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
Gray WA et al.
In the issue of September 24, 2018 on The Lancet the results of the IMPERIAL study, a randomized trial of comparison of two drug-eluting stents in patients with femoropopliteal disease, the Eluvia paclitaxel-eluting stent (Boston Scientific) and the Zilver PTX paclitaxel-eluting stent (Cook Medical), have been reported.
The trial, conducted at 65 centers in the United States, Canada, New Zealand, Belgium, Germany, Austria, and Japan, randomized 465 patients with native SFA or proximal popliteal artery lesions with stenosis of at least 70% by visual angiographic assessment 2:1 to Eluvia or Zilver PTX.
The one-year primary patency, assessed by duplex ultrasound, was 86.8% with Eluvia and 81.5% with Zilver PTX, a difference that met criteria for noninferiority (the primary endpoint) and for superiority. Similarly, the primary safety endpoint was major adverse events (including MALE and MACE), and Eluvia was shown to be noninferior to Zilver PTX (4.9% vs 9.0%).
The results of this study provide new positive evidences on the role of drug eluting stent technology for the treatment of femoropopliteal obstructions. In particular when a simple plain balloon angioplasty fails to achieve an optimal results (i.e. due to the occurrence of flow limiting dissections) the use of these devices should guarantee a good vessel patency at least at one year, despite a stent implantation.
Finally it is of note one finding from the trial that could cause some discussion was positive remodeling, which was seen in six patients treated with Eluvia (2.1%). This phenomenon in an expansion of the vessel wall surrounding the stented segment. Even though these six patients did not experience any adverse events a meticulous long term follow up is necessary.
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