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- Document type:
- Journal Article; Multicenter Study; Randomized Controlled Trial; Article
- Author(s):
- Windecker, S; Simon, R; Lins, M; Klauss, V; Eberli, FR; Roffi, M; Pedrazzini, G; Moccetti, T; Wenaweser, P; Togni, M; Tüller, D; Zbinden, R; Seiler, C; Mehilli, J; Kastrati, A; Meier, B; Hess, OM
- 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. METHODS AND 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.
- Journal title abbreviation:
- Circulation
- Year:
- 2005
- Journal volume:
- 111
- Journal issue:
- 20
- Pages contribution:
- 2617-22
- Language:
- eng
- Fulltext / DOI:
- doi:10.1161/CIRCULATIONAHA.104.486647
- Pubmed ID:
- http://view.ncbi.nlm.nih.gov/pubmed/15883209
- Print-ISSN:
- 0009-7322
- TUM Institution:
- I. Medizinische Klinik und Poliklinik (Kardiologie)
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