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IMPERIAL - IMPERIAL
Contribution To Literature:
The IMPERIAL trial showed that Eluvia DES results in superior primary patency at 12 months compared with the Zilver PTX DES for femoropopliteal peripheral interventions.
Description:
The goal of the trial was to assess the safety and efficacy of Boston Scientific’s Eluvia drug-eluting stent (DES) compared with Cook Medical’s Zilver PTX DES for patients with peripheral artery disease.
Study Design
Patients meeting criteria were randomized in a 2:1 fashion to receive either Boston Scientific’s Eluvia DES (n = 309) or Cook Medical’s Zilver PTX DES (n = 156). These are both self-expanding stents and elute paclitaxel. Dose of paclitaxel is lower in the Eluvia stents (0.167 mcg/mm2 vs. 3 mcg/mm2). The Eluvia stents also have a fluorinated polymer that allows for more gradual elution of the drug.
- Total number of enrollees: 465
- Duration of follow-up: 12 months
- Mean patient age: 68 years
- Percentage female: 33%
Inclusion criteria:
- Rutherford category 2, 3, or 4
- Lesion(s) in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA)
- Stenosis ≥70% by visual angiographic assessment
- Vessel diameter 4-6 mm
- Total lesion length 30-140 mm
Exclusion criteria:
- Target lesion/vessel previously treated with drug-coated balloon (<12 months prior) or previously stented
- Prior surgery of the SFA/PPA in the target limb
- Use of atherectomy, laser, or other debulking devices
- Dialysis
Other salient features/characteristics:
- Smoking: 83%
- Diabetes mellitus: 42%
- Coronary artery disease: 47%
- Lesion length: 83 cm
- Reference vessel diameter: 5.0 mm
- Moderate/severe calcification: 64%
- Chronic total occlusion: 31%
Principal Findings:
The primary endpoint, primary patency at 12 months on duplex ultrasound for Eluvia vs. Zilver PTX, was 86.8% vs. 81.5%, p for noninferiority < 0.0001.
Secondary outcomes for Eluvia vs. Zilver PTX:
- Major adverse events: 4.9% vs. 9.0%, p = 0.098
- Target limb amputation: 0% vs. 0.3%, p = 1.0
- Clinically driven target lesion revascularization: 4.5% vs. 9.0%, p = 0.067
- Stent thrombosis: 1.7% vs. 4.0%, p = 0.20
- Stent fracture: 0.3% vs. 0%, p = 0.43
There was no difference in ankle-brachial index or walking impairment between the two groups at 12 months.
Interpretation:
The results of this trial indicate that the Eluvia DES results in superior primary patency at 12 months compared with the Zilver PTX DES for femoropopliteal peripheral interventions. Revascularization rates were also numerically lower in the Eluvia arm. These are important findings since Zilver PTX is the only FDA-approved DES for peripheral use available in the United States. Although both stents are self-expanding and elute paclitaxel, there are differences in dose and duration of elution. Primary patency for Zilver PTX was lower in this trial than in the ZILVER-PTX pivotal trial (83.1%), and could be related to longer lesion length in the current trial (83 vs. 65 cm, respectively). Longer-term results are awaited.
References:
Gray WA, Keirse K, Soga Y, et al., on behalf of the IMPERIAL Investigators. A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet 2018;392:1541-51.
Editorial Comment: Cassese S, Byrne RA. Endovascular stenting in femoropopliteal arteries. Lancet 2018;392:1491-3.
Presented by Dr. William A. Gray at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2018), San Diego, CA, September 22, 2018.
Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Amputation, Coronary Angiography, Coronary Stenosis, Ankle Brachial Index, Coronary Artery Disease, Drug-Eluting Stents, Femoral Artery, Myocardial Revascularization, Paclitaxel, Percutaneous Coronary Intervention, Peripheral Arterial Disease, Smoking, Stents, Thrombosis, Ultrasonography, Vascular Diseases
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