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SAN DIEGO -- For femoropopliteal peripheral artery disease, the novel Eluvia paclitaxel-eluting, polymer-coated stent was on par with the Zilver PTX paclitaxel-coated, polymer-free stent, a randomized trial showed.
Primary patency was 81.5% with Zilver PTX and 86.8% with Eluvia, which met noninferiority for the primary efficacy endpoint and superiority too in a post-hoc analysis, William Gray MD, of Lankenau Heart Institute in Wynnewood, Pennsylvania, reported here at the Transcatheter Cardiovascular Therapeutics meeting and online in .
The primary safety endpoint of the composite of 1-month all-cause mortality and 12-month major amputation of the target limb or target lesion revascularization also met noninferiority criteria. Freedom from those major adverse events was 94.9% with Eluvia and 91.0% with Zilver PTX.
Notably, the clinically-driven target lesion revascularization and stent thrombosis rates were both about 50% less than with Zilver PTX.
"The findings support the effectiveness of the longer paclitaxel elution profile of the Eluvia stent in preventing restenosis while maintaining similar safety to a contemporary comparator," Gray and coauthors wrote.
The trial is "landmark" as the first head-to-head stent comparison in femoropopliteal applications, commented Michael Jaff, DO, of Newton-Wellesley Hospital in Newton, Massachusetts, and study discussant at the late-breaking clinical trial session.
The most important thing is that patients walk better for longer periods of time without needing a repeat intervention, Jaff said. But he also highlighted the potential for "excellent clinical outcomes at a lower cost" from savings on repeat interventions.
The trial included 465 patients with symptomatic lower-limb ischemia presenting as claudication with atherosclerotic lesion in the femoral artery or proximal popliteal artery. The study subjects were from 65 centers in Austria, Belgium, Canada, Germany, Japan, New Zealand, and the USA. Patients were randomly selected to receive either the Eluvia or Zilver PTX stent.
Other secondary measures, the researchers found, were similar in both arms of the study and improved after stent implantation. At 12-month follow, 86% of patients in the Eluvia group and 85% in the Zilver PTX group had symptoms that were classified as 0 or 1 (none to mild claudication) on the Rutherford scale.
The researchers acknowledged that the study findings may be limited in generalizability to patients who have longer lesions and that they set the noninferiority margin (corresponding to a 3% difference in observed primary patency rate) based on expert opinion.
No patients died by 1 month in the trial. The rate of target limb major amputation was 0.3% for Eluvia and 0.0% for Zilver PTX.
The researchers also found at 12-month followup that clinically-driven target lesion revascularization (TLR) were 4.5% for Eluvia and 9.0% for Zilver PTX. Other stent outcomes for Eluvia versus Zilver PTX were:
- Stent Thrombosis: 1.7% for Eluvia and 4.0% for Zilver PTX
- Stent Fractures: 0.3% for Eluvia and 0.0% for Zilver PTX
Considering that other studies are based on 5 years results, panelist Gary Ansel, MD, of OhioHealth Heart & Vascular in Columbus, said "I think these findings are compelling, the only caveat is that these are 1 year results."
"However, the observed patency rates were similar to the assumed rates used in the sample size calculation, supporting the validity of the analyses," Gray and colleagues continued.
In reviewing their findings, the researchers concluded, "the use of a polymer-coated paclitaxel-eluting stent in patients who require superficial femoral artery or popliteal intervention is a reasonable approach to [maximize] intermediate-term patency and to maintain haemodynamic and clinical improvement without repeat re-intervention."
Disclosures
The study was funded by Boston Scientific.
Gray reported relationships with Boston Scientific.
Jaff reported non-financial relationships with Abbott Vascular, Boston Scientific, Medtronic Vascular, and Cordis, and financial relationships with Micell, Philips-Volcano, Vactronix, Venarum, and the American Orthotics and Prosthetics Association. He also reported owning equity in Embolitech, PQ Bypass, and Vascular Therapies, and has served as a member of the Executive Committee for the National Institutes of Health BEST-CLI trial.
Primary Source
The Lancet
Gray W, et al "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" The Lancet 2018; DOI: 10.1016/S0140-6736(18)32262-1.
Secondary Source
Transcatheter Cardiovascular Therapeutics
Gray W, "Twelve-month results of the imperial randomized trial comparing the eluvia and zilver ptx stents for treatment of femoropopliteal arteries" TCT 2018.