title: 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.
  
  
  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.
authors.affiliation: Cardiovascular Research Center, Lutheran University of Brazil, Brazil. zagoac@uol.com.br
authors.forename: Alexandre C
authors.initials: AC
authors.lastname: Zago
authors.forename: Bruno S
authors.initials: BS
authors.lastname: Matte
authors.forename: Luciana
authors.initials: L
authors.lastname: Reginato
authors.forename: Germán
authors.initials: G
authors.lastname: Iturry-Yamamoto
authors.forename: Ana
authors.initials: A
authors.lastname: Krepsky
authors.forename: Luiz Carlos C
authors.initials: LC
authors.lastname: Bergoli
authors.forename: Julise
authors.initials: J
authors.lastname: Balvedi
authors.forename: José C
authors.initials: JC
authors.lastname: Raudales
authors.forename: Eduardo K
authors.initials: EK
authors.lastname: Saadi
authors.forename: Alcides J
authors.initials: AJ
authors.lastname: Zago
mesh_terms: D000368:Aged; D000924:Anticholesteremic Agents / Q000009:adverse effects* / Q000494:pharmacology; D017023:Coronary Angiography / Q000379:methods; D023903:Coronary Restenosis / Q000209:etiology / Q000473:pathology*; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D000068338:Everolimus; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000494:pharmacology; D008297:Male; D008875:Middle Aged; D058426:Neointima / Q000209:etiology / Q000473:pathology*; D019821:Simvastatin / Q000009:adverse effects* / Q000494:pharmacology; D020123:Sirolimus / Q000009:adverse effects / Q000031:analogs & derivatives / Q000494:pharmacology; D018084:Ultrasonography, Interventional / Q000379:methods
chemical_list: D000924:Anticholesteremic Agents; D007166:Immunosuppressive Agents; D000068338:Everolimus; D019821:Simvastatin; D020123:Sirolimus