Contribution To Literature:

The ILLUMENATE US trial shows that PTA with a paclitaxel-based DCB is superior to PTA with a regular balloon for primary patency in patients with short to moderately long femoropopliteal arterial lesions.


The goal of this trial was to assess safety and efficacy of a novel paclitaxel-coated balloon (2 mcg/mm2) compared with routine percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal peripheral arterial disease.

Study Design

Patients with superficial femoral artery (SFA) and/or popliteal arterial stenoses were randomized in a 2:1 fashion to balloon angioplasty with a drug-coated balloon (DCB) (n = 200) or standard balloon (n = 100).

Inclusion criteria:

  • Rutherford class 2-4 symptoms
  • Lesion in SFA and/or popliteal arteries

Exclusion criteria:

  • Known intolerance to study medications, paclitaxel, or contrast agents that in the opinion of the investigator cannot be adequately pretreated
  • Total number of enrollees: 300
  • Duration of follow-up: 12 months
  • Percentage female: 40%
  • Percentage with diabetes: 50%
  • Previous or current smokers: 80%
  • Lesion characteristics: Mean lesion length, 85 mm; restenotic lesions, 15%; total occlusions, 20%; severe calcification, 44%; 0-1 patent run-off, 32%

Principal Findings:

The primary efficacy endpoint, clinically driven target lesion revascularization at 12 months for DCB vs. standard balloon, was 93.6% vs. 87.3%, p < 0.05.

Secondary endpoints for DCB vs. standard balloon, primary patency at 12 months, was 82.3% vs. 70.9%, p < 0.05.


The results of this trial indicate that PTA with a novel low-dose paclitaxel-coated balloon is superior to PTA with standard angioplasty alone in moderately long lesions in the SFA and/or popliteal arteries. These data are similar to the LEVANT 2 trial, which used a different balloon but the same drug (differences are in balloon design and dose of paclitaxel). Direct comparison of DCBs with drug-eluting stents is awaited. In the ZILVER-PTX trial with a PES, the rate of primary patency with PES was 83.1% at 1 year (mean lesion length 65 mm), compared with 82.3% in the current trial. Cost-effectiveness analyses are also awaited.


Presented by Dr. Sean P. Lyden the Transcatheter Cardiovascular Therapeutics meeting (TCT 2016), Washington, DC, November 2, 2016.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Aortic Surgery, Interventions and Vascular Medicine

Keywords: Angioplasty, Angioplasty, Balloon, Constriction, Pathologic, Drug-Eluting Stents, Myocardial Revascularization, Paclitaxel, Peripheral Arterial Disease, Stents, Transcatheter Cardiovascular Therapeutics, Vascular Diseases

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