Aortic & peripheral vascular diseaseCohort study

3-Year Outcomes of Drug-Eluting Stent vs Drug-Coated Balloon for Femoropopliteal Artery Lesions

JACC Cardiovasc IntervPublished

  • Retrospective cohort study
  • multicentre registry
  • propensity-score matched

median follow-up (Q1-Q3) 22.5 months (8.8-37.1 months); 484 patency losses

Authors' conclusion

Despite successful lesion preparation, DES demonstrated significantly higher primary patency over 3 years. However, this did not translate into a clinical benefit, as freedom from CD-TLR rates remained comparable between groups.

Study context

Population
Patients undergoing endovascular therapy for femoropopliteal artery disease after successful lesion preparation (<50% residual stenosis, no Grade D or higher dissection)
Participants
1,406 patients · 314 matched pairs
Exposure
Drug-eluting stents (DES) vs drug-coated balloons (DCB) without bailout stenting
  • DESn = 342
  • DCBn = 1,064reference
Outcome
Primary patency and freedom from clinically driven target lesion revascularization (CD-TLR)
Follow-up
3 years

Main finding

As reported in the abstract

GroupPrimary patencyFreedom from clinically driven target lesion revascularization (CD-TLR)
DES65.3% (95% CI 58.9%-72.4%)73.2% (67.5%-79.4%)
DCB59.5% (54.8%-64.5%)72.2% (68.0-%76.7%)
  • DES vs DCB: P = 0.042 — primary patency
  • DES vs DCB: P = 0.27 — freedom from CD-TLR

Observational data: associations, not effects.

Further findings

Primary patency by lesion length >150 mm and dissection Grade C (subgroup)

Greater benefit from DES in reducing restenosis risk
  • interaction P = 0.007 (lesion length >150 mm)
  • interaction P = 0.013 (dissection Grade C)

Original publication

3-Year Outcomes of Drug-Eluting Stent vs Drug-Coated Balloon for Femoropopliteal Artery Lesions. JACC Cardiovasc Interv. Published 8 September 2025. doi:10.1016/j.jcin.2025.07.034

Summarised from the published abstract; every number is checked against it