Circulation Journal
Online ISSN : 1347-4820
Print ISSN : 1346-9843
ISSN-L : 1346-9843
Cardiovascular Intervention
First-in-Man Study of Simvastatin-Eluting Stent in De Novo Coronary Lesions
– The SIMVASTENT Study –
Alexandre C. ZagoBruno S. MatteLuciana ReginatoGermán Iturry-YamamotoAna KrepskyLuiz Carlos C. BergoliJulise BalvediJosé C. RaudalesEduardo K. SaadiAlcides J. Zago
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2012 年 76 巻 5 号 p. 1109-1114

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Background: Statins have anti-inflammatory and antiproliferative properties irrespective of their cholesterol-lowering effects. The aim of the present study was to evaluate a simvastatin-eluting stent (SimvES) in the treatment of de novo coronary lesions. Methods and Results: Forty-two patients with de novo coronary artery lesions were assigned to SimvES, bare-metal stent (BMS) or everolimus-eluting stent (EES) implantation followed by intravascular ultrasound (IVUS) for neointimal quantitative analysis. Six months later, quantitative coronary angiography (QCA) and IVUS were repeated. QCA showed no binary restenosis, a mean in-stent late loss of 1.05±0.25mm (BMS, 1.12±0.48mm; EES, 0.20±0.16mm) and a diameter stenosis of 33.5±7.1% (BMS, 35.5±15.30%; EES, 7.2±3.12%). Control IVUS showed a mean in-stent obstruction of 18.3±9.4% (BMS, 32.8±19.1%; EES, 9.8±2.4%) and a neointimal volume index of 1.58±0.75mm3/mm (BMS, 2.93±1.76mm3/mm; EES, 0.80±0.16mm3/mm). Thrombus, late incomplete apposition and major adverse cardiac events were not observed. Conclusions: In this sample of patients with de novo coronary lesions, the use of a SimvES was not related to major adverse cardiac events, but it was associated with a higher level of neointimal proliferation than expected. (Circ J 2012; 76: 1109-1114)

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© 2012 THE JAPANESE CIRCULATION SOCIETY
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