First-in-man study of simvastatin-eluting stent in de novo coronary lesions: The SIMVASTENT study

Abstract

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, baremetal 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.