ILLUMENATE US - ILLUMENATE US
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.
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%
- 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
- 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
- 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
< Back to Listings