INTRODUCTION: Previous data demonstrated 17β estradiol's (17β-E) antiproliferative and pro-healing properties. The ETHOS® eluting stent, combines the R-stent® platform to a bioestable polymer (Bravo®), impregnated with 17β-E. OBJECTIVE: To evaluate safety and efficacy of the ETHOS 17β-E eluting stent by the analysis of the incidence of 6month major cardiac adverse events (MACE) and percent intimal volume obstruction (IVUS). METHODS: A hundred twenty-seven patients were treated for de novo single lesions in native coronary arteries, and divided into 4 groups: 1) Control (bare-metal stent); 2) ETHOS® I slow-release; 3) ETHOS® I moderate-release; 4) ETHOS® II (slowrelease and lower doses of drug and polymer). Clinical, angiographic and IVUS follow up were performed 6 months after the index procedure. RESULTS: The mean age was 61.1 ± 10 years and 74% were men. Six-month IVUS volume obstruction were similar among the 4 groups (respectively 31 ± 14 mm³; 31 ± 14 mm³; 33 ± 11 mm³ and 30 ± 11 mm³; p = 0.84), as well as coronary quantitative angiography measurements. Similar results were observed regarding the incidence of MACE, although the occurrence of target-lesion revascularization was higher in the ETHOS® II group (respectively 6.2%, 6.2%, 12.9% e 18.8%; p = 0.08), without statistical significance. No cases of definite or probable thrombosis were reported. CONCLUSION: The ETHOS 17β-E eluting stent was feasible and safe in all the tested formulations. However, there was no additional antiproliferative effect over bare-metal stents.
Estradiol; Angioplasty, transluminal, percutaneous coronary; Stents; Coronary restenosis
