First-in-Man Study of Simvastatin-Eluting Stent in De Novo Coronary Lesions - The SIMVASTENT Study

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 +/- 0.25 mm (BMS, 1.12 +/- 0.48 mm; EES, 0.20 +/- 0.16 mm) 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 +/- 0.75 mm(3)/mm (BMS, 2.93 +/- 1.76 mm(3)/mm; EES, 0.80 +/- 0.16 mm(3)/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)