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.
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).
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%
- 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
- 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
The primary efficacy endpoint, primary patency at 12 months for DCB vs. standard balloon, was 83.9% vs. 60.6%, p < 0.001.
Secondary endpoints for DCB vs. standard balloon:
- Freedom from clinically driven target lesion revascularization (TLR): 94.8% vs. 85.3%, p = 0.01
- Target limb amputation: 0.5% vs. 0%, p > 0.99
- Primary patency for DCB vs. standard balloon: 75.9% vs. 61.0%, p = 0.025
- Clinically driven TLR: 12.1% vs. 30.5%, p < 0.001
- All-cause mortality: 6.5% vs. 5.1%, 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. Results were durable at 2 years of follow-up. 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.
Brodmann M, Werner M, Meyer DR, et al., on behalf of the ILLUMENATE EU RCT Investigators. Sustainable Antirestenosis Effect With a Low-Dose Drug-Coated Balloon: The ILLUMENATE European Randomized Clinical Trial 2-Year Results. JACC Cardiovasc Interv 2018;11:2357-64.
Editorial Comment: Klein AJ, Feldman DN. The Era of Drug-Coated Balloons: Are All Created Equal? JACC Cardiovasc Interv 2018;11:2365-7.
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;135:2227-36.
Keywords: Amputation, Angioplasty, Angioplasty, Balloon, Calcification, Physiologic, Constriction, Pathologic, Cost-Benefit Analysis, Drug-Eluting Stents, Myocardial Revascularization, Paclitaxel, Peripheral Arterial Disease, Stents, Vascular Diseases
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