Evidence for the use of drug eluting stents in below-the-knee lesions

Abstract

Peripheral arterial disease has become more and more present in daily practice, mostly due to the increase of cardiovascular risk factors, especially in below the knee (BTK) area in diabetic patients. Critical limb ischemia (CLI) is the most usual clinical presentation with a major amputation rate of 30%, mortality rate of 25%, and chronic pain of 20% at one year. Nowadays, endovascular treatment is usually the first choice, given the high comorbidity of those patients. Angioplasty and stenting in BTK lesions have already proven their efficacy in CLI treatment. However, BTK revascularization remains highly controversial in the treatment of intermittent claudication in TASC 2 recommendations. Restenosis being the major pitfall in BTK procedures, the use of drug-coated devices is one of the actual answers. We performed an extensive review of the literature over the last 15 years on the use of drug-eluting stents (DES) in BTK revascularization. DES has been compared to balloon angioplasty, in the ACHILLES trial, bare metal stents (BMS), in the DESTINY and YUKON trials, drug eluting balloons, in a trial guided by Siablis, and paclitaxel has even been compared to sirolimus in the PARADISE trial. In conclusion, DES is one of the solutions to the increase of BTK arteriopathy in CLI patients. Angiographic results are better, compared to BMS, in terms of primary patency, restenosis and TLR rates. However clinical results are missing. Treated lesions in the literature are short lesions. And DES is a metal balloon expandable stent with greater risks of compressions and stent fractures than nitinol self expandable stents, and such complications are known to increase post operative restenosis rates. Further reports are still needed on this matter.