Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos in Below-the-Knee Arteries to Treat Critical Limb Ischemia - ACOART-BTK

Contribution To Literature:

The ACOART-BTK trial showed that use of Litos DCB was superior to balloon angioplasty alone for angiographic and clinical outcomes among patients with CLI and BTK disease.


The goal of the trial was to assess the safety and efficacy of the Litos drug-eluting balloon among patients with chronic limb-threatening ischemia (CLI).

Study Design

Patients with CLI undergoing angioplasty of ≥1 below-the-knee (BTK) vessel were randomized in a 1:1 fashion to either further drug-coated balloon (DCB) use (n = 52) or no further intervention/balloon angioplasty result alone (n = 53).

  • Total number of enrollees: 105
  • Duration of follow-up: 12 months
  • Mean patient age: 75 years
  • Percentage female: 24%

Inclusion criteria:

  • CLI (Rutherford class ≥4)
  • Stenosis ≥50% or occlusion of ≥40 mm by visual estimation located in BTK arteries with distal runoff 

Exclusion criteria:

  • Patients with absence of pedal arch (Kawarada classification type 3) or those who needed dilatation of the arch to re-establish its patency
  • Age <18 years
  • Life expectancy <1 year
  • Contraindication to combined antiplatelet treatment
  • Known allergy to nickel or paclitaxel
  • Need for major amputation at the time of enrollment
  • Failure to recanalize intended above-the-knee arteries

Other salient features/characteristics:

  • Previous femoral/popliteal revascularization: 16%
  • Previous tibial revascularization: 16%
  • Baseline ankle-brachial index: 0.38
  • Rutherford class 5: 84%, class 6: 8%
  • Mean lesion length: 180 mm
  • Target vessel: anterior tibial artery: 65%, posterior tibial: 14%
  • Chronic total occlusion: 68%

Principal Findings:

The primary efficacy, 6-month angiographic late lumen loss for DCB vs. balloon angioplasty, was 0.51 vs. 1.31 mm (p < 0.001).

Secondary outcomes for DCB vs. balloon angioplasty:

  • Restenosis >50%: 37.9% vs. 87.1% (p < 0.001)
  • Occlusion:  8.6% vs. 48.4% (p < 0.001)
  • Death at 12 months: 7.7% vs. 13.2% (p = 0.2)
  • Freedom from target lesion revascularization: 90% vs. 59% (p < 0.001)
  • Complete healing: 89.4% vs. 74.5% (p = 0.05)
  • Healing time: 5.2 vs. 7.7 months (p = 0.005)


The results of this trial indicate that the use of Litos DCB was superior to balloon angioplasty alone for angiographic and clinical outcomes among patients with CLI and BTK disease.

Litos DCB is coated with paclitaxel (3 mg/mm2) in a matrix containing magnesium stearate as an excipient. This is different from other paclitaxel-based DCBs in use in the United States. There was concern regarding long-term mortality with paclitaxel-based DCBs based on a meta-analysis, but more recent long-term assessments have not confirmed this signal. A similar assessment would be important for this balloon as well.


Liistro F, Angioli P, Ventoruzzo G, et al. Randomized Controlled Trial of Acotec Drug-Eluting Balloon Versus Plain Balloon for Below-the-Knee Angioplasty. JACC Cardiovasc Interv 2020;13:2277-86.

Editorial Comment: Spiliopoulos S, Reppas L. Is There Still Hope for Infrapopliteal PCB Angioplasty?: Positive Data From the ACOART-BTK Single-Center Randomized Trial. JACC Cardiovasc Interv 2020;13:2287-8.

Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Vascular Medicine, Aortic Surgery, Cardiac Surgery and SIHD, Interventions and Vascular Medicine, Chronic Angina

Keywords: Angioplasty, Angioplasty, Balloon, Angioplasty, Balloon, Coronary, Arterial Occlusive Diseases, Constriction, Pathologic, Coronary Occlusion, Coronary Restenosis, Coronary Stenosis, Geriatrics, Myocardial Ischemia, Myocardial Revascularization, Paclitaxel, Vascular Diseases

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