85 Review www.expert-reviews.com ISSN 1743-4440 © 2012 Expert Reviews Ltd 10.1586/ERD.11.67 Infrapopliteal angioplasty & stenting Critical limb ischemia (CLI) constitutes a life- threatening pathology associated with an almost 37% 2-year mortality rate, while the annual incidence of the disease is estimated to be 220 cases/million [1,2] . The definition of CLI is centered on the conception of ‘limb-threatening ischemia’, describing a high-grade ischemia that without prompt revascularization will result in major amputation [3] . As a result, CLI is consid- ered to be responsible for approximately 90% of the major amputations performed worldwide [2,4] . Infrapopliteal arterial occlusive disease, with or without concomitant femoropopliteal artery disease, has been recognized as the main cause of CLI, especially in diabetic patients where multi- level, diffuse lesions of the distal tibial vessels are commonly noted [5,6] . Moreover, amputations may occur in diabetic patients with infrapop- liteal arterial disease alone, while amputation in these patients is also largely associated with neuropathic ulceration, architectural changes in the foot and infection. Although infrainguinal, distal bypass surgery has long been considered the gold standard treatment for CLI, a great number of patients are not eligible, owing to the absence of suitable vein conduits and/or patent nondiseased distal run-off vessels, as well as the presence of various underlying comorbidities commonly present in the CLI population [7] . On the other hand, the continuous technological evolution of percutaneous interventional tech- niques and experience, along with the develop- ment of novel low profile materials, dedicated to below-the-knee (BTK) management of arterial occlusive disease, contributed to the establish- ment of infrapopliteal angioplasty as an effective alternative to bypass surgery [8–10] . Moreover, the minimally invasive nature of the procedure, which results in very low morbidity, mortality and complication rates, pushes modern CLI management algorithms towards a more ‘endo- vascular first’ rationale, especially in patients with a life expectancy of <2 years [11,12] . Among the drawbacks of balloon angioplasty still remains the potential of a suboptimal acute outcome due to elastic recoil and/or flow-limiting dissection resulting to technical failure and/or progressive vascular restenosis with relapse of clinical symptomatology. In order to cope with the imminent technical failure of balloon angio- plasty, bail-out stenting with balloon expand- able bare-metal stents (BMS) was used. Although bail-out stenting using balloon expandable BMS improved the initial technical success rates of BTK endovascular treatment, BMS application Dimitris Karnabatidis*, Stavros Spiliopoulos, Konstantinos Katsanos and Dimitris Siablis Department of Radiology, Angiography Suite, Patras University Hospital, GR 265 04, Rion, Greece *Author for correspondence: Tel.: +30 2610 999219 Fax: +30 2610 993445 karnaby@upatras.gr Endovascular procedures have evolved to the mainstream treatment of choice for revascularization of infrapopliteal obstructive disease, especially in patients suffering from critical limb ischemia and multiple comorbidities. However, standard balloon angioplasty is limited by the potential of a suboptimal acute outcome due to elastic recoil and/or flow-limiting dissection, followed by neointimal hyperplasia and progressive vascular restenosis even in the case of bare-metal stent use. Drug-eluting stents and drug-coated balloons are emerging endovascular technologies with the promise of significant inhibition of vessel restenosis and improved clinical outcomes. The current review outlines the drug-eluting properties of those instruments and summarizes the currently available clinical data. The authors critically appraise the current status and also provide a glimpse of the near future of endovascular below-the-knee treatments. KEYWORDS: angioplasty • balloon • below-the-knee • claudication • critical limb ischemia • drug-coated • drug-eluting • infrapopliteal • stent Below-the-knee drug-eluting stents and drug-coated balloons Expert Rev. Med. Devices 9(1), 85–94 (2012) Author Proof