By Nicola Troisi, Department of Surgery, Vascular and Endovascular Surgery Unit, San Giovanni di Dio Hospital, Florence, Italy
Endovascular treatment is now the preferred treatment method for symptomatic patients with atherosclerotic disease of the iliac arteries (the “endovascular-first” approach). The STAG trial demonstrated that technical success was higher and major complications were lower when a stent was placed. Primary stenting seems to have significant benefits, not only on angioplasty alone but also on selective stenting, even in very complex lesions (TASC C and D lesions). Self-expanding and balloon-expandable stents have unique characteristics that are suitable to different lesion morphologies; both stent-types have demonstrated similar outcomes. Carbon-coated stents have a large application in the treatment of coronary artery disease with low rates of in-stent thrombosis and restenosis.
Furthermore, allergy to surgical implants is not rare. Surrounding the stents with a Bio Inducer Surface reduces the release of metal ions in the blood, so the use of carbon-coated stents has been suggested in patients with nickel allergy.
We retrospectively evaluated our experience with carbon-coated stents (Easy HiFlype and Easy Flype, manufactured by CID SpA, a member of Alvimedica Group) in the revascularisation of atherosclerotic iliac artery lesions.
Between January 2012 and June 2016, 54 carbon-coated stents in 40 patients were implanted at our centre. Preliminary early and one-year outcomes were been evaluated in terms of major morbidity, mortality, primary patency, primary assisted patency, secondary patency, absence of target lesion revascularisation (TLR), healing of the lesions/relief of symptoms, and limb salvage.
The patients were predominantly males (32/40, 80%) with a mean age of 71 years (range 46–94). In 15/40 cases (37.5%) patients had a critical limb ischaemia. One patient (2.5%) had a documented nickel allergy and underwent the implantation of two stents without any reactions (Figure 1). Mean duration of follow-up was 13.9 months (range 1–48). At 30 days, no patients had died and one had undergone surgical revision of percutaneous femoral access.
The one-year preliminary primary patency, primary assisted patency, secondary patency, absence of TLR, and limb salvage rates were 89.8% (Figure 2), 97.4%, 100%, 92.1%, and 100%, respectively. Uni- and multivariate analyses showed that absence of post-stent balloon dilatation significantly affected the one-year primary patency rate. Furthermore, none of the other pre- or intraoperative factors significantly affected the primary assisted patency, the secondary patency, and the absence of TLR rates.
In conclusion, use of carbon-coated stents in atherosclerotic iliac lesions is safe and effective. At one year the preliminary overall patency rates were excellent, as was as the rate of absence of TLR. We believe that post-stent balloon dilatation should therefore be recommended in all cases.
The main limitations of this preliminary study seem to be the absence of a control group, the relatively small number of patients enrolled, and the absence of a long-term follow-up period. So, further studies, even multicentric, with longer follow-up and larger population sizes, are needed to validate these outcomes.