Randomized comparison of a titanium-nitride-oxide-coated stent with a stainless steel stent for coronary revascularization: the TiNOX trial.
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.
Windecker
Stephan
S
Invasive Cardiology, Department of Cardiology, University Hospital Bern, Switzerland. stephan.windecker@insel.ch
Simon
Rüdiger
R
Lins
Markus
M
Klauss
Volker
V
Eberli
Franz R
FR
Roffi
Marco
M
Pedrazzini
Giovanni
G
Moccetti
Tiziano
T
Wenaweser
Peter
P
Togni
Mario
M
Tüller
David
D
Zbinden
Rainer
R
Seiler
Christian
C
Mehilli
Julinda
J
Kastrati
Adnan
A
Meier
Bernhard
B
Hess
Otto M
OM
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
D020099:Coated Materials, Biocompatible; D013193:Stainless Steel; C009495:titanium dioxide; C041500:titanium nitride; D014025:Titanium