title: Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study.
abstract: BACKGROUND
  Restenosis remains an important limitation of interventional cardiology. Therefore, we aimed to determine the safety and efficacy of sirolimus (a cell-cycle inhibitor)-coated BX Velocity stents.
  
  
  RESULTS
  Thirty patients with angina pectoris were electively treated with 2 different formulations of sirolimus-coated stents (slow release [SR], n=15, and fast release [FR], n=15). All stents were successfully delivered, and patients were discharged without clinical complications. Independent core laboratories analyzed angiographic and 3D volumetric intravascular ultrasound data (immediately after procedure and at 4-month follow-up). Eight-month clinical follow-up was obtained for all patients. There was minimal neointimal hyperplasia in both groups (11.0+/-3.0% in the SR group and 10.4+/-3.0% in the FR group, P:=NS) by ultrasound and quantitative coronary angiography (in-stent late loss, 0.09+/-0.3 mm [SR] and -0.02+/-0.3 mm [FR]; in-lesion late loss, 0.16+/-0.3 mm [SR] and -0.1+/-0.3 mm [FR]). No in-stent or edge restenosis (diameter stenosis >or=50%) was observed. No major clinical events (stent thrombosis, repeat revascularization, myocardial infarction, or death) had occurred by 8 months.
  
  
  CONCLUSIONS
  The implantation of sirolimus-coated BX Velocity stents is feasible and safe and elicits minimal neointimal proliferation. Additional placebo-controlled trials are required to confirm these promising results.
authors.affiliation: Institute Dante Pazzanese of Cardiology, São Paulo, Brazil. diretoriaidpc@uol.com.br
authors.forename: J E
authors.initials: JE
authors.lastname: Sousa
authors.forename: M A
authors.initials: MA
authors.lastname: Costa
authors.forename: A
authors.initials: A
authors.lastname: Abizaid
authors.forename: A S
authors.initials: AS
authors.lastname: Abizaid
authors.forename: F
authors.initials: F
authors.lastname: Feres
authors.forename: I M
authors.initials: IM
authors.lastname: Pinto
authors.forename: A C
authors.initials: AC
authors.lastname: Seixas
authors.forename: R
authors.initials: R
authors.lastname: Staico
authors.forename: L A
authors.initials: LA
authors.lastname: Mattos
authors.forename: A G
authors.initials: AG
authors.lastname: Sousa
authors.forename: R
authors.initials: R
authors.lastname: Falotico
authors.forename: J
authors.initials: J
authors.lastname: Jaeger
authors.forename: J J
authors.initials: JJ
authors.lastname: Popma
authors.forename: P W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000368:Aged; D001158:Arteries; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000517:prevention & control*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000601:surgery*; D003692:Delayed-Action Preparations; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D020123:Sirolimus; D015607:Stents; D016896:Treatment Outcome; D017539:Tunica Intima / Q000000981:diagnostic imaging / Q000601:surgery*; D018084:Ultrasonography, Interventional
chemical_list: D020099:Coated Materials, Biocompatible; D003692:Delayed-Action Preparations; D007166:Immunosuppressive Agents; D020123:Sirolimus