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Background and Objectives: Endovascular technologies have significantly improved the outcome of patients with critical limb ischemia (CLI). Drug eluting stents (DES) have documented their efficacy against percutaneous transluminal angioplasty (PTA) and bare metal stents (BMS) in infrapopliteal arterial occlusive disease. However, late in-stent neoatherosclerosis may lead to vascular lumen loss and eventually thrombosis. Polymer free DES constitute a new technology aiming to improve long term patency which their action is still under investigation. The purpose of this study is to report the mechanism of action and to provide a literature review of a novel polymer free amphilimus eluting stent (Cre8, Alvimedica, Instabul, Turkey) in infrapopliteal arterial disease. Methods: Publications listed in electronic databases, European Union Drug Regulating Authorities Clinical Trials Database, as well as scientific programmes of recent interventional vascular conferences were searched. Three studies were included. We analyzed primary and secondary patency, major amputation rate, freedom from CD-TLR, and mortality. Results: Cre8 was implanted in 79 patients with CLI. Most of the patients (n = 65) were Rutherford class 5–6 (82.3%), and diabetes mellitus (DM) was present in 66 patients (83.5%). Mean primary patency was 82.5% at 12 months. Mean lesion stented length was 20 mm and 35 mm in two studies. Mean limb salvage was 91.3% at 12 months. Freedom from CD-TLR was reported in two out of the three studies and was 96% and 83.8%. Mortality was 15% and 23.8% in the same studies, whilst it was not reported in one study. Conclusion: Stenting of infrapopliteal arteries with Cre8 is safe and feasible in patients with CLI and diabetes. All studies have shown very good primary patency and freedom from CD-TLR at 12 and 24 months. Larger observational prospective studies and randomized trials are necessary to establish long term effectiveness and clinical outcomes using the non-polymer Cre8 DES.

Objective To compare the safety and efficacy of 3 kinds of permanent, biodegradable and polymer free drug eluting stents in the treatment of unprotected left main coronary artery disease (UPLM). Methods A total of 259 UPLM patients diagnosed by coronary angiography and underwent percutaneous coronary intervention (PCI) in our institute from January 2013 to June 2017 were recruited in this study. These cases were divided into 3 groups according to stent-type of left main implantation: permanent (PP-DES, n=153), biodegradable (BP-DES, n=54) and polymer free (PF-DES, n=52) groups. All the patients were followed up for 12 months. The target vessel failure (TVF), including cardiac death (CD), target vessel myocardial infarction (TVMI), target vessel revascularization (TVR), and major adverse cardiovascular events (MACE), including CD, nonfatal myocardial infarction (NFMI) and revascularization at 12 months after PCI were observed. Results There were no significant differences in sex, age, complicated high risk factors, lesions, stenting procedures, ratio of bifurcation lesions among the 3 groups (P>0.05). And no significant difference was seen in the incidences of TVF (P=0.596) and MACE (P=0.210) according to stent-type of left main implantation. Multivariate COX regression analysis showed that after 12-month follow-up, the risk of TVF and MACE had no significant correlation with stent-type of left main implantation (P>0.05). Conclusion Biodegradable and polymer free drug eluting stents have similar effects on the incidences of TVF and MACE in the treatment of UPLM when compared with permanent polymer drug eluting stent, and they are safe and effective for left main implantation.