For femoral artery disease, is a drug‑coated balloon (DCB) angioplasty preferred over a drug‑eluting stent (DES) as first‑line therapy?

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Last updated: March 14, 2026 • View editorial policy

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Drug-Coated Balloon vs Drug-Eluting Stent for Femoral Artery Disease

For femoropopliteal lesions, drug-eluting treatment (including both DCB and DES) should be considered as first-line endovascular therapy, with either approach being acceptable as both demonstrate comparable clinical outcomes. 1

Guideline Recommendations

The 2024 ESC Guidelines provide a Class IIa, Level A recommendation stating that "drug-eluting treatment should be considered as the first-choice strategy" for femoro-popliteal lesions, without specifically prioritizing DCB over DES or vice versa. 1 This broad recommendation encompasses both technologies as equivalent first-line options.

The guidelines emphasize that endovascular therapy should be the first choice even for complex lesions, particularly in surgical high-risk patients. 1 The mode and type of revascularization should be adapted to anatomical lesion location, lesion morphology, and general patient condition. 1

Comparative Effectiveness Evidence

Short-Term Outcomes (12 Months)

The most recent 2025 meta-analysis including 3,231 femoropopliteal lesions found no significant differences between DCB and DES at 1 year for: 2

  • Primary patency (OR 1.11, p=0.61)
  • Clinically-driven target lesion revascularization (OR 1.01, p=0.97)
  • Major adverse limb events (OR 1.08, p=0.74)
  • All-cause mortality (OR 1.85, p=0.14)

The 2019 DRASTICO trial, comparing DCB with provisional stenting versus systematic DES in complex lesions (mean length 14 cm, 60% occlusions), demonstrated 12-month restenosis rates of 22% for DCB versus 21% for DES (p=0.90). 3

Medium to Long-Term Outcomes (24-36 Months)

At 2 years, the 2025 meta-analysis continued to show no significant differences between DCB and DES across all endpoints. 2

However, the 2019 REAL PTX trial revealed a trend favoring DES at 36 months, with primary patency of 54% for DES versus 38% for DCB (p=0.17), though this did not reach statistical significance. 4 Freedom from clinically-driven TLR remained around 70% in both groups at 36 months. 4

A 2022 retrospective study of 563 interventions found that for patients requiring reintervention, DES remained patent significantly longer than DCB (mean 1,277 days vs 904 days, p<0.001), representing an average of 373 additional days of patency. 5

Restenosis Considerations

A 2024 propensity-matched analysis of 678 pairs comparing high-dose DCB (IN.PACT Admiral) versus polymer-based DES (Eluvia) found significantly lower 1-year restenosis rates with DES (16.0% vs 22.0%, p=0.016). 6 However, this difference in restenosis did not translate into differences in TLR, reocclusion, or other clinical endpoints. 6

Procedural Considerations

DCB Approach

  • Requires adequate lesion preparation with balloon pre-dilation 3
  • Bailout stenting needed in 21-25% of cases 2, 3
  • Higher rate of adjunctive procedures including atherectomy (OR 0.13, p<0.001) 2
  • Leaves no permanent implant when successful without bailout stenting 3

DES Approach

  • Systematic stenting yields larger post-procedural minimal luminal diameter 3
  • Lower incidence of residual dissection compared to DCB 3
  • Places permanent metallic scaffold in highly mobile femoro-popliteal segment 1
  • May offer slightly better durability in very long-term follow-up 5, 4

Clinical Decision Framework

Both DCB and DES are appropriate first-line options with the choice based on:

  1. Lesion characteristics: Complex lesions with significant dissection after pre-dilation may favor DES for immediate scaffolding 3

  2. Operator preference and experience: DCB requires meticulous technique and willingness to perform bailout stenting when needed 2

  3. Patient factors: Younger patients or those requiring future surgical options may benefit from DCB's "leave nothing behind" approach when successful 3

  4. Long-term considerations: If maximizing durability beyond 2-3 years is paramount, DES may have a slight edge based on trend data 5, 4

Safety Profile

Both technologies have been deemed safe by the FDA after initial mortality concerns with drug-eluting treatment were investigated and not confirmed in large national databases. 1 All-cause mortality rates are comparable between DCB and DES approaches. 2, 6

Common Pitfalls

  • Inadequate lesion preparation with DCB: Failure to achieve optimal pre-dilation before DCB application increases bailout stenting rates 2
  • Overreliance on angiographic restenosis: Higher restenosis rates with DCB do not necessarily translate to worse clinical outcomes or increased reintervention rates 6
  • Ignoring anatomic complexity: Very long lesions (>20 cm) or chronic total occlusions may require individualized approach 3

References

2
Research

Primary Drug-Coated Balloon Versus Drug-Eluting Stent for Native Atherosclerotic Femoropopliteal Lesions: An Updated Systematic Review and Meta-Analysis.

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists, 2025

6
Research

High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment.

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists, 2024

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.