The endovascular approach for in-stent restenosis in femoropopliteal disease

Abstract

In-stent restenosis remains one of the main drawbacks of stenting the femoropopliteal segment, and leads to stent failure and repeated interventions. A variety of endovascular techniques have been investigated so far to reduce this phenomenon, including plain angioplasty, atherectomy, new stent deployment, cutting balloons and cryoplasty but without satisfactory mid- and long-term results. More recently drug-eluting devices have been applied in femoropopliteal in-stent restenosis with promising results. The aim of this review is to analyse the indication and effectiveness of those endovascular techniques for the treatment of in-stent restenosis.

Keywords:

• angioplasty
• in-stent restenosis
• peripheral vascular disease
• stent

Financial & competing interests disclosure

M Krokidis is a consultant at both BTG and GLG. D Tsetis has a Consulting Investigator Agreement with Qualimed Innovative Medizinprodukte GmbH. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Use of metal stents has been recently increasing as primary or bailout stenting in complex femoropopliteal interventions. Physiopathology of in-stent restenosis (ISR) is related to the chronic stimuli of the stent mesh and to the complex three-dimensional deformations such as bending, torsion and axial compression of femoropopliteal segment.

• Risk of ISR has been related also to the type of stent implanted: the highest risk of ISR is reported for bare metal stents (BMS) (2-year ISR rate of 45.7%); otherwise DES demonstrated to reduce the risk of restenosis of 50% in comparison with BMS showing 74.8% primary patency at 2 years. Also covered stents showed improved results in the VIASTAR trial where 1 year PP was 71.3%.

• Generally, an ‘endovascular first approach’ instead of surgery to either claudicant or CLI patient with femoropopliteal ISR should be attempted due to common presence of cardiovascular co-morbidities and the more likely need of repeated intervention.

• Main issues to be considered for the treatment of the femoropopliteal ISR are: type of lesion: stent fracture or restenosis/ occlusion, location of disease (popliteal or SFA) and vessel geometry, edge or ISR, patient’s clinical condition/history and availability of devices.

• POBA, CB angioplasty and debulking atherectomy showed unfair results over a mid- and long-term follow-up in treating femoropopliteal ISR (i.e., Dick et al. [17] found 6-month recurrent ISR POBA 65 vs CB 75%, p = 0.73); excimer-laser atherectomy seems to be superior as compared to POBA and directional atherectomy. That is, Shammas et al. [19] reported that excisional atherectomy was a significant predictor of TLR at 1 year (hazard ratio 2.679, 95% CI: 1.015–7.073, p = 0.047).

• Drug-eluting balloons alone have showed optimal results in Tosaka I ISR lesions, but weaker results are evident in long and complex lesions (Tosaka type II and III): 2-year follow-up by Virga et al. after treatment of ISR with DEB showed recurrent ISR: Class I, 12.5%; Class II, 33.3%; Class III, 36.3% p = 0.05.

• Excimer-laser atherectomy devices associated with DEB may represent the best option for the treatment of complex femoropopliteal lesions, allowing long-term patency rates. Van den Berg et al. [49] reported a 91.7% primary patency at a mean follow-up of 14.3 months in Class III ISR lesions.

• Re-stenting of femoropopliteal ISR should be considered only in case of BMS fracture or need to reline a previous BMS (i.e., P2, P3). Both covered stents and drug-eluting stents have showed optimal outcomes.

Notes