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).

  • Total number of enrollees: 300
  • Duration of follow-up: 12 months
  • Mean patient age: 69 years
  • 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%

Inclusion criteria:

  • Rutherford class 2-4 symptoms
  • Lesion in SFA and/or popliteal arteries
  • Angiographic evidence of 70-99% stenosis or chronic total occlusions
  • Lesion lengths between 30-180 mm
  • Successful wire crossing of lesion
  • Target vessel diameter 4-6 mm

Exclusion criteria:

  • Known intolerance to study medications, paclitaxel, or contrast agents that in the opinion of the investigator cannot be adequately pretreated
  • Aortic aneurysm >5 cm
  • Hemorrhagic stroke within 3 months
  • Endovascular treatment of target lesion within 6 months, or previous bypass graft to target lesion
  • Chronic kidney disease (creatinine >2.5 mg/dl)
  • Significant contralateral or ipsilateral common femoral disease requiring intervention during index
  • Acute or subacute thrombus
  • Concentric calcification
  • Prior stent placement in target vessel
  • Residual stenosis >70%, stent placement, or flow-limiting dissectionn following pre-dilatation

Principal Findings:

  • Primary safety endpoint, composite of freedom from device- and procedure-related death through 30 days, and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months for DCB vs. standard balloon: 92.1% vs. 83.2%, p = 0.001 for noninferiority, p = 0.024 for superiority
  • Target limb major amputation: 0% vs. 0%
  • Primary efficacy endpoint: primary patency at 12 months: 76.3% vs. 57.6%, p = 0.003

Secondary endpoints for DCB vs. standard balloon:

  • Cardiovascular death: 1.6% vs. 2.1%
  • All target lesion revascularization: 9.5% vs. 17.9%, p = 0.04
  • All-cause mortality: 2.6% vs. 2.1%, p > 0.99
  • Change in ankle-brachial index: 0.17 vs. 0.16, p = 0.89
  • Change in walking impairment questionnaire composite score: 16.0 vs. 17.5, p = 0.55
  • Bailout stent placement: 6% vs. 6%, p = 1.0


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.


Krishnan P, Faries P, Niazi K, et al. Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies. Circulation 2017;136:1102-13.

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

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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