title: Randomized comparison of a titanium-nitride-oxide-coated stent with a stainless steel stent for coronary revascularization: the TiNOX trial.
abstract: BACKGROUND
  Stent coating with titanium-nitride-oxide has been shown to reduce neointimal hyperplasia in the porcine restenosis model. We designed a prospective, randomized, clinical study to investigate the safety and efficacy of titanium-nitride-oxide-coated stents compared with stainless steel stents.
  
  
  RESULTS
  Ninety-two patients with de novo lesions were randomly assigned to treatment with titanium-nitride-oxide-coated stents (n=45) or stainless steel stents of otherwise identical design (n=47; control). Baseline characteristics were similar in both groups. At 30 days, no stent thromboses or other adverse events had occurred in either group. Quantitative coronary angiography at 6 months revealed lower late loss (0.55+/-0.63 versus 0.90+/-0.76 mm, P=0.03) and percent diameter stenosis (26+/-17% versus 36+/-24%, P=0.04) in lesions treated with titanium-nitride oxide-coated than in control stents. Binary restenosis was reduced from 33% in the control group to 15% in the titanium-nitride oxide-coated stent group (P=0.07). Intravascular ultrasound studies at 6 months showed smaller neointimal volume in titanium-nitride-oxide-coated stents than in control stents (18+/-21 versus 48+/-28 mm3, P<0.0001). Major adverse cardiac events at 6 months were less frequent in titanium-nitride-oxide-coated stents than in control stent-treated patients (7% versus 27%, P=0.02), largely driven by a reduced need for target-lesion revascularization (7% versus 23%, P=0.07).
  
  
  CONCLUSIONS
  Revascularization with titanium-nitride-oxide-coated stents is safe and effective in patients with de novo native coronary artery lesions. Titanium-nitride-oxide-coated stents reduce restenosis and major adverse cardiac events compared with stainless steel stents of otherwise identical design.
authors.affiliation: Invasive Cardiology, Department of Cardiology, University Hospital Bern, Switzerland. stephan.windecker@insel.ch
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Simon
authors.forename: Markus
authors.initials: M
authors.lastname: Lins
authors.forename: Volker
authors.initials: V
authors.lastname: Klauss
authors.forename: Franz R
authors.initials: FR
authors.lastname: Eberli
authors.forename: Marco
authors.initials: M
authors.lastname: Roffi
authors.forename: Giovanni
authors.initials: G
authors.lastname: Pedrazzini
authors.forename: Tiziano
authors.initials: T
authors.lastname: Moccetti
authors.forename: Peter
authors.initials: P
authors.lastname: Wenaweser
authors.forename: Mario
authors.initials: M
authors.lastname: Togni
authors.forename: David
authors.initials: D
authors.lastname: Tüller
authors.forename: Rainer
authors.initials: R
authors.lastname: Zbinden
authors.forename: Christian
authors.initials: C
authors.lastname: Seiler
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
authors.forename: Otto M
authors.initials: OM
authors.lastname: Hess
mesh_terms: D000368:Aged; D020099:Coated Materials, Biocompatible / Q000592:standards*; D017023:Coronary Angiography; D005260:Female; D006083:Graft Occlusion, Vascular / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization / Q000379:methods*; D016037:Single-Blind Method; D013193:Stainless Steel; D015607:Stents / Q000009:adverse effects / Q000592:standards*; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control; D014025:Titanium
chemical_list: D020099:Coated Materials, Biocompatible; D013193:Stainless Steel; C009495:titanium dioxide; C041500:titanium nitride; D014025:Titanium