Drug-Eluting Balloon Therapy for Femoropopliteal Occlusive Disease: Predictors of Outcome With a Special Emphasis on Calcium

J Endovasc Ther. 2015 Oct;22(5):727-33. doi: 10.1177/1526602815600156. Epub 2015 Aug 6.


Purpose: To assess the association of patient, lesion, and procedure variables, including calcification, with late lumen loss (LLL) after use of drug-eluting balloon (DEB) therapy in patients with femoropopliteal arterial disease.

Methods: In this retrospective study, 91 patients (mean age 72.0±8.62 years; 50 men) were analyzed at 6 months after DEB treatment. Lesions were located in the superficial femoral artery (SFA, n=68) and popliteal artery (n=23). Lesion calcification was graded by a core laboratory using 2 published scoring indices: the peripheral artery calcification scoring system and a grading system based on circumference (arc) and length of calcium.

Results: The median LLL after 6 months was 0.2 mm (interquartile range -0.5, 1.14) overall and varied significantly across lesions with differing severity of calcification (p=0.042). However, LLL did not differ based on calcium location (intimal, medial, or mixed) or calcium length (p=0.351 and p=0.258, respectively). Additional predictors of LLL after DEB treatment included diabetes (p=0.034), coronary artery disease (p=0.024), and prior intervention (p=0.013). Interestingly, the severity of residual stenosis after the intervention did not have any impact on the LLL during follow-up (Spearman r = -0.238).

Conclusion: Severity of lesion calcification is associated with LLL after treatment with DEB. One possible approach to overcome this limitation might be plaque modification or removal prior to DEB usage. Nevertheless, clinical data that support this hypothesis are currently lacking.

Keywords: angioplasty; calcification; drug-coated balloon; drug-eluting balloon; late lumen loss; peripheral artery disease; popliteal artery; superficial femoral artery.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angioplasty, Balloon / adverse effects
  • Angioplasty, Balloon / instrumentation*
  • Cardiovascular Agents / administration & dosage*
  • Chi-Square Distribution
  • Coated Materials, Biocompatible*
  • Constriction, Pathologic
  • Equipment Design
  • Female
  • Femoral Artery*
  • Germany
  • Humans
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Peripheral Arterial Disease / diagnosis
  • Peripheral Arterial Disease / therapy*
  • Popliteal Artery*
  • Retrospective Studies
  • Risk Factors
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Vascular Access Devices*
  • Vascular Calcification / diagnosis
  • Vascular Calcification / therapy*


  • Cardiovascular Agents
  • Coated Materials, Biocompatible