal lesions.
  • To evaluate outcomes up to 36 months post-intervention.

Main Methods:

  • A multicenter, randomized trial involving 150 patients with symptomatic femoropopliteal disease.
  • Patients were randomized to either primary DES implantation or DCB angioplasty with bailout stenting.
  • Primary patency at 12 months and secondary endpoints including major adverse events and clinical outcomes were assessed up to 36 months.

Main Results:

  • At 12 months, primary patency was comparable between DES (79%) and DCB (80%) groups (p=0.96).
  • At 36 months, primary patency decreased to 54% for DES and 38% for DCB (p=0.17), showing a trend favoring DES.
  • Freedom from clinically driven target lesion revascularization was over 90% at 12 months, decreasing to around 70% at 36 months in both groups. Overall mortality was 7.3% through 36 months.

Conclusions:

  • DES and DCB with bailout stenting demonstrate comparable effectiveness and safety at 12 months for femoropopliteal interventions.
  • A trend favoring DES over DCB was observed in terms of patency up to 36 months.
  • Clinical outcomes were sustained through 36 months for both treatment strategies.
Abstract

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