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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.
Background:
Randomized trials of drug-eluting stents (DES) and drug-coated balloons (DCB) for femoropopliteal interventions reported superior patency rates for both strategies compared to standard balloon angioplasty. To date, head-to-head comparisons are missing.
Objectives:
The authors sought to compare DES versus DCB for femoropopliteal lesions through 36 months.
Methods:
Within a multicenter, randomized trial, 150 patients with symptomatic femoropopliteal disease were randomly assigned to primary DES implantation or DCB angioplasty with bailout stenting after stratification for lesion length (≤10 cm, >10 cm to ≤20 cm, and >20 cm to ≤30 cm). The primary effectiveness endpoint was primary patency at 12 months assessed by Kaplan-Meier. Secondary endpoints comprised major adverse events including death, major amputations, and clinically driven target lesion revascularization, and clinical outcomes.
Results:
More than one-half of lesions were total occlusions, and the stenting rate was 25.3% in the DCB group. Kaplan-Meier estimates of primary patency were 79% and 80% for DES and DCB at 12 months (p = 0.96) but decreased to 54% and 38% through 36 months (p = 0.17), respectively. Freedom from clinically driven target lesion revascularization was >90% at 12 months but dropped to around 70% at 36 months in both groups. Overall, the mortality rate through 36 months was 7.3%, with 1 procedure-related death in the DCB group. Improvement of clinical outcomes was sustained through 36 months.
Conclusions:
Patency rates at 12 months suggest comparable effectiveness and safety of DES versus DCB plus bailout stenting in femoropopliteal interventions; a trend in favor of the DES was observed up to 36 months. (Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery [REAL PTX]; NCT01728441).
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