Biodegradable stents show high technical and clinical success

The midterm efficacy of a biodegradable poly-L-lactic acid (PLLA) stent in the treatment of SFA occlusive disease was assessed in 35 de novo lesions between June 2009 and April 2011. This was a retrospective review and included patients ranging from Rutherford 2 to 5 with TASC II A and B lesions ranging from 2.5-13 cm (mean 6.8 cm). Over half (57.1%) of the lesions were occlusions. Follow-up included clinical examination and color-flow duplex imaging. Researchers reported a technical success rate of 100% with no intraoperative or 30 day complications. Primary and secondary patency rates were 77.1% and 97.1% at 24 and 36 months, respectively. At 30 mo, US confirmed complete resorption of the stent structures. Clinical improvement was defined as upward shift of at least 2 Rutherford categories and was seen in all patients.

Comment:

The data presented in the above manuscript are very promising and reflect acceptable patency rates in a well-represented study population. However, as illustrated in the manuscript, many questions remain unanswered in this potential “new frontier.” Will long-term studies show inflammatory changes and/or foreign body reaction resulting in increased rates of late restenosis secondary to hyperplasia? Will drug-eluting technology increase long-term patency rates and what will the optimal agent be? Will a multicenter randomized trial comparing BMS, DES, and biodegradable stents be supported? Clearly these questions, and many others, will need to be answered before this technology may be fully adopted. Regardless, the manuscript is noteworthy and contributes to the existing body of literature in this evolving field.

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Macroscopic view of the Igaki–Tamai stent, a premounted, balloon-expandable PLLA stent that is also self-expandable with straight bridges and gold markers at both ends (arrows). The PLLA monofilament (molecular mass, 183 kDa) coil stent is designed in a zigzag helical structure. The PLLA decomposes in the presence of oxygen following implantation, over a period of 12–18 months. (Reproduced with permission from Kyoto Medical Planning).

Angiographic images of a short, severe lesion of the distal SFA before (a) and after (b, c) deployment of the Igaki–Tamai stent. The arrows highlight the location and visibility of the proximal and distal gold markers.


Citation: Silingardi, R. et al. Midterm Results of Endovascular Treatment of Superficial Femoral Artery Disease with Biodegradable Stents: Single-Center Experience. Journal of Vascular and Interventional Radiology (2015). doi:10.1016/j.jvir.2014.10.050


Post author: Luke Wilkins, MD