Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons in the Treatment of Infrapopliteal Artery Lesions (AcoArt II-BTK)

J Endovasc Ther. 2021 Apr;28(2):215-221. doi: 10.1177/1526602820969681. Epub 2020 Oct 29.


Purpose: To compare the safety and efficacy of drug-coated balloon (DCB) vs uncoated balloon angioplasty in the treatment of de novo and restenotic infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI).

Materials and methods: The prospective, multicenter, randomized study AcoArt II-BTK study (ClinicalTrials.gov identifier NCT02137577) enrolled 120 patients who were randomly assigned to angioplasty with either a DCB (n=61; mean age 70.7±7.4 years; 36 men) or a conventional balloon catheter (n=59; mean age 70.8±9.0 years; 36 men). There were no significant differences observed in baseline clinical or target lesion characteristics between the groups. The target lesion length was 169.95±86.35 mm in the DCB group vs 179.93±80.16 mm in the control group, and approximately three-quarters of the lesions were chronic occlusions. Primary patency was assessed by angiography at 6 months, and mortality and clinically-driven target lesion revascularization (CD-TLR) were evaluated at 12 months.

Results: Primary patency at 6 months was 75.0% in the DCB group and 28.3% in the control group (p<0.001), while late lumen loss was 0.43±0.62 mm for DCBs vs 0.99±0.55 mm for controls (p<0.001). Freedom from CD-TLR at 12 months was 91.5% in the DCB group vs 76.8% in the controls (p=0.03); there was no significant difference in mortality (1.7% DCB vs 3.6% controls; p=0.53).

Conclusion: This study demonstrated that the Litos/Tulip DCBs are safe and effective in treating infrapopliteal lesions, with improved angiographic and clinical outcomes vs plain balloon angioplasty. The DCBs demonstrated significantly higher primary patency with fewer CD-TLRs than conventional angioplasty. The safety of the DCBs was noninferior to that of the uncoated balloons after 1 year of follow-up.

Keywords: anterior tibial artery; balloon angioplasty; below-the-knee artery; chronic limb-threatening ischemia; chronic total occlusion; drug-coated balloon; mortality; patency; randomized clinical trial; target lesion revascularization.

Publication types

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

MeSH terms

  • Aged
  • Angioplasty, Balloon* / adverse effects
  • Coated Materials, Biocompatible
  • Femoral Artery
  • Humans
  • Male
  • Middle Aged
  • Peripheral Arterial Disease* / diagnostic imaging
  • Peripheral Arterial Disease* / therapy
  • Pharmaceutical Preparations*
  • Popliteal Artery / diagnostic imaging
  • Prospective Studies
  • Time Factors
  • Treatment Outcome
  • Vascular Patency


  • Coated Materials, Biocompatible
  • Pharmaceutical Preparations

Associated data

  • ClinicalTrials.gov/NCT02137577