ILLUMENATE European Randomized Clinical Trial - ILLUMENATE EU RCT

Contribution To Literature:

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

Description:

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

Study Design

Patients with superficial femoral artery (SFA) and/or popliteal arterial stenoses were randomized in a 3:1 fashion to balloon angioplasty with a drug-coated balloon (DCB) (n = 222) or standard balloon (n = 72). Bail-out stenting was necessary in 13% of patients.

  • Total number of enrollees: 294
  • Duration of follow-up: 12 months
  • Mean patient age: 68 years
  • Percentage female: 30%
  • Percentage with diabetes: 37%
  • Previous or current smokers: 86%
  • Lesion characteristics: Mean lesion length: 72 mm, restenotic lesions: 9%, total occlusions: 19%, severe calcification: 12%, 0-1 patent run-off: 24%

Inclusion criteria:

  • Rutherford class 2-4 symptoms
  • Lesion ≥70% in SFA and/or popliteal arteries
  • One or two de novo or restenotic lesions with cumulative length of 30-200 mm
  • Reference vessel diameter 4-6 mm
  • Lesion treatable by no more than two devices
  • Patent (<50% stenosis) inflow artery
  • At least one patent (<50% stenosis) tibioperoneal run-off artery

Exclusion criteria:

  • Contraindication to dual antiplatelet therapy
  • Aneurysm in target vessel, iliac artery, or popliteal artery
  • Hemorrhagic stroke within 3 months
  • Planned vascular interventions within 14 days before or 30 days after treatment
  • Previous vascular surgery of target lesion
  • Unstable angina pectoris, myocardial infarction, liver failure, renal failure, or chronic kidney disease within 30 days of procedure
  • Severe calcification precluding adequate PTA
  • Acute or subacute thrombus in target vessel
  • Prior stent placement in target vessel
  • Adjunctive therapies (i.e., laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy) in the target lesion or vessel

Principal Findings:

Primary efficacy endpoint, primary patency at 12 months for DCB vs. standard balloon: 83.9% vs. 60.6%, p < 0.001

Secondary endpoints for DCB vs. standard balloon:

  • Freedom from clinically driven target lesion revascularization: 94.8% vs. 85.3%, p = 0.01
  • Target limb amputation: 0.5% vs. 0%, p > 0.99

Interpretation:

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 (different balloon, different dose of paclitaxel) and ILLUMENATE US (same balloon and drug dose) trials. Direct comparison of DCBs with drug-eluting stents is awaited. In the ZILVER-PTX trial with a paclitaxel-eluting stent (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.

References:

Schroeder H, Werner M, Meyer DR, et al., on behalf of the ILLUMENATE EU RCT Investigators. Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: 1-Year Results of the ILLUMENATE European Randomized Clinical Trial. Circulation 2017;Apr 19:[Epub ahead of print].


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